My Comments to the Presidential Commission

I rather belatedly learned that the Presidential Commission for the Study of Bioethical Issues was seeking public comment on the Federal and international standards for protecting the health and well-being of participants in scientific studies supported by the Federal Government. The deadline for comments is tomorrow, May 2.

Here are my comments, hastily cribbed from the conclusion of my book:

To the Presidential Commission for the Study of Bioethical Issues,

Thank you for the opportunity to comment on the Federal and international standards for protecting the health and well-being of participants in scientific studies supported by the Federal Government.

Last year I published Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 (Johns Hopkins University Press), a work of scholarly history. The book concludes with the following findings.

1. The present system of IRB oversight is not based on empirical investigation of ethical abuses committed by social scientists.

2. Policy makers failed to explore alternative measures to prevent such abuses as do occur.

3. Medical and psychological researchers have been well represented on almost every official body that has set IRB policy. In contrast, official bodies have included at most a token representation from the social sciences.

4. The extension of IRB oversight over most social science research was largely unintentional, or at least so flawed that no one has been willing to take responsibility for it. University officials point to federal rules, while the authors of those rules claimed they were powerless to avoid the creep of regulation. In contrast, health officials have repeatedly asserted their wish to deregulate most or all social research.

5. While some scholars look back to what Robert Levine terms "the good old days" of IRB review of medical research before the 1998 OPRR crackdown, there has never been a golden age of IRB review of the social sciences.

6. The creators of today's IRB system treated history carelessly. They claimed to learn from the past, pointing out the wrongs of the Tuskegee Syphilis Study and the human radiation experiments, and noting the longevity of the IRB system as a reason to continue it. But they have dismissed the past when it suited them.

For close to half a century, health officials have imposed a regulatory system designed for medical experimentation upon scholarly disciplines with wholly different ethics and methods. They have done so not by persuasion, but by denying scholars in the social sciences and humanities a chance to shape the rules under which they must work.

While regulators occasionally acknowledge this truth, they have offered meaningful relief only when pressured by Congress or the secretary of health and human services. Absent such pressure, the Office for Human Research Protections has consisently ignored the concerns of social scientists. In recent years, for example, it has failed to deliver promised guidance on the definition of research (Patricia Cohen, "As Ethics Panels Expand Grip, No Field Is Off Limits," New York Times, 8 February 2007); failed to respond to the dozens of comments it received in response to its 26 October 2007 Federal Register notice; and apparently endorsed contradictory statements about oral history.

To remedy such problems once and for all, Congress should amend the National Research Act to restrict its scope to the research discussed during the 1973 Senate hearings that still serve as the evidentiary record for that act. The wording of such a restriction can be drawn from E. L. Pattullo's formula of 1979: "There should be no requirement for prior review of research utilizing legally competent subjects if that research involves neither deceit, nor intrusion upon the subject's person, nor denial or withholding of accustomed or necessary resources."

Please also see American Association of University Professors, "Research on Human Subjects: Academic Freedom and the Institutional Review Board" (2006), http://www.aaup.org/AAUP/comm/rep/A/humansubs.htm, and American Historical Association, "Statement on IRBs and Oral History Research," February 2008, http://www.historians.org/perspectives/issues/2008/0802/0802aha1.cfm.

Sincerely,

Zachary M. Schrag