Thursday, October 28, 2010

Ohio State Restricts LGBTQ Research, Ponders Reforms

Two Ohio State University professors, James Sanders and Christine Ballengee-Morris, complain about IRBs' impacts on research and teaching in their fields and report on efforts at reform.

[James H. Sanders III and Christine Ballengee-Morris, "Troubling the IRB: Institutional Review Boards' Impact on Art Educators Conducting Social Science Research Involving Human Subjects," Studies in Art Education: A Journal of Issues and Research in Art Education 49 (2008): 311-327. Yes, it's two years old, but I just found out about it recently.]

Many of the complaints are familiar enough. The authors--one in arts policy, the other in art education--lament biomedical models, delays in approvals, and "lengthy boiler-plate consent forms." Yet the article advances the conversation about IRBs in two interesting ways.

First, the article highlights the difficulty of getting IRB approval to study lesbian, gay, bisexual, transgender, and queer self-identified youth. The authors would like to know "how LGBTQ students experience the World Wide Web, art and culture, and their self-image, or how they establish resilient behaviors." But, they find, "Conservative IRB interpretations of federal regulations requiring parental consent of all human subjects under 18, may have failed to protect the rights and welfare of LGBTQ adolescent research participants, and further dissuade researchers from studying all but (safe) consenting adult heterosexual subjects."

Second, the article describes reform efforts at Ohio State. Advised by colleagues to "be intentionally vague . . . speak in generalities, or simply not tell what we were actually doing," the authors did consider "lying to a repressive and controlling body that claims to care about human subjects' protections and then denies autonomy or voice to those living with repression." Instead, they joined 160 faculty members to petition their Office of Research to reconsider its policies.

The result was the issuance in 2007 of the Report of the IRB Working Group for Research in the Social and Behavioral Sciences." That report offers a number of constructive suggestions. For example,

  • Relaxing the requirement that all changes to a protocol be reported to the IRB, even if they "have absolutely no material impact on a human subject's participation in a study."
  • Accepting that interviewers cannot foresee in advance all the topics they may raise in a conversation.
  • Informing investigators about their right to appeal decisions to the IRB chair, the full board, or the institutional official.
  • Listing approved protocols, so researchers do not have to reinvent the wheel when submitting their own projects.

The 2007 report ends with a strong call for IRB policy to be shaped by the faculty. It specifically recommends the active participation of the University Research Committee, which is comprised mostly of regular facutly:

It is also important that there be continuing transparency and communication of IRB policy and procedure development among the faculty, the Office of Research, the IRB Policy Committee, and ORRP [Office of Responsible Research Practices]. To ensure that such consideration and implementation occurs, we recommend that an ad-hoc subcommittee of the University Research Committee be appointed for this purpose. This subcommittee should receive regular reports from the IRB Policy Committee regarding the development of new policies related to the Working Group's recommendations and suggestions, and from the ORRP staff regarding progress in staffing, website development, and electronic submission procedures.

In the longer term, it is important for the University Research Committee to participate actively in the human subject protection program at Ohio State, and to assess and suggest additional improvements to the operations of ORRP and the IRB. We strongly encourage the University Research Committee to set up a means to do so.

As of their writing, however, Sanders and Ballengee-Morris had yet to see improvement:

In short, one is required to think through every possible contingency and clearly communicate how such contingencies would be addressed. While the process itself strengthens the research design, the unreasonableness of some alternative scenarios posed by those unfamiliar with the researchers' field of study have been stifling. In response, many students and colleagues have chosen to change methods or abandon their research problems, rather than be subjected to this arduous, frustrating, and at times, humiliating process.

Tuesday, October 26, 2010

Dreger Wants to Scrap IRBs

On the heels of Laura Stark's Los Angeles Times op-ed calling for the replacement of local IRBs with centralized boards of experts, historian Alice Dreger has published her own call for a national system of ethics review based on expertise and transparency.

