Ethical commitments, principles, and practices guiding intracranial neuroscientific research in humans

Creators: Feinsinger, Ashley; Pouratian, Nader; Ebadi, Hamasa; Adolphs, Ralph; Andersen, Richard; Beauchamp, Michael S.; Chang, Edward F.; Crone, Nathan E.; Collinger, Jennifer L.; Fried, Itzhak; Mamelak, Adam; Richardson, Mark; Rutishauser, Ueli; Sheth, Sameer A.; Suthana, Nanthia; Tandon, Nitin; Yoshor, Daniel; NIH Research Opportunities in Humans Consortium

Abstract

Leveraging firsthand experience, BRAIN-funded investigators conducting intracranial human neuroscience research propose two fundamental ethical commitments: (1) maintaining the integrity of clinical care and (2) ensuring voluntariness. Principles, practices, and uncertainties related to these commitments are offered for future investigation.

Additional Information

© 2021 Elsevier. Available online 19 January 2022. The authors gratefully acknowledge the support of NIH BRAIN Initiative program officers and staff who organized the Research Opportunities in Humans (ROH) Consortium, including Karen David, Jim Gnadt, and Khara Ramos. We also acknowledge the contributions of other ROH Consortium members who contributed perspectives to the manuscript. Finally, we acknowledge the patients who have participated in relevant studies that have helped form the experiences and perspectives included in the current report. All investigators were supported by BRAIN Initiative and NIH funding, including U01 NS098961 (A.F. and N.P.), R01 MH121373 (A.F. and N.P.), U01 NS118739 (U.R. and A.M.), U01 NS117765 (E.C.), U01 NS103082 (N.S.), U01 NS117838 (N.S.), R01 MH110831 (A.M.), P50 MH094258 (R. Adolphs and A.M.), U01 NS103780 (R. Adolphs), U01 NS113339 (M.S.B.), R01 NS065395 (M.S.B.), U01 NS108922 (J.C.), U01 NS123125 (J.C.), U01 NS108930 (I.F.), R01 NS084017 (I.F.), U01 NS123127 (R. Andersen), U01 NS121472 (S.S.), U01 NS108923 (S.S.), R01 NS110424 (M.R.), U01 NS117836 (M.R.), U01 NS098969 (M.R.), R01 NS115929 (N.E.C.), UH3 NS114439 (N.E.C.), U01 DC016696 (N.E.C.), U01 NS117836 (N.E.C.), and U01 NS098981 (N.T. and N.E.C.). Additional support provided by NSF 1756473 (I.F.) and California Institute for Regenerative Medicine (CLIN2-12319, A.M.). S.S. received funding from McNair Foundation. R. Adolphs received funding from Simons Foundation Collaboration on the Global Brain. N.S. received funding from the McKnight Foundation. Author contributions. A.F. and N.P. led discussions, abstracted principles, and drafted, edited, and finalized the manuscript. H.E. documented discussions and edited the manuscript. All other authors significantly contributed to content and perspectives and edited the manuscript. Declaration of interests. S.S. is a consultant for Boston Scientific, Neuropace, and ZimmerBiomet. N.P. is a consultant for Abbott Laboratories. N.T. is a surgical committee member for the Medtronic SLATE trial.

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