Notice Number: NOT-MH-16-014

Key Dates
Release Date: May 27, 2016
Response Date: July 29, 2016

Issued by
NIH BRAIN Initiative (braininitiative.nih.gov)
National Institute of Mental Health (NIMH)
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Drug Abuse (NIDA)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)

Purpose

This is a Request for Information (RFI) soliciting input to identify a set of core ethical issues associated with research involving the human brain and resulting from advancements in neurotechnology research and development.

Background

The BRAIN Initiative: The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, will show how individual cells and complex neural circuits interact in both time and space. The work is well underway (see http://www.braininitiative.nih.gov) and the application of the innovative tools and technologies will ultimately lead to new ways to treat and prevent brain disorders. NIH is one of several federal agencies involved in the BRAIN Initiative. Planning for the NIH component of the BRAIN initiative is guided by the long-term scientific plan, “BRAIN 2025: A Scientific Vision,” which details seven high-priority research areas and calls for a sustained federal commitment of $4.5 billion over 12 years.

To address current challenges and lay a more stable foundation for future generations of researchers, the NIH is seeking input from the community about opportunities and areas/topics where ethical issues related to neuroscience research might be considered. The overall aim is to integrate ethical insight into progress under the BRAIN Initiative, and proactively consider ethical implications of the research.

Information Requested

The NIH strives to maximize the impact of the taxpayers’ investments in biomedical research. Specific to this RFI, input from researchers, academic institutions, professional societies and other stakeholders is solicited on potential topics to explore where the BRAIN Initiative might invest resources in the area of neuroethics, particularly pertaining to emerging neurotechnologies. While we welcome input from the community on any areas germane to neuroethics, we are particularly interested in feedback on the following topics:

• Areas for policy guidance that might be useful for Principal Investigators and Institutional Review Boards regarding emerging neuroethics issues associated with neurotechnology research and development. We welcome responses that point to specific strengths or weaknesses in current policies and suggestions for how we can expand and/or improve these policies.
  
  
• The evolving breadth of neural data and associated issues such as:
  • Who should own the data (the research participant, the investigator, the institution, the public)?
  • Storage of data (in the cloud, via federated databases?) and security concerns
  • Who should have access to these data (by whom, how quickly, for how long, types of data)?
  • Privacy concerns and protection from discrimination for those whose neural data are shared
  • Unintended uses of data
    
    
• Special considerations associated with novel neuromodulation and neuroimaging technologies:
  • Activation and monitoring of devices (who does it, when is it done)
  • Responsibility for the long-term maintenance of such devices
  • Security regarding the telemetry of data to remote storage devices
  • Potential culpability concerns regarding predictions from neural data
    
    
• Informed consent issues, specifically pertaining to studies using novel neurotechnologies
  • Establishing greater uniformity in the informed consent process
  • The participant perspective on the consent process
  • How consent permits/hinders what is possible with technological advances
  • Issues for special populations such as pregnant women, children, and those with physical and/or intellectual disabilities or cognitive impairment
    
    
• How to best integrate neuroethics, as appropriate, in workshops and training opportunities and when communicating neuroscience research findings to:
  • Press
  • Lay public
  • Political leaders
  • Scientific Community
    
    
• Translation of new tools and technologies for neuroscience research to contexts beyond the clinic/bench: Ethics of commercialization, public-private partnerships, wider application of imaging technologies for commercial purposes, and conflicts of interest
  
  
• The use of ex vivo human brain tissue; including ownership and privacy issues
  
  
• Specific neuroethics questions that could be addressed using a focused research approach
  
  
• Any other issues that respondents feel are relevant

How to Submit a Response

Responses must be submitted electronically through BRAIN-info-nimh@mail.nih.gov by July 29, 2016.
This RFI is for planning purposes only and should not be construed as a solicitation for applications or an obligation on the part of the government. The government will not pay for the preparation of any information submitted or for the government’s use of that information.

The NIH will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. Responses to the RFI may be reflected in future funding opportunity announcements. The information provided will be analyzed, may appear in reports, and may be shared publicly on an NIH website. Respondents are advised that the government is under no obligation to acknowledge receipt of the information or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any non-proprietary technical information in any resultant solicitation(s), policies or procedures.

Inquiries

Please direct all inquiries to:

Email: BRAIN-info-nimh@mail.nih.gov