Background While community engagement is increasingly promoted in global health research to improve ethical research practice, it can sometimes coerce participation and thereby compromise ethical research. This paper seeks to discuss some of the ethical issues arising from community engagement in a low resource setting. Methods A qualitative study design focusing on the engagement activities of three biomedical research projects as ethnographic case studies was used to gain in-depth understanding of community engagement as experienced by multiple stakeholders in Malawi. Data (...) was collected through participant observation, 43 In-depth interviews and 17 focus group discussions with community leaders, research staff, community members and research participants. Thematic analysis was used to analyse and interpret the findings. Results The results showed that structural coercion arose due to an interplay of factors pertaining to social-economic context, study design and power relations among research stakeholders. The involvement of community leaders, government stakeholders, and power inequalities among research stakeholders affected some participants’ ability to make autonomous decisions about research participation. These results have been presented under the themes of perception of research as development, research participants’ motivation to access individual benefits, the power of vernacular translations to influence research participation, and coercive power of leaders. Conclusion The study identified ethical issues in community engagement practices pertaining to structural coercion. We conclude that community engagement alone did not address underlying structural inequalities to ensure adequate protection of communities. These results raise important questions on how to balance between engaging communities to improve research participation and ensure that informed consent is voluntarily given. (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)

Background Community engagement models have provided much needed guidance for researchers to conceptualise and design engagement strategies for research projects. Most of the published strategies, however, still show very limited contribution of the community to the engagement process. One way of achieving this is to document experiences of community members in the CE processes during project implementation. The aim of our study was to explore the experiences of two research naïve communities, regarding a CE strategy collaboratively developed by researchers and (...) study communities in a multicountry study. Methods The study was carried out in two research naïve communities; Gwanda, Zimbabwe and uMkhanyakude, South Africa. The multicentre study was a community based participatory ecohealth multicentre study. A qualitative case study approach was used to explore the CE strategy. Data was collected through Focus Group Discussions, Key Informant Interviews and Direct Observations. Data presented in this paper was collected at three stages of the community engagement process; soon after community entry, soon after sensitisation and during study implementation. Data was analysed through thematic analysis. Results The communities generally had positive experiences of the CE process. They felt that the continuous solicitation of their advice and preferences enabled them to significantly contribute to shaping the engagement process. Communities also perceived the CE process as having been flexible, and that the researchers had presented an open forum for sharing responsibilities in all decision making processes of the engagement process. Conclusions This study has demonstrated that research naïve communities can significantly contribute to research processes if they are adequately engaged. The study also showed that if researchers put in maximum effort to demystify the research process, communities become empowered and participate as partners in research. (shrink)

ABSTRACTBuilding trust between researchers and communities involved in research is one goal of community engagement. This paper examines the implications of community engagement for trust within communities, including trust among community volunteers who assist with research and between these volunteers and other community members. We describe the experiences of two groups of community volunteers recruited as part of an HIV and TB intervention trial in Malawi: cluster representatives, recruited both to act as key informants for TB suspects and mortality reporting (...) and to identify and report community concerns, and community counsellors, recruited to provide semi-supervised HIV self-testing. We examine tensions experienced due to playing multiple roles, and the implications of volunteer responsibilities for short- and long-term community relationships. Data was collected through a workshop, in-depth interviews and focus group discussions with volunteers and community members. While the volunteer system init... (shrink)

Around the world, a growing number of communities are voicing their demands for authority in the governance of research involving them. Many such communities have experienced histories of exploitative, stigmatizing, intrusive research that failed to benefit them. To better understand what strategies communities are developing in order to have a say in research oversight, we conducted a scoping review of the international peer-reviewed and grey literature. Three primary strategies were identified: (1) guidelines; (2) community review boards; and (3) community advisory (...) boards. Guidelines include documents developed by, with, or for communities to outline ethical behavior or conduct in research with or within the community. Community review boards offer ethical review of research protocols, much like traditional research ethics boards, but are community led and focus on community interests. Community advisory boards consist of representatives from a given community and are developed to advise institutions or research teams on community-level ethical matters pertaining to research projects. Initiatives led by Indigenous communities far outnumbered others in the sample, reflecting the legacy of continuous Indigenous resistance to research as a tool of colonialism. In several cases, communities in marginalized neighbourhoods, where harmful and exploitative research practices have taken place, emphasized the significance of community-led governance grounded in shared geographical and social contexts. We discuss some of the beneficial and challenging features of each type of strategy and offer recommendations for stakeholders who wish to support community-led efforts in research ethics. (shrink)

ABSTRACT The expansion of health research to low and middle income countries has increased the likelihood of exploitation and undue influence in economically vulnerable populations. In behavioral research, “reasonable availability”, which was originally developed for biomedical research and advocates for the equitable provision of any product developed during the research process, cannot always prevent exploitation. In such cases and settings, the informed consent process may lack cross-cultural validity and therapeutic misconceptions may arise. This article advocates for a mutual learning framework (...) where international researchers can gain cultural competence while training and empowering local partners, increasing community ownership of health research. (shrink)

