IRBs Should Evaluate Risk Empirically

By Gwendolyn Bradley

For the first time since 1981, the federal government is considering major changes to the regulations governing institutional review boards (IRBs), which are charged with protecting the rights and welfare of participants in biomedical and behavioral research. Since 1981, the AAUP has expressed concern about the potential for human subjects’ research protections to interfere with academic freedom, most recently in its 2006 report Research on Human Subjects: Academic Freedom and the Institutional Review Board (http://www.aaup.org/aaup/comm/rep/a/humansubs.htm).

In July, the Department of Health and Human Services released an advance notice of proposed rulemaking, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” In our comments on the new proposal, which were principally written by Zachary Schrag of George Mason University, the AAUP makes four main recommendations:

  1. IRBs should evaluate risk based on empirical evidence.
  2. There should be no IRB review of interview, observation, and survey research with legally competent adults.
  3. Not all data should be considered as sensitive as current health data.
  4. The federal government should not regulate human-subject research for which it does not provide funding.

The AAUP’s Committee A on Academic Freedom and Tenure reactivated its Subcommittee on Academic Freedom and the Institutional Review Board, which will prepare a report on the advance notice of proposed rulemaking and the comments submitted to the Department of Health and Human Services in time for the spring 2012 Committee A meeting.

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