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

Abstract

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.

Transparent reporting of recruitment and informed consent approaches in clinical trials recruiting children with minor parents in sub-Saharan Africa: a secondary analysis based on a systematic review

“…This secondary analysis was based on the same search strategy and screening steps as the primary analysis [ 9 ], but we used different eligibility criteria (see Eligibility criteria) and performed separate full-text assessments.…”

“…The search strategy included the elements of IC, decision-making, CTs, minors, and SSA. We performed the first search in July 2017 and updated it in March 2019 based on a revised and improved search strategy [ 9 ]. The references of included articles were not systematically searched.…”

“…Previous evidence from CTs in low- and middle-income countries (LMICs) indicates that researchers face particular challenges when implementing informed consent (IC) for children with minor parents. The legal status of minor parents and their ability to consent for their children is often unclear [ 9 ]. The appropriate consenting person (i.e.…”

“…Sometimes also ad hoc solutions tailored to local customs might be implemented [ 7 , 10 ]. However, despite the need for careful ethical considerations for this research group [ 11 ], evidence on practices is scarce and described typically in secondary studies, if at all [ 9 ].…”

“…We conducted a systematic literature review including any type of literature to gain evidence on how IC is provided for children with minor parents in SSA. In a primary analysis published elsewhere [ 9 ], we focused on publications providing evidence about children recruited in CTs having minor parents and/or the respective consent process. While our search also retrieved CT publications, none were eligible for the primary analysis since they all lacked such evidence.…”