Protection of persons with mental disorders from research risk: a response to the report of the National Bioethics Advisory Commission.

For the last several years, the National Bioethics Advisory Commission (NBAC) has considered several complex issues relating to biomedical research. Prominent among these considerations has been the protection of the rights and welfare of human research subjects, and the NBAC recently submitted to the president a report entitled Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity. The importance of careful protection of vulnerable populations from undue or inappropriate risk in human subject research cannot be overemphasized, and the NBAC report includes recommendations that would strengthen such protection. However, the creation of workable mechanisms that allow appropriate risk-benefit judgments and that preserve respect for the autonomy of participating research subjects is challenging indeed. We believe that the NBAC has developed recommendations that strengthen protections for individual research participants. However, several key elements of the report are stigmatizing to persons with psychiatric disorders, and they could, if adopted as new federal regulations, inappropriately impede critical categories of psychiatric research.