Speaking for those with diminished decisional capacity

Public ready to serve as surrogate

Gary Pettett, M.D., F.A.A.P.
Fellow, Center for Practical Bioethics

America’s nearly 70 million post-WWII “baby boomers” are now reaching their 60’s and beyond. Estimates suggest that as many as 30% will develop aged-related dementias of which Alzheimer’s Disease is the most common paradigm.

Efforts to prevent or minimize the health burden of dementia will be critical to sustaining a comprehensive and affordable health care system for an aging population.

Unfortunately, our current understanding of the epidemiology and pathophysiology of many of these disorders is incomplete. Clinical research designed to expand our knowledge of age-related disorders and answer many of these questions is essential.

However, much of that research will require the participation of elderly individuals with diminished decisional capacity. Despite years of debate, the absence of clear public policy on the participation of patients with diminished decisional capacity in clinical research leaves much of this work undone. Who will speak for those who cannot speak for themselves?

Interestingly, the public seems to be reasonably comfortable with the concept of a family surrogate to speak for those who have lost decisional capacity. In the January 13th issue of Neurology, Kim, et al.[1] reported the results from the 2006 Health and Retirement Survey, a biennial survey of a representative sample of Americans aged 51 and older.

Participants were queried specifically as to whether one would want to participate in a research study, whether our society should allow family surrogate consent for participation in clinical research, and whether one would allow surrogates some or complete leeway to override stated personal preferences.

In 2006, the Center for Practical Bioethics published a policy brief, Protecting Research Subjects with Diminished Capacity, providing a series of recommendations that might serve as a template for the development of public policy on clinical research in patients with diminished capacity.

These recommendations addressed the need to ensure that studies involving adult subjects with diminished capacity are conducted on firm ethical ground, that uniform procedures should be established for identifying surrogate decision-makers and defining the extent of their authority when acting on behalf of adults with diminished-capacity, and develop clearly defined criteria for determining the allowable levels and types of research related risks that would be appropriate for adults with diminished capacity.

Never before has research on age-related dementia been more important or more needed. The public seems ready. The ethical issues are not entirely new. Many were debated at length during the formulation of the federal guidelines for protecting human subjects in clinical research in the early 1970’s.

It is time now to focus our efforts on developing meaningful public policies and guidelines that foster clinical research to help us more fully understand and manage age-related dementias. The social and economic cost of ignoring these issues will far exceed the investment required to develop more effective health care for one of the most rapidly growing segments of our population.

Link:

Decide for Me When I Can't, Most People Say
HealthDay News
January 21, 2009

The survey of people age 51 and older found that at least 68 percent believed family surrogates should be able to grant consent for a mentally incapacitated loved one to participate in a research study.

[1] Kim SYH, Kim HM, Langa KM, et al. Surrogate Consent for Dementia Research. Neurology 2009, 72:149-155.