BackgroundThe use of a Community Advisory Board is one method of ensuring community engagement in community based research. To identify the process used to constitute CABs in Zambia, this paper draws on the perspectives of both research team members and CAB members from research groups who used CABs in Lusaka. Enabling and restricting factors impacting on the functioning of the CAB were identified.MethodsAll studies approved by the University of Zambia Bioethics Research Committee from 2008 – (...) 2012 were reviewed to identify those studies that were likely to include a CAB. Eight teams with studies that included a CAB were identified. For each of these studies, consent was obtained to conduct an informal interview with a research team member and to obtain contact details for one CAB member. In total 14 interviews were conducted with 8 research team members and 6 CAB members from 12–30 August 2013.ResultsIdentification of potential CAB members from the community and their participation in developing the terms of reference for CABs was perceived to have contributed to the success of the CAB. Due to the trust that the community had in members of their community the CABs were then in a stronger position to influence community participation in the research. Training of CAB members was identified as a factor that enhanced the functioning of a CAB. Lack of commitment and low literacy levels of CAB members posed a threat to the role of the CAB. Although compensation in the form of a stipend was not provided, CAB members were provided with transport reimbursements for attending meetings.ConclusionsSelection of CAB members from within the community contributed to community confidence in the CAB, enhancing its ability to act as an effective link between study team and community. This contributed positively to the conduct of the study and enhanced community awareness and acceptance of the research. However, establishment of study specific CABs has the potential to compromise CAB independence due to support provided by the research team in the form of transport reimbursements and other forms of support. Consideration should be given to establishing community wide Community Advisory Boards that could function across a range of studies to increase independent objective decision-making. (shrink)

BackgroundCommunity engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of (...) important ethical issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation.MethodsIn this paper, drawing upon interviews with the members of a Community Advisory Board on the Thai-Myanmar border, we describe and critically reflect upon an approach to community engagement which was developed in the context of international collaborative research in the border region.Results and conclusionsDrawing on our analysis, we identify a number of considerations relevant to the development of an approach to evaluating community engagement in this complex research setting. The paper also identifies a range of important ways in which the Community Advisory Board is in practice understood by its members to have morally significant roles and responsibilities beyond those usually associated with the successful and appropriate conduct of research. (shrink)

Community engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification (...) of important ethical issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation. (shrink)

Background Community advisory boards have expanded beyond high-income countries and play an increasing role in low- and middle-income country research. Much research has examined CABs in HICs, but less is known about CABs in LMICs. The purposes of this scoping review are to examine the creation and implementation of CABs in LMICs, including identifying frequently reported challenges, and to discuss implications for research ethics. Methods We searched five databases for publications describing or evaluating CABs in LMICs. Two researchers (...) independently reviewed articles for inclusion. Data related to the following aspects of CABs were extracted from included publications: time, country, financial support, research focus, responsibilities, and challenges. Thematic analyses were used to summarize textual data describing challenges. Results Our search yielded 2005 citations, 83 of which were deemed eligible for inclusion. Most studies were published between 2010 and 2017. Upper-middle-income countries were more likely to have studies describing CABs, with South Africa, China, and Thailand having the greatest numbers. The United States National Institutes of Health was the main source of financial support for CABs. Many CABs focused on HIV research. Thirty-four studies reported how CABs influenced the informed consent process for clinical trials or other aspects of research ethics. CAB responsibilities were related to clinical trials, including reviewing study protocols, educating local communities about research activities, and promoting the ethical conduct of research. Challenges faced by CABs included the following: incomplete ethical regulations and guidance; limited knowledge of science among members of communities and CABs; unstable and unbalanced power relationships between researchers and local communities; poor CAB management, including lack of formal participation structures and absence of CAB leadership; competing demands for time that limited participation in CAB activities; and language barriers between research staff and community members. Several challenges reflected shortcomings within the research team. Conclusions Our findings examine the formation and implementation of CABs in LMICs and identify several ethical challenges. These findings suggest the need for further ethics training among CAB members and researchers in LMICs. (shrink)

BackgroundCommunity Advisory Boards (CAB) have become essential organs of involving communities in HIV clinical trials especially in developing countries. However, limited empirical evidence exists on the role of CABs in low and middle-income countries including Tanzania. This study aims at exploring the role of CABs in community-based HIV clinical trials conducted in Tanzania.MethodologyWe adopted a phenomenological approach to purposefully select HIV clinical trial stakeholders. These included CAB members, researchers and Institutional Review Board (IRB) members in Tanzania. We (...) conducted In-depth Interviews (IDIs) with ten participants and three Focus Group Discussions (FGDs) with eighteen participants. The data were thematically analyzed with the aid of MAXQDA software version 20.2.1.ResultsThe findings indicate that at every stage of implementation of a community-based HIV clinical trial, a functioning CAB is important for its success. This importance is based on contextualization of the informed consent process and protocol, managing rumours in the community, weighing trial risks and benefits, sensitizing the community, assisting participant recruitment, tracing and retention. However, being perceived as financial beneficiaries than community representatives emerged as a challenge to CAB members. ConclusionThe study empirically indicates the need for functioning CABs in every stage of implementation of community-based HIV clinical trials. The roles of which are interwoven in serving research goals and protecting the interests of the community and that of trial participants. (shrink)

