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Dear Colleague Letter: Board Change to Policy; Assessment of Risks; Faculty Sponsor Statement Clarification

Institutional Review Board for the Protection of Human Subjects

March 10, 2000

Dear Colleague:

As you probably know, the Academic Senate has passed and the President has concurred with a new University Policy regarding Protection of Human Subjects of Research. This policy REPLACES and SUPERCEDES all previous policies. It becomes effective on July 1, 2000. The IRB is now working to provide you with new forms/formats and instructions to match the intent of the new policy. We hope to have the new forms ready so that departments can give Spring Semester instruction about them for Fall implementation.

You will be receiving a draft version of the forms sometime before Spring Recess. This will be your chance to weigh in on a matter of practical significance to yourselves and your students. In some cases we will be suggesting minor changes; in others material changes which we hope will facilitate the processes. We are hoping for a broad response. It will be appropriate for individuals to respond, or for departments or groups within departments to respond. In the meantime, the IRB will be conducting reviews of Standard and Expedited protocol applications as before.

Two matters continue to cause problems for applicants, and we believe that supervising faculty are in the best position to apply a remedy. The fundamental problem is that researchers consistently underestimate the risk to human subjects. Perhaps it would be good to let students know that the research risk, whatever it is, continues to be "the risk" no matter what security measures are taken and no matter what is disclosed in the "informed consent" document. Risk, security, and informed consent are the three primary elements of the judgment made about the sensitivity of the research and the plan for protection of the human subjects.

Second, we have asked faculty members supervising students to provide us with a statement about the research, particularly its methodology, as they forward the proposal to the IRB. We know that the student actually does the labor of bringing the application to the IRB, but the act of forwarding is intended in the policy. We need to have statements from the faculty that go to the three primary elements: inherent risk, methodology, and risk management. These statements should not be perfunctory; they should be instructive for the student and the IRB. It may well be that the risk is negligible, the methodology standard, and the security measure embodied in the informed consent and anonymity/confidentiality processes straightforward. The IRB does not consider this to be the "default" position.

We hope that faculty in the ensuing months will renew their efforts to provide the Board with the much needed professional opinions requested on the Faculty Supervisor's Form, and have an opportunity to discuss these matters with members of the Board. Currently the following University personnel and faculty are members: Tony Battaglia (Chair), Elizabeth Deschenes, Elizabeth Ortiz, Leslie Swigart, Bonnie Kellogg, Leonard Albright, Henry Fung, and James Brett.



Tony Battaglia, Chair

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