The full content of Annals is available to subscribers

Subscribe/Learn More  >
Research and Reporting Methods |

Streamlining Ethical Review

Joseph Millum, PhD; and Jerry Menikoff, MD, JD
[+] Article, Author, and Disclosure Information

From the Clinical Center Department of Bioethics and Fogarty International Center, National Institutes of Health, Bethesda, and the Office for Human Research Protections, Rockville, Maryland.

Disclaimer: The views expressed in this commentary are those of the authors and are not necessarily those of the U.S. Department of Health and Human Services or its operating divisions, the National Institutes of Health and the Office of the Assistant Secretary for Health.

Acknowledgment: The authors thank Ezekiel Emanuel for his helpful comments.

Potential Conflicts of Interest: None disclosed. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M10-1459.

Requests for Single Reprints: Joseph Millum, PhD, Clinical Center Department of Bioethics and Fogarty International Center, National Institutes of Health, 10 Center Drive, Building 10, Room 1C118, Bethesda, MD 20892-1156; e-mail, millumj@cc.nih.gov.

Current Author Addresses: Dr. Millum: Clinical Center Department of Bioethics and Fogarty International Center, National Institutes of Health, 10 Center Drive, Building 10, Room 1C118, Bethesda, MD 20892-1156.

Dr. Menikoff: Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

Author Contributions: Conception and design: J. Millum, J. Menikoff.

Drafting of the article: J. Millum, J. Menikoff.

Critical revision of the article for important intellectual content: J. Millum, J. Menikoff.

Final approval of the article: J. Millum, J. Menikoff.

Ann Intern Med. 2010;153(10):655-657. doi:10.7326/0003-4819-153-10-201011160-00008
Text Size: A A A

The review system for human subjects research in the United States has been widely criticized in recent years for requirements that delay research without improving human subject protections. Any major reformulation of regulations may take some time to implement. However, current regulations often allow for streamlined ethics review that does not jeopardize—and may improve—protections for research participants. The authors discuss underutilized options, including research that need not be classified as human subjects research, categories of studies that can be exempt from ethical review, studies that need only undergo expedited review by 1 institutional review board (IRB) member, and simplifying reviews of multicenter research by using the IRB of 1 institution. The authors speculate on multiple reasons for the underuse of these mechanisms and exhort IRBs and researchers to take advantage of these important opportunities to improve the review process.





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).


Submit a Comment/Letter
Submit a Comment/Letter

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.


Buy Now for $32.00

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Related Articles
Topic Collections
PubMed Articles
Surgical innovation: the ethical agenda: A systematic review. Medicine (Baltimore) 2016;95(25):e3790.
Division and discord in the Clinical Trial Regulation. J Med Ethics Published online Jul 18, 2016;
Forgot your password?
Enter your username and email address. We'll send you a reminder to the email address on record.