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.)

Shamoo cites with approval the 2006 AAUP report, "Research on Human Subjects: Academic Freedom and the Institutional Review Board." The report, he notes,

does not recommend an exemption from IRB approval for all social and behavioral studies. But it does suggest exempting low-risk research, which it defines as "research whose methodology consists entirely of collecting data by surveys, conducting interviews, or observing behavior in public places." The report distinguishes such research from studies that could reveal personal information, like genetic abnormalities or risky behavior, and recommends IRB approval for them.

In 2002, while I was a member of the National Human Research Protections Advisory Committee, I expressed concern about requiring IRB reviews for such low-risk research, studies of public data, and class projects involving observational studies conducted by undergraduates, which usually must be done on such a short timetable as to make IRB approval impossible. I argued then that low-risk research should be exempt from federal regulation unless the studies could result in a breach of subjects' privacy or disclosures that could pose unreasonable risks to subjects.

In the rare instances when low-risk research could cause harm, other mechanisms, such as improved education and training for investigators, would be more sensible than overly restrictive regulations. Currently most new researchers are required to take just one online course lasting a few hours. Only a few universities require as much as 30 hours of training in the responsible conduct of research or research ethics. That amount of preparation should be mandatory for all investigators.

For the most part I agree with Shamoo's argument, including his call for training in research ethics. (See "Ethical Training for Oral Historians.")

But Shamoo mischaracterizes the AAUP report, which recommends that "research on autonomous adults whose methodology consists entirely in collecting data by surveys, conducting interviews, or observing behavior in public places, be exempt from the requirement of IRB review—straightforwardly exempt, with no provisos, and no requirement of IRB approval of the exemption." No provisos means that researchers would, in fact, be free to interview consenting adults about their genetic abnormalities or risky behavior. (Ask me about my 33d tooth!)

Nor does Shamoo explore just what he means by "low-risk research," a term not used in the AAUP report. Does he propose exempting only research that bears little risk of harm? Or research that bears little risk of ethical wrong?

Research can be both ethical and risky, even harmful. Investigative journalism is the clearest example; earlier this year, the Washington Post's investigation of conditions at Walter Reed hospital rightfully destroyed the careers of some prominent Army officers and civilian officials. We need a system that allows researchers in the social sciences and humanities to work within the limits of their disciplines' ethical codes, and the laws that govern all people--not the medical ethics encoded in the Belmont Report.

The last word goes to E. L. Pattullo, who explained all of this in 1979 [Robert J. Levine, et al., panelists, "The Political, Legal, and Moral Limits to Institutional Review Board (IRB) Oversight of Behavioral and Social Science Research," in Paula Knudson, ed., PRIM&R through the Years: Three Decades of Protecting Human Subjects, 1974-2005 (Boston: PRIM&R, 2006), 39-40.]:

The fact that a considerable number of social studies have resulted in subjects experiencing boredom, humiliation, self-doubt, and outrage I do not question. Further, it would be surprising if there were not others in which breaches of confidentiality, especially, have led to more dire consequences—though I am not aware of any such cases. Nevertheless, there remains a world of difference between a lost leg and a lost job. Neither is desirable, but few would find the choice hard—and the difference has great significance, given our traditional belief in the undesirability of trying to prevent social injury by imposing prior restraint on speech. . . The possible harm that inheres in most social research is of a kind that we decided long ago we must risk as the necessary price for a free society. . .

As subjects, we could be entrapped, exposed, and embarrassed, with only the laws of slander, libel, privacy, and contract to protect us. But we are thus exposed already to friends, enemies, journalists, acquaintances, and strangers. Rather than accept regulation that begins to erode freedom of speech, would it not be wiser to return scientists to the ranks occupied by our friends and enemies?

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