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Regional ethics organizations for protection of human research participants

Nature Medicine volume 10, pages 1283–1288 (2004)Cite this article

Today, almost no one feels satisfied with protections for human participants in clinical research1,2. Clinical investigators are frustrated by a review process that seems bureaucratic and inefficient. Institutional review board (IRB) and ethics committee members and staff feel overworked, sometimes baffled by ambiguous regulations, and uncertain of calls for accreditation. Regulators, stymied by their limited authority, worry about criticism for inaction despite harm to research participants. Commercial sponsors of research see the system as inefficient and repetitive. Foreign researchers and governments often view the requirement to follow US regulations as culturally insensitive and even imperialistic. The public finds each alleged case of unethical practice and the recent deaths of several research participants troubling and indicative that the system is broken3. “Dissatisfaction with the current system is widespread...[and] major reforms are in order”1.

In Europe, the European Union Clinical Trials Directive, championed by the pharmaceutical industry to streamline ethical review and create a single clinical trials market in Europe, instituted a number of measures aimed at creating explicit timelines for review of research protocols and requiring only a single review per country4. Full implementation was slated to occur in May 2004, too recently for evaluation. But many view these changes as increasing the bureaucracy related to research and therefore slowing progress, especially in relationship to emergency research5,6. Others worry it will increase the legal language and length of informed consent documents, as well as potentially worsen protections without achieving a single market for clinical trials4,7. Most importantly, because the Directive does not require institutions to participate after the first ethics committee approval, it may not actually streamline reviews of clinical trials. Other efforts to streamline local ethics review of clinical trials, such as those in England, seem to have simply added more reviews and lengthened the process8.

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Authors and Affiliations

  1. School of Law, University of California, Berkeley, Berkeley, 94720-7200, California, USA

    Anne Wood

  2. Department of Clinical Bioethics, Warren G. Magnuson Clinical Center, Bethesda, 20892-1156, Maryland, USA

    Christine Grady & Ezekiel J Emanuel

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  2. Christine Grady
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  3. Ezekiel J Emanuel
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Wood, A., Grady, C. & Emanuel, E. Regional ethics organizations for protection of human research participants. Nat Med 10, 1283–1288 (2004). https://doi.org/10.1038/nm1204-1283

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