title: Community recommendations on biobank governance: Results from a deliberative community engagement in California.
abstract: 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.
authors.affiliation: Department of Pathology and Laboratory Medicine, University of California Los Angeles, Los Angeles, California, United States of America.
authors.forename: Sarah M
authors.initials: SM
authors.lastname: Dry
authors.affiliation: Philip R. Lee Institute for Health Policy Studies, University of California San Francisco, San Francisco, California, United States of America.
authors.forename: Sarah B
authors.initials: SB
authors.lastname: Garrett
authors.affiliation: Department of Social and Behavioral Sciences, Institute for Health and Aging, University of California San Francisco, San Francisco, California, United States of America.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Koenig
authors.affiliation: Division of General Internal Medicine and Health Services Research, University of California Los Angeles, Los Angeles, California, United States of America.
authors.forename: Arleen F
authors.initials: AF
authors.lastname: Brown
authors.affiliation: Department of Biomedical Ethics, The University of British Columbia, Vancouver, B.C., Canada.
authors.forename: Michael M
authors.initials: MM
authors.lastname: Burgess
authors.affiliation: Genentech, Inc., South San Francisco, California, United States of America.
authors.forename: Jen R
authors.initials: JR
authors.lastname: Hult
authors.affiliation: Office of Research Ethics, Simon Fraser University, Burnaby, B.C., Canada.
authors.forename: Holly
authors.initials: H
authors.lastname: Longstaff
authors.affiliation: School of Population and Public Health, The University of British Columbia, Vancouver, B.C., Canada.
authors.forename: Elizabeth S
authors.initials: ES
authors.lastname: Wilcox
authors.affiliation: Independent Scholar, Torrance, California, United States of America.
authors.forename: Sigrid Karina
authors.initials: SK
authors.lastname: Madrigal Contreras
authors.affiliation: Center for Clinical and Translational Science Institute, University of California Los Angeles, Los Angeles, California, United States of America.
authors.forename: Arturo
authors.initials: A
authors.lastname: Martinez
authors.affiliation: University of California, Office of the President, Oakland, California, United States of America.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Boyd
authors.affiliation: Philip R. Lee Institute for Health Policy Studies, University of California San Francisco, San Francisco, California, United States of America.
authors.forename: Daniel
authors.initials: D
authors.lastname: Dohan
mesh_terms: D000328:Adult; D000368:Aged; D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence*; D035843:Biomedical Research / Q000193:education / Q000331:legislation & jurisprudence*; D003256:Community Participation; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006306:Health Surveys; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D015141:Los Angeles; D008297:Male; D008875:Middle Aged; D036301:Qualitative Research; D012495:San Francisco; D014495:Universities