Monday, May 28, 2007

Scott Atran, "Research Police – How a University IRB Thwarts Understanding of Terrorism"

Blogger's note: In March the Harvard Crimson mentioned an unpublished essay by ethnographer Scott Atran of the University of Michigan, detailing his complaints about the IRB process. With Dr. Atran's kind permission, I present the complete essay here. ZMS


Scott Atran, research director in anthropology at the National Center for Scientific Research in Paris, visiting professor of Psychology and Public Policy at the University of Michigan, and presidential scholar in sociology at the John Jay College of Criminal Justice in New York City.*


Many bemoan the academic community's lack of input and influence in shaping society's understanding and actions regarding one of the most pressing issues of our time – terrorism.

On one side, those close to the "war on terrorism" often argue that academics are stuck in a post-Vietnam syndrome, basically out to lunch on the "hard" issues of helping their own society defend against aggressors or build enduring peace, or even acknowledging that there may be fundamental clashes between different cultural values that underlie and sustain conflict. In an article in The National Interest, "Thinking Outside the Tank," senior Rand analyst Steve Simon and counter-terrorism expert Jonathan Stevenson surmised that "scholars are now farther than ever from furnishing creative analytical support to policymakers," and recommended that academics should be left to their irrelevance.

On the other side, many in academia fear that their intellectual interests, integrity and independence could again be corrupted, as in the McCarthy and Vietnam years, and as in societies where governments have dictated what those interests should be, such as Nazi Germany, Soviet Russia, Saddam's Iraq, or many of our current allies in the Muslim world. Often they believe that the U.S. administration's motives in "the war against terrorism" are dishonest and that its effects disastrously corrode civil society and international relationships. They believe that academics should stay above the fray, but remain critically-minded.

Both sides have valid points, but also tend to exaggerate the naivété or malevolence of the other side. That's not unique to these groups; it's pretty much a character of adversarial groups anywhere, anytime. Research by Stanford social psychologist Lee Ross and others shows that individuals tend to misperceive differences between groups as more extreme than they really are, and also that individuals believe that their own group sees the world more objectively than other groups.
But a strong impediment to academic involvement in the great social issue of where terrorism comes from and what to do about it may not be from any lack of will or interest, but from the narrow vision of a relatively young but increasingly powerful bureaucratic institution that rigidly rules university research – the Institutional Review Board (IRB).

The roots of the IRB go back to the Nuremberg trials, where recognition of the need for guidelines dealing with human subjects in research emerged following disclosure of medical experimentation abuses by Nazi doctors. But the three guiding principles for IRBs were only formally codified in the 1979 "Belmont Report" by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (established by Public Law 93-348): Beneficence (to maximize benefits for science, humanity, and research participants and to avoid or minimize risk or harm), Respect (to protect the autonomy and privacy rights of participants), Justice (To ensure the fair distribution among persons and groups of the costs and benefits of research). At one of my home institutions, the University of Michigan, you can't even submit research for IRB approval until you take a test showing that you've memorized these principles.

Despite these good intentions, almost anyone who has tried to do research with human subjects outside of standard contexts has horror stories to tell about IRB demands to fit research that explores unfamiliar settings into a structurally familiar mode, no matter how arbitrary or uncomfortable the fit for subjects or researchers. What's a standard context? In non-clinical psychology, for example, well over 90 percent of studies are done within a few miles of major research universities, typically with undergraduates, and then usually generalized to Homo sapiens without a blink.

Many complaints, my own included, often have more to do with conflicts over procedures and protocols than over the nature and value of the research itself. For example, it's standard procedure to have subjects sign statements of informed consent acknowledging that the researcher has told them clearly and understandably what the study is about, making provisions to safeguard subjects from physical or psychological harm or discomfort, clarifying issues of how data will be accessed and used, spelling out costs and payments, and so on. IRBs do genuinely care about protecting the people who are being studied from being exploited or coming to harm. And so do I; I've used my research to help set up a forest reserve for the last Lowland Maya of northern Guatemala and to provide backdoor channels for Middle East truce negotiations. But it took me months to convince the University of Michigan IRB that Maya who can't read or write can't sign consent forms, that if they could they wouldn't (these Maya once put their "X" on a piece of paper they couldn't read, signing away most of their land), and that collective payment to subjects in the form of supplies for the community's forest reserve was a better idea than individual payments that would cause jealousies.

