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.
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.
Gene editing in the environment must consider uncertainty about potential benefits and risks for different populations and under different conditions. There are disagreements about the weight and ...balance of harms and benefits. Deliberative and community‐led approaches offer the opportunity to engage and empower diverse publics to co‐create responses and solutions to controversial policy choices in a manner that is inclusive of diverse perspectives. Stories, understood as situated accounts that reflect a person's life experiences, can enable the articulation of nuanced perspectives, diversify how perspectives are communicated, encourage wider participation, open dominant perspectives to challenge, and invite participants to assess appropriate empathy and precaution in collective positions. An emphasis on storytelling in deliberations on gene editing of organisms emphasizes carefully designed recruitment and facilitation to support hearing from a range of perspectives, including those that present a different set of assumptions than those that may be held by experts or other stakeholders, among these, consideration of how to understand our relationships to nature.
...all known genetic predispositions will be available and, depending on the data sharing policy, accessible to a wide range of researchers and, possibly, the public at large--this, at a time when we ...are still seeking to understand the social, clinical, and personal implications of genetic information. More research and policy analysis on the issues associated with data release is clearly needed, including an analysis of the actual harms and benefits resulting from publicly accessible data; the implications for family members and relevant communities; the appropriate balance between public access and individual privacy interests; and considerations regarding compensation for research-related injury resulting from participation in personal genome research.
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.
► Many biobanks are not able to meet traditional informed consent requirements or guarantee privacy protection. ► A loosening of informed consent and privacy requirements should be matched by an increased emphasis on good governance. ► This paper suggests four principles that should be taken into account in constructing biobanks governance. ► Concrete implementation of the principles is illustrated using the example of a particular biobank, the BC Generations Project.
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.
► There are considerable social and ethical challenges associated with human tissue biobanks. ► Public deliberation offers an important avenue for appropriate social norms to be developed and communicated to policy makers. ► This study demonstrates a structured approach to public deliberation that allows for greater facility in translating public values into policy. ► Conducted in March of 2009 in Vancouver, Canada, the study focuses on local institutional biobanking practices of the BC BioLibrary. ► Implications of the study have broader relevance for international debates on the ethics and governance of biobanks.
Invasive environmentally transmitted parasites have the potential to cause declines in host populations independent of host density, but this is rarely characterized in naturally occurring ...populations. We investigated (1) epidemiological features of a declining bare-nosed wombat (
) population in central Tasmania owing to a sarcoptic mange (agent
) outbreak, and (2) reviewed all longitudinal wombat-mange studies to improve our understanding of when host population declines may occur. Over a 7-year period, the wombat population declined 80% (95% CI 77-86%) and experienced a 55% range contraction. The average apparent prevalence of mange was high 27% (95% CI 21-34), increased slightly over our study period, and the population decline continued unabated, independent of declining host abundance. Combined with other longitudinal studies, our research indicated wombat populations may be at risk of decline when apparent prevalence exceeds 25%. This empirical study supports the capacity of environmentally transmitted parasites to cause density independent host population declines and suggests prevalence limits may be an indicator of impending decline-causing epizootics in bare-nosed wombats. This research is the first to test effects of density in mange epizootics where transmission is environmental and may provide a guide for when apparent prevalence indicates a local conservation threat.
Landscape epidemiology provides a valuable framework to interpret, predict, and manage spatiotemporal patterns of disease. Yet, owing to the difficulty of detecting pathogen occurrence in ...free-ranging wildlife, disentangling the factors driving disease dynamics remains a considerable challenge, particularly at fine spatial scales. Here, we investigated the fine-scale landscape epidemiology of sarcoptic mange—a visually apparent disease caused by the mite Sarcoptes scabiei—in bare-nosed wombats (Vombatus ursinus), by: (1) characterizing the distribution and density of wombats within the landscape and (2) examining the effect of environmental variation on the occurrence and apparent prevalence of mange. Wombats were heterogeneously distributed over 19.4 km of transect space (0.096–1.39 wombats ha−1) and seven months of time (increasing by a factor of 1.76). Wombat density was negatively associated with distance to vegetation cover, supporting a general propensity for wombats to occur and burrow near vegetation (native and exotic, excluding pasture). The apparent prevalence of mange varied spatially (3.1–37.5%), with the probability of disease greater in wombats with minimal vegetation and low-lying pans in their estimated home range. We observed trends of increased prevalence in areas with more burrows available per wombat and in individuals occurring near vegetation cover (although not within their home range). Wombat density and active burrow density did not influence the prevalence of mange. This research emphasizes the fine scale at which spatiotemporal patterns of disease can manifest and is the first to investigate the influence of host density for any species with indirect transmission of S. scabiei. Collectively, our results suggest that individuals inhabiting less optimal habitat (pasture) may be at greater risk of disease, or that diseased wombats may be competitively excluded from more optimal habitat (vegetated areas). We discuss implications for understanding and managing mange in wombats and cross-applicability to other mange-affected species with environmental transmission.
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