Reports Bring Several Changes To IRBs

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A series of new reports, regulations, and recommendations on the conduct of human-subjects research will lead to substantial changes in the inner workings of institutional review boards, which supervise human-subjects research.

This spring, the Department of Health and Human Services’ Office of Inspector General issued one report on the status of its 2-year-old recommendations on protecting human research subjects, another on the U.S. Food and Drug Administration’s oversight of clinical trials, and two others on recruiting subjects for clinical trials. In late May, DHHS Secretary Donna E. Shalala announced several related initiatives. One requires formal training of IRB members and investigators working with human subjects. Another requires increased monitoring of clinical trials. A third is a legislative proposal to allow the FDA to fine investigators and institutions for violations of informed consent rules.

This increased attention to human-subjects protections is no accident, says Paul Root Wolpe, Ph.D., a faculty associate at the University of Pennsylvania’s Center for Bioethics.