On terrorism, though, my row with IRB is different. There are very, very few scholars who directly talk to terrorists or those who inspire and care for them, although there's no end to elaborate theories and voluminous books on the subject. But I'm an anthropologist who believes in the principle, first spelled out by Isaac Newton in a letter to Nathaniel Hawes, that: "If, instead of sending the observations of able seamen to able mathematicians on land, the land would send able mathematicians to sea, it would signify much more to the improvement of navigation and the safety of men's lives and estates on that element."

On the basis of this principle, joined to solid research proposals, the National Science Foundation and Department of Defense independently granted a considerable sum of the U.S. taxpayer money to our cross-disciplinary, multi-university, international team (including researchers from Michigan, MIT, Harvard, Northwestern, Germany, France, Israel, Palestine and Indonesia) to interview jihadis in different settings, and run experiments with them on a range of theoretically interesting issues, including how group dynamics can trump individual personality in motivating suicide bombers, and how sacred values can limit rational choice with cultural taboos that block tradeoffs and kill attempts at compromise and negotiation. For example, our society considers that selling children or selling out one's country is immoral and sociopathic; many Native Americans believe that uninhabited burial grounds ought not be violated no matter what the majority voters decide or what material compensation is offered. But what's sacred and non-negotiable for jihadis, and what policy implications follow?

To date, UM's's arguments are these: You can't interview failed suicide bombers or their sponsors who are prisoners, because prisoners cannot, in principle, freely give informed consent. Thus, the IRB stipulated that parole boards must be kept abreast of everything and lawyers had to come along into the jail cells of the Bali bombers to verify that questions weren't potentially prejudicial to the prisoners. But it's nigh impossible to do serious anthropology or psychology with a lawyer present, and there are no parole boards in Indonesian military prisons. Nor is there any reasonable likelihood of that this sort of research will worsen the condition of convicted mass killers. Even if the IRBs conditions could be met, UM's told me that it considers research with prisoners like these to be "in principle" incompatible with the rights of human subjects and therefore "never" likely to be approved. This, despite the fact that the prisoners and the organizations that originally sponsored their actions are more than willing to give their consent and eager to get their ideas out.

So what about interviewing freely operating jihadis and would-be suicide bombers. Initially, the IRB decided that federal funds could not be used, despite well-accepted guarantees of complete anonymity (no recording of names, physical characteristics, places, settings, etc), because subjects might inadvertently reveal operational plans that could put them in jeopardy. Although any statement of consent would expressly inform subjects not to talk about operations, IRB's argument was that government intelligence services, or others, might find out about the interviews to identify and use against subjects. I do believe it is reasonable for the IRB to require a researcher not to ask about current or future operations because such information could put the interviewer in an impossible ethical bind with respect to whether to inform authorities so that victims lives might be spared. But it seems unreasonable to prevent research wherever avoidance of ethical dilemmas cannot be foolproof.

As it turns out, in August 2005 I did inadvertently find out about the formation of a rogue Jemaah Islamiyah suicide squad, thoifah moqatilah (fighting group), and vague plans to attack western targets, possibly tourist spots in Bali again. And I did report this to the U.S. Senate Foreign Affairs staff at a briefing on my research in September 2005, shortly before the October Bali bombing. But my receiving this information, and the moral obligation to report it, did not seriously compromise the health or welfare of the suicide bombers who carried out the attack or those who sponsored them. And if it had? If the suicide bombers had been stopped because of the information I inadvertently obtained, then by UM's's moral logic I would have been ethically remiss by disrespectfully violating the bombers' wishes in helping to save their lives and the lives of their intended victims.

Other IRBs, it is true, might have balanced this ostensible ethical lapse on Respect with the values of Beneficence and Justice. But I also apparently failed to make a sufficient case of the "costs and benefits" to the university and society of the research, though I pointed out that my interviews with radical Islamist leaders resulted in fruitful contacts during a crucial Middle East ceasefire negotiation and that any lives saved should count as a net benefit of the research. More generally, helping to understand why someone would want to blow up Manhattan, London, Tel Aviv or Jakarta could help to stop Manhattan, London, Tel Aviv or Jakarta from getting blown up and that, too, would be a pretty good benefit. But that argument was not, it appears, strong or clear enough.

