be ascertained, if the patient currently were able to make and express competent decisions. The substituted judg- ment standard is highly consistent with respect for patient autonomy. When it cannot reasonably be ascertained what the patient would have decided if competent, the guardian is expected to rely on the traditional best interests standard. That test mandates that decisions be made in a manner that, from the guardian’s perspective, would confer the most benefit and the least burden on the ward.
A number of alternatives to plenary, private guardian- ship exist for assisting older individuals with cognitive impairments to navigate through the vicissitudes of daily life. Some of these alternatives involve advance planning, while others are imposed on the individual in the absence of such planning.
A variety of legal and financial strategies have evolved that enable individuals, while still mentally and physically capable of rationally making and expressing their own choices, to plan ahead for the contingency of future incapacity. These advance planning mechanisms promote the principle of autonomy by permitting an individual to prospectively direct or shape subsequent personal decisions even if contemporaneous expression of wishes has become impossible.
Many of these devices pertain to prospective influence over monetary matters; they include joint bank accounts, automatic deposits, living trusts, personal money manage- ment services, powers of attorney, and durable powers of attorney. The chief advance planning mechanisms avail- able for future medical decisions are the living will and the durable power of attorney for health care. These written directives are discussed in depth elsewhere in this text.
Although it usually works reasonably as intended, advance financial and health care planning sometimes goes badly awry. The geriatric clinician may become aware, for instance, of an agent named under a now-incapacitated patient’s durable power of attorney who is misusing or exploiting the patient’s finances, abusing the patient, or grossly neglecting the patient’s medical needs. In such cir- cumstances, the clinician confronts ethical quandaries about whether to initiate a guardianship proceeding or otherwise request court involvement. When the clinician sees no other effective, less restrictive means of dealing with such scenarios, referring the situation to the legal sys- tem, through official notification of the local APS agency, is probably the best course to follow.
There also is evidence that physicians not infrequently fail to honor patients’ advance medical directives.27 A number of initiatives have been launched in a concerted effort to educate both medical professionals and the gen- eral public about the significance and expectations of advance medical planning.
The majority of people who become decisionally inca- pacitated have failed to take advantage of the advance planning mechanisms just outlined. For this bulk of the cognitively impaired population, alternatives to standard plenary, private guardianship fall into two categories: alter- native forms of guardianship (e.g., limited and/or tempo- rary) and alternatives to guardianship.
Research with Older Human Participants 561
For a growing number of older persons whose cognitive impairments would technically qualify them for guardian- ship, plenary or limited, the most pressing practical prob- lem is the unavailability of family members or close friends who are willing and able to assume guardianship responsi- bilities. In the absence of a state public guardianship sys- tem, local volunteer guardianship program, or sufficient assets to hire a private, proprietary professional guardian, the cognitively incapacitated individual with no family or friends (the “unbefriended”) often literally “fall between
Important decisions, including those involv-
ing medical treatment, may by default go without being made until an emergency has developed and the doctrine of presumed consent applies.
Even in the absence of advance planning for incapacity by the individual, some form of official guardianship for the cognitively incapacitated older person is by far the exception rather than the rule. Unplanned alternatives to guardianship include representative payees for govern- ment benefit payments, adult protective services (APS) (including their emergency intervention powers), family consent statutes, and the informal but universally accepted practice of asking next of kin for authorization to provide or withhold specific interventions.
RESEARCH WITH OLDER HUMAN PARTICIPANTS
The generic legal aspects of conducting biomedical or behavioral research involving human participants is dealt with elsewhere in this volume. However, given the dispro- portionate prevalence of dementias and other severe men- tal disabilities among the elderly, the legal and ethical Catch 22 of conducting biomedical and behavioral research using older human participants who are severely demented or otherwise cognitively compromised presents a particular dilemma.29 On the one hand, progress in developing effective treatments and cures for medical and psychological problems associated with dementia requires that research projects be done in which individuals suffer- ing from the precise problems of interest be the basic units of study. At the same time, paradoxically, those very prob- lems that qualify an individual for eligibility as a subject in such a research project often make it impossible for that person to engage in a rational and autonomous decision- making process about his or her own participation as a research subject.30 This irony is exacerbated by the fact that research participants generally are more vulnerable to pos- sible exploitation, and hence need more protection, than patients in therapeutic situations because of, among other things, the researchers’ potential conflicts of interest.31
Federal regulations covering biomedical and behavioral research require that informed consent for participation be obtained from the “subject or the subject’s legally author- ized representative.”32 However, a subject’s legally author- ized representative is defined in circular fashion to mean an “individual or judicial or other body authorized under applicable [presumably state] law to consent on behalf of a