Dataset Information

Community recommendations on biobank governance: Results from a deliberative community engagement in California.

ABSTRACT: 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.

SUBMITTER: Dry SM

PROVIDER: S-EPMC5325297 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Community recommendations on biobank governance: Results from a deliberative community engagement in California.

Dry Sarah M SM Garrett Sarah B SB Koenig Barbara A BA Brown Arleen F AF Burgess Michael M MM Hult Jen R JR Longstaff Holly H Wilcox Elizabeth S ES Madrigal Contreras Sigrid Karina SK Martinez Arturo A Boyd Elizabeth A EA Dohan Daniel D

PloS one 20170224 2

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 des ...[more]

PMID: 28235046

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Project description:BackgroundSelecting effective implementation strategies to support guideline-concordant dental care is a complex process. We are drawing on data collected during the DISGO study to reflect on barriers we encountered in implementing a deliberative engagement process for discussing implementation strategies relevant to the evidence-based guideline targeted in this intervention. The goal is to identify factors that may influence the success of deliberative engagement as a technique to involve healthcare staff in identifying priorities for implementation strategies.MethodsWe drew on online chat transcripts from the deliberative engagement forums collected during the DISGO study. The chat transcripts were automatically generated for each discussion and captured the written exchanges between participants and moderators in all participating dental clinics. Chat transcripts were analyzed following a content analysis approach.ResultsOur findings revealed barriers to the successful implementation of deliberative engagement in the context of the DISGO study. Participants were not familiar with the materials that had been prepared for the forum and lacked familiarity with the topic of deliberation. Participants also did not share divergent viewpoints and reinforced existing ideas rather than introducing new ideas.ConclusionsIn order to ensure that obstacles that were encountered in this study are not repeated, it is important to carefully consider how staff can effectively be prepared for the deliberations. Participants must be familiar with the content of the guideline, and most questions about the content and evidence should be answered before the deliberative engagement sessions. If perspectives among staff on a guideline are homogenous, briefing materials should introduce perspectives that complement existing views among staff. It is also necessary to create an environment in which staff are comfortable introducing opinions that may not be held by the majority of colleagues.Trial registrationThis project is registered at ClinicalTrials.gov with ID NCT04682730. The trial was first registered on 12/18/2020. https://clinicaltrials.gov/ct2/show/NCT04682730 .

Project description:BackgroundThe role of the private sector in health is clear in many countries but engagement can be improved. The World Health Organization (WHO) developed a global strategy in 2020 focused on engaging the private sector in health service delivery through governance in mixed health systems and detailed six governance behaviours to guide its Member States. To operationalise these global ideas into practice, the Regional Office for Africa conducted a multi-country study to understand perceptions around the six governance behaviours. This article examines the perceptions of respondents from 13 African countries on the governance environment for private sector engagement in health.MethodsData were collected through an online survey that was distributed to individuals from ministries of health and their partner organisations, private sector institutions and initiatives in countries and development organisations (n = 81) across 13 countries. The survey was based on the following six governance behaviours: build understanding, enable stakeholders, nurture trust, foster relations, align structures and deliver strategy.ResultsResults showed that respondents had mixed perceptions of the governance environment for private sector engagement in health in their respective countries. Although 88% of respondents (n = 63/72) were familiar with the general inclusion of the private sector in national health sector plans, 63% of respondents (n = 45/71) noted there was limited or no integration of the private sector in the health system, and further, 28% of respondents noted there was no private sector reporting in health information systems (n = 19/69). Key opportunities presented in more than one governance behaviour include: (i) increasing private sector engagement in public sector activities, (ii) establishing clear roles and responsibilities through formal partnership agreements, (iii) improving data sharing through shared health information systems, (iv) incentives and subsidies, (v) capacity building, (vi) creating norms, guidelines, and regulations and (vii) conducting joint monitoring and evaluation. Many of these outlined overlapping concepts are not exclusive to one behaviour, thus, it is evident that when targeted, there is the potential to improve numerous governance behaviours. This further reiterates the view that the governance behaviours should be understood as connected and not unrelated areas.ConclusionsThe study provides insight into the perceptions of respondents from select African countries on the governance environment for private sector engagement in health. These findings can inform the development of strategies and interventions to support and enhance private sector engagement in health in the region.

Project description:ObjectivesSelecting effective implementation strategies to support guideline-concordant dental care is a complex process. For this research project, an online deliberative forum brought together staff from dental clinics to discuss the strengths and weaknesses of implementation strategies and barriers to implementation of a component of a dental (pit-and-fissure) guideline. The goal was to determine whether deliberative engagement enabled participants' sharing of promotive and prohibitive voice about implementation strategies to promote guideline-concordant care.DesignQualitative analysis of online chat transcripts of facilitated deliberations from 31 small group sessions.SettingKaiser Permanente Dental (KP Dental) in the USA.ParticipantsAll staff from 16 dental offices.ResultsThe directed content analysis revealed that participants shared prohibitive and promotive voice when offering critique of the barriers and the implementation strategies suggested by the researchers. The analysis also revealed that the focus of the deliberations often was not on the aspect of the pit-and-fissure guideline intended by the research team for deliberation.ConclusionsThe deliberative forum discussions were a productive venue to ask staff in dental clinics to share their perspectives on strategies to promote guideline-concordant care as well as barriers. Participants demonstrated prohibitive voice and engaged critically with the materials the research team had put together. An important limitation of the deliberation was that the discussion often centred around an aspect of the pit-and-fissure guideline that already was implemented well. To ensure a deliberation oriented towards resolving challenging aspects of the pit-and-fissure guideline, greater familiarity with the guideline would have been important, as well as more intimate knowledge of the current discrepancies in guideline-concordant care.Trial registration numberThis project is registered at ClinicalTrials.gov with ID NCT04682730. The trial was first registered on 18 December 2020. https://clinicaltrials.gov/ct2/show/NCT04682730.

Project description:BACKGROUND:Health system expenditure on cancer drugs is rising rapidly in many OECD countries given the costly new treatments and increased rates of use due to a growing and ageing population. These factors put considerable strain on the sustainability of health systems worldwide, sparking public debate among clinicians, pharmaceutical companies, policy-makers and citizens on issues of affordability and equity. We engaged Canadians through a series of deliberative public engagement events to determine their priorities for making cancer drug funding decisions fair and sustainable in Canada's publicly financed health system. METHODS:An approach to deliberation was developed based on the McMaster Health Forum's citizen panels and the established Burgess and O'Doherty model of deliberative public engagement. Six deliberations were held across Canada in 2016. Transcripts were coded in NVivo and analysed to determine where participants' views converged and diverged. Recommendations were grouped thematically. RESULTS:A total of 115 Canadians participated in the deliberative events and developed 86 recommendations. Recommendations included the review and regular re-review of approved drugs using 'real-world' evidence on effectiveness and cost-effectiveness; prioritisation of treatments that restore patients' independence, mental health and general well-being; ensuring that decision processes, results and their rationales are transparent; and commitment to people with similar needs receiving the same care regardless of where in Canada they live. CONCLUSIONS:The next steps for policy-makers should be to develop mechanisms for (1) re-reviewing effectiveness and cost-effectiveness data for all cancer drugs; (2) making disinvestments in cancer drugs that satisfy requirements relating to grandfathering and compassionate access; (3) ensuring fair and equitable access to cancer drugs for all Canadians; and (4) fostering a pan-Canadian approach to cancer drug funding decisions.

Dataset Information

Community recommendations on biobank governance: Results from a deliberative community engagement in California.

Publications

Community recommendations on biobank governance: Results from a deliberative community engagement in California.

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