ObjectivePrevious reviews on participants' comprehension of informed consent information have focused on developed countries. Experience has shown that ethical standards developed on Western values may not be appropriate for African settings where research concepts are unfamiliar. We undertook this review to describe how informed consent comprehension is defined and measured in African research settings. MethodsWe conducted a comprehensive search involving five electronic databases: Medline, Embase, Global Health, EthxWeb and Bioethics Literature Database (BELIT). We also examined African Index Medicus and Google Scholar for relevant publications on informed consent comprehension in clinical studies conducted in sub-Saharan Africa. 29 studies satisfied the inclusion criteria; meta-analysis was possible in 21 studies. We further conducted a direct comparison of participants' comprehension on domains of informed consent in all eligible studies. ResultsComprehension of key concepts of informed consent varies considerably from country to country and depends on the nature and complexity of the study. Meta-analysis showed that 47% of a total of 1633 participants across four studies demonstrated comprehension about randomisation (95% CI 13.9-80.9%). Similarly, 48% of 3946 participants in six studies had understanding about placebo (95% CI 19.0-77.5%), while only 30% of 753 participants in five studies understood the concept of therapeutic misconception (95% CI 4.6-66.7%). Measurement tools for informed consent comprehension were developed with little or no validation. Assessment of comprehension was carried out at variable times after disclosure of study information. No uniform definition of informed consent comprehension exists to form the basis for development of an appropriate tool to measure comprehension in African participants. ConclusionsComprehension of key concepts of informed consent is poor among study participants across Africa. There is a vital need to develop a uniform definition for informed consent comprehension in low literacy research settings in Africa. This will be an essential step towards developing appropriate tools that can adequately measure informed consent comprehension. This may consequently suggest adequate measures to improve the informed consent procedure. ObjectifLes normes ethiques elaborees selon les valeurs occidentales ne sont peut-etre pas appropriees au contexte africain oU les concepts de recherche ne sont pas familiers. Cette revue decrit comment la comprehension du consentement eclaire est definie et mesuree dans les cadres de recherche africains. MethodesDes recherches ont ete effectuees sur Medline, Embase, Global Health, EthxWeb, base de donnees de la Bioethique Litterature, Index Medicus African et Google Scholar pour des publications pertinentes sur la comprehension du consentement eclaire dans les etudes cliniques menees en Afrique sub-saharienne. 29 etudes repondaient aux criteres d'inclusion; une meta-analyse a ete possible pour 21 etudes. La comprehension des participants sur les domaines du consentement eclaire dans toutes les etudes admissibles a ete comparee directement. ResultatsLa comprehension des concepts cles du consentement eclaire varie considerablement selon les pays et depend de la nature et de la complexite de l'etude. La meta-analyse a montre que 47% des participants ont compris la randomisation (IC95%: 13,9 - 80,9%), 48% ont compris le placebo (IC95%: 19,0 - 77,5%), 30% ont compris le concept de meprise therapeutique (IC95%: 4,6 - 66,7%). Les outils de mesure de la comprehension du consentement eclaire etaient developpes avec peu ou pas de validation. ConclusionsLa comprehension des concepts cles du consentement eclaire est faible en Afrique. Il y a une necessite vitale d'elaborer une definition uniforme pour la comprehension du consentement eclaire dans les cadres de recherche avec un faible niveau d'alphabetisation en Afrique. ObjetivoLos estandares eticos desarrollados basandose en valores occidentales podrian no ser apropiados para emplazamientos Africanos en donde los conceptos de investigacion no son familiares. En esta revision se describe como la comprension del consentimiento informado se define y mide en un centro de investigacion Africano. MetodosSe buscaron publicaciones relevantes sobre la comprension del consentimiento informado en estudios clinicos en africa subsahariana en Medline, Embase, Global Health, EthxWeb, Bioethics Literature Database, African Index Medicus y Google Scholar. 29 estudios satisfacian los criterios de inclusion y el metaanalisis era posible para 21. La comprension del consentimiento informado por parte de los participantes se comparo directamente en todos los estudios elegibles. ResultadosLa comprension de conceptos claves del consentimiento informado vario de forma considerable entre paises, y dependia de la naturaleza y de la complejidad del estudio. El meta-analisis mostro que un 47% entendia la aleatorizacion (IC 95% 13.9-80.9%); un 48% entendia el placebo (IC 95% 19.0-77.5%); y un 30% entendio el concepto terapeutico errado (IC 95% 4.6-66.7%). Las herramientas para medir la comprension del consentimiento informado se desarrollaron con poca o ninguna validacion. ConclusionesEn africa, la comprension de conceptos claves del consentimiento informado es pobre. Existe una necesidad vital de desarrollar una definicion uniforme para la comprension del consentimiento informado en lugares con bajos niveles de alfabetizacion en africa.
