Effect of a study map intended to support informed consent in transplant research.

Context: Research participants' informed consent is integral to the protection of human subjects; studies exploring the enhancement of standard informed consent processes have had mixed success in increasing patients' understanding of complex research protocols.

Objective: To determine the effect of a "study map," a flow diagram of a research protocol, on research participants' understanding of research purpose and procedures.

Design: This study was an experimental posttest-only design using 30 research participants enrolling in a study of decision making and recovery among living kidney donors. Participants were randomly assigned to the standard care group (verbal description with consent documents) or the experimental group (standard of care plus study map). An instrument measured perceived and objective understanding, and the differences between groups were determined by an independent t test.

Discussion: The high level of comprehension in the control group made detecting improvements in understanding difficult. Objective knowledge and perceived understanding were positively related, suggesting the importance of periodically confirming comprehension with research participants during the informed consent process. Future research should examine the effect of study maps in patients with lower educational levels.

Results: Knowledge levels were high in all participants (mean objective = 3.7 on a 5-point scale, SD = 1.02; mean subjective = 9.3 on a 10-point scale, SD = 1.29). There was a significant relationship between objective knowledge and perceived understanding (r = 0.56, P = .001); however, the study map itself had no significant effect on objective or perceived understanding.