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

BMC Medical Ethics

Research Article

Paul Kutyabami¹  Nelson K Sewankambo¹  Elly Katabira¹  Ronald Kiguba¹  Stephen Kiwuwa¹ 

[1] Makerere University College of Health Sciences, Kampala, Uganda;

关键词: Consent Process;    Immune Reconstitution Inflammatory Syndrome;    Public Health Research;    Informed Consent Process;    Indirect Benefit;   

DOI  :  10.1186/1472-6939-13-21

 received in 2011-04-09, accepted in 2012-08-13,  发布年份 2012

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© Kiguba et al.; licensee BioMed Central Ltd. 2012