Reporting the details of consent procedures in clinical trials

Ré, Rafael Dal; Solberg, Berge; Fuhr, Uwe; Eriksson, Stefan

doi:10.1016/j.jclinepi.2019.09.014

Cited by 2 publications

(1 citation statement)

References 5 publications

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“…Consequently, the need to provide more details was debated [ 76 ]. Some critics question the practicality of adding succinct IC process descriptions, implying that it can be assumed that the adequacy of IC was evaluated and established by a competent ethics committee that has approved the CT [ 77 ]. While we agree that extensive IC descriptions in CT publications are not practical, given journals’ limited word count, it can also not be ignored that consent processes carry not only ethical but also scientific implications.…”

Section: Discussionmentioning

confidence: 99%

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

2021

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Background Standardised 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. Methods We 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. Results None 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. Conclusions Reporting 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 registration CRD42018074220.

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Section: Discussionmentioning

confidence: 99%