Appreciation of Research Information in Patients with Bipolar Disorder
Ethicists have debated whether patients with serious mental illness can appreciate the risks of research participation and make autonomous decisions; however, there is little empirical data on patients’ abilities to appreciate the purpose and goals of research and discern any associated risks. This study examined the abilities of patients with bipolar disorder (veterans and non-veterans recruited between ’03 and ’05) to understand and make decisions regarding research participation. Investigators analyzed survey data for 51 patients to determine their: 1) appreciation of, or insight into their mental illness; 2) appreciation of the overall goals of research; 3) ability to discern level of risk; and 4) the degree of influence from external factors (e.g., family members, doctors) on their decisions about whether to participate in research.
Findings suggest that patients with bipolar disorder were able to weigh risk levels associated with various studies, and to appreciate that their participation was voluntary. However, patients demonstrated two misconceptions: their appreciation of the goals of research was flawed (a substantial proportion had difficulty distinguishing clinical research from clinical care), and they incorrectly applied concepts of ‘double-blind’ and ‘randomization.’ In addition, more than half believed that their primary mental health provider could convince them to participate in a study even if they did not want to. This suggests that clinician researchers should be cautious when approaching their own patients to participate in research if they also are an investigator. Overall, results indicate that mania associated with bipolar disorder does not substantially influence patients’ appreciation of research participation.
Misra S, Socherman R, Hauser P, and Ganzini L. Appreciation of Research Information in Patients with Bipolar Disorder. Bipolar Disorders July 2008;10(5):635-46.
This study was supported through both HSR&D and the Cooperative Studies Program. All authors are part of the Portland VA Medical Center, Portland, OR.