Engaging communities in community-based health research is increasingly being adopted in low- and middle-income countries. The use of community advisory boards is one method of practicing community involvement in health research. To date, few studies provide in-depth accounts of the strategies that CAB members use to practice community engagement. We assessed the perspectives, experiences and practices of the first local CAB in Eswatini, which was implemented as part of the MaxART Early Access to ART for (...) All study. Trained Swazi research assistants conducted two focus group discussions and 13 semi-structured interviews with CAB members who had been part of the MaxART study for at least 2.5 years. Interviews explored CAB composition and recruitment, the activities of CAB members, the mechanisms used to engage with communities and the challenges they faced in their role. The MaxART CAB played an active role in the implementation of the Early Access to Art for All study, and activities mainly focused on: promoting ethical conduct, in particular privacy, consent and confidentiality; communication and education, communicating about the study and educating the community on the benefits of HIV testing and early access to HIV treatment; and liaising between the community and the research team. Strategies for interacting with communities were varied and included attending general community meetings, visiting health facilities and visiting public places such as cattle dipping tanks, buses, bars and churches. Differences in the approach to community engagement between CAB members living in the study areas and those residing outside were identified. The experiences of the first CAB in Eswatini demonstrate that community engagement using CABs is a valuable mechanism for engaging communities in implementation studies. Considerations that could impact CAB functioning include clearly defining the scope of the CAB, addressing issues of CAB independence, the CAB budget, providing emotional support for CAB members, and providing continuous training and capacity building. These issues should be addressed during the early stages of CAB formation in order to optimize functioning. (shrink)

Engaging communities in community-based health research is increasingly being adopted in low- and middle-income countries. The use of community advisory boards is one method of practicing community involvement in health research. To date, few studies provide in-depth accounts of the strategies that CAB members use to practice community engagement. We assessed the perspectives, experiences and practices of the first local CAB in Eswatini, which was implemented as part of the MaxART Early Access to ART for (...) All study. Trained Swazi research assistants conducted two focus group discussions and 13 semi-structured interviews with CAB members who had been part of the MaxART study for at least 2.5 years. Interviews explored CAB composition and recruitment, the activities of CAB members, the mechanisms used to engage with communities and the challenges they faced in their role. The MaxART CAB played an active role in the implementation of the Early Access to Art for All study, and activities mainly focused on: promoting ethical conduct, in particular privacy, consent and confidentiality; communication and education, communicating about the study and educating the community on the benefits of HIV testing and early access to HIV treatment; and liaising between the community and the research team. Strategies for interacting with communities were varied and included attending general community meetings, visiting health facilities and visiting public places such as cattle dipping tanks, buses, bars and churches. Differences in the approach to community engagement between CAB members living in the study areas and those residing outside were identified. The experiences of the first CAB in Eswatini demonstrate that community engagement using CABs is a valuable mechanism for engaging communities in implementation studies. Considerations that could impact CAB functioning include clearly defining the scope of the CAB, addressing issues of CAB independence, the CAB budget, providing emotional support for CAB members, and providing continuous training and capacity building. These issues should be addressed during the early stages of CAB formation in order to optimize functioning. (shrink)

BackgroundCommunity engagement is a key component in health research. One of the ways health researchers ensure community engagement is through Community Advisory Boards (CABs). The capacity of CABs to properly perform their role in clinical research has not been well described in many resource limited settings. In this study, we assessed the capacity of CABs for effective community engagement in Uganda.MethodsWe conducted a cross sectional study with mixed methods. We used structured questionnaires and key informant interviews (...) (KII) to collect data from CAB members, trial investigators, and community liaison officers. For quantitative data, we used descriptive statistics while for qualitative data we used content analysis.ResultsSeventy three CAB members were interviewed using structured questionnaires; 58.9% males, median age 49 years (IQR 24–70), 71.2% had attained tertiary education, 42.5% never attended any research ethics training, only 26% had a training in human subject protection, 30.1% had training in health research, 50.7% never attended any training about the role of CABs, and 72.6% had no guidelines for their operation. On the qualitative aspect, 24 KIIs cited CAB members to have some skills and ability to understand and review study documents, offer guidance on community norms and expectations and give valuable feedback to the investigators. However, challenges like limited resources, lack of independence and guidelines, and knowledge gaps about research ethics were cited as hindrances of CABs capacity.ConclusionThough CABs have some capacity to perform their role in the Ugandan setting, their functionality is limited by lack of resources to facilitate their work, lack of independence, lack of guidelines for their operations and limited knowledge regarding issues of research ethics and protection of the rights of trial participants. (shrink)

