Neuroethics Roadmap

The ACD Working Group on BRAIN 2.0 Neuroethics Subgroup (BNS) was formed to develop a Neuroethics Roadmap for the NIH BRAIN Initiative; review priority areas identified in the BRAIN 2025 (pdf, 1.2 mb) 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 tool/neurotechnologies, and/or those tools/neurotechnologies are applied to advancing the goals of the NIH BRAIN Initiative.

The BNS has conducted a portfolio review and held a public workshop on neuroethical issues posed by research through the BRAIN Initiative. The BNS would now appreciate comments from the public on draft findings and analysis detailed in a Neuroethics Roadmap. The Neuroethics Subgroup has also provided analysis and findings to the Working Group on BRAIN 2.0 for inclusion in theWorking Group’s initial thoughts. The public comment period on the Neuroethics Roadmap has closed. The findings and analysis from the BNS will be presented to the Advisory Committee to the Director, NIH, for consideration at a public meeting on Jun 13-14, 2019.




The Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative aims to revolutionize our understanding of the human brain with a priority of developing and using new tools and neurotechnologies for “... acquiring fundamental insight about how the nervous system functions through understanding circuit function from single cells to complex behaviors.” The BRAIN Initiative conveys an ethical imperative to improve human health through building an understanding of the brain and its functions. Brain disorders exert a considerable toll on human health, accounting for a substantial proportion of the world's health problems. Together, brain injury combined with neurologic, psychiatric, and substance-use disorders are a leading cause of the global burden of disease, and their incidence is expected to rise. Yet, effective methods to prevent and treat brain disorders remain limited, despite substantial investments in neuroscience research.

About this Document

In this Neuroethics Roadmap, the NIH ACD BRAIN Initiative Neuroethics Subgroup (BNS) presents its findings and analyses regarding neuroethics issues in current and potential research as part of the BRAIN Initiative. The BNS also offers some specific suggestions regarding NIH activities in the BRAIN Initiative. The BNS proposes that the Advisory Committee to the Director, NIH (ACD) recommend to the NIH Director that the NIH, specifically the NIH BRAIN Initiative, consider the findings, analysis, and suggestions in this report for integration, rather than as a parallel effort, into the BRAIN Initiative research program. The BNS recognizes that the some of their findings and suggestions go beyond the mission of the NIH or would require NIH to work with other Federal agencies and non-Federal entities and stakeholders. In those cases, the BNS proposes that the ACD recommend to the NIH Director that NIH look for opportunities to engage with broader stakeholder communities to address issues and achieve outcomes consistent with the spirit of the BNS Neuroethics Roadmap.


Brain diseases affect people across the lifespan and in every corner of the globe, exerting considerable impacts on society, which affect public health and economic stability. These  impacts are worsened through health disparities that limit availability of effective treatments to all individuals who could benefit from them. BRAIN Initiative-generated neurotechnologies and insights are transforming our capacity to understand complex spatial and temporal circuits and systems, thereby offering new hope to prevent, diagnose, or treat devastating brain diseases that rely on proper function of these circuits. 

The first 5 years of this unparalleled effort has yielded significant discoveries in all seven priority areas designated by the BRAIN Initiative’s flagship strategic plan, BRAIN 2025: A Scientific Vision (see text box above). These advances span three-dimensional maps of cell types and activity-dependent gene expression, high-speed three-dimensional imaging of neural activity, novel methods of neuromodulation, a range of sensors and probes that continue to advance ongoing discovery, among others. Powerful new modes of computational analyses and data-science methods such as machine learning offer powerful and efficient investigational tools. Although neuroscience research entails ethical issues common to other areas of biomedical science, it conveys other, unique considerations. From its beginning, the BRAIN Initiative appreciated the importance of neuroethics, as articulated in the BRAIN 2025 report:

“… mysteries unlocked through the BRAIN Initiative, and through neuroscience in general, are likely to change how we perceive ourselves as individuals and as members of society. Many of these discoveries will raise more questions than they answer. We may need to consider, as a society, how discoveries in the area of brain plasticity and cognitive development are used to maximize learning in the classroom, the validity of neuroscience measurements for judging intent or accountability in our legal system, the use of neuroscience insights to mount more persuasive advertising or public service campaigns, the issue of privacy of one’s own thoughts and mental processes in an age of increasingly sophisticated neural ‘decoding’ abilities, and many other questions. Questions of this complexity will require insight and analysis from multiple perspectives and should not be answered by neuroscientists alone.”

BRAIN 2025: 7 Priority Areas

Priority Area 1. Identify and provide experimental access to different brain cell types to determine their roles in health and disease

Priority Area 2. Generate circuit diagrams ranging from synapses to the whole brain

Priority Area 3. Develop and apply improved methods to monitor neural activity

Priority Area 4. Link brain activity to behavior through precise interventional tools that change neural-circuit dynamics

Priority Area 5. Understand the biological basis of mental processes via new theoretical and data-analysis tools

Priority Area 6. Develop innovative technologies to understand the human brain and treat its disorders

Priority Area 7. Integrate new technological and conceptual approaches produced in goals #1‐6 toward understanding cognition, emotion, perception, and action in health and disease


The role of neuroethics in the BRAIN Initiative

BRAIN Initiative research also has exciting but unknown potential to challenge the typical ways we think about life, death, each other, and ourselves. The results of neuroscience research affect what we know about how the brain produces complex thoughts and behaviors. This knowledge could reveal core mechanisms that underlie human thoughts, emotions, perceptions, actions, identity, and memories. Ethical questions and challenges are intertwined with this research, the results of which may change what many people view as consciousness, agency, and human nature. It is clear that as our understanding of the brain increases – along with the arrival of neurotechnologies to intervene with its many functions – neuroethical questions will likely emerge at every turn. These questions deserve sensitive and systematic responses, as well as development of concrete implementable goals to ensure that neuroscience research and neuroethics are tightly integrated. 

The authors of the BRAIN 2025 report also noted, “Although brain research entails ethical issues that are common to other areas of biomedical science, it entails special ethical considerations as well. Because the brain gives rise to consciousness, our innermost thoughts and our most basic human needs, mechanistic studies of the brain have already resulted in new social and ethical questions.” Recognizing the vitality of ethics to the BRAIN Initiative, the National Institutes of Health (NIH) established a Neuroethics Working Group to anticipate and recommend overall approaches for how the BRAIN Initiative might navigate ethical issues. The Neuroethics Working Group has held several public meetings and published guiding principles and other papers in the neuroethics literature. Since 2017, the NIH BRAIN Initiative has also issued specific neuroethics funding announcements and has funded neuroethics research projects.

In the recent, interim review of BRAIN 2025 (“BRAIN 2.0”), the NIH Director re-emphasized the integral value of neuroethics in the BRAIN Initiative and established a neuroethics subcommittee of the Advisory Committee to the Director (ACD) conducting this mid-course review. He charged this group, the NIH ACD BRAIN Initiative Neuroethics Subgroup (BNS) with developing a Neuroethics Roadmap (this document) and called for integration of neuroethics in future BRAIN-Initiative efforts by incorporating neuroethics principles and research opportunities into the BRAIN 2.0 report, work that is underway.

What is neuroethics and why is neuroethics important?

Bioethics involves deliberation, analysis, and research to inform well-considered ethical decisions guided by principles and values as well as notions of fairness, respect, and benefit. Bioethical principles can help guide and shape practices, institutions, implications, and social impacts of science, clinical practice, and health care. While certain bioethical issues frequently recur in biomedicine and clinical practice, others emerge anew as science evolves. Among current topics of considerable interest within the realm of bioethics are synthetic biology, gene-editing, and transplantation; many issues related to clinical research and care; and issues related to research with animals and humans.

More specifically, neuroethics is concerned with ethical, legal, and social issues arising from the conduct, application, and implications of neuroscience and neurotechnologies in a variety of contexts. These range from medical practice to research to commercial interests to society at large. The International Neuroethics Society defines neuroethics as "... a field that studies the implications of neuroscience for human self-understanding, ethics, and policy.” There are many issues important to neuroethics that are familiar and important bioethical issues. These include the responsible conduct of research, the ethics of research with humans and non-human animals, data privacy, risk mitigation, health-care access, and others. Yet because brain function is intimately connected to our understanding of identity, human responsibility, privacy, authority, agency, personhood, and normality, neuroethics is distinct from the broader topic of bioethics. Neuroethics also has an important role in sorting the opportunities and ramifications of various neurotechnologies – defined as any technology that informs our understanding of the brain and its functions, including higher-order activities like consciousness and thought. Neurotechnologies are currently being developed as both research tools (to visualize or otherwise measure brain function) and as therapies, to repair brain dysfunction. (see Chapter 3. Neuroethics and Neurotechnologies)

At two extremes, perceptions of neuroethics may appear esoteric or even punitive. Importantly, neuroethics is not a set of rules or compliance mechanisms, and its role should not be seen as limited to implementing oversight of the responsible conduct of research. Rather, fully integrating neuroethics with neuroscience offers tremendous opportunity for new research insights, inviting new fields including the humanities into scientific discourse, bringing science to people in a way they care about it – in addition to its vital role of protecting research participants and guarding against potential malign intent by rogue actors.

Neuroethics encompasses reflection, analysis, and research – to inform, enable, and strengthen neuroscience research. The intended reach of neuroethics goes beyond ethical conduct of neuroscience research, to the clinical and societal applications of this work. Neuroethical consideration frames responsible acquisition and use of knowledge about the brain and the nervous system. It also facilitates planning for – and in some cases, adjusting for the implications of – how such knowledge is applied to human health, illness, and behavior. Given the unprecedented precision of new neurotechnologies and the brain's centrality to human identity, familiar bioethics topics take on new dimensions and complexities. These include privacy, fairness, liberty, personal identity, informed consent, and moral responsibility. Neuroethics might tackle questions such as: i) which brain circuits or function influence our ability to act rationally to be capable of voluntary, intentional actions; ii) what is authenticity, and is it jeopardized when our executive function is damaged or when an implanted central nervous system device alters our interests, evaluations, or responses?; iii) when are people not responsible for their actions and behavior, and/or do certain neurological characteristics or neural devices reduce culpability for their actions?; iv) what does privacy mean in the setting of neurotechnologies, and how does one protect against possible threats to people’s innermost thoughts?; and v) how should one apply considerations of justice related to neural development, plasticity, and access to possible technological improvements. Many more questions are easily conceivable. These topics are considered throughout the chapters of this Neuroethics Roadmap, both in the context of current research and as they relate to future discoveries and technologies.

What existing ethical guidance applies to neuroethics and is there a need for more?

Multiple sources of guidance and guidelines currently inform neuroscience research; these are described briefly below and do not constitute an exhaustive analysis but rather highlight recent useful approaches to thinking about and dealing with neuroethical issues. Using these and other guidelines and methods, however, there remains a need for deliberation and dialogue, anticipating possible impacts on individuals, populations, and society (see Chapter 6. Integrating Neuroethics).

Belmont Report

Often considered a seminal source of ethics guidance, the 1978 Belmont Report, issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, is somewhat unique among ethical guidance in that it concisely analyzes three principles that underlie the ethics of research with humans (see Table 1). The report applies these principles – respect for persons, beneficence, and justice – to specific research-related activities. The Belmont principles are known for their simplicity, clarity, reach, and endurance – but they require context and balancing when applied to individual applications. They form the basis for U.S. federal regulations (both the Common Rule and Food and Drug Administration (FDA) regulations) and other ethical-guidance documents that govern protection of human research participants. Importantly, however, the three Belmont principles are not unique to clinical research – they are familiar and applicable principles in other domains, such as health care. Over time, potential limitations of the Belmont principles have been raised in light of evolving research practices and the importance of other considerations such as transparency and the impact of research on groups. This debate has led to rethinking possible additional principles for the ethical conduct of research. More recently, some have suggested the need for a set of Belmont principles specific to research with neurotechnologies and to neuroscience.


National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1978



Application to clinical research

Respect for persons

To respect, and not interfere with, the self-determined choices and actions of autonomous individuals; and to provide additional protections for those with diminished autonomy

Informed consent for enrollment and ongoing participation


To never deliberately harm another, to maximize benefits and minimize risks, and to promote the welfare of others

Analysis of risks and benefits

and determination that benefits justify the risks


To be fair in the distribution of social goods such as the benefits and burdens of research

Fair procedures and outcomes in the selection of subjects

Presidential Commission for the Study of Bioethical Issues

At the outset of the BRAIN Initiative in 2013, the Presidential Commission for the Study of Bioethical Issues was tasked to identify “... proactively a set of core ethical standards – both to guide neuroscience research and to address some of the ethical dilemmas that may be raised by the application of neuroscience research findings.” The Commission sought the advice of many experts at multiple public hearings and published two volumes entitled Gray Matters. The first recommends the integration of ethics early and explicitly throughout the processes of neuroscience research. Such integration could take several forms, such as education at all levels; institutional infrastructure; research on the ethical, legal, and social implications of BRAIN Initiative research; consultation on research ethics; stakeholder engagement; and inclusion of an ethics perspective within the research team. The second volume recognized that while some ethical issues in neuroscience are not unique to neuroscience, many become even more pronounced. Gray Matters, Volume 2 focused on three controversial and timely topics that illustrate ethical tensions and societal implications: cognitive enhancement, consent capacity, and neuroscience and the legal system, and issued 14 specific recommendations across these three areas (see text box, below).

