Comparison of group counseling with individual counseling in the comprehension of informed consent: a randomized controlled trial

Abstract

BackgroundStudies 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.MethodsParents 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.ResultsA 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.ConclusionsThe 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.Trial RegistrationClinical Trial Registry - India (CTRI): CTRI/2009/091/000612

Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

“…Sarkar et al tested a focus group intervention with parents in rural India, finding no significant improvement [13]. Aaronson et al, conversely, found significant improvement with extra phone conversations [29].…”

“…Preferences between interventions and controls were either insignificant or showed that participants significantly preferred the interventions [19,27,29,32,35,43,47,52-54]. Accrual rates, tracked for trials with real parent studies, were also reported as improved or unchanged by interventions in all categories [13,23,29,43,52,55,56], with one exception [46]. These findings are consistent with those discussed in the 2004 review [14].…”

“…These improvements or enhancements often rely on altering standard paper consent documents or elements of the process, or medium in which information is delivered or by which consent is obtained. For example investigators have tested enhanced design methodologies [2], multimedia tools and technologies [11], altered counseling or dialogue [12], and the provision of quizzes that give immediate feedback [13]. Many of these efforts aim to shorten the consent form document and increasing potential participants’ understanding of what was explained to them.…”

Us Irbs Confronting Research in the Developing World

“…Studies have shown that over 80% of subjects in the developing world do not understand basic concepts such as placebo, randomization and the ability to withdraw from a study at any time without negative consequences. 22 Questions arise as to why these possibilities do not influence IRB deliberations more, and whether IRBs consider or ignore this evidence. The fact that at a certain point, IRBs may be seeking to follow regulations more than protecting human subjects poses critical questions that require additional research.…”

Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials

“…Since 2004, there have been several intervention studies to increase informed consent understanding in clinical trials, but the majority has assessed specifics of a clinical trial rather than on the eight basic elements of informed consent (Campbell, Goldman, Boccia, & Skinner, 2004; Hutchison, Cowan, & Paul, 2007; Moseley, Wiggins, & O’Sullivan, 2006; Olver, Whitford, Denson, Peterson, & Olver, 2009; Sarkar et al, 2010; Wray, Stryker, Winer, Demetri, & Emmons, 2007). While we do not view HIV/AIDS clinical trials as unique in their informed consent process, we do know that there currently are over 1000 HIV/AIDS clinical trial protocols, with numerous sites per protocol, actively, or soon to be recruiting potential subjects both nationally and internationally (NIH, 2010).…”