It has been suggested that community advisory boards can play a role in minimising exploitation in international research. To get a better idea of what this requires and whether it might be achievable, the paper first describes core elements that we suggest must be in place for a CAB to reduce the potential for exploitation. The paper then examines a CAB established by the Shoklo Malaria Research Unit under conditions common in resource-poor settings – namely, where individuals join (...) with a very limited understanding of disease and medical research and where an existing organisational structure is not relied upon to serve as the CAB. Using the Tak Province Border Community Ethics Advisory Board as a case study, we assess the extent to which it might be able to take on a role minimising exploitation were it to decide to do so. We investigate whether, after two years in operation, T-CAB is capable of assessing clinical trials for exploitative features and addressing those found to have them. The findings show that, although T-CAB members have gained knowledge and developed capacities that are foundational for one-day taking on a role to reduce exploitation, their ability to critically evaluate studies for the presence of exploitative elements has not yet been strongly demonstrated. In light of this example, we argue that CABs may not be able to perform such a role for a number of years after initial formation, making it an unsuitable responsibility for many short-term CABs. (shrink)

BackgroundCommunity engagement within biomedical research is broadly defined as a collaborative relationship between a research team and a group of individuals targeted for research. A Community Advisory Board is one mechanism of engaging the community. Within genomics research CABs may be particularly relevant due to the potential implications of research findings drawn from individual participants on the larger communities they represent. Within such research, CABs seek to meet instrumental goals such as protecting research participants and their (...) community from research-related risks, as well as intrinsic goals such as promoting the respect of participants and their community. However, successful community engagement depends on the degree to which CABs legitimately represent and engage with communities targeted for research. Currently, there is little literature describing the use of CABs in genomics research taking place in developing countries, and even less in the field of genomics research relating to mental illness. The aim of this article is to describe and consider the contributions made by a researcher-driven, population-specific CAB in a genomics of schizophrenia research project taking place in South Africa, from the perspective of the research team.DiscussionFour broad discussion topics emerged during the CAB meetings namely: 1) informed consent procedures, 2) recruitment strategies, 3) patient illness beliefs and stigma experiences, and 4) specific ethical concerns relating to the project. The authors consider these discussions in terms of their contributions to instrumental and intrinsic goals of community engagement.SummaryThe CAB gave valuable input on the consent processes and materials, recruitment strategies and suggested ways of minimizing the potential for stigma and discrimination. All of these contributions were of an instrumental nature, and helped improve the way in which the research took place. In addition, and perhaps more importantly, the CAB made a unique and important contribution relating to intrinsic functions such as promoting the respect and dignity of research participants and their community. This was particularly evident in ensuring sensitivity and respect of the community’s traditional beliefs about schizophrenia and its treatment, and in this way promoting a respectful relationship between the research team and the participants. (shrink)

Community engagement to protect and empower participating individuals and communities is an ethical requirement in research. There is however limited evidence on effectiveness or relevance of some of the approaches used to improve ethical practice. We conducted a study to understand the rationale, relevance and benefits of community engagement in health research. This paper draws from this wider study and focuses on factors that shaped Community Advisory Group members’ selection processes and functions in Malawi. A qualitative (...) research design was used; two participatory workshops were conducted with CAG members to understand their roles in research. Workshop findings were triangulated with insights from ethnographic field notes, key informant interviews with stakeholders, focus group discussions with community members and document reviews. Data were coded manually and thematic content analysis was used to identify main issues. Results have shown that democratic selection of CAG members presented challenges in both urban and rural settings. We also noted that CAG members perceived their role as a form of employment which potentially led to ineffective representation of community interests. We conclude that democratic voting is not enough to ensure effective representation of community's interests of ethical relevance. CAG members’ abilities to understand research ethics, identify potential harms to community and communicate feedback to researchers is critical to optimise engagement of lay community and avoid tokenistic engagement. (shrink)

This paper analyzes communication with a language that is vague in the sense that identical messages do not always result in identical interpretations. It is shown that strategic agents frequently add to this vagueness by being intentionally vague, i.e. they deliberately choose less precise messages than they have to among the ones available to them in equilibrium. Having to communicate with a vague language can be welfare enhancing because it mitigates conflict. In equilibria that satisfy a dynamic stability condition intentional (...) vagueness increases with the degree of conflict between sender and receiver. (shrink)

