Saturday, January 31, 2009

And the Bush Was Not Consumed

Robert Dingwall kindly alerted me to Scott Kim, Peter Ubel, and Raymond De Vries, "Pruning the Regulatory Tree," Nature 457 (29 January 2009), 534-535.

The authors have complex disciplinary backgrounds. Kim has an MD and a PhD in philosophy, and teaches psychiatry. De Vries has a PhD in sociology and the title of associate professor of bioethics/medical education. And Ubel has an MD and describes himself as a "physician and behavioral scientist." Together, they are unusually well prepared to think about the full range of disciplines affected by human subjects regulations.

The authors complain that IRB review of minimal risk research wastes time and money, infringes academic freedom, and threatens public health by impeding important research. They conclude that "it is unethical to support a system that creates a significant financial, scientific, clinical and ethical burden with virtually no counterbalancing good."

To fix this, they propose "a simple regulatory change that is far-reaching, equitable and yet low risk: exempt minimal-risk research from IRB review." In their scheme, researchers would still "complete a brief application describing research procedures, risks, burdens and the potential loss of otherwise expected benefits to the subjects. An institution-designated person reviews the application, and exempted protocols would not be subject to further IRB review. The application becomes the project's registration and serves as an accountability document."

This sounds fine on the surface, but the proposal raises some questions.

Tuesday, January 27, 2009

Blame the ESRC?

David Hunter kindly alerted me to Sarah Dyer and David Demeritt, "Un-Ethical Review? Why It Is Wrong to Apply the Medical Model of Research Governance to Human Geography," Progress in Human Geography 33 (2009).

Dyer and Demeritt attack the Economic and Social Research Council's 2005 Research Ethics Framework, the basic document guiding British Research Ethics Committees (RECs) in their oversight of social research. Some of this attack strikes me as misplaced, since it ignores elements of the Framework that address the authors' concerns.

For example, the authors complain that

in the case of critical social science, the aim of the research is typically to expose wider social injustices and in that way actually harm those who benefit from them. But, following the injunction of the ESRC (2005: para 3.2.5) that ‘[p]articipants’ interests or well-being should not be damaged as a result of their participation in the research’, it would be impossible to secure permission to interview employers whose discriminatory practices a researcher was hoping to expose and thereby end. (55)

But the ESRC understands this (somewhat), noting,

Much social science research has a critical role to play in exploring and questioning social, cultural and economic structures and processes (for example relating to patterns of power and social inequality), and institutional dynamics and regimes that disadvantage some social groups over others, intentionally or not. Such research results may have a negative impact on some of the research subjects. (22)

Likewise, Dyer and Demeritt write,

there are times when safety, either of the investigator or of research subjects themselves, means that research subjects cannot be informed about the true nature of research [such as] studies of human trafficking, illegal workers’ gang masters, and so on. In such cases the notion of asking participants to sign a consent form of the sort envisioned by the ESRC (2005) is ridiculous, and the ill of deception balanced by the importance of the research and a commitment to protecting anonymity. (57)

But the Research Ethics Framework recognizes this problem, stating, "informed consent may be impracticable or meaningless in some research, such as research on crowd behaviour, or may be contrary to the research design, as is often the case in psychological experiments where consent would compromise the objective of the research. In some circumstances – such as users of illegal drugs – written consent might also create unnecessary risks for research subjects." (21)

The real problem, it seems, is not the ethical content of the Research Ethics Framework, but the structure it employs to promote those ethics. Project-by-project committee review may be unable to handle the complexity and unpredictablity of social science research. As Dyer and Demeritt write,

Whereas drugs trials involving vast sums of money, or biomedical research on extremely vulnerable people in enormous pain need only gain anticipatory approval, the ESRC argues that because ‘purposes, methods, and intended uses’ of qualitative research evolves as it proceeds, this kind of research should be required to seek REC approval on multiple occasions. Such a disproportionate response is itself unethical if it overburdens researchers such that worthwhile research does not get done. (57)

The underlying issue is that committee review is a process specifically tailored to experimental research. The more a researcher fits the experimental model, the more detailed her protocol will be, and the more amenable to prior review. It's the open-ended, qualitative researcher who has the low signal-to-noise ratio, and for whom ethics committee represent such a waste of time.

Monday, January 26, 2009

IRB Says Women Can't Be Photographed

The New York Times reports IRB interference with a study that combines medical and social research. (Gina Kolata, "Fitness Isn’t an Overnight Sensation," 21 January 2009).

Carl Foster, an exercise physiologist at the University of Wisconsin, La Crosse, was amused by ads for a popular piece of exercise equipment. Before-and-after photos showed pudgy men and women turned into athletes with ripped bodies of steel . . .

“We said: ‘Wait a minute. You can’t change yourself that much,’ ” Dr. Foster said. So he and his colleagues decided to experiment. Suppose they recruited sedentary people for a six-week exercise program. Would objective observers notice any changes in their bodies?

The plan was to photograph volunteers wearing skimpy bathing suits and then randomly assign them to one of three groups: cardiovascular exercise, weight lifting or control. Six weeks later, they would be photographed again.

Their heads would be blocked out of the photos, which would be shuffled. Then the subjects and judges would rate the body in each photo on a scale of 1 to 10, with 10 being spectacular.

