"Special Scrutiny": A Targeted Form of Research Protocol Review

3 February 2004 | Volume 140 Issue 3 | Pages 220-223

Research participants require ongoing protection of the kind already established in law and regulation. However, "special scrutiny" for certain types of research is also needed. Three criteria for special scrutiny are 1) research that involves initial experiences of translating new scientific advances into humans, especially when the intervention is novel, irreversible, or both; 2) research with a known or credible risk for significant harm [death or serious disability are the clearest examples] to research participants as a consequence of the experimental intervention and with no potential for offsetting direct medical benefit; or 3) research with a protocol that raises ethical questions about research design or implementation for which there is no consensus. Special scrutiny recognizes that not all research protocols are equally ethically challenging and aims to provide appropriate protection for all research participants.

Author and Article Information

From United Hospital Fund, New York, New York; Johns Hopkins University, Baltimore, Maryland; National Institutes of Health, Bethesda, Maryland; University of Minnesota, Minneapolis, Minnesota; and Duke University Medical Center, Durham, North Carolina, on behalf of the Consortium to Examine Clinical Research Ethics.

Acknowledgments: The authors thank Angela J. Bowen, MD, Western Institutional Review Board, Olympia, Washington; Ezekiel J. Emanuel, MD, PhD, National Institutes of Health, Bethesda, Maryland; Alan R. Fleischman, MD, New York Academy of Medicine, New York, New York; Kenneth A. Getz, CenterWatch, Boston, Massachusetts; and Carianne Tucker, MPH, Center for the Study of Medical Ethics and Humanities, Duke University Medical Center, Durham, North Carolina, for their valuable contributions to this manuscript.

Grant Support: By the Doris Duke Charitable Foundation.

Potential Financial Conflicts of Interest:Employment: D. Hammerschmidt (Infra); Consultancies: D. Hammerschmidt (Infra); Honoraria: D. Hammerschmidt (Infra).

Requests for Single Reprints: Jeremy Sugarman, MD, MPH, MA, Phoebe R. Berman Bioethics Institute, Johns Hopkins University, Hampton House 351, 624 North Broadway, Baltimore, MD 21205.

Current Author Addresses: Ms. Levine: United Hospital Fund, 350 Fifth Avenue, 23rd Floor, New York, NY 10118.

Dr. Faden: Bioethics Institute, Johns Hopkins University, Hampton House 511, 624 North Broadway, Baltimore, MD 21205.

Dr. Grady: Department of Clinical Bioethics, National Institutes of Health, Building 10, Room 1C118, 10 Center Drive, Bethesda, MD 20892-1156.

Dr. Hammerschmidt: Box 480, Mayo Building, University of Minnesota, Minneapolis, MN 55455.

Dr. Eckenwiler: Center for the Study of Medical Ethics and Humanities, Duke University Medical Center, Box 3040, 108 Seeley G. Mudd Building, Durham, NC 27710.

Dr. Sugarman: Phoebe R. Berman Bioethics Institute, Johns Hopkins University, Hampton House 351, 624 North Broadway, Baltimore, MD 21205.