Background Institutional review board (IRB) expertise is necessarily limited by maintaining a manageable board size. IRBs are therefore permitted by regulation to rely on outside experts for review. However, little is known about whether, when, why, and how IRBs use outside experts.Methods We conducted a national survey of U.S. IRBs to characterize utilization of outside experts. Our study uses a descriptive, cross-sectional design to understand how IRBs engage with such experts and to identify areas where outside expertise is (...) most frequently requested.Results The survey response rate was 18.4%, with 55.4% of respondents reporting their institution’s IRB uses outside experts. Nearly all respondents who reported using outside experts indicated they do so less than once a month, but occasionally each year (95%). The most common method of identifying an outside expert was securing a previously known subject matter expert (83.3%). Most frequently, respondents sought consultation for scientific expertise not held by current members (69.6%). Almost all respondents whose IRBs had used outside experts reported an overall positive impact on the IRB review process (91.5%).Conclusions Just over half of the IRBs in our sample report use of outside experts; among them, outside experts were described as helpful, but their use was infrequent overall. Many IRBs report not relying on outside experts at all. This raises important questions about what type of engagement with outside experts should be viewed as optimal to promote the highest quality review. For example, few respondents sought assistance from a Community Advisory Board, which could address expertise gaps in community perspectives. Further exploration is needed to understand how to optimize IRB use of outside experts, including how to recognize when expertise is lacking, what barriers IRBs face in using outside experts, and perspectives on how outside expert review impacts IRB decision-making and review quality. (shrink)

There is wide agreement that community engagement is important for many research types and settings, often including interaction with ‘representatives’ of communities. There is relatively little published experience of community engagement in international research settings, with available information focusing on Community Advisory Boards or Groups (CAB/CAGs), or variants of these, where CAB/G members often advise researchers on behalf of the communities they represent. In this paper we describe a network of community members (‘KEMRI Community (...) Representatives’, or ‘KCRs’) linked to a large multi-disciplinary research programme on the Kenyan Coast. Unlike many CAB/Gs, the intention with the KCR network has evolved to be for members to represent the geographical areas in which a diverse range of health studies are conducted through being typical of those communities. We draw on routine reports, self-administered questionnaires and interviews to: 1) document how typical KCR members are of the local communities in terms of basic characteristics, and 2) explore KCR's perceptions of their roles, and of the benefits and challenges of undertaking these roles. We conclude that this evolving network is a potentially valuable way of strengthening interactions between a research institution and a local geographic community, through contributing to meeting intrinsic ethical values such as showing respect, and instrumental values such as improving consent processes. However, there are numerous challenges involved. Other ways of interacting with members of local communities, including community leaders, and the most vulnerable groups least likely to be vocal in representative groups, have always been, and remain, essential. (shrink)

New techniques for the genetic modification of organisms are creating new strategies for addressing persistent public health challenges. For example, the company Oxitec has conducted field trials internationally—and has attempted to conduct field trials in the United States—of a genetically modified mosquito that can be used to control dengue, Zika, and some other mosquito-borne diseases. In 2016, a report commissioned by the National Academies of Sciences, Engineering, and Medicine discussed the potential benefits and risks of another strategy, using gene drives. (...) Driving a desired genotype through a population of wild animals or insects could lead to irreversible genetic modification of an entire species. The NASEM report recommends community, stakeholder, and public engagement about potential uses of the technology, and it argues that the engagement should occur as research advances, well before gene drives are deployed. Yet what “engagement” means in practice is unclear. This article seeks clarity on this problem by offering a justification for community engagement and drawing out implications of this argument for the implementation and desired outcomes of community engagement. Community engagement is essential when it comes to research that would release genetically modified insects or animals into the environment. By contrast, obtaining informed consent from people who live near such a proposed field trial is neither necessary nor sufficient. Drawing on the epistemic and moral arguments for deliberative democracy, I propose two discrete mechanisms of community engagement: community advisory boards and deliberative forums, neither of which has been systematically incorporated into research governance. The proposed mechanisms would engender respect for persons who live near field trials, even when the results of deliberation override some individuals’ preferences. Community engagement foregrounds the community in our thinking about humans’ relationship to nature, and it implies that deciding to release genetically modified insects or animals into the wild ought to be a collective decision, not one made by product developers, policy-makers, private companies, research funders, or scientists alone. (shrink)