The volunteers were men, age 18 to 40 (the university’s human-subjects review board looked askance at having women photographed and rated like that).

This is another case where Canada's TCPS (even the existing version) shows a more sophisticated undertsanding of research ethics than does the Belmont Report or the U.S. regulations. Whereas the Belmont authors were concerned about vulnerable populations being inappropriately targeted for medical studies, they did not think about the arbitrary exclusion of populations, or the stigmatization of competent adults as incompetent. By contrast, Article 5.2 of the 2005 version of the TCPS states that "women shall not automatically be excluded from research solely on the basis of sex or reproductive capacity."

I am unaware of any U.S. regulation or guidance that so specifically forbids the kind of sexism displayed by the La Crosse IRB. Still, it's disappointing that that IRB thinks adult women incapable deciding for themselves whether to participate in a study open to men.

For this study's implications for advertising law, see Rebecca Tushnet's 43(B)log.

Thursday, January 22, 2009

Canada Considers a New TCPS

The Research Ethics Blog alerted me to the relase of the Draft 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS), Canada's manifesto of research ethics. The document is strong in its recognition of critical inquiry. But it is weak in establishing mechanisms to meet its stated goals of proportionate review and reasoned decision-making. It fails to address some of the key concerns in the 2004 report, Giving Voice to the Spectrum, and threatens to leave social scientists not much better off than they are today.

Saturday, January 10, 2009

OHRP to Revise Website

OHRP has called for feedback on the "content, format, navigation or any other aspect" of its website. Below are the comments I sent in.

Dear OHRP,

Thank you for your invitation for suggested improvements to the OHRP website. Before making any suggestions, I must first thank you for the existing website, which contains a great deal of extremely valuable information. As a historian, I particularly appreciate the historical material, including the Belmont Report oral history section, and the compilation of key notices from the Federal Register dating back to 1973.

With this in mind, let me suggest some additional material that would be helpful.

1. Responses to calls for comments

When OHRP issues calls for comments in the Federal Register, it routinely advises that "comments received within the comment period, including any personal information provided, will be made available to the public upon request." While I am grateful to OHRP staff for sending me electronic versions of these comments in replies to my requests, I suggest that all comments be posted on the OHRP website as well. The comments I have seen constitute thoughtful, informed positions on the regulation of human subjects research and mark significant contributions to the debate on the subject. They have been the subject of reporting in the press, suggesting the wide interest in them.

Placing the comments on the website would insure equal access to those comments by all concerned, and would solve the problem of electronic files that are too big for easy transmission by e-mail. Posting would also preserve the comments for future readers, a key concern given that many issues crop up repeatedly. For example, in 2007, OHRP requested comments on expedited review. Anyone responding to that call would have benefited from access to the comments received in reply to the similar call of 1997. But those earlier comments seem to have been lost to history.

2. Reports to which OHRP has contributed

In June 2008, the Human Subjects Research Subcommittee published a report called "Expedited Review of Social and Behavioral Research Activities." Perhaps this is not technically an OHRP report, but the Subcommittee was co-chaired by the acting director of OHRP, and both he and Mr. Drew of OHRP were members of the working group that produced the report. Yet there is no link to the report on the OHRP website, nor did I receive notice of it from the OHRP-L@LIST.NIH.GOV mailing list. When OHRP staff, acting in their official capacities, contribute to a report like this, it should be announced on the list and a link added to the OHRP site.

3. A complete copy of the Bell Report

Your current page,, includes a copy of "Evaluation of NIH Implementation of Section 491 of the PHS Act, Mandating a Program of Protection for Research Subjects," published in 1998. But it does not include the technical appendices mentioned on page ii of that report, nor have I been able to locate a copy of those appendices. Posting them would be of value.

4. A link to OPRR Reports

The section on "Historical Documents" on the page does not mention the OPRR Reports posted at As the latter page indicates, most of these documents exist "solely as a reference for historical purposes." I am very glad that these documents are online, but I suggest that as historical documents, they deserve a link under the "historical documents" section. For that matter, I'd like to see the "Historical Documents/Information" section, including the Federal Register notices, given its own page, but I realize this wish may reflect my unusual perspective as a historian. I would also like a note added clarifying if the OPRR Reports now online represent all or just some of the OPRR Reports sent out during that office's existence.

Thank you again for this opportunity to comment on the website. If I think of additional suggestions, I will be sure to send them in.


Zachary M. Schrag
Assistant Professor of History, George Mason University

Thursday, January 1, 2009

Happy New Year, OHRP

In February 2007, the New York Times reported on scholars' frustration with IRB review of social research. OHRP assured reporter Patricia Cohen that it was working on the problem:

Bernard A. Schwetz, director of the federal Office for Human Research Protections, which administers the regulations, acknowledges that the guidelines covering the boards’ actions have not been clear enough and says he intends to make public new proposed guidelines before the end of the year.

Later in the article, Schwetz "said the new guidelines 'will give a lot of examples and will give more guidance on how to make the decision on what is research and what is not.'" This makes it clear that the 2007 call for comments on expedited review is not what he had in mind.

With the end of 2008, the promised guidelines are more than a year late.

This may be for the best. Schwetz seemed determined to continue OHRP's history of trying to regulate everything, while under Menikoff, we might expect better results. But OHRP and its predecessors have made a lot of empty promises over the years, and it's frustrating to see that tradition continued.