Abstract
BACKGROUND: Studies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent. METHODS: Parents of children participating in a trial of nutritional supplementation were randomized to receive either group counseling or individual counseling prior to administration of the informed consent. To assess the participant's comprehension, a structured questionnaire was administered approximately 48-72 hours afterwards by interviewers who were blinded to the allocation group of the respondents. RESULTS: A total of 128 parents were recruited and follow up was established with 118 (90.2%) for the study. All respondents were aware of their child's participation in a research study and the details of sample collection. However, their understanding of study purpose, randomization and withdrawal was poor. There was no difference in comprehension of key elements of the informed consent between the intervention and control arm. CONCLUSIONS: The results suggest that the group counseling might not influence the overall comprehension of the informed consent process. Further research is required to devise better ways of improving participants' understanding of randomization in clinical trials.