FOOTNOTES December 2000
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The Executive Officer’s Column

Weighing In On Protecting Human Research Participants: Let Our Voices Be Heard

As Executive Officer, I receive calls and e-mails on a host of issues every week. That is part of what makes the job of serving sociology and sociologists so interesting. But this fall, somewhat unexpectedly, there has been a decided increase in inquiries about one such topic; that is, what to do in the face of unanticipated actions of Institutional Review Boards (IRB) with respect to the approval of research involving human participants. From graduate students to seasoned scholars, many more questions are being raised about the rules governing IRBs and, more to the point, about how IRBs are interpreting federal guidelines for the Protection of Human Subjects (Title 45 CFR 46).

IRBs may be overreaching in what they do because of the high level of attention to their work. The death of a teenager in September 1999 in a gene therapy experiment at the University of Pennsylvania and other recent events have set in motion considerable rethinking about the federal system for the protection of human subjects in research.

Over the past year, the National Bioethics Advisory Commission has been undertaking a review of the relevant regulations and the role and functioning of IRBs. The Commission met in early December and released a draft report on December 19, 2000.

Sociologists are urged to comment during the 60-day period ending February 17, 2001 (see www.bioethics.gov).

Also, the newly created Office of Human Research Protection, located in the Office of the Secretary in the Department of Health and Human Services, is off to an active start. This Office is examining the system for the protection of human subjects and whether reform should include accreditation of IRBs and certification of members (http://ohrp.osophs.dhhs.gov/). The first meeting of the Advisory Committee to that Office meets on December 20-21 as I conclude this column.

Finally, the Institute of Medicine Board on Health Sciences Policy has established the Committee on Assessing the System for the Protection of Human Subjects of Research, with its first task focusing on accreditation standards. A first meeting of this Committee was held on December 18, and an open forum is expected in January (see www.iom.edu/hsp).

As the above should make clear, much is going on engaging ASA’s attention and deserving of member input. Unfortunately there is only limited presence of social and behavioral scientists on these advisory bodies. Therefore, it is important for us to add our input in other ways. Please share your views with me via regular mail or e-mail (levine@asanet.org). As readers may recall, in last April’s Footnotes, I indicated that the ASA was participating in a “working group” convened by the American Association of University Professors (AAUP) on the role of IRBs. A report on that effort is on the AAUP homepage (www.aup.org/IRBdoc.htm), and we are eager to receive comments. I also want to ask those who did not respond to a brief set of questions last April to do so now. The Service on an IRB survey is posted at http://www.asanet.org/forms/irbform.html. It was helpful then and, in this period of heightened activity and action, could not be more relevant.

Felice J. Levine