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

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.

IRB Thinks Overweight People Are Less Capable of Giving Informed Consent

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]

Judge Demands Boston College Oral Histories

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

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]

Veterans Denied Chance to Comment on Foreign Policy

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"

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.]

Blogday

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

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.

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

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."

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

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.

Claude Fischer: Zealous IRBs Can Derail Social Studies

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.]

Health Researcher Complains of "Social Science Types" and HIPAA

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

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.]

Criminologists: IRB Demands Threatened Confidentiality

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.]

Kojo Nnamdi Show on Common Rule Now Online

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

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

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

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

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.

PRIM&R: IRBs Don't Write Consent Forms

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.

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

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

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

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

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.

New York Times: Menikoff Promises Not to Restrict Public Information

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.]

In ANPRM Comments, Anthropologists Champion Free Inquiry

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.

Rohde Reviews Ethical Imperialism

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.]

OHA Endorses AHA ANPRM Talking Points

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

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.

AAUP Posts ANPRM Comments

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

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.]

What is Behavioral Research?

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

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.

Tuchman Reviews Ethical Imperialism

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.]

ANPRM Comments: Oral Historians Call for Exclusion from Common Rule

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:

ANPRM Question 25: Read the Statute

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.)

Would ANPRM's Audits Require Massive Record-Keeping?

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.

Professional Geographer Focuses on IRBs

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!

Boellstorff Warns of ANPRM Ethics Creep

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.

Circuit Court Affirms Right to Record Videos in Public

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.

Canadian Tortoise Beats American Hare

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

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?

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.

ANPRM Comment Period Extended to October 26

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

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.

Emanuel: ANPRM Will End Reliance on Worthless Gut Reactions

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 surprises 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.

Sociologist: IRBs Have Almost Killed Fieldwork

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.]

Aristotle: History Is Not Generalizable

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?

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

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]

A Quick Guide to the ANPRM

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

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:

Chronicle of Higher Ed Reports on ANPRM

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

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

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

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.

Inside Higher Ed Reports on ANPRM

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?

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.

Will ANPRM Limit the Use of Published Data?

Despite the ANPRM's general goal of "reducing burden, delay, and ambiguity for investigators," the proposed policy for the re-use of pre-existing data threatens to increase all of those by expanding the current definition of human subjects research.

AHA Alerts Members to ANPRM

Robert Townsend, Deputy Director of the American Historical Association, alerts AHA members to the significance of the ANPRM in a blog post: AHA Today: Getting Free of the IRB: A Call to Action for Oral History. The post points up the need for historians to think broadly as they prepare their comments on the ANPRM and not passively accept the categories devised by bioethicists.

ANPRM's Problem Statement: Helpful but Incomplete

One of the many remarkable sections of the July 26 advance notice of proposed rulemaking (ANPRM) is its admission that the Common Rule is flawed.

(Note: I have added a link to the ANPRM at the top of the link list in the sidebar.)

Since the 1970s, IRB apologists have claimed that federal regulations are flexible enough, and that local IRBs are to blame for any problems. In 2007, for example, Jerry Menikoff quoted with approval Jeffrey Cohen's 2006 claim that "the regulations provide sufficient flexibility for the efficient and appropriate review of minimal risk research. IRB review of such research does not have to be burdensome or unreasonable if IRBs appropriately utilize the flexibility in the regulations." Menikoff reiterated his claim of "flexibility within the system" in his 2009 speech, “The Legal Assault on the Common Rule."

After thirty years of such claims, it is wonderfully refreshing that the ANPRM takes so seriously many of the critiques leveled at the federal regulations themselves. And the ANPRM helpfully organizes those critiques into seven general categories.

On the other hand, ANPRM's problem statement (pages 44513-44514 in the Federal Register version) overlooks some major critiques. Fortunately, some of those critiques are implicitly recognized by some of the ANPRM's proposals.

Elliott Wants to Scrap IRBs

Carl Elliott, author of White Coat, Black Hat: Adventures on the Dark Side of Medicine, calls IRBs "incapable" and wants them replaced.

[Carl Elliott, Useless Pharmaceutical Studies, Real Harm, New York Times, 29 July 2011.]

Report on Research Compliance on ANPRM

The August issue of Report on Research Compliance covers ANPRM.

["Human Research Protections Prerule Mandates Regs for Non-Govt. Studies," Report on Research Compliance, August 2011]

The report has a statement from Art Caplan:

“These are long-overdue changes,” Art Caplan, director of the Center for Bioethics at the University of Pennsylvania, told RRC. “The current system involves too much red tape and paperwork in proportion to the protection given to subjects. In some ways the system of human subjects protection — informed consent and review by IRBs [i.e., institutional review boards] — has been hijacked by legal concerns so that more attention is given to institutional and investigator protection than subject empower- ment. These changes help remedy that problem.”

