The Institutional Review Board and Beyond: Future Challenges to the Ethics of Human Experimentation

Abstract

...Nevertheless, in the American context, the very proliferation of these committees [institutional review boards], to the point where they are to be found in every type of institution conducting research, raises critical questions about uniform standards and performance. Is it truly the case that a "one size fits all" approach works well? Are the same general procedures for appointing members and defining their obligations appropriate for reviewing research conducted not only at the Central Intelligence Agency (CIA), the Bureau of Prisons, and the National Institutes of Health (NIH), but also at for-profit hospitals, local community hospitals, and university-affiliated, tertiary-care centers? Does it make sense to give the leadership of an institution, which by its very nature cannot survive without the funds and fame brought in by clinical research, the responsibility for appointing the membership of a monitoring committee? Or, more broadly framed, is the local and institutional basis of IRB organization still appropriate? Are the assumptions that initially underlay that choice still valid? The goal of this essay is to suggest that the answers to these questions may well be no, and to provide some modest, but potentially important, recommendations for change. IRBs can take credit for remarkable accomplishments, but it may be time to revise the framework governing human experimentation.