Friday, January 26, 2007

Still no evidence?

Twenty-six years ago today, on 26 January 1981, the Department of Health and Human Services published in the Federal Register its "Final Regulations Amending Basic HHS Policy for the Protection of Human Research Subjects." (PDF) The department rejected a proposal by several social-science organizations to "exempt all research utilizing legally competent subjects if that research involved neither deceit nor intrusion upon the subject’s person, nor the denial or withholding of accustomed or necessary resources." It justified this decision in empirical terms, stating that "despite some general comments that the regulations would impede social research, the Department has been presented no evidence that social science research that may present risks to subjects has been unduly hampered by the requirement for IRB review and approval" (emphasis added).

What's striking is the department's suggestion that evidence of undue hampering might have changed its decision on the regulations. Twenty-six years later, it's a good deal easier to find such evidence. See, for example,
  • Jennifer Howard, "Oral History Under Review," Chronicle of Higher Education, 10 November 2006.
  • AAUP, "Research on Human Subjects: Academic Freedom and the Institutional Review Board," (2006)
  • Robert L. Kerr, "Unconstitutional Review Board? Considering a First Amendment Challenge to IRB Regulation of Journalistic Research Methods," Communication Law & Policy 11 (2006): 393–447.
  • American Ethnologist 33, No. 4 (November 2006)
  • Journal of Applied Communication Research 33, No. 3, (August 2005).
  • Patricia Loomis Marshall, "Human Subjects Protections, Institutional Review Boards, and Cultural Anthropological Research" Anthropological Quarterly 76 (Spring 2003): 269-285
Even scholars who have served on IRBs despair when confronted by all the stories of inappropriate review.

Is it time for the federal government to revisit its decision?

No comments: