Toward Comprehension: Improving Informed Consent in Behavioral Genetic Research
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This applied experimental study examined components of informed consent documents created to enhance awareness, retention, and recall of information. It was conducted as an online study of 216 research pool participants who were considering participation in a behavioral genetic study. Following completion of the IPIP-NEO personality measure, posed as a screening procedure for participation in a study of genetic influences on personality, participants were randomly assigned to one of eight conditions (27 per condition). They were presented with one of eight experimenter-constructed informed consents with requested potential participation, during the following week, in a genetic study that involved donation of a buccal swab sample. Predicated upon a 2 x 2 x 2 between-subjects design, consent stimuli were created based on information processing theories, and they varied on three dimensions: length (short or long), structure (traditional or narrative), and comprehension check (present or absent). Following exposure to one of the consents, participants completed a free response seven-item recall questionnaire that reflected the central components of the information in the consent: risk, access to data, participation time, donation of a buccal sample, cost, and ability to withdraw from the study. Three independent raters, who were unaware of the study design or hypotheses, coded responses based on the degree of congruence between the free recall responses and information in the constructed informed consent. An overall composite comprehension score, a zero-to-seven scale, with seven indicating high comprehension, was created and constituted the primary dependent variable. Comprehension was measured directly after the informed consent presentation (by an immediate free recall measure) and one week later (by a delayed free recall measure and by a separate delayed multiple choice recognition measure) for the 54 persons who returned to participate in the proposed study. Debriefing indicated that the study was hypothetical and genetic sampling did not occur. Participant comprehension was low over all conditions and at the three measurement points. Separate 2 x 2 x 2 between-subjects ANOVAs for immediate recall, delayed recall, and delayed recognition did not reveal significant main or interaction effects. Repeated measures analysis comparing immediate with delayed recall did not show significant main effects or interactions. A mixed between-within analysis, comparing delayed recall with delayed recognition, revealed significantly higher comprehension scores in delayed recognition compared with delayed recall. However, there were no significant differences in main effects across the eight conditions in ether of the delayed measurements. The informed consent modifications tested in this study did not enhance awareness, comprehension, or recall of central elements of consent posed in this hypothetical investigation. The implications for future research, including designs and approaches for enhancing informed consent, were presented.