Background Community involvement in research has been advocated by researchers, communities, regulatory agencies, and funders with the aim of reinforcing subjects’ protection and improving research efficiency. Community involvement also has the potential to improve dissemination, uptake, and implementation of research findings. The fields of community based participatory research conducted with indigenous populations and of participatory action research offer a large base of experience in community involvement in research. Rules on involving the population affected when conducting research (...) have been established in these fields. But what is the role of community engagement in clinical research and observational studies conducted in biomedical research outside of these specific areas? Main body of the abstract More than 20 years ago, in the field of HIV medicine, regulatory bodies and funding agencies recommended the constitution of a formal organism, the Community Advisory Board, as part of the study requirements for HIV trials. More recently, CABs have been adopted and used in other fields of medical research, such as malaria. CABs are not without limitations, however, and there is little research on the effectiveness of their use in achieving community protection and participation. Nevertheless, CABs could be a model to import into clinical trials and observational research where no alternative model of community representation is currently being used. Conclusions Allocating more resources to training and shifting more power to community representatives could be part of the solution to current CAB limitations. However, for researchers to be able to apply these recommendations on community involvement, certain conditions need to be met. In particular, funding agencies need to recognize the human and financial resources required for serious community involvement, and the academic environment needs to take community involvement into account when appraising, mentoring, and training researchers. (shrink)

BackgroundCommunity engagement in research is valuable for instrumental and intrinsic reasons. Despite existing guidance on how to ensure meaningful CE, much of what it takes to achieve this goal differs across settings. Considering the emerging trend towards mandating CE in many research studies, this study aimed at documenting how CE is conceptualized and implemented, and then providing context-specific guidance on how researchers and research regulators in Uganda could think about and manage CE in research.MethodsWe conducted qualitative interviews and focus group (...) discussions involving forty-one respondents who were experienced in HIV/aids biomedical research involving CE. Thirty-eight of these were directly or indirectly associated with Uganda’s leading research institution in the field of HIV/aids. They included Principal Investigators, Community Liaisons Officers, Research Ethics Committee members and Community Advisory Board Members. Three respondents were from Uganda National Council for Science and Technology. Data were collected between August 2019 and August 2020, using audio-taped focus group discussions and key informant interviews, transcribed and analyzed manually to generate themes and subthemes.ResultsThree major themes emerged: goals or value of CE; the means of CE, and, the evaluation of CE. Goals or value of CE generated four subthemes representing the overarching goals of CE: Promote communities’ agency; Generate and sustain trust; Protect and promote communities’ rights and interests; and, Help studies optimize participation in the form of enrolment and retention of participants. What usually comes under the nomenclatures of methods, strategies, and approaches of CE, such as town-hall meetings, sports events, drama, and the like, should simply be understood as the means of CE, and it is not desirable to hold pre-conceived and fixed ideas about the best means to conduct CE in research since a lot depend on the context. Finally, the study found that despite CE’s critical importance, which suggests the need to track and evaluate it, CE is currently intermittently evaluated, and for inadequate motivations.ConclusionsExisting guidance on how to conduct robust CE in research is no substitute for creativity, flexibility, and reflexivity on the part of both researchers and research regulators. (shrink)

D’ALONZO KT. Nursing Inquiry 2010; 17: 282–288 Getting started in CBPR: lessons in building community partnerships for new researchersThere is a growing interest in community‐based participatory research (CBPR) methods to address issues of health disparities. Although the success of CBPR is dependent upon the formation of community‐researcher partnerships, new researchers as well as seasoned investigators who are transitioning to CBPR often lack the skills needed to develop and maintain these partnerships. The purpose of the article is to (...) discuss the competencies needed by new researchers to form successful CBPR partnerships. The author presents a series of strategic steps that are useful in establishing academic–community partnerships and in initiating, maintaining and sustaining CBPR projects. These steps include suggestions regarding community engagement, selection of community advisory board members, outreach, the community’s role in problem identification, selection of research methodologies, considerations related to the community setting, need for flexibility and patience, ‘insider vs. outsider’ conflicts, commitment and training issues, timing concerns for tenure‐track faculty and the process of community empowerment. Community‐based participatory research is both rewarding and time consuming, for both the researcher and members of the community. Given its promise to address health disparities, it is imperative that researchers acquire the skills needed to develop and cultivate durable community‐researcher partnerships. (shrink)

The analysis presented here lays out the ethical warrants for requiring community oversight of health research conducted in international settings. It reviews the inadequacies with the current standards of individual informed consent and research ethics committee review, and then, shows how a broader population-based public health perspective raises new demands on justice involving due consideration of the rights, harms and benefits to the community as a whole. As developed here, an ethical standard that requires community oversight of (...) health research is justified on three principled grounds: respect for community autonomy and their right to self-determination; due consideration of the consequences of the research for the community as a whole; and, a more complete understanding of human autonomy. The paper concludes with practical recommendations regarding the composition of Community Advisory Boards to ensure that they have legitimate decision-making authority in diverse socio-cultural contexts. (shrink)

