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Factors related to volunteer comprehension of informed consent for a clinical trial.

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Department of Social and Environmental Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.


The informed consent process has become a universal requirement for research involving human subjects. Its goal is to inform volunteers regarding research in order to make decision to participate or not. This study aimed to measure volunteers' comprehension levels concerning the clinical trial and to find out factors associated with that comprehension levels. Eighty-one volunteers who enrolled in a malaria clinical trial were recruited into the study. A semi-structured questionnaire was used to collect the information. Non-participant observation was used to observe the process of informed consent. Volunteers were interviewed three days after being recruited into the trial. The results show the volunteers' comprehension was low. Only 44% of volunteers had an acceptable level of comprehension. It also revealed that 20 volunteers were not aware of being volunteers. Most volunteers knew about the benefits of participating in the trial and realized that they had the right to withdraw from the study, but not many knew about the risks of the trial. The results indicated the method of informing about the trial affected the volunteers' comprehension level. No relationship was found between comprehension level and volunteers' socio-demographic characteristics and their attitude toward the consent process. The findings from this study demonstrate volunteers who participated in the clinical trial were not truly informed. Further studies regarding enhancing volunteers' understanding of the trial are needed.

[Indexed for MEDLINE]

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