Gray Matters Vol. 2 Neuroethics Recommendations for Neuroscience

  1. Prioritize Existing Strategies to Maintain and Improve Neural Health
  2. Prioritize Treatment of Neurological Disorders
  3. Study Novel Neural Modifiers to Augment or Enhance Neural Function
  4. Ensure Equitable Access to Novel Neural Modifiers to Augment or Enhance Neural Function
  5. Create Guidance About the Use of Neural Modifiers
  6. Responsibly Include Participants with Impaired Consent Capacity in Neuroscience Research
  7. Support Research on Consent Capacity and Ethical Protections
  8. Engage Stakeholders to Address Stigma Associated with Impaired Consent Capacity
  9. Establish Clear Requirements for Identifying Legally Authorized Representatives for Research Participation
  10. Expand and Promote Educational Tools to Aid Understanding and Use of Neuroscience within the Legal System
  11. Fund Research on the Intersection of Neuroscience and the Legal System
  12. Avoid Hype, Overstatement, and Unfounded Conclusions
  13. Participate in Legal Decision-Making Processes and Policy Development
  14. Establish and Fund Multidisciplinary Efforts to Support Neuroscience and Ethics Research and Education


In addition to the Gray Matters reports, the Commission had previously published a set of principles useful for assessing emerging technologies, appearing in New Directions: The Ethics of Synthetic Biology and Emerging Technologies. These principles are intended to illuminate and guide public policy choices to ensure that new technologies, including synthetic biology, are developed in an ethically responsible manner (see Table 2 below). They complement other sources of ethical guidance and are relevant to development and application of new neurotechnologies and BRAIN Initiative research. 

Table 2.  Principles for Assessing Emerging Technologies

Presidential Commission for the Study of Bioethical Issues 2010

Public Beneficence Responsibility to maximize public benefits while minimizing public harms
Responsible Stewardship Prudent vigilance- practical, sensible, cautious ways for assessing likely benefits, safety, and security risks both before and after projects are undertaken.  Limiting scientific projects and exploration when necessary out of collective concern for current and future people and the environment
Intellectual Freedom and Responsibility Intellectual freedom coupled with the responsibility of individuals and institutions to use their creative potential in morally responsible ways.
Democratic Deliberation Collaborative decision making that embraces respectful debate of opposing views and active participation of citizens and the public
Justice and Fairness Concern about fair distribution of the benefits and burdens across society


Nuffield Council on Bioethics

Table 3. Ethical Framework for Novel Neurotechnologies

UK Nuffield Council 2013

Foundational Principles

Beneficence- developing interventions and technologies to address suffering from brain disorders, yet

Caution- because of uncertainties and possible effects on our brains

Key Interests

Individual interests in safety, protection risks, impacts on privacy, and promotion of autonomy

Public interests in equity of access and promoting trust in neurotechnologies

 Virtues- necessary in promoting and protecting the identified interests

Inventiveness, humility, and responsibility


In Neurotechnologies: Intervening in the Brain, the Nuffield Council on Bioethics – an independent body in the United Kingdom that examines and reports on ethical issues in biology and medicine – proposed two foundational ethical principles (beneficence and caution), as well as key interests and virtues that together form an ethical framework. Beneficence is required for developing and applying therapeutic neurotechnologies because of the "... suffering caused by brain disorders and an absence of other suitable treatments,” but caution is also needed based upon uncertainty about the benefits and risks of these technologies, their novelty, and possible unexpected effects given our still-limited knowledge of brain function. In articulating implications of the two principles, the Council identified five interests warranting particular attention for individuals (for effects of treatment decisions on people’s lives) and to the public more generally. The five key interests are: i) protection of safety, taking into account risks and expected benefits; ii) promotion of autonomy, in the sense of supporting an individual’s capacity to make his or her own decisions ; iii) protection of individual privacy, bearing in mind that some devices may collect sensitive personal data; iv) promotion of equity both in terms of access to innovative products and for addressing social stigma and discrimination; and v) promoting public understanding of, and trust in, novel neurotechnologies. Finally, this Council proposed that in seeking to protect and promote these identified interests, three virtues are especially relevant and should guide the activities of all involved parties across a wide range of settings and technologies. These are: i) inventiveness (such as technological innovation) and identifying ways to enhance access; humility in acknowledging the limits of our knowledge and capabilities; and responsibility, through robust research and clinical practices and avoiding exaggeration, hype, or premature claims.

Morningside Group

Concerned that existing guidance was insufficient or not specific enough to address the complex issues presented by neurotechnologies focused upon brain-computer interfaces and artificial intelligence, a multidisciplinary team convened meetings in 2016 and 2017, which resulted in the "Morningside Group" guidance. This group of neuroscientists, neurotechnologists, clinicians, ethicists, and machine-intelligence engineers identified four major distinct ethical issues related to neurotechnologies and artificial intelligence: i) privacy and consent, ii) agency and identity, iii) augmentation, and iv) bias. They offered several recommendations to address these concerns globally, including adding "neuro-rights" to international treaties, regulating the use of neurotechnology for augmentation and military use, and regulating the use and sale of neural data.

Global Neuroethics Working Group of the International Brain Initiative

Held annually in South Korea since 2017, the Global Neuroethics Summit, a workshop hosted by the Neuroethics Workgroup of the International Brain Initiative, links global neuroethics efforts around the globe. Leveraging momentum from an international consortium of seven large-scale nation-level brain-initiative efforts, the Summit recognized the critical influence of cultural values and perspectives related to both neuroethics and neuroscience – in particular, highlighting the need for culturally informed and culturally aware neuroethical inquiry. Summit delegates have developed a set of cross-cultural neuroethics questions meant to encourage neuroscientists across various brain projects to consider neuroethical questions (NeQN, see Table 4). The questions are further discussed and applied throughout this Neuroethics Roadmap.

The NeQNs are intended to be adaptable and informed by country-relevant cultural values and frameworks, with the goal of acknowledging possible diverse understandings and values related to specific concepts and interests. For example, the need to protect brain-research participant privacy is universally important but varies in scope. Summit delegates concluded that developing a culturally informed global framework for neuroethics requires attention to inclusivity, education, and communication. These questions were used by the International Brain Initiative projects in a special 2019 neuroethics-focused issue of Neuron. While these are the first published set of neuroethics questions for neuroscientists, we anticipate that they can be further refined or expanded base on each project’s needs. BRAIN may also choose to adapt these further after deeper exploration of them in the second half of BRAIN.

Table 4.  Neuroethics Questions for Neuroscientists (NeQN)

1. What is the potential impact of a model or neuroscientific account of disease on individuals, communities, and society?

1a. Possible unintended consequences on social stigma and self-stigma

1b. Possible social or cultural biases in research design or interpretation of scientific results?

2. What are the ethical standards of biological material and data collection and how do local standards compare to those of global collaborators?

2a. Protecting the privacy of human brain data (e.g. Images, neural recordings, etc.) and data, in immediate or legacy use beyond the experiment?

2b. Special regard for brain tissue and its donors due to tissue origin and its past

3. What is the moral significance of neural systems that are under development in neuroscience research laboratories?

3a. What requisite or minimum features of engineered neural circuitry generate concern about moral significance?

3b. Are ethical standards for research adequate and appropriate for evolving methodologies and brain models?

4. How could brain interventions impact or reduce autonomy?

4a. Identifying measures to ensure optimal autonomy and agency for participants/users

4b. Responsibility for effects (where responsibility broadly encompasses legal, economic, and social contexts)

5. In which contexts might a neuroscientific technology/innovation be used or deployed?

5a. Identifying applications that might be considered misuse or best uses beyond the laboratory?

5b. Does this research raise different and unique equity concerns and, if so, have equitable access and stakeholder benefit been considered?


BRAIN Neuroethics Working Group Guiding Principles

The NIH BRAIN Neuroethics Working Group proposed eight neuroethics guiding principles as points to consider for researchers, Institutional Review Boards (IRBs), and others involved in the conduct of BRAIN Initiative-funded research (Table 5). Two overarching principles frame the eight Neuroethics Guiding Principles: i) pursuing neuroscience research is an ethical imperative because of the immense suffering and economic impact of brain disorders around the world; and ii) neuroethics is vital to and should be integrated with neuroscience research. The Neuroethics Guiding Principles are meant to guide neuroscientists, particularly BRAIN Initiative-supported researchers, to help them consider the ethical, legal, and societal implications of their work in dialogue with other key stakeholders.


 Table 5. Neuroethics Guiding Principles

Neuroethics Working Group, NIH BRAIN Initiative 2018



Make assessing safety paramount

Gene editing technologies such as CRISPR/Cas9 may offer hope for mitigating or eliminating brain disorders, yet risks and long-term effects are unknown, and there is potential for off-target effects.  When researching innovative approaches, attend to preclinical data, monitor safety throughout, and inform participants about possible unexpected safety issues. 

Anticipate special issues related to capacity, autonomy, and agency

Anticipate possible changes in preferences and agency, such as personality changes reported by some after deep brain stimulation for movement disorders; or deciding about control over stimulation parameters when brain stimulation paradigms target reward processing and motivation circuits.  Seeking informed consent from participants, while simultaneously manipulating neural processes necessary for consent capacity and autonomous choice.

Protect the privacy and confidentiality of neural data

Protecting large, shared databases containing brain imaging data, as someday a brain MRI might be as identifying as a fingerprint. Determining who has access to personally identifiable information.

Attend to possible malign uses of neuroscience tools and neurotechnologies

Researchers' have a responsibility to try to predict plausible misuses, prevent it when possible through design and security measures and ensure that participants, IRBs, government officials and others understand possible risks

Use caution when moving neuroscience tools and neurotechnologies into medical or non-medical uses

Discourage the premature widespread use or inappropriate adoption of new technologies such as neural markers of pain or deception, especially those offered directly to consumers or in non-health care settings, such as the legal system.

Identify and address specific concerns of the public about the brain

The public may worry that a beneficial improvement in ability to control a dysfunctional brain (e.g. from memory loss or seizures) has a flip-side, potentially threatening cognitive liberty. Or have justified concerns that research could “make a person someone else," or result in entities that have morally significant human-like features.  

Encourage public education and dialogue

Balancing appropriate understanding of neurological advances while avoiding hyperbole and correcting overly optimistic interpretations.

Behave justly and share the benefits of neuroscience research and resulting technologies

Identifying strategies to ensure wide sharing of the benefits of novel technologies and interventions and avoid exacerbating existing health disparities or inequalities. 



Several other important efforts are not mentioned in detail in this Neuroethics Roadmap but have been developing scientific guidance for particular neurotechnologies and contexts for their use. These include the Human Performance Enhancement Report from the American Academy of Arts and Sciences and Principles for Responsible Innovation in Neurotechnology led by policy organizations such as the Organization for Economic Cooperation and Development. This latter group has had a recent focus on neuroethics and how neuroethics might be integrated into public-private-partner led neuroscience research

Ethical attention guided by frameworks such as those listed here, accompanied by  careful reflection will continue to be essential when decisions are made about how to obtain knowledge about the brain and how to interpret it; about who uses the knowledge generated; as well as the implications of such knowledge for clinical practice, public health, other social institutions, and society. The selected frameworks, principles, and recommendations highlighted in this chapter provide guidance at multiple levels, for those who conduct, fund, disseminate, implement, and use neuroscience research.

In addition to the frameworks and principles described herein, important legal and regulatory requirements must be considered – for example, those that regulate the protection of humans

and non-human animals in research (see Chapter 2. Understanding Ourselves: The Uniqueness of Neuroscience and Chapter 4: Neuroethics and Research on Animals, respectively). Scientists testing and developing emerging technologies should consider relevant general principles from the Belmont Report as well as the Presidential Commission’s principles for assessing emerging technologies. The BRAIN Initiative’s Neuroethics Guiding Principles, the Nuffield Council’s ethical framework, the NeQNs from the Global Neuroethics Summit, and issues and ideas that may be developed, are more targeted and specific in bringing attention to particular issues that arise in neuroscience and neurotechnology research. These latter resources raise many considerations relevant to BRAIN Initiative research, including the possible effects of neurotechnologies on agency, identity, capacity, and public trust, and risks associated with augmentation, hype, bias, and possible misuse of technologies and data. As brain research develops, it is possible – perhaps likely – that new concerns will arise that require additional consideration and that may point to refining guidelines or developing new ones. Going forward, the BRAIN Initiative should be prepared to support these discussions.