After many months, the IRB decided to release emergency funds that were specifically awarded by the National Science Foundation for "high risk research" to do pilot interviews with freely operating jihadis, but with two caveats: no group identifications should be registered (this forbids comparing, say, Jemaah Islamiyah to Hamas, or to any other group in the world, which puts a serious constraint on a project aimed at comparative understanding of jihadi groups); and no personal details should be collected (this rules out asking what personally may have motivated someone to join jihad, which puts a serious constraint on understanding what motivates individual jihadis). In a penultimate round of discussions, the IRB seemed to have accepted the argument that labels like "Group A" versus "Group B" were permissible and that general descriptions of motivations without any details that could identify persons, places or events were allowed.

In the end, UM's IRB decided that the permission it had given me to carry out the truncated emergency research could not be pursued further, even on matters that had been previously approved, and against which no new objections had been raised. Although initial research results were tentative, as in almost any research project, the research itself could not reasonably have been judged shoddy or trivial: preliminary results of the research were published in reputable scientific and public outlets, including articles in Science and Nature magazines, The Washington Quarterly and Foreign Policy, and The New York Times and Wall Street Journal.

Because the IRB has dictatorial powers, with no right of representation by those being judged and no right of appeal to any higher authority in the university – or for that matter, in the land – it seemed the research was dead. It turns out, however, that after intense lobbying by several faculty and university administrators, the IRB did ultimately give temporary dry approval (approval to plan research only, with no involvement of human subjects) for one of the research projects, although the IRB declined to do so for the identical design on another project. But dry approval only means that money may be spent for travel and meetings with colleagues to discuss the results of previous research and to plan for future research, but not to have students or anyone else undertake research, or even to analyze or do any work with the results of previous research. For those who may think that sounds crazy, the IRB has a stunning reply: because the implications of previously collected data or previous findings related to human subjects may have implications for those subjects, or other humans, that may be different from the implications originally foreseen, then any proposal for the analysis of secondary data that does not directly involve human subjects must be treated as a new proposal involving human subjects. This is a chilling constraint that has the potential to stop a research program dead in its tracks, in the face of any politically correct wind, no matter how advanced that research or how distant from any living or dead human subjects.

My own view is that most of this is nuts: how is anybody in academia ever going have as much as possible to offer in this whole mess – though people in academia keep complaining that the government doesn't pay attention to serious scholars – if no one can even talk to the people most involved? Now, it's getting next to impossible to even talk to people who are dying to kill in order to better understand why they die to kill, or just why they want what they want. And, of course, IRB expressly forbids even thinking about trying to stop them from actually doing what they want because that could interfere with their rights. "Don't ask, don't tell" isn't enough – IRB wants guarantees that the opportunity for discovery can never arise.

Ask any anthropologist, political mediator, or hostage negotiator worth their salt and they'll tell you that you need to show empathy and respect towards the other party to learn anything of true or lasting value. If that's what the IRB required it would be good and right. But that isn't what IRB asks for: IRB rules say nothing about promoting empathy for subjects, only about following to the letter rules that are tailored to respect subjects' individual rights to their own privacy and property as if the research were in an American university classroom or laboratory.

I'd like to be clear that I don't simply blame the members of UM's IRB. I think the major fault lies with the IRB as an institution and the rules it is required to implement, rather than the people enforcing the rules. Perhaps one remedy is that certain kinds of IRB approvals should be taken at the national rather than the university level, though institutionally protected from the political riptides of the electoral cycle. The advantage of a national board is that their sponsors could be government agencies whose interests focus more on their mission (such as national security) than on protection of undergraduate students. A national board (or boards) could then use guidelines that would differ from those designed to protect interests of typical subjects. There are various ways to define the domain of a national board, such as "prisoner's and those hiding from the law." Alternatively, it could be defined as using subjects who are relevant to national security (under a very narrow formulation). One would have to decide whether, for example, studies of urban gangs in the USA should be covered or not by a national board.

There are, to be sure, also serious disadvantages to a national IRB, including the potential for pressure from the sponsors to say "anything goes." So, another remedy might be to change the guidelines used by university IRB's that would apply to special circumstances, such as working with violent militants, where even requiring respect may be tricky. Perhaps most important, all the boards should understand and evaluate the facts to some definable standard and apply the same values, unless there were defensible differences in community standards. Lack of inter-board reliability is a guarantee of lack of validity in judgment of facts and in judgment of values.

