Surrogate Decision Making for Severely Cognitively Impaired Research Subjects: The Continuing Debate

Abstract

As research into Alzheimer's disease and other dementing disorders becomes more complex, risky, invasive, and commonplace, the need intensifies for discussion of the ethics of involving persons with dementia in research, specifically research of greater than minimal risk and of no expected direct benefit to the subject. (It is beyond the scope of this paper to consider the ethical issues related to research involvement of cognitively impaired children or children or adults with intermittent and/or reversible cognitive or psychiatric impairments. For such discussions, refer to the references in notes 1–6.) Reviewing such studies pushes our traditional analysis tools to their limits. Simply balancing and prioritizing the basic ethical principles of respect for persons, beneficence, and justice that serves us well in reviewing the vast majority of studies is inadequate when reviewing research of such ethical complexities as studies with marked risks and no expectation of direct benefit to subjects unable to consent or withdraw. Moving up to the level of theory, placing these principles within the commonly applied frameworks of consequentialism, deontology, or virtue ethics bring us no closer to reducing the tensions such research creates between upholding individual autonomy and advancing society's need to learn how to treat and cure these devastating diseases. What is needed is the introduction of more contemporary moral analyses. Specifically, we need to become more inclusive of the diversity of values perspectives of our general citizenry. In more theoretical terms, we ought to elevate to a more central role a communitarian perspective and a feminist ethics emphasis on relationships and context as we rush to keep in step, ethically, with this rapidly expanding area of medical inquiry.