[Show abstract][Hide abstract] ABSTRACT: Decision-makers are challenged to incorporate public input into priority-setting decisions. We conducted a pan-Canadian survey of decision-makers in cancer control to investigate the types of evidence, especially evidence supplied by the public, that are utilized in health care priority-setting. We further examined how normative attitudes and contextual factors influence the use of public engagement as evidence at the committee level. Administered between November and December 2012, 67 respondents from 117 invited individuals participated in the survey. The results indicated that public engagement was infrequently utilized compared to clinical effectiveness evidence or cost evidence. General positive agreement between normative attitudes towards the use of evidence and the frequency of evidence utilization was observed, but absence of correlative agreement was found for the types of evidence that are supplied by the general public and for cost-effectiveness inputs. Regression analyses suggested that public engagement was unevenly utilized between jurisdictions and that educational background and barriers to implementing public input may decrease the odds of using public engagement as evidence. We recommend that institutions establish a link between committee members' normative attitudes for using public engagement and its real-world utilization.
Full-text · Article · Dec 2014 · Social Science & Medicine
[Show abstract][Hide abstract] ABSTRACT: Public trust is critical in any project requiring significant public support, both in monetary terms and to encourage participation. The research community has widely recognized the centrality of public trust, garnered through community consultation, to the success of large-scale epidemiology. This paper examines the potential utility of the deliberative democracy methodology within the public health research setting. A deliberative democracy event was undertaken in Tasmania, Australia, as part of a wider program of community consultation regarding the potential development of a Tasmanian Biobank. Twenty-five Tasmanians of diverse backgrounds participated in two weekends of deliberation; involving elements of information gathering; discussion; identification of issues and formation of group resolutions. Participants demonstrated strong support for a Tasmanian Biobank and their deliberations resulted in specific proposals in relation to consent; privacy; return of results; governance; funding; and, commercialization and benefit sharing. They exhibited a high degree of satisfaction with the event, and confidence in the outcomes. Deliberative democracy methodology is a useful tool for community engagement that addresses some of the limitations of traditional consultation methods.
[Show abstract][Hide abstract] ABSTRACT: The proliferation of large biorepositories and the staggering advances in our ability to analyse large numbers of human genomes relatively quickly and cost-effectively have been important drivers in the move towards personalised medicine. However, our advances in the development of these tools have outstripped our performance in addressing the issues of ethics and consent surrounding health policy and governance of such repositories, the implications of proliferation of genomic information for the individual and its potential for misuse. Public consultation is urgently needed in the development of ethical guidelines for these emergent issues; however, effective strategies for facilitating community engagement and informed debate have been lacking. Public consultation through deliberative democracy is bringing an essential new dimension to public engagement in the genomic medicine era.
[Show abstract][Hide abstract] ABSTRACT: Biobanks are increasingly being created specifically for research purposes. Concomitantly, we are seeing significant and evolving
shifts in research ethics in relation to biobanking. Three discrete shifts are identified in this article. The first extends
the ethical focus beyond the protection of human subjects to the promotion of broader community benefits of research utilizing
biobanked resources, and an expectation that these benefits will be shared. The second involves the evolution of the traditional
consent paradigm for future research uses of biobanks resources that are not in contemplation at the time of donation. The
third involves a move away from single project management to more dynamic governance accountability to research participants
and the public. These shifts may take different local and institutional forms but share common recognizable elements.
No preview · Article · Mar 2014 · Public Health Ethics
[Show abstract][Hide abstract] ABSTRACT: The last 20 years have seen a shift from the view that publics need to be educated so that they trust science and its governance to the recognition that publics possess important local knowledge and the capacity to understand technical information sufficiently to participate in policy decisions. There are now a variety of approaches to increasing the role of publics and advocacy groups in the policy and governance of science and biotechnology. This article considers recent experiences that demonstrate that it is possible to bring together those with policy making responsibility and diverse publics to co-produce policy and standards of practice that are technically informed, incorporate wide social perspectives and explicitly involve publics in key decisions. Further, the process of deliberation involving publics is capable of being incorporated into governance structures to enhance the capacity to respond to emerging issues with levels of public engagement that are proportionate to the issues.
