Dave Wendler, PhD; Kiran Prasad, BS
Disclaimer: The opinions expressed in this article are the authors' and do not represent any position or policy of the National Institutes of Health, the U.S. Public Health Service, or the U.S. Department of Health and Human Services.
Acknowledgment: The authors thank Frank Miller, Alan Fleischman, Jim Childress, Rebecca Dresser, Don Rosenstein, Evan DeRenzo, David Shore, Jack Schwartz, Steve Burton, and Ezekiel Emanuel for their helpful suggestions.
Requests for Single Reprints: Dave Wendler, PhD, Room 1C118, Building 10, National Institutes of Health, Bethesda, MD 20892.
Current Author Addresses: Dr. Wendler and Ms. Prasad: Department of Clinical Bioethics, National Institutes of Health, Room 1C118, Building 10, National Institutes of Health, Bethesda, MD 20892.
The National Bioethics Advisory Commission has proposed new safeguards for clinical research with adults who are unable to consent. Three other major U.S. groups have also proposed additional safeguards for this population, and existing Canadian and European guidelines already include such safeguards. While these six guidelines agree on some safeguards, they disagree on others. To allow important research to proceed while protecting adults who are unable to consent, it will be crucial to resolve these differences. This paper uses a side-by-side comparison of these six guidelines to highlight their major points of consensus, analyze their significant differences, and distill six core safeguards.
Table 1. Scope of the Recommendations
Table 2. Core Safeguards
Table 3. Required Safeguards in Specific Cases
Table 4. Roles and Responsibilities
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.
Wendler D, Prasad K. Core Safeguards for Clinical Research with Adults Who Are Unable To Consent. Ann Intern Med. 2001;135:514–523. doi: 10.7326/0003-4819-135-7-200110020-00011
Download citation file:
Published: Ann Intern Med. 2001;135(7):514-523.
Results provided by:
Copyright © 2017 American College of Physicians. All Rights Reserved.
Print ISSN: 0003-4819 | Online ISSN: 1539-3704
Conditions of Use
This PDF is available to Subscribers Only