Community engagement (CE) is gaining prominence in global health research. A number of ethical goals–spanning the instrumental, intrinsic, and transformative–have been ascribed to CE in global health research. This paper draws attention to an additional transformative value that CE is not typically linked to but that seems very relevant: solidarity. Both are concerned with building relationships and connecting parties that are distant from one another. This paper first argues that furthering solidarity should be recognized as another ethical goal for CE (...) in global health research. It contends that, over time, CE can build the bases of solidaristic relationships—moral imagination, recognition, understanding, empathy—between researchers and community members. Applying concepts from existing accounts of solidarity, the paper develops preliminary ideas about who should be engaged and how to advance solidarity. The proposed approach is compared to current CE practice in global health research. Finally, the paper briefly considers how solidaristic CE could affect how global health research is performed. (shrink)

Background Factors that could potentially act as facilitators and barriers to successful recruitment strategies in perinatal clinical trials are not well documented. The objective was to assess lay persons’ understanding of the informed consent for randomized clinical trial in emergency obstetric and newborn care. Methods This was a qualitative study conducted among survivors of severe obstetric complications who were attending the post-natal clinic of Kawempe National Referral Hospital, Uganda, 6–8 weeks after surviving severe obstetric complications during pregnancy or childbirth. The (...) study that involved 18 in-depth interviews was conducted from June 1, 2019 to July 6, 2019. The issues explored included perceptions of the purpose and necessity to conduct such research how research-related information would be disclosed, and what could be the potential benefits and risks of participation. The data was analyzed by thematic analysis. Results Respondents felt that research was necessary to investigate the cause, prevention or complications of an illness, especially as much was known about some pregnancy and newborn complications. Most believed that the emergency contexts affects whether and what prospective participants may understand if information about research was disclosed. Whereas they did not see the value of procedures like randomization, they felt that if these and any other procedures necessary should be done transparently and fairly. The decisions to participate would significantly be influenced by possibility of risk to the unborn baby or the newborn. Solidarity was an important influence on decision-making. Conclusions Respondents valued participation in RCTs in emergency obstetric and newborn care. However, they expressed concerns and valued openness, transparency and accountability with regard to how clinical trials information is disclosed and the decision-making process for clinical trial participation. While autonomy and solidarity are contradictory values, they complement each other during decision-making for informed consent. (shrink)

BackgroundSharing de-identified individual-level health research data is widely promoted and has many potential benefits. However there are also some potential harms, such as misuse of data and breach of participant confidentiality. One way to promote the benefits of sharing while ameliorating its potential harms is through the adoption of a managed access approach where data requests are channeled through a Data Access Committee (DAC), rather than making data openly available without restrictions. A DAC, whether a formal or informal group of (...) individuals, has the responsibility of reviewing and assessing data access requests. Many individual groups, consortiums, institutional and independent DACs have been established but there is currently no widely accepted framework for their organization and function.Main textWe propose that DACs, should have the role of both promotion of data sharing and protection of data subjects, their communities, data producers, their institutions and the scientific enterprise. We suggest that data access should be granted by DACs as long as the data reuse has potential social value and provided there is low risk of foreseeable harms. To promote data sharing and to motivate data producers, DACs should encourage secondary uses that are consistent with the interests of data producers and their own institutions. Given the suggested roles of DACs, there should be transparent, simple and clear application procedures for data access. The approach to review of applications should be proportionate to the potential risks involved. DACs should be established within institutional and legal frameworks with clear lines of accountability, terms of reference and membership. We suggest that DACs should not be modelled after research ethics committees (RECs) because their functions and goals of review are different from those of RECs. DAC reviews should be guided by the principles of public health ethics instead of research ethics.ConclusionsIn this paper we have suggested a framework under which DACs should operate, how they should be organised, and how to constitute them. (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)

Research funders, regulatory agencies, and journals are increasingly expecting that individual-level data from health research will be shared. Broad consent to such sharing is considered appropriate, feasible and acceptable in low- and middle-income settings, but to date limited empirical research has been conducted to inform the design of such processes. We examined stakeholder perspectives about how best to seek broad consent to sharing data from the Mahidol Oxford Tropical Medicine Research Unit, which implemented a data sharing policy and broad consent (...) to data sharing in January 2016. Between February and August 2017 qualitative data were collected at two sites, Bangkok and the Thai-Myanmar border town of Mae Sot. We conducted eighteen semi-structured interviews. We also conducted four focus group discussions with a total of nineteen people. Descriptive and thematic coding informed analysis of aspects of data sharing that are considered most important to inform participants about, and the best ways to explain complex and abstract topics relating to data sharing. The findings demonstrated that clinical trial participants prioritise information about the potential benefits and harms of data sharing. Stakeholders made multiple suggestions for clarifying information provided about data sharing on such topics. There was significant variation amongst stakeholders’ perspectives about how much information should be provided about data sharing, and it was clear that effective information provision should be responsive to the study, the study population, the individual research participant and the research context. Effectively communicating about data sharing with research participants is challenging in practice, highlighting the importance of robust and effective data sharing governance in this context. Broad consent should incorporate effective and efficient explanations of data sharing to promote informed decision-making, without impeding research participants’ understandings of key aspects of the research from which data will be shared. Further work is required to refine both the development of core information about data sharing to be provided to all research participants, and appropriate solutions for context specific-challenges arising when explaining data sharing. (shrink)