Thursday, January 27, 2011

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.

Wednesday, January 19, 2011

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.

Friday, January 14, 2011

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.]

Tuesday, January 11, 2011

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.

Sunday, January 9, 2011

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.

Thursday, January 6, 2011

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.

Saturday, January 1, 2011

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.