Advance Directives for Research Involving Adults with Advancing Dementia

By Celia B. Fisher, Ph.D.

As advance directives for health care have become increasingly accepted in society, some have suggested that similar directives by those with advancing cognitive impairment can enhance substitute decision-making for research participation once an individual’s mental capacity has been compromised.

Among the problems inherent in issuing and following advance directives is that neither the individual in the early stages of increasing mental disability, nor those who will serve as his or her legal guardians can know with certainty how the prospective participant will think and feel in a deficient state. In the face of such uncertainty, protectionist policies precluding research with the cognitively disabled and paternalistic approaches taking consent authority away from the participant, are equally undesirable.  Rather, despite limitations in foreseeing future reactions, the prospective participant is still the most expert in envisioning how he or she would respond to experimental procedures in an eventual state of cognitive impairment.

Persons with advancing cognitive impairments cannot make decisions regarding future research participation in isolation. The process of obtaining ethically acceptable advance directives require a series of ongoing co-learning experiences among scientists, the prospective participant, and substitute decision-maker. This process, like that of obtaining informed consent, must insure that participant decisions are free of coercion and exploitation. Most importantly, prospective participants must be encouraged to provide the investigator and future substitute decision-makers information that helps them understand:  (a) the participant’s value system; (b) the way he or she evaluates pain, discomfort, and embarrassment;  (c ) his or her views on altruism;  and (d)  other  aspects of the person’s character and perspective that will allow legal guardians to approach consent decisions from the participant’s perspective.

Future guardians must also be encouraged to share with prospective participants their moral philosophies on consent relevant dimensions so that both can decide whether or not the advance directives can be carried out in a manner that honors both the participant’s and the substitute decision-maker’s value orientations.  As in research with persons already identified as cognitively  impaired, there is no ethical justification for over-riding an advance directive that indicates dissent to participate in research.  However, from a justice-care perspective, advance directives which do not rule out participation in specific types of studies do not replace the moral decision-making responsibility of the legal guardian. The fiduciary nature of legal guardianship obliges substitute decision-makers to take ultimate responsibility for deciding the extent to which research participation protects the rights and welfare of those who have placed their trust in them.

From Fisher, C. B. (1999). Relational ethics and research with vulnerable populations. In Reports on research involving persons with mental disorders that may affect decision-making capacity (Vol. 2, pp. 29–49). Commissioned Papers by the National Bioethics Advisory Commission. Rockville, MD: National Bioethics Advisory Commission. Retrieved October 26, 2009, available here.

For further information, see this article on surrogate consent for dementia research in the latest edition of IRB: Ethics & Human Research, published by The Hastings Center.

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