A Review Assessing Participants’ Understanding of Informed Consent for Clinical Trials in Africa

Abstract

Background: Informed consent provides detailed information to the participants to make informed voluntary and rational decision to participate in a study. It is a communication tool between investigator and the subject to ensure that high research ethical standards are followed. This review paper assessed the level of participants’ understanding of the information given to them by researchers during the clinical research. Methods: A review approach was used to achieve the study objective. Results: The findings showed that the level of comprehension varied from study to study. There was a good comprehension in four domains; purpose, voluntariness, benefits and right to withdraw. Poor comprehensions were mostly in risks, side effects, and blinding. Higher level of education, repeated assessments of comprehension, time spent by the researcher explaining and clarifying the information influenced the comprehension. Conclusion: The study findings point out that comprehension to informed consent is still a challenge that needs to be addressed during the field study. Once the consent is given it becomes a distant memory for most of the participants. This implies that proper tools and cut off points to determine participants’ comprehension need to be developed for standard assessment of such.