[Alice Dreger, "Nationalizing IRBs for Biomedical Research – and for Justice," Bioethics Forum, 22 October 2010.]

Troubled by her IRB's approval of a project she considers unethical, and by Carl Elliott's White Coat, Black Hat: Adventures on the Dark Side of Medicine, Dreger concludes that the system of local review is ineffective:

We’ve reached the point where many people in medicine and medical ethics don’t even expect IRBs to act as something other than liability shields for their universities. But do patients who come to us only to be turned into subjects know that? Do they know that there is literally a price on their heads put there by research recruiters?

I’ve come to believe we need a radical solution. Maybe what we need is a nationalized system of IRBs for biomedical research, one that operates on the model of circuit courts, so that relationships cannot easily develop between the IRBs and the people seeking approval. This system could be run out of the Office for Human Research Protections and involve districts, similar to the federal courts system. Deliberations would be made transparent, so that all interested parties could understand (and question) decisions being made.

Think of the advantages: the possibility of actually focusing on the protection of human subjects first and foremost, free of conflicts of interest; the possibility of having nothing but trained professionals (not rotating unqualified faculty and staff) sitting on review panels; the possibility of marking biomedical research as clearly different from the social science and educational research unreasonably managed by many IRBs; the possibility of much greater transparency to those interested in seeing what’s going on; the possibility of having multi-center trials obtain a single approval from one centralized IRB, rather than trying to manage approvals from multiple local institutions. And the possibility of shutting down the deeply opaque, highly questionable private IRBs Elliott describes as being increasingly used by universities. (Go ahead, call me a Communist for caring about the Common Rule.)

Her Communist leanings aside, I don't know why Dreger presents her argument as a defense of the Common Rule, which fails to distinguish between biomedical and social research, puts ethics review in the hands of rotating unqualified faculty and staff, and keeps deliberations opaque. But her wish for the kind of coordination and transparency provided by the court system has a long lineage. I've quoted it before, and I'll quote it again:

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

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

It is not lack of good intentions or hard work that leads IRBs to restrict ethically sound surveys while permitting unethical experimental surgery. It is the ignorance and isolation identified by Katz in 1973 and still in place today.

Wednesday, October 13, 2010

Stark Wants to Scrap IRBs

Sociologist Laura Stark is a careful observer of the IRB system, having based her dissertation on archival research and direct observations of three university IRBs. In 2008, I complained that the dissertation, "Morality in Science," reported but failed to condemn bad IRB behavior. In a newly published essay, Stark takes a more critical stance.

[Laura Stark, "Gaps in Medical Research Ethics," Los Angeles Times, 8 October 2010.]

In her essay, Stark traces today's IRB system back to systems established in the 1960s at the NIH Clinical Center, which performed experiments on "hundreds of healthy prisoners, conscientious objectors, unemployed people and students living in their hospital as subjects." She finds that system included two basic flaws: it failed to inform the public about what was going, and it gave no voice to dissenting members of ethics boards. These flaws, she argues, remain in today's system of ethics review.

To remedy them, Stark proposes that the new Presidential Commission for the Study of Bioethical Issues "rebuild the regulations from the ground up." She writes,

New rules should include these changes:

Replace the thousands of local review boards that labor independently at universities and hospitals here and abroad with a small number of ethics-review networks organized around specific research methods rather than around institutions. The networks would be better equipped to handle multi-site studies that are now commonplace, and would remove the political biases of some outlier institutions.

Consider the advantages and disadvantages of outsourcing ethics review to private companies, which review research for a fee.

Finally, empower research participants by posting the results of ethics reviews online. The current system includes community representatives who presumably speak on behalf of research participants, but that's not good enough.

Though the essay does not specifically mention IRB review of research in the social sciences and humanities, the dissertation gives examples in which the lack of transparency and lack of expertise impeded such projects. Thus, Stark's call for expert boards and published results of ethics review could address non-biomedical research as well as the medical research that is her chief concern. And while Stark presents her proposals as ways to ensure better protection for research participants, they could also benefit those researchers who now fall victim to inexpert boards. Because the current system fails both researchers and participants, reform can benefit them both.

