Suggested methods for resolving ethical issues or reducing risks that may arise in conducting research with the mentally ill as subjects.
With no "gold standard" for determining competency, researchers will have to use a sliding scale to balance impairments in decision-making capacity and the degree of risk to the patient. Advance directives, in which patients, while they are still competent, agree to participate in research in the future when they are no longer competent to give informed consent, have been suggested as a remedy to the problem.
In order to provide adequate protection as the levels of risk and impairment increases, the use of monitors has been suggested as an added safeguard. Monitors should be independent persons, family members of, or advocates for, the mentally ill. Independent monitors can also serve as Institutional Review Board members, assist in the informed consent process, or observe recruitment, assessment, and debriefing of research subjects.
As capacity decreases and impairment increases, surrogates should play an increasing role in decisions. Surrogates' decisions, especially in research involving more than minimal risk, should be based on substituted judgment (what the patient would have wanted) rather than best interests (what the family thinks would be most helpful for the patient).
Researchers must be aware of any conflicts among their multiple responsibilities as investigator, as clinician, and as administrator. They must disclose any conflict of interest in this regard, and, where necessary, divest themselves of roles and responsibilities and use caution about the potential abuse arising from the "therapeutic illusion."