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
Wendler D, Prasad K. Core Safeguards for Clinical Research with Adults Who Are Unable To Consent. Ann Intern Med. 2001;135:514–523. doi: https://doi.org/10.7326/0003-4819-135-7-200110020-00011
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Published: Ann Intern Med. 2001;135(7):514-523.
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