정신과 연구대상 환자의 동의능력에 대한 조사

Competence of Psychiatric Research Subjects

This study was designed to evaluate the competence of psychiatric research subjects and then to identify the possible relationship between the competence and demographic and clinical characteristics of the research subjects. The subjects were 61 schizophrenics who had been admitted to Yong-In mental hospital and had participated in two clinical studies. Thirteen questions to evaluate the competence to give an informed consent were presented to them and the author interviewed patients. The main results were as follows. 1) Thirty six point one ^ said they had been asked for an informed consent, and 29.5% said that they had participated in the research voluntarily. 2) Only a few patients understood the contents of the informed consent 3) The rate of the patients who were convinced of confidentiality was 45.9%. 4) Some patients agreed with the clinical studies being done in the hospital setting, but many patients showed the negative attitudes toward their being research subjects. 5) The patients aged 30-39 years showed much concern for the possible risk of research. Patients with lower level education seldom participated voluntarily. 6) In Brief Psychiatric Rating Scale (BPRS), the patients who thought that there had been no informed consent showed higher total scores and higher thought disturbance cluster scores. The involuntary participants showed higher thought disturbance and higher paranoia cluster scores. The paients who understood the procedure of the research showed higher anxiety-depression cluster scores. The results suggest that the most schizophrenic patients do not understand the contents of the informed consent More efforts to explain the contents of the informed consent are expected for the schizophrenic patients.