Your humble blogger is also quoted, complaining about the lack of attention to the experience of other countries. I did overlook ANPRM's footnote 28: "Cribb R. Ethical regulation and humanities research in Australia: Problems and consequences. Monash Bioethics Rev 2004;23(3):39–57." Other than that, has anyone found references to the workings of ethics committees in other countries?

ANPRM Hits Federal Register; Comments Due September 26

The ANPRM is in today's Federal Register, Volume 76 Issue 143 (Tuesday, July 26, 2011)

Comments are therefore due before 5 p.m. on September 26, 2011.

Emanuel and Menikoff Explain the ANPRM

Ezekiel Emanuel, head of the Department of Bioethics at NIH, and Jerry Menikoff, director of OHRP, explain the ANPRM for readers of the New England Journal of Medicine.

[Ezekiel J. Emanuel and Jerry Menikoff, "Reforming the Regulations Governing Research with Human Subjects," New England Journal of Medicine, 25 July 2011. h/t Michelle Meyer]

The essay is a very helpful introduction to the ANPRM, clearer than the ANPRM itself. The authors conclude,

After 20 years, and the introduction of significant changes to the research landscape, many believe that the Common Rule needs revision. The ANPRM offers a rare opportunity for needed modernization that is consistent with the President’s mandate to enhance protections while simultaneously eliminating unreasonable burdens. Not everyone will agree with every proposed change. But the ideal should not be the enemy of substantial progress in achieving these two important goals. If this reform effort fails, 20 years from now, someone might write an article for the Journal to bemoan the fact that the Common Rule has undergone essentially no change in 40 years.

Fine, I'll say it. I agree with Jerry Menikoff.

New York Times Reports on ANPRM

Andrew Pollack, "Rule Changes Proposed for Research on Humans," New York Times, 24 July 2011.

Like the Washington Post story, this lacks any explanation of who wrote the ANPRM or why it came out now. But it does have some good quotations:

“It’s a terrible drag on getting good research done,” said Dr. Robert J. Levine, a professor of medicine and a bioethicist at Yale who headed the university’s institutional review board for 31 years. He said Sunday that while he had not thoroughly reviewed the government’s lengthy proposal, he was encouraged by what he had seen.

and

Carl Wieman, associate director for science at the White House Office of Science and Technology Policy, said it was now difficult to observe teachers and students in classrooms to help determine what makes a good teacher, given all the consent required. “You’re not doing anything here except watching people,” he said.

Washington Post Reports on ANPRM

David Brown, "U.S. proposes rule changes for human-subject research," Washington Post, 23 July 2011.

Feds Ponder Biggest IRB Rules Changes in 30 Years!

On Friday, the U.S. Department of Health and Human Services posted an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, to be published in the July 25 Federal Register.

The ANPRM seeks to "enhance the effectiveness of the research oversight system by improving the protections for human subjects while also reducing burdens, delays, and ambiguity for investigators and research subjects." In 92 pages, it suggests dozens of potential changes, some of them quite major. They would represent the biggest regulatory changes to the US IRB system since the revision of 45 CFR 46 in 1981.

Watch this space for extensive and frequent commentary on specific provisions in the proposal as I draft comments prior to the end of the 60 day comment period. (September 22? How do they count these things?)

For now, I will just register my delight that the federal government has finally acknowledged that the flaws in the present system are not mere anomalies, but represent systematic problems that demand regulatory reform.

Oh, and thanks for the three citations to my work! Attention has been paid!

U of Michigan Reports Some Progress

The University of Michigan has released the results of a 2009 survey of investigator experiences in human research. The survey suggests that matters have improved somewhat since the university launched its HRPP Policy Innovation and Demonstration Initiative in 2007, but that more work remains to be done.

[Survey Research Center, Institute for Social Research, University of Michigan, "2009 Follow-Up Survey of Investigator Experiences in Human Research," December 2010. h/t: Human Research Protections Blog.]

Alarmist Views on Harvard Facebook Study

The Chronicle of Higher Ed reports a debate over a study of Facebook profiles, started in 2006 by Jason Kaufman of Harvard's Berkman Center for Internet & Society. The debate suggests that researchers may not be aware of how easy it can be to identify allegedly anonymous institutions and individuals, but that neither IRBs nor outside critics may understand all the implications of a study either.

[Marc Parry, "Harvard's Privacy Meltdown," Chronicle of Higher Education, 10 July 2011.]

