Previous Studies in Research Ethics and Informed Consent in Schizophrenia

Initial work in this area resulted in the development of a method for evaluating participants' understanding of the information in an informed consent interview. The Evaluation to Sign Consent (ESC) is now used at the MPRC and at other research sites as a screening tool. Patients are not permitted to enroll in a clinical research study until they can demonstrate adequate knowledge of their rights as participants and the study's procedures, risks and benefits.

Working with leading experts in the field, we have developed new ways to study decisional capacity in schizophrenia. Using capacity assessments designed specifically for people with schizophrenia, we have found that, although they usually have poorer decisional capacity than a healthy comparison group at first, most patients' capacity can improve significantly if they are given the right education. In practical terms, this means that as long as researchers doing clinical studies are willing to provide study-related education, people with schizophrenia can usually learn what they need to know to give informed and voluntary consent. In addition, the work in this area has shown that severity of psychosis is not a very good predictor of decisional capacity. A better predictor is patients' cognitive ability, which we measure with tests of memory, attention, problem solving and other skills. So it is not necessarily the case that patients who appear more ill than others are less able to consent.

In a related line of research, we have investigated the way people with schizophrenia perceive risk. Biases in people's beliefs about their own vulnerability to harm could influence how they make decisions in a variety of contexts. It has been shown that people generally feel that they are less likely to experience unpleasant or harmful events and more likely to experience pleasant or beneficial events compared to other people. We investigated whether schizophrenia patients share what is termed "optimistic bias". Results showed that both schizophrenic subjects and healthy controls showed an optimistic bias in general, especially for events people usually think they can control. But interestingly, the patients were actually more realistic than the control subjects; they showed less unrealistic optimism about their own vulnerability to harm. This study has helped us further understand how patients with schizophrenia perceive risk, which is an important factor in their decisional capacity.

Printer friendly Email this page