The degree to which individuals with schizophrenia are able to provide informed consent to participate in research is an important and highly controversial issue. Recent studies (including our own pilot investigation) suggest that individuals with schizophrenia, on average, may have relatively impaired decision-making ability, but that many are able to provide informed consent. Nonetheless, the issue remains complex and becomes even more so within the context of medication free schizophrenia research. There is clearly a need for scientifically rigorous and ethical medication-free schizophrenia research, but there exists the valid concern that individuals may be able to provide consent at the beginning of a given study that requires a medication taper and subsequently """"""""lose"""""""" this capacity following discontinuation of medication. The proposed research will directly measure the degree to which informed consent capacity changes following discontinuation of antipsychotic medication and whether this change is related to worsening psychiatric symptoms, increasing cognitive impairment, or both. It will also be determined whether reduced informed consent capacity can be remediated. At the time of enrollment, subjects will already be scheduled to undergo a medication-free period on an inpatient schizophrenia research unit with 24-hour supervision, and all decisions regarding discontinuation and reinstatement of medication will be made independently of the proposed research project. Assessment of informed consent capacity (using a hypothetical drug study scenario), neuropsychological functioning and psychiatric symptoms will be administered before and at the end of a 14-day medication free period. Subjects who demonstrate significantly reduced decisional capacity at the end of the medication-free interval will participate in an educational intervention focused on remediating this capacity and will then be reassessed. We are unaware of any investigation that has directly addressed this important scientific and ethical question in the manner that we propose. Our findings will have significant implications for the continued development of ethical guidelines that provide adequate subject protection without placing undue restrictions on important scientific advance, and will also lay the foundation for larger studies of informed consent capacity in vulnerable populations.
| Moser, David J; Reese, Rebecca L; Schultz, Susan K et al. (2005) Informed consent in medication-free schizophrenia research. Am J Psychiatry 162:1209-11 |