DOJ: "There Is No Academic Privilege"

As reported in Inside Higher Ed, the Department of Justice has filed a brief in the British government's effort to gain access to oral history records at Boston College. The Department asks the court to honor the U.S. attorney's subpoena on the grounds that "there is no academic privilege which shields the material from disclosure."

SACHRP to Hear from Presidential Commission

The Secretary’s Advisory Committee on Human Research Protections (SACHRP)
has posted the agenda for its July meeting. The committee will receive a briefing on the Presidential Commission for the Study of Bioethical Issues from the commission's executive director.

Any chance the phrases "nitpicking monster" or "mortifyingly stupid" will be used?

The committee will also get a report from its own Subcommittee on Harmonization.

SACHRP Now Lacks Social Scientists

Anthropologist Patricia A. Marshall, the sole social scientist on the Secretary's Advisory Committee on Human Research Protections (SACHRP), completed her term on the committee in March, along with three other members.

Erdos: U.K. Data Protection Act May Stifle Research

David Erdos of the University of Oxford kindly alerted me to two recent publications in which he warns that the United Kingdom's Data Protection Act 1998, which implements European Union requirements, could inhibit social research in much the same way human subjects laws and regulations have done in the United Kingdom, Canada, and the United States.

David Erdos, "Systematically Handicapped? Social Research in the Data Protection Framework, Information & Communications Technology Law 20, no. 2 (2011): 83-101,
doi: 10.1080/13600834.2011.578925
David Erdos, "Stuck in the Thicket? Social Research under the First Data Protection Principle," International Journal of Law and Information Technology 19, No. 2 (2011), doi:10.1093/ijlit/ear001.]

New FWA Terms Allow Alternatives to Belmont

In September 2010, OHRP posted drafts of new FWA form and FWA Terms of Assurance. In my comments, I asked that the drafts be revised to make clear that under 45 CFR 46.103(b)(1), institutions have the right to choose any statement of principles they wish, including statements they formulate themselves. Other comments also made this point.

I also asked that the FWA terms allow institutions to conform to the current version of Canada's Tri-Council Policy Statement, rather than the 2005 version mentioned in the OHRP draft.

OHRP has now released the new version of the FWA terms. I am happy to report that both of my suggestions have been adopted.

U.S. and British Governments Subpoena Oral Histories

Last month, the United States Attorney’s office filed a subpoena for two tapes that were recorded as part of the Boston College’s Oral History Archive on the Troubles in Northern Ireland. It did so at the request of the Police Service of Northern Ireland, part of the British Government. As reported by the New York Times, British authorities apparently want the tapes for an investigation into murders and kidnappings committed decades ago.

The CITI Program as Mortifyingly Stupid, Marxist Doxology

The Presidential Commission for the Study of Bioethical Issues has posted videos and transcripts of its Meeting Five, held May 18 and 19 in New York City. I earlier linked to the Commission's summary of the statement by Ronald Bayer, professor and co-chair of the Center for the History of Ethics of Public Health at the Mailman School of Public Health at Columbia University. Now that we have the verbatim text, it is worth quoting as well.

Overall, Bayer lamented that the IRB system has "turned itself into an object of ridicule and sometimes contempt in a way that I think is dangerous to those who believe in the ethical conduct of research."

Particularly choice is Bayer's description of the CITI Program, a widely used online training course in research ethics, which Columbia University requires researchers to complete every three years.

Dreger on Naming Names

Alice Dreger explains why historians are reluctant to promise either anonymity or nonmaleficence:

Real accountability requires real names.

Dingwall on Isomorphism

Will Pakistan set up ethics committees for social science regardless of whether it has had problems with social research ethics?

Sex Researcher Calls for "An Evidence-Informed Process"

Brian Mustanski, Associate Professor, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, calls for "moving the IRB process of risk/benefit assessment from being entirely subjective to being evidence-based."

[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, published online 29 April 2011.]

Ethics Experts Stupefied by a "Nitpicking Monster"

blog.Bioethics.gov, the official blog of the Presidential Commission for the Study of Bioethical Issues, reports on two experts' frustration with the gap between the good intentions behind the IRB system and the depressing reality faced by researchers.

Australian Political Scientist: "Causing Harm . . . May Be the Whole Point"

Anthony Langlois, Associate Professor in the Department of International Relations at Flinders University, Adelaide, Australia, and a former member and chair of that university's Social and Behavioural Research Ethics Committee, finds that Australia's 2007 National Statement on Ethical Conduct in Human Research is an improvement over earlier policies, but that it still leaves an "ill fit between the requirements of [the medical] model of research ethics review and the nature of humanities and social sciences research."

