Assuring Adequate Protections in International Health Research: A Principled Justification and Practical Recommendations for the Role of Community Oversight

Buchanan, David; Sifunda, Sibusiso; Naidoo, Nasheen; James, Shamagonam; Reddy, Priscilla

doi:10.1093/phe/phn027

Cited by 17 publications

(10 citation statements)

References 47 publications

(48 reference statements)

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“…In this paper, I have provided concrete examples of some of the ethical tensions experienced in the course of research while trying to apply the ethical guidelines derived from western universities in rural Lao PDR. These ethical tensions around autonomy, beneficence and justice are not new and have been subject of overlapping discourses 4,5,8,11,18,22,27–30 . However, they are not always explicitly discussed in public health programs, where the teaching of research ethics is not universal.…”

Section: Discussionmentioning

confidence: 99%

“…Other studies have highlighted the challenges in securing genuine informed consent in low‐income countries. They have argued that the concept of informed and voluntary consent is inherently culturally bound, is based on western values of individual autonomy, self‐determination and freedom, and may not translate across cultures 11,18–22 . This may particularly be the case in a collectively oriented culture such as Lao PDR and a hierarchical, one‐party state.…”

Section: Fieldwork and Ethical Challengesmentioning

confidence: 99%

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Ethical challenges in cross‐cultural research: a student researcher's perspective

Durham

2014

Australian and New Zealand Journal of Public Health

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Section: Discussionmentioning

confidence: 99%

Section: Fieldwork and Ethical Challengesmentioning

confidence: 99%

Ethical challenges in cross‐cultural research: a student researcher's perspective

Durham

2014

Australian and New Zealand Journal of Public Health

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“…First, informing and consulting members of the broader community on the ongoing research is seen as an additional protection for ethical conduct of the research besides that provided by ethics committee approvals and informed consent [ 3 , 5 ]. Communities can act as gatekeepers [ 11 ] for the principles of respect for persons, beneficence, and justice, as affirmed by the Belmont report [ 12 ], extending their meaning to the people affected by the research, even if they are not research participants.…”

Section: Main Textmentioning

confidence: 99%

“…A power shift is needed in which CABs can assume a more intrinsic role—for instance, participating in setting the study agenda with researchers and evaluating the appropriateness and relative priority of future studies—rather than having a purely instrumental role, such as providing guidance in the wording of the informed consent form or helping with recruitment and enrolment [ 13 , 33 , 36 ]. This shift of power would also imply a shift in paradigm, from individual-only protection to community protection [ 3 , 5 ].…”

Section: Main Textmentioning

confidence: 99%

Community involvement in biomedical research conducted in the global health context; what can be done to make it really matter?

Fregonese

2018

BMC Med Ethics

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BackgroundCommunity 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 abstractMore than 20 years ago, in the field of HIV medicine, regulatory bodies and funding agencies (such as the US National Institutes of Health) recommended the constitution of a formal organism, the Community Advisory Board (CAB), 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.ConclusionsAllocating 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.

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“…This paper presents data on the functions and operations of CABs in HIV/AIDS vaccine trials in South Africa. This is part of a larger study designed to assure adequate protections for participants in HIV/AIDS clinical prevention research (Buchanan, Sifunda, Naidoo, Reddy & James, 2008).…”

Section: Introductionmentioning

confidence: 99%

The role of community advisory boards in health research: Divergent views in the South African experience

Reddy

Buchanan

Sifunda

et al. 2010

SAHARA-J: Journal of Social Aspects of HIV/AIDS

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In the light of the growing involvement of community advisory boards (CABs) in health research, this study presents empirical findings of the functions and operations of CABs in HIV/AIDS vaccine trials in South Africa. The individual and focus group interviews with CAB members, principal investigators, research staff, community educators, recruiters, ethics committee members, trial participants and South African AIDS Vaccine Initiative (SAAVI) staff members demonstrated differences in the respondents' perceptions of the roles and responsibilities of CABs. These findings question the roles of the CABs. Are they primarily there to serve and be accountable to the community, or to serve the accomplishment of the research objectives? Four emergent themes are discussed here: purpose; membership and representation; power and authority; sources of support and independence. The CABs' primary purpose carries significant implications for a wide range of issues regarding their functioning. The dual functions of advancing the research and protecting the community appear to be fraught with tension, and require careful reconsideration. Résumé À la lumière de l'implication croissante des conseils consultatifs communautaires (CAB) dans la recherche dans le domaine de la santé, cette étude présente les résultats empiriques des fonctions et des opérations des CAB dans les essais vaccinaux sur le VIH/ SIDA en Afrique du Sud. Les entretiens individuels et en groupe ont été menés avec les membres des CAB, les principaux chercheurs, le reste du personnel, les éducateurs de la communauté, les recruteurs, les membres du comité d' éthique, les participants aux essais et la South African AIDS Vaccine Initiative (SAAVI). Les auteurs ont mis en évidence les différences de perception des personnes interrogées à propos des rôles et des responsabilités des CAB. Ces conclusions posent la question du rôle de ces derniers. Sont-ils d'abord là pour être au service de la communauté et être responsable devant elle, ou sont-ils là pour permettre d'atteindre les objectifs de l' étude menée ? Quatre thèmes ont été relevés et sont examinés ici : le but du CAB, sa composition et sa représentation, son pouvoir et son autorité, ses soutiens et son indépendance. S'interroger sur le principal objectif des CAB est essentiel car le choix de telle ou telle réponse entraîne des conséquences importantes sur leur mode de fonctionnement. Sa double fonction consistant à la fois à faire progresser la recherche et à protéger la communauté semble entraîner des tensions et ne plus être tenable. Keywords

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Assuring Adequate Protections in International Health Research: A Principled Justification and Practical Recommendations for the Role of Community Oversight

Cited by 17 publications

References 47 publications

Ethical challenges in cross‐cultural research: a student researcher's perspective

Ethical challenges in cross‐cultural research: a student researcher's perspective

Community involvement in biomedical research conducted in the global health context; what can be done to make it really matter?

The role of community advisory boards in health research: Divergent views in the South African experience

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