INFORMED CONSENT FOR CLINICAL TRIALS: A REVIEW

Abstract

Objective: To identify and highlight challenges related to informed consent processfor 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 withclinical trials.

Design: Review of peer-reviewed articles.

Data extraction: Online searches were done and requests for reprints from correspondingauthors and institutional subscription.

Data synthesis: Information categorised accordingly.

Results: Informed consent for clinical trials conducted in sub-Saharan Africa (SSA) isnot always “truly informed” or “truly voluntary”. Guidelines for obtaining informedconsent are often difficult to implement because of low literacy levels, socio-economicand cultural factors. The local ethics committees, whose role is critical in informedconsent, are weak, ill-equipped or non-existent in some countries. Many participantsmay have incomplete understanding of the various aspects of the clinical trials due tolanguage barriers, the way information is disclosed or terms used for informed consentdocuments. In some settings, clinical trials are the only access to health care servicesfor the local population. Further, participants may enroll with perceived notion ofcure of their conditions, for monetary or material benefits.

Conclusions: There is need for national guidelines on clinical research including ethicsreview, compensation of subjects, requirements for research investigators, facilitiesand ethics committees as well as budgetary allocation. These guidelines must not onlyaddress specific and unique local circumstances but also meet minimum internationalclinical research standards. Local bioethics and research capacity should be developedand strengthened with research sponsors contributing towards this. Local research isneeded on the validity and reliability of informed consent for clinical trials and factorsinfluencing that in different socio-cultural settings in SSA.