[Anthony J. Langlois, "Political  Research  and  Human  Research  Ethics  Committees," Australian Journal of Political Science 46 (2011): 139-154, DOI: 10.1080/10361146.2010.544287. Also available as a preliminary preprint. Thanks to Professor Langlois for mentioning the essay on socialsciencepsace.com.]

Bersoff Reviews Ethical Imperialism

Donald N. Bersoff, a professor of psychology and law at Drexel University, has reviewed Ethical Imperialism for PsycCRITIQUES, the American Psychological Association's online database of book reviews.

[Donald N. Bersoff, "Common Rule or Common Ignorance? A Review of Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009 by Zachary M. Schrag," PsycCRITIQUES 56, Release 18 (4 May 2011), Article 3.]

My Comments to the Presidential Commission

I rather belatedly learned that the Presidential Commission for the Study of Bioethical Issues was seeking public comment on the Federal and international standards for protecting the health and well-being of participants in scientific studies supported by the Federal Government. The deadline for comments is tomorrow, May 2.

Here are my comments, hastily cribbed from the conclusion of my book:

University of Iowa: Ask IRB Before Reading Poetry

I recently reported on the University of Iowa's Stanley Graduate Awards for International Research, whose information page seems to require applicants to contact the IRB, even if they are studying twelfth‐century church records, ancient Greek and Roman houses, or Neanderthal worked bone technology.

Harvard Law Fellow Tweets PRIM&R SBER

Michelle Meyer, an academic fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, Harvard Law School, is live tweeting the ongoing PRIM&R SBER conference in Boston.

To read her tweets, which so far include some especially interesting comments from Ezekiel Emanuel and C. K. Gunsalus, search the hash tag #primr_sber11.

[Many thanks to Dr. Meyer for alerting me.]

USC Frees Oral History

The University of Southern California has ruled that oral history projects are not subject to IRB review.

University of Iowa: Ask IRB Before Researching Neanderthals

Someone at the University of Iowa apparently thinks that the IRB has jurisdiction over research with dead Neanderthals.

Hope College Frees Oral History

Hope College, a liberal arts college in Michigan, has posted Oral History Research Guidelines that give substantial leeway to oral history projects:'

Perspectives on History Interviews Me

The April 2011 issue of Perspectives on History, the newsmagazine of the American Historical Association, features an interview with your humble blogger by Robert B. Townsend, the AHA’s assistant director for research and publications.

ETA (4-14-2011): The interview is currently viewable only by members of the AHA, but I understand it will become open to all on May 1.

Princeton Offers PhD Students Serious Training in Historians' Ethics

Google alerted me to an innovative effort to train historians in the responsible conduct of research.

[Angela Creager and John Haldon, "Responsible Conduct of Research Workshop, June 14-15, 2010," Princeton University.]

Law Professor Sees Broad Role for IRBs in Virtual Worlds

Professor Joshua A. T. Fairfield of the Washington & Lee University School of Law explores the law of research in virtual worlds.

[Joshua Fairfield, "Avatar Experimentation: Human Subjects Research in Virtual Worlds." (November 29, 2010). U.C. Irvine Law Review, Symposium Issue, 2011; Washington & Lee Legal Studies Paper No. 2010-14. Available at SSRN: http://ssrn.com/abstract=1717057.]

Fairfield makes some important points about how researchers interested in these environments might apply ethical guidelines developed for older forms of research. But the article pays insufficient attention to the limits of ethical guidance developed to govern medical experimentation, misstates some of the provisions of current regulations, and downplays the troubles Internet researchers have faced with IRBs.

Beauchamp Derides Federal Definition of Research

Along with Whitney and Schneider's article on the cost in lives of ethics board review of biomedical research, the "ethics symposium" in April 2011 issue of the Journal of Internal Medicine features an intriguing essay by Tom Beauchamp, Senior Research Scholar at the Kennedy Institute of Ethics and Professor of Philosophy at Georgetown University.

[T. L. Beauchamp, "Why Our Conceptions of Research and Practice May Not Serve the Best Interest of Patients and Subjects, Journal of Internal Medicine 269, no. 4, (April 2011): 383-387, doi: 10.1111/j.1365-2796.2011.02350_1.x]

As a staffer of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the 1970s, Beauchamp played a key role in the development of the Belmont Report. Yet in this essay, he disparages one of the National Commission's most enduring legacies: the definition of research encoded in today's federal regulations.

The Costs of Ethical Review, Part II

Researchers on both sides of the Atantic are trying to measure how the delay due to ethics review in medical research can harm or kill those who would benefit from innovative therapy.

