[Show abstract][Hide abstract] ABSTRACT: Public participation is increasingly an aspect of policy development in many areas, and the governance of biomedical research is no exception. There are good reasons for this: biomedical research relies on public funding; it relies on biological samples and information from large numbers of patients and healthy individuals; and the outcomes of biomedical research are dramatically and irrevocably changing our society. There is thus arguably a democratic imperative for including public values in strategic decisions about the governance of biomedical research. However, it is not immediately clear how this might best be achieved. While different approaches have been proposed and trialled, we focus here on the use of public deliberation as a mechanism to develop input for policy on biomedical research. We begin by explaining the rationale for conducting public deliberation in biomedical research. We focus, in particular, on the ELS (ethical, legal, social) aspects of human tissue biobanking. The last few years have seen the development of methods for conducting public deliberation on these issues in several jurisdictions, for the purpose of incorporating lay public voices in biobanking policy. We explain the theoretical foundation underlying the notion of deliberation, and outline the main lessons and capacities that have been developed in the area of conducting public deliberation on biobanks. We next provide an analysis of the theoretical and practical challenges that we feel still need to be addressed for the use of public deliberation to guide ethical norms and governance of biomedical research. We examine the issues of: (i) linking the outcomes of deliberation to tangible action; (ii) the mandate under which a deliberation is conducted; (iii) the relative weight that should be accorded to a public deliberative forum vs other relevant voices; (iv) evaluating the quality of deliberation; and (5) the problem of scalability of minipublics.
[Show abstract][Hide abstract] ABSTRACT: 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.
Social Science [?] Medicine 07/2012; 75(9):1604-11. · 2.73 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Ongoing debate exists around how best to manage the issue of informed consent for research involving human tissue biobanks. However, the issue is well recognized and covered in the academic literature. A related and arguably equally important issue that to date has not received much attention is how best to manage the process of identifying and initially contacting individuals for their participation in a biobank. While many population-based biobanks strive for random sampling of healthy participants from the general population, disease-based biobanks usually need to rely on some sort of referral process to achieve specificity for type and subcategories of disease. There are thus numerous ethical implications regarding the way in which this referral process is managed. In this article we begin by providing a brief outline of the nature of the problems associated with the initial introduction between a biobank and potential research participants. We then consider data from a recent public deliberation on the topic of human tissue biobanking. In these discussions, participants were posed questions regarding their views pertaining to the introduction of potential donors to biobanks, and asked to make recommendations to be considered by policy makers in British Columbia, Canada. Based on these data we conclude that there is general agreement that introduction of research biobanks to potential donors should be conducted face to face, and by a medical professional known to the donor, and depending on donor circumstances, is acceptable during either pre- or postoperative periods. The strong preference for the introduction to involve a family physician should be considered in the future design of biobank contact and consent processes.
Biopreservation and Biobanking 02/2012; 10(1):12-21. · 1.50 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: 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.
Social Science [?] Medicine 08/2011; 73(3):367-74. · 2.73 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: 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.
Public Understanding of Science 07/2010; 19(4):486-96. · 1.87 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: 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.
Public Understanding of Science 03/2010; 19(2):212-24. · 1.87 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Medical research to improve health care faces a major problem in the relatively limited availability of adequately annotated and collected biospecimens. This limitation is creating a growing gap between the pace of scientific advances and successful exploitation of this knowledge. Biobanks are an important conduit for transfer of biospecimens (tissues, blood, body fluids) and related health data to research. They have evolved outside of the historical source of tissue biospecimens, clinical pathology archives. Research biobanks have developed advanced standards, protocols, databases, and mechanisms to interface with researchers seeking biospecimens. However, biobanks are often limited in their capacity and ability to ensure quality in the face of increasing demand. Our strategy to enhance both capacity and quality in research biobanking is to create a new framework that repatriates the activity of biospecimen accrual for biobanks to clinical pathology.
The British Columbia (BC) BioLibrary is a framework to maximize the accrual of high-quality, annotated biospecimens into biobanks. The BC BioLibrary design primarily encompasses: 1) specialized biospecimen collection units embedded within clinical pathology and linked to a biospecimen distribution system that serves biobanks; 2) a systematic process to connect potential donors with biobanks, and to connect biobanks with consented biospecimens; and 3) interdisciplinary governance and oversight informed by public opinion.
