0

The full content of Annals is available to subscribers

Subscribe/Learn More  >
Ideas and Opinions |

“Special Scrutiny”: A Targeted Form of Research Protocol Review

Carol Levine, MA; Ruth Faden, MPH, PhD; Christine Grady, PhD; Dale Hammerschmidt, MD; Lisa Eckenwiler, PhD; Jeremy Sugarman, MD, on behalf of the Consortium to Examine Clinical Research Ethics
[+] Article and Author 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.


Ann Intern Med. 2004;140(3):220-223. doi:10.7326/0003-4819-140-3-200402030-00013
Text Size: A A A

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.

Figures

Tables

References

Letters

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Comments

Submit a Comment
Submit a Comment

Summary for Patients

Clinical Slide Sets

Terms of Use

The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.

Toolkit

Buy Now

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Advertisement
Related Articles
Topic Collections
Forgot your password?
Enter your username and email address. We'll send you a reminder to the email address on record.
(Required)
(Required)