Over three years ago, in testimony before the House Science Committee, Dr. M.R.C. Greenwood, Chancellor of the University of California, Santa Cruz, argued that "the traditions and structure of research in the U.S. today depends on replication and refutation, which means… sufficient data and methods," and that "balancing the perceived risks of open access with the risks to the health and vitality of the research community is exactly the kind of issue that calls for a new partnership between the research community and the government." That partnership is woefully lacking when it comes to dealing with terrorism, in part because universities and the government have chained themselves to an institution that not only never fathomed dealing with suicide bombers – true not just for IRBs – but which lacks the flexibility and imagination to face the problem. Yet suicide bombers are here; they've burst upon the world and, along with their sponsors and supporters, are changing how societies seek security and interact. This needs to be looked at up close. So IRBs, let the scholars go out to sea.

*I wish to thank Robert and Amy Axelrod, Richard Nisbett, Douglas Medin, Steven Pinker, Baruch Fischhoff and Charles Strozier for suggestions on an earlier draft. They bear no responsibility for any arguments presented here.

Thursday, May 24, 2007

Even the Best IRB Can Antagonize Researchers

Judging from Samuel P. Jacobs's story, "Stern Lessons For Terrorism Expert," Harvard Crimson, March 23, 2007, the Harvard IRB is pretty darn good when it comes to non-biomedical research. Policy researcher Jessica E. Stern learned from the IRB to "not learn the names of many of the people she is interviewing—preferring to use pseudonyms—thus protecting the privacy of her interviewees and making her notes less valuable to federal investigators." She states, “Harvard’s IRB is the only one I know of to approve the kind of research I do. They’ve bent over backwards to make what I do possible, which is better than any other IRB.” Law professor Elizabeth Warren has “never encountered an IRB as helpful as Harvard’s."

Yet another researcher finds "the process is so cryptic and idiosyncratic" that "his students often can’t anticipate the reasons why the institutional review board will reject a proposal." And Stern herself, who got valuable help from the IRB, complains that "Before I came to Harvard, I had pretty remarkable interviews with terrorists . . . There are a lot of reasons that those kind of interviews would be hard today. One of them is the post-September 11 environment, but the other is the IRB strictures.” One project, to interview radical black Muslims, died entirely because of the delay in approval. (Note: this is just what Robert Kerr warned us about.)

How can we have the best of both worlds—helpful advice without arbitrary rejections and delays? Voluntary review.

Wednesday, May 23, 2007

Jeffrey Cohen: More Argument Without Evidence

In a new posting on his blog, Jeffrey Cohen writes,

One of the major propositions that the critics of IRB review of social research put forth is that minimal risk social research with competent adults should be completely exempt from IRB review. On the surface, this makes some sense. We're talking about research that is unlikely to harm anyone and where adults can decide for themselves whether to participate. Why do we need to review such research? Based on my experience personally reviewing thousands of research protocols in the social sciences, there is one basic problem with this - researchers are human beings. Human beings are not perfect - they overlook things, make mistakes and and can't be totally objective about their own work. If researchers were perfect, if they always took all of the ethical issues into account when planning and conducting their research, then we wouldn't need IRB review. But they are not perfect - none of us are perfect. So, every research activity needs an independent, objective review.


Characteristically, Cohen offers not a single example of a social research project whose ethical content was improved by his or any IRB review, much less one that could only be improved thanks to the broad definitions and coercive rules now used by IRBs. (And no, forcing interviewers to carry lists of mental-health centers doesn't count.) If he has such examples, he should offer them. If not, a vague reference to "thousands of research protocols" is unlikely to persuade a community of scholars trained to think critically and to weigh evidence.

Monday, May 21, 2007

Zywicki, "Institutional Review Boards as Academic Bureaucracies"

My colleague Todd J. Zywicki, of Mason's law school, has posted on SSRN his contribution to the forthcoming Northwestern Law Review issue on IRBs: "Institutional Review Boards as Academic Bureaucracies: An Economic and Experiential Analysis," http://ssrn.com/abstract_id=983649

As stated in the abstract, the article "argues that the problem is that IRBs are fundamentally bureaucracies, and that this bureaucratic structure explains much of their frequent suboptimal decision-making. The poor performance of IRBs is thus not a consequence of those individuals who comprise it, but rather a reflection of their bureaucratic nature. The bureaucratic nature of IRBs appears to do nothing to improve the decisions that they make, while being the source of many of their problems."

