Challenges and Lessons From Conducting A Paediatric Clinical Trial in Sub-Saharan Africa: The Case of the Praziquantel Oral Dispersible Tablets Phase II Study in Côte d’Ivoire

N’Goran, Eliézer K.; Aka, Nda Angbeletchi David; Ouattara, Mamadou; Huber, Eric; Bezuidenhout, Deon; Kourany-Lefoll, Elly

doi:10.1016/bs.apar.2018.09.002

Cited by 11 publications

(15 citation statements)

References 9 publications

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“…In five articles, minor parents were allowed to consent for research participation of their children [ 22 , 25 , 31 , 34 , 35 ]. In four articles, consent by minor parents was denied [ 23 , 24 , 26 , 37 ]. One of these articles reported that researchers first allowed minor parents to consent for the CT, but later reconsidered their procedure, as the ethics committee changed its policy during the course of the CT [ 24 ].…”

Section: Resultsmentioning

confidence: 99%

“…A majority (n = 11) of articles addressed challenges in designing an appropriate IC approach for CTs involving children with minor parents [ 22 – 24 , 28 , 29 , 31 – 35 , 37 ]. Most of these articles highlighted a lack of or inconsistency in local laws and guidance on the rights of minors in relation to clinical research [ 23 , 24 , 28 , 29 , 31 , 32 , 37 ]. A further challenge addressed in two older articles was a lack of local ethical review, as no local ethics committee existed at that time [ 22 , 25 ].…”

Section: Resultsmentioning

confidence: 99%

“…Other articles offered general recommendations concerning IC implementation in SSA [ 23 , 25 – 27 , 30 – 32 , 34 , 35 , 37 ]. These involved a consideration for the local context and norms [ 23 , 27 , 31 , 32 , 34 ], the capacity of local ethics committees and regulatory authorities [ 30 , 31 ], the availability of context-adapted research guidelines and laws [ 26 , 37 ], and the representation of target populations in research advisory boards [ 35 ].…”

Section: Resultsmentioning

confidence: 99%

“…Further, the conditions to reach emancipated or “mature minor” status, through marriage, parenthood, etc., vary across countries, as do the rights ensuing from the respective status. In N’Goran et al, minor parents could be considered emancipated when married; however, they could not provide consent for their children’s research participation [ 23 ]. Lema et al mention that minor parents may have the authority to consent for their children’s medical care while not being considered mature enough to consent to their own research participation autonomously [ 32 ].…”

Section: Discussionmentioning

confidence: 99%

“…In studies where minor parents were not considered emancipated or competent to consent independently for their children, consent was provided by an adult proxy [ 23 , 24 , 37 ], which included the other parent (if an adult), grandparents, or legally authorised representatives or guardians. This approach raises the problem of identifying appropriate decision-makers, a known issue for paediatric research in the SSA context [ 30 ].…”

Section: Discussionmentioning

confidence: 99%

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Informed consent approaches for clinical trial participation of infants with minor parents in sub-Saharan Africa: A systematic review

Pretto-Lazarova¹,

Brancati-Badarau²,

Burri³

2020

PLoS ONE

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Background Regulations are vague regarding the appropriate decision-maker and authority to consent for children of minor parents participating in clinical trials. In countries with high rates of underage mothers, such as in sub-Saharan Africa, this lack of guidance may affect the rights of potential paediatric participants already bearing increased vulnerability. It can also influence the recruitment and generalizability of the research. We provide evidence and discuss informed consent management in such cases to inform best practice. Materials and methods We searched PubMed/MEDLINE, Embase, CINAHL, and Google Scholar for articles published up to March 2019. In total, 4382 articles were screened, of which 16 met our inclusion criteria. Studies addressing informed consent in clinical trials involving children with minor parents in sub-Saharan Africa were included. We performed descriptive and qualitative framework analyses. The review was registered in PROSPERO: CRD42018074220. Results Various informed consent approaches were reported. Articles supporting individual consent by minor parents based on emancipation or “mature minor” status lacked evidence in the context of research. National laws on medical care guided consent instead. When no laws or guidance existed an interpretation of the local decision-making culture, including community engagement and collaboration with local ethics committees, defined the informed consent approach. Conclusions The review emphasises that the implementation of informed consent for children with minor parents may be variable and hampered by absent or ambiguous clinical trial regulations, as well as divergent local realities. It may further be influenced by the research area and study-specific risks. Clear guidance is required to help address these challenges proactively in clinical trial planning. We provided a set of questions to be considered in the development of an ethically acceptable informed consent approach and proposed information that should be integrated into international clinical trial guidelines.

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