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Respecting The Right To Research: Proxy Consent And Subject Assent In Alzheimer's Disease Clinical Trials, Mikaela L.J. Louie

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, …