Zywicki is right to note that people who gain money, power, and prestige from controlling other people's work have an incentive to define their duties broadly, even as they fret about researchers' conflicts of interest. Ironically, he seems only dimly aware of the extent to which administrators have seized power from researchers. He writes, "IRBs are fundamentally bureaucracies," not understanding that IRBs themselves are committees of researchers, and that the true bureaucracies are the university compliance offices. He notes, "there is reported to be a growing IRB conference circuit," suggesting his unfamiliarity with PRIM&R and its administrator-dominated conferences. And he makes no mention of the creation, in 1999, of the "Certified IRB Professional" as a new kind of administrator, someone who has staked a great deal on the maintenance, if not expansion, of IRBs' reach.

But buried in the essay is another explanation of the IRBs' expansion:

With respect to university bureaucracies such as IRBs, at least some of the growth in their internal administrative burden has been spurred by governmental regulations. In addition, the preoccupation of IRBs with paperwork and forms has been promoted by a regime of “fear” of governmental oversight, “[f]ear by the institution that it will be ‘out of compliance’ with one or more aspects of the paperwork, and so subject to penalty upon audit (be that by the NIH, the Office for Human Research Protection, the US Department of Agriculture, or whatever other organization is involved).”


How much of the growth of IRB staffs is due to the internal dynamic Zywicki stresses compared to the growing external threat of federal penalty? One way to find out would be to compare the growth of compliance regimes to major OHRP enforcement actions. If as Zywicki notes, the Northwestern University Office for the Protection of Research subjects "grew from two full-time professionals in the late 1990s to 25 professionals and an administrative staff of 20 last year," I'd like to know how much of that growth took place as a response to the suspension of sponsored research at Hopkins, Virginia Commonwealth, and other universities.

Without far more research on the actual workings of IRBs and compliance offices around the country, we can't test hypotheses such as Zywicki's.

Saturday, May 19, 2007

A Trimmer PRIM&R

In my previous posting, I detailed the ways that the composition of PRIM&R's board and the operations of its conferences fail to match its stated mission, and I suggested what it would take for PRIM&R to live up to its claim to serve "the full array of individuals and organizations involved in biomedical and social science/behavioral/educational research." The other option, of course, would be for it to scale back its ambitions to serving merely "the full array of individuals and organizations involved in biomedical research," a noble task and one that its biomedical membership is far better equipped to handle.

PRIM&R's adopting this approach would mean recognizing that current regulations were written with biomedical research in mind and have never suited social science. It should therefore use its prestige to advocate broader exemptions from federal regulation for non-biomedical research. Such exemptions might exclude from IRB review:

* Research involving survey or interview procedures, where the subjects are legally competent, and where the investigator identifies himself/herself, and states that he/she is conducting a research survey or interview

* Research involving the observation (including observation by participants) of public behavior in places where there is no recognized expectation of privacy.

and

* Research involving the observation (including observation by participants) of public behavior in places where there is a recognized expectation of privacy, except where all of the following conditions exist:

(i) Observation are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects,

(ii) the observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, and

(iii) the research deals with sensitive aspects of the subject's own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol.


I fear that Dr. Cohen will reject such proposed exemptions, taking them as evidence that I have "no interest in making IRB review work better for researchers, but only in eliminating IRB review for [my] research." Before he does so, let me point out that these exemptions are not my creations, but those of a joint subcommittee of the American Association of University Professors' Committee A on Academic Freedom and Tenure and Committee R on Government Relations. They were published as a report on Regulations Governing Research on Human Subjects, Academe, December 1981, 358-370.

A member of the subcommittee, and a signatory to the recommendations, was Sanford Chodosh, MD, the founder of PRIM&R.

Wednesday, May 16, 2007

PRIM&R's Public Responsibilities

Jeffrey Cohen writes, "I don't understand why you continue to criticize a program designed to explain and encourage the use of the flexibility available in the regulation and to promote communication and collaboration between IRBs and investigators to facilitate research." His comment shows that I have not made clear my concern with PRIM&R's constitution and operation. Let me suggest, therefore, that PRIM&R is a semi-official body that fails to conduct itself in a manner commensurate to its power and responsibility.

