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Broad consent for research with biological samples: workshop conclusions
journal contributionposted on 2023-05-18, 12:29 authored by Grady, C, Lisa EcksteinLisa Eckstein, Berkman, B, Brock, D, Cook-Deegan, R, Fullerton, S, Greely, H, Hansson, MG, Hull, S, Kim, S, Lo, B, Pentz, R, Rodriguez, L, Weil, C, Wilfond, BS, Wendler, D
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 Center’s 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.
Publication titleAmerican Journal of Bioethics
Department/SchoolFaculty of Law
Place of publicationUnited States
Rights statementThis article is not subject to U.S. copyright law.