[Ian Roberts, David Prieto-Merino, Haleema Shakur, Iain Chalmers, Jon Nicholl, "Effect of Consent Rituals on Mortality in Emergency Care Research," Lancet 377, no. 9771 (26 March 2011): 1071-1072, doi:10.1016/S0140-6736(11)60317-6; S. N. Whitney and C. E. Schneider, "Viewpoint: A Method to Estimate the Cost in Lives of Ethics Board Review of Biomedical Research," Journal of Internal Medicine 269, no. 4, (April 2011): 396-402, doi: 10.1111/j.1365-2796.2011.02351_2.x See also The Costs of Ethical Review. Hat tips to Rebecca Tushnet and Simon Whitney.]

Bioethical Issues Commission Narrows Scope of Investigation

In January, I complained that President Obama had asked the Commission for the Study of Bioethical Issues 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."

Inside Higher Ed Reports on Li v. Brown University

Inside Higher Ed reports on the Brown University professor who is suing the university over IRB restrictions. The story quotes your humble blogger.

[Dan Berrett, "IRB Overreach?," Inside Higher Ed, 18 March 2011.]

Defino Notes Big Drop in OHRP Letters and Cases

Theresa Defino, editor of Report on Research Compliance, kindly alerted me to her recent analysis of OHRP activity and allowed me to post a reprint of the article.

["Big Drop in OHRP Letters, Open Cases Raise Questions of Agency Commitment," Report on Research Compliance, March 2011, 1-3.]

Notre Dame Frees Oral History

I stumbled across the Notre Dame Office of Research's IRB Procedures Manual & Guidelines. The manual, which bears no date, appears to give considerable leeway to oral historians:

AAHRPP and PRIM&R Plan Conferences

Both the Association for the Accreditation of Human Research Protection Programs, Inc ., (AAHRPP) and Public Responsibility in Medicine and Research (PRIM&R) plan conferences next month. AAHRPP's conference, "Breaking Down Barriers, will be held in Washington, April 6-8, then PRIM&R meets in Boston, April 28-29, for a "Social, Behavioral & Educational Research Conference."

Report from APPE

Earlier this month I traveled to Cincinnati for the annual meeting of the Association for Practical and Professional Ethics. There I met a fascinating group of researchers, ethicists, university administrators, IRB staff, and IRB members--with significant overlap among those groups.

One conference panel was devoted to Ethical Imperialism. Lyndall Angel of Charles Sturt University chaired the session, and John J. Laukaitis (Elmhurst College), Douglas J. Adams, (University of Arkansas), and William L. Gannon (University of New Mexico) provided comments on the book.

Professor Sues Brown University Over IRB Mission Creep

Jin Li, Associate Professor of Education at Brown University, has sued the university in federal court for forbidding her from using data from a study she conducted with private funding.

[Alexandria D'Angelo, "Professor Says Brown U Has a Lot of Nerve," Courthouse News Service, 1 March 2011. Thanks to Illuminata for catching this.]

Who Should Investigate Research Misconduct?

Two recent items do not directly involve IRBs, but they raise broader issues of accountability for research misconduct.

[Erin O'Connor and Maurice Black, "Save Academic Freedom," Inside Higher Ed, 28 February 2011; Alice Dreger, "Darkness's Descent on the American Anthropological Association: A Cautionary Tale," Human Nature (published online 16 February 2011).]

Jessee Reviews Ethical Imperialism

Dr. Erin Jessee of Simon Fraser University reviews Ethical Imperialism for the Oral History Review. [First published online February 15, 2011, doi:10.1093/ohr/ohr027.]

She finds the book "an impressive assessment of IRBs, from their tenuous beginnings in the early 1960s as a practical response to a perceived threat to the public from medical research to its present status as a threat to academic freedom in the social sciences" and "a significant contribution to those oral historians and related practitioners who would seek to challenge IRB's right and ability to adequately evaluate their research projects, particularly before the research has been conducted."

Anxious Pessimism on UK's New Framework for Research Ethics

In March 2010, the United Kingdom's Economic and Social Research Council (ESRC) released its Framework for Research Ethics (FRE) as a successor to its 2005 Research Ethics Framework (REF).

David Erdos kindly alerted me to the November 2010 (Volume 15, Issue 4) issue of Sociological Research Online, which devotes a special section to essays about the new framework.

The six essays in the section suggest that British sociologists are wary of their research ethics committees and the expanded authority granted to them by the new framework.

Cautious Optimism on Canada's TCPS2

Ted Palys and John Lowman of the School of Criminology, Simon Fraser University, find that the second edition of Canada's Tri-Council Policy Statement (TCPS2), released in December 2010, offers significant improvements over the first edition of 1998.