Medical Research Council, Capetown, South Africa Nasheen Naidoo Medical Research Council, Capetown, South Africa Shamagonam James Medical Research Council, Durban, South Africa Priscilla Reddy Medical Research Council, Capetown, South Africa * Corresponding author: 306 Arnold House, School of Public Health & Health Sciences, University of Massachusetts, Amherst, MA 01003, USA. Tel.: (413) 545 1005; Email: Buchanan{at}schoolph.umass.edu ' + u + '@' + d + ' '//--> . Abstract The analysis presented here lays out the ethical warrants for requiring community (...) oversight of health research conducted in international settings. It reviews the inadequacies with the current standards of individual informed consent and research ethics committee review, and then, shows how a broader population-based public health perspective raises new demands on justice involving due consideration of the rights, harms and benefits to the community as a whole. As developed here, an ethical standard that requires community oversight of health research is justified on three principled grounds: respect for community autonomy and their right to self-determination; due consideration of the consequences of the research for the community as a whole; and, a more complete understanding of human autonomy. The paper concludes with practical recommendations regarding the composition of Community Advisory Boards to ensure that they have legitimate decision-making authority in diverse socio-cultural contexts. CiteULike Connotea Del.icio.us What's this? (shrink)

The Hanford Advisory Board (HAB) is a broadly representative, deliberative body that provides formal policy advice on Department of Energy (DOE) proposals and decisions at the Hanford nuclear cleanup site near Richland, Washington. Despite considerable skepticism about the effectiveness of citizen advisory boards, we contend that the HAB offers promising institutional innovations. Drawing on our analysis of the HAB’s formal advice as well as our interviews with board members and agency officials, we explore the HAB’s unique (...) design, outline a normative framework for evaluating participatory institutions, and assess the HAB’s effectiveness in rendering the DOE accountable to the local public. (shrink)

In 2005 the new Governor of Puerto Rico appointed a panel of experts to evaluate the healthcare system of Puerto Rico and make recommendations. Among other things, the panel recommended the creation of an advisory board on bioethics for the commonwealth of Puerto Rico.

A romance with the concept of community has long characterized activist healthcare movements and has more recently been taken up by academic medical centers as a sign of virtuous civic engagement. During the late 1960s, the word community, as deployed by administrators at prestigious AMCs, became increasingly politicized, commodified and racialized. Here, we analyze how the concept of community was initially framed in the 1963 Community Mental Health Centers Act, the first legislation to establish community (...) mental health centers in America. We then examine the Health Policy Advisory Center’s analysis of the proposed Washington Heights Community Mental Health Center to be run by Columbia University’s College of Physicians and Surgeons, an institution that had historically neglected residents’ health needs. Community pushback against Columbia’s plan to build a multi-block center, amplified by medical students and residents critical of the professionalized community mental health movement, escalated in the late 1960s, leading the city’s planning board to reject Columbia and approve a community council’s plan for preventive and rehabilitative local services. These conflicting overtones of “community” still inform understandings of the word in medicine today; thus, a critical historical analysis of “community” is warranted. (shrink)

In many countries the debate over the role that physicians may play in ending life has been limited to the judiciary and other law making institutions, professional medical organizations; and academics. Because of their multidisciplinary and diverse membership, ethics committees may be a particularly appropriate venue through which these discussions can be expanded to include a much larger community. In addition, ethics committees generally act in only advisory capacities because they do not actually make decisions, so they may (...) provide a forum for open discussions in ways that the court and the medical boards cannot. (shrink)

We have national guidelines for the responsible conduct of research (RCR) and procedures for handling allegations of misconduct in Finland. The guidelines have been formulated and updated by the Finnish Advisory Board on Research Integrity (TENK). In this article, we introduce and evaluate the national RCR guidelines. We also present statistics of alleged and proven RCR violation cases and frequency of appeals to TENK on the decisions or procedures of the primary institutions. In addition, we analyze the available (...) data on seven investigated cases in more detail. Positive aspects in the Finnish system are a fairly good infrastructure to investigate suspected RCR violations and a wide concept of RCR violations, which consists of fabrication, falsification, plagiarism, misappropriation, and other misbehaviors. However, the guidelines contain poorly elaborated definitions, do not treat the complainant and the suspect in an equal way, and need to be revised. Confusion about the concepts and criteria of the RCR violations seems to be common in primary institutions and among the complainants. Even if research institutions and universities have officially adhered to the national RCR guidelines, slipping from the guidelines occurs quite commonly. All these factors lead to frequent dissatisfaction with the decisions or procedures applied, high rate of appeals to TENK, and far from optimal functionality of the system. (shrink)

