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.
Highlights
Academic medical centers, health systems, industry, and government are developing biorepositories to collect and store samples and data from entire patient or communitybased populations as a resource for advancing translational research, e.g., the national biorepositories established or in development in Iceland, the United Kingdom, and the United States (US)[1,2]
We identified a total of 57 unique recommendations from the deliberative community engagement (DCE) events (29 in Los Angeles (LA), 28 in San Francisco (SF)). 23 recommendations (10 in LA; 13 in SF; S3 Table) were similar and supported by the vast majority of participants at both LA and SF events (80% or more at each site). 30 recommendations were voted on at only one site, and 4 recommendations received high levels of support at only one site
In an era where healthcare data breaches are common and surveillance by government and commercial entities appears unavoidable, the biomedical research community may be well-served to proactively build and maintain a trusting relationship with the public, who constitute its research subjects and beneficiaries, above and beyond what is required by lawmakers
Summary
Health systems, industry, and government are developing biorepositories (or biobanks) to collect and store samples and data from entire patient or communitybased populations as a resource for advancing translational research, e.g., the national biorepositories established or in development in Iceland, the United Kingdom, and the United States (US)[1,2]. The US Federal Government, via an Advance Notice of Proposed Rule Making (2011) and Notice of Proposed Rule Making (2015), is actively reconsidering how to improve its Common Rule protections of human research subjects [6,7]. Among other issues, they seek to align the Common Rule with current practices and future needs of biobank research by recognizing risks posed by advances in genomics, genotype-disease correlations that may require return of research results, unspecified future research, and large-scale health records research. The notices reveal, that we have limited evidence on how to operate and oversee biobanks to assure that biobanks remain trustworthy and continue to enjoy patient and public participation [11,12]
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