Integrating neuroethics and neuroscience 

The BRAIN Initiative has emphasized the value of integrating neuroscience and cognitive science with technology and engineering, as well as encouraging neuroscience to be a boldly multidisciplinary exercise. To continue to confront challenging and emerging ethical questions arising from studying the brain, neuroethics benefits from integration with neuroscience – intentionally including scholarship from philosophy, psychology, law, theology, sociology, and other areas. Integrating a neuroethics perspective into neuroscience research design and conduct will have a powerful, positive impact on research and the knowledge it generates. Neuroethicists can help to scan the horizon and assist in anticipating and navigating ethical concerns, and they can also help guide how neuroscience research is designed, conducted, interpreted, and applied. Neuroethics should be intentionally integrated into neuroscience projects, but neuroethics research should also continue as independent scholarship that complements experimental neuroscience. Opportunities are many and include: i) seeking the advice of a neuroethicist on experimental design and details of research protocols; ii) collaborating with a neuroethicist to explore a unique ethical concern related to the implementation of an experiment or possible implications of study findings; or iii) collaborating with a neuroethicist to conduct parallel neuroethics research. Neuroethics research might be conceptual, normative, empirical, policy-related, or some combination of these (see text box below).

Types of Neuroethics Research

Conceptual (normative) neuroethics research

  • Analysis of specific concepts such as privacy or personal identity
  • Philosophical research about normative questions (i.e., what ought to constitute desirable or acceptable social behaviors?)
  • Examples: How should one define and treat people with various levels of consciousness? Does fluctuating capacity from disease, a brain injury, or a brain intervention indicate a need to rethink informed consent? 

Conceptual and normative neuroethics research may draw from existing literature and theories, as well as practices from law, philosophy, theology, and neuroscience. The October 2018 issue of the journal Neuroethics, for example, published conceptual papers on neuroscience and free will, self-governance, self-control, and decision-making.

Empirical neuroethics research

  • Systematic data collection to ascertain views, values, or practices of researchers, patients, research participants, or the public
  • May employ social-science methodologies such as quantitative surveys or qualitative interviews and could also include experimental designs to test the impact of interventions or other experimental manipulations.
  • Examples: The BRAIN Initiative has funded a number of neuroethics empirical projects.


The need for neuroethics research

Like the Human Genome Project, the BRAIN Initiative is a wide-ranging endeavor that can raise equally wide-ranging ethical, social, and legal issues. Tools and knowledge emanating from decoding the human genome transformed biomedicine dramatically. In the decades hence, individual labs across the globe – not to mention citizen scientists and children in school – have ready access to relatively easy-to-use methods to “read” DNA that have found ways to bypass regulatory scrutiny. Such access has opened many new doors of investigation, launching numerous new fields of ‘omics inquiry as well as numerous controversies. Newfound experimental access to our genome has even coined many phrases, such as the “language of life.”

Another important consequence of the Human Genome Project has been a tendency for people in many segments of society to embrace a form of genetic essentialism – some people equate “who we are” with our genes. Will the BRAIN Initiative have a similar reductionist effect on how we as humans view ourselves? Will we equate “who we are” with brain function at the expense of alternative, more relational conceptions of identity? Is society prepared?

These are not just rhetorical questions, but a call for systematic neuroethics research to learn how neuroscience will have impacts beyond the bench and how it will set new societal norms. Moreover, unlike blood samples and DNA, brain tissue and the data derived from it might be considered more sensitive given the connection between the brain and personally identifying behavior. Well-known ethical standards and practices for human research participants are in place – including institutional requirements for IRB review, data safety and monitoring, and other formal oversight mechanisms. Because modern neuroscience will continue to pose difficult ethical challenges for research with human participants, relying upon existing biomedical research ethics guidelines alone will not be adequate to contend with the aims and consequences of the BRAIN Initiative.

In summary, neuroethics is integral to the BRAIN Initiative and cannot be separated from it. Neuroethics provides an opportunity for deliberation, analysis, and research that both catalyzes, improves, and enables neuroscience. This Neuroethics Roadmap charts the way forward to maximize innovation and value from the BRAIN Initiative in a way that prioritizes benefits for humanity at large. To do so, it explains what neuroethics can offer, provides neuroethics principles and guidelines to help shape ethical neuroscience and its applications, promotes neuroethics research, and endorses integration of neuroethics with neuroscience at multiple levels, through the articulation of implementable goals.

This chapter considers the moral significance of the brain, various approaches to neuroscience, and key assumptions underlying beliefs about the brain and modern neuroscience. The chapter concludes with a discussion of the ethical frameworks needed to guide neuroscience and the BRAIN Initiative responsibly.

The moral significance of the brain

What do we know?

Identity is intimately linked with the brain. This is true both for subjective views of identity (What makes me the kind of person that I am?) and for philosophical notions of personal identity (What is it that makes someone the same person over time?). A major goal of neuroscience is understanding how activity in our brains translates into thousands of behaviors on a minute-to-minute basis. With this aspiration come goals of better understanding “who we are” and fundamental behaviors that are believed to contribute to human attributes, such as forming personal narratives for identity, exercising free will, and defining socially acceptable actions.

The brain enables our experiences, memories, agency, creativity, and ideas. These cognitive properties make human life distinctive from other forms of animal life and distinctive from one person to another. Because the brain contributes so significantly to a sense of self, the prospect of a severe and irreversible brain injury casts doubts about whether post-injury the “same person” will emerge even as the body survives. Severe injuries to other organs, even those requiring whole-organ transplants, do not usually raise similar concerns about subjective identity.

Philosophical notions of personal identity invite many questions and assertions. In Western philosophical traditions, humans are classified as “persons” by virtue of their ability to make decisions independently and rationally (a concept known as rational “agency”). Personal autonomy – one contemporary variant of rational agency – is an individual’s ability to act thoughtfully on motivations, appetites, or desires they could endorse at a higher cognitive level of self-reflection (Dworkin, 1970; Frankfurt, 1971). Put another way, an autonomous person acts deliberately according to his or her own values. Both personhood and autonomy require complex cognitive functions supported by the brain – functions which, in turn, give human existence its felt coherence. Seventeenth-century English philosopher and physician John Locke wrote in 1694 that a person is “a thinking intelligent being, that has reason and reflection, and can consider itself as itself, the same thinking thing, in different times and places.”  

Second, in addition to providing the enabling conditions for personhood and autonomy, the brain plays a crucial role in theories of personal identity. What does it mean for someone to remain the same person over time? What does it mean for person A be the same person as person B many decades later, or after a serious accident? One prevalent view of personal identity defines it in terms of the continuity of memory between person A and person B; a person is the same person only if B remembers experiences that A had. Even those philosophers who argue there is no single underlying self that remains the same across all our various stages of life nonetheless agree that people care most about the survival of their memories when faced with a catastrophic threat to the body, either sudden or gradually degenerative. Because memory depends upon the physical integrity of the brain, personal identity too seems to be intimately tied to the physical continuity of the brain.

What could we learn? Neuroethics research opportunities

One can appreciate how the effects of disease can change both subjective and personal identity. It is relatively easy to understand that severe memory loss can affect perception of self and the ability to make rational decisions; but other disease processes may also influence the lens through which a person sees the world and how that person interacts with others. In addition to effects on an individual, disease can influence the dynamics of a group – family members or support systems – and thus potentially change the identity of that group and its interactions.

As described above, the moral significance of the human brain likely derives from its role in defining personhood, rational agency, personal identity, and personal interactions – all of which are crucial for grounding our everyday moral judgments of ourselves and others. In light of these considerations, it is important to consider several assumptions that accompany this modern view of the human brain. This area is ripe for conceptual and empirical neuroethics research by collaborative teams of philosophers and others who explore these questions not only about research participants and users of new neurotechnologies and neuroscientific insights, but also involving current and future neurotechnology users.

Assumptions about the brain and about neuroscience

What do we know?

Ever since the 18th century Enlightenment period, superstitions and mystical beliefs have been progressively unseated by scientific, philosophical, and ethical rationalism. For many people, rationalism is considered to be the most significant and valuable human characteristic. For proponents of rationalism, science provides the means by which everything in the world can be demystified and catalogued – understood – from the starry heavens above to humankind itself. If humans are rational beings by nature by virtue of the structure and functioning of their species-specific brains, then to study the human brain is thus to study “ourselves” in essence. 

Like many rationalist traditions, neuroscience has a tendency to veer toward mechanistic and reductionist approaches. Mechanistic views of the brain are evident in BRAIN 2025, “The most important outcome of the BRAIN Initiative will be a comprehensive, mechanistic understanding of mental function that emerges from synergistic application of the new technologies and conceptual structures developed under the BRAIN Initiative.” It may be worth recognizing, and reconsidering, the human tendency to assume that a person and their suffering is simply a “mechanical breakdown in need of a technical fix” (as psychiatrist and medical anthropologist Arthur Kleinman rendered it. Yet, reductionistic and mechanistic research has fueled great breakthroughs in neuroscience that, in turn, improve human health by means of knowledge that transforms our understanding of disease and allows us to alleviate suffering. A careful balance between reductionism and humanism can provide a path forward, thus advancing science and gaining its benefits without reducing an individual to a series of circuits and mechanisms.

Specific words color how scientists working in different fields think about concepts. While the BRAIN Initiative acknowledges the importance of the lived experience and the need for interdisciplinary research, systematic scientific study of the brain often adopts terminology more descriptive of machines, “Synaptic connections can change strength as a result of recent activity in the circuit, meaning that circuit architecture is constantly modified by experience. A thinking brain can therefore be viewed as an immensely complex pattern of activity distributed across multiple, ever-changing circuits” (BRAIN 2025). A single scientific approach cannot reconcile individual brain-cell function with combined, system-wide activity that drives behavior in an individual. Hence, scientists must inevitably parcel study of these tasks and combine their outputs later to integrate the many dimensions of our lived experiences. Because one may never fully comprehend the entirety of the human brain and how it contributes to the identity of an individual, it will be useful to look in parallel at mechanisms as well as at influences due to cultures, societal structures, and other concepts related to the human experience. (See Neuroethics Moonshot)

What could we learn? Neuroethics research opportunities

As noted above, the various metaphors one uses to describe the brain carry practical ramifications. Taken alone, reductionistic and mechanistic approaches in brain research may fail to acknowledge the importance of cultural and other, non-brain biological systems that could be crucial to understanding brain function. It is known, for example, that sensory neurons in another organ, the gut, are hard-wired to the brain, and that neurotransmitter-producing gut bacteria may have an effect on mental health. In addition to proximal influences from within the body that may affect brain function, it is important to consider how social and cultural influences outside the body might affect brain structure and function in all its domains. Understanding behavioral or cognitive disorders may need to take into account cultural, genetic, and experiential influences. Many diverse factors can significantly influence research outcomes or applications at the levels of both individuals and populations. Given the extensive interconnectivity of neural networks that control motor, sensory, cognitive, and behavioral functions – even apparently simple motor functions may be influenced by cultural or experiential factors in ways that are not yet understood.

To what extent are psychological processes and neural activities universal or culture-specific? The vast majority of functional magnetic resonance (fMRI) studies (about 90 percent) evaluating the effects of cultural background on brain activity during cognitive processing have been conducted in individuals from Western populations using Western participants, which constitute only 12 percent of the world’s people. Given the potential for variations in neural processes between cultural groups and geographical regions, including a wide range of individuals and populations from across the globe in neuroscience research will undoubtedly enhance both rigor and applicability of the findings (NeQN3).

Neuroscientists should study the brain at multiple levels. To the extent that neurons, glial cells, and other brain cells are conceptualized as the basic building blocks of brain function, reductionist approaches will appropriately continue to guide experimentation directed at understanding molecular signaling and biophysical properties of these cells. From this focal point, one can “zoom out” to study how brain cells form integrated networks and comprise whole brain regions. Further “out” still is the study of cognitive, social, and behavioral outcomes of brain function as well as their interplay. Neuroethicists have appreciated this need for a multidimensional analysis by a broadly focused neuroscience research community.

Ethical frameworks reconsidered

Scientists can learn much about the brain through research studies involving human participants. Many experiments are acceptable in non-human animals and yield fundamental insights into basic neurobiology that provide a foundation for moving to human experimentation. But studies in humans must proceed with extra caution. New tool development ultimately hopes to enable insights into human brain function while at the same time, employing of these tools in humans should endeavor to respect the autonomy and personhood of all individuals who come into contact with these neurotechnologies. Modern neuroscience can pose difficult ethical challenges for human studies, yet redoubling people’s attention to traditional research ethics alone may not be adequate to deal with anticipated neuroethics issues. Some reconsideration of the ethical frameworks used by the BRAIN Initiative may be necessary.