Genomic biobanking research is undergoing exponential growth in Africa raising a host of legal, ethical and social issues. Given the scientific complexity associated with genomics, there is a growing recognition globally of the importance of science translation and community engagement for this type of research, as it creates the potential to build relationships, increase trust, improve consent processes and empower local communities. Despite this level of recognition, there is a lack of empirical evidence of the practise and processes for (...) effective CE in genomic biobanking in Africa. To begin to address this vacuum, 17 in-depth face to face interviews were conducted with South African experts in genomic biobanking research and CE to provide insight into the process, benefits and challenges of CE in South Africa. Emerging themes were analysed using a contextualised thematic approach. Several themes emerged concerning the conduct of CE in genomic biobanking research in Africa. Although the literature tends to focus on the local community in CE, respondents in this study described three different layers of stakeholder engagement: community level, peer level and high level. Community level engagement includes potential participants, community advisory boards and field workers; peer level engagement includes researchers, biobankers and scientists, while high level engagement includes government officials, funders and policy makers. Although education of each stakeholder layer is important, education of the community layer can be most challenging, due to the complexity of the research and educational levels of stakeholders in this layer. CE is time-consuming and often requires an interdisciplinary research team approach. However careful planning of the engagement strategy, including an understanding of the differing layers of stakeholder engagement, and the specific educational needs at each layer, can help in the development of a relationship based on trust between the research team and various stakeholder groups. Since the community layer often comprises vulnerable populations in low and middle income countries, co-development of innovative educational tools on genomic biobanking is essential. CE is clearly a component of a broader process best described as stakeholder engagement. (shrink)

Bioethicists have long debated the content of sponsors and researchers' obligations of justice in international clinical research. However, there has been little empirical investigation as to whether and how obligations of responsiveness, ancillary care, post-trial benefits and research capacity strengthening are upheld in low- and middle-income country settings. In this paper, the authors argue that research ethics guidelines need to be more informed by international research practice. Practical guidance on how to fulfil these obligations is needed if research groups and (...) other actors are to successfully translate them into practice because doing so is often a complicated, context-specific process. Case study research methods offer one avenue for collecting data to develop this guidance. The authors describe how such methods have been used in relation to the Shoklo Malaria Research Unit's vivax malaria treatment (VHX) trial (NCT01074905). Relying on the VHX trial example, the paper shows how information can be gathered from not only international clinical researchers but also trial participants, community advisory board members and research funder representatives in order to: (1) measure evidence of responsiveness, provision of ancillary care, access to post-trial benefits and research capacity strengthening in international clinical research; and (2) identify the contextual factors and roles and responsibilities that were instrumental in the fulfilment of these ethical obligations. Such empirical work is necessary to inform the articulation of obligations of justice in international research and to develop guidance on how to fulfil them in order to facilitate better adherence to guidelines' requirements. (shrink)

Debates about what constitutes benefits in human research continue to be less informed due to a lack of empirical evidence from the developing world. This study aimed to explore what constitutes benefits in HIV vaccine trials in Tanzania and examine inherent ethical implications. A qualitative case study design was deployed and a total of 29 purposively selected study participants comprising of experienced researchers, institutional review board members and community advisory board members were included. Collected data were (...) analyzed by thematic analysis aided by computer software: MAXQDA version 20.4.0. The study findings indicate that there is a growing appreciation of benefits beyond actual vaccines to include 1) capacity building at individual, community, institutional and regulatory levels; and 2) non‐capacity building related benefits such as strengthened collaborations, ancillary care and employment opportunities. So, as the struggle for viable HIV vaccines continues, other benefits that have accrued from such trials are not to be blindsided especially for developing countries like Tanzania. (shrink)

BackgroundFor over 35 years, Africa has continued to host HIV vaccine trials geared towards overturning the HIV/aids pandemic in the continent. However, the methods of sharing the vaccines, when available remain less certain. Therefore, the study aims to explore stakeholders’ perspectives in the global South, in this case, Tanzania, on how HIV vaccines ought to be fairly shared.MethodsThe study deployed a qualitative case study design. Data were collected through in-depth interviews and focus group discussions with a total of 37 purposively (...) selected participants. This included researchers, institutional review board members, a policymaker, HIV/aids advocates, and community advisory board members. The data obtained were inductively and deductively analyzed.Results Findings indicate that HIV vaccines can be shared fairly under the principles of distributive justice (contribution, need and equality). Thus, contribution-based sharing ought to be utilized upon the necessity to prioritize vaccine access or subsidized trial benefits to host communities. Need-based sharing ought to be considered for non-host communities that are at an increased risk of HIV infection. Lastly, equal-based sharing would be useful at later stages of vaccine distribution or when the aforementioned principles are deemed morally inappropriate. However, none of the benefit-sharing approaches is free of limitations and a counterbalancing sense of unfairness.ConclusionFair sharing of HIV vaccines, when available, ought to be informed by the contribution, need and equality principles of distributive justice. Countries in the global south including Tanzania are likely to be prioritized during the distribution of the HIV vaccines due to their participation in HIV vaccine trials and due to the disproportionate HIV burden evident in the region. (shrink)

