Subject(s)
Christianity , Holocaust , Judaism , Social Values , Attitude , Homicide , Humans , Interpersonal Relations , PhilosophySubject(s)
Child Welfare , Ethics, Medical , Human Experimentation/legislation & jurisprudence , Patient Participation , Adolescent , Australia , Canada , Child , France , Humans , Informed Consent , Mental Competency , Risk , United StatesSubject(s)
Decision Making , Legal Guardians , Mental Competency/legislation & jurisprudence , Mental Disorders/drug therapy , Mentally Ill Persons , Advance Directives , Beneficence , Canada , Federal Government , Humans , Informed Consent/legislation & jurisprudence , Judicial Role , Mental Disorders/diagnosis , Paternalism , Personal Autonomy , Psychotropic Drugs/adverse effects , Psychotropic Drugs/therapeutic use , Risk Assessment , Social Justice , Social Values , Treatment Refusal/legislation & jurisprudence , UncertaintySubject(s)
Human Experimentation , Informed Consent , Aged , Alzheimer Disease , Canada , Humans , Mental Competency , Patient AdvocacySubject(s)
Ethics, Medical , Euthanasia/legislation & jurisprudence , Canada , Humans , Morals , NetherlandsABSTRACT
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.
Subject(s)
Ethics, Medical , Human Experimentation , Informed Consent/legislation & jurisprudence , Mental Competency/legislation & jurisprudence , Mental Disorders/psychology , Nontherapeutic Human Experimentation , Advisory Committees , Canada , Ethics Committees/legislation & jurisprudence , Ethics Committees, Research , Humans , Living Wills , Personal Autonomy , Persons , Research Subjects , Vulnerable PopulationsABSTRACT
The developmentally disabled constitute a vulnerable population in the context of nontherapeutic experimentation. Their vulnerability is characterized by diminished decision-making capacity and by susceptibility to coercive situations that may bring voluntariness into question. The international consensus is that research involving this population should be permitted, but only if the consent of a legal guardian is obtained and appropriate safeguards are introduced. Therefore, legislation regulating the ethical conduct of research should be enacted, including provision for substituted consent in the research context. Although researchers seeking the participation of a developmentally disabled individual in a protocol must presume the person to be capable of participating in the decision, they must conduct competency assessments if the person's ability to make such a decision is in doubt. Information must be presented in such a way as to maximize the individual's contribution, and capacity must be reevaluated on an ongoing basis. In addition, research on the developmentally disabled presents specific challenges to establish competency, the selection of subjects, the characteristics of the decision maker, and the model to be used in making substituted decisions.
