Rationale: Each UC Biomedical campus contains tens to hundreds of biorepositories. These operations collect human biological samples (tissues and fluids) and associated data for use in research. UC biobanks traditionally have established their own governance structure, which includes rules for accessing, storing and sharing samples/data, including informed consent practices. Governance, a complicated process, has myriad ethical implications including risk to individuals, identifiability, and data sharing. At UC and elsewhere, archived samples were not collected under current/emerging standards for informed consent. Decisions need to be made about the future appropriate use of these samples and data, especially in light of recent concerns about identifiability of “anonymous” genomic samples. Currently, there is little information about community perspectives on appropriate governance of extant biorepositories within UC. [Collections include samples that were initially collected as part of clinical care as well as collections done under research protocols.]
We will leverage an existing NIH-funded study, EngageUC; this study will develop an ethical, efficient, and sustainable system for biorespository research across the UC system. EngageUC includes a robust community engagement (CE) component in which community members who represent the diversity of California will be brought together to be educated about biobanking and to provide informed viewpoints on optimal consenting techniques. This input will then be used to inform a clinical trial of consenting mechanisms to develop an evidence base for prospective collection of biorepository samples. However, EngageUC is focused specifically on establishing policies for informed consent and governance for NEW collections moving forward, and does not examine how samples and data in existing biorespositories – including samples with varying forms of informed consent – should be governed.
This proposal leverages the EngageUC CE activities to develop and refine approaches for managing governance of extant biorepositories in the UC system. This project will: (a) extend planned CE activities by including an array of additional stakeholder groups who bring valuable insights on extant biorepositories; (b) work with community stakeholders, biorepository researchers, and UC institutional officials to develop consistent and comprehensive approaches for managing governance of UC’s extant biobanks; (c) and translate these approaches into policies that are feasible and acceptable for governance of existing biorepositories.
Criteria and metrics for success
Short term criteria for success will include conversations with diverse stakeholder groups to elicit perspectives about governance of extant biobanks and the recommendation of alternative governance approaches for adoption by the UC BRAID consortium including how specimens will be stored, labeled, accessed, and shared; whether and how current perspectives on consent will be incorporated. Long term we anticipate translation of approaches into UC policy.
Approximate cost and justification
The primary costs of the study will be salary support and administrative costs. We require 15% effort for the program manager and 10% effort for one faculty member as well as RA support. Administrative costs will be those associated with setting up meetings between community groups, researchers, and institutional officials. We are requesting $50,000 total.
EngageUC team leaders bring expertise in biorepository research and management, informed consent research, community engagement, and ethical dimensions of informed consent. The team also has experience in mixed-methods research and the translation of research into policy. Jen Hult, MPH, is Senior Program Manager of EngageUC. Elizabeth Boyd, PhD, is Associate Vice Chancellor, Ethics and Compliance at UCSF and Program Director of the CTSI’s Regulatory Knowledge and Support program. Daniel Dohan, PhD, is Associate Professor of Health Policy and Social Medicine at the UCSF Institute for Health Policy Studies (IHPS), where he also serves as Associate Director for Training and Development. Sarah Dry, MD, is Associate Professor and Associate Chair for Research Services in the UCLA Department of Pathology. Arleen Brown, MD, PhD, is Associate Professor of Internal Medicine and Health Services Research and Leader of the UCLA CTSI Community Engagement and Research Program. Barbara Koenig, PhD, is Professor of Social and Behavioral Sciences at UCSF. An internationally-renown bioethicist, Dr. Koenig brings extensive experience in research on biobanking and community engagement and will be the primary faculty member involved in this project.
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