Institutional Review Blog

Li and Brown Continue Negotiations

2012-01-23T12:01:00.002-05:00

A correspondent asks for an update in the case of Jin Li, the Brown professor who sued her university after its IRB restricted her research.

I checked Public Access to Court Electronic Records (PACER) and found that on January 13, the parties jointly asked for an extension of the discovery deadline, telling the court "that they continue to negotiate a settlement of the claims. Due to the efforts made negotiating a settlement, only minimal discovery has been propounded so far. As such, if the parties are unable to settle, then the parties will need time to complete formal discovery."

I have posted the motion and other key documents on my IRB Documents page.

Survey: 28% of Linguists Report Inappropriate IRB Demands

2012-01-18T10:34:00.000-05:00

The response to the ANPRM from the Linguistic Society of America led me to an interesting article describing the result of an international survey of linguists about their encounters with ethics review. Though the author of the article claims that "in general, ethics regulation appears to be working," her data suggest that IRB review exacts a heavy cost in time and knowledge with little clear benefit.

[Claire Bowern, "Fieldwork and the IRB: A Snapshot," Language 86 (December 2010): 897-905 | DOI: 10.1353/lan.2010.0048]

Bowern surveyed "approximately 100 linguistic fieldworkers" in several countries (about half in the U.S. and Canada) about their responses to human subjects review.

She finds:

for the most part, the regulation of field linguistic research is working, and the problems are concentrated in just a few (though complex) areas. These primarily involve informed consent and its documentation, and provisions for anonymity. A rare but worrying problem is that some ethics boards are requiring the destruction of primary research materials.

More specifically, when asked whether they had changed their research as a result of IRB review, 71 percent of those responding had not, and many of those who had made only minor modifications. Yet some number (Bowern does not say how many) had curtailed or abandoned a project because of IRB review.

Moreover, though 57 of 79 responders reported no methodological conflicts,

Of the remaining twenty-two responses, nine mentioned problems with written consent forms. Some were required to use forms that in their view were too technical, or that exaggerated the risks to which participants would be exposed. Others were required to gain ‘informed consent’ in writing even when working with nonliterate research participants, and as a result both researcher and research participants felt that the consent process created an atmosphere of intimidation. One researcher mentioned having been reprimanded for submitting a consent form signed with an ‘X’.

The other most common problem involved the use of standardized questions. As mentioned above, several respondents reported that their IRB required them to clear all research questions in advance, which was incompatible with the emergent research method the researcher wished to use.

Others mentioned problems with IRBs requiring the destruction of primary data on an endangered language, and one mentioned an issue involving the secondary use of data. Two mentioned that their protocols had initially been rejected because of their IRB’s incorrect assumptions about the cultural background of research participants (for example, one person reported that their IRB had assumed that all speakers of nonstandard US English are African American, and therefore that the research was targeting a particular ethnic group). A few mentioned the area of payment (that an IRB required payment to research participants in cash (and recorded by receipt), which offended local customs). Another respondent gave the example of an ethics board requiring responses to be anonymous in language description where the consultants had expressed a wish to be identified and acknowledged for their work on their language.

Finally, a few people stated that the IRB process had made them more conscious of their ethical responsibilities toward research participants and their communities.

Moreover, several respondents had shied away from interviewing children and teenagers for fear of additional IRB requirements, though doing so could have helped document language shift among speakers of endangered languages. And some had destroyed materials to meet IRB demands, despite an ethical duty to preserve such materials for future researchers.

Bowern puts her findings in rosy terms:

In general, the review process appears to be working, in that more than two thirds of the respondents were seeking approval, gaining it with a minimum of protocol revision, conducting their research, and not reporting problems even when given the opportunity to do so anonymously. The majority of respondents were not required to alter their protocols; a few were asked to make minor changes, which did not affect the results and probably led to a better experience for the participants. Problems are confined to a few areas. This suggests that the ‘social science victim narrative’, as Stark (2007:785) has called the idea that social scientists are ill-served by IRBs, is not as prevalent in linguistics as we might have imagined from anecdotal reports.

Bowern apparently did not ask researchers if IRB changes protected participants, so she is guessing when she writes that those changes "probably led to a better experience for the participants." To the contrary, only "a few" respondents said the "the IRB process had made them more conscious of their ethical responsibilities toward research participants and their communities." Bowern does not compare the number of researchers with this response to the number who reported that participants felt intimidated by the consent process.

More significantly, saying "more than two thirds" faced only minor problems is the same as saying "more than a quarter" (22 of 79 respondents) had their work significantly disrupted by IRB meddling. I hope that not all linguists share Bowern's tolerance of a system that so commonly intimidates participants and diminishes knowledge.

SBS White Paper Calls for Drastic Reform

2012-01-16T23:12:00.000-05:00

Weighing in at 72 pages, the "Social and Behavioral Science White Paper" is the most detailed response to the ANPRM from scholars in the social sciences. The paper presents a grim picture of the state of IRB review and is generally supportive of the ANPRM's goal of reform. But it offers detailed, helpful warnings about the potential effects of the proposed "excused" category and the adoption of HIPAA as a model for confidentiality requirements. Though it shies away from the toughest questions about the IRB system, it is a good expression of the frustrations felt by so many researchers in the social sciences and humanities.

[American Educational Research Association et al., "Social and Behavioral Science White Paper on Advanced Notice for Proposed Rulemaking (ANPRM), Federal Register 44512-531 (July 26, 2011); ID Docket HHS-OPHS-2011-0005," 26 October 2011.]

Authorship

The response bears an impressive pedgriee. It was drafted by Felice J. Levine--who has been involved with IRB issues for over a decade--Richard O. Lempert, and Paula R. Skedsvold, and endorsed by almost two dozen scholarly and professional organizations:

American Educational Research Association
Federation of Associations in Behavioral and Brain Sciences
Consortium of Social Science Associations
American Political Science Association
American Sociological Association
Association of Psychological Science
Association of Population Centers
Cognitive Science Society
Council of Professional Associations on Federal Statistics
Human Factors and Ergonomics Society
Inter-university Consortium for Political and Social Research
Law and Society Association
National Academy of Neuropsychology
National Communication Association
NORC
Population Association of America
Social Science History Association
Society for Behavioral Neuroendocrinology
Society for Computers in Psychology
Society of Experimental Social Psychology
Society for Industrial and Organizational Psychology
Society for Judgment and Decision Making

While it's not clear exactly how much input these organizations had in the final document, it may be that some of them pushed for the White Paper's critical stance. For example, a column in the American Sociological Association's newsletter mentions the role of Harry Perlstadt in prodding the ASA to respond to the ANPRM. Some of the key concerns voiced in the White Paper resemble some of Perlstadt's own comments.

In any case, I trust regulators will take seriously such a long response from so large a group of organizations. Certainly I do, and I remark on the following features.

Criticisms of the Status Quo

Spread throughout the White Paper are suggestions that the current Common Rule has serious flaws.

The regulations are vague

The regulations are hard to understand. The White Paper finds that the exemption for studies of educational practices "been administered with ambiguity, uncertainty and inconsistency regarding the activities that are not covered by 45CFR46."

Similarly, the White Paper blames the regulations for encouraging IRBs to overestimate risk:

There is considerable ambiguity in the discussion of psychological risk in 45CFR46 creating a danger that IRBs will misjudge the nature of possible psychological harms and overestimate their likely magnitudes and risks. The result will be unneeded reviews and unnecessary regulation of important but low risk SBS research. Among the negative psychological risks labeled “psychological harms” that human subjects may experience are such emotions as boredom, worry, frustration, annoyance, stress, upset, guilt, and loss of self confidence. These may be minor in magnitude or transitory and may even stimulate new levels of personal insight or self awareness.

Even the definition of human subjects research is flawed:
We suggest that rather than focus on what does or does not contribute to generalizable knowledge (which in fields of science and scholarship can be a rather insulting task) or making judgments based solely on the disciplinary identification of researchers, it would be wiser to define the categories of research activities that 45CFR46 should cover adhering to the explicit definition of human subjects, as is relied on in exemptions 46.101(b)(2), (b)(3), and (b)(4), for example.
IRBs base decisions on unrealistic assessments of risk

The White Paper repeatedly warns against allowing IRBs to base decisions on improbable risks, suggesting that its authors understand that IRBs now do this routinely. The paper calls for regulations that will judge risk and harm "not in the abstract or by envisioned worst case scenarios" and suggests that "unlikely deviant cases should not drive decision making."

Such vivid imagination also infects consent requirements:

One of the primary factors contributing to the length and complexity of informed consent forms is the perceived need for institutions (through their IRBs) to require researchers to identify and mention every conceivable risk to human subjects, however remote. We assume institutional concerns with federal regulatory compliance and liability issues drive this requirement. However, in doing so, human subjects are presented with mounds of information that aid neither in comprehending their role in the research effort nor in assessing the risks and benefits associated with participation.

IRBs impose unnecessary levels of scrutiny

The White Paper finds that IRBs are overregulating research. Exempt studies have been "beset by delays," and studies that should be expedited suffer "regulatory creep to full review . . . given the all too common migration to full review by IRBs over time."

It also hints that IRBs are currently overstepping their mission to protect human subjects. In a strongly worded reply to Question 27, the White Paper states,

Consideration of other factors can limit research that needs to be done and chill the freedom of inquiry that scientists need to advance knowledge. We are concerned that factors other than human subjects protection not creep into the work of IRBs. It is of paramount importance that other considerations do not color the work or judgment of IRBs and that policy considerations do not interfere with academic freedom and the pursuit of knowledge. In addition, we urge emphasizing the core principle, perhaps with examples, to make its intention inescapably clear.
The regulations encourage inappropriate requirements for informed consent

The White Paper finds that

Current regulations as well as the proposed changes continue to assume a one-dimensional mental model of written consent at one point in time. In general, the informed consent process could benefit from more research (e.g., what do human subjects want to know, what do they comprehend, what kinds of information are most relevant to making a decision about participation) so that any changes to the regulations are evidence-based.
Overregulation has a price

Finally, the White Paper notes that these problems impose a high price:

the burdens to IRBs and to researchers are major and costly impediments to socially valuable research and that much of the impulse for this long overdue review is a sense of the need to divest IRBs of regulatory obligations that distract them from focusing on research that involves more than minimal risk.
Overregulation is a systemic problem

All told, "SBS researchers . . . often encounter IRBs that look only to guidance developed with biomedical research in mind even when the guidance is poorly suited to the proposed SBS research."

Rather than dismiss such IRB failures as anomalies, the White Paper sees them as the result of systemic pressures to overregulate.

It warns of "the drift toward hyper-regulation" and blames the system itself, noting, "A conservative bias is natural in a system that threatens to penalize insufficient scrutiny but that does not sanction unwarranted review." For example, it notes that OHRP's suggestion that researchers not be allowed to determine if their projects are exempt has created the "danger of a slippery slope of hyper-regulation and decisions that do not reflect legislative intent but instead the risk-aversion of IRBs."

The result is that "Institutional practices surrounding human subjects regulations are increasingly driven by regulatory and legal liability concerns, rather than concerns for the welfare of human subjects."

Concerns about the "Excused" Category

The White Paper warns that moving from "exempt" to "excused" could make things worse, not better.

Our concern is with the functional abandonment of an exempt category for research activities that are best left as uncovered by 45CFR46. To relocate activities as excused that have previously been classified as exempt from 45CFR46 and then to introduce new requirements they must meet is potentially a step backwards. The logic that led to the original creation of the exempt category for activities that fall outside of the province of 45CFR46 is principled and compelling. Whether the current categories and classifications of exempt are all the right choices is not the issue. The point here is that to shift activities that have been determined to be outside of the purview of 45CFR46 so that they now fall within it may, no matter how limited the requirements for excused research, place new burdens on work that as a matter of policy or principle should be outside of the scope of human subjects research.

I don't know if I would go so far as to say the current exemptions are based on "logic," but the 1981 Federal Register announcement did present them as a means to "clarify coverage questions, significantly reduce the work load of IRBs, and thus allows IRBs to concentrate on the review of research which involves a greater degree of risk to subjects."

Concerns about Confidentiality Rules and HIPAA

The White Paper sees in the ANPRM's proposed confidentiality regime "a new set of informed consent requirements about prior human subjects that are not based on empirical study but on potentially misleading if not erroneous, assumption about the likely intentions of human subjects and their wishes in agreeing to participate in research."

It complains that the ANPRM "does not build on the expertise or decades of guidance and experience in considering the relationship between consent, data protection, and appropriate data access and use," and warns that its proposal to require fresh consent for new uses of data "could have a devastating effect on much SBS and other large sample research where contacting subjects for additional consent will often be difficult, never complete, and not practically possible if in the interest of subject privacy identifiers and contact information was not originally collected or, if collected, retained in the data set."

And it is particularly scornful of the ANPRM's proposal to base human subjects requirements on HIPAA, which it dissects in detail, concluding that "Privacy acts like FERPA or HIPPA [sic] have their place for protecting administrative record systems under their aegis, but they fall short as guidance for preparing, storing, protecting data or stipulating conditions for public access or restricted data use. "Indeed, "Absent instances of serious harms associated with survey interviews or other means of data collection, we see no need to require standardized means of data security and information protection at the data gathering phase. We urge strongly against further consideration of this additional burden with no obvious benefit."

Recommendations based on the ANRPM

The White Paper addresses the problems it identifies with the following solutions:

To fix hyper-protection, require empirical evidence

The White Paper responds to Question 4 with the suggestion that
regulations should be changed to make clear that IRBs should only consider “reasonably foreseeable risks or discomforts.” The proposed language properly emphasizes that although IRBs should evaluate the likelihood that harms might be more than minimal, they should not speculate about every possible harm. If harm is not reasonably foreseeable (likely), then the probability of that harm is minimal. As emphasized earlier in this white paper, the language should speak of “harm” in the same way it speaks of “discomfort” rather than use the word “risk.” It is the possibility of harm and not risk that must be foreseeable. If, for example, the risk of harm is one in 10 million, the risk is reasonably foreseeable, but it would be unreasonable to foresee harm.

One way to deploy such evidence would be the the collection of "Documents based on materials appropriate to similar studies or previously approved for use in similar expedited research—whether approved at the same institution or not—[which] should qualify as acceptable templates for expedited studies." (cf. Alexander Halavais's recent suggestions.)

The White Paper also argues that "Risks should not be considered greater than minimal simply because deception is involved" and that "Absent a sufficient research base, the rules should not presume that any particular study feature creates more than minimal non-physical risks." If a procedure does make it onto the list for expedited review, it should not be removed "except where a clear pattern of harm has developed."

Similarly, "The vague language of 'emotionally charged' is unsatisfactory because topics that elicit no strong emotional reaction from most persons will be emotionally charged for some."
To fix informed consent, reduce the regulatory requirements

The White Paper recommends that non-clinical researchers not be burdened with irrelevant requirements that they tell participants about "appropriate alternative procedures or treatments," that the research is experimental, and that injuries will be compensated. More generally, it calls for "research on comprehension and modes of inviting consent."

I think the White Paper could have gone a little further here, also dropping the requirement that researchers disclose "reasonably foreseeable risks and benefits." I don't think commercial or political researchers offer such information, which in many social science projects will be "none."
To fix regulatory creep, require due process protections

The White Paper enthuses about the ANPRM's suggestion that IRBs be required to provide written justification every time they impose more scrutiny than is required by the regulations. It suggests that if an IRB wants to deny excused status to a proposal, "it should be incumbent on the reviewer to state specifically in writing what aspect of a registration document leads to doubt a project’s excused status and to refrain from review where it finds none."

It also
strongly support[s] the requirement of an appeals process. The consequences of an IRB’s denying or substantially limiting how research can proceed could be severe, affecting those who might reap the benefits of the research, the immediate interests of the researcher, and the interests of institution or society over the longer run. When consequences are great, the fallibility of judges suggests the desirability of an appeals mechanism.

By contrast, the White Paper calls for regulators to trust researchers: "Researchers can for the most part be trusted to make fair initial assessments so long as they must register their studies and know they risk being audited."
Base confidentiality requirements on research

The White Paper recommends rather than use HIPAA as a starting place, the regulations should encourage institutions to develop standards based on "National Research Council reports, in the ethics codes of professional associations, and in the practices employed by entities like the ICPSR which are responsible for storing and disseminating SBS data varying in sensitivity." And it suggests that "in almost all cases pre-existing data, whether collected for research or non-research purposes, should be reusable without consent as long as risks to human subjects are minimal and sufficient confidentiality protections are in place."

Recommendations Beyond the ANPRM

Some of the White Paper's most intriguing suggestions concern matters not raised directly by the ANPRM.

Some suggest that the current exemptions are too narrow. For example, the White Paper suggests that the current 45 CFR 46.101(b)(3)(i) exemption for research on "elected or appointed public officials or candidates for public office" be not only preserved but expanded to cover "any person who has public figure status." And it calls for projects to be excused from review

where access to a location or to subjects is given by a person entitled to give access to a research setting and where the data will be collected by observation or by other methods that themselves qualify as excused so long as the data collected will not be linked to named persons. A business might, for example, provide a researcher access to observe and analyze how plant architecture affects worker interactions, or a police department may allow researchers to ride in police cars to observe exchanges between police and citizens.

The White Paper also envisions an ongoing, inclusive process of policy formation more like Canada's. The paper supports the creation of a panel to review the expedited review list every two years, and urges "strongly that SBS sciences be visibly present on that panel because of the preponderance of research in SBS fields that are appropriate for expedited review."

More generally, it calls for SBS researchers to be represented in policy-making bodies. It hopes that "An interagency committee under OSTP would facilitate communication and planning across agencies as new issues arise and ensure that the focus is not predominately biomedical." It calls for a National Research Council committee to "examine what types of research activities are appropriately exempt and how these determinations should be made going forward," and asks that if an adverse-event reporting system is developed, the "creators of such a system to include non-DHHS agency representatives and SBS researchers in the development so that concerns may be addresses at the outset. Similarly, attempts to standardize forms should involve agencies who have signed on to the Common Rule and a wide range of research approaches, including SBS research."

Some Silences and a Departure

Taken together, the White Paper offers some stinging critiques of the current regulations and the ANPRM's proposals, while applauding some of the ANPRM's bolder proposals. It is worth noting, however, the degree to which the White Paper fails to examine some basic assumptions underlying today's IRB system.

First, the White Paper pays homage to the Belmont Report, noting that "our aim is to foster revisions to the Common Rule that are consistent with the principles set forth in the Belmont Report in 1979." Yet it calls for the abandonment of two of the three Belmont "applications" for minimal risk research, stating that a weighing of risks against benefits and a determination that subjects be equitably selected are unnecessary for such research. If major chunks of the Belmont Report are inapplicable to so much research, why keep that report as the basis of ethics governance? Why not start fresh?

Second, the White Paper suggests that the regulations be revised to abandon the distinction between research that is designed to produce generalizable knowledge, but it does not propose a clear alternative definition of human subjects research. This runs the risk of expanding the reach of the Common Rule, which the White Paper clearly does not want.

Third, the White Paper fails to note just how drastically the current regulations fall short of its standards for sound policy. The White Paper wants rules that are based on "a clear pattern of harm," "are evidence-based," and "reflect legislative intent." It concludes that "any decision to expand the Common Rule be evidence-based, and that research be funded to provide needed evidence."

Yet it ignores the fact that the requirements for IRB review of research in the humanities and social sciences have never met any of these standards. If the authors of the White Paper believe that "absent instances of serious harms" research should not be restricted, why not call for the wholesale liberation of the social sciences? If they believe that the Common Rule should only be expanded based on evidence proceeding from funded research, why not apply that criterion retroactively to the existing regulations?

Finally, buried in the paper is the claim that "IRBs are experts in research ethics, but seldom are experts in data security and data protection." While the emphasis in that sentence is clearly on the second half, it is a pity that the authors did not scrutinize the first. The White Paper tells us that IRBs impose inappropriate consent requirements, base decisions in improbable estimates of risk, get distracted by concerns other than the protection of research subjects, and "chill the freedom of inquiry." How, then, do they conclude that "IRBs are experts in research ethics"? Given that IRBs have shown themselves so inept, why does the White Paper believe that "research that poses greater than minimal risk should be reviewed by a fully convened IRB and that 45CFR46 should not be changed in that regard"?

Though it shies away from asking if there is any reason to think the IRB system is worth preserving, the White Paper represents a substantial departure from more accommodationist writings by some of the individuals and organizations it represents. In 2008, for example, two of the White Paper's lead authors--Felice J. Levine and Paula R. Skedsvold-- believed that "significant regulatory reform [was] not likely." Accordingly, they offered what I considered fairly tame suggestions for reform based on the premise that "creative use of the flexibility within the current system might resolve some of the pressing concerns of social and behavioral science investigators while ensuring adequate oversight of research involving human participants." Now, with regulatory reform at least on the table, it is delightful to learn that they have so many proposals for dramatic changes in the regulations.

NIH Pledges $1 Million for Research on IRB Regulations

2012-01-12T11:10:00.002-05:00

A January 10 HHS press release notes that "the National Institutes of Health is committing $1 million to support research that will be used to evaluate the impact of the revisions to the HHS regulations governing human subject research that are currently being considered. Assessing the impact of the revisions that are ultimately implemented will be critical to the development of an evidence-based approach to ensuring the effectiveness of human research subject protections."

You have my attention.

h/t: Theresa Defino.

Anthropologist: IRBs Create "the Worst of Possible Worlds"

2012-01-11T11:36:00.002-05:00

Jonathan Stillo, a PhD candidate in medical anthropology at the CUNY Graduate Center, writes with great sensitivity of the ethical challenges he faced while studying mortally ill patients at a tuberculosis sanatorium in Romania. He suggests that IRB review was at best an irrelevance and at worst a hindrance to his efforts at ethical research.

[Jonathan Stillo, "The Trobriand Islanders Never Friended Malinowski on Facebook," 30 November 2011, CAC.OPHONY, and "Research Ethics in Impossibly Unethical Situations," CAC.OPHONY, 21 December 2011. Another hat tip to the indefatigable Roberto Veloso. I realize the IRB angle on this may be the least interesting part of Stillo's story, but this is the blog I have.]

The background is this: Stillo "spent over two years studying TB and much of that was spent talking to dying people and sometimes even holding their hands while they died. The field site was amazing—visually stunning, but tragic. It was a place of abandonment where many patients would go to die, not just of TB, but also of its complicating factors: poverty and hopelessness."

Doing this research meant getting close to people suffering from pain, despair, and even the guilt that they had infected loved ones with an incurable disease. Eventually, he won their trust by talking to them about their lives, something doctors were unwilling to do.

Stillo's IRB impeded this process. As he explains,

Part of my initial problem was I didn't know how to ask the patients to let me interview and survey them. Following my IRB protocol, I showed them my stamped informed consent, a full page of Romanian legalese with talk of risks and benefits. I would read sections out loud and the more "informed" the patients became the more uncomfortable they became. This level of formality does not exist in most aspects of their lives. They could not understand that if I only wanted to talk with them, why I needed such involved paperwork with multiple signatures, dates and stamps. In fact, when I submitted my original protocol to the Romanian medical ethics board, I was laughed at and told that this research did not need approval because it was not "clinical".

What did patients care about? That I would protect their identities and that the process was voluntary. Everything else, including talk of risks and benefits, names and numbers of people to contact, made them uncomfortable. They just wanted my assurance that I would maintain their confidentiality by not publishing their names. Many patients did not even have an expectation of privacy and did not feel qualified to make the decision as to whether or not they should participate in my research. They did not want to hear about protocols. Rather, they wanted someone that they trusted to tell them it was ok and that they could trust me. A document from my IRB could not accomplish this, only someone else vouching for me could . . .

Ultimately consent, at least in my research site, has little to do with my protocols and institutional approvals. For the patients informed consent is not something I read out loud to them, it is earned over the course of months through drinking coffee, staring off the balcony and exchanging stories of our families. It is something I take seriously not because of the IRB, but because I know that the people sharing their lives with me trust me on a personal level. I owe it to them to behave in a way that is ethically appropriate and respects their humanity and dignity. I think at this point we have a system of ethics approval which is designed by clinicians and enforced by lawyers for the protection of hospital and university endowments in a litigious society. It is the worst of possible worlds and despite best intentions 20 years from now, future researchers will read of all of the unethical research that took place even in this age of IRBs.

In short, the IRB forced Stillo to adopt an approach that made dying people uncomfortable. Only when he abandoned that approach could he bring them comfort instead.

Comments on the two posts report similar problems. Ben Spatz, commenting on the first post writes,

I've always been confused by IRB guidelines for reasons exactly like these. In fact, this confusion is part of why I don't do the kind of research that requires IRB protocol. I can't imagine developing meaningful relationships with people while being bound to this kind of strict and highly limited interpretation of ethics. It's like an institutionalized codification and reduction of what it means to have an ethical relationship with another human being.

"Hillary," writing on the second post, agrees:

Like you, I've found that the lengthy IRB consent form I need to pass across the desk often has the opposite effect from what is intended. Rather than instilling my interviewee with trust someone is indeed supervising, and that clear boundaries have been demarcated, it instead heightens awareness to a place of suspicion that hadn't been there before. "I thought this was just an interview about this neighborhood in the 70s?" Suddenly they're wary of being trapped– very different from your TB patients, but similarly besides the point of what I am trying to do/create. "What am I signing away my rights to? Are you trying to 'catch' me saying something about gentrification (or affordable housing or artists or local politics) that will soon come back to bite me?"

While I would never ignore the historical need for safeguards that attempt to root out flatly unethical behavior in the name of "research," you've highlighted the many ways in which the current IRB protocols can miss the mark. And for certain projects, it can turn a normal discussion– in which questions should be freely raised by either party– into a three-party conversation, with the anonymous IRB as the unknown quantity.

Wrapping it up, Stillo comes to the same place:

What I would hope for is a less formalized process and a more discipline centered discussion of the ethical ramifications and possible challenges of a proposed research project beforehand–maybe this could be something that ones dissertation committee would do. Something like this might enable an actual conversation about ethical matters and rather than the present IRB structure which encourages researchers to "pass" it in order to get grants, publish etc. In practice, I just don't see the IRB as productive–it does not help us think through our research and find ways to make it more ethical for the participants, rather it is punitive. You can be punished for stepping outside of your approved protocol, but it is not as if the IRB is assisting you to produce more effective, humane protocols- rather, they are just giving a thumbs up or thumbs down (I know, because after getting resistance on some points in my own protocol, I asked the IRB if they would like to suggest a way to do this so that it fit within their definition of ethical–apparently this is not the way things work, but if the IRB is the sole possessor of institutional ethics, then why not involve it in the creative process rather than simply in the destruction of protocols that are deemed unethical?)

