Community recommendations on biobank governance: Results from a deliberative community engagement in California

• Published in: PloS one Vol. 12; no. 2; p. e0172582
• Main Authors: Dry, Sarah M, Garrett, Sarah B, Koenig, Barbara A, Brown, Arleen F, Burgess, Michael M, Hult, Jen R, Longstaff, Holly, Wilcox, Elizabeth S, Madrigal Contreras, Sigrid Karina, Martinez, Arturo, Boyd, Elizabeth A, Dohan, Daniel
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 24.02.2017; Public Library of Science (PLoS)
• Subjects: Adult; Aged; Biological Specimen Banks - legislation & jurisprudence; Biomedical Research - education; Biomedical Research - legislation & jurisprudence; Citizen participation; Colleges & universities; Community; Community involvement; Community Participation; Consent; Design; Dry, Sarah; Ethical aspects; Ethics; Feasibility studies; Female; Health care; Health Knowledge, Attitudes, Practice; Health Surveys; Humans; Informed Consent - legislation & jurisprudence; Internet; Laws, regulations and rules; Los Angeles; Male; Medicine and Health Sciences; Metropolitan areas; Middle Aged; Minority & ethnic groups; People and places; Populations; Project feasibility; Qualitative Research; R&D; Random sampling; Research & development; Research and Analysis Methods; Research institutions; Research methodology; Researchers; San Francisco; Social Sciences; Statistical sampling; Tissue banks; Tissue preservation; Universities; United States; Canada; Los Angeles California; San Francisco California; California; United States > US; Iceland
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0172582

United States-based biorepositories are on the cusp of substantial change in regulatory oversight at the same time that they are increasingly including samples and data from large populations, e.g. all patients in healthcare system. It is appropriate to engage stakeholders from these populations in new governance arrangements. We sought to describe community recommendations for biorepository governance and oversight using deliberative community engagement (DCE), a qualitative research method designed to elicit lay perspectives on complex technical issues. We asked for stakeholders to provide input on governance of large biorepositories at the University of California (UC), a public university. We defined state residents as stakeholders and recruited residents from two large metropolitan areas, Los Angeles (LA) and San Francisco (SF). In LA, we recruited English and Spanish speakers; in SF the DCE was conducted in English only. We recruited individuals who had completed the 2009 California Health Interview Survey and were willing to be re-contacted for future studies. Using stratified random sampling (by age, education, race/ethnicity), we contacted 162 potential deliberants of whom 53 agreed to participate and 51 completed the 4-day DCE in June (LA) and September-October (SF), 2013. Each DCE included discussion among deliberants facilitated by a trained staff and simultaneously-translated in LA. Deliberants also received a briefing book describing biorepository operations and regulation. During the final day of the DCE, deliberants voted on governance and oversight recommendations using an audience response system. This paper describes 23 recommendations (of 57 total) that address issues including: educating the public, sharing samples broadly, monitoring researcher behavior, using informative consent procedures, and involving community members in a transparent process of biobank governance. This project demonstrates the feasibility of obtaining meaningful input on biorepository governance from diverse lay stakeholders. Such input should be considered as research institutions respond to changes in biorepository regulation.