NIH – BRAIN Initiative: Research on the Ethical Implications of Advancements in Neurotechnology and Brain Science (R01 Clinical Trial Optional)

October 30, 2018 by School of Medicine Webmaster

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. It is expected that the application of these new 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. This FOA is based on careful consideration by the NIH of the recommendations in the BRAIN 2025 Report, and input from the NIH BRAIN Multi-Council Working Group. Videocasts of the NIH BRAIN Multi-council Working Group are available at

To enable rapid progress in development of new technologies as well as in theory and data analysis, the BRAIN Initiative encourages collaborations between neurobiologists and scientists from statistics, physics, mathematics, engineering, and computer and information sciences; and NIH welcomes applications from investigators in these disciplines.

NIH encourages BRAIN Initiative applications from investigators that are underrepresented in the biomedical, behavioral, or clinical research workforce (see data at and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). Such individuals include those from underrepresented racial and ethnic groups, those with disabilities, and those from disadvantaged backgrounds.

NIH also encourages businesses to participate in the BRAIN Initiative. It is possible for companies to submit applications directly to BRAIN Initiative program announcements or to collaborate with academic researchers in joint submissions. Small businesses should consider applying to one of the BRAIN Initiative small business FOAs (

In addition to the National BRAIN initiative, the NIH continues to have a substantial annual investment in neuroscience research. The Institutes and Centers contributing to the NIH BRAIN Initiative ( support those research efforts through investigator-initiated applications as well as through specific FOAs. Potential applicants to this FOA are strongly encouraged to contact Scientific/Program staff if they have any questions about the best FOA for their research.

The BRAIN Initiative will require a high level of coordination and sharing between investigators. While this FOA does not use a cooperative agreement mechanism, it is expected that BRAIN Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings and in other activities.

This FOA is related to the Recommendations in the BRAIN 2025 report ( Specifically, this FOA solicits applications that will address recommendations from “Section III- Implementation: Goals, Deliverables, Timelines and Costs” of the Final Report regarding the “Ethical conduct of research” and “Ethical and societal implications of new technologies and scientific discoveries”.

Research Objectives

One of the defined themes in the BRAIN 2025 report is: “Considers ethical implications of neuroscience research.” Although ethical issues that are common to other areas of biomedical science also impact brain research, there are special ethical considerations unique to brain research. Considering that the brain gives rise to consciousness, our innermost thoughts, and our most basic human needs, it comes as no surprise that mechanistic studies of the brain have revealed novel social and ethical questions. With respect to research supported by the BRAIN Initiative, it is clear there are additional ethical issues in areas such as brain imaging and modulation, data privacy, informed consent, and several additional opportunities that warrant focused attention. It is clear that these critical issues should be considered both through thoughtful discussion and empirical research. Specifically, BRAIN 2025 describes the importance of “Support for data-driven research to inform ethical issues arising from BRAIN Initiative research, ideally with integrated activities between ethicists and neuroscientists.” In addition, feedback solicited through a recent BRAIN Neuroethics Request for Information underscores that the broader public and scientists alike endorse that scientific advances and technology development are well-served by thoughtful consideration of potential ethical issues.

This FOA seeks to provide opportunities to directly consider the integration of ethical issues with BRAIN-supported scientific advances. Specifically, this FOA seeks to support efforts addressing core ethical issues associated with research focused on the human brain and resulting from emerging technologies and advancements in research and development supported by the BRAIN Initiative. The hope is that efforts supported under this initiative might be both complimentary and integrative with the transformative, breakthrough neuroscience discoveries supported through the BRAIN Initiative.

While there are many ethical topics that might be suitable for leveraging an integrated research approach, input from the Neuroethics Working Group ( of the BRAIN Multi-Council Working Group and feedback from a Request For Information (RFI) on BRAIN Neuroethics has helped inform priority areas of ethics best suited for this FOA. Indeed, the BRAIN Initiative currently supports several research project grants focused on neuroethics. For this FOA, applications that focus on the following areas relevant to the BRAIN Initiative would be considered of particular interest:

  • Research on risk/benefit analyses and informed consent practices in human neuroscience research with neural devices, and long-term obligations to patient populations
  • Studies that probe the ethical implications/considerations of both collecting large volumes of brain data and the sharing of such for broader scientific purposes
  • Studies that explore the evolving richness of collected human neural data and considerations such as data ownership, access, de-identification and re-use practices, privacy, and unintended uses
  • Studies that consider the ethical implications of evolving neuromodulation and neuroimaging technologies, specifically as they pertain to the infrastructure of these technologies (activation and monitoring of devices, long-term maintenance, data security, intended and unintended use of these new technologies)
  • Studies that empirically consider different perspectives on the distinction between invasive versus non-invasive brain imaging and/or neuromodulation; particularly as those views are similar or different between groups such as participants, researchers, physicians, families, and the broader public view
  • The ethical implications of access to and use of emerging neurotechnologies and their relationship to informed consent (participant perspective on the consent process, consent with special populations, changes in consent capacity associated with disease progression)
  • Ethical issues unique to research that leverages opportunities with human brain tissue
  • Ethical issues associated with predictive/diagnostic research related to brain disorders
  • Public, researcher, and/or research participant attitudes and decision-making about monitoring or modulating brain function for purposes of improving our understanding of human brain function and/or reducing illness and disability due to brain diseases and disorders
  • Cybersecurity/privacy considerations, such as effective security and safeguards for human brain data and wireless transmissions to/from neural devices; gaps/provisions needed in existing regulatory models
  • Studies focused on the advances in neural recording and/or neuromodulation specifically for use in children
  • Research efforts to link neural data with behavioral data to better understand and/or diagnose brain diseases and disorders

All potential applicants are strongly encouraged to consult the Scientific/Research Contacts listed below to discuss the alignment of their proposed work with the FOA goals.

Deadlines:  February 4, 2019, October 9, 2019 and October 9, 2020 (letters of intent due 30 days prior to the deadline)


Filed Under: Funding Opportunities