How ethical is your clinical trial?

Miller, Lori; Foláyan, Morẹ́nikẹ́ Oluwátóyìn; Allman, Dan; Nkala, Busi; Kasirye, Lillian Mutengu; Mingote, Laia Ruiz; Calazans, Gabriela Junqueira; Mburu, Rosemary; Ntombela, Fanelesibonge; Ditmore, Melissa Hope

doi:10.1111/j.1742-1241.2010.02421.x

Cited by 14 publications

(11 citation statements)

References 15 publications

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“…However, the notion of ‘community’ has often been too loosely applied with the risk that those eventually engaged for study purposes are not true representatives of the research participants and their communities. To ensure that community collaboration processes are effective, we propose the adoption of guidelines developed to facilitate meaningful community engagement during HIV prevention research [16–18]. This involves actively building relationship between researchers, communities and other stakeholders, and developing mechanisms that enable community members to have real collaborative decision-making power in the research process.…”

Section: Discussionmentioning

confidence: 99%

Stakeholders’ engagement with Ebola therapy research in resource limited settings

Foláyan

Brown²,

Haire

et al. 2015

BMC Infect Dis

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BackgroundThe current Ebola Virus Disease (EVD) outbreak in West Africa is the largest in history. As of February 18th 2015, 23,258 cases of EVD have been cumulatively reported from Nigeria, Senegal, Guinea, Liberia, Mali, Sierra Leone, Spain, the United Kingdom and the United States of America resulting in more than 9,000 deaths. It is therefore exigent to develop prevention and treatment therapies for EVD.DiscussionSeveral new EVD treatments are in clinical development at this time. Based on lessons learned, four critical processes need to be implemented before clinical trials begin. First, all global EVD research need to be coordinated to promote data sharing and synergistic overlap, while reducing unnecessary duplication of efforts. The World Health Organization is well-placed to undertake such an endeavor. Second, governments of affected nations where trials are being proposed need to lead discussions regarding immediate access to any proven medications for epidemics. Also, governments need to leverage international resources to support and expand existing national expertise to jointly conduct high-caliber clinical research; and resources must be used to enhance local technical skills and expand existing personnel. Third, ethics committees must review protocols, monitor the research process, and work closely with research scientists to insure the ethical integrity of research throughout the trials. Fourth, community advisory boards (CAB) need to be formed, linked with existing community leadership structures and organized in conjunction with trial implementation. These community structures should work together with ethics committees to facilitate the study design, informed consent process, and study implementation.SummaryWe must facilitate communication and mutual understanding between trial communities and research teams, and promote positive collaborations between all stakeholders engaged in EVD research. The community engagement process for EVD research is crucial to address myths and misconceptions, and to promote study volunteers’ understanding of the research details. The collaboration between all stakeholders is crucial for continued long term partnership to address EVD outbreak and none of the stakeholders should be left behind in ongoing efforts to develop EVD therapies.

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Section: Discussionmentioning

confidence: 99%

Stakeholders’ engagement with Ebola therapy research in resource limited settings

Foláyan

Brown²,

Haire

et al. 2015

BMC Infect Dis

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“…The community engagement process requires that community members are consulted at the beginning of the research project in an open, collaborative process [ 51 ]. Benefits of community consultation include strengthening local ownership of the research, effective communication between stakeholders, and the promotion of mutual understanding between trial communities and researchers [ 52 ]. Community engagement strategies include training of laypersons on ethics committees to reviewand provide constructive feedback on EVD vaccine protocols that addresses cultural context for study implementation, developing plans to engage and dialogue with formal and informal community structures about the research implementation [ 51 ], and discussing benefit-sharing mechanisms [ 34 ].…”

Section: Debatementioning

confidence: 99%

Ebola vaccine development plan: ethics, concerns and proposed measures

Foláyan

Yakubu

Haire³

et al. 2016

BMC Med Ethics

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BackgroundThe global interest in developing therapies for Ebola infection management and its prevention is laudable. However the plan to conduct an emergency immunization program specifically for healthcare workers using experimental vaccines raises some ethical concerns. This paper shares perspectives on these concerns and suggests how some of them may best be addressed.DiscussionThe recruitment of healthcare workers for Ebola vaccine research has challenges. It could result in coercion of initially dissenting healthcare workers to assist in the management of EVD infected persons due to mistaken beliefs that the vaccine offers protection. It could also affect equity and justice. For example, where people who are not skilled health care professionals but who provide care to patients infected with Ebola (such as in home care settings) are not prioritized for vaccination. The possibility of study participants contracting Ebola infection despite the use of experimental vaccine, and the standard of care they would receive, needs to be addressed clearly, transparently and formalized as part of the ethics review process. Future access to study products in view of current status of the TRIPS agreement needs to be addressed. Finally, broad stakeholder engagement at local, regional and international levels needs to be promoted using available communication channels to engage local, regional and international support. These same concerns are applicable for current and future epidemics.SummarySuccessful Ebola vaccine development research requires concerted efforts at public dialogue to address misconceptions, equity and justice in participant selection, and honest discussions about risks, benefits and future access. Public dialogue about Ebola vaccine research plans is crucial and should be conducted by trusted locals and negotiated between communities, researchers and ethics committees in research study sites.

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“…Context may influence the ways in which benefits and risks are perceived by the participants, particularly in settings with large resource inequities . Using knowledge of the health and social structures to inform community engagement practice is a critical component of designing research studies appropriately . Researchers conducting clinical trial studies in low‐resource settings can integrate the findings of this study to protect participant autonomy through integrating them into the communication of trial procedures.…”

Section: Introductionmentioning

confidence: 99%

Clinical trials in low‐resource settings: the perspectives of caregivers of paediatric participants from Uganda, Tanzania and Kenya

Berg

Ogutu

Sewankambo

et al. 2019

Tropical Med Int Health

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ObjectivesVaccine clinical trials in low‐resource settings have unique challenges due to structural and financial inequities. Specifically, protecting participant and caregiver autonomy to participate in the research study can be a major challenge, so understanding the setting and contextual factors which influence the decision process is necessary. This study investigates the experience of caregivers consenting on behalf of paediatric participants in a malaria vaccine clinical trial where participation enables access to free, high‐quality medical care.MethodsWe interviewed a total of 78 caregivers of paediatric participants previously enrolled in a phase II or III malaria vaccine clinical trial in Uganda, Tanzania and Kenya. Interviews were qualitative and analysed using a thematic framework analysis focusing on the embodied caregiver in the political, economic and social reality.ResultsCaregivers of participants in this study made the decision to enrol their child based on economic, social and political factors that extended beyond the trial into the community and the home. The provision of health care was the dominant reason for participation. Respondents reported how social networks, rumours, hierarchal structures, financial constraints and family dynamics affected their experience with research.ConclusionsThe provision of medical care was a powerful motivator for participation. Caregiver choice was limited by structural constraints and scarce financial resources. The decision to participate in research extended beyond individual consent and was embedded in community and domestic hierarchies. Future research should assess other contexts to determine how the choice to participate in research is affected when free medical care is offered.

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How ethical is your clinical trial?

Cited by 14 publications

References 15 publications

Stakeholders’ engagement with Ebola therapy research in resource limited settings

Stakeholders’ engagement with Ebola therapy research in resource limited settings

Ebola vaccine development plan: ethics, concerns and proposed measures

Clinical trials in low‐resource settings: the perspectives of caregivers of paediatric participants from Uganda, Tanzania and Kenya

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