Suggested steps for neuroscience research involving human participants

  • Examine neuroscience-specific ethical issues to assure that research and informed-consent processes are ethically appropriate, and that IRBs are well-informed
  • When conducting human studies with neuromodulators, including drugs, outline in detail potential end-of-trial and post-trial responsibilities
  • Report plans for managing participants who may benefit from study participation
  • For non-clinical scientists working with human research participants, include a clinician on the research team
  • Specify in advance potential psychosocial risks to potential research participants. These include changes in self-identity, effects of personality changes on interpersonal relationships, and others.
  • Consider using “real-world” samples in research whenever possible (such as including participants with co-existing conditions), to maximize research relevance and generalizability.


As with all emerging fields, for innovative neuroscience projects involving human research participants, a full understanding of risks and benefits is unknown, including human psychosocial and other non-biological risks. For example, both researchers and participants must consider the risks associated with participating in a trial regardless of the outcome. What happens after a study is over? Due to the innovative nature of tools and neurotechnologies, study participants may not have continued, affordable access to the technologies used in the study – potentially returning them to their pre-study self but knowing that the technology provided a successful treatment that is unavailable to them. Researchers have an ethical responsibility to develop detailed protocols regarding if and how they will handle post-study follow up for participants who benefit from an experimental treatment and for those who don’t benefit, and have candid discussions with research participants about the often-overlooked physical and psychological risks associated with a successful intervention.

Furthermore, the BRAIN Initiative ultimately strives to understand nondiseased brain function, but researchers are limited in what they learn from typical study populations – even when healthy controls are included in research designs and data analyses. Researchers and regulators will inevitably see tensions as proposals seek to study healthy brains, and as risk/benefit ratios for healthy volunteers shift. These are difficult ethical challenges, but they can be tackled through systematic analysis of emerging technologies paired with innovative rubrics for evaluating risk-benefit ratios in research. These important conversations should involve both conceptual research of ethical, legal, and regulatory guidelines and stakeholder views about risks and benefits in neuroscience research, and apply guidelines and lessons learned from other fields of research.

Implementable goals:

  • Given the potential for characterizing core characteristics of human brains as well as variations in neural processes between cultural groups and geographical regions, neuroscientists should include a wide range of individuals and populations from across the globe in neuroscience research in order to enhance both rigor and applicability of the findings.
  • Although not unique to neuroscience, nomenclature is ever important. Efforts should be made to clarify concepts such as consciousness, empathy, and free will, as these are not always used to impart the same meaning in neuroscience research. Even hypotheses that attempt to explore human difference based on socially constructed identities such as race and gender must be carefully examined to avoid replicating and even enhancing already damaging biases in society.
  • Interdisciplinary research teams can help facilitate exploration of how assumed meanings and socially constructed identities influence how studies are designed and how results are interpreted.  As we gain deeper insights about early disease stages – for example, pre-symptomatic markers indicating atypical circuitry – will the distinction between “typical” and “atypical” shift? Such an integrated approach involving neuroethics and neuroscience is within the purview of the BRAIN Initiative.

These questions are ripe for conceptual and empirical neuroethics research.

Finally, the BRAIN Initiative may need an additional ethical approach that goes beyond simply reinforcing the wheel of human-subject research ethics. That is, a separate ethical framework might be necessary to address issues that go beyond the ethical design, conduct, and oversight of particular neuroscientific research protocols. Why is this?

Consider the metaphor of the “moonshot” that often frames the discourse around the BRAIN Initiative. The original Moonshot – the United States Project Apollo mission that landed a human on the moon in 1969 – is widely heralded as a great triumph and is often cited as an example of what American science can achieve under the best circumstances of dedicated effort and focused funding. But it is easy to forget that the Moonshot was a very controversial program in its day. It involved enormous financial expenditures and the diversion of resources from other pressing social needs. It even cost the lives of three astronauts who volunteered for the Apollo 1 mission. And it was never certain it would ever succeed. The moonshot, and all other metaphorical moonshots thereafter, heighten the need for an ethics framework that can operate at the level of large, government coordinated scientific initiatives. What would such an ethical framework look like?

An overarching ethical framework for the BRAIN Initiative should place the principles of social beneficence and distributive justice front and center. While the BRAIN Initiative aims to expand knowledge, its moral worth derives not from the intrinsic value of new knowledge, but from the ways in which that knowledge can be used to improve the human condition. Social beneficence is implicit in the consequentialist moral justification for science. What would it mean therefore for the BRAIN Initiative to fulfill its social obligation of beneficence? There are open questions involving what counts as relevant social benefits, who bears the duty of providing and distributing these social benefits, to whom such benefits are owed, and how far this duty extends. The questions of “what,” “who,” “to whom,” and “how far” are crucial and have not been adequately addressed in the BRAIN Initiative. An ethical framework that elicits, engages, and provides reasonable answers to these difficult questions is necessary. This new ethical framework might also have to address the threat of cultural and other social biases that may become reinforced by the BRAIN Initiative.


The BRAIN Initiative is dedicated to revolutionizing the world’s understanding of the human brain through the development of tools, methods, and knowledge bases that will advance fundamental understanding of brain function – with a particular focus on circuit-level analyses. This work is expected to lay the groundwork for a dramatically enhanced understanding of ways in which the brain can be coopted by disease, as well as provide new frameworks for effective interventions and therapies to treat brain disorders. However, as new neurotechnologies are developed, and new insights into the mechanisms of brain function and disease are discovered and refined, there is an obligation – and an opportunity – to continually consider, anticipate, and address potential neuroethical issues that may arise. In this way, neuroethics may be used not to impede, but to advance the ability of BRAIN research to have the greatest societal impact.

The first 5 years of the BRAIN Initiative saw progress in each of its designated research Priority Areas, some resulting in exceptional and unexpectedly rapid knowledge growth. BRAIN 2.0 will likely see significant advances in integrative strategies cross-cutting these Priority Areas, building upon groundwork laid during BRAIN 1.0.

 Table 6. Neuroethics Questions for Neuroscientists (NeQN)

1. What is the potential impact of a model or neuroscientific account of disease on individuals, communities, and society?

1a. Possible unintended consequences on social stigma and self-stigma

1b. Possible social or cultural biases in research design or interpretation of scientific results?

2.  What are the ethical standards of biological material and data collection and how do local standards compare to those of global collaborators?

2a. Protecting the privacy of human brain data (e.g. Images, neural recordings, etc.) and data, in immediate or legacy use beyond the experiment?

2b. Special regard for brain tissue and its donors due to tissue origin and its past

3. What is the moral significance of neural systems that are under development in neuroscience research laboratories?

3a. What requisite or minimum features of engineered neural circuitry generate concern about moral significance?

3b. Are ethical standards for research adequate and appropriate for evolving methodologies and brain models?

4. How could brain interventions impact or reduce autonomy?

4a. Identifying measures to ensure optimal autonomy and agency for participants/users

4b. Responsibility for effects (where responsibility broadly encompasses legal, economic, and social contexts)

5. In which contexts might a neuroscientific technology/innovation be used or deployed?

5a. Identifying applications that might be considered misuse or best uses beyond the laboratory?

5b. Does this research raise different and unique equity concerns and, if so, have equitable access and stakeholder benefit been considered?


In this chapter of the Neuroethics Roadmap, we employ the structure of these scientific Priority Areas for BRAIN as a framework for identifying companion neuroethical issues and neuroethics research opportunities. Identifying neuroethics issues is often not an intuitive process for neuroscientists. In anticipation of such issues it is useful to align scientific progress of BRAIN with the previously derived Neuroethics Questions for Neuroscientists (NeQNs), developed by consensus at the Global Neuroethics Summit (see Table 6) in collaboration with many large-scale brain research efforts including members of BRAIN. As described in Section 1 of the Roadmap, these NeQNs can help focus attention on potential neuroethical issues and research opportunities that can then be judiciously addressed. To illustrate this rubric for the identifying neuroethical issues, the anticipated scientific advances highlighted in this section of the Roadmap will be cross-referenced with NeQNs that may be useful in eliciting any associated neuroethical concerns. As well, the frontier nature of neuroscience research also presents challenges related to unintended consequences deriving from their novelty including for example appropriate informed-consent procedures when it is impossible to quantify unintended consequences of controlling brain circuits, it is important to view neuroethical issues in context of the Neuroethics Guiding Principles (see Table 7) which can also be informed by the NeQNs. The principles offer a framework for prioritizing values and for ethical guidance for the conduct of BRAIN research including new technology development.


 Table 7: Neuroethics Guiding Principles


  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


Priority Area 1. Discovering Diversity

What do we know?

This BRAIN 2025 goal aims to develop a systematic and detailed understanding of the genetic, morphological, and physiological characteristics of different cell types throughout the nervous system as well as their potential roles in brain processes. Achieving this goal will permit development and use of genetic and molecular tools to identify cells – and ultimately, modulate their behavior in specific brain areas and circuits. This aspect of BRAIN 1.0 has been very successful, greatly expanding our knowledge of the number and diversity of cell types in the brain of different organisms, while also enabling us to quantify differences and likenesses between organisms.

What could we learn? Neuroethics research considerations

The rapid growth of technologies for gene editing (e.g., CRISPR), creating better viral vectors, tissue processing, imaging, and in-situ analysis of cells suggest that researchers are on the cusp of identifying and selectively modifying specific cell types, genes, or proteins in living systems. As research using models of human neural circuitry becomes more sophisticated, questions will arise about the appropriate boundaries for cell-type based manipulations that involve nonhuman animals, in particular (cite NHP genetic manipulation work) (see Chapter 4. Neuroethics and Research with Animals) as well as how increasingly sophisticated engineered neural circuitry and systems may challenge how we morally consider them (NeQN3).


Neuroethics Research Opportunity

What are the requisite or minimum features of engineered neural circuitry required to generate a concern about moral significance? (NeQN3a)

Collaborative research involving scientists, philosophers, and ethicists can define, create systematic approaches in conceptual and empirical work, and analyze testable measures of neurally derived features that would cause tension for donors, scientists, and members of the public. Importantly, exploring these ethical perspectives from a variety of stakeholders should incorporate multicultural research design and dissemination of information. The work should also explore the global relevance of these neuroethical considerations.


Research samples

Aside from general issues noted above, the origin of samples obtained for BRAIN Initiative-funded work invokes questions about the nature of the samples, applicability and privacy. Related to the former, initial work on discovering and characterizing cell types should not focus on a single species, or one societal group or sex or race or age, ensuring that bias is mitigated, and that the benefits of neuroscience research can apply to individuals from numerous populations (NeQN1b). Related to privacy, consent from individuals who provide tissues, either while alive or after death, should address the long-term consequences of such a donation for themselves and their relatives. These issues should be addressed within the informed-consent process and on a continuing basis should unintended information be derivable from these tissues such as stigma or broader application (NeQN1b, NeQN5b, Guiding Principles 3, 8). Important to note that in an era of data sharing, it may be the legacy use of the data derived from the sample, rather than just the tissue itself that warrants privacy consideration (NeQN2a). Further, as research models evolve, they may warrant additional scientific and ethical review: At what point should in-vitro or ex-vivo human cells or samples be considered to warrant greater moral significance or revised research standards? These issues raise neuroethical questions about moral significance that should not only involve scientists and ethicists, but also incorporate how to address concerns the general public may have (NeQN3a,b, Guiding Principle 6).

Cell/tissue manipulation

This cell-census component of the BRAIN Initiative raises familiar ethical, legal, and social implications that have already emerged from genomic research; for example the ability to introduce whole genes into cells warrants forethought about the resulting effects on function (e.g., on circuits, both in the recipient individual but also in later generations) (NeQN5a, Guiding Principle 1). However, there may be unique considerations with manipulations that alter brain function. Along with decisions on which cells should be targeted (healthy or diseased), a framework will be needed to revisit aspirations for these methodologies and what distinguishes restoring cognitive health versus enhancing cognitive function or altering learning and memory (NeQN1a, NeQN5, see also CHAPTER 5: BEYOND THE BENCH: REAL-WORLD TRANSLATION OF NEUROSCIENCE RESEARCH). The ability to manipulate cells and tissues may enable researchers to understand more about cell identity – and in time, perhaps individual identity. How does this bear on privacy for not only individuals who participate in studies, but family members as well? (NeQN2a, Guiding Principle 3).

Priority Area 2. Maps at Multiple Scales

What do we know?

