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Consent for Research With Biological Samples: One-Time General Consent Versus a Gift Model

David Wendler, PhD
[+] Article, Author, and Disclosure Information

From the National Institutes of Health Clinical Center, Bethesda, Maryland.

Disclaimer: The views expressed are those of the author and do not represent any position or policy of the National Institutes of Health, the Department of Health and Human Services, or the U.S. government. The National Institutes of Health had no role in the preparation, review, or approval of the manuscript.

Acknowledgment: The author thanks Sara Hull for her comments on a previous version of the manuscript.

Financial Support: This work was completed as part of the author's official duties as an employee of the National Institutes of Health Clinical Center.

Potential Conflicts of Interest: None disclosed. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-2688.

Requests for Single Reprints: David Wendler, PhD, Department of Bioethics, NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD 20892-1156; e-mail, mailto:dwendler@nih.gov.

Author Contributions: Conception and design: D. Wendler.

Drafting of the article: D. Wendler.

Critical revision of the article for important intellectual content: D. Wendler.

Final approval of the article: D. Wendler.

Administrative, technical, or logistic support: D. Wendler.

Ann Intern Med. 2012;156(8):596-598. doi:10.7326/0003-4819-156-8-201204170-00011
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Scientific advances have dramatically increased the value of stored human biological samples, generating debate about the appropriate consent process for these samples for research not specified at the time of sample collection. The recent Advance Notice of Proposed Rulemaking raises the possibility of incorporating one-time general consent into U.S. federal regulations governing research with human biological samples. Some have proposed that a gift model may be more appropriate. This commentary compares how well each model addresses 5 central challenges faced by investigators and concludes that one-time general consent is preferred.

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Consent makes the law (Consensus facit legem)
Posted on April 23, 2012
Hugh, Mann, Physician
Eagle Rock, Mo 65641
Conflict of Interest: None Declared

Informed consent is a redundancy, because being properly informed is a precondition of consent. Without being properly informed, a patient or client cannot give any legitimate, binding consent. Therefore, it is imperative that all professionals withhold any request for agreement or signatures, until after all information and questions have been fully addressed.

Conflict of Interest:

None declared

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