Ultimately, I think that ethical review is something that we can do better. I think the process has been hijacked by business people, lawyers and clinicians and all of this has little to do with the research that is happening in the social sciences and humanities. Hilary, your experience with participants becoming more suspicious once they saw your consent forms mirrors my own. This level of formality raises suspicion, it did for me at the sanatorium and I can see how it would in your research too. This is a tough balance, obviously the participants need to know their rights, but the consent forms, especially as they tend to be written make everything sound so much more perilous than it actually is. I wonder how useful it even is to have these fancy consents if they are going to be presented by someone like me who boils it down to "the most important thing is that I will keep your identity confidential and that this is voluntary and you don't have to answer any questions you don't want to." How that gets turned into a full page of risks and benefits i still don't understand…

NOTE: Stillo does believe that "There is definitely a role for ethics reviews, especially in fields such as medicine where lives are at stake." But I wonder if this belief is based on serious investigation or the CITI Program indoctrination he received. One sign of an incomplete understanding of medical history is his captioning of a photograph, "Tuskegee syphilis study doctor injects subject with placebo." As Susan Reverby notes in Examining Tuskegee, p. 288, the rubber tubing on the subject's arm indicates that blood is being drawn.

Washington Post Confuses "Research," "Experiment," and "Medical Experiment"

2012-01-09T10:24:00.002-05:00

On January 1, the Washington Post ran an editorial, "Medical Experiments on Humans," claiming that "in 2010, the federal government funded 55,000 experiments worldwide on human subjects" and citing "Moral Science."

But "Moral Science" does not make that claim. Rather, it states that "The federal government supported more than 55,000 human subjects research projects around the globe in fiscal year 2010, mostly in medical and health-related research, but also in other fields such as education and engineering." It does not break the 55,000 figure into experimental and non-experimental approaches.

The editorial shows some awareness of the complexity of human subjects research, noting that many people "take part in projects fueled by federal dollars that focus on social science and education research." But the editorial's headline, "Medical Experiments," does not match the data in the body of the editorial. As we proceed with regulatory reform, I hope editorial boards will learn to read and write more carefully.

The Ethical Imperialism of Moral Science

2012-01-04T12:36:00.002-05:00

I have posted extended comments about Moral Science as

Zachary M. Schrag, "The Ethical Imperialism of Moral Science," Bioethics Forum, 4 January 2012.

Does Moral Science Think the System is Working?

2012-01-02T10:24:00.000-05:00

I am struggling to understand an apparent contradiction in the Presidential Commission's report, Moral Science.

On page 42, we learn that

The current U.S. system provides substantial protections for the health, rights, and welfare of research subjects and, in general, serves to "protect people from harm or unethical treatment" when they volunteer to participate as subjects in scientific studies supported by the federal government.

But on page 55, the report concedes that

There remains a dearth of knowledge about the actual efficacy of human subjects protections. Given this, the Commission recommends that the federal government support an expanded operational research agenda to study the effectiveness of human subjects protections.

If there is a dearth of knowledge about the actual efficacy of human subjects protections, how could the Commission conclude that the current system serves to protect people from harm or unethical treatment?

And if there is a dearth of knowledge about the actual efficacy of human subjects protections, why does the Commission recommend that the federal government "require that all federal agencies conducting human subjects research adopt human subjects regulations that are consistent with the ethical requirements of the Common Rule"?

Happy New Year, OHRP!

2012-01-01T10:59:00.000-05:00

I started 2009, 2010, and 2011 with complaints that OHRP had failed to act on two reform initiatives it had undertaken in 2007.

In February 2007, Bernard Schwetz promised that by the end of 2007, OHRP would issue new guidelines that would give a lot of examples and will give more guidance on how to make the decision on what is research and what is not." And in October 2007, OHRP formally requested "written comments on a proposed amendment to item 5 of the categories of research that may be reviewed by the institutional review board (IRB) through an expedited review procedure, last published in the Federal Register on November 9, 1998 (63 FR 60364)."

OHRP has yet to issue Schwetz's promised examples and guidance, or to amend the expedited review list. But July's ANPRM goes so far toward honoring both of these promises that I can say with full voice, Happy New Year, OHRP! I look forward to a cooperative and productive 2012.

AAA Draft Code: "Easily Remembered" or Overly Simplistic?

2011-12-28T11:13:00.000-05:00

The American Anthropological Association (AAA) has released a draft code of ethics, the latest step in a revision process that began in late 2008, as well as a Final Report of The Task Force for Comprehensive Ethics Review. An Executive Board subcommittee is taking comments until January 30, 2012, at ethicsfeedback@aaanet.org.

As a non-anthropologist who respects disciplinary differences, I don't mean to tell anthropologists what to do, and I do not plan to submit a comment to the subcommittee. But I can point out that while the two documents represent an impressive effort, the draft code does not reflect all the concerns of some anthropologists who have thought seriously about ethical obligations.

The draft code lists "core principles . . . expressed as concise statements which can be easily remembered for use by anthropologists in their everyday professional lives."

The principles are

1. Do no harm
2. Be open and honest regarding your work
3. Obtain informed consent and necessary permissions
4. Balance competing ethical obligations due collaborators and affected parties
5. Make your results accessible
6. Protect and preserve your records
7. Maintain respectful and ethical professional relationships

Let's take a look at them.

Do No Harm

As I noted last year, when this principle was first proposed several scholars raised objections while others supported it.

The Task Force report acknowledges this debate:

Past codes specifically stated that anthropologists owe their primary ethical obligation to the people they study. While the members of the Task Force were sympathetic to this view, it became increasingly clear that it reflected a cherished anthropological value rather than an actual principle of ethical practice. Anthropologists "studying up," studying those in power, do not owe a greater ethical obligation to powerful individuals than to those vulnerable to that power. Nor is that value equally applicable to all kinds of anthropologists without either broad exclusions or special pleading (e.g., archaeologists, paleoanthropologists). While acknowledging the problematic nature of this previous principle, the Task Force nevertheless did discuss concerns that its removal weakens what had traditionally been perceived to be clear guidance for anthropologists caught in conflicting positions between the needs of research participants, sponsors, and other populations. We wish to note that this was a difficult issue for the Task Force, and we were never able to reach unanimity.

The new code does place responsibility for one's actions squarely on the anthropologist, however. It requires her/him to consider the impacts of the work and its potential to cause harm. The Task Force is keenly aware that the Do No Harm principle is also complex and problematic, yet we feel this more directly and immediately addresses the ethical imperative informing the older "primary responsibility" statement, while recognizing that anthropologists study all kinds of individuals and institutions, some of whom do not necessarily command our primary allegiance or obligation. As was the case with the 1998 revisions to the Code, this topic demanded much energy and emotion. We think the intense investment in this discussion – as we witnessed it among ourselves and in the wider membership through comments left on the blog -- is a strength of our Association, and we assume attention to and investment in this topic will continue among our members for the foreseeable future.

I see no such complexity in the draft code itself. Can an anthropologist studying "those in power" ethically expose their wrongdoing? The report seems to say yes, but the draft code says no.

Nor do I see that draft code's blunt language as consistent with the AAA's response to the regulatory proposals of this summer:

The research world is rife with projects whose results bore, interest, annoy, please, anger, or enlighten research participants (just as they do fellow researchers). This world is not generically the people's enemy. On the contrary, those of us working in US colleges, universities, news media, and research institutions have inherited traditions of free inquiry whose continuation is vital to this country's political, economic and social life. It would be deeply ironic if a regulatory system put in place to protect human beings were transformed into a device focused on restricting their power to know the world.

The draft code's explanatory section on "Do No Harm" does note that "Anthropologists may choose to move beyond research to a position of advocacy." But I don't think advocacy and critical inquiry are the same thing. One can enter and leave a research project without becoming an advocate, yet still bore, interest, annoy, please, anger, or enlighten research participants.

Be open and honest regarding your work

The clear intent here is to discourage, in the task force report's terms, "clandestine research in which informed consent could not possibly, by design or context, be adequately and fairly given." In other words, no spying for the CIA.

It is not clear if the code considers the duty to be open and honest regarding one's work to extend to, for example, oppressive governments. As Brian du Toit wrote in 1980,

There are persons who feel that certain kinds of research have to be conducted in a clandestine manner, and that unethical behavior is somehow excusable. Such research might involve subversive groups, the American Communist Party, the Ku Klux Klan, and depending on your philosophical persuasions, even the Pentagon. Pierre van den Berghe says of his research in South Africa that "from the outset I decided that I should have no scruples in deceiving the government. . ." Does informed consent become arguable when a social scientist studies groups or organizations who are by his/her evaluations dishonorable, anti-social, or morally outrageous? Should a researcher be ethical when studying superordinatates? Through whose definition are these moral evaluations reached? [Brian M. du Toit,"Ethics, Informed Consent, and Fieldwork," Journal of Anthropological Research 36 (Autumn 1980): 274-286, JSTOR.]

Du Toit concluded that "the social scientist is obliged to represent the true nature of his study, to clarify aims and methodology to those to be studied, to treat them and the information gathered with dignity, and to produce protection or support promised to those studied." I think this means that he considered van den Berghe's deception of the South African government unethical, though it's not clear from the essay.

In any case, I cannot find in either the draft code or the task force report any guidance on the question of deceiving authoritarian governments or subversive groups.

Obtain informed consent and necessary permissions

The draft code is somewhat nuanced, explaning, for example, that

The informed consent process is necessarily dynamic, continuous and reflexive. Anthropologists should initiate this process as a part of project design and continue through implementation as an ongoing dialogue and negotiation with research participants. Informed consent does not necessarily imply or require a particular written or signed form. It is the quality of the consent, not its format, which is relevant.

In 1996, Murray Wax disparaged the "dogma of informed consent" on the grounds that

"Informed consent is meaningful when a specific procedure is then to be administered at a specific time to a specific (powerless) research subject. However, in much ethnographic research, the researcher is not about to administer a specific procedure, but is initiating a long-term and open-ended social process among a group which typically possesses major powers in its own right. Because the social process will be jointly constructed by the investigator and the numerous and varied members of the host community, its outcomes are unknown, although the fieldworker's desired goal is recognition as a fellow human being and so allowing a form of membership and participation. [Murray L, Wax, "Reply to Herrera," Human Organization 55 (1996): 238]

The AAA draft code defines "informed consent" to resemble more the process described by Wax than the terms of the Belmont Report. But in doing so, I wonder if it risks confusion when anthropologists and IRBs find themselves using one term with two different meanings, as may also prove the case with "do no harm."

Moreover, the code fails to address some of the questions posed by du Toit back in 1980. Du Toit posed several questions about consent by children; when can a parent speak for a child when deciding to offer an object or photograph to a researcher? At what age can a child consent? As children reach maturity, can they change their minds about a study?

I'm guessing I know the answer here: it depends on the context. As the AAA response to the ANPRM so nicely put it,

even reference to "children" and the like only make sense in light of particular conditions and local cultural conditions. The Common Rule specification of "vulnerable populations" may make sense in most situations in the US, but may not make sense in other settings where social categories may differ (e.g., where the relevant distinction may be ritually initiated vs. uninitiated boys).

I am less certain what the draft code would suggest about the duty of getting consent from superordinates. Du Toit asked, "If a person's behavior is public, such as that of an office manager, company director, or police chief, but this person refuses consent for a study of that office, is the researcher at liberty to expose that person by name? Is the researcher exposing the public role, or also entering into the private realm of that official?" I see no answers in the draft code.

Balance competing ethical obligations due collaborators and affected parties

The gloss on this principle reads in part, that

Anthropologists have an obligation to distinguish the different kinds of interdependencies and collaborations their work involves, and to consider the real and potential ethical dimensions of these diverse and sometimes contradictory relationships, which may be different in character or change over time. When conflicts between ethical standards or expectations arise, anthropologists need to make explicit their ethical obligations, and develop an ethical approach in consultation with those concerned. Anthropologists must balance these competing ethical obligations while recognizing their obligation to avoid harm to those they study. Anthropologists should not agree to conditions which inappropriately change the purpose, focus, or intended outcomes of their research, nor should they mislead sponsors or collaborators about the nature of the work or its outcomes. Anthropologists remain individually responsible for making ethical decisions.

This passage is particularly hard to to understand without context or examples.

I was struck by the acknowledgment that anthropologists may need to recognize "differing ethical frameworks of collaborators representing other disciplines or areas of practice." I think this means they should not be surprised when other scholars fail to share their outrage about cooperation with the U.S. military.

Make your results accessible

This one seems relatively clear. While less absolute than the "do no harm" principle, it sets up the sharing of research findings--especially with research participants--as the norm, but admits exceptions "such as where participants have been fully informed and have freely agreed to limited dissemination."

This section notes that "Proprietary, classified or other research with limited distribution raises complex ethical questions." It's not clear if this includes publication in professional journals that are open only to paying subscribers and institutions. The AAA has shown leadership on this front, making its publications available free or at reduced prices to underresourced institutions around the world. But neither the code or the task force report mention such initiatives explicitly, so I just don't know how far this principle goes.

Protect and preserve your records

Like the previous principle, this one states a norm ("the interests of preservation ordinarily outweigh the potential benefits of destroying materials for preserving confidentiality") but also points to legitimate exceptions to that norm. It takes a similar approach to the ownership of the anthropologist's records. Normally, they belong to the anthropologist; but other arrangements may be appropriate.

Maintain respectful and ethical professional relationships

This section applies not to human subjects research per se, but to professional obligations not to "plagiarize, nor fabricate or falsify evidence," and to acknowledge the contributions of others, including students.

Final Thoughts

In sum, the draft code strikes me as uneven. Some sections appropriately acknowledge that rules have exceptions, but the earlier passages fail to allow for the possibility that scholars have the right, and even the duty, to hold people accountable for their public behavior, and to evade unjust restrictions on liberty.

The code also leaves me pessimistic about the value of codes in general. A set of principles followed by some paragraphs of explanation for each is better than just a bare list. But I am inclined to agree with Patty Gray's comment that

the circumstances of anthropological research done for corporate or marketing purposes is going to involve a slightly different set of ethical issues than anthropological research done for the purpose of discovering new knowledge about human beings and their lived experience, and sharing that knowledge in venues such as teaching, scholarly publications and academic conferences, popular communication (non-academic writing, public lectures, etc.). If you try to mix together these rather different "flavours", you are just going to get a mess that no one can swallow. I would rather see you serve them all up with their own individual integrity and let their nuances show through.

I am therefore more excited by the task force recommendation that

The AAA should produce and periodically update a publication of case studies of ethical dilemmas anthropological researchers, teachers and practitioners might face, suitable for use in graduate training, post-doctorate training, and continuing education.

This was the approach taken by the American Psychological Association in its 1973 Ethical Principles in the Conduct of Research with Human Participants, and by the AAA in its 1987 Handbook on Ethical Issues in Anthropology. (Not mentioned in the task force report; I wonder if they knew about it.) More recently, the Macquarie University ethics training module has taken this case-study approach.

These documents are easier to understand, and more likely to provoke reflection, than the abstractions in the code. Moreover, since the code clearly responds to specific controversies (notably over Human Terrain Systems) without naming them, a document presenting case studies would be more transparent than the ones here. I would go so far as to say that a collection of case studies should have preceded the development of more abstract guidelines, so that everyone would know what was at stake.

Note 1. In addition to stating the principles, the draft code notes that "The American Anthropological Association does not adjudicate assertions of unethical behavior, and these principles are intended to foster discussion, guide anthropologists in making responsible decisions, and educate." That is not to say that it will never again seek to do so; the task force recommends "that if the Executive Board wishes to pursue an adjudicative code as a possibility, it should appoint a committee to consider this matter only after the EB has determined if it is in a position to make a financial and philosophical commitment to this process."

Note 2. The AAA has a lousy server. This blog post was delayed by multiple periods in which I could not access the two main documents and their supporting materials. This problem was aggravated by the decision to post each section's bibliography as a separate PDF file. Make your results accessible, indeed!

IRB Thinks Overweight People Are Less Capable of Giving Informed Consent

2011-12-20T10:11:00.000-05:00

Since it concerns a medical study, this is a little off-topic for this blog, but a recent essay tells us something about the paternalist mindset of IRBs and their reliance on guesswork.

[Jerry Rabow, "An IRB Public Member’s Education," Journal of Clinical Research Best Practices 7 (December 2011). h/t Roberto Veloso]

Writing in the Journal of Clinical Research Best Practices, Jerry Rabow--a retired lawyer and non-affiliated, non-scientist member of the IRB at the Cedars-Sinai Medical Center in Beverly Hills--boasts of persuading his IRB to reject "a clinical study to evaluate the effectiveness of a new procedure for bariatric (weight loss) surgery."

Rabow believes that overweight people are more vulnerable to disappointment and less capable of making informed decisions than are other adults considering experimental surgery:

Participants would be drawn from a psychologically vulnerable population (seriously overweight individuals who had tried and failed other methods of weight loss, such as diet, exercise and counseling). Assuming that the placebo effect and eating regimen would not secure long-term weight loss for the control group, individuals randomized to the sham surgery might experience stress and disillusionment from yet another personal "failure" — the inability once again to lose weight despite attempting to adhere to the prescribed eating regimen.

Low self-esteem of the participants could also make them especially vulnerable during the consent process, due to societal views that are often openly critical of people who are seriously overweight (based, I believe, on the erroneous view that all obesity is a consequence of ignorance or lack of willpower). Taken together with the participants' past failed attempts to lose weight, these special vulnerabilities to psychological pressure to solve their obesity problems raise the question as to whether their signature on any ICF [Informed Consent Form] could be relied upon as signifying truly voluntary informed consent, at least in the absence of special consent procedures.

Rabow does not explain how he arrived at his understanding of overweight adults' capacity to make decisions or what "special consent procedures" he thinks necessary when recruiting them to a study.

Judge Demands Boston College Oral Histories

2011-12-17T17:19:00.000-05:00

Judge William G. Young has ruled that Boston College must turn over oral history recordings and materials to him so he can decide whether to share them with U.S. prosecutors.

The full ruling and other coverage can be found at Boston College Subpoena News. The Boston Globe also covers the story.

Presidential Commission Prescribes Medical Ethics for Everyone

2011-12-16T09:25:00.000-05:00

The Presidential Commission for the Study of Bioethical Issues has released a 200-page report, Moral Science: Protecting Participants in Human Subjects Research. Continuing a decades-old tradition, the report treats medical experimentation as the model for all research with human beings, ignoring the rights and responsibilities of researchers in other fields.

[Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research, December 2011]

The report is a response to President Obama's November 2010 request for "a thorough review of human subjects protection to determine if federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the federal government."

At the time of that charge, I warned,

the commission lacks the full range of expertise to review all the federal regulations and international standards that govern human subjects protection. Since the 1960s, committees and commissions composed of medical researchers, psychological researchers, and bioethicists have advised regulators and presidents about human subjects protections without adequately consulting researchers in the social sciences and humanities, who then find themselves subject to rules they were not allowed to shape.

Unfortunately, the report continues this trend.

The Commission claims to have made "attempts to understand the full range of human subjects research conducted or supported by the federal government." (44) But the Commission seems to have been only dimly aware that not all "human subjects research" is medical experimentation.

One passage refers to "Early stage translational research [that] serves to test physiological effects or biological functions of new drugs and medical interventions but is not necessarily designed to benefit subjects " and to "Research in other fields, including housing, social work, and criminology . . ."(19) Ah, yes. The social sciences as Other. A few pages later we get a reference to "Research beyond public health and medicine, in social science and related fields, [that] can involve thousands of research subjects through increasingly accessible survey tools and methodologies that expand experimental rigor." (21) Again with the "experimental rigor."

When the Commission tried to imagine "Non-Clinical Human Subjects Research," it came up with three examples all dealing with health in some way: a HUD study of obesity and diabetes, a DOE study of long-term health impacts from the atomic bombing of Japan, and a DOJ study of the safety of stun guns. (38, Table 2.2).

And several portions of the report suggest that the authors were thinking only about medical research. For example, the report claims that the Common Rule and FDA regulations "extend to most, although not all, research conducted in the United States and nearly all research funded with public monies outside of the country." (32) But these regulations do not cover the vast machinery of marketing surveys conducted every day by private corporations, much less the identifiable private information collected by every supermarket with a loyalty card program. If you understand what human subjects research is under present definitions, you know that the bulk of human subjects research conducted in the United States is not regulated. Nor should it be, if it only involves asking questions of adults.

The consequence of this misunderstanding is a failure to understand that different research enterprises involve different ethical principles. In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research's Belmont Report ignored warnings that medical ethics were not appropriate for all fields. Today's Commission still wants to shove everyone into the Belmont box:

Medical research that poses risk of physical injury rightly raises more concerns than does routine social survey research, for example. Nonetheless, the same ethical principles govern all of these activities, and serve as enduring guideposts that must not be ignored. (3)

Naturally, if you believe that all ethics is medical ethics, why not make humanities majors study bioethics in college?

Recommendation 7: Expand Ethics Discourse and Education

To ensure the ethical design and conduct of human subjects research, universities, professional societies, licensing bodies, and journals should adopt more effective ways of integrating a lively understanding of personal responsibility into professional research practice. Rigorous courses in bioethics and human subjects research at the undergraduate as well as graduate and professional levels should be developed and expanded to include ongoing engagement and case reviews for investigators at all levels of experience. (22)

Moreover, Recommendation 13 wants the federal government to "require that all federal agencies conducting human subjects research adopt human subjects regulations that are consistent with the ethical requirements of the Common Rule." (102) Unless "human subjects research" is redefined, this could sweep into a flawed system researchers who are sponsored by non-signatory executive agencies, like the National Endowment for the Humanities, and perhaps even legislative agencies like the Library of Congress.

Medical ethics for everyone!

The irony here is that by ignorning ethical complexity, the Commission threatens to diminish rather than enhance "a lively understanding of personal responsibility."

The only really hopeful note in the report is its section on the ANPRM. The Commission "generally supports the objectives of the ANPRM and the goal of better protecting human subjects while reducing burden, delay, and ambiguity for investigators," and it has even learned from the ANPRM that "many social and behavioral scientists have argued that their research is over-regulated in the current system." (97) But no one on the Commission seems to have grasped the ANPRM's message that some research "may be more appropriately covered by ethical codes that differ from the ethical principles embodied in the Common Rule."

Veterans Denied Chance to Comment on Foreign Policy

2011-12-15T12:52:00.000-05:00

In a comment on Alex Halavais's blog post on IRBs, Wynn W. Gadkar-Wilcox of Western Connecticut State University relates a horror story:

I will never forget a case from several years ago in which we were asked to approve a study that asked veterans of the wars in Iraq and Afghanistan their opinion of the foreign policy of the Bush administration, and the study was denied because of fears that the question might trigger PTSD. Ridiculous. If that study triggers post-traumatic stress, then vets should never be allowed to take history or political science courses.

We need to remember that this kind of IRB abuse diminishes not only the freedom of researchers, but also the freedom of participants--in this case veterans denied the chance to comment on national policy--and of all who can benefit from research.

Gadkar-Wilcox, who identifies himself as "a long-time member of an IRB," also notes that "sometimes IRB’s do important work, such as when they prevent (in one case I remember) the distribution of a non-anonymous survey to students that asked them to reveal potentially illegal conduct. In general, though, there is plenty of overregulation."

Halavais Calls for "Open Publication of IRB Protocols or Ethics Reflections"

2011-12-15T11:58:00.000-05:00

In an essay in Nature and on his blog, Alexander Halavais, president of the Association of Internet Researchers, calls for funders to require "the open publication of IRB protocols or ethics reflections."

[Alexander Halavais, "Social Science: Open Up Online Research," Nature 480 (8 December 2011): 174–175, doi:10.1038/480174a; Alexander Halavais, "IRBs and Clean Secrets, A Thaumaturgical Compendium, 8 December 2011.]

The Problem: Secrecy

In his Nature essay, Halavais details the problems that Internet researchers face when submitting protocols to inexpert boards.

High levels of scrutiny are clearly necessary for a drug trial. But scrutinizing whether gamers would be traumatized by being asked questions about dressing up as characters for conventions — to take an example from my students' research — is an issue best addressed by the researchers, who have had much more exposure to the participants and the culture being examined.

For those who research online interactions, it can be especially frustrating to have a board filled with members who have never used Facebook or played World of Warcraft. Although IRBs can, and sometimes do, bring in experts who can address the context of the research more directly, this happens more rarely than it should . . .

The decisions of IRBs seem to be idiosyncratic and, by extension, capricious, especially when multi-site research is approved by several boards, yet held up by others. In the case of a colleague, each of two review boards insisted on having the other approve a protocol first.

Looking for the source of IRB caprice, he finds it in IRB secrecy:

The greatest problem faced by the ethics system is secrecy. Review boards must make decisions with limited access to previous cases. Their decisions are rarely available to other IRBs or to researchers who could make productive use of their precedents — particularly in new areas of research such as online social science, in which review boards tend to have little experience and would therefore benefit most from the experience of others.

This, of course, has been a problem since at least 1973, when Jay Katz testified that "The review committees work in isolation from one another, and no mechanisms have been established for disseminating whatever knowledge is gained from their individual experiences."

The Solution: Transparency

Katz's proposed remedy was "the publication of the important [IRB] decisions rendered at the local and national level. This would radically change the current uninformed and secretive climate which pervades research decisionmaking. At present, decisionmaking remains divorced from pertinent prior decisions of other committees or from scholarly and public evaluation and criticism." He wanted Congress to establish this system, with a permanent National Human Investigation Board at its apex.

[Jay Katz, testimony, U.S. Senate, Quality of Health Care—Human Experimentation, 1973: Hearings before the Subcommittee on Health of the Committee on Labor and Public Welfare, Part 3 (93d Cong., 1st sess., 1973), 1053.]

Halavais, too, wants research ethics to be made transparent, but he doesn't count on Congress or IRBs to lead the way. As he notes in Nature, "The IRB system is conservative by design; we must look elsewhere for change."

So instead of seeking the publication of IRB decisions (the outputs), Halavais wants the publication of researcher applications (the inputs). And, he blogs, even "if you don’t have to have IRB approval, I think funders should still require you to talk about the ethical considerations of your research, and journals should require you to publish this online when you do not have an IRB-approved protocol to provide." He elaborates (in Nature):

Most government funding agencies and private foundations prominently promote open data sharing and collaboration. Were they to make the open publication of IRB protocols or ethics reflections a requirement for receiving funding, it would provide a crack in an otherwise too-secretive process. Many journals expect social-science research to have been inspected by an IRB before submission; a few even require authors to sign a statement of IRB approval. None requires that the approved protocol be provided to the journal or published. They should. Although some information would need to be redacted from such documents — including anything that might violate the privacy of participants or of the researchers — they would open a new window on ethics considerations.

Some Questions

I applaud Halavais for this bold reimagining of a system of research ethics, and I hope he will flesh out some needed details.

1. Is boilerplate OK?

Halavais wants researchers to "talk about the ethical considerations of your research," but he doesn't explain what that would look like. As Rena Lederman noted in 2007, neuroscientists using an fMRI machine

developed a standard set of very detailed responses to the IRB questionnaire (e.g., about what subjects will experience, the safety risks they will face, and the measures that will be taken to minimize those risks). The only parts of the questionnaire that are individualized—apart from the researchers’ names, ranks, and contact information—are the brief project descriptions (what they are looking for this time and what they hope to learn from the data). Generally, since the basic responses are all, by now, familiar to our IRB, the main ethical dilemma faced in discussing fMRI protocols concerns the possibility that a pathology might show up in a brain scan and the consequent question of whether and how the researchers ought to inform subjects.