[Ted Palys and John Lowman, "What's Been Did and What's Been Hid: Reflections on TCPS2," 18 January 2011]

Library Research Round Table Calls for Papers on IRBs

Melora Norman kindly forwarded the following:

Call for Presentations

2011 Library Research Round Table Forums at ALA Annual Conference,
New Orleans, LA
June 23-28,2011

The Library Research Round Table (LRRT) will sponsor the Chair’s Research Forum at the 2011 American Library Association Annual Conference in New Orleans, LA (June 23-28). The LRRT Forums are a set of programs at the ALA Annual Conference featuring presentations of LIS research, in progress or completed, followed by discussion.

Chair’s Forum Topic: Institutional Review Boards

Does the NSF Have an Oral History Policy?

An independent scholar has been told by a National Science Foundation program officer that if she plans to do oral history she should "speak in the application to the problem of IRB review."

If the NSF is requiring IRB review of oral history, it is out of step with the recent actions other federal agencies, including the Smithsonian, the Army, and the Office for Human Research Protections.

I am not aware of any NSF policy document on this issue, so it is not clear if the program officer's statement represented the NSF position or the officer's personal views.

Obama’s Impossible Request

Bioethics Forum has published my essay, "Obama’s Impossible Request," which concerns the president's November 24 charge to the Presidential Commission for the Study of Bioethical Issues.

President Obama asked the commission 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." I term this an impossible request.

No, Seriously

Irena Grugulis, Professor of Employment Studies at Bradford University in the United Kingdom, complains that an ethics committee imposed medical standards on her organizational research.

[Irena Grugulis, "Research Ethics and James Bond," Social Science Spaces, 6 January 2011.]

She writes,

My own work is probably about the least harmful you can imagine. I spent last year conducting an ethnography of a computer games company, watching the way people learned skills and the way they were managed. No under-18s, no members of vulnerable groups, no illegal activities. Everyone was told who I was in advance by the company, both company and individuals would be anonymised in any publications and before observing anyone I would ask their permission. So far so unexceptional, and the only problem I anticipated was whether informants would be happy to accept Krispy Kreme doughnuts in exchange for being mithered at work.

Enter the ethics committee. They insisted on full written consent from every worker in the offices (about 250), every delivery person and – on the occasions I went off for a chat with informants – every barrista who served us coffee and waitress who brought us pizzas (no, seriously). An extensive correspondence later, since that would have effectively made an ethnography impossible, they grudgingly agreed to let me proceed and turned their attention to other social science projects. They queried the relevance of research into trade unions and advised that researcher to take steps to ensure their personal safety (because union members are sooooo dangerous), issued formal guidance that interviews over 30 minutes required special permission from the committee and, in the famed Battle of PostModernist Hill, decided that auto-ethnography should be barred.

As Grugulis notes, such restrictions violated the guidelines of both the British Sociological Association and the Economic and Social Research Council. This shows that even in countries such as Canada and the United Kingdom, where social scientists have worked out ethics guidelines nominally more pluralist than the Belmont Report, ethics committees continue to impose medical rules on non-medical fields.

[Note, 14 January 2011: I originally entitled this post, "Ethics Committee Hampered Management Research." On reflection, I realized that that headline did not do justice to the wit and exasperation of Professor Grugilis's story.]

Sociologists Find IRBs Serve Organizational Interests, Not Professional Ethics

Sociologists Carol Heimer (Northwestern) and JuLeigh Petty (Vanderbilt) find that IRBs "substitute bureaucratic ethics for professional ethics."

[Carol A. Heimer and JuLeigh Petty, "Bureaucratic Ethics: IRBs and the Legal Regulation of Human Subjects Research," Annual Review of Law and Social Science 6 (2010): 601-626.]

Much of the article consists of concise, accurate summaries of many of the complaints lodged against IRBs, including some by your humble blogger. (The bibliography lists well over 100 works on IRBs and research ethics.) Heimer and Petty categorize these complaints as "critiques of IRB law as law, critiques of IRBs as regulation, and critiques of IRBs as a system of norm making." Critics have charged that IRBs act lawlessly, do more harm than good, and deny researchers the opportunity to shape the norms that govern them. "IRBs seem to have lost sight of their original objective," Heimer and Petty state, summarizing some of this work. "No longer collective bodies of researchers deliberating together about the ethical dilemmas they encounter, IRBs are instead agents of the university (or research center). Rather than protecting research subjects from harm, they now seem especially focused on protecting universities and research centers."

To these complaints (which they mostly seem to endorse), Heimer and Petty add three of their own.

