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Broad consent for research with biological samples: workshop conclusions


Grady, C and Eckstein, LG and Berkman, B and Brock, D and Cook-Deegan, R and Fullerton, S and Greely, H and Hansson, MG and Hull, S and Kim, S and Lo, B and Pentz, R and Rodriguez, L and Weil, C and Wilfond, BS and Wendler, D, Broad consent for research with biological samples: workshop conclusions, American Journal of Bioethics, 15, (9) pp. 34-42. ISSN 1526-5161 (2015) [Refereed Article]

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This article is not subject to U.S. copyright law.

DOI: doi:10.1080/15265161.2015.1062162


Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health (NIH) Clinical Centerís Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and timely topic.

Item Details

Item Type:Refereed Article
Keywords:biomedical research, informed consent, regulatory issues, research ethics
Research Division:Philosophy and Religious Studies
Research Group:Applied ethics
Research Field:Legal ethics
Objective Division:Law, Politics and Community Services
Objective Group:Justice and the law
Objective Field:Justice and the law not elsewhere classified
UTAS Author:Eckstein, LG (Dr Lisa Eckstein)
ID Code:102521
Year Published:2015
Web of Science® Times Cited:178
Deposited By:Faculty of Law
Deposited On:2015-08-26
Last Modified:2017-11-09

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