Lederman used this model to write "standardized descriptions of anthropological research," noting, for example, the inappropriateness of consent forms. She then posted this for others to use. Would such standardized descriptions satisfy Halavais?

(Side note. In the comments section to Lederman's post, one researcher reports trying out Lederman's application and being told by the IRB to get written consent anyway.)

2. Is an approved protocol the same as an ethical reflection?

L. L. Wynn surveyed ethnographers and found that "32 percent of the respondents actually believed that the [committee-required] modifications were 'detrimental to the welfare of the informants or research participants.'" If an IRB forces a researcher to change her plans in ways that endanger research participants, it seems unfair to require that researcher to publish the flawed protocol unless it is accompanied by a disclaimer.

Now, that could lead to some interesting results if researchers routinely declared, in writing, that they thought their IRBs were endangering research participants. But I wonder if Halavais intends to put researchers in so awkard a spot.

3. Why keep the IRB?

In a throwaway line in his Nature piece, Halavais writes, "The solution is not to do away with the IRB, but rather to make amendments that render its dysfunctions less acute."

Why?

In sketching a requirement for public declarations of ethics, Halavais envisions a complex system that brings researchers, funders, journals, and readers into dialogue about research ethics, without necessarily involving IRBs. If such a system gets off the ground, why would we want to maintain a system of "idiosyncratic and, by extension, capricious" review by ignorant IRBs?

Just because the IRB system has been around a long time is no reason to assume it should persist.

Blogday

2011-12-13T13:32:00.002-05:00

Yesterday marked the fifth birthday of the Institutional Review Blog.

Not long after starting the Blog, I explained my intentions to Inside Higher Ed:

Schrag said that the problems with IRBs will probably remain for some time. "I think the regulations themselves are poorly drafted, with terms that are not well defined, and I anticipate problems until they are amended," he said. "Perhaps until then, I'm going to have to keep up the blog."

With the ANPRM out, I am closer to retirement as blogger than I dared to hope five years ago.

Bush Official: Ask IRB Before Speaking in Public Park

2011-12-08T13:06:00.000-05:00

Diane Auer Jones, U.S. assistant secretary of postsecondary education in the George W. Bush administration, believes that professors should seek IRB permission before giving political speeches in public parks.

Since October, Andrew Ross, Professor of Social and Cultural Analysis at New York University, has been floating the idea that indebted students and graduates might sign a pledge not to make further payments on their loans once one million debtors had signed.

Jones is currently vice president for external and regulatory affairs for the Career Education Corporation, whose business model apparently consists of persuading students to take out government-backed loans by exaggerating their job prospects on graduation. Angered by Ross's ideas, she wrote in her blog on the Chronicle of Higher Education website that "it is time for NYU to take action to silence Andrew Ross." She included a link to a video of Ross speaking in Washington Square Park, near the NYU campus.

When Ross (a member of the AAUP’s Committee A on Academic Freedom) replied that his views are protected by academic freedom, Jones dismissed the idea. "If Dr. Ross wishes for his call to default on student loans to be covered under the umbrella of academic freedom," she wrote, "then I would ask to see the written consent he received from his IRB to engage students in this experiment in cultural studies."

Jones's post reveals her to be as ignorant of the regulations governing human subjects research as she is contemptuous of academic freedom. She claims that "Academics--or at least the agencies that fund their work--do not believe that the right of academic freedom trumps the rights of individuals who may be harmed, either directly or indirectly, by the scholarly pursuit of knowledge, no matter how well intentioned that research might be."

In fact, 45 CFR 46.111 specifically instructs IRBs not to consider "possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility," thus disregarding the indirect harms of the pursuit of knowledge. And I doubt that even the country's worst IRB office would consider Ross's speech in a public park to be research under the Common Rule.

Still, it's noteworthy that when Jones sought a weapon with which to silence a professor, the first rhetorical cudgel at hand was the IRB.

[h/t: Roberto Veloso]

Note. Jones's second post may contain the seeds of a stronger argument when she asks, "does [Ross's] academic freedom free him from financial obligation for the damage he is inflicting?" That seems to suggest she thinks Ross liable for tortious interference in the contract between debtor and lender. I don't know if that's a good argument, but it's got to be better than the human-subjects claim.

This Time, Vote as If Your Whole Research Agenda Depended on It

2011-12-08T10:00:00.000-05:00

Alice Kessler-Harris, president of the Organization of American Historians (OAH), devotes her column in the November OAH Outlook to the question of "Historians and the Institutional Review Board."

Naturally, much of the piece introduces the IRB controversy to those historians who may not be familiar with it:

For several chaotic years, IRBs have exercised what, in my view, seems like unwarranted influence over the research agendas of historians. Resentful professors have been asked to tell IRBs who they want to interview and why. Assistant professors who have not asked for prior permission have been told they cannot publish articles on which they have worked for years. Graduate students have been told to alter the questions they want to ask. In an illustration of the treacherous slippery slope, IRBs--claiming "information risk"--have suggested that archivists require researchers who want to access transcripts of interviews and data sets to acquire IRB clearance first.

Kessler-Harris frames this warning in an interesting way, noting that when the ANPRM was released this summer, the OAH Executive Board was able to "make its voice heard" by consulting with other historians' organizations and submitting a formal response. She then uses these actions to stress the importance of member participation:

So why should you vote in this year's OAH election? Because next year, your elected board will be called upon to take anther equally important step. If you want to be sure that you will have an active and engaged executive board to represent your interests, look for your ballot and vote when it arrives.

I am still working my way through the ANPRM comments, but I suspect that many organizations took a similar approach, relying on existing ethics committees or executive boards to speak for the members. This approach balanced the wish to represent a broad membership with the need to act during the brief window for comment--originally 60 days, extended to 90. So I think Kessler-Harris is quite right to use the ANPRM as an example of the need for elected representatives within a scholarly discipline.

Special Issue of Qualitative Sociology: "Ethics Beyond the IRB."

2011-12-07T15:24:00.000-05:00

I have just learned that the September 2011 issue of Qualitative Sociology is a special issue on the topic, "Ethics Beyond the IRB." It may be some time before I can address this issue in depth, but meanwhile here is the table of contents.

Qualitative Sociology
Volume 34, Number 3 / September 2011
Special Issue: Ethics Beyond the IRB
Guest Editors: Kathleen Blee and Ashley Currier

Kathleen M. Blee and Ashley Currier, "Ethics Beyond the IRB: An Introductory Essay," 401-413.
Rachel L. Einwohner, "Ethical Considerations on the Use of Archived Testimonies in Holocaust Research: Beyond the IRB Exemption," 415-430.
Bernadette Barton, "My Auto/Ethnographic Dilemma: Who Owns the Story?", 431-445.
Gloria González-López, "Mindful Ethics: Comments on Informant-Centered Practices in Sociological Research," 447-461
Ashley Currier, "Representing Gender and Sexual Dissidence in Southern Africa," 463-481.
Leila J. Rupp and Verta Taylor, "Going Back and Giving Back: The Ethics of Staying in the Field," 483-496.
Melissa Swauger, "Afterword: The Ethics of Risk, Power, and Representation," 497-502.

Claude Fischer: Zealous IRBs Can Derail Social Studies

2011-11-30T16:13:00.000-05:00

Claude Fischer, professor of sociology at UC Berkeley, links IRB restrictions with the death of The Statistical Abstract of the United States and fears that they and other trends "combine to increasingly blind policymakers and the public to what is going on in America."

[Claude Fischer, "Stumbling in the Dark," Made in America (blog), 22 November 2011,
http://madeinamericathebook.wordpress.com.]

Fischer writes that in addition to the cuts to census data collection and the National Science Foundation's behavioral science programs,

Social research has been boxed in from another angle by what many scholars consider a too-obsessive concern about privacy. For example, my colleagues and I found that it extremely difficult if not impossible to obtain decades-old information about neighborhoods – for example, the proportion of the workers living in a particular census tract in 1960 who held professional jobs. The fear, baked into U.S. Census rules, is that with enough such general data we might be able to identify a particular person in a census report 50 years ago and find out, say, how much money he made.

Social scientists on campuses have been struggling against zealous IRB’s – university Institutional Review Boards — that must approve any research conducted by faculty on human subjects. Designed quite properly to prevent harm to subjects of studies, particularly subjects of medical treatments, the IRBs in many places have expanded their mission to closely supervising social science research. Some, for example, treat the posing of survey questions – say, asking respondents’ opinions about social issues – or even the gathering of historical records as if they were in the same category as injecting people with drugs. This zealotry sets up great hurdles that delay or derail social studies. Doctoral students, in particular, can have careers crippled by these restrictions. (See statements by social science organizations here in 2001 and here in 2011.)

(At one time here at Berkeley, the local IRB, according to some reports, entertained the idea of “social harm”: research that might impugn a social group — for instance, showing that women get more emotional in some settings than men — ought to be stopped. That would pretty much stop social research altogether.)

Readers of Ethical Imperialism will know that in 1972 Berkeley's IRB chair, Bernard Diamond, did indeed announce his intention to screen research that could threaten the reputations of social groups. Faculty protested this infringement on academic freedom, and the university reversed this policy in the spring of 1973.

Fischer suspects that today's "restrictions on social science may also reflect yet another attitude held by some, both left and right: the conviction that there is no need to gather the data, because they already know the answers." Indeed, IRB regulations and procedures do make more sense if you believe that social science plays an unimportant role in a democracy.

Health Researcher Complains of "Social Science Types" and HIPAA

2011-11-26T08:43:00.002-05:00

Since I have frequently documented the complaints of social scientists who suffer from inappopriate conditions imposed by medically oriented IRBs, it seems fair to report a story going the other way, related on a Scientific American blog by Judy Stone, MD:

This past summer, I went to India to volunteer at a hospital and to try and help them with their self-identified problem with tuberculosis. There was considerable debate as to whether or not IRB approval was necessary—my infectious disease colleagues felt it was not, as it was part of a public health initiative and the "research" was no different than that conducted every day in public health departments. The social science types at the U.S. university I was working with all insisted we obtain IRB approval, a time-consuming and, in some settings, expensive process. (Many IRBs levy an administrative charge of $1-2,000 per study). And the folks in India could have cared less, nor did they understand the fuss, as there is next to no patient privacy in their crowded facility, nor was it culturally relevant. All they wanted was help caring for their patients.

Stone does not relate what happened next: whether she did, in fact, seek IRB approval, and--if so--what level review she received or what kinds of restrictions she faced.

Ultimately, Stone blames not the social science types but flaws in the regulations and laws, especially HIPAA, which she blames for "failing to provide any protection for clinical research subjects [while] increasing research costs and probably reducing participation . . ." She hopes "that reason will prevail, and the HIPAA rules will be eliminated for clinical research."

Stark Reviews Ethical Imperialism

2011-11-25T14:11:00.000-05:00

Laura Stark, assistant professor of sociology at Wesleyan University, reviews Ethical Imperialism for the American Journal of Sociology. She finds that the occasional "keen observation . . . is not harnessed to a broader analytic framework or explanatory apparatus."

[Laura Stark, Review of Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 by Zachary Schrag, American Journal of Sociology 117 (November 2011): 1019-1021.]

Stark apparently rejects my conclusion that "IRB review of the social sciences and the humanities was founded on ignorance, haste, and disrespect." Instead, she claims that

research methods commonly used in the social sciences were included in the regulations because of contemporary concerns about social, legal, and ﬁnancial risks—not only the (nonexistent) physical risks of sharing information with a social researcher. To understand how worries about nonphysical risks might have seemed legitimate to historical actors, readers should bring to the book a sense of broader political conversations at the time about civil rights, "privacy," and expert authority.

One can find some evidence to support such a thesis. For example, I report the 1967 recommendations of the Panel on Privacy in Behavioral Research, which supported the idea of institutional review out of concern with privacy. Yet that same panel concluded that

because of its relative inflexibility, legislation cannot meet the challenge of the subtle and sensitive conflict of values under consideration, nor can it aid in the wise decision making by individuals which is required to assure optimum protection of subjects, together with the fullest effectiveness of research . . . Institutions differ in their internal structures and operating procedures, and no single rigid formula will work for all. (Ethical Imperialism, 36)

Of course, Congress and the executive agencies ignored this advice, passing legislation imposing rigid formulae. Most of my book is a narrative of such disconnects between the people genuine concerned with the issues that Stark notes and those who had the power to pass rules over the objections of the former group.

Stark and I may disagree most on our understanding of the power of individuals and groups to shape the law. Back in 2007, I complained about Stark's use of the passive voice in describing the origins of the IRB system, and I am sorry to see her still relying on it: "research methods commonly used in the social sciences were included in the regulations because of contemporary concerns . . ." The active voice would have required her to explain who exactly was so concerned. Congress? The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research? NIH officials?

But Stark discounts the value of studying people, arguing that my "historical interpretations tend to be character assessments of individuals rather than reﬂections on how IRBs connected to broader social processes or how IRB debates ﬁt into a wider political context." Indeed, I do study individuals, and small groups such as the National Commission. I do so in the belief that people, and not "broader social processes," write laws, regulations, and guidance. And I was unable to find anyone with the power to craft those rules who was also seriously interested in the problems of social science.

Stark also accuses me of crafting a narrative in support of a policy position, writing, "Schrag's concern is to justify the view that most social scientists' research should not be subject to the federal regulations."

As I explained in my preface,

I approached this project with as open a mind as I could, abandoning some of my preconceptions as my research progressed. In particular, I began my investigations expecting to find that the officials who wrote today's human subjects regulations had wholly failed to consider the impact of their work on nonbiomedical research, and I was repeatedly surprised to learn how frequently (if superficially) they debated the subject. I hope all those interested in the topic, regardless of their positions, will likewise let themselves be surprised by the facts in this account. (x)

Either Stark overlooked this passage, or she doesn't believe me.

Criminologists: IRB Demands Threatened Confidentiality

2011-11-23T09:48:00.002-05:00

Two professors of criminal justice--Mitch Librett of Bridgewater State College and Dina Perrone of California State University at Long Beach--describe IRB demands that endangered research participants. They suggest that "the oversight element and informed consent requirement of IRBs may in fact represent the greatest threat to the well-being of participants, which is contrary to the mission, purpose and objective of IRBs."

[Mitch Librett and Dina Perrone, "Apples and Oranges: Ethnography and the IRB," Qualitative Research 10 (2010): 729-747, DOI: 10.1177/1468794110380548.]

IRB Demanded that Boss Be Informed

At the heart of the article of the article are the authors' accounts of IRB interference in their own criminal justice research.

The first concerns Librett's dissertation research, which he began while still a serving police officer. Librett wanted to interview five serving officers about the effects of undercover work, including "work-related psychological disorders [especially post-traumatic stress disorder (PTSD)], or any other difficulties (i.e., alcohol or other substance abuse)." (Brackets in original.) Since the disclosure of some of these effects could get a police officer fired or even prosecuted, Librett wanted to offer his narrators "an absolutely ironclad guarantee that any revelations would never be traceable to an identifiable person." Thus, he planned to interview them outside of their work settings and to avoid publishing any information that could identify them or even their agencies.

Librett describes the resulting exchange with the IRB:

IRB: You've presented a very persuasive argument. However we are unable to approve your request. We absolutely must have letters of cooperation from the agencies involved, there's too much liability involved here.

M.L: But sir, if I ask for official participation from the agencies, then the participants' identities might be compromised. We are talking about very small agencies here, and it wouldn't take an intimate knowledge of quantum physics for a police chief to figure out which undercover officer I was interviewing – when there is only one in the department.

IRB: Well, we just can't approve it without official permission.

Librett eventually settled for interviewing two retired police officers at significant cost to his research. He preferred to sacrifice his findings rather than accede to an IRB demand that would have put his narrators at risk.

IRB Demanded that Researcher Disclose Names and Tapes

Perrone had less trouble getting initial approval for her study of "club drug" users, but she was frustrated by her IRB's demand that she get signed consent forms. As she and her narrators understood, such consent forms posed more threat than protection, since they would create a document stating, in effect, that the signer used illegal drugs.

[Yes, I know that 45 CFR 46.117 allows IRBs to "waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds . . . that the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality." The problem here is that Perrone's IRB didn't understand that, and the rule itself requires the investigator to offer subjects forms that will endanger them.]

Perrone got around this by giving each informant the "option to sign any name she/he chose." How this process boosted trust or protected subjects is anyone's guess.

Perrone's IRB more seriously threatened her subjects when it investigated her research as part of an audit of randomly selected projects.

As part of the audit, the IRB demanded "the keys linking the pseudonyms the participants had chosen to their biographical information" and "an actual audiotaped recording of an interview session held with informants." Both demands raised the chances that the narrators' illegal drug use would become known in ways that hurt them, and forced Perrone to violate the promises she had made to them. Still, she gave in.

Perrone was perplexed and stressed that she had assured her participants that no one would listen to the tapes but her. Therefore, the IRB's 'audit' violated the trust participants had in Perrone, and breached confidentiality. The auditors stressed that as members of the IRB, they have the legal authority to listen to the tape. Perrone conceded, however there was not much choice here. As in all cases, refusal to comply with requests from IRB results in cancellation of projects, failure to complete dissertations, and the resultant damage to careers. Perhaps more importantly, disinformation and grapevine anecdotal evidence may prevent some projects from ever being attempted in the first place.

Questioning the Model

Reflecting on such experiences, Librett and Perrone assert "a fundamental disconnect between what the typical Institutional (or Ethical) Review Board will perceive as essential to safeguard the rights of human subjects and critical ethnographers' interest in maintaining a high degree of trust and partnership with their research participants."

They note that ethnographic projects "are by definition open-ended and unpredictable as far as the sort of questions that will be asked, the activities that will take place in the field, and the direction of interview protocols" and that "Ethnographers are hardly psychic. They are unable to accurately predict possible events with any degree of certainty in the field. While psychologists or hard scientists are not psychic either, their research is often conducted in closed and controlled laboratory environments."

Because the course of research is so hard to predict, Librett and Perrone note that "the greatest potential for harm to participants in an ethnography is the release of the participants' true names and/or identifying information. Thus, the IRBs' focus on research plans is quite beside the point."

They do not say so explicitly, but a logical next step would be to replace prospective review of field research with "ethical proofreading" of manuscripts just prior to publication to make sure that they did not violate any promises of confidentiality. [See Carole Gaar Johnson, "Risks in the Publication of Fieldwork," in Joan E. Sieber, ed., The Ethics of Social Research: Fieldwork, Regulation, and Publication (New York: Springer-Verlag, 1982).]

Additional Points

Librett and Perrone also pose some minor points, which perhaps could use elaboration. They write that "ethnographies may not fall within the definition of research, as it is currently defined in federal regulations. Ethnographies are by nature decidedly unsystematic. There is no testing and whatever knowledge is generated is heuristic. While ethnography most certainly is science, in that it informs our understanding of significant phenomena, it is not systematic or generalizable; it lies beyond the realm of positivism." Given the history of the National Commission, which specifically mentioned anthropological research in its IRB report, it's bold to claim that ethnography does not fit the regulatory definition of research. But perhaps there is a case to be made.

The authors also claim that "if a legal authority – police or court – had asked for [tape-recordings of interviews] Perrone would have certainly been free to state that the records had been 'lost' (without consequence) . . ." A researcher who receives a subpoena for her recordings may indeed seek to quash the subpoena, but falsely claiming that the records had been lost, or destroying the records, could in fact have very unpleasant legal consequences.

Kojo Nnamdi Show on Common Rule Now Online

2011-11-22T13:26:00.002-05:00

Yesterday I had the pleasure of joining Jerry Menikoff of OHRP and Kathy Hudson of NIH on an episode of the Kojo Nnamdi Show entitled, "Rethinking the "Common Rule": The Ethics of Research with Human Subjects." We received many thoughtful, informed comments and questions.

I don't think any of us said anything that will surprise those who have followed the ANPRM debate closely, but I was pleased to hear Dr. Hudson concede that "The level to which current IRB protections actually protect participants is a somewhat understudied area. And I would hope that as we put these new rules in place that we can actually try to measure how effective they are in protecting participants in research."

In other words, after 45 years of imposing IRB review on researchers, we might begin asking if it does any good.

The audio recording and a transcript are now online at the link above.

Radio Show to Feature Menikoff, Hudson, and Me

2011-11-17T14:04:00.002-05:00

On Monday (November 21) at 1pm, WAMU's Kojo Nnamdi Show will air "Rethinking the 'Common Rule': The Ethics of Research with Human Subjects." Jerry Menikoff of OHRP, Kathy Hudson of NIH, and I will discuss the ANPRM.

The show airs in Washington on 88.5 FM and is streamed online.

AAUP and Me

2011-11-13T19:52:00.000-05:00

I earlier mentioned that I helped draft the AAUP comments in response to the ANPRM. I am pleased to report that I have since joined the AAUP's Subcommittee on Academic Freedom and the Institutional Review Board, which since 1981 has sought to keep IRB oversight within reasonable bounds.

PRIM&R: Efficiency Is Not an Ethical Value

2011-11-08T11:17:00.000-05:00

Before moving on to other subjects, I wish to note one last passage in the PRIM&R response to the ANPRM:

The stated purpose of issuing this ANPRM is to make the process of human subjects protection more efficient. We fully recognize the potential benefits of accomplishing this goal. But we also want to note that efficiency itself is not a moral imperative or even an ethical value; human subjects protection should not be compromised by a desire for increased efficiency, a view we believe OHRP shares.

Really?

Is there no ethical problem when bright, curious undergraduates are forbidden from seeking answers to their questions? When a researcher abandons a project after months of inaction by the IRB? Or finds that by the time she gets approval, she has missed the chance to do her research? When IRB inefficiency delays medical research that can save lives?

I had thought that PRIM&R recognized justice as an ethical value. And justice delayed is justice denied.

Harvard Law School to Sponsor ANPRM Conference

2011-11-04T11:39:00.002-04:00

Michelle Meyer of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School kindly alerted me to a conference on the ANPRM planned for May 18 and 19, 2012. The following comes from the official announcement.

Conference Announcement and Call for Proposals: The Future of Human Subjects Research Regulation

The Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School is pleased to announce plans for our annual conference, this year entitled: “The Future of Human Subjects Research Regulation” The one and a half day event will take place Friday, May 18 and Saturday May 19, 2012 at Harvard Law School in Cambridge, Massachusetts.

Conference Description

The U.S. Department of Health and Human Services recently released an Advanced Notice of Proposed Rulemaking (ANPRM), titled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” which proposes to substantially amend the Common Rule for the first time in twenty years. This development, as well as attention by the Presidential Commission for the Study of Bioethical Issues, suggests we are at a moment when the regulation of human subjects research is ripe for re-thinking. This conference is meant to gather leading experts from the U.S. and across the globe to assist in that rethinking.

For further information on the call and for application requirements and deadlines, please see http://www.law.harvard.edu/programs/petrie-flom/events/conferences/humansubjects/hsrconfcall.pdf

Proposals are due November 25.

PRIM&R: IRBs Don't Write Consent Forms

2011-11-03T20:01:00.000-04:00

PRIM&R's ANPRM comments make the helpful concession that "consent forms have become longer, more complicated, more 'legalistic,' and less useful as sources of information to potential subjects." But PRIM&R does not wish its members blamed for this trend, and claims that IRBs do not write consent forms. While this may be true in a technical sense, I believe it fails to acknowledge IRBs' share of responsibility for the problem.

Here's PRIM&R's version:

IRBs neither interact with subjects nor write consent forms. Rather, consent forms are often written by sponsors and sometimes by investigators, who then present them to an IRB as part of its review of the research. IRBs work with what is submitted to them, so we strongly urge that OHRP remind sponsors and investigators that they have an obligation to create clear and understandable consent forms prior to submitting them to IRBs for review, and that they are the entities that actually design and conduct research which makes them primarily responsible for protecting human subjects. As discussed below, we recognize that consent forms have become increasingly legalistic documents designed to protect institutions and sponsors rather than to protect human subjects. This is not, though, a problem created by IRBs, and often there is little an IRB can do to correct this in the face of institutional and sponsor pressure.

I think this would surprise Lee A. Green, Julie C. Lowery, Christine P. Kowalski, and Leon Wyszewianski:

Most IRBs returned applications for revision, requiring changes to consent procedures, study protocols, and forms. Especially in the beginning of the study, this feedback was often helpful in refining the protocol and clarifying the consent form. However, revisions continued to be requested at an undiminished rate even late in the recruitment phase of the study, when the study protocols and consent forms had been refined through revisions at multiple previous centers. At least one resubmission was required at 76 percent (31 of 41) of the sites, and three or more (up to six) resubmissions were needed to secure IRB approval from 15 percent (6 of 41) of the sites. The types of revisions required by the sites were categorized into editorial versus procedural revisions. Editorial revisions include changes in wording to the consent or clarifications in the protocol, while procedural revisions include changes in the actual procedures described in the protocol. All sites that requested revisions requested editorial revisions; indeed, nine sites each requested more than 10 editorial revisions apiece. Procedural revisions were required in only 12 percent (5 of 41) of the sites. Of the five procedural revisions requested, three were requests to eliminate the consent form and use a cover letter instead. No discernible patterns in the specifics of the editorial revisions emerged; they comprised a wide range of requests for deleting or adding sentences or paragraphs, phrasing, tense, and word choice.

Or Jim Vander Putten:

You can imagine my surprise when several of the IRBs rejected the proposals on the basis of an inconsistent array of style issues, such as consent forms not cumulatively paginated (e.g., 1 of 3, 2 of 3, etc) and either written or not written in the past tense. The time delays associated with revision and re-submission of these IRB proposals (some of which were rejected a second time) were measured in months, and would have been even longer had we been required to complete each institution’s responsible conduct of research training program. These delays began a chain reaction of subsequent delays in data collection, research conference proposal submissions and presentations, and manuscript submissions for publication consideration. For untenured faculty, these delays can present formidable obstacles to meeting institutional expectations for scholarly productivity leading to tenure and promotion.

Or the various communication scholars who described their experiences in 2005:

We once submitted an informed consent form that had previously been approved. It was virtually identical to the previous one except for minor wording and title changes. The IRB came back with eleven major changes required before it could be approved . . .

We had intentionally prepared a very clear, concise, non-academic script and consent form for the subjects explaining the study’s nature, goals, procedures, etc. However, the IRB did not approve of the script or consent form we prepared because they said that these respondents would include some illiterate or marginally educated individuals. They assumed the factory workers were not educated enough to read and understand our forms. Even though we informed the IRB that all employees at this factory were required to have a minimum of a high school diploma for employment, the IRB provided us with a script and consent form they created. Their materials were clearly written by a committee of academics; longer sentences, more polysyllabic words, more complex sentence structures. We were very surprised that they preferred their form over our own. While the IRB’s goal may have been to protect human subjects from harm, we did not see how their more complex script and consent form helped accomplish this objective.

