Request Information RFI): Guidance Opportunities Neuroethics NIH BRAIN Initiative) Notice Number: NOT-MH-16-014 Key Dates Release Date: 27, 2016 Response Date: July 29, 2016 Related Announcements None Issued NIH BRAIN Initiative braininitiative.nih.gov) National Institute Mental Health NIMH) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose is Request Information RFI) soliciting input identify set core ethical issues associated research involving human brain resulting advancements neurotechnology research development. Background BRAIN Initiative: Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative® aimed revolutionizing our understanding the human brain. accelerating development application innovative technologies, researchers be able produce new dynamic picture the brain that, the first time, show individual cells complex neural circuits interact both time space. work well underway
http://www.braininitiative.nih.gov) the application the innovative tools technologies ultimately lead new ways treat prevent brain disorders. NIH one several federal agencies involved the BRAIN Initiative. Planning the NIH component the BRAIN initiative guided the long-term scientific plan, ldquo;BRAIN 2025: Scientific Vision,” details seven high-priority research areas calls a sustained federal commitment 4.5 billion over 12 years. address current challenges lay more stable foundation future generations researchers, NIH seeking input the community opportunities areas/topics where ethical issues related neuroscience research might considered. overall aim to integrate ethical insight progress under BRAIN Initiative, proactively consider ethical implications the research. Information Requested NIH strives maximize impact the taxpayers’ investments biomedical research. Specific this RFI, input researchers, academic institutions, professional societies other stakeholders solicited potential topics explore where BRAIN Initiative might invest resources the area neuroethics, particularly pertaining emerging neurotechnologies. While welcome input the community any areas germane neuroethics, are particularly interested feedback the following topics: Areas policy guidance might useful Principal Investigators Institutional Review Boards regarding emerging neuroethics issues associated neurotechnology research development. welcome responses point specific strengths weaknesses current policies suggestions how can expand and/or improve policies. evolving breadth neural data associated issues such as: should own data research participant, investigator, institution, public)? Storage data the cloud, via federated databases?) security concerns should access these data whom, quickly, how long, types data)? Privacy concerns protection discrimination those whose neural data shared Unintended uses data Special considerations associated novel neuromodulation neuroimaging technologies: Activation monitoring devices does it, is done) Responsibility the long-term maintenance such devices Security regarding telemetry data remote storage devices Potential culpability concerns regarding predictions neural data Informed consent issues, specifically pertaining studies using novel neurotechnologies Establishing greater uniformity the informed consent process participant perspective the consent process consent permits/hinders is possible technological advances Issues special populations such pregnant women, children, those physical and/or intellectual disabilities cognitive impairment to best integrate neuroethics, appropriate, workshops training opportunities when communicating neuroscience research findings to: Press Lay public Political leaders Scientific Community Translation new tools technologies neuroscience research contexts beyond clinic/bench: Ethics commercialization, public-private partnerships, wider application imaging technologies commercial purposes, conflicts interest use ex vivo human brain tissue; including ownership privacy issues Specific neuroethics questions could addressed using focused research approach Any issues respondents feel relevant to Submit Response Responses must submitted electronically through
BRAIN-info-nimh@mail.nih.gov July 29, 2016. RFI for planning purposes only should be construed a solicitation applications an obligation the part the government. The government not pay the preparation any information submitted for government’s of information. NIH use information submitted response this RFI its discretion will provide comments any responder's submission. Responses the RFI be reflected future funding opportunity announcements. information provided be analyzed, appear reports, may shared publicly an NIH website. Respondents advised the government under obligation acknowledge receipt the information provide feedback respondents respect any information submitted. proprietary, classified, confidential, sensitive information should included your response. government reserves right use any non-proprietary technical information any resultant solicitation(s), policies procedures. Inquiries Please direct inquiries to: Email:
BRAIN-info-nimh@mail.nih.gov