Biobanks are increasingly hailed as powerful tools to advance health research. The social and ethical challenges associated with the implementation and operation of biobanks are equally well-documented. One of the proposed solutions to these challenges involves trading off a reduction in the specificity of informed consent protocols with an increased emphasis on governance. However, little work has gone into formulating what such governance might look like. In this paper, we suggest four general principles that should inform biobank governance and illustrate the enactment of these principles in a proposed governance model for a particular population-scale biobank, the British Columbia (BC) Generations Project. We begin by outlining four principles that we see as necessary for informing sustainable and effective governance of biobanks: (1) recognition of research participants and publics as a collective body, (2) trustworthiness, (3) adaptive management, and (4) fit between the nature of a particular biobank and the specific structural elements of governance adopted. Using the BC Generations Project as a case study, we then offer as a working model for further discussion the outlines of a proposed governance structure enacting these principles. Ultimately, our goal is to design an adaptive governance approach that can protect participant interests as well as promote effective translational health sciences.
Providing technical and experiential information without overwhelming participants' perspectives presents a major challenge to public involvement in policy decisions. This article reports the design and analysis of a case study on incorporating expert and stakeholder knowledge without including them as deliberators, while supporting deliberative participants' ability to introduce and critically assess different perspectives. Analysis of audio-recorded deliberations illustrates how expert and stakeholder knowledge was cited, criticized and incorporated into deliberations. In conclusion, separating experts and stakeholders from deliberations may be an important prima facie principle when the goal is to enhance citizen representation on technical issues and related policy.
This paper reports on the design, implementation, and results of a structured public deliberation on human tissue biobanking conducted in Vancouver, Canada, in 2009. This study builds on previous work on the use of deliberative democratic principles and methods to engage publics on the social and ethical implications of human tissue biobanking. In a significant refinement of methods, we focus on providing public input to institutional practice and governance of biobanks using a tailored workbook structure to guide participants' discussion. Our focus is on the local context and practices of a particular institution, the BC BioLibrary. However, elements of both the methodological innovations and the ethical guidance implied by our findings are generalisable for biobanking internationally. Recommendations from the deliberative forum include issues of informed consent, privacy protections, collection of biospecimens, governance of biobanks, and how to manage the process of introduction between biobanks and potential donors. Notable findings include public support for research use of anonymised un-consented tissue samples when these come from archived collections, but lack of support when they are collected prospectively.
This paper addresses the dilemmas of participant sampling and recruitment for deliberative science policy projects. Results are drawn from a deliberative public event that was held in April and May, 2007. The research objective of The BC Biobank Deliberation was to assess deliberative democracy as an approach to legitimate policy advice from a subset of British Columbians concerning the secondary use of human tissues for prospective genomic and genetic research. The overall goal was to have participants identify key values that should guide a biobank in British Columbia. This paper assesses our team's group decision-making processes concerning participant sampling for the 2007 event. Results presented here should allow the reader to critically examine our team's choices and could also be used to assist advocates of deliberative democracy and others who may wish to propose similar events in the future.
Decisions about funding health services are crucial to controlling costs in health care insurance plans, yet they encounter serious challenges from intellectual property protection--e.g., patents--of health care services. Using Myriad Genetics' commercial genetic susceptibility test for hereditary breast cancer (BRCA testing) in the context of the Canadian health insurance system as a case study, this paper applies concepts from social contract theory to help develop more just and rational approaches to health care decision making. Specifically, Daniel's and Sabin's "accountability for reasonableness" is compared to broader notions of public consultation, demonstrating that expert assessments in specific decisions must be transparent and accountable and supplemented by public consultation.