Tuesday, July 29, 2008

The Dormant Right to Ethical Self-Determination

The Common Rule, in 45 CFR 46.103(b)(1), requires that each institution receiving funding from a Common Rule agency must 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.

In contrast, OHRP's Federalwide Assurance requires U.S. institutions to pledge that

All of the Institution's human subjects research activities, regardless of whether the research is subject to federal regulations, will be guided by the ethical principles in: (a) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, or (b) other appropriate ethical standards recognized by federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects, known as the Common Rule.

Curious about the discrepancy, I submitted a Freedom of Information Act request for a list of those institutions that selected something other than the Belmont Report. In response, I received a letter, dated July 15, with a list of 36 institutions, mostly health clinics and hospitals. Of teaching institutions, only two--Langston University and Northeast Iowa Community College--had declined to endorse the Belmont Report. Langston listed the Common Rule itself as a statement of ethical principles. I have not gotten a reply to my query to Northeast Iowa, but I must suppose it likewise does not challenge the Belmont Report meaningfully.

Thus, with two possible exceptions, it's fair to say that OHRP has persuaded every college and university in the United States to promise that the Belmont Report will guide all "human subjects research activities."

Let's review.

1. The Common Rule (46.101) exempts a broad range of activities from IRB review. These exemptions were granted in response to a hard fight by social scientists, and they came with the promise that they would "exclude most
social science research projects from the jurisdiction of the regulations
." But since 1995, OPRR/OHRP has rendered these exemptions meaningless by insisting that researchers cannot themselves determine if the exemptions apply. As a result, IRBs routinely ignore the exemptions.

2. The Common Rule (46.102) applies only to "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Rather than trying to understand what the National Commission meant by this, OHRP officials redefine "generalizable" based on a phone call from the nation's worst IRB or an awkward medical analogy.

3. The Common Rule (46.103) gives institutions the choice of any ethical principles they like; they can even write their own. OHRP imposes the Belmont Report.

4. The Common Rule (46.107) promises that IRBs will include members expert in all the research they review. But OHRP does not enforce that requirement for the social sciences.

No, the Common Rule doesn't look so bad on paper. But since the mid-1990s, its alleged enforcers at OPRR and OHRP have ignored the provisions crafted in 1981 to address the concerns of social scientists, the President's Commission, and members of Congress. I am pessimistic about OHRP's capacity to fix a broken system, because OHRP itself has done so much to break it.

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