This BRAIN 2025 research area is focused on developing detailed knowledge of the structural and functional spatial representations of activity and interconnectivity within the brains of different model organisms, at scales ranging from individual synapses to large-scale connectivity of human brain regions. This project has supported the development of significantly enhanced methods for generating structural and functional maps from ex-vivo and living brains in species ranging from worms and flies to humans. Although improvements to non-invasive human-brain imaging technologies during BRAIN 1.0 have been incremental, technologies such as fMRI are improving in speed and signal-to-noise ratio. Moreover, portable, near-infrared spectroscopy can already provide non-invasive readouts of brain activity in social settings (and portable PET and MRI systems are in development). These enhanced imaging methods, combined with studies across species, could soon reveal functional activity and connectivity patterns that may potentially be interpreted in terms of the capacity for thought, mood states, behavior, and personality – directly from physical observations of the human brain. As described in the BRAIN 2025 report, an eventual goal is to discover how the human brain produces cognition and behavior at the “speed of thought,” information that could inform how people make decisions that form the basis of personality and self. The wider availability of such techniques for human use may prompt non-medical, commercial, consumer, or judicial use of such technologies and care will be needed to determine which contexts technology or innovation can be justly deployed (NeQN5, Guiding Principle 8; see Chapter 5: Beyond the Bench: Real-World Translation of Neuroscience Research).

What could we learn? Neuroethics research considerations

In this Priority Area, similar neuroethical considerations apply to those detailed in the Discovering Diversity Priority Area related to sample selection and use, along with the need to protect information that could plausibly be extracted from tissues donated by human research participants or patients. Distinct in this Priority Area are neuroethical questions related to mapping studies. For example, currently, transcranial direct current stimulation is being used in non-medical, non-research settings toward improving neurological performance. Such issues are not directly within the scope of current BRAIN Initiative-funded research, but they are relevant to consider as federally funded research finds application in everyday life (see Chapter 5: Beyond the Bench: Real-World Translation of Neuroscience Research, NeQN5, Guiding Principle 5).

A pervasive challenge with all research involving humans is defining “normal” in the context of health and disease, but also in the context of human variation and individual identity and personality. Scientific studies in nonhuman and human animals using male-only samples have sometimes generated incorrect general assumptions resulting in adverse health consequences or reinforced negative biases about socially constructed groups already present in society, These factors should be taken into consideration to ensure that large-scale studies to understand the brain’s maps and networks both sample from (and can thus benefit) a fully representative cross section of our society. Communication and use of the results of such studies should also be carefully managed to ensure that the design of experiments and interpretation cannot be subverted to fuel existing negative societal biases or prejudices (NeQN1a,b, Guiding Principle 7).


Neuroethics Research Opportunity

How can human brain data (e.g., images, neural recordings, etc.), and the privacy of participants from whom data is acquired, be protected in case of immediate or legacy use beyond the experiment? (NeQN2a)

There is an opportunity for collaborative study about the scientific capabilities of BRAIN Initiative research as well as consideration of legal definitions and historical and evolving public views about neuroprivacy. Part of the assessment of public views could involve exploring new types of informed-consent processes, in particular, for research involving neural recordings. Other projects could explore and assess best practices for community engagement and communication strategies with neuroethical issues on stigma, bias, and privacy. Cultural views across and within cultures and geographic regions will provide greater insight into such technologies might be received and used within a global landscape.


Priority Area 3. Brain in Action

What do we know?

This BRAIN 2025 research area aims to identify and understand neural activity patterns that underlie cognitive processing and behavior. The BRAIN Initiative has supported many recent advances enabling recording and modulation technologies that are to be used in non-human animals. Studies are now deploying new technologies for large-scale recording of multiple variables (including neural activity and neurotransmitter concentrations) within non-human animals engaged in complex tasks or more naturalistic behaviors compared to previous anesthetized or head-fixed activities. A parallel area of significant growth has been the application of machine vision and deep-learning approaches to large-scale quantification of non-human animal behavior – from counting the number of times a fruit fly grooms itself in a dish to tracking the paws and whisker movements of a mouse during real-time brain imaging. While much of this work and preliminary insights are from nonhuman animals, the aspiration is to expand these abilities, with greater precision and to larger numbers of recorded neurons, including novel non-invasive imaging technologies, into humans.

What could we learn? Neuroethics research considerations

New combinations of brain activity and behavioral data are beginning to enable development of models and theories that can depict and reproduce the brain’s computational codes that lead to complex behaviors. In this Priority Area, similar neuroethical considerations about potential for bias and stigma as well as neuroprivacy apply as detailed in Priority Area 2. Maps at Multiple Scales. One distinguishing feature is the issues around developing non-invasive brain recording devices.

Wearable human-brain imaging technologies are permitting brain to behavior correlative studies in humans. Knowledge emerging from these studies could allow us to assess mood states, behavior, and personality directly from physical observations of the brain, or even from assessment of physical behavior in different environments. Therefore, the same careful considerations will be needed related to risks of reinforcing bias by dividing participants along socially constructed identities as well as with privacy (NeQN1b and NeQN2a). Wearable neurotechnology is not only an interest of biomedical researchers, but it is already an area of active exploration in the commercial sector as a wellness or cognitive enhancement tool. While not the intended context for BRAIN research, insights from BRAIN will likely extend beyond the BRAIN community and its mandate. Ethical stewardship of studies exploring “brain in action” maps of designated ‘normal’ and ‘abnormal’ brains, particularly as they relate to mental health as well as implications for enhancement will require considerations of privacy and best uses and possible restricted uses beyond the biomedical setting (NeQN5 and Guiding Principle 5). To be clear, the weight and responsibility of this is not work for the neuroscientists alone. These questions of uses “beyond the bench” are best explored as a multi-stakeholder project. (see box). In addition, performing best ethical practices also relies on mechanisms and infrastructure to support the scientists’ ability to do so.


Neuroethics Research Opportunity

In which contexts might a neuroscientific technology/innovation be used or deployed? (NeQN5)

Ethical stewardship of neuroscience and its products requires a scientist’s involvement in anticipating best uses and possible misuse. However, to identify frameworks for best use and misuse, research should involve an anticipatory approach scanning the horizon for possible contexts for use in the near and intermediate future as well as exploring existing ethical and legal guidelines with a diverse set of stakeholders including end users, consumers, scientists, ethicists, legal scholars, as well as members from the policy community. Importantly, the exploration of this anticipatory work should include a global community who may have differing values and priorities for the use of such research findings and developments that may be at odds with national views and policies.


Priority Area 4. Demonstrating Causality

What do we know?

This BRAIN 2025 research area aims to test our understanding of the brain through perturbations that lead to predictable outcomes (cause and effect). This research encompasses technological development and refinement of experimental methods such as optogenetics that permit specific cells within the brain to be turned on or turned off or chemogenetics that enables pharmacological manipulation of specific cells– enabling evaluation of the immediate and long-term effects of these perturbations on brain function or behavior. A direct analogy in humans is deep-brain stimulation used to alleviate Parkinson’s tremors. As techniques for performing manipulations of brain-cell activity become more refined, selective, and deployable, our understanding of how such manipulations affect brain function and behavior is also becoming more sophisticated. At the heart of this priority area is the development of interventional technology that can manipulate the brain for desired behaviors with an ultimate goal that insights will provide ways to relieve unwanted brain function and behaviors that arise from brain diseases such as mental illness or degenerative disease. In order to ensure that such insights and abilities to intervene with the brain result have the greatest impact for alleviated suffering, careful consideration should be made of how such interventions may intentionally or unintentionally impact or reduce autonomy, capacity, and agency (NeQN4, Guiding Principle 2).

What could we learn? Neuroethics research considerations

Unknown consequences of manipulation.

Although physiological manipulation of cells and tissues is currently a valuable tool for neuroscientists seeking to understand brain circuits in non-human animals, and in some cases in humans, these techniques hold significant potential for therapeutic use. For example, they could also be used to intentionally augment, restore, and/or redirect brain function (see Priority Area 6, below). Current genetically targeted methods of brain-cell manipulation such as optogenetics require genetic modification of a non-human animal through breeding or viral transfection, as well as delivery of intense light to the location requiring “activation.” Other technologies such as chemogenetics also require genetic modification of specific cells but then only require systemic drug delivery for activation. While most researchers do not envision this technology being used in humans, similar genetic therapies are being explored (including optogenetics in the eye as a treatment for blindness). What is more likely in humans are invasive studies including deep brain stimulation, multi-electrode array recordings from the surface of the brain, and noninvasive stimulation such as ultrasound and transcranial magnetic stimulation. With any of these technologies, the aim would be to manipulate or control the brain in a way that a patient or participant could not do on their own. In other words, there’s a challenge to the user’s autonomy and agency. Therefore, at times, there may be a need to explore how measures can be put in place to ensure an optimal level of autonomy and agency for users (NeQN4, Guiding Principle 2). Part of this discussion should involve exploration of how measures for override or user control of stimulation parameters can be offered to users that would be not only beneficial and desired by participants, but also balanced with what scientists understand are optimized parameters for use in treating particular aspects of disease. Further, considerations for safeguards from hacking or misuse as well as understanding of who takes ultimate responsibility for ongoing support for the technology beyond the lifetime of a research project and unintended consequences of device use will also maximize technologies developed under this priority (NeQN4b, Guiding Principle 4).


Neuroethics Research Opportunity

Debate about cognitive enhancement has been active for many years. See, for example, The President’s Council on Bioethics. Beyond therapy: Biotechnology and the Pursuit of Happiness. Deeper exploration is warranted about the scientific possibilities and limits of today’s and tomorrow’s neuroscientific advances – and the conceptual separation between therapy and enhancement. Collaborative research involving scientists, ethicists, legal scholars, and practitioners exploring evolving societal definitions of disease and aspirations for wellness as well as research involving ethical and legal standards in this space on a global scale are needed. These conceptual ethics approaches can also be complemented by public engagement research exploring public awareness, opinions and assumptions about neuroscience and enhancement. One significant question to explore with regard to neurotech development in this space is: Does neuroscience raise different and unique equity concerns and, if so, have equitable access and benefit of stakeholders been considered? (NeQN5b)


Risk analysis

Research is needed to understand the unique health and safety risks, as well as potential unanticipated consequences of an intervention, on a person’s autonomy, capacity, and agency including those related to altering features of personality and memories (NeQN4a, Guiding Principles 1,2). In addition, a valuable part of this risk analysis might include comparisons of newly developed BRAIN intervention with existing ones and even re-evaluation of older ones based on new insights derived from research in BRAIN. A better understanding of how existing interventions, even psychostimulants, affect the brain, acutely and long-term, is sorely needed and should represent a backdrop for considering the advantages and disadvantages of new interventions. It may be that focal interventions are safer than pharmacological interventions in terms of side effects. Importantly, features of ‘risk’ should include not only physical harms, but also social ones. Given the potential complexity of the effects of interventions on autonomy, agency, and capacity, neuroethical research combined with scientific efforts could help sort out what participants and scientists understand about these terms and how they evaluate their importance in the context of these interventions. Because participants may have difficulty understanding the unique risks that result from manipulating circuit function, informed consent processes may warrant deeper review (NeQN4, Guiding Principle 2).

Neuroethics Research Opportunity

Can neurotechnology be designed with technological safeguards that enhance an individual’s autonomy, or that protect negative impacts on his or her agency? (NeQN4)

Such research should involve a mixed team of scientists, ethicists, and future end-users. Collaborative research evaluating current societal, ethical, legal meanings of responsibility when technologies function well (or when they do not) could help inform new best practices and guidelines for this type of research. Approaches would include conceptual work on understanding divergent and shared meanings for these terms for stakeholders as well as empirical work assessing understanding, values, and preferences in BRAIN-Initiative funded research.



Priority Area 5. Identifying Fundamental Principles

The BRAIN 2025 report identified a central role for data analysis, theory, and modeling for the purpose of extracting information from data sets, and for developing conceptual and algorithmic frameworks for interpreting circuit dynamics underlying key brain processes like sensory processing, motor control, and decision-making. As noted above, such work will ultimately provide the conceptual backbone for interpretation of data and ultimately understanding of how the brain functions and malfunctions. Neuroethical issues and research in this Priority Area overlap with those described in the other Priority Areas, above, and is not repeated here. However, data sharing is a key element associated with this Priority area, as elaborated further below, sharing raises ethical concerns familiar to any field which collects large datasets, but also could raise a greater degree of tension due to the potential sensitivity of brain-based data.

Data sharing

Large amounts of data are required to enable development and testing of theories and models. However, the imperative for experimentalists to share their data – and the need for others to mine and extract information from highly complex, multi-dimensional and multi-modal data – presents significant challenges and has a topic of significant discussion among scientists. Data sharing – including analyses, algorithms, and shared access to infrastructure – is an essential component of open and equitable science. It is also a hallmark of rigorous and ethical research. While many of the challenges related to data sharing are technical, just as significant are the social and cultural challenges, i.e. convincing a profession that relies on the currency and attribution of peer-reviewed publications to openly share data without the guarantee of “credit” raises tensions in any discipline. Therefore, there are legitimate concerns of scientists that must be addressed in addition to the need to provide support and incentives to engage in data sharing.