First, they employ the "lens of inequality," finding that "the regulations fail in part because the research process does not go as the regulators imagine and because the regulations do not address the social sources of the big inequalities. Furthermore, the regulations support inequality when they prevent research on powerful groups who harm others." IRBs fret over the details over consent forms, ignoring evidence that "potential research subjects actually pay little attention to consent forms and later do not even remember the details in them." At the same times, IRBs ignore "structural inqualities" (most notably, "the big inequality that the majority of the global research funds address the health problems of the wealthy few") while perpetuating inequality by preventing social researchers from studying powerful groups, including sellers of loose cigarettes.

I find the section on "the big inequality" the least persuasive part of this article. Heimer and Petty too readily accept the claims of Jill Fisher and Adriana Petryna that (in the words of Heimer and Petty) "the focus on abstract, universal principles in the Belmont Report deflects attention from the structural conditions and inequalities under which the unethical treatment of research subjects has taken place." Fisher and Petryna mischaracterize both the Belmont Report and the Common Rule by claiming (in Petryna's words) that "so long as an investigator [can] document that his or her subjects could deliberate about personal goals and act 'under the direction of such deliberation,' it [is] ultimately up to the subjects themselves to judge the acceptability of the risks they [take]."

In fact, the Belmont Report specifically warns against imposing the burdens of research "upon poor ward patients, while the benefits of improved medical care [flow] primarily to private patients," and the Common Rule requires IRBs to determine that "risks to subjects are reasonable in relation to anticipated benefits" and that "selection of subjects is equitable," independently of ensuring informed consent.

Whether IRBs are able to do this, and to do this without inappropriately restricting a great deal of ethical research, is another question. But it's unfair to charge the National Commission or the authors of the regulations with ignoring the problem of structural inequality and the challenge it poses to a consent-based model.

After the section on the "lens of inequality," Heimer and Petty "look at IRBs through the lens of professions." Noting that "the regulation of human subject research is a growth industry," they warn that rather than cede the power to declare a project exempt (as suggested by accommodationist reformers like Levine and Skedsvold), "IRB professionals [may] defend and perhaps seek to expand their jurisdiction." In doing so, they are protecting "their livelihood, a secure niche on the edges of the research and scholarly world." And they will have help: "OHRP’s focus on documentation helps explain why IRB professionals and not bioethicists are the growth sector in human subjects regulation."

Finally, Heimer and Petty "examine IRBs and research enterprises as organizations." Here they find that "a complex mixture of coercion by the government, fear of loss of funding, individual professional self-interest . . . and a desire not to be seen to be on the wrong side of a key cultural divide" do more to explain the growth of IRBs than do the Nuremberg Trials and other documented cases of unethical research.

They conclude with a grim assessment:

As the regulation of human subjects research has been institutionalized, professional competition and the protection of organizational interests seem to have carried the day. A bureaucratized research ethics is essentially an ethics of documentation. The task of translating the principles of autonomy, beneficence, and justice was never going to be easy. But translations that ignore structural inequalities, delay or reduce valuable research, and substitute bureaucratic ethics for professional ethics may not bring as much progress as we hoped.

UConn IRB Encouraged Failed Effort at Insitutional Anonymity

Professor George R. La Noue of the University of Maryland, Baltimore County, who so kindly reviewed my book, also alerted me to a case of IRB interference in a significant work of sociology. [He mentions the case in George R. La Noue and Alexander Bush, "Institutional Review Board Rules: Should One Size Fit All Disciplines?" presented at Fifth Annual Conference on Interdisciplinary Social Sciences, Cambridge University, August 2-6, 2010. The paper is available on request from Professor La Noue.]

In 2009, Gaye Tuchman, a University of Connecticut sociologist, published Wannabe U: Inside the Corporate University, which the University of Chicago Press calls an "eye-opening exposé of the modern university."

The book describes the growing power of central administrators at a public university and is based in large part on participant observation. Rather than identify the university she studied, Tuchman uses the term "Wannabe University" and creates fictitious names for everyone involved, including the presidents and provosts. In the book, Tuchman notes that "as my university's institutional review board had specified, I never taped or took pictures of anyone or anything on the campus." (17) Presumably, the prohibition on photography of even inanimate objects was designed to obscure the identity of the institution.

This was a fool's errand. As Harold Orlans put it in a manuscript first written in 1954,

"It is a popular pastime of academic cognoscenti to disclose 'anonymous' towns and authors. . . . Without undertaking any special search, we have noticed the real names of 'Middletown,' 'Southerntown,' 'Cotton,' 'Yankee City,' 'Cantonville,' 'Elmtown,' and 'San Carlos' identified in print: it is standard form for book reviewers to reveal the name of an 'anonymous' community."

