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

Abstract

BackgroundObtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. PurposeTo systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods.MethodsThe search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique.ResultsMeta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation existed between included studies: control processes, the presence of a human proctor, real vs. simulated protocol, and assessment formats.ConclusionsEnhanced consent forms and extended discussions were most effective in improving participant understanding. Interventions of all categories had no negative impact on participant satisfaction or study accrual. Identification of best practices for studies of informed consent interventions would aid future systematic comparisons.

Ethical Conducts of Professors, Undergraduates and Graduate Students: The View of Dental School Patients

“…However, the bias in not remembering about signing informed consent can be explained by the fact that subjects might not understand the contents of the term (13,(18)(19)(20). Best practice already obliges researchers to comply with a range of legal and ethical obligations, with a particular focus on informed consent and research transparency (6,15,16,18,21).…”

“…The patient and his/her rights are being respected, as required by Resolution CNS 466/12 (11), since it is necessary to show all procedures, risks and benefits, which must be written in language that is accessible and understandable to the research subject (1,(13)(14)(15)(16)18). It should be noted that the person's autonomy should…”

“…Therefore, research subjects should know their participation is voluntary and they must understand what health researchers will do and decide whether or not to give their consent to participate in a study (8,(12)(13)(14)(15)(16). Currently, many studies are conducted in educational institutions and the research subjects are patients who need the clinical services of those institutions.…”

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