Neurotechnologies continue to become more sensitive, more robust, more portable, and multimodal. The proliferation of neuroscience into society offers great promise for new insights and improved social policy. But with these dramatic and rapid shifts come difficult ethical questions about the collection, interpretation, application and access of scientific data. A key component to this Priority Area is the aggregation of data collected across large numbers of non-human animals, humans, labs, and institutions.

NIH has several data-sharing policies, as does the BRAIN Initiative itself. These policies have been implemented in multiple ways, including developing a central repository for data, standardized analysis procedures, and policies for data sharing. Responsible data sharing promotes equity, whereas exclusion of data can lead to knowledge confined to a limited group of individuals. Purposeful exclusion of data may lead to hypotheses that reinforce previously held biases (NeQN1b).

Brain data come in many formats, including measurements from genetic, genomic, protein, functional, imaging, and behavioral analyses. These different data types are usually compiled into specific databases with specific standards. As the need for integration across data types and platforms evolves – a key goal for BRAIN 2.0 – it may be necessary to revise data-sharing policies to encompass the widening utility of the data. For human data, participant-privacy issues have always been paramount, primarily with regard to identity. We consider human brain data different because of its potential to gain insight into an individual’s thoughts and other aspects of an individual. As the BRAIN Initiative moves ahead (and neuroscientists work across the globe outside of the BRAIN Initiative), increasing amounts of data will accumulate from diverse experimental approaches that will likely be more individually precise – and potentially more identifiable. We need to understand more about public awareness and concern about brain privacy (see Chapter 5: Beyond the Bench: Real-World Translation of Neuroscience Research, NeQN2a).

Should all brain data be shared?

When neuroscience data are used to investigate brain function, ethical use of the data requires i) noting its source; ii) insuring that it was properly obtained according to ethical guidelines and university, company and/or local, national, or international statutes; iii) using only the subset of data required to query the question of interest; and iv) properly acknowledging the data source. However, there are circumstances that may preclude universal data sharing. These special circumstances include, for example, when a research participant’s identity could be compromised from combining that individual’s composite datasets, which was neither envisioned nor specified in the informed-consent process.

Neuroethics Research Opportunity

What are the ethical standards of biological material and data collection and how do local standards compare to those of global collaborators? (NeQN2)

The Human Brain Project has produced a report on data sharing, privacy, and practices moving forward as informed by exploration of conceptual analyses of privacy, public opinions on privacy, as well as technical and legal analysis. Not only does this represent the type of interdisciplinary work that BRAIN’s neuroethics research should strive to do, they represent a rich opportunity for collaboration. Their current activities related to the ethics of data sharing align with similar goals of the BRAIN Initiative and could provide a fertile ground for research on best practices for neuroethics research, neuroscience data collection, and public engagement. International collaboration and active dialogue about these practices will also be critical as much of these data sharing practices occur on a global backdrop and will require deeper reflection of the ethical standards of data collection nationally and how these compare to those of global collaborators (NeQN2).


Big data practices as well as data access have transformed the possibilities of the applications of data and what kinds of information can be derived. The purpose of big data analytics is to create new unanticipated knowledge and in so doing, appreciating what information can be derived from data and anticipating risks is a significant challenge. One way to address this issue is to have routine review in collaboration with scientists, data analysts and ethicists to evaluate how new analyses might open new opportunities for risk, particularly of re-identification.

While IRB approval is an important practice for conducting research with human participants, IRBs are not uniform in considering the special circumstances associated with BRAIN Initiative-derived data. In cases where collecting brain data is the goal of an experimental protocol, local IRBs should obtain neuroethics input, thereby ensuring that the consequent data have been vetted for these concerns. As the data become more complex as a result of combining different data types, more information about human participants including unintended data disclosure will be decodable. Anticipating the impact of the availability of these data is difficult and will likely pose new neuroethical concerns. Given this changing data and analysis landscape, it would be prudent for institutional and Office for Human Research Protections (OHRP) IRB guidance to be revisited on an ongoing basis to insure that current guidance sufficiently protects the participant, and if not, then new guidance should be proffered to deal with the associated issues. 

International collaboration and active dialogue about these practices will also be critical as much of these data sharing practices occur on a global backdrop and will require deeper reflection of the ethical standards of data collection nationally and how these compare to those of global collaborators (NeQN2).

Neuroethics Research Opportunity

What are the possible unintended consequences of neuroscience research on social stigma and self-stigma? Is it possible that social or cultural bias has been introduced in research design or in the interpretation of scientific results? (NeQN1)

Develop practices to enhance inclusiveness and reduce bias. Studies should be designed to investigate the impact of many variables on brain function, including but not limited to, sex, race, and cultural experiences. Explicit attention should be given to questions about who will benefit from neuroscience research advances, and how to promote equitability across these and other important domains. Neuroethical deliberation is necessary and requires thoughtful input beyond neuroethics alone – including, for example, experts in sex/gender differences, cultural and societal differences, disease advocacy, and other topics related to human variation.


Priority Area 6. Human Neuroscience

This BRAIN 2025 research area aims to develop innovative technologies to understand the human brain, with the ultimate goal of treating its disorders. In this Priority Area, new technological and conceptual approaches are integrated and applied to discover how dynamic patterns of neural activity become cognition, emotion, perception, and action in both health and disease. Such neurotechnologies can be used to monitor the brain to understand details of how it works in health and disease, as well as to design neurotechnologies to treat brain dysfunction. Currently, there is nothing that replaces the human brain as a model for understanding high-level complex outputs of the brain such as cognition. While human studies are conducted judiciously, studies in humans are often considered the most ethically complex (see Chapter 2. Studying Ourselves: The Uniqueness of Neuroscience)

What could we learn? Neuroethics research considerations

Human samples and recordings

Most human brain samples (and invasive recordings) come from diseased brains in which intervention has been warranted, or after the individual has died. Neuroethical research should examine how to define acceptable ways to acquire tissues and measurements from healthy brain tissue that can provide valuable and necessary control information (NeQN1a). Additional studies can explore how to coordinate efforts between researchers (including internationally) to ensure that large-scale census type work spans sufficiently diverse populations to ensure equitable benefit (NeQN1b). Other topics for consideration include the potential need for guidelines pertaining to use of human cells in the context of multicellular assemblies such as organoids and assembloids that, as the complexity increases, may attain moral status (NeQN3 as mentioned in Priority 1 and Chapter 2: Studying Ourselves: The Uniqueness of Neuroscience).

Noninvasive recording and imaging

The ability to perform non-invasive neuroimaging presents a number of areas of potential neuroethical concern, including: i) unexpected access to incidental findings; ii) detection of clinical biomarkers of latent or impending disease; and iv) use of neuroimaging for national security, legal, and marketing activities. Imaging for clinical biomarkers is becoming more common, and it will likely be combined with self-reports and expert observations to better evaluate clinical state. Neuroethical research could explore the ethical consequences when neuroimaging results diverge from what an individual research participant or patient experiences and what his or her provider gleans from the technology. Other questions surround decision-making related to data sharing and how that may differ among disease contexts (e.g., concussion vs. depression, NeQN1a). Another scenario to consider might be the prospect of identifying the potential to develop disease – such as Alzheimer’s – decades before symptoms appear. This may have implications for employment and insurance coverage, for example (NeQN1a).

Both implanted electrodes and noninvasive approaches that generate behavioral and neural recordings may uncover decodable information that can create privacy violations for an individual and at times family members as well. As discussed in Priority Area 3, these potential risks raise questions about appropriate use, sharing, and protections for data beyond its first use in an experiment. Importantly participants must have the knowledge and realistic expectations for de-identification in order to consent to providing their data. This is particularly important as technology and decoding algorithms as well as coupling with other experimental modalities may advance to the point that it may be possible to interpret brain states without a research participant’s permission (NeQN2a and discussed above in Priority Area 3). Importantly, algorithms, which may be assumed to be objective, should be explored and acknowledged for the possibility of carrying the inherent and unrecognized biases of their creators (NeQN1b). 

Noninvasive neuromodulation

Invasive human recording and modulation

Brain-computer interfaces are already in widespread use; the work of the BRAIN Initiative will accelerate their development and the precision with which they can influence brain function. One current example is use of deep-brain stimulation to shorten or block seizures. New technologies under development will likely have the capability to monitor neural or neurotransmitter activity over long periods of time and to provide detailed patterned stimulation in a closed-loop (operator-independent) manner. This means that monitoring and manipulation occur in real time without control of the individual wearing the device.

Devices that are implanted into the brain entail a high level of risk, as they inevitably create an intimate connection between a device and an individual – along with risk of infection, rejection and the need for long-term care of the recipient and maintenance of the device. This reality raises significant and immediate neuroethical questions. The detail with which brain states can be monitored will likely improve as we obtain more robust/sensitive recording technology, such as flexible mesh electrodes that detect and potentially modulate electrical activity of many cells and can thus displace current limitations of available electrodes, such as static immobility and stiffness. The impact of these technologies is likely to increase dramatically with nanotechnologies that bring innovation related to materials science, optics, chemistry, and learning algorithms.

It is of note that the health and well-being of participants in invasive technology research presents heightened neuroethical concerns. If a participant benefits from the technology, then the question of what happens at the end of the study becomes more salient. Does the device remain implanted and functioning? Or what happens if it is removed, which would likely return the participant to his/her pre-therapeutic status? If the device remains who is responsible for its maintenance, ensuring that it functions well and monitoring of the participants health consequences long-term? These are important questions as the participant may be particularly vulnerable at the time of informed consent. Further there are long-term consequences beyond the participant including those for his/her immediate family.

Neuroethics Research Opportunity

Collaborative research projects between neuroscientists and neuroethicists could explore how to define and operationalize in a lab setting terms and features of sentience. These studies could also work toward developing technologies to measure sentience and other features. See also Neuroethics Moonshot.


Neuroethical research is needed to address several scenarios that will likely arise sooner than later. Examples include the value and risks of medically unnecessary work such as implantation of an experimental device that alters brain activity in healthy individuals and informed consent processes for neurosurgical patients for research associated with, but not necessary for medical care. In addition, broader questions that warrant deeper exploration are the long-term responsibilities for scientists, funding agencies, or device companies who implant devices in research participants as well as ownership and rights of participants to access to data from an implanted device.


The examples provided above illustrate neuroethical considerations framed by opportunities to integrate neuroscience research with what we expect to learn (as well as where it is difficult to anticipate what to expect) about understanding the human brain and behavior. When considering the important issues of agency, self, emotions, decision making – and even more familiar issues of learning and memory and consciousness – it is important to recognize that the biological underpinnings of these aspects of our personhood remain obscure (see Neuroethics Moonshot). Yet, there is a moral imperative to use the knowledge gained from the BRAIN Initiative to alleviate suffering from brain diseases and disorders. Intellectual freedom for scientists must be coupled with individual and institutional responsibility to assure morally responsible behavior – as well as establishing practical and sensible ways to assess societal benefits, safety, and security risks both before and after research, and limiting scientific projects and exploration when necessary. The neuroethical impacts and implications of BRAIN Initiative-funded research should be assessed on an ongoing basis. Further, ongoing efforts contributed by the global neuroethics community to define appropriate limits and develop concrete guidelines are essential.


There is a long history of the use of laboratory animals in biomedical research and a significant and longstanding set of best practices and oversight regime for the care and use of those animals. These include the prospective ethical review of research by Institutional Animal Care and Use Committees (IACUCs) and ongoing institutional review of animal care. BRAIN-Initiative research involving animals is conducted with these best practices in mind and is subject to the same oversight. However, particular features of BRAIN Initiative research involving animals warrant specific ethical attention, including but not limited to research that mimics human neurological disease and symptoms, research seeking insights into cellular level interactions in the brain and their relationship to consciousness, non-human animal models with human cells in the nervous system, and other work to create “humanized” animal models of various species to better study human behavior and disease. 

The prospect of ongoing and future work in these and other areas raises new and unique ethical questions. These include:

  • How to assess when such research is appropriate
  • How to minimize animal use while maximizing data output from animals used in BRAIN Initiative-funded research
  • Appropriate justificatory criteria for creating and using of “humanized” animal models
  • Ethical implications of research results that yield deeper understanding of animal consciousness, and therefore animal suffering

The answers to these and other questions will provide greater clarity and rationale in support of the uses of animals in BRAIN Initiative research and in so doing will help to make more explicit the importance of and justification for that research in support of human health. These sorts of queries and their analysis are not intended to limit the use of animals but rather to help articulate the criteria for when and why research is critically important to pursue, and by the same token when it is not.   Analysis of the sorts of ethical issues note will also have implications for the humane care and treatment of animals engaged in BRAIN Initiative-funded research.