Or, for that matter, AAHRPP:

IRBs are too rigid in consent document development, often using the precise wording in the 45 CFR 46.116 required elements of informed consent. In fact, many use even the exact order of the elements as written in 45 CFR 46.116. Guidance about elements that are optional, elements that are more important than others, or formatting sections would be helpful to the research community.

I would be curious to know what evidence PRIM&R has that "institutional and sponsor pressure" is behind this.

Is PRIM&R "Unaware" of Historians' Complaints?

2011-10-28T15:57:00.000-04:00

PRIM&R has posted its ANPRM comments.

There are a number of interesting points, but let's start with the response to Question 25, about the possible exclusion of "certain fields of study" from the Common Rule.

Executive director Joan Rachlin writes,

Regarding the ANPRM’s question about whether the Common Rule should be revised to explicitly state that certain activities that have traditionally not been viewed as research (classics, history, languages, literature, and journalism, e.g.) are not covered (Q. 25), PRIM&R is unaware that the failure to exclude these fields from the Common Rule has ever been a problem for scholars in classics, or literature, etc., and therefore questions whether such a provision is even worth considering. That said, PRIM&R suggests that determinations regarding what is and is not subject to IRB review should be made on the basis of the specific research activity in question, and not on the basis of an investigator’s scholarly discipline. This would address some current inconsistencies regarding what type of inquiry gets reviewed.

"Classics, or literature, etc.?"

What's up with the "etc."? Has Rachlin not heard the complaints from historians, linguists, and journalists? Or has she heard the rumbling, but thinks that if she avoids writing "history," "language," or "journalism," those problems will go away?

History. It's the new bear taboo.

Blogged Down

2011-10-28T15:55:00.002-04:00

The ANPRM comment period has now closed, with (as of this writing) 1099 public submissions at the regulations.gov website. A taxing number!

I imagine the bulk of these will concern biomedical research issues beyond the scope of this blog. Even so, extracting some of the most significant comments about the social sciences and humanities is going to be a lot of work, and I apologize in advance for what I expect to be some pretty scrappy blogging for the rest of the year.

In ANPRM Comments, American Historical Association Calls for Oral History Deregulation

2011-10-25T16:37:00.000-04:00

As reported on AHA Today, the American Historical Association has submitted its ANPRM comments, with clear opposition to IRB oversight of oral history and the imposition of medical privacy rules to history research.

My Comments on the ANPRM

2011-10-25T16:32:00.000-04:00

In addition to having assisted with the comments submitted by the American Association of University Professors and the American Historical Association, today I submitted the following comments on the ANPRM. The PDF version may be easier to read.

25 October 2011

Jerry Menikoff, MD, JD
Office for Human Research Protections
1101 Wootton Parkway, Suite 200
Rockville, MD 20852

Dear Dr. Menikoff:

Thank you for the opportunity to comment on the advance notice of proposed rulemaking, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators” (docket ID number HHS–OPHS–2011–0005). I am grateful to all of the ANPRM’s creators for taking this first step toward a much needed reform of the present system of research regulation.

I write these comments as the author of “How Talking Became Human Subjects Research: The Federal Regulation of the Social Sciences, 1965-1991,” Journal of Policy History 21 (2009): 3-37, and Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 (Baltimore: Johns Hopkins University Press, 2010), both of which were graciously cited in the ANPRM. I also edited the 2011 special issue of the Journal of Policy History on human subjects research, which featured Susan Reverby’s influential article on the Public Health Service experiments in Guatemala. And since 2006, I have edited the Institutional Review Blog, http://www.institutionalreviewblog.com.

I contributed to the response to the ANPRM submitted earlier by the American Association of University Professors, and I was consulted by the authors of the response submitted by the American Historical Association. I endorse those two responses wholeheartedly.
In addition to the comments in those documents, I wish to offer the attached observations, which reflect only my views and may not represent those of the AAUP, AHA, George Mason University, or any other institution.

Sincerely,

Zachary M. Schrag, PhD
Associate Professor of History

Zachary M. Schrag

Associate Professor

Department of History and Art History

George Mason University

Comments on advance notice of proposed rulemaking,
“Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators”

25 October 2011

Question 4. IRBs Need Help Assessing Risk

Question 4: Should the regulations be changed to indicate that IRBs should only consider “reasonably foreseeable risks or discomforts”?

A. I support this change and suggest adding the word “significant” to describe the risks that may be considered.

Comments

The ANPRM acknowledges that “it is not clear that . . . [IRB] members have appropriate expertise regarding data protections.” That is true, but it is not clear that IRB members have appropriate expertise regarding physical risk, psychological risk, the benefits of particular restrictions, or any of the other factors that they would need to do their appointed tasks.

The ANPRM notes that when identical proposals are submitted to multiple IRBs, researchers can expect “widely differing outcomes regarding the level of review required.” But that is just a small part of the problem. Given identical proposals, IRBs will disagree about a great many things.[1] This is not just a problem for multi-site studies; it is also an indicator that IRBs are making many or most of their decisions based on guesswork. That is, if the same proposal given to three IRBs comes back with three wildly different demands for changes, at some level it means that two of the three have offered bad advice. In extreme cases, a committee may applaud part of an application as “eloquent and well-grounded in the literature,” only to fault the same section when the same application is reviewed after revisions.[2]

Jay Katz pointed to the basic problem back in 1973:

The review committees work in isolation from one another, and no mechanisms have been established for disseminating whatever knowledge is gained from their individual experiences. Thus, each committee is condemned to repeat the process of finding its own answers. This is not only an overwhelming, unnecessary and unproductive assignment, but also one which most review committees are neither prepared nor willing to assume.[3]

This statement is as true today as it was then.

To remedy this problem, I call for regulations and guidance that require IRBs to use available empirical evidence when making decisions. I concur with the 1999 recommendation of the Working Group of the Human Subjects Research Subcommittee of the National Science and Technology Council: “In determining whether there might be a reasonable risk or damage related to divulging the sensitive information, etc., it is not enough that there be merely some hypothetical possible risk that can be construed. Rather, the risks resulting from disclosure must be readily appreciable and significant.”[4]

Regardless of the specific adjectives and adverbs used, any regulation should be accompanied by guidance recommending that IRBs base their decisions on empirical evidence. If a researcher can show that a given method is in regular use, and an IRB cannot show that the method regularly abuses research participants, the research should proceed.[5]

IRBs should also document the reasons for their decisions, something they seem to be doing now at a low rate.[6]

The University of Texas’s 2009 report, “Trust, Integrity, and Responsibility in the Conduct of Human Subjects Research,” encourages IRBs to act based on “evidence‐based research” and “empirical studies.” The federal government should do the same.

Finally, I recommend the establishment of a national clearinghouse to disseminate the empirical findings of researchers and IRBs.

Question 25. The Common Rule Should Cover Only Biomedical and Behavioral Research

Question 25. Are there certain fields of study whose usual methods of inquiry were not intended to or should not be covered by the Common Rule (such as classics, history, languages, literature, and journalism) because they do not create generalizable knowledge and may be more appropriately covered by ethical codes that differ from the ethical principles embodied in the Common Rule? If so, what are those fields, and how should those methods of inquiry be identified? Should the Common Rule be revised to explicitly state that those activities are not subject to its requirements?

Answer: The Common Rule currently claims to regulate all “research” even though it has no statutory authority to do so. It is this over-reaching that diminishes protections for research subjects while imposing burden, delay, and ambiguity on investigators. The Common Rule should be rewritten to emphasize its applicability only to biomedical and behavioral research.

I therefore endorse the proposal made by the American Anthropological Association, in its comments on the ANPRM, to limit the Common Rule to the oversight of two kinds of work:

1. Biomedical and other study procedures involving risks of physical harm to human participants: that is, more specifically, harm defined in 76 FR 44515 II(A) as “characterized by short term or long term damage to the body such as pain, bruising, infection, worsening current disease states, long-term symptoms, or even death.”

2. Human experimentation and other methodologies whose results depend for their validity on limiting or controlling the information available to research subjects: that is, study designs reliant either on the passive withholding of information concerning what the study is about or on the active provision of misinformation: e.g., the use of placebos in biomedical clinical trials; the use of confederates in behavioral research concerning competition, conformity and the like; and the deceptive presentation of fictional narratives as actual news reports in social research concerning public opinion.[7]

This definition would achieve many of the objectives of the ANPRM and bring the regulations into compliance with the underlying statute and the intent of Congress.

Statutory authority covers only biomedical and behavioral research

As the ANPRM notes, the Common Rule draws its statutory authority primarily from 42 USC 289, which calls for the establishments of IRBs “to review biomedical and behavioral research involving human subjects.”

The ANPRM also cites 42 USC 300v, which established the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Section 300v(a)(1) of that title calls for membership in the commission to be split among three groups: (A) “individuals who are distinguished in biomedical or behavioral research,” (B) “ individuals who are distinguished in the practice of medicine or otherwise distinguished in the provision of health care,” and (C) “individuals who are distinguished in one or more of the fields of ethics, theology, law, the natural sciences (other than a biomedical or behavioral science), the social sciences, the humanities, health administration, government, and public affairs.”

Thus, federal law distinguishes between “biomedical or behavioral research” on the one hand and “the social sciences, the humanities, health administration, government, and public affairs” on the other, and it covers only the former categories. As the deputy general counsel of the Department of Health, Education, and Welfare put it in 1979, “if Congress had wished . . . to cover all human subjects research, rather than just biomedical and behavioral, it could have done so.”[8]

The Common Rule should reflect the underlying statutes and apply only to biomedical and behavioral research.

The Common Rule should cover only research methods that have proven risky

The ANPRM notes that “While physical risks generally are the greatest concern in biomedical research, social and behavioral studies rarely pose physical risk but may pose psychological or informational risks. Some have argued that, particularly given the paucity of information suggesting significant risks to subjects in certain types of survey and interview-based research, the current system over-regulates such research.” I agree with the latter assessment.

Both the statute and the regulations were designed to address concerns raised in the 1973 Senate hearings. As the secretary of HEW explained in 1976,

The types of risk situations against which the regulations were designed to protect are suggested by the areas of concern which were addressed in the legislative hearings held in conjunction with the enactment of section 474 of the Public Health Service Act, 42 USC 289 1-3 (added by Pub. L. 93-348) . . .

The subjects addressed included the use of FDA-approved drugs for any unapproved purpose; psycho-surgery and other techniques for behavior control currently being developed in research centers across the nation; use of experimental intrauterine devises; biomedical research in prison systems and the effect of that research on the prison social structure; the Tuskegee Syphilis Study; the development of special procedures for the use of incompetents or prisoners in biomedical research; and experimentation with fetuses, pregnant women, and human in vitro fertilization . . .[9]

The hearings did not address the risks of survey, observation, and interview-based research. Nor has the experience subsequent decades shown that this kind of research is particularly risky. One can find exceptions, but these are rare. Stuart Plattner put it well in 2006. “In all the years I was responsible for human-subjects issues at NSF, I never learned of one case in which a respondent was actually harmed from participation in anthropological research.” He concluded, “although the possibility of harm to participants in ethnographic research is real, the probability of harm is very low.”[10]

As the ANPRM notes, “Over-regulating social and behavioral research in general may serve to distract attention from attempts to identify those social and behavioral research studies that do pose threats to the welfare of subjects and thus do merit significant oversight.”

Different scholarly disciplines adhere to different ethical codes

The U.S. IRB system was designed by experts in the ethics of medical and psychological experimentation. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research wrote the Belmont Report without any regard to the ethical codes developed by journalists or scholars in the social sciences and the humanities, and it is a poor fit for their work. Its insistence on the equitable selection of subjects is simply irrelevant when a researcher chooses people based on their unique characteristics. More significantly, instructions to “do no harm” cannot apply to investigative journalism and other forms of critical inquiry. IRBs have consistently proven themselves unable to make this distinction.[11]

The new “excused” category may not work for research in which real names are the norm

When institutions do impose IRB authority on oral history and other research in which participants are generally identified, they can generally rule it exempt under the current Common Rule. But this category may disappear under the present proposal.

If that happens, this kind of research would be an awkward fit for the new “excused” category, which emphasizes privacy. While the new category rules “allow subjects to authorize researchers to disclose the subjects’ identities, in circumstances where investigators wish to publicly recognize their subjects in published reports, and the subjects appreciate that recognition,” its clear emphasis is on preserving the confidentiality of information. The present Common Rule does not require anonymity, but its emphasis on confidentiality has led IRBs to impose inappropriate demands on researchers, such as requiring oral historians to anonymize their narrators or destroy recordings and transcripts. If, as is likely, institutions determined that real-name research was not eligible for the new excused category, IRBs would find themselves reviewing research the ANPRM considers only a distraction.

Alternatively, institutions allow real-name research to proceed under the excused category. But if that were the case, then historians, journalists, and folkorists would find themselves submitting forms that said only that they did not intend to follow most of the provisions of the excused category. This would be nothing but a waste of time and paper.

non-generalizability has proven an unreliable tool

ANPRM’s Question 25 hints that regulators are considering letting journalists, historians and other humanists off the hook by declaring their work to be non-generalizable, and therefore not subject to regulation under the Common Rule.

Yet non-generalizability has proven an unreliable tool. OHRP has muddied the waters, apparently contending—for example—that “Open ended interviews are conducted with surviving Negro League Baseball players in order to create an archive for future research” would constitute generalizable research because “the creation of such an archive would constitute research under 45 CFR part 46 since the intent is to collect data for future research.”[12]

This conflicts with OHRP’s earlier determination that “oral history interviews, in general, are not designed to contribute to generalizable knowledge.” If generalizable means that some future researcher might conceivably use the information, then nothing is non-generalizable. Do not daily newspapers; criminal, civil and congressional investigations; and disease monitoring all create an archive for future research?

Moreover, as Robert Townsend of the American Historical Association has noted,

The argument [that oral history is not generalizable] prompted some derision from outside the field, from academics who interpreted the phrase to say simply “history is not research.” (As a case in point, the vice president for research at my own university, after a fairly contentious meeting on the subject, wished me well on my “non-research dissertation.”)

We also received a number of complaints from within the discipline. Some historians argue that history does contribute generalizable knowledge, even if it bears little resemblance to the scientific definition of the word. And faculty members at history of medicine departments and in the social science side of history warned that this position undermined both their institutional standing and their ability to obtain grants. They made it clear that however finely worded, stating that history did not constitute research in even the most bureaucratic terms could have some real financial costs to the discipline.[13]

More fundamentally, no one can be sure what generalizable means. It is left undefined in the Common Rule. The Belmont Report version is longer, but hardly more helpful:

The term “research” designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

This goes some way to distinguish research from diagnosis of an individual patient—the main goal of that section of the Belmont Report—but I am not even sure of that; I would hope that an MRI operator diagnosing a patient has an objective and a set of procedures designed to reach that objective.

Nor does it distinguish science from journalism, which regularly permits conclusions to be drawn and expresses statements of relationships.

Conversely, qualitative social scientists debate whether their work is generalizable. So “generalizable” covers research that the National Commission did not want covered and leaves uncovered research that the Commission did seek to regulate.

Serious observers have noted the problem. Tom Beauchamp recently complained that “generalizable knowledge,” like other terms, “can be understood in several ways.”[14] Rena Lederman has found that “the regulatory definition did little to resolve the very ambiguities within medical practice for which it was designed. Heroic efforts of clarification can be found in works that interpret the Common Rule for IRBs. Nevertheless, to this day it continues to be a frequent topic of debate in IRB circles.”[15] And in 2008, David Strauss of the Secretary’s Advisory Committee on Human Research Protections complained that “we shouldn’t be reviewing research that we don’t think needs to be reviewed because some folks 30 years ago, at the end of a long, hot day, decided to use the word ‘generalizable’ . . . We have to have language that makes sense to us.”[16]

The American Anthropological Association’s proposal makes sense.

Questions 68 and 69. The federal government should monitor both the costs and benefits of IRB review

Question 68: With regard to data reported to the Federal government:

a. Should the number of research participants in Federally funded human subjects research be reported (either to funding agencies or to a central authority)? If so, how?

Answer. I agree with the ANPRM’s intent “not to expand the information that has to be reported.” Qualitative researchers should not be expected to produce quantitative data. That is, for a researcher whose results already depend on careful counts, it is relatively easy to report figures to federal regulators. But an ethnographer who attends mass events should not be expected to guess how many people he or she observed. Nor should an interviewer have to tabulate how many people he or she interviewed in a given year.

b. What additional data, not currently being collected, about participants in human subjects research should be systematically collected in order to provide an empirically-based assessment of the risks of particular areas of research or of human subjects research more globally?

Answer. These questions seem to envision collecting only data on adverse events and unanticipated problems that come about as a result of research. What about adverse events and unanticipated problems that result from IRB review? In order to know if the system is working well, we must measure its costs as well as its benefits. Thus, the government should establish a formal mechanism for registering researcher and participant complaints about inappropriate restrictions and requirements.

Question 69: There are a variety of possible ways to support an empiric approach to optimizing human subjects protections. Toward that end, is it desirable to have all data on adverse events and unanticipated problems collected in a central database accessible by all pertinent Federal agencies?

Answer. The most recent comprehensive data on the IRB system as a whole come from the mid-1970s survey conducted for the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. If new data are collected, they should be analyzed and presented in a form accessible to the general public as well as federal agencies.

Questions 9 and 73: Both the Belmont Report and the Common Rule require constant interpretation and periodic revision

Question 9: How frequently should a mandatory review and update of the list of research activities that can qualify for expedited review take place? Should the list be revised once a year, every two years, or less frequently?

A. Not only the expedited-review list be reviewed at least every three or four years, but so should the entire regulation. And the regulation should be overhauled every twelve years in the light of experience.

Question 73: To what extent do the existing differences in guidance on research protections from different agencies either facilitate or inhibit the conduct of research domestically and internationally? What are the most important such differences influencing the conduct of research?

A. The National Science Foundation and the Agency for International Development have posted interpretations that discourage overregulation of classroom activities, oral history, journalism, and other endeavors.[17] This shows the value of reducing OHRP’s role as the sole lead agency for the interpretation of the Common Rule. Instead, agencies that sponsor non-health research should have a greater voice.

Comments

The ANPRM contemplates creating “a standing Federal panel” to review and update the list of research activities that can qualify for expedited review.

This is far too modest a proposal. In fact, a standing federal panel should be empowered to offer guidance on all elements of the regulations and to revise the regulations themselves periodically. Moreover, the Belmont Report should be retired and replaced with a statement on research ethics that can be updated to reflect current thinking and experience.

No ethical or legal statement can address all future cases, so a sound regulatory system will provide for interpretation and revision. Congress understood this need when it called for a National Advisory Council for the Protection of Subjects of Biomedical and Behavioral Research that would “review periodically changes in the scope, purpose, and types of biomedical and behavioral research being conducted and the impact such changes have on the policies, regulations, and other requirements of the Secretary for the protection of human subjects of such research.”[18] Similarly, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research did its work expecting that it would be constantly revised and interpreted. As commissioner Albert Jonsen has written

my colleagues and I fully anticipated that an Ethical Advisory Board (EAB) would he established as a standing agency within the Department of Health and Human Services. We had so recommended in almost all of our reports. We expected that such a Board could be the living oracle of Belmont’s principles. Just as our Constitution requires a Supreme Court to interpret its majestically open-ended phrases, and, if I may allude to my own Catholic tradition, as the Bible requires a living Magisterium to interpret its mystic and metaphoric message, so does Belmont, a much more modest document than Constitution or Bible, require a constantly moving and creative interpretation and application.[19]

Congress abolished the National Advisory Council in 1978. Since then, there have been various federal bodies charged with reviewing the protection of human subjects. But these have been largely ineffectual. For one thing, they have lacked the power to issue guidance. Under the current system, SACHRP can make recommendations to OHRP, but only OHRP can issue the guidance. This creates a bottleneck.

In some cases, federal regulators have explicitly refused to offer clear decisions about murky regulatory language. In 2003, for example, Dr. Carome of OHRP issued guidance about the applicability of the Common Rule to oral history that left both historians and university administrators unsure how to proceed. Pressed to clarify his stance, he stated that OHRP was too busy to do so.[20]

What little guidance the federal government has provided often takes the form of quasi-official statements that are not binding on institutions and therefore have little effect. For example, in 1999, a Working Group of the Human Subjects Research Subcommittee of the National Science and Technology Council offered some sound advice on interpreting the Common Rule. But the guidance came with the warning that it had been prepared by “a working group of individuals who attend the Human Subjects Research Subcommittee, Committee on Science, National Science and Technology Council. The document does not necessarily represent the position of any of their respective agencies.”[21] Similarly, the National Science Foundation website presents some sensible interpretations in its “Frequently Asked Questions and Vignettes: Interpreting the Common Rule for the Protection of Human Subjects for Behavioral and Social Science Research.”[22] However, their force is undercut by the disclaimer that “These notes represent the personal opinion of the Human Subjects Research Officer and do not supersede the official documents referred to.”[23]

What we need is a permanent federal body with the power to issue prompt, clear, official guidance. It must be more representative than the current bodies such as SACHRP or the Presidential Commission for the Study of Bioethical Issues. In 2003, the National Research Council’s Panel on Institutional Review Boards, Surveys, and Social Science Research concluded that “Any committee or commission established to provide advice to the federal government on human research participant protection policy should represent the full spectrum of disciplines that conduct research involving human participants.”[24] Neither the presidential commission nor SACHRP approach this standard.

The Canadian Panel on Research Ethics offers a promising model. Because its members are appointed by the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council (NSERC) and the Social Sciences and Humanities Research Council (SSHRC), the panel is more representative than its U.S. counterparts. And it has shown itself to be responsive to the concerns of researchers. The second edition of its Tri-Council Policy Statement, released in 2010, offers sensible guidance on organizational research, Internet research, and qualitative research—topics that U.S. bodies have scarcely addressed. Better still, it has promised ongoing interpretation of the regulations, the first of which appeared in August 2011.[25] Australia likewise expects its guidelines be “reviewed at least every five years.”[26]

I therefore recommend that the United States emulate the best features of the Canadian system of regulation: representation by all parties, regular updates to both regulations and ethical standards (every three to five years), and full-scale reconsideration at intervals of no more than twelve years. To this end, I endorse the American Anthropological Association’s call for

the creation of a commission constituted specifically of social scientists (e.g., sociologists and the like), humanistic social researchers (e.g., cultural anthropologists and the like), and humanists (e.g., historians, legal scholars, and the like). Rather than adapting strategies developed to protect biomedical information—which are fundamentally incompatible with core intellectual and ethical commitments of humanistic social studies—this commission would be tasked with developing alternative guidance appropriate for their fields.

The ANPRM notes that “although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise.” I expect the next decades to witness equally dramatic changes, so I suggest a mechanism for periodic revision of the regulations. While it is true that the ANPRM “offers a rare opportunity for needed modernization,” there is no reason for opportunities to remain rare.[27]

[1] Linda C. Thornton, “The Role of IRBs in Music Education Research,” in Linda K. Thompson and Mark Robin Campbell, eds., Diverse Methodologies in the Study of Music Teaching and Learning (Charlotte, North Carolina: Information Age, 2008), 201-214; Jim Vander Putten, “Wanted: Consistency in Social and Behavioral Science Institutional Review Board Practices,” Teachers College Record, 14 September 2009; Alexander Halavais, “Rethinking the Human Subjects Process,” DMLcentral, June 14, 2010, http://dmlcentral.net/blog/alexander-halavais/rethinking-human-subjects-process.

[2] Brian Mustanski, “Ethical and Regulatory Issues with Conducting Sexuality Research with LGBT Adolescents: A Call to Action for a Scientifically Informed Approach,” Archives of Sexual Behavior 40 (April 29, 2011): 673-686.

[3] Jay Katz, testimony, U.S. Senate, Quality of Health Care—Human Experimentation, 1973: Hearings before the Subcommittee on Health of the Committee on Labor and Public Welfare, Part 3 (93d Cong., 1st sess., 1973), 1050

[4] James D. Shelton, “How to Interpret the Federal Policy for the Protection of Human Subjects or “Common Rule” (Part A),” IRB: Ethics and Human Research 21 (November-December 1999), 7.

[5] Mustanski, “Ethical and Regulatory Issues.”

[6] Survey Research Center, Institute for Social Research, University of Michigan, “2009 Follow-Up Survey of Investigator Experiences in Human Research,” December 2010, table 15.

[7] American Anthropological Association, “Comments on Proposed Changes to the Common Rule (76 FR 44512),” 19 October 2011, http://www.regulations.gov/#!documentDetail;D=HHS-OPHS-2011-0005-0431

[8] Zachary M. Schrag, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 (Baltimore: Johns Hopkins University Press, 2010), 100.

[9] Department of Health, Education, and Welfare, “Secretary’s Interpretation of ‘Subject at Risk,’” Federal Register 41 (28 June 1976), 26572.

[10] Stuart Plattner, “Comment on IRB Regulation of Ethnographic Research,” American Ethnologist 33 (2006), 526.

[11] Jonathan T. Church, Linda Shopes, and Margaret A. Blanchard, “Should All Disciplines Be Subject to the Common Rule?,” Academe, May-June 2002, 62-69; Malone, Ruth E., Valerie B. Yerger, Carol McGruder, and Erika Froelicher. “‘It’s Like Tuskegee in Reverse’: A Case Study of Ethical Tensions in Institutional Review Board Review of Community-Based Participatory Research,” American Journal of Public Health 96, no. 11 (November 2006): 1914-1919.

[12] “Michael Carome’s Email”, n.d., http://www.nyu.edu/research/resources-and-support-offices/getting-started-withyourresearch/human-subjects-research/forms-guidance/clarification-on-oral-history/michael-caromes-email.html.

[13] Robert B. Townsend, “AHA Today: Getting Free of the IRB: A Call to Action for Oral History”, August 1, 2011, http://blog.historians.org/news/1382/getting-free-of-the-irb-a-call-to-action.

[14] T. L. Beauchamp, “Viewpoint: Why our conceptions of research and practice may not serve the best interest of patients and subjects,” Journal of Internal Medicine 269 (April 2011): 383-387.

[15] Rena Lederman, “Comparative ‘Research’: A Modest Proposal concerning the Object of Ethics Regulation,” PoLAR: Political and Legal Anthropology Review 30, no. 2 (November 1, 2007): 305-327.

[16] Secretary’s Advisory Committee on Human Research Protections, Transcript, Sixteenth Meeting, 16 July 2008, 264.

[17] National Science Foundation, “Frequently Asked Questions and Vignettes: Interpreting the Common Rule for the Protection of Human Subjects for Behavioral and Social Science Research,” http://www.nsf.gov/bfa/dias/policy/hsfaqs.jsp; “Protection of Human Subjects in Research Supported by USAID,” 26 December 2006 (http://www.usaid.gov/policy/ads/200/200mbe.pdf

[18] Public Law 93-348.

[19] Albert R. Jonsen, “On the Origins and Future of the Belmont Report,” in James F. Childress, Eric M. Meslin, and Harold T. Shapiro, eds., Belmont Revisited: Ethical Principles for Research with Human Subjects (Washington: Georgetown University Press, 2005), 10.

