A program of quality improvement in transfusion safety. Experience at Saint-Camille Hospital

Because of concerns about competence and voluntariness, the mentally disordered constitute a vulnerable population in the context of nontherapeutic biomedical research and, as such, are in need of protection. Despite others' concern about protecting the mentally disordered, their decision-making potential should also be respected and maximized, allowing such individuals to consent to participate in experiments subject to an evaluation of their competence to make such a decision. Competent mentally disordered persons who anticipate future incapacity should be able to issue research directives or durable powers of attorney whereby they can provide explicit consent to participate in nontherapeutic research. When he or she becomes incompetent, a substitute decision maker should be able to provide consent on behalf of the mentally disordered person within established parameters. Nontherapeutic experimentation with the mentally disordered should be permitted, but only within the boundaries of ethical permissibility delineated by legislated guidelines. At present, the legal status of substituted consent for nontherapeutic procedures is uncertain and requires legislation, which in addition to legalizing such consent, would provide guidelines for substitute decision makers and for the creation of research directives. These guidelines should include restrictions on the scope of research, obligations of researchers, rights of subjects, and responsibilities of research ethics committees (RECs). In all cases, the voluntary and informed consent of the person or substitute decision maker must be obtained.