title: Broad Consent for Research With Biological Samples: Workshop Conclusions.
abstract: 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.
authors: a National Institutes of Health Clinical Center.
authors: Christine
authors: C
authors: Grady
authors: Lisa
authors: L
authors: Eckstein
authors: Ben
authors: B
authors: Berkman
authors: Dan
authors: D
authors: Brock
authors: Robert
authors: R
authors: Cook-Deegan
authors: Stephanie M
authors: SM
authors: Fullerton
authors: Hank
authors: H
authors: Greely
authors: Mats G
authors: MG
authors: Hansson
authors: Sara
authors: S
authors: Hull
authors: Scott
authors: S
authors: Kim
authors: Bernie
authors: B
authors: Lo
authors: Rebecca
authors: R
authors: Pentz
authors: Laura
authors: L
authors: Rodriguez
authors: Carol
authors: C
authors: Weil
authors: Benjamin S
authors: BS
authors: Wilfond
authors: David
authors: D
authors: Wendler
mesh_terms: D018070:Biological Specimen Banks / Q000941:ethics / Q000458:organization & administration / Q000592:standards / Q000639:trends; D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D003142:Communication; D003226:Congresses as Topic; D026689:Ethical Analysis; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D009316:National Institutes of Health (U.S.); D026684:Personal Autonomy; D014019:Tissue Donors; D014481:United States
keywords: Keywords:; biomedical research; informed consent; regulatory issues; research ethics