[20] Schrag, Ethical Imperialism, 157.

[21] Shelton, “How to Interpret the Federal Policy,” 6-9.

[22] National Science Foundation, “Frequently Asked Questions and Vignettes.”

[23] National Science Foundation, “Human Subjects,” http://www.nsf.gov/bfa/dias/policy/human.jsp

[24] Constance F. Citro, Daniel R. Ilgen, and Cora B. Marrett, eds., Protecting Participants and Facilitating Social and Behavioral Sciences Research (Washington: National Academies Press, 2003), 8.

[25]Panel on Research Ethics, TCPS 2 Interpretations, http://www.pre.ethics.gc.ca/eng/policy-politique/interpretations/Default/

[26] Australian National Health and Medical Research Council, Australian Research Council, and Australian Vice-Chancellors’ Committee, National Statement on Ethical Conduct in Human Research (Canberra: Australian Government, 2007), 97.

[27] Ezekiel J. Emanuel and Jerry Menikoff, “Reforming the Regulations Governing Research with Human Subjects,” New England Journal of Medicine, 25 July 2011

New York Times: Menikoff Promises Not to Restrict Public Information

2011-10-24T11:28:00.000-04:00

Today's New York Times reports on historians' and social scientists' hopes and concerns about the ANPRM, especially the prospect of deregulating oral history while restricting the reuse of social science data.

[Patricia Cohen, "Questioning Privacy Protections in Research," New York Times, 24 October 2011.]

The story quotes three historians--Linda Shopes, Alice Kessler-Harris, and your humble blogger--all expressing hope that the ANPRM will lead to the end of IRB oversight of oral history and concern that privacy rules based on HIPAA will restrict archival research. It also cites the public responses posted by the American Anthropological Association and the American Association of University Professors.

In response to such concerns,

Jerry Menikoff, director of the federal Office for Human Research Protections, which oversees the Common Rule, cautions that any alarm is premature, saying that federal officials do not intend to pose tougher restrictions on information that is already public. "If the technical rules end up doing that, we'll try to come up with a result that's appropriate," he said.

The article ends with Menikoff's sentiments:

Dr. Menikoff said, "We want to hear all these comments." But he maintained that when the final language is published, critics may find themselves saying, "Wow, this is reasonable stuff."

I'm only a cockeyed optimist, but I think that is entirely possible.

In ANPRM Comments, Anthropologists Champion Free Inquiry

2011-10-23T13:48:00.000-04:00

The American Anthropological Association has posted comments on the ANPRM to the regulations.gov website. Composed by AAA Committee on Ethics member Lise Dobrin and former Committee chair Rena Lederman, the 23-page document is stunningly eloquent and thorough in its indictment of the present IRB system and the shortcomings of the ANPRM. And it offers two bold and constructive suggestions that could point the way to a true reform.

The comment is organized in the haphazardly ordered sequence of the ANPRM's questions. Here, I extract some major features.

Critiques of the Status Quo

Taken together, the comment's descriptions of the status quo present a bleak picture.

"Even though their modes of planning differ from the experimental designs that IRBs expect, folklorists, interpretive sociocultural anthropologists and the like consider what they do to be research (in their respective disciplinary senses), present it as such to their IRBs, and are therefore advised by IRBs to submit applications. However, when they do so, their protocols are evaluated as 'poorly designed': as bad research, rather than simply not 'research' (in the present regulatory sense)."
"Anthropologists preparing to engage in participant observation routinely experience review of their protocols by board members who lack expertise in the standard methods anthropologists employ . . . This situation has demoralized individual researchers and encouraged widespread cynicism about the value of regulatory oversight."
"Our colleagues have reported that many rounds of requests for clarifications and changes can be as discouraging as outright disapproval."
"While we were preparing these comments, one anthropologist mentioned to us that she was forced to model her consent documents for classroom observations and interviews on forms designed for medical interventions such as intubation. Her IRB prevented her from adjusting her consent forms—using language that would be clear and pragmatically appropriate for the study population—to facilitate truly informed consent. We must recognize that foreign participants can be baffled and overwhelmed by procedures that Americans take for granted, such as 'initialing' a line."

Attacks on Muddled Language

The comment is particularly effective in its insistence that "the vagueness of the key regulatory definitions is a key cause of the relentless expansion in the workload of IRBs." It offers several examples of unhelpfully vague language, both in the current regulations and the ANPRM:

"The current definition of 'minimal risk' (45 CFR 46.102(i)) is ambiguous and the examples provided are not (and cannot be) comprehensively helpful."
"'Psychological' risk is a slippery, inherently subjective concept. As such, it is likely to become a fresh source of uncertainty and cautious reviewing, thereby undermining the point of this proposed rulemaking."
"Our expertise in cross-cultural research further leads us to view as fruitless efforts to specify across-the-board 'types of questions' or topics (e.g., sexuality) as inherently 'greater than minimal risk'. . . the ANPRM's effort to predetermine offensive or risky topics is inherently flawed."
"The term 'related methodologies' is inadequate: the proposed rulemaking offers no principled approach to creating that grouping or interpreting that phrase."
"[Question 23] asks about the circumstances under which it should be permissible to waive consent for research involving 'existing data and biospecimens.' We find the phrasing of this question extremely troubling as it reveals a lack of distinction between the very general concept of 'data' with the very specific notion of 'biospecimens'. So long as the framing of ethical regulations continues to take for granted a model of research in which 'biospecimens' are the prototypical form of 'data', there is no hope of achieving a reasonable, efficacious regulatory system."
"If our concern is to identify 'risks' to human research participants, then generalizable/not- generalizable is not a useful diagnostic for distinguishing reviewable from not-reviewable research. Literary scholars and historians write biographies that transform private individuals into public figures and shape their reputations (not infrequently for the worse) whereas survey researchers typically anonymize their respondents since their research questions concern social trends and mass phenomena. Nevertheless, survey researchers, but not biographers, have been made subject to the Common Rule. Clearly, 'generalizability' has not proved a helpful resource for comparing the relative risks of these activities."
"Existing lists include activities familiar to marketing researchers (e.g., taste-testing) but regularly omit mention of activities familiar to linguists, anthropologists, and others (e.g., conversation analysis, elicitation of grammaticality judgments, participant observation). The 'human subject protection' rationale for these omissions is obscure: one suspects that they may simply be unfamiliar to the list authors.
Second, such lists are confusing to researchers and IRBs because different disciplines use methodological terms (e.g., 'interview') differently. Additionally, as the ANPRM itself notes, because research methodologies are dynamic, any enumeration of techniques is likely to need endless adjustment. The ANPRM indirectly acknowledges this problem when it ends its lists with the phrase 'and [other] similar procedures.'"
"The definition of 'human subject' makes quite explicit reference to biomedicine ('venipuncture' and 'medical records'). Indeed, the term is drawn from biomedical and experimental science usage, where 'subjects' are understood to respond to stimuli introduced and controlled by experimenters. However, most social and humanities research construes human participants as more proactively engaged (in various particular senses) in the research process: as open-ended interview 'respondents', oral history 'narrators', or ethnographic 'informants', 'consultants', and 'interlocutors'. Consequently, 'human subject' imports misleading connotations into IRB evaluations of social and humanistic research (introducing inaccurate study design expectations concerning 'subject selection' and the like). "

Skepticism of HIPAA

The comment emphasizes that "the use of HIPAA standards—'which were designed for dealing with health information'—are most definitely not 'appropriate for use in all types of research studies, including social and behavioral research.'"

A Radical Redefinition

The comment's boldest proposal is to redefine the scope of the regulation:

Whereas the Common Rule currently applies to 'research; involving 'human subjects' (45 CFR 46.102d, f), we recommend that a revised Common Rule apply only to the following two kinds of work:

1. Biomedical and other study procedures involving risks of physical harm to human participants: that is, more specifically, harm defined in 76 FR 44515 II(A) as "characterized by short term or long term damage to the body such as pain, bruising, infection, worsening current disease states, long-term symptoms, or even death."

2. Human experimentation and other methodologies whose results depend for their validity on limiting or controlling the information available to research subjects: that is, study designs reliant either on the passive withholding of information concerning what the study is about or on the active provision of misinformation: e.g., the use of placebos in biomedical clinical trials; the use of confederates in behavioral research concerning competition, conformity and the like; and the deceptive presentation of fictional narratives as actual news reports in social research concerning public opinion."

The comment later clarifies that "we recommend adopting a more precise definition of what is being regulated (human experimentation and study procedures involving physical risks to participants). Doing so would obviate the need for listing 'Excused' activities in the first place."

On the one hand, this would be a radical reduction in IRB authority; IRBs would be left with no power over researchers using surveys, interviews, and observation, power they have claimed since the first policies of the 1960s.

On the other hand, this is a very conservative proposal, in that it would restrict the regulatory power to the statutes on which it claims to be based.

The comment notes that it is proposing a "default-out reviewing strategy," in which activities could proceed unless they hit one of the triggers in the new definition, as opposed to the "current strategy [which] defines the object of IRB review relatively generally and then labors to identify and enumerate specific methodologies or types of study eligible for 'exemption' or 'expediting.'" Indeed. In 1981, HHS explicitly rejected the "suggestion that the regulations should define what is covered rather than list specific exemptions if research were exempted from coverage unless it met the criteria proposed by the commentators" lest "other categories of research involving significant risk . . . would be inadvertently exempted from coverage." This was a terrible mistake, and the AAA rightly condemns it.

The comment particularly wants participant observation, "sociocultural anthropology's distinctive research method," excused from IRB review.

I was puzzled by the combination of the comment's call to narrow the regulatory definition of research and its apparent expectation that there would still be some regulatory oversight over some social research. Thus, the response to question 15 imagines "obviat[ing] the need for listing 'Excused' activities in the first place," while the response to question 19 "strongly support[s] the idea that researchers who are engaged in 'excused' research adhere to a 'brief (i.e. no more than one week) waiting period' before commencing with their project."

I wonder if this apparent contradiction is the result of the ANPRM's format, which more or less forces respondents to argue in the alternative.

A Proposal for a Social and Humanistic Commission

The comment's second major suggestion is

the creation of a commission constituted specifically of social scientists (e.g., sociologists and the like), humanistic social researchers (e.g., cultural anthropologists and the like), and humanists (e.g., historians, legal scholars, and the like). Rather than adapting strategies developed to protect biomedical information--which are fundamentally incompatible with core intellectual and ethical commitments of humanistic social studies--this commission would be tasked with developing alternative guidance appropriate for their fields.

As the anthropologists note, such a commission is already functioning in Canada, where the Social Sciences and Humanities Research Council helps shape the Tri-Council Policy Statement and its interpretations. Like the call for a meaningful definition of research, this proposal is a bold assertion of what should be common sense. The anthropologists suggest the Association for Practical and Professional Ethics and the Consortium of Social Science Organizations as organizations that should have a greater role in shaping rules.

Again, I see some tension in this proposal between the comment's wish for more expert review and its defense of "the existing local model of IRB process." The comment rightly "attribute[s] the phenomenon of 'mission creep' in some part to the fact that institutions labor under the anxiety of federal audits. This contributes to an adversarial atmosphere in which it is only rational for boards and IRB administrators to emphasize bureaucratic documentation over situationally appropriate ethical decision-making." Yet its complaints about "variable interpretations by IRBs" could hint at problems with the local model itself.

Similarly, in response to question 9, the comment states that "We view a 'systematic, empirical assessment of the levels of risk' as impractical." Yet in just the previous section, a reply to question 8, the comment cites a National Academy of Science report to argue that "every exposure to [ionizing] radiation produces a corresponding increase in cancer risk." So there's an example of a practical, empirical assessment of the level of risk.

I am the last person to suggest an uncritical mapping of such a medical finding onto non-medical fields, but I still think some empirical evidence about nonmedical research can help guide rulemakers and local IRBs. For example, it seems that experience has shown that people who study universities should not count on being able to disguise the identity of their research sites (especially when they study their home institutions), and that interviews with survivors of trauma pose little risk of causing further trauma.

Respect for Historians

Though naturally emphasizing the concerns of anthropologists, the AAA comment goes out of its way to stress both the value of historical research and the dangers the ANPRM's muddier ideas pose. For example,

Taken literally, the wording of this question is directly applicable to historiography, which accords special credibility to the study of records collected (often by interactions with persons) for purposes unrelated to that of the investigator. To require consent in such a case 'based on the likelihood of identifying the research subject' would cause IRB (or HIPAA Privacy Board) workloads to rise dramatically and historical scholarship to grind to a halt."

I expect historians to make this point, but for anthropologists to do so is an act of collegial generosity.

An Endorsement of Freedom

In several sections, the AAA raises a value often missing in discussions of human subjects regulation: "the rights of citizens in a free society, researchers and participants alike."

My favorite expression of this value--and my favorite passage of all in the comment--comes in response to question 27, which asks about the risks that IRBs should consider. The anthropologists respond:

The research world is rife with projects whose results bore, interest, annoy, please, anger, or enlighten research participants (just as they do fellow researchers). This world is not generically the people's enemy. On the contrary, those of us working in US colleges, universities, news media, and research institutions have inherited traditions of free inquiry whose continuation is vital to this country's political, economic and social life. It would be deeply ironic if a regulatory system put in place to protect human beings were transformed into a device focused on restricting their power to know the world.

I have in the past been quite critical of anthropologists' approach to the IRB debate, in large part because of what I understood as their failure to accept that safeguarding freedom will inevitably bore, annoy, anger or otherwise harm some people being studied. The AAA's response to the ANPRM changes that. It strikes me as not only a much-needed set of comments on the proposals immediately before us, but also as a welcome assertion of anthropologists' rights and responsibilities in the pursuit of knowledge.

Rohde Reviews Ethical Imperialism

2011-10-21T08:36:00.000-04:00

Joy Rohde, assistant professor of history at Trinity University, reviews Ethical Imperialism for the Journal of American History and finds it "a valuable contribution to the history of federal science policy and a useful critique of a system ill-suited to the uses to which it is being put."

[Joy Rohde, Review of Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009, by Zachary M. Schrag, Journal of American History 98 (2011): 600, doi: 10.1093/jahist/jar274.]

Rohde writes,

Schrag's evidence leaves no doubt. Federal commissions repeatedly failed to recognize important distinctions between the methods and subjects of biomedical and psychological research and those of the social sciences. In some cases, like that of the Belmont Report (1978), policy makers failed to seek appropriate outside advice from qualified researchers. In others, such as that of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974–1978), policy makers listened to input from social scientists, yet inexplicably wrote rules that papered over difficult disciplinary and ethical distinctions.

Rohde does find that "Schrag's evidence also indicates that social scientists’ plight might be, in part, their own doing. Social scientists have repeatedly failed to reach consensus within their own disciplines about the ethical limits of methods such as deception, the ethical threats posed by certain forms of research sponsorship, and the abilities of their own professional associations to serve as ethics police forces."

This is a good description of the 1990s, but in the 1960s and 1970s, social scientists achieved a remarkable consensus about IRBs. Here's hoping the 2010s will reprise those earlier efforts.

OHA Endorses AHA ANPRM Talking Points

2011-10-19T10:51:00.000-04:00

The Oral History Association Council has endorsed the talking points on the ANRPM posted earlier by the American Historical Association, and it is encouraging its members to submit an abbreviated version of them as a formal comment to HHS.

h/t: Rob Townsend.

AHA Posts ANPRM Talking Points

2011-10-18T10:10:00.000-04:00

The American Historical Association (AHA) has issued a set of "talking points" to "invite comments and concerns from members as we craft our response, and as a guide to historians and related specialists looking to craft their own response to the federal proposal."

Robert B. Townsend, "Oral History and Information Risk: A Response to the Federal Proposal," AHA Today, 17 October 2011.

The main argument is for "the full exclusion of oral history from IRB oversight," rather than its incorporation into the proposed "Excused" category. In addition, the talking points warn that new proposals for the use of existing data could set "an impossibly high bar for the future use of archival or public use data sources will seriously inhibit our understanding of the past, including future projects that would hold scientists accountable for their misuse of research subjects (such as the recent study exposing U.S. research practices in Guatemala in the 1940s) . . ."

The AHA has not yet drafted a formal comment, which will, I hope, translate these broad points into responses to specific questions in the ANPRM. But historians can use the talking points to alert regulators to the key issues involved.

AAUP Posts ANPRM Comments

2011-10-13T23:55:00.002-04:00

The American Association of University Professors has posted a reply to the ANPRM. I am proud to have contributed to this document.

Compliance Administrator Wants ANPRM to Address Subparts

2011-10-10T16:17:00.003-04:00

Writing for PRIM&R's blog, amp&rsand, Wendy Tate, assistant director of process improvement and compliance at the University of Arizona, complains that the ANPRM fails to address the subparts of 45 CFR 46.

[Wendy Tate, "What's Missing in the ANPRM?," amp&rsand, 5 October 2011.]

Tate points to Subpart B, which imposes special restrictions on research involving pregnant women. She writes,

Subpart B is a good discussion point for understanding how important it is for the subparts to be included in the ANPRM discussion. Having been a pregnant woman myself and speaking to other women who have been pregnant, there are very few times in a pregnancy when a woman is vulnerable. These times generally center around labor and delivery. Pregnant women make decisions every day that can affect their unborn children. These decisions range from what to eat and drink, to taking prenatal vitamins, to long distance travel, to choosing medical care. Research needs to be done in this population.

The FDA has stated that excluding pregnant women from clinical trials is unethical. Revision or removal of subpart B will go a long way toward harmonizing regulations and gathering important information on how drugs work in women, as well as to avoid the discriminatory status of being a “woman of childbearing potential.” It seems to me that combining necessary changes to the subparts with the ANPRM review process would be the most expeditious way to accomplish this.

So far, so good.

Subpart C could also use rethinking, since it was written with biomedical research in mind but has been used to block important social research requiring interviews of prisoners.

Subpart D could also use reconsideration. It limits research on children, defined as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." But what jurisdictions specify the legal age for being interviewed, surveyed, or observed? This confusion between patient and subject disrupts important research on adolescents.

Canada has made progress on these fronts. Article 4.3 of the 2010 TCPS states that "Women shall not be inappropriately excluded from research solely on the basis of their reproductive capacity, or because they are pregnant or breastfeeding." And Article 4.4 states that "Children shall not be inappropriately excluded from research solely on the basis of their age or developmental stage." The TCPS does not offer similar language about prisoners, but neither does it suggest restrictions as strict as those of Subpart C.

What is Behavioral Research?

2011-10-05T10:46:00.000-04:00

An anonymous comment on an earlier post asks, "Could you clarify the difference between behavioral science and social science?"

Robert Veatch stated the basic problem in his 1973 testimony to the House Subcommittee on Public Health and Environment:

If the proposal before us is an act for the protection of human subjects of biomedical and behavioral research, it is crucial to have a clear understanding of what constitutes "behavioral research." I note that in the definitions (sec. 1213) the term is nowhere defined. It may have two meanings. To many social scientists it will have a rather limited meaning--research in behaviorist psychology--while to the layman it may mean more broadly any research to study human behavior including all social scientific investigation. It is my hope that the intent of the bill is to use the latter meaning. If not, the act may be considerably less inclusive in application than the present HEW guidelines, which clearly are meant to apply to all social scientific research (in which subjects are 'at risk). To leave such ambiguity is a tragedy.

[U.S. House of Representatives, Biomedical Research Ethics and the Protection of Human Research Subjects: Hearings before the Subcommittee on Public Health and Environment of the House Committee on Interstate and Foreign Commerce (93d Cong., 1st sess., 1973), 240]

Veatch was right about the tragic ambiguity of the statute. But I do not think he was right about the laymen's understanding of behavioral research, at least if laymen are to include congressmen and senators. As the secretary of HEW noted in 1976, "The types of risk situations against which the regulations were designed to protect are suggested by the areas of concern which were addressed in the legislative hearings held in conjunction with the enactment of section 474 of the Public Health Service Act, 42 U.S.C. 289l-3 (added by Pub. L. No. 93-343) . . ."

Congress took almost no testimony about social science (e.g., it did not invite Laud Humphreys to testify), and nothing resembling testimony about the humanities. It did take testimony about behavioral control, and available evidence suggests that it was to oversee that kind of research that the word "behavioral" was included in the statute.

(Much more on this in Ethical Imperialism.)

If we are to align the regulations to the wording and intent of the statute, we have two choices. 1. Define behavioral by method (e.g., intervention, not interaction.) 2. Define behavioral by subject matter (designed to study mental and physical health, not social conditions.) Either could lead to improvements.

AHA Warns of ANPRM's HIPAA Proposals

2011-10-03T14:04:00.000-04:00

Rob Townsend of the American Historical Association warns of the ANPRM's idea of subjecting a broad range of data to protections bassed on the provisions of the Health Insurance Portability and Accountability Act (HIPAA). If this proposal is implemented carelessly, historians could find themselves barred from some archival research.

"Could History Become an Information Risk'?," AHA Today, 28 September 2011.

If these new restrictions were implemented in a uniform way to encompass all research subject to IRB review, they could extend even to archival research and effectively make those restrictions permanent. For a number of years now, former AHA Council member Linda Shopes has been warning that the rules could lead to regulations on archival research “simply because they deal with the activities of human beings.” The new proposal makes that possibility quite explicit, by encompassing “researchers’ use of pre-existing data (i.e. data that were previously collected for purposes other than the currently proposed research study)” and insists that a researcher acquire “written consent” if he or she “obtains information that identifies the subjects.” The proposal is not clear about whether consent agreements obtained by the original interviewer or host archive would be adequate for subsequent research, but the general tendency in these regulations to seek “one size fits all” solutions makes this deeply worrisome.

The post encourages AHA members to submit comments in response to the ANPRM. "At the very least, the regulations should allow for some sort of sunset provision—similar to those for U.S. census data—to assure that someday historians will be able to make use of the information collected in the present."

Tuchman Reviews Ethical Imperialism

2011-09-29T15:27:00.000-04:00

Gaye Tuchman, author of Wannabe U: Inside the Corporate University, reviews Ethical Imperialism for Contemporary Sociology: A Journal of Reviews.

[Gaye Tuchman, "Review of Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009," Contemporary Sociology: A Journal of Reviews 40, no. 5 (2011): 617 -619.]

As a sociologist, Tuchman enjoyed the sections dealing with the history of her discipline. "It is a real treat," she writes, "to read how Ithiel DeSola Pool, James Davis, Albert Reiss, Howard Becker, Edna Bonacich and Jack Katz all more or less agreed that the regulations harm social science."

Tuchman apparently disagrees with Donald Bersoff's sense that "Schrag, as an academic historian, has an axe to grind." She writes,

this scholarly book does not read like the result of anger. Rather, it is the dry and thoroughly researched story of how IRBs came to be, how they came to adopt rules designed for medical, biological, and psychological researchers and then to apply them to the social sciences, how those rules became institutionalized, and how the rules protect universities rather than the people who serve as subjects and informants in social science research.

Tuchman herself finds that

IRB regulations and especially their application to social science are examples of an accountability regime, a politics of surveillance, control, and market management that disguises itself as the value-neutral and scientific administration of individuals and organizations that increasingly dominate American higher education. At colleges and universities, the accountability regime is itself redolent of neoliberalism, an approach to socio-economic policy that lauds the efficiency of private enterprise, promotes the effectiveness of managerial oversight by fostering individual and institutional accountability, and seeks to increase the role of the private sector in determining the political and economic priorities of the state. IRBs are just one piece of the new higher-education complex that has been mandating missions statements and strategic plans, encouraging profit from (copyrighted) research, assessing teaching practices, fiddling with faculty governance, and expanding the (largely powerless) contingent labor force.

IRBs protect universities, not researchers, not the subjects or informants whom social scientists observe and interview. At my own university, I can think of graduate-student projects that (I believe) the IRB killed, because the research would have made the university look bad.

ANPRM Comments: Oral Historians Call for Exclusion from Common Rule

2011-09-26T23:55:00.000-04:00

Of the 253 public submissions filed in response to the ANPRM as of 26 September 2011, 17 showed up in a search for the term "oral history."

One, submitted by Nancy M. P. King, JD, and Ana S. Iltis, PhD of the Wake Forest University Center for Bioethics, Health, and Society, calls for IRB jurisdiction over oral history and journalism. No First-Amendment champions they.

Another, from Julie Ozier, Assistant Director, Institutional Review Board, Vanderbilt University, briefly answers Question 25, "Yes, oral history since again the projects are ill defined (by design) and it take[s] a willing participant to provide their 'story.'"

The remaining 15 come from historians who have been burned by IRBs and want a way out. Just two of them, Kathryn Edgerton-Tarpley and Alan Lessoff, see merit in the proposed Excused category; the rest want nothing at all to do with IRB regulations.

Edgerton-Tarpley wins the prize for best horror story, in which she relates how the San Diego State IRB proved more censorious than the Chinese government. Runner-ups are the reports submitted by James Williams and Kristin Hoganson about the chilling effects on student work .

Here are the comments, in order of their posting:

Blake Slonecker, Waldorf College, August 15

I am a historian who studies social activism in the 1960s and 1970s. As a result, oral history is a vital component of my source base. The IRB process--both in graduate school and at my first academic position--has been a continual thorn in my side, without providing any of my interview subjects with additional protections. In fact, very often the IRB paperwork has made subjects far less inclined to participate in the study, despite minimal risks. Eliminating the IRB process for oral histories that meet certain basic criteria would be a boon not only to me and my colleagues, but to our interview subjects as well. Thank you for your consideration.

Thomas Scott, Kennesaw State University, August 15

I would like to argue that oral history should not be covered by the Common Rule and therefore should not be subject to IRB supervision. Oral history differs from research in scientific fields in a number of important ways. Rather than conducting anonymous surveys for the purpose of generating statistical data, oral historians concentrate on individual memories and ask narrators to sign a release, giving the copyright for the interview to the interviewer or to the library, archive, museum, or other organization that will house the interview. While medical and psychological examiners for obvious reasons need to protect the privacy of their subjects, oral historians in all but the most sensitive cases must be able to cite the names of the people they interview and when and where the interview was conducted. Otherwise, their research will have little credibility with other historians. While scientific researchers typically work from a script and ask all subjects the same questions, oral historians are trained to start with a minimal number of open-ended questions, listen to what the interviewee says, and then follow-up with unscripted questions designed to elicit more detail or to pursue a line of inquiry that was unanticipated before the interview began. I have headed an oral history project at Kennesaw State University since 1978, and it seems to me that the most important information I have gathered has come from unscripted follow-up questions after interviewees expressed opinions and provided information that were interesting, relevant, and unexpected. For several decades the Oral History Association has published a statement on “Principles and Best Practices.” The OHA guidelines say a great deal about ethical behavior and protecting interviewees from possible harm. In my own project, I have always returned edited transcripts to the interviewees to give them a chance to rethink and correct what they have said before I open the interview to the public. Following the OHA guidelines, I have always called to their attention any part of the interview that could possibly be libelous or could in any way cause them harm. While oral history is clearly a form of research, it is very different from scientific research and should not be subject to the same requirements that are needed in other fields.

