Every psychiatric theory and treatment must be tested ultimately on humans. Often the only appropriate group for testing is the hospitalized mentally ill who are diagnosed as having a schizophrenic or affective disorder. Trials of new psychotropic medications are examples of this type of research. Thus, in order for the field of psychiatry to progress and discover more effective treatments, research must be done with the mentally ill. However, the competency of the mentally disabled to consent to experimental treatments remains a controversy. This project is a continuation of a series of empirical studies whicha are investigating the capacity of psychiatric and medical patients to give informed consent to research. Earlier results demonstrate that psychiatric patients tend to make similar decisions with respect to participation in research and do not appear to be more vulnerable in the research process (i.e. they do not expose themselves to greater dangers or risks). This proposal will further clarify the competency of the mentally ill in order to help determine whether safeguards are necessary. Specifically the several questions will be addressed. 1. Do psychotropic medications alter patients abilities to give informed consent? On one hand, it is argued that patients must be stabilized on psychotropic drugs prior to obtaining any form of consent, while on the other hand, it is also argued that the drugs are """"""""mind-controlling"""""""" and, hence taking them precludes the possibility of a true consent. Both of these positions present difficulties for psychiatric research. 2. Are the most severely disturbed psychiatric patients - those recently hospitalized with diagnoses of schizophrenic disorders or affective disorders - unable to give informed consent? 3. Are patients who are non-responsive to standard psychotropic drugs and, hence, most likely to be selected as candidates for new drugs, less able to consent than patients who are responsive? 4. Finally, demographic factors, which have recently been suggested to be more predictive of competency of patients than diagnosis, will be examined in patients diagnosed as having schizophrenic or affective disorders. All of these findings will have practical value for those who conduct psychopharmacologic research and can serve to develop federal policy with respect to the mentally disabled research subject.
| Cournos, F; McKinnon, K; Stanley, B (1991) Outcome of involuntary medication in a state hospital system. Am J Psychiatry 148:489-94 |
| McKinnon, K; Cournos, F; Stanley, B (1989) Rivers in practice: clinicians' assessments of patients' decision-making capacity. Hosp Community Psychiatry 40:1159-62 |
| Sieber, J E; Stanley, B (1988) Ethical and professional dimensions of socially sensitive research. Am Psychol 43:49-55 |
| Stanley, B (1988) An integration of ethical and clinical considerations in the use of placebos. Psychopharmacol Bull 24:18-20 |