While neuroethics questions related to animal research apply to all species of animals used, these questions seem particularly acute for research involving non-human primates (NHPs), because of their greater neurological complexity and therefore greater parallels to states of consciousness and suffering experienced by humans. In addition, neuroscience research seems poised to enter a period where demand for the use of NHPs will increase sharply as the ability to observe and manipulate brain circuitry becomes more and more possible. 

These and other questions like them should be studied as neuroethics research questions. The conceptual and ethical analysis of the results of such neuroethics research will begin to provide greater understanding not only about animals and animal life, but in support of greater understanding of humans and human health. 

What do we know?

The animal-ethics literature (both conceptual and empirical) is important for identifying ethical issues in the use of non-human animals, ensuring that ethical principles are applied consistently in research employing various animal models – as well as to affirm the relevance and appropriateness of specific animal models for various neuroscience research studies. These discussions must keep pace with rapid developments in research, including development of genetically identical monkey clones for research, development of rhesus monkeys with human neurons in their brains [ref], and others. In addition, fuller discussions among diverse stakeholder groups – neuroscientists, animal behaviorists, ethicists, and others – will inform deeper and more sophisticated understanding of ethical issues in neuroscience research involving non-human animals on all sides of ongoing animal-use debates. 

As noted above, these include questions about consciousness, pain, and suffering, and may even offer insights into human cognition and the neurological bases for personhood, as discussed in Chapter 2. Understanding Ourselves: The Uniqueness of Neuroscience. In examining these questions, neuroscience research may also challenge intuitions about animal behavior – particularly related to the moral standing of NHPs and humans. Greater understanding about the lives of non-human animals through research may affect balancing risk-benefit ratios as we better understand the experience of animals and as animal models more closely approximate the human experience. To make the point more succinctly, greater understanding of the various ways that animals experience the world is both a research advantage and an ethical challenge. This is particularly true of research with NHPs, given their close genetic relationship to humans and the characteristics they offer as research models of human complexity. 

Increasingly sophisticated approaches are being used to create non-human animal models that approximate human neurological conditions, illnesses, and diseases. The tools used for such research blend stem-cell advances and precise genome-editing techniques, which elicit unique ethical issues. As noted in the report of a recent National Academies workshop on creating NHP models of neurological diseases, the value of such animal models must be carefully assessed in light of the information they might yield for human health, and many ethical questions must be addressed when developing such models, including: “Does it matter what disease is being modeled?” “How are the symptoms associated with the disease managed?” and “Is ‘humanization’ in animal models different in NHPs compared with other species?

What could we learn? Neuroethics research opportunities

The BRAIN Initiative should support or participate in efforts to explore and characterize ethical aspects of different animal models in neuroscience and have a process for using the results of these explorations to inform policy and practice. As noted below, we suggest that the BRAIN Initiative develop a process be undertaken to create guidance for researchers who develop and use animal models with increasing numbers of humanized traits. This will be particularly important and useful as NHP models of human neurological conditions, illnesses, and diseases emerge, and as work with them yields insight and information. Animal models such as Aplysia and mice have been used successfully to help understand higher-order brain behaviors such as the molecular biology of learning and memory. Each model system brings addressable well-developed “species-shared” biologies to experimental paradigms. This may be true for research with NHPs as experiments move toward understanding traits that are more human, such as particular aspects of consciousness that inform concepts such as personhood. As biological aspects and their resulting characteristics are added to non-human species such as NHPs to make them more biologically similar to humans, they likewise seem to become more morally similar. As neuroscience research yields greater scientific insights into the structure and function of animal brains, insights will follow that inform sentience, consciousness, the experience of pain and suffering – and more generally, what we understand about the inner lives of animals.  These conceptual aspects of animal experiences are closely connected to ethics of the use and treatment of animals, whether as more humanized models or not, and so they deserve attention as fundamental research questions that require carefully constructed projects involving neuroscientists, ethics scholars, and other individuals engaged in animal care and use. The findings of such research will have important implications for training, education, funding priorities, policies, and practices related to the use of animal models in neuroscience research.

Responsible use of research animals in BRAIN research

As noted above, animal use in biomedical research is governed by a longstanding set of policies and practices: BRAIN Initiative-funded research included. However, the unique characteristics of neuroscience research demand an evaluation of whether – and if so, how – existing policies and practices may be refined, revised, or augmented. The BNS identified four priority areas for attention: 


  1. A framework and related criteria should be articulated for when use of NHPs in neuroscience research is justified. Advancing neuroscience research will very likely lead to a growing demand for use of NHPs. Accountability and careful stewardship require clear standards for the ethical acceptability and appropriate use of this valuable and scarce resource. Commitment to these values and the policies resulting from them are reflected in i) the decision by NIH to end research involving chimpanzees on the grounds that it could no longer meet identified principles and criteria and ii) ongoing public workshops to discuss the appropriate use of NHPs. 
  2. Ethical analysis and related guidance for humanization in animal models. Over the course of the last year, at least three separate national workshops were convened to discuss various aspects of the use of NHPs in research, all of which included presentations and discussions on neuroscience research and on the creation and use of NHPs with “humanized” characteristics. These models generally seek to take advantage of physiology or characteristics in common with humans or created to mimic or parallel features of human neurophysiology and/or neurological disease, with the expectation that symptoms and therefore experience in the animals are similar to humans. This raises questions about both the quantity and quality of animal suffering, since it can be posited (and is an interesting and important research question) that increased humanization of animal models will concomitantly increase these animals’ experience of the symptoms created, or could result in more invasive or burdensome interventions than in non-humanized models. Should greater humanization of animals require greater justification? How should such humanization be factored into ethical consideration of the use of non-human animal models, and does the species matter?
  3. Increasing levels of research involving NHPs suggests greater collaboration among researchers in the United States and globally. Such collaboration would take fullest advantage of the types and numbers of research animals used and reduce duplication – to minimize the numbers of NHPs used in research studies. Encouraging global cooperation with other international brain initiatives and taking leadership to facilitate it is consistent with both efficient and responsible use and stewardship of NHPs wherever they are used: an important role for NIH to play.
  4. Related to Priority Area 3. Brain in Action, and as highlighted in Chapter 3: Neuroethical Issues with Neurotechnologies, the status of NHPs as a research resource demands enhanced data sharing, reflecting responsible stewardship. For example, data from use of NHPs in BRAIN Initiative-funded research could be required to be shared quarterly rather than waiting for publication. This requirement could be facilitated by a BRAIN Initiative-sponsored online portal to deposit NHP data and experimental protocols prepublication. Such an action would minimize duplication of resources as well as advance research.


The implications of BRAIN Initiative-funded research stretch beyond traditional medical and research contexts. Many fields of study outside the natural sciences are now directly engaging with neuroscience as reflected by the emergence of several interdisciplinary “neuro-and-” fields. These include neuroanthropology, neuroeconomics, neurosociology, educational neuroscience, neurolaw, neurohistory, neuroscience and literary criticism, and even neuropolitics. Paralleling this scholarly interest in neuroscience is an increased appetite from the private sector to invest in neurotechnology. In recent years, more than 10,000 neurotechology patents have been filed. Firms now offer brain-based consulting for corporations and political campaigns, and companies are developing brain-based virtual-reality video games. Even professional sports teams are now using electroencephalogram (EEG) headbands to monitor and improve athlete performance.

In particular, there is a need for scientific accountability to be closely examined. For instance, should a scientist-entrepreneur in a private-sector setting be held to the same standards as a scientist in an academic setting? Does a scientist who knows that her or his research may be used in a setting beyond research and medicine have an ethical obligation to engage with stakeholders in that setting? Should NIH-funded researchers consider potential unintended uses of their scientific discoveries and technological developments? Do some partnerships – for instance those that raise concerns about militarizing neuroscience – run counter to the NIH mission to promote human health? This chapter considers progress to date and the need for greater attention and increased interagency dialogue regarding unresolved questions of accountability and potential regulatory gaps beyond the bench (NeQN5).

Brain privacy

What do we know?

Brain privacy is at the forefront of concerns about the growing appearance of neuroscience and its applications across society. Non-scientists, too, are concerned. A 2018 nationally representative survey of the American public found that “mental thoughts” and “image content in mind” were both ranked highly as sensitive content (BRAIN Initiative Multi-Council Working Group Meeting - February 2019, special workshop dedicated to data sharing and data privacy). Concerns about brain privacy are justified because human thought begins in the brain. As a result, collection of brain data could theoretically allow for (either unintentionally or intentionally) decoding thoughts that an individual may prefer not to share.

But how to protect brain privacy is challenging. We do not yet agree, as scientists and as a society, what constitutes “brain privacy,” what should be protected, and how much protection is needed. Moreover, most concerns relate to inferences based upon experimental measurements of brain structure and function – calling to mind the quality of that experimental data. For instance, a low-resolution structural brain scan from 1990 showing no gross anatomical abnormalities told us little about an individual’s thoughts. But with greater spatial and temporal resolution from tools developed through the BRAIN Initiative, a brain image today or in a few years might tell a different story.

In 2025 – the horizon line for the BRAIN Initiative – neuroscience will likely remain limited in its ability to decode complex mental life. But even if science-fiction visions of mind-reading are not accurate, there are realistic scenarios that pose grave privacy concerns. For example, more diverse forms of data, including brain data, are being used alongside descriptive data from many sources such as traditional clinical interviews eliciting symptoms, signs, and behaviors related to mental disorders. That information could lead to the definition of pre-symptomatic and prodromal state biomarker risk factors. The medical and research justifications for this shift are logical: why wait until full-blown symptoms arise to start treating a disease if we could use brain (and other biological) indicators to intervene earlier? Yet the privacy concerns introduced by the potential use of such biomarkers are profound. Take, for example, the biomarker-based definition of Alzheimer’s disease proposed in 2018. If eventually adopted, the new definition of Alzheimer’s would be based upon multiple biomarkers, including evidence of neurodegeneration. Under the revised definition, many individuals would find themselves cognitively healthy, but on the “Alzheimer’s spectrum,” based upon their biomarkers. Keeping this data private would be of paramount importance because it could negatively affect an individual’s job outcomes, social relationships, and insurance premiums. Yet, existing legal protections remain lacking.

What could we learn? Neuroethics research opportunities

Neuroethics research on brain privacy requires more data and less speculation. Interdisciplinary research opened the door to provide relevant stakeholders with a realistic understanding of what might be possible in brain decoding in the near future – as well as what will remain science fiction. Refined research approaches are also needed to identify more precisely how brain data is being collected, stored, used, and shared outside the lab. These studies might identify specific gaps in the protection of human research participants. Uncovering evidence of neurodegeneration in an individual during a research experiment or clinical trial triggers established protocols per IRB guidance. These protocols are not so clear, if they exist at all, outside the lab. In the context of EEG-based brain wearables sold to consumers for neurofeedback, constitutional protections are replaced by contractual provisions. A consumer agrees to an end-user license agreement specifying privacy terms, which are not controlled by federal privacy laws applicable to biomedical research and health care.

Table 8. Comparison of Contexts: When Neuroscience Leaves the Lab



Context: Neuroimaging in Medical Research

Context: Neuroimaging in Clinical Treatment

Context: Neuroimaging in Criminal Prosecution

Context: Neuroimaging in Market Research to Increase Product Sales

Context: Direct to Consumer Sale of Neurotechnology

Context: DIY Neurostimulation

Context: Neuroimaging in Military Intelligence Interrogation

Context: Neurostimulation of Healthy Soldiers to enhance abilities/reduce sleep dependency

Brain scan/ Brain stimulation of:

Research participants


Criminal defendants

Paid focus group members



Enemy Combatants



Improve knowledge and health

Improve patient health

Criminal prosecution or criminal defense

Increase sales of products

Productivity; Entertainment; Enhancement

Enhancement; entertainment

Elicit actionable intelligence

Improve combat capabilities of soldiers

NIH Mission applicable?









Already happening?



Yes: thousands of cases involving brain science

Yes: many companies now offering neuromarketing services

Yes: DTC neurotech market predicted to be $3 billion in 2020

Yes: DIY neurostimulation is well established

Unknown: Military has not revealed extent of its interrogation methods

Yes: DARPA- funded research projects


Potential next steps: Implementable goals

There is a need to establish working groups to consider and guide brain privacy policy. Although ensuring brain privacy will not happen quickly; taking the necessary steps to achieve this important goal must begin now to understand and analyze sector-specific privacy concerns and develop potential remedies. The convening of expert working groups, with diverse stakeholders, is a necessary step in forging productive and practical brain privacy policy that also addresses data sharing.

However, perhaps the first action is to determine whether or how much of a concern the public may have or be aware of the need for neural privacy. Studies assessing public attitudes regarding brain privacy and other issues will be important to guide not only policy, but also public awareness and public-engagement activities. The Human Brain Project has already begun such a project in collaboration with the Danish Board of Technology Foundation. This group conducted public-engagement forums to inform integration of a data-protection action plan throughout the life of the Human Brain Project.

