Abstrakt

Knowledge of Informed Consent among Healthy Volunteers Participating In Bioavailability / Bioequivalence (BA/BE) Studies

R Arunkumar, A Ruckmani, A Manoranjani, R Lakshmipathy Prabhu, and A Priya

Bioavailability/Bioequivalence studies are special type of clinical trials conducted to establish that the generic drugs are equivalent to the innovator drugs and mostly healthy volunteers participate in these studies. The volunteers must be enrolled in BA/BE studies only after obtaining a written, informed consent. There are reports that the study subjects often fail to understand the important aspects of the study even after informed consent. Hence this project was executed to assess the knowledge of informed consent among healthy volunteers who participate in BA/BE studies. The study was conducted among the volunteers visiting CROs to participate in BA/BE studies. A questionnaire containing 20 questions selected from ICH-GCP was used to assess the knowledge of informed consent. Each correct answer was given a score of 5. The volunteer’s knowledge of informed consent was categorized as excellent, good, average and poor based on the total score they obtained, excellent - 80 and above, good - 60 to 75, average - 40 to 55 and poor - 35 and less. In this survey, a total of 100 volunteers participated. Among them, 63 were men and 37, women. 12 volunteers scored less than 35 and they were categorized to have poor knowledge of informed consent and 30 volunteers scored average. 22 volunteers had good knowledge and 36, excellent knowledge of informed consent. It is evident that many of the volunteers have scored more than average in the assessment of their knowledge of informed consent. However to certain essential questions on informed consent, their answers were not found to be satisfactory and hence there is a need to educate the researchers and volunteers on the importance of informed consent in BA/BE studies.