Broad Consent for Research With Biological Samples: Workshop Conclusions

• Type of Material: Article
• Authors: Christine Grady, NIH Clinical Center; Lisa Eckstein, University of Tasmania; Ben Berkman, National Human Genome Research Institute; Dan Brock, Harvard University; Robert Cook-Deegan, Duke University; Stephanie M. Fullerton, University of Washington; Hank Greely, Stanford University; Mats G. Hansson, Uppsala University; Sara Hull, National Human Genome Research Institute; Scott Kim, NIH Clinical Center; Bernie Lo, The Greenwall Foundation; Rebecca Pentz, Emory University; Laura Rodriguez, National Human Genome Research Institute; Carol Weil, National Cancer Institute; Benjamin S. Wilfond, Seattle Children’s Hospital; David Wendler, NIH Clinical Center
• Language: English
• Date: 2015-09-02
• Publisher: Taylor & Francis (Routledge)
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2015, Taylor & Francis Group, LLC.
• Final Published Version (URL): http://dx.doi.org/10.1080/15265161.2015.1062162
• Title of Journal or Parent Work: American Journal of Bioethics
• ISSN: 1526-5161
• Volume: 15
• Issue: 9
• Start Page: 34
• End Page: 42
• Grant/Funding Information: The workshop was funded by the NIH CC Department of Bioethics.
• Keywords: Medical Ethics; Social Sciences; Social Issues; regulatory issues; Social Sciences, Biomedical; research ethics; GENETIC RESEARCH; informed consent; Life Sciences & Biomedicine; OPT-OUT; biomedical research; Ethics; Science & Technology; RESEARCH PARTICIPANTS; HEPATITIS; PUBLIC-ATTITUDES; BIOBANK RESEARCH; POPULATION; DONORS; Biomedical Social Sciences; Social Sciences - Other Topics
• Research Categories: Health Sciences, General

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.