Nan Mullenneaux, Duke University, August 15

I was so pleased to learn that Research Protections that govern oral history research may be streamilined. I fully support the American Historical Association's ideas for separating oral history from other more dangerous research involving human subjects., but maintaining its status as "research" to allow for financial support. As a professor, I have many students interested in oral history but put off by the complex paperwork and seemingly inappropriate instructions. I support restrictions that demand sensitivity, responsibility, and accountability, but not those that hamper rigorous investigation. Thank-you.

Robert Luckett, Jackson State University, August 15

As a historian, I am writing to ask that the application of completely inappropriate rules and criteria to historical research be reconsidered, particularly through what has constituted a growing, intrusive IRB process that discourages the pursuit of oral history. I ask that HHS consider the complete exclusion of certain forms of research such as oral histories from the “Common Rule” governing human-subject research.

Gabrielle Spiegel, Johns Hopkins University, August 15

I would like to argue that historians should be exempted from having to procure IRB approval when doing Oral history research. The goals of oral history research are often fundamentally at odds with the procedures and particular forms of protection of human subjects required for IRB approval of research. Notably, it is often the name of a person and his or her specific relation to a past historical event that makes their testimony valuable. Having to suppress such facts therefore vitiates the force , authority and authenticity of the material collected in interviews. Although this is not invariably the case, it is true enough of the time to make IRB approval a hindrance to well-conducted and reported historical research on contemporary topics, in which the existence of living witnesses provides valuable information which cannot be procured in other ways. I strongly urge the IRB to consider exempting historical work from its review procedures and protocols, which are designed for scientitic, not humanistic research. I write as a past President of the American Historical Association who worked closely with oral historians to try to amend the regulations governing their activities.

Kathryn Edgerton-Tarpley, San Diego State, August 16

I am writing to you to express my strong support for the current proposal to re-evaluate the rules governing human-subject research. As a professor of modern Chinese history, oral history is an important part of my research on Chinese responses to and cultural constructions of famines and floods. I also supervise M.A. students who have tried to conduct oral history in China. Having been through the IRB process at my university in 2008, and having tried (unsuccessfully) to help an M.A. student negotiate the process last year (2010), I can say from experience that the policies and procedures of the IRB create significant and wholly unnecessary hurdles to conducting good oral history research.

The IRB wanted detailed information about who I would interview in China, and prior approval of the questions I would ask each interviewee. Anyone who has conducted oral history, however, knows that the historian often learns of new interviewees as he/she conducts his/her work, and that the freedom to ask new questions based on information an interviewee has raised is absolutely crucial. This meant that the questions I actually asked interviewees in China often differed significantly from those the IRB had approved before I began my work. The demand that I have interviewees fill out written consent forms also proved quite off-putting to many of my Chinese respondents. In sum, the demands of the IRB bear little resemblance to the actual process of conducting good oral history research, in China or elsewhere.

While my proposal did eventually receive IRB approval, my M.A. student’s proposal was rejected so many times that she eventually gave up her plan to conduct oral history research in China. My student had met with several visiting professors from one of my university’s sister universities in China, and had arranged to travel to that Chinese university to interview Chinese women there about their view of China’s One-Child policy. The IRB repeatedly rejected her list of questions, even though her supervising professors had approved them, and demanded more information and tighter parameters than were possible for my student to provide before she arrived in China. Because my student wanted to interview well-educated adult women about a widely-known policy, her project posed minimal risk. However, the IRB proved so slow and so unreasonable that the entire spring semester and summer passed without a resolution, and in the end my student had to cancel her trip to China and rely on text-based sources alone. In short, the intrusion of overzealous IRB oversight into a very low-risk project robbed this M.A. student of an important, exciting opportunity to conduct oral history in China and include current Chinese voices in her thesis.

In conclusion, it is time for the HHS to stop extending to oral history rules that were established to protect human subjects from dangerous medical and psychological experiments. There is no need for such intrusive oversight of projects that simply ask consenting adults to talk about their life experiences. Adult interviewees can easily choose not to answer questions that make them uncomfortable or that might in some way bring them harm. I thus urge the HHS to recommend a new category, “Excused” to cover research that poses “no more than minimal risk,” involves only “competent adults,” and includes reasonable “data security and protection standards.”

Anna Krome-Lukens, PhD Candidate, History, University of North Carolina at Chapel Hill, August 16

As both a research assistant for UNC's Southern Oral History Program and a historian with many colleagues who use oral history in their research, I'd like to submit my opinion that oral history interviews should be exempt from IRB requirements. While IRB guidelines certainly have a valuable function in the health and social sciences, they often require things of oral historians that are impossible, given the methods of our discipline. For example, IRB regulations often require researchers to submit a list of interview questions as part of the pre-research approval process. This procedure is anathema to oral historians, who prepare assiduously for each interview but never know where the interviewee's recollections will take them. Regulation of oral history is best left to the ethical standards of the discipline; there is no reason for Institutional Review Boards to be involved.

James Williams, Albert Gore Research Center, Middle Tennessee State University, August 16

As a professional historian and practitioner of oral history for more than twenty years, I urge the Department of Health and Human Services to exempt the vast majority of oral history projects and interviews from Institutional Review Board oversight. Oral historians instead should fall under the regulations and standards promulgated by the Oral History Association and adopted by many professional historical organizations. The archive that I direct conducts one of the largest oral history projects in Tennessee. We participate in the Veterans Oral History Project (Library of Congress) and have completed oral history project for the National Park Service. Students under my supervision conduct oral history interviews for their undergraduate and graduate courses. We provide a valuable historical service to various publics by conducting these projects that, frankly, have been slowed down, impeded, and reduced in scope by the requirement to submit each and every interview and project to our IRB. As 99% of our interviewees do not come from vulnerable populations, to force regulations for that vast majority for the sake of the very occasional project that potentially could deal with a vulnerable population is a great example of administrative overreach. The federal government's interest in oral history should be negligible. I find it ironic that I can conduct oral history projects as a contractor for federal agencies who do not feel bound by HHS regulations on oral history (as they have their own policies and protocols, which are entirely less burdensome than HHS's). However, to conduct an interview on my own campus--only because of fear of the loss of federal funding--triggers hours of needless work on my part and on the part of the IRB members to rubber stamp a project. It is time once and for all for common sense to prevail, for HHS to listen to the history professionals, and to state clearly that its protections do not apply to oral history projects.

David K. Robinson, Professor of History Truman State University, August 23

Oral History projects have been unduly burdened by Institutional Review protocols that really have nothing to do with oral history. For this reason I want to support a letter, to this effect, that was sent to the Office of Human Research Protections, back in 2007. Please find that letter at the following link: http://www.historians.org/press/OralHistoryExclusionLetter.pdf I will quote only the conclusions: We believe that “oral history” should therefore be removed from category 7 and explicitly exempted from IRB review. Given our research into the way these policies are infringing on historical research that poses minimal risk of harm, we side with the recent recommendation from the American Association of University Professors, that “research on autonomous adults whose methodology consists entirely in collecting data by surveys, conducting interviews, or observing behavior in public places, be exempt from the requirement of IRB review—straightforwardly exempt, with no provisos, and no requirement of IRB approval of the exemption.”2 However well meaning and well intentioned the original decision to include oral history in Category 7, in practice, the application of these rules to oral history are not appropriate and fundamentally impede and abridge scholarly work in our discipline. The proposed changes to category 5 seem to increase the likelihood that the harm being done to current members of our profession will be extended to future generations, as the simple gathering and use of such materials will become more circumscribed and difficult. Thank you for giving me this opportunity to support our efforts to clarify this policy.

Simson Garfinkel, August 29

Regarding question 25, I have been troubled by the inconsistent application of the Common Rule to many fields not originally envisioned. The ANPRM mentions history, language, literature and journalism: these are all problem areas. As a practicing journalist I have frequently noted that I do not require IRB approval to do federally funded journalism but I do require IRB approval to do federally funded scientific interviews. I have seen problems in ethnography and anthropology as well: few IRB’s are willing to approve a multi-year protocol that say, essentially, “I’m going to live with the natives, talk to them, take notes on what they say, and publish a book in 5-10 years.” Yet this is the basis of both many journalistic and ethnographic endeavors. Today the only way to work such efforts is to argue that it is not scientific research. This has caused problems for political scientists and ethnographers, who maintain (rightly or wrongly) that they are engaged in scientific research.

Efforts to extend the Common Rule to journalism are particularly troublesome, both because of First Amendment issues, and because journalism seems to violate the “Beneficence” principle of the Belmont Report. That is, it is rarely in the interest of a politician or a business leader to speak with a journalist!

Likewise, I am troubled by the longstanding application of the Common Rule to oral history projects, as these projects are essentially journalistic in nature. The common rule should be revised to explicitly state that history, oral histories, language, literature, journalism, and ethnography are not subject to its requirements, especially when experimenters in these areas employ unstructured interviews that use journalistic methodology. Yet I have seen many oral history projects encounter IRB problems. I personally offered tapes of many oral histories that I had collected in the 1980s and early 1990s to an oral history project and had my efforts rebuffed because I did not have IRB approval when I performed the interviews.

Alan Lessoff, Professor of History, Illinois State University, September 6

I would like to add my voice to those professional historians who are calling for implementation of something like an "excused" category to apply to most oral history. I say this as a current departmental IRB representative and someone with long experience in other capacities with the issue. The research of my professional colleague, Zachary Schrag, documents what many of us have long known: that there has never been a persuasive rationale for the extension of IRB oversight to oral history or similar forms of social science and humanities research. Also, as Schrag likewise explains and as many of us have experienced directly, the overall structure, emphases, and priorities of the IRB system make the system a poor fit for the types of ethical issues that oral historians face most of the time. One could provide many, many examples gathered over the years to support this position. At my university, colleagues who run the IRB and the adminstrators who manage it are generally sympathetic to the problem and work to carry out their duties in a constructive way. But understandably, their priorities are psychological and educational research, crucial at our university. Historians submitting protocols continually face irrational amounts of frankly irrelevant work to conform to the guidelines. Unlike Schrag, I do not believe that history should be removed from human subjects protection regulations altogether. Our colleagues in other departments have a legitimate interest in monitoring the ethical character of our research. But only some sorts of oral history research--for example medical history, criminal-justice history, and some forms of family or social-welfare history--truly conform to the intention and procedures of the IRB system. The contemplated "excused" category provides a middle ground, since it requires historians to document that they are following appropropriate ethical practices, but only in relevant cases would a protocol be necessary.

Kristin Hoganson, University of Illinois, Urbana-Champaign, September 15

My field is the 19th century, so I do not apply for IRB approval for my own work. But I have found that including History as an IRB field has a chilling effect on teaching. My students can no longer interview friends, neighbors, relatives, etc. about their service in World War II or Vietnam. They can no longer ask grandma or grandpa questions with the intention of using their answers to add an oral history component to their research papers. I have advised a student in the McNair Program (aimed at encouraging underrepresented students to become college professors) who used up most of the time he should have spent doing his research trying to get IRB approval. I have other students change their research topics so as to avoid the IRB process. Why can journalism students call me up for comments without IRB approval but my students cannot ask anybody questions? This seems like a freedom of speech violation. When I worked with my McNair student to get IRB approval, I was directed to websites full of information about medical experiments. This is completely irrelevant to what we Historians do. Like journalism students, we ask people questions, which they can choose to answer or not. My students have no power of coercion. Indeed, pre IRB days, they used to report that older people loved to have an audience for their stories. I think oral history, like journalism, should be exempt because the line between them is a blurry one indeed.

Harold Cook, Brown University, September 21

I am acutely aware of how the regulations on human subject research, when applied to oral history research, can handicap research and the presentation of research. I urge you to think carefully about whether the regulation of human subjects research, which should of course apply to biological research, also applies to research that is non-intervensionist, without even touch involved. Research that involves no biological intervention should be free of the regulations that apply to human subjects research. Thank you.

Troy Reeves, University of Wisconsin-Madison Libraries, September 23

As the head of a campus oral history program, I submit my comments with the hope that they can lead to a world on campuses around the country where oral history projects are as best exempted from the current IRB review or at least current IRBs are given specific language to fast track oral history projects with as minimal review as possible. As the current system stands, IRB can delay or stifle the collection of history on campus. I do not or will not argue that people doing oral history on campus need some type of guidance, oversight, or support. But this can be done using tools, such as the Best Standards and General Principles of the Oral History Association, or putting humanists on IRBs to add to the board a voice that understands and can argue for the difference in oral history or similar type interviewing that the interviews that should fall under IRB review. It can also be done by changing the language to either place oral history and similar type interviewing outside the IRB bounds.

Samuel Martland, September 26

Please put new human-subject research rules in place that are appropriate for the ethical practice of oral history. That means allowing open-ended oral history interviews, allowing historians to identify interviewees (subjects) who agree to be identified, and generally operating on the assumption that interviews and conversations have minimal risk. It is, frankly, silly that some IRBs have barred historians from undertaking the kinds of interviews that reporters, historical society members, and kids in high school do routinely without IRB review, and which practically no one has ever said are risky. I have never done oral history myself, since I am a nineteenth-century specialist, but I know that good historical research requires following the thread of the evidence and asking further questions. Sometimes I also wonder whether chatting with another historian is “human subject research,” and then I realize the absurdity of the situation. As a historian, I am most familiar with the plight of oral historians before IRBs, but I think the new rules should also extend to literary scholars talking to authors, political scientists interviewing political leaders, linguists getting samples of dialects, and pretty much any other research about people that has no reasonable chance of being any more harmful than any other day-to-day conversation. I don’t think it’s productive to say that oral history isn’t covered because it does not produce generalizable results. The rules should be based on what the researcher is asking the human subjects to do, or what kind of information s/he’s asking them to reveal, not on what the final product of the research will look like.

ANPRM Question 25: Read the Statute

2011-09-26T09:53:00.000-04:00

It is September 26, the original comment deadline for the ANPRM, and the beginning of the final 30 days of the extended comment period. Here I offer my latest draft comments on the crucial Question 25. (This is adapted from my August 5 post.)

Answer: The Common Rule should cover only biomedical and behavioral research. It should be rewritten to exclude explicitly the social sciences, humanities, and journalism.

General comments on the scope of the Common Rule

For those interested in academic freedom, the most important questions in the ANPRM are those gathered as Question 25. I am heartened that OSTP and HHS have posed these vital questions, and I reply that the Common Rule should cover only the biomedical and behavioral research that Congress has authorized HHS to regulate.

Statutory authority covers only biomedical and behavioral research

Thus, federal law distinguishes between “biomedical or behavioral research” on the one hand and “the social sciences, the humanities, health administration, government, and public affairs” on the other. As the deputy general counsel of the Department of Health, Education, and Welfare put it in 1979, “if Congress had wished . . . to cover all human subjects research, rather than just biomedical and behavioral, it could have done so.”[1]

The Common Rule should reflect the underlying statutes and apply only to biomedical and behavioral research.

The Common Rule should cover only research methods that have proven risky

Both the statute and the regulations were designed to address concerns raised in the 1973 Senate hearings. As the secretary of HEW explained in 1976,

Different scholarly disciplines adhere to different ethical codes

The new “excused” category may not work for research in which real names are the norm

Non-generalizability has proven an unreliable tool

ANPRM's Question 25 hints that regulators are considering letting journalists, historians and other humanists off the hook by declaring their work to be non-generalizable, and therefore not subject to regulation under the Common Rule.

The advantage of this approach is that it has something of a track record. The idea that "journalism, history, biography, philosophy" generally fall outside of the regulatory definition of research because they are not generalizable dates back at least to the 1999 report of the Human Subjects Research Subcommittee, Committee on Science, National Science and Technology Council, which argued that

a key aspect of research is that there be a systematic design in advance, generally utilizing a scientific approach or protocol, for the definite purpose of contributing to generalizable knowledge. Research can include a wide variety of activities including: experiments, observational studies, surveys, tests, and recordings designed to contribute to generalizable knowledge. It generally does not include such operational activities as: medical care, quality assurance, quality improvement, certain aspects of public health practice such as routine outbreak investigations and disease monitoring, program evaluation, fiscal or program audits, journalism, history, biography, philosophy, "fact-finding" inquiries such as criminal, civil and congressional investigations, intelligence gathering, and simple data collection or data collection for other purposes. However, some of these activities may include or constitute research in the specific circumstance where there is clear advance intent to contribute to generalizable knowledge with a formal scientific protocol.[5]

The ANPRM seems to suggest that the 1999 position might be "explicitly" written into the Common Rule, thus locking it in place and giving historians and narrators the freedom to converse without seeking official permission. For example, the Common Rule could be amended to read

For purposes of this policy, research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. This policy does not cover such operational activities as: medical care, quality assurance, quality improvement, certain aspects of public health practice such as routine outbreak investigations and disease monitoring, program evaluation, fiscal or program audits, journalism, history, biography, philosophy, "fact-finding" inquiries such as criminal, civil and congressional investigations, intelligence gathering, and simple data collection or data collection for other purposes.

Yet this would leave problems.

For one thing, non-generalizability has proven an unreliable tool. OHRP has muddied the waters, apparently contending--for example--that "Open ended interviews are conducted with surviving Negro League Baseball players in order to create an archive for future research" would constitute generalizable research because "the creation of such an archive would constitute research under 45 CFR part 46 since the intent is to collect data for future research."[7]

This conflicts with OHRP’s earlier determination that "oral history interviews, in general, are not designed to contribute to 'generalizable knowledge." If generalizable means that some future researcher might conceivably use the information, then nothing is non-generalizable. Do not daily newspapers; criminal, civil and congressional investigations; and disease monitoring all create an archive for future research?

Moreover, as Robert Townsend of the American Historical Association has noted,

More fundamentally, no one can be sure what generalizable means. It is left undefined in the Common Rule. The Belmont Report version is longer, but hardly more helpful:

The term ”research" designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

Nor does it distinguish science from journalism, which regularly permits conclusions to be drawn and expresses statements of relationships.

Conversely, qualitative social scientists debate whether their work is generalizable. So "generalizable" covers research that the National Commission did not want covered and leaves uncovered research that the Commission did seek to regulate.

Serious observers have noted the problem. Tom Beauchamp recently complained that "generalizable knowledge," like other terms, "can be understood in several ways."[9] Rena Lederman has found that "the regulatory definition did little to resolve the very ambiguities within medical practice for which it was designed. Heroic efforts of clarification can be found in works that interpret the Common Rule for IRBs. Nevertheless, to this day it continues to be a frequent topic of debate in IRB circles."[10] And in 2008, David Strauss of the Secretary’s Advisory Committee on Human Research Protections complained that "we shouldn't be reviewing research that we don't think needs to be reviewed because some folks 30 years ago, at the end of a long, hot day, decided to use the word 'generalizable' . . . We have to have language that makes sense to us."[11]

The Common Rule can be rewritten to exclude the research that should not be subject to oversight

I can imagine various ways to align the Common Rule with the statutes and the known risks. One would be to exclude particular types of research from the scope of the regulation.

In 1979, twelve scholarly and educational organizations offered the following formula:

These regulations do not apply to research using legally competent subjects that involves neither deceit nor intrusion upon the subject’s person nor denial or withholding of accustomed or necessary resources.[12]

In 2006, the American Association of University Professors offered similar proposal:

Research on autonomous adults whose methodology consists entirely in collecting data by surveys, conducting interviews, or observing behavior in public places, [shall] be exempt from the requirement of IRB review—straightforwardly exempt, with no provisos, and no requirement of IRB approval of the exemption.[13]

The regulatory definition must change

In addition, the regulatory definition must change. The Common Rule currently claims to regulate “research” even though it has no statutory authority to do so. It should be rewritten to emphasize its applicability only to biomedical and behavioral research.

For example, in place of the current definition of research, it could present a definition of biomedical and behavioral research:

Biomedical and behavioral research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge about the structure and function of the human mind and body. It does not include research about specific individuals, social groups, or organizations.

Alternatively, we could borrow language about "health information" from 46 CFR 160.103 and insert it in the Common Rule:

For purposes of this policy, research means biomedical and behavioral research.

Biomedical and behavioral research means an investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge by systematically collecting health information. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

(1) Health information through intervention or interaction with the individual, or

(2) Identifiable private health information.

Health information means any information, whether oral or recorded in any form or medium relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual. It does not include incidental information about an individual's health, such as the mention of a past illness in the course of an interview about a broad range of subjects.

Either of these definitions would achieve many of the objectives of the ANPRM and bring the regulations into compliance with the underlying statute.

I do not expect that this definition will resolve all cases; every definition has a core and hazier penumbra.[14] I therefore urge the establishment of a federal body that will offer guidance on the hard cases after consulting the scholarly societies whose members will be affected.

[1] Zachary M. Schrag, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 (JHU Press, 2010), 100.

[2] Department of Health, Education, and Welfare, "Secretary‘s Interpretation of ‘Subject at Risk,’" Federal Register 41 (28 June 1976), 26572.

[3] Stuart Plattner, “Comment on IRB Regulation of Ethnographic Research,” American Ethnologist 33 (2006), 526.

[4] Jonathan T. Church, Linda Shopes, and Margaret A. Blanchard, "Should All Disciplines Be Subject to the Common Rule?," Academe, May-June 2002, 62-69; Malone, Ruth E., Valerie B. Yerger, Carol McGruder, and Erika Froelicher. “‘It’s Like Tuskegee in Reverse’: A Case Study of Ethical Tensions in Institutional Review Board Review of Community-Based Participatory Research,” American Journal of Public Health 96, no. 11 (November 2006): 1914-1919.

[5] U.S. Agency for International Development, “Guide for Interpreting the Federal Policy for the Protection of Human Subjects”, February 2, 1999, http://www.usaid.gov/our_work/global_health/home/TechAreas/commrule.html.

[6] Michael A. Carome, "Letter to Linda Shopes and Donald A. Ritchie, 22 September 2003," http://www.historians.org/press/IRBLetter.pdf (24 June 2008)

[7] “Michael Carome’s Email”, n.d., http://www.nyu.edu/research/resources-and-support-offices/getting-started-withyourresearch/human-subjects-research/forms-guidance/clarification-on-oral-history/michael-caromes-email.html.

[8] Robert B. Townsend, “AHA Today: Getting Free of the IRB: A Call to Action for Oral History”, August 1, 2011, http://blog.historians.org/news/1382/getting-free-of-the-irb-a-call-to-action.

[9] T. L. Beauchamp, “Viewpoint: Why our conceptions of research and practice may not serve the best interest of patients and subjects,” Journal of Internal Medicine 269 (April 2011): 383-387.

[10] Rena Lederman, “Comparative ‘Research’: A Modest Proposal concerning the Object of Ethics Regulation,” PoLAR: Political and Legal Anthropology Review 30, no. 2 (November 1, 2007): 305-327.

[11] Secretary’s Advisory Committee on Human Research Protections, Transcript, Sixteenth Meeting, 16 July 2008, 264.

[12] J. W. Peltason, "Comment on the Proposed Regulations from Higher Education and Professional Social Science Associations," IRB: Ethics and Human Research 2 (February 1980), 10

[13] “AAUP: Research on Human Subjects: Academic Freedom and the Institutional Review Board”, 2006, http://www.aaup.org/AAUP/comm/rep/A/humansubs.htm.

[14] Frederick Schauer, “A Critical Guide to Vehicles in the Park,” New York University Law Review 83 (2008).

Would ANPRM's Audits Require Massive Record-Keeping?

2011-09-23T14:39:00.000-04:00

Part of the ANPRM's proposal for a new category of Excused research is an audit regime for projects that researchers declare eligible for Excusal. An observer asks whether this requirement would impose inappropriate burdens on researchers. I am hopeful that it would not, but commenters on the ANPRM should be aware of this possibility as they answer question 21.

The ANPRM explains:

We are considering a mechanism to track Excused research, and to audit only a small but appropriate portion of such research, because it would still be subject to other regulatory protections, such as the proposed data security and information protection standards and certain consent requirements. In addition, such a mechanism to track and audit Excused research will also enable institutions to assure that the research does indeed meet the criteria for inclusion in the Excused category. (That is all that an audit would in most cases involve: a brief review of the registration form, similar to what many institutions currently do when they determine whether a study is exempt.) Key to this would be a requirement that researchers register their study with an institutional office by completing a brief form. This would make the institution aware of the research and identify the study’s principal investigator. In addition the institution could choose to review some of the submissions at the time they are filed (and we contemplate that this would only be done in a relatively small percentage of the filings) and if deemed appropriate, require that the study be sent for expedited review or, in exceptionally rare cases, convened IRB review.

The proposed auditing requirement is intended to encourage institutions to use the regulatory flexibility proposed for the Excused category of research. Rather than maintaining many institutions’ current practice of routinely requiring that research that meets the current exemption categories undergo some type of review before it is permitted to proceed, the proposed auditing requirement would provide institutions with information needed to assess their compliance with the new Excused category without unnecessarily subjecting all such research to either prospective review, or even routine review sometime after the study is begun.

Writing on the IRB Forum, Dr. John H. Noble Jr. warns that such an audit mechnanism could impose new burdens:

Maybe I can offer some insight about conducting audits from efforts of the government auditors I worked with in the 1970s-1980s. Far too often the auditors conclude that an audit cannot be completed because of lack of needed records. Ironically, the proposed new Common Rule requiring random retrospective audits of exempt studies, unless accompanied by very specific record-keeping requirements for the various kinds of research that might be considered "exempt," as well as the noted institutional uncertainty and concern about "regulations, laws, obligations and risks," seems likely to add to the burden of PIs, the research institutions, sponsors, and IRBs. Will the lack of a specific document or record create an "audit exception" that is deemed blameworthy? That said, in my experience the common reason that organizations were able to walk away from a government audit as "not susceptible to audit for lack of needed records" was to avoid disclosure of illegalities. What happens when the prosecution lacks the evidence to prosecute? Check out what penalties can be imposed for lack of adequate record-keeping. For a start, see, for example: http://pcaobus.org/Standards/Auditing/Pages/Auditing_Standard_3_Appendix_A.aspx and http://www.picpa.org/Content/AreasOfInterest/EmployeeBenefitPlans.aspx and http://www.irs.gov/businesses/article/0,,id=183208,00.html and http://en.wikipedia.org/wiki/Health_Insurance_Portability_and_Accountability_Act .

Yummy, I see adoption of such a rule as guaranteeing full-employment for lawyers and auditors who will flock to help the thousands of research institutions that exempt certain studies as SOP. I would also add statisticians, who will have to design adequate size samples of the exempt studies in order to satisfy the audit requirements in this regard. Some of us government retirees with program evaluation and audit experience may well be drawn out of retirement to fill the demand for expertise to implement the proposed new Common Rule--if it is serious about moving in this direction. It is important to keep in mind that when audits and auditors become part of regulatory equation, it is only a matter of time before government audit standards will be evoked or modified to encompass the new activity. Be careful of what you pray for!!!

