AAN position statement: Ethical issues in clinical research in neurology

Benjamin Tolchin; Robin Conwit; Leon G Epstein; James A Russell; Ethics, Law, and Humanities Committee, a joint committee of the American Academy of Neurology, American Neurological Association, and Child Neurology Society

doi:10.1212/WNL.0000000000009241

AAN position statement: Ethical issues in clinical research in neurology

Neurology. 2020 Apr 14;94(15):661-669. doi: 10.1212/WNL.0000000000009241. Epub 2020 Mar 16.

Authors

Benjamin Tolchin¹, Robin Conwit², Leon G Epstein², James A Russell²; Ethics, Law, and Humanities Committee, a joint committee of the American Academy of Neurology, American Neurological Association, and Child Neurology Society

Affiliations

¹ From 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.
² From 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.

Abstract

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.

Publication types

Review

MeSH terms

Bioethics*
Biomedical Research / ethics*
Humans
Informed Consent / ethics*
Neurology / ethics*
Societies, Medical / ethics
United States

Grants and funding

UL1 TR001863/TR/NCATS NIH HHS/United States