We first need to understand PRIM&R's special status as a chosen instrument of the federal government. Unlike scholarly associations, whose letters to OHRP get brushed off, PRIM&R has long functioned as an arm of OHRP and its predecessor, OPRR. For example,


  • OHRP promotes and distributes PRIM&R's "Investigator 101" CD-ROM. Similarly, PRIM&R prepared the first edition of the Department of Health and Human Services' IRB Guidebook.
  • Former OPRR head Charles McCarthy serves on the PRIM&R board; Cohen, a former OHRP official, co-organized the last conference; and current OHRP officials participate as PRIM&R conference faculty.
  • OHRP exhibits at PRIM&R conferences, and OHRP officials, particularly Michael Carome, use PRIM&R conferences to offer guidance that then gets broadcast by IRB consultants, such as Dr. Cohen.



Given these connections, an IRB member or staffer could reasonably assume that following PRIM&R's guidance is a good way to avoid sanctions by OHRP. (Indeed, she would be foolish to assume otherwise.) Since it these staffers who then return to their institutions and impose conditions on research there, PRIM&R is a key link in the chain between federal power and the daily work of researchers.

PRIM&R itself recognizes this function. For example, the recent conference provided attendees with documents offering guidance on the regulatory definition of human subjects research and the proper application of the exemptions. Since providing just such guidance is one of the responsibilities of OHRP, the conference organizers must feel pretty confident that they have OHRP's blessing to take over this important role. (Note that unlike real OHRP guidance, PRIM&R's documents are not made public.)

If this is so, what must PRIM&R do to use its power wisely and justly?


1. Identify its constituents



PRIM&R's website states that "since 1974, PRIM&R has served the full array of individuals and organizations involved in biomedical and social science/behavioral/educational research." But what constitutes that full array? Is "social science/behavioral/educational research" one category or three? If the latter, what disciplines come under which category? And are there varieties of research (such as folklore, nonfiction writing, and law) that fit none of those categories, yet that face IRB review?

I would like to see PRIM&R list all the disciplines that come under review by IRBs whose members it trains. Then it could try to make some distinctions, for example, between disciplines that offer therapy or advocacy and those that do not; disciplines that study the body and those that do not, disciplines that use formal scientific protocols and those that do not; and the like. This would lead to a second task:

2. Include a range of disciplinary perspectives



As I mentioned earlier, PRIM&R's board of directors is dominated by researchers and administrators from hospitals and medical schools. They cannot be expected to be expert in the ethics and methodologies of the full range of disciplines in the behavioral sciences, social sciences, humanities, and professions, nor could any group of scholars drawn from any one field. If PRIM&R wants to offer sound guidance to researchers in all fields subject to IRB review, it should include them on every level, from conference panels to editorial boards to the board of directors itself. The goal should be that each field has the chance to shape any guidance that affects that field, so PRIM&R does not again, for example, offer a conference panel on oral history with no historians present.

Since the vast bulk of IRB review does concern biomedical research, I would not expect equal numbers for researchers in other fields. But I do think that folklorists should have as much power to shape PRIM&R's advice on folklore as physicians have to shape PRIM&R's advice on medical research. If this requires a complex committee structure, so be it.


3. Include a range of viewpoints



Prior to the recent conference, Dr. Cohen wrote me, "if you would like to participate in the conference, we'd be happy to work you in to the program (provided you have something constructive to say)." Now he writes, "I can only conclude that you have no interest in making IRB review work better for researchers, but only in eliminating IRB review for your research."

Does that mean that someone who believes in wider exemptions from review has nothing constructive to say, and therefore no place in PRIM&R? This would contradict Cohen's earlier pride in having invited Linda Shopes, who has advocated an oral-history exemption far longer and more effectively than I. And it would contradict the above-mentioned panels at the last conference, which seem to assume that the proper scope of exemptions has yet to be determined.

I suggest that PRIM&R invite participants based on their knowledge, experience, and ability to represent their discipline, not their adherence to a party line, and that it make public its criteria for choosing participants in all of its endeavors. Perhaps I am not the right person to represent my field at PRIM&R conferences, but Taylor Atkins sure as heck isn't either.