I am hopeful that the human-research audit regime need not be nearly as elaborate as the financial and health analogies Dr. Noble offers. It could instead resemble the retrospective audits now used in cases of alleged plagiarism, fabrication, and falsification. Researchers are not subject to "very specific record-keeping requirements" beyond general scholarly norms that they retain enough notes and other materials that they can answer probing questions about their research. This system is not perfect (consider the debate over Michael Bellesiles's soggy notepads), but I think it suffices.

Moreover, I would think that in most cases, an audit could be conducted using solely published materials. That is, if you declare that your research is Excused because you are only talking to people, and then you publish an article about the LSD you gave them, that would be a problem.

Still, given the history of IRB regulations so far, it would be a mistake to ignore Dr. Noble's nightmare. I recommend that replies to question 21 suggest that the auditing system not impose any new record-keeping requirements. And I agree that the proposal for "random selection" is odd. Why not limit audits to cases in which institutions have reason to suspect noncompliance as is now the case with plagiarism, fabrication, and falsification?

[Note: In deference to the IRB Forum's policy I secured Dr. Noble's permission to quote his posting.]

Professional Geographer Focuses on IRBs

2011-09-21T16:32:00.000-04:00

The Professional Geographer has posted a six-item special section on "Protecting Human Subjects Across the Geographic Research Process," edited by Patricia L. Price.

Do I have time to write about each of these as we enter the last stretch of the ANPRM comment period? I do not!

As a placeholder, then, I offer the table of contents:

Focus: Protecting Human Subjects Across the Geographic Research Process (Guest Editor: Patricia L. Price)

Introduction: Protecting Human Subjects Across the Geographic Research Process
Patricia L. Price

DOI:10.1080/00330124.2011.596780

Subjectivity, Power, and the IRB
Deborah G. Martin & Joshua Inwood

DOI:10.1080/00330124.2011.596781

Bridging Guidelines and Practice: Toward a Grounded Care Ethics in Youth Participatory Action Research
Amy Ritterbusch

DOI:10.1080/00330124.2011.596783

IRBs as Asset for Ethics Education in Geography
Dan Trudeau

DOI:10.1080/00330124.2011.596786

Geography, Me, and the IRB: From Roadblock to Resource
Patricia L. Price

DOI:10.1080/00330124.2011.596789

Institutional Review for Research in the Social Sciences from the Federal Perspective
Scott M. Freundschuh

DOI:10.1080/00330124.2011.596791

Boellstorff Warns of ANPRM Ethics Creep

2011-09-11T20:41:00.001-04:00

Occupational Health & Safety alerts me to a comment on the ANPRM posted on September 1 by Tom Boellstorff, Professor of Anthropology, University of California, Irvine, and Editor-in-Chief, American Anthropologist.

Boellstorff welcomes the idea of the Excused category and the ANPRM's deemphasis of written consent forms, which, he says, "are often hard to understand and designed more to protect home institutions from liability than truly inform those being studied." He also believes that social scientists may be able to address concerns about data security.

On the other hand, Boellstorff worries that two of the ANRPM's proposals could lead to the same kind of ethics creep we have seen with the current Common Rule.

First, he warns of the ANPRM's handling of "'vulnerable' populations." He writes,

The proposed revisions retain the concept of "vulnerable" populations, but without ever providing a clear definition of what vulnerability might entail. As it stands, the examples provided of vulnerable populations are "children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons." There are at least two issues here. First, social science researchers have long noted that we have a real dearth of quality research on children and prison populations due to the very high barriers IRBs often place on conducting research on such populations, even when it is only informational risk that is at issue. In other words, the notion of "vulnerable" needs to be recalibrated in light of research that carries only informational risk. Often, research on children or prisoners should qualify for Excused status. Second, the notion of "economically or educationally disadvantaged persons" is so broad so as to include a majority of the world's population under its scope. The mere fact of being disadvantaged does not mean someone is "vulnerable" with respect to social science research that carries only informational risk. It is crucial that the ANPRM be revised to reflect this fact. The notion of "competent" may be more useful, though at present it is limited to "adults who would be able to provide 'legally effective informed consent."

Second, Boellstorff worries that ANPRM's Question 16, which envisions stricter scrutiny of "emotionally charged" topics, would hinder legitimate research about sexuality.

My concern is that while it is "sexual abuse" that is named, there is a real danger that this could be taken to mark all research on sexuality as "emotionally charged." Any abuse in theory can be emotionally charged. Marking out sexual abuse (and physical abuse more generally) as emotionally charged can contribute to the singling out of sexuality research as ethically suspect, which is counterproductive for encouraging careful work on this important topic.

I concur with Boellstorff's points and admire the brevity and clarity of his comments.

As of September 9, the ANPRM docket on regulations.gov contained 185 public submissions. I hope to post about more of them soon.

Circuit Court Affirms Right to Record Videos in Public

2011-09-07T10:05:00.002-04:00

As noted by the New York Times, a recent First Circuit decision in Glik v. Cunniffe affirms the First Amendment right to make video recordings in public places.

The appellee, Simon Glik, had a particularly strong case because he was filming police officers making an arrest. As the court noted in its August 25 decision, "Gathering information about government officials in a form that can readily be disseminated to others serves a cardinal First Amendment interest in protecting and promoting 'the free discussion of governmental affairs.'"

Moreover, even had Glik been affiliated with a university, his actions did not constitute human-subjects research under the current regulatory definition, since he did not voluntarily interact with the officers he was filming. (They interacted with him by arresting him on bogus charges, but I would hope no IRB would hold that against him.)

Still, it is worth considering the significance of the court's more general statement that the First Amendment protects the gathering of information as well as its dissemination:

It is firmly established that the First Amendment's aegis extends further than the text's proscription on laws "abridging the freedom of speech, or of the press," and encompasses a range of conduct related to the gathering and dissemination of information. As the Supreme Court has observed, "the First Amendment goes beyond protection of the press and the self-expression of individuals to prohibit government from limiting the stock of information from which members of the public may draw." First Nat'l Bank v. Bellotti, 435 U.S. 765, 783 (1978); see also Stanley v. Georgia, 394 U.S. 557, 564 (1969) ("It is . . . well established that the Constitution protects the right to receive information and ideas."). An important corollary to this interest in protecting the stock of public information is that "[t]here is an undoubted right to gather news 'from any source by means within the law.'" Houchins v. KQED, Inc., 438 U.S. 1, 11 (1978) (quoting Branzburg v. Hayes, 408 U.S. 665, 681-82 (1972)).

At the very least, such statements complicate claims that "human-subjects research is a privilege and not a right."

Canadian Tortoise Beats American Hare

2011-09-06T11:00:00.000-04:00

In the United States, human subjects regulations remained unchanged for twenty years, and almost unchanged for thirty. Then, in July, federal regulators proposed dramatic changes but gave citizens only sixty days to respond. When scholarly and professional organizations complained, that period was extended to a leisurely ninety days. Once that period closes, scholars may need to wait additional decades for such a chance to shape the regulations under which they must work.

Meanwhile, the Canadian Interagency Advisory Panel on Research Ethics has released its first responses to written requests for interpretation of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), only eight months after the release of that document. Whereas Americans must wait years for regulators to respond to their concerns, Canadians are promised contact with a policy analyst within 48 hours and, as we have seen, may get formal interpretations within months. If the past is a guide, they can expect amendments to the TCPS every few years (the first edition was amended three times) and perhaps another full revision after twelve.

The protection of research participants should be subject to constant improvement. We will not get sensible rules from decades of inaction interrupted by brief spasms of debate.

Website Covers Boston College Oral History Subpoena

2011-09-03T21:41:00.000-04:00

An anonymous comment on my post, DOJ: "There Is No Academic Privilege", alerts me to Boston College Subpoena News, described as a "website following Boston College's motion to quash the DoJ subpoena." The site does not credit its authors, but it seems to have useful information.

Does the ANPRM's Appeals Provision Address IRB Incompetence?

2011-08-31T21:40:00.000-04:00

A correspondent suggests that the ANPRM fails to address the problem of incompetent IRBs, such as IRBs that lack the expertise necessary to do their work or otherwise fail to meet all the requirements of the existing Common Rule. I am inclined to disagree.

First, though the ANPRM's problem statement is too diplomatic to state that IRBs are doing a poor job, the ANPRM cites some scholarship reporting serious flaws in the system.

One striking example is the three citations to Lee A. Green, Julie C. Lowery, Christine P. Kowalski, and Leon Wyszewianski, "Impact of Institutional Review Board Practice Variation on Observational Health Services Research," Health Services Research 41 (February 2006): 214–230. Apparently frustrated by the 4,680 hours of staff time it took to win IRB approval for a multisite study of physician practices, the researchers decided to study their own notes to figure out what had sucked up the equivalent of more than two years of work. They found all sorts of IRB-generated problems and concluded that "several features of the IRB system as currently configured impose costly burdens of administrative activity and delay on observational health services research studies, and paradoxically decrease protection of human subjects." Just by citing such studies, the ANPRM recognizes IRB fallibility to a greater degree than other official documents I've seen.

Second, the ANPRM's questions 27 through 29 at least raise the possibility that IRBs are making serious errors. Question 27 asks if IRBs remember that they "should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among the research risks that fall within the purview of its responsibility." In other words, it acknowledges that IRBs may frequently overlook some of the protections for research built into the regulations.

Question 29 asks if IRBs that act in ways not specified by the regulations be required to say that they are doing so "in furtherance of increased transparency." Here again, the implication is that IRBs are acting in ways not intended by the framers of the regulation, and either failing to notice that they are doing so, or not bothering to explain their actions.

Most dramatically, Question 28 raises the possibility of a mandatory appeal mechanism. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research specifically rejected such a provision, arguing that "an IRB should have the final word at its institution regarding the ethical acceptability of proposed research involving human subjects." Though the Commission had heard accounts of what Robert Levine later called "remarkably stupid behavior by IRBs," (PRIM&R Through the Years, 32), its members ultimately decided that maintaining IRB authority was more important than protecting researcher rights. Since then, groups like the AAUP have pointed to the "unchecked power granted to IRBs" as a contributor to IRB malfunction.

I would like to suggest, then, that the ANPRM contains a more radical critique of the IRB system than one would get from reading its problem statement alone. I encourage those who want significant change to answer Question 28 and call for an appeal mechanism as an important step toward addressing IRB incompetence.

ANPRM Comment Period Extended to October 26

2011-08-31T14:14:00.000-04:00

The Department of Health and Human Services has extended the comment period for the ANPRM to October 26. HHS has posted a preliminary announcement, and the official announcement is planned for the September 1 Federal Register.

The Years Spin By

2011-08-30T23:54:00.000-04:00

In his presentation to the Presidential Commission for the Study of Bioethical Issues today, Ezekiel Emanuel showed some textual slides that were visible during the live webcast but do not show up--at least on my browsers--when I replay the recording.

One of these slides featured a timeline of events leading to the current system of human subjects protections. That timeline featured two common errors.

First, Emanuel dated the Belmont Report to 1979. You will see this date a lot: on the NIH website in a blurb for Belmont Revisited, and--until I fixed it just now--on the Wikipedia entry, .

But read the report itself, and there's the date, 30 September 1978, at the top of each of the four transmission letters. The report even has a DHEW publication number, 78-0012, indicating the year in which it was published.

True, the report appeared in the Federal Register on 18 April 1979. But dating the Belmont Report to April 1979 is like dating the Declaration of Independence to August 1776, because that's when it was engrossed. We don't launch fireworks on August 2.

Second, Emanuel suggested that 45 CFR 46 was first promulgated in 1981. In fact, the first version of 45 CFR 46 was promulgated on 30 May 1974.

These errors are of little consequence by themselves. But I would like to think that an acquaintance with the history of IRB policy--an acquaintance complete enough that getting these dates right becomes second nature--would help today's policymakers gauge the probable outcomes of the various proposals on the table.

Emanuel: ANPRM Will End Reliance on Worthless Gut Reactions

2011-08-30T14:25:00.000-04:00

I watched the webcast of this morning's appearance by Ezekiel Emanuel before the Presidential Commission for the Study of Bioethical Issues. There were no huge suprises in Emanuel's presentation; much of it repeated points he had made in the New England Journal of Medicine. But I found some of his remarks, and the Commission's response, noteworthy.

(Parenthetical citations indicate the approximate time on the recording posted on the Commission website)

First, Emanuel emphasized his wish for a "risk-based review process" (6:00) and "a learning process that would be constant and dynamic to reflect actual risk" (8:55) rather than what he termed "gut reactions . . . which is worthless." (10:20)

This was a bit of a surprise, since it seems more ambitious than the proposals in the ANPRM itself. For example, the ANPRM imagines that "all data on adverse events and unanticipated problems collected in a central database accessible by all pertinent Federal agencies," (Question 69), but it does not explain how that database would filter down to individual IRBs. True, the ANPRM proposes a permanent federal body to update the criteria for expedited review, but that is just one element of determining what research methods impose risks.

Second, Emanuel noted that "written consent would be required for all use of biospecimens." (7:40) He did not mention such a requirement for datasets. Does this represent a backing away from ANPRM Question 46, which imagines requiring written consent for "unanticipated future analysis of data"?

Third, Emanuel noted that covering all research nationwide would require an act of Congress, and that is unlikely to happen. (9:20) But, he claimed, HHS could impose the Common Rule on all research conducted by institutions that receive federal funding. He described this as "a regulatory way of trying to achieve the goal incrementally." (9:45).

I am puzzled by Emanuel's simultaneous deference and indifference to the limits of statutory authority. The 26 January 1981 Federal Register notice announcing the revised 45 CFR 46 stated:

HHS has carefully considered its proposed policy regarding the regulation of non HHS-funded research in light of the comments received and the statutory basis for the more expansive interpretation. The public comment, including that of the President’s Commission, revealed a broad based and significant amount of objection to the extension. Further, the HHS General Counsel has advised that there is no clear statutory mandate in the National Research Act to support a requirement for IRB review of other than Public Health Service-funded research. Therefore, the Secretary of HHS, after considering a number of possible options, has decided not to extend the requirements for prior IRB review and approval to non HHS-funded research.

The statute has not changed. Why does Emanuel think that HHS now has statutory authority to require IRB review of research not directly funded by the federal government?

Finally, I was heartened by the commissioners' reaction to Emanuel's presentation. While the commissioners asked tough, detailed questions, none of them displayed any knee-jerk defensiveness on behalf of the status quo. This is a relief, because the ANPRM is a bold document, and it may need the high-level support that the Presidential Commission can provide.

Note. Emanuel pronounced "ANPRM" as "ay-en-pee-ar-em." It strikes me that a community used to EN-back, NUR-pack, and SACK-harp could save time by saying "AN-perm."

Sociologist: IRBs Have Almost Killed Fieldwork

2011-08-26T09:53:00.001-04:00

Laurie Essig, Assistant Professor of Sociology and Women's & Gender Studies at Middlebury College and a contributor to the Chronicle of Higher Education's Brainstorm blog, complains that "IRBs have effectively shut down our ability to actually find out about people’s lived experiences. IRBs have treated speaking with someone as equivalent to experimenting on them and have almost killed fieldwork in the process."

[Laurie Essig, "The IRB and the Future of Fieldwork," Brainstorm: Ideas and Culture, 12 August 2011.]

She offers four examples:

"A friend, who used to interview prisoners, gave it up since prisoners are 'vulnerable populations' and getting IRB approval is far more difficult than getting through the prison doors."
"Another acquaintance who used to research sexuality among young people has had to give it up since if there’s one thing you canNOT speak with people under 18 about it’s sex."
Essig "was called in because I had interviewed people who identified as transgendered and did not treat these people as a 'vulnerable population,' which includes prisoners, terminally ill persons, children, people with mental illness, and pregnant women.
Essig "was told that I had to get cosmetic surgery patients to sign permission slips to speak with me even though the interviews would be anonymous and details would be changed in such a way as to protect everyone’s identity . . . People love it when you offer them anonymity and then ask for a signature. Really makes them want to open up to you."

Essig calls the ANPRM "a huge improvement," though she does not offer specific proposals for reform. I fear she may be disappointed as she reads the ANPRM carefully, since none of the 74 (or 152) questions raises the possibility of redefining vulnerable populations as Essig and others might wish. [See also "Sex Researcher Calls for "An Evidence-Informed Process".]

As for her fourth complaint, the existing Common Rule already encourages IRBs to "waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds . . . that the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality." It's not clear how the ANPRM reforms would address basic IRB incompetence, though requiring an appeal mechanism (ANPRM Question 28) would be a good start.

I am disappointed that Essig derides the famous studies by Stanley Milgram and Philip Zimbardo, calling them not only "incredibly unethical" but also pointless. "After all," she writes, "these sort of human experiments were not just unethical, but ultimately gave us little information that we didn’t already have: people basically suck and they more or less will do anything if a white guy in a lab coat tells them to."

In fact, while both studies remain controversial, they both contributed significantly to our understanding of human nature. See, e.g., Robert Levine, review of Thomas Blass, The Man Who Shocked the World: The Life and Legacy of Stanley Milgram, American Scientist 92 (July-August 2004): 368-370; Rose McDermott, review of Philip Zimbardo, The Lucifer Effect: Understanding How Good People Turn Evil, Political Psychology 28 (Oct., 2007): 644-646.

Nor should Essig claim that IRBs "protect research subjects from . . . the kind of researchers who would recreate prison situations to see how nasty humans could be to total strangers." Ethical or not, Zimbardo's prison experiment was IRB approved.

Aristotle: History Is Not Generalizable

2011-08-25T11:40:00.000-04:00

I stumbled across the following passage from Aristotle's Poetics:

It is not the function of the poet to relate what has happened, but what may happen--what is possible according to the law of probability or necessity. The poet and the historian differ not by writing in verse or in prose. The work of Herodotus might be put into verse, and it would still be a species of history, with meter no less than without it. The true difference is that one relates what has happened, the other what may happen. Poetry, therefore, is a more philosophical and a higher thing than history: for poetry tends to express the universal, history the particular.

So history is not subject to the Common Rule, but poetry is.

How Many Questions Must an ANPRM Ask?

2011-08-22T14:41:00.002-04:00

Officially, the ANPRM asks 74 questions. In an effort to simplify things for scholars in the social sciences and humanities, I offered a list of just ten. The University of Rochester takes the other tack, counting 152 questions.

However many questions you care to answer, you've got 35 days left.

H/T: Human Research Protections Blog.

CITI Program as Mind-Numbing, Coercive, Counterproductive McEthics

2011-08-12T09:45:00.001-04:00

Sanjay Srivastava of The Hardest Science kindly alerted me to a newly published critique of the mortifyingly stupid CITI Program.

[Jennifer J. Freyd, "Journal Vitality, Intellectual Integrity, and the Problems of McEthics," Journal of Trauma & Dissociation, available online: 15 July 2011, DOI:10.1080/15299732.2011.602290]

Freyd, the editor of the Journal of Trauma & Dissociation, writes,

Beginning a few years ago many researchers have also been required by their institutions to complete regular mandatory “education” in research ethics. Although the intentions of these requirements are surely good, the resulting implementation has created a new industry of mind-numbing on-line ethics training and testing.

My own institution, like many others, requires all researchers to regularly complete testing using Collaborative IRB Training Initiative (CITI, www.citiprogram.org/) software. The problem is that passing the CITI tests is neither sufficient nor necessary for ethical behavior. Rather, this method of education and testing is so superficial and coercive that it is arguably counterproductive, promoting a false sense of security and even breeding cynicism. The information presented in the curriculum includes some valuable points, numerous irrelevant details, and a non-trivial amount of incorrect information and opinion labeled as fact. This information is then tested through multiple-choice quizzes shortly after presentation so that no long term retention is required. The only thinking occurs when disputable information is presented and tested; then the researcher must select between purposely entering a wrong answer in order to pass the test or possibly failing the test and thus being unable to do research.

Furthermore, it is considered permissible by many research communities for researchers to scan the CITI study materials at the same time as completing the quiz, thus requiring no retention of study materials even in the short run. In still other research communities, answer sheets are circulated. Although these strategies are obviously against the rules and arguably unethical, the rates of such cheating are apparently very high, probably in part because researchers consider the whole endeavor a foolish waste of time and in part because people will conform to what they believe is normative no matter if it is technically prohibited. It is ironic than an education initiative focused on ethics promotes such unethical behavior. There is very little intellectual integrity in the CITI educational experience from either the perspective of the testing itself or the behavior of the test takers.

Although knowledge is necessary, ethical behavior in research fundamentally involves motivation, problem-solving, and sometimes difficult cost-benefit analyses. What we need instead is a meaningful and intellectually honest educational experience: engage in a debate; serve on the IRB; conduct a study on research ethics. Like many of my colleagues I complete the required CITI training because I must in order to be allowed to conduct research, but each time I go through this process I come out feeling like I've been force-fed a high-fat low-nutrition meal at McEthics.

In case readers missed her point, she also terms the CITI program "hypocritical."

I can't argue with any of these characterizations, nor with Freyd's wish for more interactive ethics training, like the Princeton workshop for historians. But I hope that Freyd and other critics will consider the results of the University of Connecticut survey and take a look at Macquarie University's Human Research Ethics for the Social Sciences and Humanities. The former suggests that a large majority of researchers prefer online training, and the latter shows that web-based training need not be mired in irrelevant details, incorrect information, or opinion labeled as fact.

While we must do away with multiple-choice testing, the chief problem with the CITI Program is not its format but its content, which seems to have been written mostly by administrators and consultants, rather than scholars. If institutions were to allow their researchers to complete online training developed by experts in individual disciplines and written to scholarly standards, researchers could enjoy ethics meals at once fresh, affordable, convenient, attractive, and nutritious.

A Quick Guide to the ANPRM

2011-08-09T10:02:00.000-04:00

The ANPRM's 74 questions may overwhelm some scholars and scholarly organizations that might wish to respond; already several organizations have called for the comment period to be extended to 120 days.

In the hope of of making things easier, I have tried to lay out some of the most pressing questions in "How should human subjects regulations change? A guide to “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators” for scholars in the social sciences, humanities, and journalism, and the organizations that serve them."

I welcome comments on this document.

Research Psychologist Blogs ANPRM

2011-08-09T08:22:00.000-04:00

Sanjay Srivastava, associate professor in the Department of Psychology at the University of Oregon, has been posting some helpful observations about the ANPRM on his blog, The Hardest Science:

I particularly appreciate his "first reactions" section of the "What the proposed human subjects rules would mean" post:

Overall I think this sounds like mostly good news for social and behavioral researchers, if this actually happens. It’s possible that after the public comment period they’ll drop some of these changes or do something completely different.

I’d ideally like to see them recognize that certain research activities are protected speech and therefore should be outside of all federally mandated regulation. At the very least, universities have had to figure out whether to apply the Common Rule to activities like journalism, folklore and oral history research, etc. It would be nice to clear that up. (I’d advocate for a broader interpretation where interviews and surveys are considered protected speech regardless of who’s doing them. “Do you approve of how the President is doing his job?” is the same question whether it’s being asked by a journalist or a political scientist. But I’m not holding my breath for that.)

The HIPAA stuff makes me a little nervous. It appears that they are going to require the same level of security for a subject’s response to “Are you an outgoing person?” as for the results of an STD test. There also does not seem to be any provision for research where you tell subjects up front that you are not offering or guarantee confidentiality. For example, it’s pretty common in social/personality psych to videotape people in order to code and analyze their behavior, and later in another study use the videotapes as stimuli to measure other people’s impressions of their behavior. This is done with advance permission (I use a special consent form that asks if we can use videotapes as stimuli in future studies). Under the new rules, a videotape where you can see somebody’s face is considered fully identifiable and subjected to the most stringent level of control. Even just giving your own undergraduate RAs access to code the videotapes might require a mountain of security. Showing it to new subjects in a new study might be impossible.

So I do have some concerns, especially about applying a medical model of data security to research that has low or minimal informational risks. But overall, my first reading of the proposed changes sounds like a lot of steps in the right direction.

This is just what we need: scholars reading the ANPRM carefully and thinking about what its various proposals would mean for their research and teaching. Srivastava cares about the HIPAA restriction on "full-face photographic images and any comparable images"; other researchers will emphasize other details.

Srivastava has also posted some thoughtful comments on the mortifyingly stupid CITI Program, including his frustrating correspondence with a CITI staffer who offered empty promises to revise misleading language.

Chronicle of Higher Ed Reports on ANPRM

2011-08-08T09:32:00.002-04:00

The Chronicle of Higher Education reports on the ANPRM, emphasizing historians' concerns.

[Ryan Brown, "Historians Welcome Contemplated Changes in Human-Research Guidelines," Chronicle of Higher Education, 7 August 2011.]

Your humble blogger is quoted, as is Rob Townsend of the American Historical Association. The president-elect of the Oral History Association, Horacio N. Roque Ramírez, calls for some kind of review process to ensure that historians are familiar with the ethical implications of their work. But he agrees that current procedures are "tedious and nonsensical."

Agreed. I would go just a bit further, arguing that IRB oversight is a barrier to serious consideration of the ethics of oral history, since it has done so much to discredit the idea of ethics review.

ANPRM: Organizations Seek Longer Comment Period

2011-08-06T20:54:00.002-04:00

Public Citizen and PRIM&R have both requested that the ANPRM comment period be extended to 120 days.

The more I grasp the complexities responding to the ANPRM, the less adequate 60 days seems to me.

Wall Street Journal Blogs ANPRM

2011-08-06T13:02:00.002-04:00

Christopher Shea, author of the landmark 2000 article, "Don't Talk to the Humans: The Crackdown on Social Science Research," notes Rob Townsend's call to action on the ANPRM.

[Christopher Shea, "Historians and Human-Subjects Research," Wall Street Journal: Ideas Market, 5 August 2011]

Shea writes,

Understandably, some social scientists want to know why historians should get a pass on paperwork and oversight that takes up lots of their own time.

So the question is: How can oral (or, more generally, contemporary) historians escape inappropriate IRB scrutiny without denigrating their own work? Or, to back up a step, should they, in fact, have to go through the same procedures as social psychologists doing lab studies?

Might I interest him in a 4,800-word answer?

ANPRM: It's Time to Redefine Research

2011-08-05T12:49:00.000-04:00

In an earlier posting, I warned that the ANPRM's proposed "Excused" category could expand rather than diminish IRB interference with research in the social sciences and humanities.

Another option mentioned in the ANPRM--a redefinition of the scope of the Common Rule--could do more to achieve the ANPRM's goals of "better protect[ing] human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators." It could even the regulations with the statutes they claim as their basis.

I see several options here.

Problems with the Current Definition

The current Common Rule "applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research."

It defines "research" as

a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

and "human subject" as

a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.

The ANPRM offers the first chance in 30 years to rewrite these definitions. It does so with its Question 24 (about the application to "quality improvement, public health activities, and program evaluation studies") and the thrilling Question 25:

Are there certain fields of study whose usual methods of inquiry were not intended to or should not be covered by the Common Rule (such as classics, history, languages, literature, and journalism) because they do not create generalizable knowledge and may be more appropriately covered by ethical codes that differ from the ethical principles embodied in the Common Rule? If so, what are those fields, and how should those methods of inquiry be identified? Should the Common Rule be revised to explicitly state that those activities are not subject to its requirements?

