Improving understanding of research consent disclosures among persons with mental illness.

OBJECTIVE The objective of this study was to evaluate alternative procedures for improving the understanding of research consent disclosures by persons who have mental illness. METHODS Three groups participated in the study: persons with schizophrenia (N=79), persons with depression (N=82), and a healthy control group (N=80). The participants were guided through an informed consent process in which two factors were manipulated. One was the structure of the disclosure form; either a typical disclosure form involving standard dense text was used, or a graphically enhanced form was used. The other was the interpersonal process: the presence or absence of a third-party facilitator, with iterative feedback given to participants for whom a facilitator was not present. Participants' understanding of the disclosure was assessed with the use of recall tests that involved paraphrasing and recognition tests that involved multiple choice. RESULTS The mean understanding scores did not differ significantly between the depression and control groups, and the mean scores of the schizophrenia group were significantly lower than those of the other two groups. Neither the graphically enhanced consent disclosure form nor the presence of a third-party facilitator was associated with improved understanding. The use of iterative feedback was associated with improvement in comprehension scores in all groups. CONCLUSIONS The use of a feedback procedure in the consent disclosure process during the recruitment of persons who are mentally ill may be a valuable safeguard for ensuring adequate understanding and appropriate participation in research.