Washington Law Review


Alzheimer’s Disease is the sixth-leading cause of death in the United States and the only disease in the top ten causes of death with no prevention, treatment, or cure. To find any meaningful treatment or cure, researchers must conduct clinical trials on subjects with Alzheimer’s Disease. Subjects with Alzheimer’s Disease, however, generally lack legal capacity to consent to research due to diminished cognition. While informed consent standards for individuals who lack capacity are well settled in the medical treatment context, such standards are much less clear in the research context. A patchwork of legal and regulatory guidance addresses this issue, but no uniform framework exists. In January 2017, the federal government responded to the problem of unclear proxy consent standards by updating the Common Rule, which regulates human subjects research. Attempting to clarify prior vagueness, the regulation extended existing laws and policies on proxy consent in clinical treatment to the research context. While this was a welcome change, state laws and institutional policies remain inconsistent. Therefore, states should affirmatively enact legislation to ensure inclusion for all participants in medical research. Practically, this may be as simple as amending existing health care surrogate decisionmaking statutes—allowing proxy consent and substituted judgment in the research context explicitly. Additionally, federal regulators, Institutional Review Boards, and researchers should consider establishing an assent and dissent standard for research subjects who lack capacity, specifically in Alzheimer’s Disease clinical trials.

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