Informed Consent
In discussing research related issues with patients, clinic staff takes into consideration that patients with schizophrenia have cognitive symptoms that can interfere with their thinking. They frequently suffer from attentional difficulties, intrusive hallucinations and thought disorder. Staff, therefore, realize that obtaining informed consent for research participation is a process- not something accomplished quickly in one session.
An explanation of the rationale for a study, clarification of the risks to the patient and what will be expected of him/her during the protocol are discussed repeatedly in a variety of settings. Staff trained in obtaining informed consent meets with the subject in a variety of setting, including individual and group sessions ( where other members may participate) and, when appropriate, in sessions with the potential subject’s family, care givers or other significant people in their lives.
Information is presented slowly, straight-forwardly, and most importantly, on repeated occasions. Various educational techniques are used to help each individual understand the risks, benefits, side-effects, what he/she needs to do to get out of the study, and what will be required of him/her during the study. Prior to actually signing consent, patients are required to verbalize what they have learned, including specific risks and benefits of the protocol.
Informed Consent and Schizophrenia
Ethical human research depends on the informed and voluntary consent of the participants. Some of the most common symptoms of schizophrenia, like hallucinations, disorganized thought and cognitive impairment, often raise concerns about whether people who live with the disease are able to give voluntary informed consent on their own. That ability is often referred to as "decisional capacity."
Over the last decade researchers at the MPRC have been committed to investigating decisional capacity in schizophrenia. Our goals are to (1) determine whether, and under what conditions people with schizophrenia are capable of giving informed consent for research participation, and (2) ensuring the safe and fair treatment of people with schizophrenia who participate, or wish to participate in clinical research.
Initial work in this area focused on the development of a tool to asses decisional making capacity, and demonstrated how education can improve decisional capacity and evaluated how subjects perception of risk effects their decision making.
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.