No preview · Article · Jan 2014 · Public Understanding of Science
[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: RDX is an explosive that is also a neurotoxin and implicated in adverse health outcomes. Because of its widespread use in military and civilian operations, there is growing concern about potential environmental and health implications. One promising method of bioremediation involves genomic studies of soil microbes. These health concerns and technological issues intersect with social and political dimensions raising questions about public responses to genomic technologies and the degree of environmental accounting expected from the military. In cases of novel technologies entering into contested social spaces, public engagement can be useful to inform broader policy debates. Building on previous work, in this article, we outline the rationale, methods, and results of a public deliberation on these issues. To our knowledge, this is the first study of its kind on the issues of RDX pollution and microbial genomics, and thus provides an important baseline on public sentiment on these issues.
[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.
Full-text · Article · Jul 2012 · Social Science [?] Medicine
[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.
Full-text · Article · Feb 2012 · Biopreservation and Biobanking
[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.
Full-text · Article · Aug 2011 · Social Science [?] Medicine
[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.
No preview · Article · Jul 2010 · Public Understanding of Science
[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.
No preview · Article · Mar 2010 · Public Understanding of Science
[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.
Full-text · Article · Nov 2009 · Journal of Translational Medicine
[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.
No preview · Article · Feb 2009 · Social Science & Medicine
[Show abstract][Hide abstract] ABSTRACT: In April 2007, a research team led by M. Burgess conducted a public engagement, the BC Biobank Deliberation, focused on the issue of biobanks. The project was motivated by an observation that current policy approaches to social and ethical issues surrounding biobanks manifest certain democratic deficits. The public engagement was informed by political theory on deliberative democracy with the aim of informing biobanking policies, in particular in British Columbia (BC), Canada. The purpose of this paper is to provide a comprehensive outline of the conclusions reached by the deliberants (both recommendations based on consensus and issues that emerged as persistent disagreements). However, the process whereby the specific conclusions to be delivered to policy makers are identified is not a self-evident process. We thus provide a critical analysis of how the results of a public engagement such as the BC Biobank Deliberation can be conceptualized given the context of a large qualitative data set and an imperative to provide useful information to policy makers, while honoring the mandate under which deliberants were recruited. In particular, we make the case for distinguishing between deliberative outputs of public engagement and analytical outputs that are the product of social scientific analyses of such engagements.
Full-text · Article · Feb 2009 · Public Health Genomics
[Show abstract][Hide abstract] ABSTRACT: This chapter focuses on the ethics of involving indigenous people in research. It describes the Democracy, Ethics and Genomics project, which was organized to compare across human and non-human genomics, using the examples of biobanking and salmon genomics. Researchers were able to recruit First Nations' participants to participate in focus groups related to human biobanking, but not salmon genomics and aquaculture. This differential response suggests that some members of indigenous groups may find it less objectionable to be asked to participate in social research for health-related topics than for salmon genomics with its more immediately political and environmental aspects.
[Show abstract][Hide abstract] ABSTRACT: Large-scale population biobanks, which aim to collect biological tissues, personal health information, and genomic data, are being introduced worldwide with the promise of increasing knowledge on chronic diseases such as diabetes and heart disease. Experts recognize the need for public participation to address the many social, legal and ethical complexities raised by the introduction of biobanks for public health research. However many researchers and decision makers struggle with how to promote public participation. This paper presents six issues that public participation must address. These issues are then applied to three large scale genetic biobank projects: CARTaGENE, Generation Scotland, and the United Kingdom Biobank. Finally, the efforts of these biobanks will be compared to the British Columbia Biobank deliberation project, which implemented a deliberative public participation experiment on biobanking.
No preview · Article · Jan 2009 · Journal of Public Deliberation