Assessing the quality of informed consent in a resource-limited setting: A cross-sectional study

Abstract

BackgroundThe process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University.MethodsData were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies had been administered to each study participant.ResultsOf the 600 participants interviewed, two thirds (64.2%, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9%, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7%, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7%, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50% less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95% CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care.ConclusionsMost of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care.

Informed consent comprehension in African research settings

“…; Taiwo & Kass ; Kiguba et al . ). Most participants in countries with poorer comprehension had a low level of education.…”

“…; Kiguba et al . ) demonstrated comprehension about voluntariness towards participation (95% CI 39.0–98.5%), with perceived medical benefit cited as a main determinant (Leach et al . ; Pace et al .…”

Evaluation of the Informed Consent Process of a Multicenter Tuberculosis Treatment Trial

“…Not all participants understood that their names would not be used for presentations or that study staff could not contact their family and friends without approval. Additionally, it was not well understood that they could stop taking part in the study at any time or that medical care for TB could be obtained separately from the study, similar to findings from a previous report (Kiguba et al 2012). It is important to note that a participant’s misunderstanding of the right to confidentiality would not undermine the effectiveness of this protection; however, the right to withdraw from a study is under the volitional control of the participant.…”

Contextualizing the Informed Consent Process in Vaccine Trials in Developing Countries

“…In practice, however, achieving genuine informed consent continues to be a major challenge in many settings. Indeed, several studies have consistently shown that potential participants have major problems in understanding the basic elements of a research project as outlined on the information sheet even after repeated explanations and questioning [9][10][11][12][13][14]. Others may have serious misunderstanding including the inability to distinguish between research and clinical practice [14,15], or failure to acknowledge that they are even taking part in a research [16].…”