4. Ease participation in conferences



Now I get to Dr. Cohen's specific invitation for suggestions for future conferences. I have three:

a. Don't schedule the conference during exam week. Dr. Cohen informs me that many researchers declined his invitation to participate in the conference. My guess would be that a big part of their refusal resulted from the fact that the second week of May is exam week around the nation--not a problem for federal officials, administrators, and consultants, but a big one for active teaching faculty. As it is, I am surprised he got three researchers from the University of Minnesota; it was exam week there too. October and November are pretty busy with conferences as well for many scholars. I suggest February or March might be more fruitful.

b. Announce the conference. I'm not sure how I found out about the 2007 SBER conference, but I know it was only a few weeks before the conference, and that I did not hear about it through any of my usual reading as a historian, such as H-ORALHIST, the list for oral historians. An open call for participants, months in advance, sent to scholarly newsletters and e-mail lists might boost participation.

c. Pay the costs of researchers. Maybe PRIM&R already pays the travel costs of conference faculty, but if not, it should. Most university professors are lucky to get funding to travel to one or two conferences a year, and they want to use this to attend conferences within their own disciplines. With PRIM&R charging hundreds of IRB staffers up to $950 to attend, it should be able to subsidize a few dozen researchers.

These last three suggestions might bring a few more researchers to the next PRIM&R conference, but I think the real problem is far deeper than participation at conferences. If, as Cohen suggests, PRIM&R truly seeks "to promote communication and collaboration between IRBs and investigators to facilitate research," it will have to work much harder to include the many investigators it has so long neglected.

Thursday, May 10, 2007

Boise State University's IRB Makes a Poor First Impression

I received an anonymous comment expressing alarm about the new website of Boise State University's Office of Research Administration.

The site presents the following information about the requirement of IRB review:

Federal, state and university regulations require all research (including surveys and questionnaires) involving human subjects or data collected, directly or through records (i.e. medical records, specimens, educational test results, or legal documents) to be reviewed by an Institutional Review Board (IRB) . . .

If you are a faculty or staff member, or student at Boise State University, and your research involves the use of human subjects (either directly or through records or other data such as specimens or autopsy materials), your research requires human subjects review.

"Research" is "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge." 45 CFR 46.102(d). Research includes surveys and interviews, behavioral investigations, retrospective reviews of medical information, experiments with blood and tissue, and demonstration and service programs and clinical trials. In addition, FDA includes under the definition of reviewable research, any use of a FDA regulated product except for use of a marketed product in the practice of medicine.

Note: Any administrative, departmental or course assignments involving surveys, questionnaires and interviews designed for internal use and operations of the University do not constitute "research" within the meaning of this policy if the information or conclusion of this data is not intended for scholarly publication or for dissemination to persons outside the administrative organization of the University.


That's it. No explanation of what federal and state regulations apply. No hint of the exceptions specified in 45 CFR 46.101, nor an easy way to learn more about the requirements.

The site does offer a link to the university's "Human Research Protection Policy - BSU 6325 B," but that link, as well as others on the site, is broken. (Yesterday I wrote to the e-mail address on the site, pointing out these broken links, but I have not received a reply). There's also a link to an "IRB Guideline Summary," which in turn offers a link to a Word document called "TYPES OF IRB REVIEW AND APPROVAL," which finally lists the exceptions. Since neither of these link titles mention exceptions, a visitor who knows enough to find this document probably knows about the exceptions already.

All told, my correspondent can be forgiven for fearing (I hope mistakenly) that Boise State "seems to require submission to IRB for analysis of any record of human behavior."

Boise State's Office of Research Administration shows how to antagonize researchers before even meeting them. I would like to remind all such offices that researchers are trained to read critically. Offer them complete and accurate information, and cite your sources.


Update: The links were fixed on May 15.

Monday, May 7, 2007

PRIM&R Finds Another Social Researcher

On April 13, I noted that the preliminary faculty list for this week's "Social, Behavioral, Educational Research Conference" included only one social researcher among twenty faculty. One of the conference's organizers, Jeffrey Cohen, replied that "the final list will have more social scientists." Well, the final list includes one more researcher: Steven Pennell, Survey Director, University of Michigan. Since the total list has been expanded to 33 faculty, this brings the representation of social researchers from five percent up to six percent. Many of the panels will feature no such representation at all.

The conference announcement asks, "Why is it often so difficult for IRBs and investigators to work together effectively when reviewing sophisticated, socially sensitive social/behavioral/educational research?" One answer might be PRIM&R's apparent belief that IRB administrators can learn to regulate research without hearing from researchers.