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AAN position statement: Ethical issues in clinical research in neurology
Benjamin Tolchin1, Robin Conwit2, Leon G Epstein2
1From the Comprehensive Epilepsy Center, Department of Neurology (B.T.), Yale University School of Medicine, New Haven, CT; Epilepsy Center of Excellence, Neurology Service (B.T.), VA Connecticut Healthcare System, West Haven; Division of Clinical Research (R.C.), National Institute of Neurological Disorders and Stroke, NIH, Bethesda, MD; Division of Neurology, Department of Pediatrics (L.G.E.), Northwestern University Feinberg School of Medicine, Chicago; Stanley Manne Children's Research Institute (L.G.E.), Ann & Robert H. Lurie Children's Hospital of Chicago, IL; and Division of Neurology (J.A.R.), Lahey Hospital and Medical Center, Burlington, MA. benjamin.tolchin@yale.edu.
None:
This update to the American Academy of Neurology's 1998 position statement endeavors to provide guidance for the consistent ethical conduct and review of neurologic research involving human participants. It does so by outlining a widely used ethical framework of 7 principles derived from the foundational documents of modern bioethics, including the Nuremberg Code, the World Medical Association's Declaration of Helsinki, the Belmont Report, and the US Department of Health and Human Service's Common Rule. The position statement then applies this principle-based framework to analyze and produce recommendations for the management of common and important ethical issues encountered in neurologic clinical research. These include institutional review board oversight, equitable research participant inclusion, cognitive impairment in research participants, international studies, the replication crisis, and genetic testing and modification.
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