Article Test

Home  >  Medical Research Archives  >  Issue 149  > A Review Assessing Participants’ Understanding of Informed Consent for Clinical Trials in Africa
Published in the Medical Research Archives
Nov 2022 Issue

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

Published on Nov 28, 2022

DOI 

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.

Author info

Dorothy Kazembe, Tigist Mesfin, Abigiya Abebe, Saba Embaye, Esther Muthoka, Kedir Usmael, Mediha Ahmedin, Tsegahun Manyazewal

Have an article to submit?

Submission Guidelines

Submit a manuscript

Become a member

Call for papers

Have a manuscript to publish in the society's journal?