Main Article Content
Informed consent for clinical trials: a review
Abstract
Objective: To identify and highlight challenges related to informed consent process for clinical trials in sub-Saharan Africa. Data sources: Published original research findings and reviews in the English literature, together with anecdotal information from our current professional experiences with clinical trials. Design: Review of peer-reviewed articles. Data extraction: Online searches were done and requests for reprints from corresponding authors and institutional subscription. Data synthesis: Information categorised accordingly.
Results: Informed consent for clinical trials conducted in sub-Saharan Africa (SSA) is not always “truly informed” or “truly voluntary”. Guidelines for obtaining informed consent are often difficult to implement because of low literacy levels, socio-economic and cultural factors. The local ethics committees, whose role is critical in informed consent, are weak, ill-equipped or non-existent in some countries. Many participants may have incomplete understanding of the various aspects of the clinical trials due to language barriers, the way information is disclosed or terms used for informed consent documents. In some settings, clinical trials are the only access to health care services for the local population. Further, participants may enroll with perceived notion of cure of their conditions, for monetary or material benefits. Conclusions: There is need for national guidelines on clinical research including ethics review, compensation of subjects, requirements for research investigators, facilities and ethics committees as well as budgetary allocation. These guidelines must not only address specific and unique local circumstances but also meet minimum international clinical research standards. Local bioethics and research capacity should be developed and strengthened with research sponsors contributing towards this. Local research is needed on the validity and reliability of informed consent for clinical trials and factors influencing that in different socio-cultural settings in SSA.
Results: Informed consent for clinical trials conducted in sub-Saharan Africa (SSA) is not always “truly informed” or “truly voluntary”. Guidelines for obtaining informed consent are often difficult to implement because of low literacy levels, socio-economic and cultural factors. The local ethics committees, whose role is critical in informed consent, are weak, ill-equipped or non-existent in some countries. Many participants may have incomplete understanding of the various aspects of the clinical trials due to language barriers, the way information is disclosed or terms used for informed consent documents. In some settings, clinical trials are the only access to health care services for the local population. Further, participants may enroll with perceived notion of cure of their conditions, for monetary or material benefits. Conclusions: There is need for national guidelines on clinical research including ethics review, compensation of subjects, requirements for research investigators, facilities and ethics committees as well as budgetary allocation. These guidelines must not only address specific and unique local circumstances but also meet minimum international clinical research standards. Local bioethics and research capacity should be developed and strengthened with research sponsors contributing towards this. Local research is needed on the validity and reliability of informed consent for clinical trials and factors influencing that in different socio-cultural settings in SSA.