Stark should realize that the changes she proposes would require more than "rebuild[ing] the regulations from the ground up," since the requirement for local IRBs is encoded in federal statute, not just regulations. But a wholesale reconsideration of the IRB system by the presidential commission would be a fine first step.

Monday, October 4, 2010

Tell OHRP Belmont Isn't Everything

On September 23, OHRP posted drafts of new FWA form and FWA Terms of Assurance. It is collecting comments on the forms until October 25.

Here is what I have come up with so far. I would welcome comments on this draft for the next couple of weeks; I'd like to submit this comment by October 15 to be sure I make the deadline.


To the Office for Human Research Protections:

Thank you for the opportunity to comment on the draft revision of the "Terms of the Federalwide Assurance for the Protection of Human Subjects." I have two comments on this draft.


I am disappointed that the current draft fails to correct a longstanding discrepancy between the Common Rule and OHRP's forms. 45 CFR 46.103(b)(1) requires that each institution receiving funding from a Common Rule agency submit an assurance that includes

A statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to Federal regulation. This may include an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the institution itself.

By contrast, the draft Federalwide Assurance requires U.S. institutions to pledge that they will be guided either by the Belmont Report, the Declaration of Helsinki, or "other appropriate international ethical standards recognized by U.S. federal departments and agencies that have adopted the Common Rule." I am unaware of any documents in this third category, nor of any element of the Common Rule that requires federal approval of a statement of principles.

Thus, while the Common Rule offers institutions complete freedom in their choice of ethical principles, the current and proposed Terms of the Federalwide Assurance limit them to one or two documents. This is like guaranteeing the freedom of religion, then requiring every citizen to adhere to either the Lutheran Book of Concord or the Articles of Religion of the Methodist Church.

Instead, the first paragraph should reflect the provisions of the Common Rule. I suggest the following language:

"All of the Institution's human subjects research activities, regardless of whether the research is subject to the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule), will be guided by a statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to Federal regulation. This may include an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the institution itself. This requirement does not preempt provisions of this policy applicable to department- or agency-supported or regulated research and need not be applicable to any research exempted or waived under §46.101(b) or (i)."


The current draft allows non-U.S. institutions to comply based on "The 1998 (with 2000, 2002, and 2005 amendments) Medical Research Council of Canada Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans."

This statement has two inaccuracies. First, the Medical Research Council no longer exists; it was replaced in 2000 with the Canadian Institutes of Health Research (CIHR). Second, the TCPS is authored not only by the CIHR but also by the Natural Sciences and Engineering Research Council of Canada (NSERC) and the Social Sciences and Humanities Research Council of Canada (SSHRC). (That is what makes it a tri-council policy.)

Moreover, the Panel on Research Ethics plans to release a second edition of the TCPS in December 2010, and may amend it further while the new Terms of the Federalwide Assurance are still in effect. Rather than limit institutions to an outdated version of the TCPS, OHRP should allow non-U.S. institutions to abide by the current version.

Friday, October 1, 2010

U.S. Apologizes for 1940s Human Subjects Research

This is a little off topic for the blog, but today Secretary of State Hillary Clinton and Health and Human Services Secretary Kathleen Sebelius apologized to Guatemala for experiments done there in the late 1940s. Researchers led by a Public Health Service doctor conducted various studies of syphilis, some of which included the deliberate infection of people without their consent.

The story was brought to light by Susan M. Reverby, Marion Butler McLean Professor in the History of Ideas and Professor of Women's and Gender Studies at Wellesley College. Her article, "''Normal Exposure' and Inoculation Syphilis: A PHS 'Tuskegee' Doctor in Guatemala, 1946-48, will appear in the Journal of Policy History in 2011, in a special issue on human subjects research that I edited.

UPDATE: The New York Times has a more complete story, including a nice mention of the Journal of Policy History.