The BC BioLibrary has been embraced by biobanking leaders and translational researchers throughout BC, across multiple health authorities, institutions, and disciplines. An initial pilot network of three Biospecimen Collection Units has been successfully established. In addition, two public deliberation events have been held to obtain input from the public on the BioLibrary and on issues including consent, collection of biospecimens and governance.
The BC BioLibrary framework addresses common issues for clinical pathology, biobanking, and translational research across multiple institutions and clinical and research domains. We anticipate that our framework will lead to enhanced biospecimen accrual capacity and quality, reduced competition between biobanks, and a transparent process for donors that enhances public trust in biobanking.
Journal of Translational Medicine 11/2009; 7:95. · 3.46 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: As acknowledged in the literature, public consultation related to biobanks has been largely oriented to assuring and informing rather than seeking considered input. In April and May of 2007, the authors participated in running a deliberative public engagement event in British Columbia, Canada, which sought to enhance public input related to the governance of biobanks. The topic of the event was 'Biobanking in British Columbia (BC)' and at the event a random-digit dialed demographically stratified sample of 21 participants deliberated on what values and interests ought to be considered in the regulation and use of biobanks for health research. In this paper, we report results related to debate over the place of informed consent in biobank research. Drawing on a pre/post-survey and qualitative analysis of event transcripts, we show that participants indicated strong support for biobanks, for a general reduction in concern for withdrawal of samples, and placed a strong emphasis on the need for review of biobanks research that is independent of funders and researchers. In this context, there was persistent disagreement about when consent was required for new research activities.
Social Science [?] Medicine 01/2009; 68(4):781-9. · 2.73 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Risk researchers have traditionally examined technologies that have become stigmatized in the public realm. In this study, we examine a prior cognitive phenomenon, which assumes that technologies are classified according to the non-scientific taxonomies that individuals use to make sense of the world. We describe the coarse taxonomies revealed during five focus groups involving expert and non-expert participants. The study suggests that in discussions of salmon genomics, participants consistently conflate genomic research with transgenic applications. The authors discuss the implications of this phenomenon for public policy.
Public Understanding of Science 11/2008; 17(4):473-84. · 1.87 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Interest in whole-genome research has grown substantially over the past few months. This article explores the challenging ethics issues associated with this work.
[Show abstract][Hide abstract] ABSTRACT: In anticipation of increasing interest in public engagement, this article seeks to expand the current discussion in the neuroethics literature concerning what public engagement on issues related to neuroscience might entail and how they could be envisioned. It notes that the small amount of available neuroethics literature related to public engagement has principally discussed only communication/education or made calls for dialogue without exploring what this might entail on a practical level. The article links across three seemingly disparate examples-salmon, biobanks, and neuroethics-to consider and clarify the need for public engagement in neuroscience.
Accountability in Research 01/2008; 15(4):283-302. · 0.76 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The extension of informed consent into social science research has met with considerable opposition. The history and concept of informed consent, however, is based on a substantive ethical notion of the research relationship as informed and voluntary that is appropriate for social science research relationships. Yet social science research might sometimes be different from health research in ways that justify a different approach to informed consent and research relationships. Social science research tends to have a lower magnitude of risk, usually does not need to disrupt the therapeutic assumption common in health research contexts or when researchers are health professionals, and recruitment is sometimes incremental and reflects a building of trust and development of the research participant's role. These differences may sometimes justify novel approaches to the research relationship and require case-by-case evaluation to determine their relevance to establishing the informed and voluntary nature of the relationship through the use of informed consent procedures. Ultimately, respect for research participants requires social research into practices that can support or replace informed consent. The institutional role of informed consent and the goal of informed and voluntary research participation serve modest but important roles in health and social research. Their proper role in health and social research requires flexibility and experimentation, but does not justify abdication of informed consent or the notion of informed and voluntary participation.
Social Science [?] Medicine 01/2008; 65(11):2284-95. · 2.73 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Professional and policy discussions about the appropriate funding and allocation of health cares services are an essential part of the management of public and private health care insurance plans. However, the ability of governments and health professionals to equitably decide on the distribution of health care is being challenged by the increasing drive to patent health care technologies. Referring to the case of genetic testing for hereditary breast cancer (and Myriad Genetics' patenting of the BRCA1 & BRCA2 genes), this paper applies some concepts from moral philosophy to think through the effects of the commercialisation of genetic technologies, and what would constitute a more just and rational approach to health care decision-making, in the context of the Canadian health insurance system.
Familial Cancer 02/2006; 5(1):117-21. · 1.94 Impact Factor