Researchers and sponsors are required to assist HIV prevention trial participants to remain HIV-uninfected by ensuring access to prevention services. Ethics guidelines require that these HIV risk-reduction services be state of the art. This and related ethics recommendations have been intensely debated. This descriptive study aimed to identify actual HIV prevention practices for two HIV vaccine trials at five South African sites, to explore whether actual practices meet guideline recommendations and to discuss implications for practices and ethics guidelines. Practices were (...) examined through a review of site documents and interviews with site staff and network representatives, as well as community advisory board and research ethics committee representatives. A thematic analysis of HIV prevention practices, perspectives and perceived challenges was undertaken. Findings indicated that there was a high degree of correspondence between actual practices in South African HIV vaccine trials and guideline recommendations. Key challenges for implementing prevention services were identified as partnerships, provider-promotion of services and participant uptake of services. Practices deviated most from guidelines with regard to the description of prevention plans in informed consent forms. Recommendations are made for both practices and ethics guidelines. (shrink)

The study reports on the results of an empirical investigation of the education and recruitment processes used in HIV vaccine trials conducted in South Africa. Interviews were conducted with 21 key informants involved in HIV vaccine research in South Africa and three focus groups of community advisory board members. Data analysis identified seven major themes on the relationship between education and recruitment: the process of recruitment, the combined dual role of educators and recruiters, conflicts perceived by field (...) staff, pressure to achieve recruitment targets, problems in achieving comprehension, accountability and education as capacity building. The results raise ethical concerns about the adequacy of current informed consent processes in these settings. The study findings bear directly on current debates about issues of exploitation and the scope of moral responsibilities of researchers and funding agencies to assure that HIV clinical prevention research is conducted ethically. (shrink)

Background The world has come closer than ever to discovering a viable HIV vaccine. However, it remains less certain whether HIV vaccines should be made available to participants and communities in which trials are run no or subsidized cost. Hence the essence of this inquiry.Methodology This is a case study design using in-depth interviews (IDI) and focus group discussions (FGD) with researchers of HIV vaccine trials, institutional review board (IRB) members, HIV advocates, a policy maker, and members of (...) class='Hi'>community advisory board (CAB) in Tanzania. Participants were purposively selected and data thematically analyzed using MAXQDA software.Results Hosting a vaccine trial and the financial incapacity of individuals at increased risk of HIV were among the reasons in favor of free access to HIV vaccines. In contrast, the view that vaccines should be provided at a subsidized cost was related to high costs of vaccine development, financial return expectations by investors, and the fear of labeling the free vaccine as less important. Moreover, apart from governments and international organizations, well-off individuals could share the cost burden.Conclusion Stakeholders engaging in active discussion about sharing the viable vaccine ought to take the aforementioned concerns into account and ensure unhindered access to individuals and host communities in Tanzania and beyond. (shrink)

The purpose of this article is to understand how historical oppression has undermined health through environmental injustices that have given rise to food insecurity. Specifically, the article examines ways in which settler colonialism has transformed and contaminated the land itself, impacting the availability and quality of food and the overall health of Indigenous peoples. Food security and environmental justice for Gulf Coast, state-recognized tribes has been infrequently explored. These tribes lack federal recognition and have limited access to recourse and supplemental (...) resources as a result. This research fills an important gap in the literature through exploring the intersection of environmental justice and food insecurity issues for this population. Partnering with a community-advisory board and using a qualitative descriptive methodology, 31 Gulf Coast Indigenous women participated in semi-structured interviews about their healthcare experiences and concerns. Through these interviews, participants expressed concerns about (a) the environmental impacts of pollution on the contamination of food and on the health of tribal members; and (b) the impact of these changes on the land, such as negatively impacting gardening practices. The authors of this study document how environmental changes have compounded these concerns and contribute to the overall pollution of food and water sources and unviability of subsistence practices, severely effecting tribal members’ health. In conclusion, we show how social and environmental justice issues such as pollution, industry exploitation, and climate change perpetuate the goals of settler colonialism through undermining cultural practices and the overall health of Indigenous peoples. (shrink)

ABSTRACT The aim of this study is to determine how stakeholder engagement can be adapted for the conduct of COVID‐19‐related clinical trials in sub‐Saharan Africa. Nine essential stakeholder engagement practices were reviewed: formative research; stakeholder engagement plan; communications and issues management plan; protocol development; informed consent process; standard of prevention for vaccine research and standard of care for treatment research; policies on trial‐related physical, psychological, financial, and/or social harms; trial accrual, follow‐up, exit trial closure and results dissemination; and post‐trial access (...) to trial products or procedures. The norms, values, and practices of collectivist societies in Sub‐Saharan Africa and the low research literacy pose challenges to the conduct of clinical trials. Civil‐society organizations, members of community advisory boards and ethics committees, young persons, COVID‐19 survivors, researchers, government, and the private sector are assets for the implementation and translation of COVID‐19 related clinical trials. Adapting ethics guidelines to the socio‐cultural context of the region can facilitate achieving the aim of stakeholder engagement. (shrink)