How should scholars in the social sciences, humanities, and journalism respond? Let me offer several alternative definitions of research that could work better than the one now in place. I do so with the caveat that I think any defintion with need interpretation. The TCPS offers a model of what this would look like: each "article" is followed by a longer section explaining its "application." I hope that with the revision of the Common Rule will come some mechanism by which the federal government can offer informed interpretations as questions arise.

Option 1: Deregulate "Two People Talking"

A longstanding complaint of researchers has been that the current regulations require official permission for two adults to talk to each other, a basic human activity that should not be regulated in a free society. As the Illinois White Paper puts it:

Considerations of what is research, when inquiry becomes research, and who we are trying to protect bear especially on certain areas of academic effort. There are many cases where two people are talking with each other: in journalism, oral history, anecdotal research, and so on. When the participants are capable adults and understand that their words are being recorded, why should the special obligations of the researcher not end with honesty and truthfulness? Many such conversations cannot even be categorized as an interview in any direct or intentional sense—or it may not be clear who is primarily interrogating whom (maybe both parties intend to write about the encounter!).

In 1979, twelve scholarly and educational organizations suggested addressing such encounters with the following formula:

These regulations do not apply to research using legally competent subjects that involves neither deceit nor intrusion upon the subject’s person nor denial or withholding of accustomed or necessary resources.

In 2006, the AAUP offered similar proposal:

Research on autonomous adults whose methodology consists entirely in collecting data by surveys, conducting interviews, or observing behavior in public places, [shall] be exempt from the requirement of IRB review—straightforwardly exempt, with no provisos, and no requirement of IRB approval of the exemption.

Either one of these would achieve the ANPRM’s goal of “facilitating valuable research and reducing burden, delay, and ambiguity for investigators.” There should also be a provision for community research that might involve children or adults who are not legally competent. For example, an anthropologist living in a community should not trigger IRB review simply because he or she occasionally speaks to a child.

These proposals would not require rewriting the definitions section of the regulations. Rather, they would constitute a bifurcation of the ANPRM's prosed category of "Excused" research.

The ANPRM's proposes that Excused research would have to strip HIPAA identifiers, employ data security, and remain subject to audit.

An alternative would be to leave those requirements only for interventional research with competent adults--in ANPRM's terms, "methodologies which are very familiar to people in everyday life and in which verbal or similar responses would be the research data being collected. For example, a researcher might ask subjects to watch a video, or read a paragraph or solve puzzles, and then ask them some questions to elicit word associations or time performance of activities."

Mere interactions--especially conversations--would not require even registration. That is, the regulations could recognize these interactions as research, but determine that they are not subject to any review, before or after the research takes place.

One trick here would be to distinguish psychological inventories from other forms of survey research, but I think that could be done. For example, HIPAA refers to "health information," so one could require registration, expedited, or full review for studies that involve questions primarily designed to learn about participants' physical or mental health.

In this case, oral history, journalism, and the like could be categorized as human subjects research, but that categorization would not come with any regulatory restrictions.

Option 2: Define Research to Match the National Commission's Intentions

As the ANPRM notes, the current Common Rule is based on the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. So one possibility would be to rewrite the regulations to govern only those fields that the National Commission wanted to regulate.

It's hard to say just what those fields are, since the National Commission never listed the kinds of information gathering it did and did not want IRBs to review. But we can gather hints from its deliberations and publications, especially its 1978 Report and Recommendations: Institutional Review Boards.

At its June 1975 meeting, chairman Kenneth Ryan noted "the general Commission feeling that we are talking about biomedical, social, and behavioral research." And the 1978 IRB report makes glancing reference to both anthropology and survey research:

The requirement for documentation may place an undue burden on the research while adding little protection to the subjects. Such burdens might include a negative impact on the validity of a survey sample or introduction of an element that is incongruent with the social relationships involved in the research (e.g., in anthropological research). For research that would be burdened by a requirement of written documentation of consent, such documentation may be waived, provided that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. (For example, a physical intrusion into the body may generally require written consent, whether or not the intrusion is performed for purposes of research.) In many cases (e.g. , a survey using mailed questionnaires) it would be appropriate for the investigator to provide subjects with a written statement regarding the research, but not to request their signature. In other cases (e.g. , a telephone survey) an oral explanation might be sufficient,
because subjects can readily terminate their involvement in the research. (28-29)

and

Other situations in which informed consent might not be necessary arise in field research in the social sciences. Sometimes in such research, purely observational methods are supplemented by interaction with the persons being studied and therefore come within the Commission's definition of research involving human subjects. An IRB may waive the informed consent requirement in such research when it finds a number of factors to be present. The behavior to be studied must in some sense be public, e.g., responses of businesses or institutions to members of the public, or social behavior in public places. (30)

In its discussion of existing federal policies, the 1978 report notes that some agencies engaged in "survey research entailing no intervention in the lives or activities of the subjects. . . Although their activities fall within the Commission’s definition of research with human subjects, it should be noted that data gathering, in and of itself, has not universally been considered 'research with human subjects.'" (This is from p. 56196 of the Federal Register version of the report; the passage is cut off in the PDF of the original report.)

Finally, the Commission's IRB report complained that "when federal agencies conduct or support social experimentation, they may not consider it necessary to apply procedures for the protection of human subjects." (100) (That's pretty ironic, given that the Belmont Report claims that "Because the problems related to social experimentation may differ substantially from those of biomedical and behavioral research, the Commission specifically declines to make any policy determination regarding such research at this time.")

All of this is quite confusing, but I think we can say that the Commission hoped that regulations would cover:

"anthropological research"
"a survey using mailed questionnaires"
"a telephone survey"
"responses of businesses or institutions to members of the public, or social behavior in public places"

I think we can also say that the Commission did not wish to regulate journalism, though that's murkier still. (See Ethical Imperialism, page 62.)

And we have no evidence that the Commission sought to regulate history, folklore, or the humanities in general.

These latter fields--journalism and the humanities--were rarely if ever subject to IRB jurisdiction before 1994. And it is these fields have put up the greatest resistance to the expansion of IRB jurisdiction since then. By contrast, sociologists and anthropologists have proven more ambivalent about the process. They might prefer to have their work remain defined as human subjects research, though under an "Excused" category that would reduce the burdens of that label.

Thus, we can imagine drawing a line between the social sciences on the one hand and journalism and the humanities on the other. This would honor both the intentions of the National Commission and the general sentiments of researchers. I see at least two ways to do this.

Option 2a: Deregulate the Humanities and Journalism as Non-Generalizable

ANPRM's Question 25 is clearly targeted to historians, humanists, and journalists. (How did classics get in there?) It hints that regulators are considering letting these folks off the hook by declaring their work to be non-generalizable, and therefore not subject to regulation under the Common Rule.

The advantage of this approach is that it has something of a track record. The idea that "journalism, history, biography, philosophy" generally fall outside of the regulatory definition of research because they are not generalizable dates back at least to the 1999 report of the Human Subjects Research Subcommittee, Committee on Science, National Science and Technology Council, which argued that

a key aspect of research is that there be a systematic design in advance, generally utilizing a scientific approach or protocol, for the definite purpose of contributing to generalizable knowledge. Research can include a wide variety of activities including: experiments, observational studies, surveys, tests, and recordings designed to contribute to generalizable knowledge. It generally does not include such operational activities as: medical care, quality assurance, quality improvement, certain aspects of public health practice such as routine outbreak investigations and disease monitoring, program evaluation, fiscal or program audits, journalism, history, biography, philosophy, "fact-finding" inquiries such as criminal, civil and congressional investigations, intelligence gathering, and simple data collection or data collection for other purposes. However, some of these activities may include or constitute research in the specific circumstance where there is clear advance intent to contribute to generalizable knowledge with a formal scientific protocol.

In 2003, OHRP ruled that "most oral history interviewing projects are not subject to the requirements" of the regulation "primarily on the grounds that oral history interviews, in general, are not designed to contribute to 'generalizable knowledge.'" Most of the university policies excluding oral history from IRB jurisdiction do so on the grounds that it is not generalizable.

The ANPRM seems to suggest that the 1999 position might be "explicitly" written into the Common Rule, thus locking it in place and giving historians and narrators the freedom to converse without seeking official permission. For example, the Common Rule could be amended to read

For purposes of this policy, research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. This policy does not cover such operational activities as: medical care, quality assurance, quality improvement, certain aspects of public health practice such as routine outbreak investigations and disease monitoring, program evaluation, fiscal or program audits, journalism, history, biography, philosophy, "fact-finding" inquiries such as criminal, civil and congressional investigations, intelligence gathering, and simple data collection or data collection for other purposes.

If this were to happen, it could be a boon for scholars, research participants, and administrators alike. So the obvious response would be for historians and others to reply, "Why, yes, now that you mention it, we do not create generalizable knowledge!"

Yet this would leave problems.

For one thing, non-generalizability has proven an unreliable tool. OHRP has muddied the waters, apparently contending--for example--that "Open ended interviews are conducted with surviving Negro League Baseball players in order to create an archive for future research" would constitute generalizable research because "the creation of such an archive would constitute research under 45 CFR part 46 since the intent is to collect data for future research."

Well, you can't believe that and believe that "oral history interviews, in general, are not designed to contribute to 'generalizable knowledge." If generalizable means that some future researcher might conceivably use the information, then nothing is non-generalizable. Do not daily newspapers; criminal, civil and congressional investigations; and disease monitoring all create an archive for future research?

Moreover, as Rob Townsend noted on AHA Today,

The argument [that oral history is not generalizable] prompted some derision from outside the field, from academics who interpreted the phrase to say simply “history is not research.” (As a case in point, the vice president for research at my own university, after a fairly contentious meeting on the subject, wished me well on my “non-research dissertation.”)

We also received a number of complaints from within the discipline. Some historians argue that history does contribute generalizable knowledge, even if it bears little resemblance to the scientific definition of the word. And faculty members at history of medicine departments and in the social science side of history warned that this position undermined both their institutional standing and their ability to obtain grants. They made it clear that however finely worded, stating that history did not constitute research in even the most bureaucratic terms could have some real financial costs to the discipline.

More fundamentally, no one can be sure what generalizable means. It is left undefined in the Common Rule. The Belmont Report version is longer, but hardly more helpful:

The term ”research" designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

This goes some way to distinguish research from diagnosis of an individual patient--the main goal of that section of the Belmont Report--but I am not even sure of that; I would hope that an MRI operator diagnosing a patient has an objective and a set of procedures designed to reach that objective.

Nor does it distinguish science from journalism, which regularly permits conclusions to be drawn and expresses statements of relationships. Thus, a debt-ceiling story in this week's Washington Post finds that "It was the new Washington that started this fight . . . Then, over three fast-moving days, the old Washington swooped in to save them." That's a conclusion, and a statement of a relationship.

Conversely, qualitative social scientists debate whether their work is generalizable. So "generalizable" covers research that the National Commission did not want covered and leaves uncovered research that the Commission did seek to regulate.

Serious observers have noted the problem. Tom Beauchamp recently complained that "generalizable knowledge," like other terms, "can be understood in several ways." Rena Lederman has found that "the regulatory definition did little to resolve the very ambiguities within medical practice for which it was designed. Heroic efforts of clarification can be found in works that interpret the Common Rule for IRBs. Nevertheless, to this day it continues to be a frequent topic of debate in IRB circles." And in 2008, David Strauss of SACHRP complained that "we shouldn't be reviewing research that we don't think needs to be reviewed because some folks 30 years ago, at the end of a long, hot day, decided to use the word 'generalizable' . . . We have to have language that makes sense to us."

So, can we find sensible language to draw a distinction between the social sciences and humanities?

Option 2b: Deregulate the Humanities and Journalism as Research about Individuals

Perhaps the answer lies in language used by Michael Carome in a 2003 message: "OHRP has noted that its position regarding oral history was not based upon the fact that oral history activities involve open-ended, qualitative interviews of a nonrandom sample of individuals." Could "sample" be the key?

Obviously, quantitative researchers use samples. And one could make the case that qualitative sociologists and anthropologists do as well. That is, when they write about people whose names they conceal, are they not presenting them as representatives of a broader group?

Oral historians, by contrast, research individuals as individuals. As the Columbia University policy explains, "the scholarly oral history interview is rooted in particular recollections about history based on the individual perspective of the narrator." The "individual perspective" works for journalism and biography as well.

So perhaps we could advocate this definition:

For purposes of this policy, research means a systematic investigation, including research development, testing and evaluation, that studies people as representatives of the species as a whole or of biological and social groups. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. This policy does not cover research about individuals' unique experiences and perspectives, such as journalism, history, biography, philosophy, "fact-finding" inquiries such as criminal, civil and congressional investigations, and intelligence gathering.

Option 3: Define Research to Match Congress's Intentions

The National Research Act of 1974 (P.L. 93-348), established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and instructed it to

(i) conduct a comprehensive investigation and study to identify the basic ethical principles which should underlie the conduct of biomedical and behavioral research involving human subjects (ii) develop guidelines which should be followed in such research to assure that it is conducted in accordance with such principles, and (iii) make recommendations to the Secretary [of Health, Education, and Welfare] (I) for such administrative action as may be appropriate to apply such guidelines to biomedical and behavioral research conducted or supported under programs administered by the Secretary, and (II) concerning any other matter pertaining to the protection of human subjects of biomedical and behavioral research (emphasis added).

So when Kenneth Ryan observed "the general Commission feeling that we are talking about biomedical, social, and behavioral research," he could just as well have said, "the general Commission feeling is that we should exceed the authority granted us by Congress." For Congress had not empowered the Commission--or the Secretary of HEW--to study or regulate social research.

Today's Common Rule claims the National Research Act (encoded as 42 USC 289) as its statutory authority, but it does not limit itself to the scope of the law.

What would the Common Rule look like if it were grounded in the statute?

Option 3a: Limit the Regulations to the Concerns of Congress

One possibility was mooted in a formal interpretation by the Secretary of HEW in 1976:

The types of risk situations against which the regulations were designed to protect are suggested by the areas of concern which were addressed in the legislative hearings held in conjunction with the enactment of section 474 of the Public Health Service Act, 42 U.S.C. 289l-3 (added by Pub. L. No. 93-343), which forms part of the basis for the Departmental regulations at 45 CFR Part 46, and in the preambles to the proposed and final regulations at 45 CFR Part 46. The subjects addressed included the use of FDA-approved drugs for any unapproved purpose; psychosurgery and other techniques for behavior control currently being developed in research centers across the nation; use of experimental intrauterine devices; biomedical research in prison systems and the effect of that research on the prison social structure; the Tuskegee Syphilis Study: the development of special procedures for the use of incompetents or prisoners in biomedical research; and experimentation with fetuses, pregnant women, and human in vitro fertilization. The regulations were intended, and have been uniformly applied by the Department, to protect human subjects against the types of risks inherent in these types of activities.

In Ethical Imperialism I described this last sentence as "a poor description of DHEW’s previous actions." In an earlier draft, I called it a lie, and maybe I should have left that blunt language, since the department had not in fact limited its application to the areas of concern raised in the 1973 hearings.

But perhaps the 1976 interpretation, though not implemented at the time, would still be a wise course. This would be a radical break; while Congress did take testimony about behavior control, it did not investigate other behavioral research, like Milgram's experiments. So aligning the regulations to the concerns of Congress would mean deregulating a great deal of psychological experimentation. I am going to leave this to the psychologists to think about.

Option 3b: Limit the Regulations to the Language of the Statue

A less radical option would be to accept that HHS and other agencies have the authority to determine the scope of "behavioral research" under the statute, but that they must do so within the limits of ordinary understanding. Details can be found in my book, but suffice it to say that Ryan spoke for many when he broke research into three categories--"biomedical, social, and behavioral research"--only two of which appear in the statute. As the deputy general counsel of HEW noted in 1979, "If Congress had wished . . . to cover all human subjects’ research, rather than just biomedical and behavioral, it could have done so." (Ethical Imperialism, 100.)

The question is how to distinguish between behavioral and social research. I propose borrowing language about "health information" from 46 CFR 160.103 and inserting in the Common Rule:

For purposes of this policy, research means biomedical and behavioral research.

Biomedical and behavioral research means an investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge by systematically collecting health information. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

(1) Health information through intervention or interaction with the individual, or
(2) Identifiable private health information.

Health information means any information, whether oral or recorded in any form or medium relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual. It does not include incidental information about an individual's health, such as the mention of a past illness in the course of an interview about a broad range of subjects.

Either of these options--3a or 3b--would remove from IRB jurisdiction not only history, journalism, and the humanities (including classics!) but also most anthropology, sociology, political science, and the like.

Medical anthropology, medical sociology, and related fields might still face some forms of review, so it would be important to get the Excused category right. And we would probably need some interpretation down the road to make sure those retired Negro Leaguers could talk about their sprained ankles without triggering IRB jurisdiction.

Moreover, this broad deregulation might dismay some social scientists, particularly what I take to be a large number of anthropologists who have grown accustomed, even fond, of IRB review, and see in the regulations the chance to police dodgy practices. To them I can only say, if the problem is so bad, why don't you persuade Congress to study it?

I find this last option--making the regulations conform to the law--the most appealing, since I don't believe executive agencies should regulate behavior that Congress has not found to be a problem through the regular process of hearings, reports, and legislation. I look forward to readers' reactions to these five options and others that they wish to propose.

Inside Higher Ed Reports on ANPRM

2011-08-03T10:01:00.002-04:00

Inside Higher Ed reports on the ANPRM, with emphasis on concerns about the overregulation of the social sciences, humanites and journalism.

[Doug Lederman, "Updating the Common Rule," Inside Higher Ed, 3 August 2011]

The story quotes C. K. Gunsalus, Felice Levine, and your humble blogger. Mostly they are positive about the ANPRM, but Gunsalus and I express reservations. Hers concerns the proposal to extend the regulations to all research conducted at federally funded institutions:

"I have a hard time seeing how it makes sense to cover poets at universities but ignoring" surveys done by companies or research that takes place at fertility clinics or other entities that forgo federal funds. "I don't agree with this choice, and don't think it will solve the problem in the way they think it will."

ANPRM: May I Be Excused?

2011-08-02T19:37:00.000-04:00

One of the boldest proposals in the ANPRM, and one of enormous importance to social scientists, is the idea of replacing the current category of exempt reseach with a new category of "Excused" research. This proposal could reduce IRB and IRB-office intrusion into a great deal of social research. But, depending on the details, it could instead convert an enormous amount of presently exempt research into research subject to expedited or even full-board review.

Social scientists will need to be very careful as they respond to this proposal.

What Excused Means

Here are the basics of the Excused category, as described in Section 3 of the ANPRM.

* The current exemptions would no longer operate. Instead, various types of research that present risks to privacy but not immediate psychological or physical risks would be deemed "Excused."

* "Oral consent without written documentation would continue to be acceptable for many research studies involving educational tests, surveys, focus groups, interviews, and similar procedures."

* Excused research would be subject to "mandatory data security and information protection standards for identifiable information and rules protecting against the inappropriate re-identification of de-identified information that is collected or generated as part of a research study to minimize informational risks and thereby eliminate the need for IRBs to review informational risks of the research. For purposes of the Common Rule, we are considering adopting the HIPAA standards regarding what constitutes individually identifiable information, a limited data set, and de-identified information, in order to harmonize these definitions and concepts."

* Institutions might be required to audit a sample of excused research, but they would be discouraged from the "current practice of routinely requiring that research that meets the current exemption categories undergo some type of review before it is permitted to proceed."

How the Excused Category Could Help Social Science

* The criteria for excusal would be more objective than the current criteria for exemption.

The Common Rule currently exempts "Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation."

These ambiguous criteria now plagues social researchers. Iowa State's IRB, for example, ruled that a survey was non-exempt because it counted as a risk to reputation the danger that "some may find your opinions in the free-response section at variance with their own." More generally, the exemption has always been somewhat nonsensical in that it does not require an IRB to determine what was risky, even though the point of the Common Rule is that only IRBs should determine what is risky. Replacing the vague language about risks of liability, reputation, and the like with more objective criteria would be helpful.

The Excused category would do this with three criteria:

The research would have to be conducted with legally competent adults, a category that the ANPRM asserts is relatively clear.
The research would have to conform to rules about identifiable information, most of which are fairly objective as well.
The research could involve only "the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior." The Excused category might also include some psychological tests, such as those in which "a researcher might ask subjects to watch a video, or read a paragraph or solve puzzles, and then ask them some questions to elicit word associations or time performance of activities."

That's it. No more judgment calls about the risks of liability or harm to financial standing, employability, or reputation. No more squabbling about what those terms mean.

* Researchers could begin more quickly

Current regulations do not require administrative approval of exempt research, but OHRP recommends it, and that seems to be standard practice at most universities. Getting this approval is usually fairly quick, but not always. For example, at the University of Michigan 8 percent of exempt applications at the main-campus IRB took more than four weeks for approval, and more than half required some change to get approval.

Under the new system, "researchers would file with their institution or IRB a brief registration form (about one page long) that provides essential information about the study, including, for example, information about who will be the principal investigator, and the purpose of the study. The researchers would then be authorized to begin conducting the study after the filing (unless the institution chose to review that filing and determined that the research did not qualify as Excused)."

* Oral consent might be highlighted

The current Common Rule does not require written consent forms for exempt research and allows IRBs to waive the requirement for written consent forms if "the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context." But this provision is easily overlooked in a system that presents written consent as the norm and oral consent as an exception.

Under the ANPRM, "oral consent without written documentation would continue to be acceptable for many research studies involving educational tests, surveys, focus groups, interviews, and similar procedures." Perhaps this provision could be made more prominent.

* Real names might be explicitly allowed

The current Common Rule does not require that participants' identities be withheld, but its emphasis on confidentiality has led many IRBs to insist on inappropriate anonymity. ANPRM proposes that the rules for Excused research would explicitly "allow subjects to authorize researchers to disclose the subjects’ identities, in circumstances where investigators wish to publicly recognize their subjects in published reports, and the subjects appreciate that recognition."

Pitfalls of the Excused Category for Social Science

* Subjective criteria for questions could be re-introduced

The ANPRM imagines a number of possibilities for the category, including denying Excused status for "surveys and related methodologies" involving "topics that are emotionally charged, such as sexual or physical abuse." (Question 16) If this happens, we can imagine IRBs insisting that researchers write out all their questions in advance, so an administrator can screen them for questions about abuse, and we can expect long debates about what topics are emotionally charged. Once again, researchers who do not begin their projects with scripted questions will be turned into low-level cheaters.

* Geographical indicators would trigger IRB review

This is a big one. The ANPRM imagines that research in the Excused category would have to avoid sharing any of the 18 identifiers in the HIPAA Privacy Rule. That includes "all geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes." (One can use the initial three digits of a zip code if the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people. I think this means that I can report I am studying people in zip code 222xx, but not in Arlington, Virginia. Go figure.)

This means that any community studies that identified their sites--like "interviews with undocumented Latinos in Southern California" or observations of the function of Maori meeting houses in Aukland--would have to go through expedited for full-board review simply because its geographical specificity. This would add to IRB and researcher burdens, contrary to the goal of the ANPRM.

* Participant observation and focus groups might trigger IRB review

The proposal for the Excused category imagines that

research involving the collection and use of identifiable data, as well as data in limited data set form, could be required to adhere to data security standards modeled on the HIPAA Security Rule.

In particular, for research involving individually identifiable information, all biospecimens, and limited data sets, data security standards could require the use of reasonable and appropriate encryption for data maintained or transmitted in electronic form and strong physical safeguards for information maintained in paper form, audit trails, and access controls that allow only authorized personnel to have access to the information. (44526)

How would this work when information is gathered from groups? For example, members of a focus group see each others' faces. ["Communication Scholars’ Narratives of IRB Experiences," Journal of Applied Communication Research 33 (August 2005), 204.] And a researcher doing participant observation might strike up a conversation within hearing of other research participants.

Perhaps the rule could be interpreted to mean that all participants in a research project could be considered "authorized personnel," but that would have to be made explicit.

* Quasi-anonymous reporting might trigger IRB review

Some social scientists use pseudonyms to protect the privacy of their informants but still provide information that could be used to identify them, though with some effort. Take this passage from Kathryn Marie Dudley's End of the Line: Lost Jobs, New Lives in Postindustrial America, which uses fictitious names but not "falsified biographies."

"The mentality of many people in this community was that American Motors or Chrysler was going to be the salvation," says Ron Carleson, a business adminsitrator in the Kenosha school district. Ron grew up in Kenosha, and as the son of an optician who served many clients in the blue-collar community, he feels he has a special understanding of the day-to-day realities factory workers must deal with. (188)

Presumably, some of Carleson's co-workers and friends could identify him from this description, but most readers cannot.

I am not a big fan of such quasi-anonymity; I wonder if "Carleson" would have wanted a pseudonym had Dudley not presented that as the default choice. And maybe if a researcher concludes that a statement is so sensitive that a pseudonym is called for, research including that statement should undergo some kind of ethical proofreading before publication.

Still, social scientists preparing comments on the ANPRM should be aware that this kind of work might not be Excused.

* Unreasonable data security requirements might be imposed

The ANPRM suggests requirements for "the use of reasonable and appropriate encryption for data maintained or transmitted in electronic form and strong physical safeguards for information maintained in paper form." This could be consistent with the professional practices of social researchers, but past experience has shown the danger of relying on IRBs' and administrators' sense of what is "reasonable."

(Thanks to an anonymous commenter for pointing this out.)

* A waiting period could delay research and increase administrative burden

Question 19 imagines "a brief waiting period (e.g. one week) before a researcher may commence research after submitting the one-page registration form, to allow institutions to look at the forms and determine if some studies should not be Excused."

This would immediately defeat the ANPRM's design to "discourage having each of these registration forms undergo a comprehensive administrative review prior to commencing the study or even afterward." For what is a determination that some studies should not be Excused if not an administrative review at least as comprehensive as the ones currently used for exemption? A waiting period risks imposing prior review on all studies and retrospective review on some, thus increasing, rather than decreasing, the administrative burden.

The requirement would be particularly onerous for researchers who want to react to breaking events or whose research builds on daily observations and lacks defined starting and ending points.

Conclusion

If the standards are rewritten so that IRB review is triggered only if a project crosses clearly defined thresholds, one can imagine a system that functions much more in the ways intended by the authors of the original Common Rule, who sought to "exclude most social science research projects from the jurisdiction of the regulations."

But if the revision to the Common Rule imposes HIPAA standards, without modification, upon social science, it will be a disaster for researchers, administrators, and participants alike, since a great deal of research that is currently exempt would trigger expedited or full review on the grounds that it includes geographical information. Depending on the exact provisions concerning sensitive topics, anonymity, data security, and waiting periods, matters could be worse still.

My recommendation, then, is that while scholars in the social sciences and the humanities may be cautiously supportive of the Excused category proposal, their first choice should be a redefinition of the scope of the regulations to align them to federal law. More on that soon.