Ethical Challenges and Lessons Learned During the Clinical Development of a Group A Meningococcal Conjugate Vaccine

Abstract

Background. The group A meningococcal vaccine (PsA-TT) clinical development plan included clinical trials in India and in the West African region between 2005 and 2013. During this period, the Meningitis Vaccine Project (MVP) accumulated substantial experience in the ethical conduct of research to the highest standards.Methods. Because of the public–private nature of the sponsorship of these trials and the extensive international collaboration with partners from a diverse setting of countries, the ethical review process was complex and required strategic, timely, and attentive communication to ensure the smooth review and approval for the clinical studies. Investigators and their site teams fostered strong community relationships prior to, during, and after the studies to ensure the involvement and the ownership of the research by the participating populations. As the clinical work proceeded, investigators and sponsors responded to specific questions of informed consent, pregnancy testing, healthcare, disease prevention, and posttrial access.Results. Key factors that led to success included (1) constant dialogue between partners to explore and answer all ethical questions; (2) alertness and preparedness for emerging ethical questions during the research and in the context of evolving international ethics standards; and (3) care to assure that approaches were acceptable in the diverse community contexts.Conclusions. Many of the ethical issues encountered during the PsA-TT clinical development are familiar to groups conducting field trials in different cultural settings. The successful approaches used by the MVP clinical team offer useful examples of how these problems were resolved.Clinical Trials Registration. ISRCTN17662153 (PsA-TT-001); ISRTCN78147026 (PsA-TT-002); ISRCTN87739946 (PsA-TT-003); ISRCTN46335400 (PsA-TT-003a); ISRCTN82484612 (PsA-TT-004); CTRI/2009/091/000368 (PsA-TT-005); PACTR ATMR2010030001913177 (PsA-TT-006); PACTR201110000328305 (PsA-TT-007).

Cultural considerations for informed consent in paediatric research in low/middle-income countries: a scoping review

“…In an interesting review of lessons learnt in a paediatric vaccine trial in West Africa, Martellet and colleagues noted challenges in preparing consent procedures in some of the less common language groups included in the trial, where use of the written form was uncommon, where substantial need to rely on metaphor and paraphrase made back-translation difficult and where written documents were perceived as not being dynamic enough in cultures which valued interactivity and person-to-person exchange. They describe alternative procedures, such as the preparation of recordings of consent scripts in local languages and extensive practice sessions with research staff obtaining consent in local languages 17. Similarly, another vaccine trial in The Gambia described the successful use of Speaking Book audiovisual tools in local less common languages to consent caregivers 22…”

Profile: Vadu Health and Demographic Surveillance System Pune, India

“…VaduHDSS participation in conducting large community-based trials for meningitis, measles, typhoid, rotavirus and pneumococcal vaccines is one important contribution towards the development of safe, efficacious and affordable vaccines global use [15-20,22-25,28-30]. VaduHDSS has always led the technology portfolio within INDEPTH network and was instrumental in the development of online data repository iSHARE (www.INDEPTH-iSHARE.org).…”

Community Perspectives Associated With the African PsA-TT (MenAfriVac) Vaccine Trials

“…A sound and robust communication system in rural communities, and between health institutions and governments, is a key element for the success of a clinical trial. After receiving permission to begin the trial from the relevant government agencies and ethics committees [ 10 ], meetings were held in the local languages with the key leaders in the community including the village head, the religious leaders and village development committees, youth and women's group leaders, and other opinion leaders.…”

“…In studies involving children, the consent of husbands or heads of the compound was usually obtained. This is particularly important in rural settings [ 10 , 12 ]. Mothers and other relevant household members were also engaged and alerted about the trial.…”

“…Obtaining back-translations was a necessary and challenging process. Details of this process are highlighted in an accompanying article that focuses on ethical issues [ 10 , 12 ].…”