requested the IOM study presented in this report (Shalala, 2000; U.S. Congress, Senate, Subcommittee on Public Health, Committee Health, Education, Labor, and Pensions, 2000). Gelsinger’s death brought a sharp escalation in attention to problems with the system of research participant protections because it resulted more from the experimental intervention and failures in the system of protections than from his underlying condition. The failure to protect this young man in many ways was paradigmatic of failures in the system of protections itself—lack of accountability, conflicts of interest of the investigators and the institutions, insufficient monitoring upon trial commencement, a questionable scientific review procedure, and inadequate resources for comprehensive and stringent review and oversight.

At the institutional level, OPRR/OHRP sanctions have been imposed when systematic deficiencies and concerns regarding systemic protections for human research participants have been found. The deficiencies could be in such areas as IRB membership, education of IRB members and investigators, institutional commitment, initial and continuing review of protocols by IRBs, review of protocols involving vulnerable persons, or procedures for obtaining voluntary informed consent. Although the federal government has been finding fault at the institutional level, some have turned attention to the federal system itself, suggesting that it is in need of consolidation, harmonization, clarity, and a change in organizational culture.

In 2001, the National Bioethics Advisory Commission issued a comprehensive report on ethical and policy issues in human research. The report recommended that federal oversight be centralized and that various components of the oversight system be revised to clarify regulatory responsibilities and to provide more guidance to assist institutions in formulating and implementing policies (2001b).

Calls for such reform are not new. Since the 1974 formation of the National Commission and the activities of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1980-1983), an evolving system of protections has consistently, albeit not always successfully, tried to enhance protections for human research participants.

In response to recent concerns, many groups have taken steps to improve protections for research participants. For example, Public Responsibility in Medicine and Research, the Applied Research Ethics National Association, the Association of American Medical Colleges, and the Association of American Universities have issued policy statements, instituted workshops and training, or encouraged their member organizations to strengthen their protection procedures.

Federal agencies also have moved to strengthen and streamline the oversight system. The DHHS elevated its oversight office from NIH to the



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