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

Angela De Pretto-Lazarova,Christian Burri,Domnita Oana Brancati-Badarau

doi:10.1186/s12889-021-11079-y

Angela De Pretto-Lazarova, Christian Burri + Show 1 more

Open Access

https://doi.org/10.1186/s12889-021-11079-y

Copy DOI

Abstract

BackgroundStandardised checklists of items to be addressed in clinical study protocols and publications are promoting transparency in research. However, particular specifications for exceptional cases, such as children with minor parents are missing. This study aimed to examine the level of transparency regarding recruitment and informed consent approaches in publications of clinical trials recruiting children with minor parents in sub-Saharan Africa. We thereby focused particularly on the transparency about consenting persons (i.e. proxy decision-makers) and assessed the need to expand reporting guidelines for such exceptional cases.MethodsWe conducted a secondary analysis of clinical trial publications previously identified through a systematic review. Multiple scientific databases were searched up to March 2019. Clinical trial publications addressing consent and potentially recruiting children with minor parents in sub-Saharan Africa were included. 44 of the in total 4382 screened articles met our inclusion criteria. A descriptive analysis was performed.ResultsNone of the included articles provided full evidence on whether any recruited children had minor parents and how consent was obtained for them. Four proxy decision-maker types were identified (parents; parents or guardians; guardians; or caregivers), with further descriptions provided rarely and mostly in referenced clinical trial registrations or protocols. Also, terminology describing proxy decision-makers was often used inconsistently.ConclusionsReporting the minimum maternal age alongside maternal data provided in baseline demographics can increase transparency on the recruitment of children with minor mothers. The CONSORT checklist should require clinical trial publications to state or reference exceptional informed consent procedures applied for special population groups. A standardized definition of proxy decision-maker types in international clinical trial guidelines would facilitate correct and transparent informed consent for children and children with minor parents.Study registrationCRD42018074220.

Highlights

Standardised checklists of items to be addressed in clinical study protocols and publications are promoting transparency in research
CT Clinical trial, ethics committee (EC) Ethics committee, institutional review board (IRB) Institutional review board, NDA No data available, informed consent (IC) Informed consent a Numbers do not add up, since several features may apply and some publications were inconclusive in the description b 60% of publications since CT registration became a requirement by the ICMJE in 2005 [70] c 24% of publications since protocol publication became a requirement by the Consolidated Standards of Reporting Trials (CONSORT) statement in 2010 [17]
While some CT publications identified in our analysis indicated that children with minor parents might have been considered, none of the CT publications met a sufficient level of transparency to confirm whether such children were truly enrolled in the CTs and who consented on their behalf

Summary

Introduction

Standardised checklists of items to be addressed in clinical study protocols and publications are promoting transparency in research. Particular specifications for exceptional cases, such as children with minor parents are missing. This study aimed to examine the level of transparency regarding recruitment and informed consent approaches in publications of clinical trials recruiting children with minor parents in sub-Saharan Africa. We thereby focused on the transparency about consenting persons (i.e. proxy decision-makers) and assessed the need to expand reporting guidelines for such exceptional cases. Previous evidence from CTs in low- and middleincome countries (LMICs) indicates that researchers face particular challenges when implementing informed consent (IC) for children with minor parents. The appropriate consenting person (i.e. proxy decision-maker1) in this case may vary depending on local legal and cultural conditions. 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]

Objectives

Methods

Results

Discussion

Conclusion