multi-colored cartoon brainThe BRAIN Initiative® is a public-private collaborative effort designed to accelerate scientific understanding of the human brain by breaking ground into new areas of study and creating new technology in neuroscience. Developing new tools and technologies requires evolving ethical standards to guide integration of these new developments into scientific and clinical practice. Due to the brain’s complexity and the unique ethical implications of studying and better understanding the brain, the NIH BRAIN Initiative established a Neuroethics Working Group to provide expert input on neuroethics and help ensure that neuroethical considerations are fully integrated into the Initiative. The Neuroethics Working Group is composed of experts in neuroscience, medicine, bioethics, philosophy, and law, and its findings are reported to NIH through the advisory councils of the 10 NIH institutes and centers participating in the Initiative.

Neuroethics is a central part of the history of the NIH BRAIN Initiative. When the BRAIN Initiative launched in 2013, the Presidential Commission for the Study of Bioethical Issues was tasked with creating an ethical framework to guide neuroscience research and the application of its findings. The Commission issued a report called Gray Matters that features a number of recommendations, including the value of integrating ethics from the beginning of any neuroscience research endeavor. The second volume of the report provides direction for helpful conversations about three complex topics at the intersection of neuroscience, ethics, and society: cognitive enhancement, consent capacity, and neuroscience and the legal system.

The NIH BRAIN Initiative strategic plan, BRAIN 2025: A Scientific Vision, also highlights several goals for neuroethics, including to develop widely shared best practices in ethical brain research and to collaborate with stakeholders in the neuroscience community on the latest considerations in neuroethics. As new information is gained about the brain and its disease states, new ways of ethically handling these breakthroughs must be developed alongside them. The Neuroethics Working Group is crucial to this mission. For example, the Neuroethics Working Group organizes workshops that provide opportunities for discussion on how to advance cutting-edge neuroscience research in the most ethical manner. Recent workshops focused on the ethical implications of research using human brain tissue and research methods involving invasive and non-invasive neural devices.

Neuroethics Guiding Principles

In the past year, the Neuroethics Working Group developed a series of Neuroethics Guiding Principles to help frame and navigate the neuroethical questions that BRAIN-funded research may raise. These Guiding Principles, published in December 2018, provide an overarching framework for integrating neuroethics throughout the NIH BRAIN Initiative. The authors “envision an ongoing, iterative process of neuroethics informing the trajectory of the neuroscience research and neuroscience research informing neuroethics. As part of this process, the Guiding Principles may evolve over time, perhaps as part of work to create a set of shared norms that extends beyond NIH.”

The Principles are:

  1. Make assessing safety paramount.
  2. Anticipate special issues related to capacity, autonomy, and agency.
  3. Protect the privacy and confidentiality of neural data.
  4. Attend to possible malign uses of neuroscience tools and neurotechnologies.
  5. Use caution when moving neuroscience tools and neurotechnologies into medical or non-medical uses.
  6. Identify and address specific concerns of the public about the brain.
  7. Encourage public education and dialogue.
  8. Behave justly and share the benefits of neuroscience research and resulting technologies.

A prime example of these guiding principles at work are the special considerations that arise with respect to brain research and informed consent. Human neuroscience research participants may be suffering from Alzheimer’s dementia, schizophrenia, depression, or other conditions which may alter a person’s cognitive functioning. Researchers may find themselves in the conflicted position of seeking informed consent from a research participant whose consent capacity fluctuates over time due to a brain disorder, while also performing procedures that may alter the brain circuit activity that underlies the ability to make decisions. The challenges of an informed consent process that allows participation of those with limited or fluctuating capacity require constant attention.

A critical point raised in the Neuroethics Guiding Principles is the importance of public education and dialogue. According to the Neuroethics Working Group, “[p]ublic trust in science is a precious commodity. To the greatest extent possible, researchers should build—and retain—that trust by keeping the public informed.” Transparency, communication, and managing expectations in the face of potentially inflated research findings – and potentially inflated concerns about ethical implications of scientific advances – is a clear priority.

Dedicated to Advancing Neuroscience Research, Ethically

The neuroethics strategy for the NIH BRAIN Initiative operationalizes the neuroethics goals from BRAIN 2025, emphasizing proactive, ongoing assessment of the neuroethical implications of the development and application of BRAIN-funded tools and neurotechnologies. In addition to the Neuroethics Working Group and the framework provided by the Neuroethics Guiding Principles, the Initiative has an internal neuroethics project team composed of program staff to ensure that neuroethics is considered throughout the grant cycle. Additionally, the NIH BRAIN Initiative funds neuroethics research, with the goal that “these neuroethics research efforts will add to the neuroethics knowledge base that we draw on to ensure that NIH BRAIN Initiative research holds to the highest ethical standards, for example, through development of new neuroethics frameworks or tools that can be used in human neuroscience research laboratories.”

Moving ahead, NIH anticipates the development of a “Neuroethics Roadmap”, created by a neuroethics subgroup of the Advisory Committee to the NIH Director BRAIN Initiative Working Group 2.0, to be delivered in June 2019. The Roadmap will review priority areas identified in the BRAIN 2025 strategic plan, incorporating updates from the broader BRAIN 2.0 Working Group, and characterize the neuroethical implications that may arise as BRAIN Initiative investments produce new technological advances and those advances are applied to advancing the goals of the NIH BRAIN Initiative. The Roadmap will help guide ongoing implementation of the Neuroethics Guiding Principles, ensuring that neuroethics remains a priority as the NIH BRAIN Initiative moves forward.


Greely HT, Grady C, Ramos KM, Chiong W, Eberwine J, Farahany NA, Johnson LSM, Hyman BT, Hyman SE, Rommelfanger KS, Serrano EE. Neuroethics Guiding Principles for the NIH BRAIN Initiative. J Neurosci. 2018 Dec 12;38(50):10586-10588. doi: 10.1523/JNEUROSCI.2077-18.2018. PubMed PMID: 30541767.

Bianchi DW, Cooper JA, Gordon JA, Heemskerk J, Hodes R, Koob GF, Koroshetz WJ, Shurtleff D, Sieving PA, Volkow ND, Churchill JD, Ramos KM. Neuroethics for the National Institutes of Health BRAIN Initiative. J Neurosci. 2018 Dec 12;38(50):10583-10585. doi: 10.1523/JNEUROSCI.2091-18.2018. PubMed PMID: 30541766.