AAN position statement: Ethical issues in clinical research in neurology

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.…you can browse by subspecialty topics on Neurology.org?Go to: Neurology.org and click on "Topics" in the top navigation bar. AAN Online LearningBrowse a variety of online CME, self-assessment, and other learning activities to suit your wide-ranging interests and learning styles. Visit AAN.com/Learn.

Ethical Considerations in Clinical Trials for Disorders of Consciousness

“…To align expectations, surrogate decision-makers should be proactively counseled about the nature of the information that might accrue through study participation and their attitudes toward receiving or not receiving such information gauged. A harmonized process could accordingly be developed, analogous to AAN ethics committee guidance on handling of neurogenetic research findings “with the ultimate objective of providing participants with an option to be informed—or not—of incidentally discovered actionable results during the informed consent process prior to” testing [ 108 ]. Investigators should sensitively discuss all clinically relevant findings with the primary medical team, and they should work collaboratively to devise a responsible approach to disclosing results to surrogates in a manner that acknowledges the inherent ambiguities that might be latent in the investigational data and its defeasible interpretation [ 154 , 170 , 171 , 172 , 173 ].…”

“…A 2020 American Academy of Neurology (AAN) position statement on ethical issues in clinical research in neurology, authored by the Ethics, Law, and Humanities joint committee of the AAN, American Neurological Association, and Child Neurology Society, articulates similar standards for informed consent in situations where participants’ decision-making capacity is impaired [ 108 ]:…”

“…Of note, the informed consent process can be cognitively and emotionally demanding, and every effort should be made to ensure participants’ and surrogate decision-makers’ comprehension. In addition, where possible, researchers should consider disclosing relevant conflicts of interest during the informed consent process” [ 108 ].…”

How failure to falsify in high-volume science contributes to the replication crisis

“…Similar issues have been expressed in preclinical studies of stroke ( Corbett et al, 2017 ) in the translational neurosciences where investigators maintain flexible theory and predictions to fit methodological limitations ( Macleod et al, 2014 ; Pound and Ritskes-Hoitinga, 2018 ; Henderson et al, 2013 ), and in cancer research where only portions of published data sets provide support for hypotheses ( Begley and Ellis, 2012 ). These factors have likely contributed to the repeated failure of clinical trials to move from animal models to successful Phase III interventions in clinical neuroscience ( Tolchin et al, 2020 ). This example in the neurosciences also mirrors the longstanding problems of co-existing yet inconsistent theories in other disciplines like social psychology (see Watts, 2017 ).…”

Emerging Subspecialties in Neurology: Neuroethics

“…9,10 Normative challenges posed by experiences of patients with neurologic illnesses and caregivers underscore the pragmatic importance of neuroethics inquiry. 8,11,12 Disparities in access to and outcomes of neurological care is of growing and crucial neuroethics concern. 13 Knowledge of ethics also guides responsible neuroscience research, including managing concerns surrounding appropriate, equitable use of emerging neurotechnologies.…”