Tuesday, July 31, 2007

A Biomedical Scientist Speaks Out

Adil E. Shamoo, a professor of biochemistry and molecular biology at the University of Maryland School of Medicine and editor in chief of the journal Accountability in Research, complains that human subjects regulations "have handicapped researchers whose work poses no threat to humans." ("Deregulating Low-Risk Research," Chronicle of Higher Education, 3 August 2007; thanks to John Mueller for the heads-up.)

Schwetz Retires

Dr. Bernard Schwetz has announced his retirement as director of the Office for Human Research Protections (OHRP). Schwetz has led the office since February 2003. During that time, it has agreed to broad exemptions from IRB review for oral history, reneged on that agreement by publishing nonsensical guidance, then refused to discuss the matter with historians. Most recently, in February Schwetz told the New York Times that he intended to issue new guidelines by the end of 2007, a promise that now seems unlikely to be kept.

OHRP Reprimand Puts Forms Over Substance

The federal Office for Human Research Protections (OHRP) has reprimanded the University of California at Berkeley's Committee for Protection of Human Subjects (CPHS) for what it considers misconduct in approving several projects. For a blog on the humanities and social sciences, the most relevant project was an economic study of Kenyan women, who were asked to record their sexual encounters, finances, and family events so researchers could understand their decision to engage in risky commercial sex.

Here's what OHRP had to say about the project:

OHRP finds that the informed consent documents reviewed and approved by the CPHS for study Sex Work as a Response to Risk in Kenya (Study 2005-5-2) failed to include and adequately address the following elements required by HHS regulations at 45 CFR 46.116(a):

(a) Section 46.116(a)(2): A description of any reasonably foreseeable risks and discomforts (i.e., risks and discomforts not described).

(b) Section 46.116(a)(3): A description of any benefits to the subject or others that may reasonably be expected from the research.

(c) Section 46.116(a)(7): An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights (should include someone other than the investigator), and whom to contact in the event of a research-related injury to the subject. OHRP notes that CPHS approved an informed consent document that referenced a separate document containing the required contact information in lieu of requiring the informed consent document to contain such information.

Please note that HHS regulations at 45 CFR 46.116(d) require that an IRB find and document four specific criteria when approving waiver or alteration of some or all of the required elements of informed consent. OHRP finds no evidence demonstrating that CPHS found and documented such criteria prior to approving the informed consent document for this study, which did not include two elements of informed consent, i.e., 46.116(a)(2) and (a)(3), and which altered one element of informed consent, i.e., 46.116(a)(7).

Charge (c) strikes me as simple nitpicking. 45 CFR 46.116(a)(7) requires only that "in seeking informed consent the following information shall be provided to each subject: . . . An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject." It does not state that the information must be on the "informed consent document" rather than a separate document.

Charge (b) is also doubtful. According to a paper derived from the study, Jonathan Robinson and Ethan Yeh, "Sex Work as a Response to Risk in Western Kenya," "Respondents in Round 1 (October - December, 2005) were compensated 1,000 Kenyan shillings (US$14), and respondents in Round 2 (July - October, 2006) were compensated 1,500 Kenyan shillings (US$21) for participating in the study." Does OHRP suppose that the respondents were not told in advance that they would be paid?

And then there's charge (a), complaining of a lack of a "description of any reasonably foreseeable risks and discomforts." Just what are the reasonably foreseeable risks and discomforts to a woman keeping "a daily diary (or logbook) in which she self-reported the shocks she encountered (own illness or injury, illness or injury of another household member, death of a friend or family member, menstruation, and incidence of a sexually transmitted infection), her sexual behavior with up to 3 partners each day, her income, and her expenditures [and] additional information on client characteristics and unprotected vaginal and anal sex, separately"? Or, more precisely, who is best able to describe those risks: the IRB, the investigator, or the women who are keeping the diaries and would have to live with the consequences of their somehow getting into the wrong hands? I'd say it's the women, so a list of risks provided by a couple of American economists would be useless.

As Bradford Gray wrote in 1978, there is a "distinction between informed consent and consent forms." (American Sociologist, August 1978, 163). Joan E. Sieber and Robert J. Levine expand on this distinction in "Informed Consent and Consent Forms for Research Participants," Observer, April 2004).

OHRP also complains that

CPHS conditionally approved the above-referenced study even though CPHS noted that the protocol contained little information regarding:
(i) Ensuring that risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result (namely, sample size);
(ii) Equitable selection of subjects (namely, subject recruitment and enrollment procedure); and
(iii) Informed consent (how sought and documented).

It is not clear how the sample size would affect the ethical validity of the study. The other issues are nicely addressed in the Robinson and Yeh paper, though I can only guess what materials they submitted to CPHS in 2005. But notice that OHRP complains only that paper is missing, not that the project was ill-designed, or the participants ill-used. A true audit of the CPHS's effectiveness in this case would require going to Kenya and asking the participants in the study whether they understood the study and felt they had been treated fairly. Lacking the will or resources to do so, OHRP frets over Berkeley's failure to shoehorn a social science project into requirements devised for medical experimentation. The lesson for IRBs is that they will be judged not by the ethical content of the projects they approve, but by the adherence of consent forms to standard templates.

Berkeley's IRB is being scolded for cutting its researchers some slack, and now, I fear, other IRBs will react by becoming even stricter with social research. So much for flexibility.

Thursday, July 26, 2007

White, "Institutional Review Board Mission Creep"

Ronald F. White, a professor of philosophy at the College of Mount St. Joseph, is fed up with IRB review of the social sciences: "Institutional Review Board Mission Creep: The Common Rule, Social Science, and the Nanny State," Independent Review 11 (Spring 2007): 547-564.

Much of the piece will be familiar to those who have followed recent IRB debates, but I did enjoy White's first-hand account:

My IRB experience with graduate student projects on leadership was eye opening. A colleague and I taught the course. We spent hours checking student IRB forms, and half the semester was consumed in getting their protocols past the committee chair. All of these projects involved harmless interviews and questionnaires to be done in the workplace. The overwhelming majority of the students' employers not only supported their research, but in many instances were paying for them to attend graduate school. All of my students found the IRB debacle to be nitpicking nonsense. Many of them ultimately received an "incomplete" for the course. It would be convenient simply to blame our IRB chair for this debacle. However, that person was not only a highly competent and cooperative IRB chair and an established social scientist, but also an extraordinarily cooperative friend of mine. In short, the IRB fiasco is not about persons, but about a system.

After that initial experience, the program redefined the project so that all students could get IRB approval by providing the same answers on the form. This adaptation made IRB compliance less onerous, but it severely limited the student's choice of topics and deprived them of the opportunity to do real science. Since then, the course has introduced a whole new kind of research option for students that avoids IRB involvement. I surmise that in most educational settings, the demands of IRB compliance have led to requiring topics and projects that are easier to get past boards.

There are a couple of points here. First, as Robert Kerr has noted, research delay may be research denied, so we should not take at face value IRB claims about the low percentage of projects that are rejected outright. Second, boilerplate approval processes may lead to boilerplate research--the chilling effect that IRB critics have noted for decades.

What intrigues me most is how a philosopher got snared in this mess, and I hope to learn more about the course and the research White's students were pursuing.