[Harold Orlans, "Ethical Problems and Values in Anthropological Research," in U.S. Congress, House Committee on Government Operations, Research and Technical Programs Subcommittee, The Use of Social Research in Federal Domestic Programs: Part IV—Current Issues in the Administration of Federal Social Research (90th Cong., 1st. sess., 1967), 362.]

More recently, anthropologist Cathy Small failed miserably in her attempts to disguise herself and the site of her research—Northern Arizona University. Studies of allegedly anonymized high schools and universities contain enough information to identify them.. And Tuchman herself "knew that the reception of ethnographies had included attempts to identify their locale and even the identity of the people discussed in the book." (16)

Despite Tuchman's effort to preserve institutional anonymity, the fate of her work was no different; Inside Higher Ed quickly noted that "an abundance of evidence points to Wannabe's identity as UConn, Tuchman's employer." What a surprise.

It is not clear from the book the degree to which Tuchman resisted the IRB's request that she disguise the identity of the university. We can, however, say that the IRB encouraged her in the foolish belief that the university would remain anonymous.

Her decision to attempt anonymity had the following effects:

• It prevented Tuchman from presenting visual evidence, like screen captures of websites or photogaphs of the UConn campus.


• It reduced the accuracy of Tuchman's quotations by denying her the chance to record conversations.


• It encouraged Tuchman to think that the identities of major figures in her work, e.g., university presidents and provosts, might remain hidden, rather than writing the book in the full knowledge that she was holding these public figures accountable for their public actions.


• It prevented Tuchman from citing the published sources she used to flesh out her story. For example, she quotes stories about UConn from the Hartford Courant. (98) One can look up these quotations on Google (thus further identifying UConn as the site of Tuchman's research), but that's no substitute for proper footnotes to all published documents.


• Finally, it may have threatened the rights and welfare of any informant who spoke candidly to Tuchman in the naive belief that UConn's identity would remain hidden. Fortunately, most of the people she spoke with--especially the social scientists--appear to have been more realistic than Tuchman herself (16-17).

Tuchman also notes that "I have not interviewed current administrators, though I did feel free to ask them informal questions when I encountered them on campus or at committee meetings." (18) Tuchman does not detail the reason behind this decision, or whether the IRB was involved. But the decision reduced the book's ability to explain the events and trends at the heart of the narrative. And it is a particularly ironic decision, in that the second paragraph of the book complains that "no one ever had the audacity to ask publicly, 'Just what do you mean, President Whitmore?'" (1)

As a member of the faculty of a large public university that is perpetually "in transformation," I found some important insights in Wannabe U. But much of the book did not reflect my experience at Mason, leading me to conclude that this is not, in fact, a book about ambitious public universities in general, but rather a book about the corporatization of the University of Connecticut in particular, under the leadership of presidents Philip E. Austin and Michael J. Hogan and provosts John D. Petersen and Peter J. Nicholls. A book that acknowledged that fact, and did not avoid interviews with its central characters, would have been more respectful to its subjects and readers alike.

In her introduction, Tuchman mourns the "accountability regime" at her university and asks "why . . . has the faculty been so compliant?" (24) It is a question one could ask of her own interactions with the IRB.

OHRP's New Website

On January 3, the Office for Human Research Protections launched its redesigned website.

Of particular note to those interested in the history of IRBs is the new section on Related Resources, which contains more key documents than the previous website did, including all the reports (with appendices) produced by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

I am sorry to see that the website features none of the four items I requested when OHRP asked for comments in January 2009.

Moreover, the "Human Subjects Protection Federal Register Notices 1973 - 2007" on the Related Resources page overlooks Department of Health, Education, and Welfare, "Secretary's Interpretation of 'Subject at Risk,'" Federal Register 41 (28 June 1976): 26572, despite my drawing that omission to OHRP's attention in a follow-up e-mail to my comments.

The 1976 notice includes the curious claim that "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 2891-3 (added by Pub. L. 93-348) . . ."

As I note in my book, neither before or after this notice did federal regulators restrict their rule-making to areas of concern addressed in congressional hearings.

Three Years' Inaction at OHRP

On October 26, 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)."

By the December 26, 2007, deadline, 65 people and institutions submitted comments, two-thirds of which concerned oral history or folklore.

That was three years ago. And as far as I can tell, OHRP has taken no action on these comments.

Meanwhile, OHRP's new guidance on what constitutes research subject to regulation, which Bernard Schwetz promised before the end of 2007, is now three years overdue.