Advances in Neural Data Collection

What do we know?

Rapidly changing technological innovation is a significant driver of the shifting brain-privacy landscape. BRAIN 2025 is ushering in new technologies that will revolutionize the collection and analysis of neural data. For example, ultrahigh resolution (10.5 Tesla) scanning will produce vast amounts of new, more granular, individualized brain data. Even with much lower resolution imaging, neuroscientists have been able to use machine learning techniques and multi-voxel pattern classification to reconstruct visual images based on brain data, what the authors describe as a “proof-of-concept demonstration of an internet image search guided by mental imagery.” Moreover, when neural data is combined with real-time data collection from smart phones, social media, and biosensors, “digital phenotyping” of individuals will become possible.

These and related advances offer the promise of improved mental health interventions and understanding of brain disease, but they also raise ethical questions about consent, privacy, data collection and data storage practices, and the mis-use of this data for discrimination or exploitation.

In addition to new types of data collection and analysis, neuroimaging is also moving outside the lab. Already researchers are using electroencephalogram (EEG)-based neurotechnology to measure brain activities in real-time – such as while children learn, while athletes play sports, and while people are physically active at work or at play. Despite its use for these applications, EEG is limited by poor spatial resolution compared to other imaging techniques such as positron-emission tomography (PET) and magnetic resonance imaging (MRI). Thus, researchers are now developing methods for mobile MRI, mobile PET, and mobile magnetoencephalography (MEG). These various forms of mobile neurotechnology will likely transform neuroscience and its applications.

Mobile neuroimaging will facilitate gathering brain data in real-world settings, including from individuals who are traditionally underrepresented in biomedical research. These include individuals from racial and ethnic groups, rural residents, and those from lower-income and lower-education neighborhoods. Despite the promise, however – even for addressing health disparities – mobile neuroimaging introduces a host of ethical and legal challenges. These include how to ensure data privacy as data is collected in new settings that rely on cloud storage and how to properly use algorithms for data obtained from diverse participant populations. Other issues include how to manage return of individual-specific research results and incidental (or secondary) findings from neuroimages. These questions are particularly vexing if mobile neuroimaging is used in non-clinical and non-research settings such as direct-to-consumer brain scans.

What could we learn? Neuroethics research opportunities

These many advances in neural recording may allow for greater use of neuroscience in sectors such as education, law, and business. Indeed, one of the primary proponents of low-field MRI is the Department of Defense, and one of the earliest cases of simultaneous EEG recording of multiple individuals in real time was in a classroom setting. And in business, Facebook is using digital phenotyping approaches to identify users at risk of committing suicide. Mobile neuroimaging would seem to be a natural fit for neuromarketing and of great interest to the legal system. As the capabilities of these technologies are uncertain, neuroethics research is needed as these varied uses of neuroscience rapidly expand.

Potential next steps: Implementable goals

It is important to engage stakeholders across multiple sectors. Brain decoding, digital phenotyping, and mobile neuroimaging technologies raise unique ethical and legal questions because existing recommendations have been developed based on older, lower resolution and less mobile technologies. The BRAIN Initiative could consider convening a working group of experts and stakeholders to anticipate research, clinical, and direct-to-consumer use cases and to consider appropriate oversight standards.

Brain enhancement

What do we know?

As observed by the late psychologist Corneliu Giurgea, “Man is not going to wait passively for millions of years before evolution offers him a better brain.” While much of neuroscience is aimed at restoring damaged brain circuits to “normal” functioning, we are now at a crossroads for the next possible step: controlling brain circuitry to enhance brain function. Whether described as cosmetic neurology, neuroenhancement, brain boosting, cognitive enhancement, or some other term, humans may soon have access to new chemical and electrical interventions to willfully alter their own or others’ brain circuitry to enhance cognitive function, moral decision-making, and mood. The neuroethics of enhancement remain in flux both theoretically and empirically. Various forms of enhancement lie across a spectrum that also includes exposure to media, digital technologies, smart phones, and other experiences or devices. These accidental or incidental changes to our neurobiology range considerably in their level of intrusion – from traditional, non-invasive devices to medications to brain surgery.

Direct-to-consumer neurotechnologies are now marketed for a variety of purposes, with a projected market of $3 billion by 2020. Yet because these devices are not classified as medical devices, there is rightful worry about governance and oversight. Neurotechnology advances spurred by the BRAIN Initiative will likely accelerate enhancement experimentation, making the need for oversight even more timely.

What could we learn? Neuroethics research opportunities

Across this spectrum there remains uncertainty on how to best distinguish enhancement from treatment; whether direct-brain enhancement is ethically or legally different from traditional indirect enhancement techniques such as education; and whether and how to distinguish between the many forms of direct-brain enhancement (e.g., caffeine in coffee or soda vs. transcranial direct-current stimulation). Additionally, should brain enhancement be encouraged or discouraged in healthy children and adults? Complicating these ethical questions is the lack of reliable and systematic empirical data on how putative neuroenhancers (both drugs and devices) actually work in different types of healthy individuals, as well as their actual usage patterns.

Two lines of related empirical research are needed. First are carefully controlled studies with healthy research volunteers to evaluate the short- and long-term effects (and side effects) of drugs and devices thought to produce cognitive, moral, and mood enhancement. For instance, would any of these direct-brain interventions produce improvements in classroom or workplace productivity compared to indirect interventions? Second, and relatedly, is the need for systematic data collection on actual usage patterns of neuroenhancement drugs and devices. Who is already using them and how are they being used? Who is likely to use them in the near future and how might new technological advances change usage patterns? Answering these questions are critical to considering and managing the many emerging neuroethics concerns. 

Potential next steps: implementable goals

Efforts to further develop oversight and governance for neuroenhancement are needed. A growing body of data informs public perception of key ethical concerns with neuroenhancement. A review of 40 empirical studies found that the most common concerns are safety, coercion, fairness, integrity, and authenticity. Given these public concerns and multiple layers of uncertainty about cognitive, moral, and mood enhancement, there is a need for research into understanding the impact of enhancement in this burgeoning arena will help to identify policy infrastructure and any associated gaps.

Sector-specific issues

The missions, stakeholders, incentives, and existing safeguards in many new “neuro-and“ fields and areas of industry are different from those in traditional research and medical contexts. Although NIH-funded neuroscience research emphasizes improving health, beyond the NIH arena these incentives may be very different. In these other contexts, neuroscience may be used to enhance corporate profit, national security, systemic equity in criminal justice, individual cognitive enhancement, and much more. What oversight mechanisms exist or could be established to address the many beyond-the-bench scenarios introduced by advances in neuroscience and neurotechnology? What role does NIH have in overseeing research with neurotechnologies that are likely to be used beyond the bench? Should other entities be partners in this oversight role? For instance, as illustrated in Table 8, what about the use of brain imaging to determine whether a criminal defendant is guilty? The use of neurofeedback by a market research firm to improve product sales? Or the sale of direct-to-consumer neurostimulation devices to healthy adults for mood or cognitive enhancement? In these scenarios, the labels “patients” or “research participants” no longer apply neatly, if at all. As a result, protections and protocols established for safety, efficacy, and privacy in biomedical research settings may be neither applicable nor feasible.

Dual use of BRAIN Initiative neuroscience

What do we know?

“Dual-use” technologies are those that can be used for both peaceful and military purposes. Neurotechnology is a dual-use technology, as possible military purposes might include neuroenhancement for soldiers, reducing the trauma of post-traumatic stress disorder, brain-computer interfaces, and enhanced interrogation strategies. Law-enforcement authorities are also exploring the use of neurotechnology to aid anti-terrorism efforts through violence-risk assessment. Military use of neuroscience can be seen as a double-edged sword: offering both promise for more effective national security and peril in the case of human manipulation. Since early discussion of the dual-use challenge in the mid-2000s, neuroethics discussion of this issue has matured. Yet recent military investments in neuroscience and their implications are still unknown, inviting ongoing neuroethics scrutiny and guidance for the dual-use challenge. Efforts to frame the debate have arrived at the same general conclusion: more dialogue is needed between the neuroethics community and the public-private partners developing and deploying dual-use technology. Constructive dialogue is only possible, however, if academic neuroscientists continue to stay engaged with military research initiatives such as the Defense Advanced Research Projects Agency (DARPA) in order to address such questions as whether the ethical frameworks that govern biomedical research being considered related to the potential uses of neuroscience by military agencies. In a recent report, which was informed by receiving citizen feedback collected by public-engagement experts, the Human Brain Project has also set a path forward to address dual-use issues. NIH might consider engaging more directly with DARPA and/or the Department of Defense on potential funding decisions.

What could we learn? Neuroethics research opportunities

Most importantly, there is a need for more precise data on what types of neurotechnology are actually being developed and/or applied for national security purposes. Cross-national comparisons and collaboration would be ideal, though admittedly challenging to accomplish. If restrictions on access to research data and participants are prohibitive, then at the least researchers should be able to contribute to and review any neuroethics governance structure.

Potential next steps: Implementable goals

First, neuroscientists and neuroethicists should be convened to consider the potential for dual use of fundamental BRAIN Initiative-supported research. Balancing an interest in transparency with an understandable need for restricting public access to military neuroscience developments poses a conundrum: It is hard to conduct neuroethics evaluations of projects that cannot be discussed. Important steps forward include efforts such as those led by the Organization for Economic Co-operation and Development to ensure responsible innovation.

Second, neuroscientists and neuroethicists should expand dialogue between NIH staff, the NIH-associated neuroethics community and other entities exploring the challenge of dual-use neurotechnology both domestically and internationally. The NIH-associated neuroethics community can help to shape dialogue by engaging the public and policymakers on challenging dual-use questions. Importantly, this is a particular area where best practices in neuroethics public engagement strategies could be developed and explored. The European Union-funded Human Brain Project has a specific division of research dedicated to public engagement, which may provide a valuable collaborative opportunity for best neuroethics engagement practice research.

  1. Neuroscience and law

    What do we know?

    Neuroscience and law are related in multiple ways. For example, regulations and legislation facilitate funding for brain research. In turn, advances in understanding of brain circuitry can reshape legal doctrine and practice. Since the early 2000s, the legal and neuroscience communities have had increasing interactions. There has been an increase in the number of legal cases introducing neurobiological evidence, raising questions about criminal responsibility and sentencing, pain and suffering, capacity and competency, juvenile justice, fallibility of memory, brain injury, and bias in decision-making. Neuroscientific perspectives might inform the limits of eyewitness memory and the power of implicit biases to shape behavior. But there remains significant debate about whether neuroscience, given its current limits, is relevant for criminal law. The rapid pace of neuroscience discovery has required courts to make evidentiary decisions about whether or not to allow jurors to see particular brain data. For instance, under what conditions should a defendant accused of a violent crime be allowed to argue that a brain abnormality, identifiable in a brain scan, caused the violent behavior? Lay jurors may find brain data to be overly persuasive, even that data which is scientifically suspect. Relatedly, neuroscience might be used prematurely and inappropriately in areas such as developing treatments for offenders and assessing risk of future violent behavior.

    Related to concerns about brain privacy are concerns that neuroscientific developments will provide government or private entities with lie-detection and mind-reading capabilities. The science of functional MRI (fMRI)-based lie detection is far from ready for courtroom use, but  lack of scientific consensus does not prevent social or legal use of a technology. For instance, there have already been two cases in which a criminal defense expert wished to testify about findings from an fMRI-based lie-detection protocol administered to the criminal defendant. In addition, EEG-based memory recognition protocols have produced a growing body of research suggesting potential forensic use. In one case, such EEG memory-detection evidence was admissible as evidence. An EEG-based procedure has also been used in multiple criminal cases internationally to inform adjudication of guilt.

    What could we learn? Neuroethics research opportunities

    It is difficult to translate a brain abnormality into a legal concept. For instance, do identifiable plaques and tangles or neurodegeneration in an individual mean that the individual lacks the “capacity” to sign a binding contract? This question, and others with legal ramifications, could be studied through NIH-funded empirical research related to decision-making in aging and Alzheimer's disease. Interactions between neuroscientists and legal stakeholders might inform behavioral-health factors that affect not only health and livelihood, but also justice.

    Potential next steps: Implementable goals

    First, more systematic standards and recommendations for the proper use of neuroscience in law should be developed. Among the challenges to be addressed include how to translate the complex and probabilistic nature of neuroscience findings into simple, often binary legal outcomes (e.g., guilty or not guilty), as well as how to ethically navigate an adversarial legal system

    Second, legal and neuroscientific communities should continue to interact frequently and meaningfully. This is already happening, for instance, as part of the NIH Helping to End Addiction Long-term (HEAL) initiative – in which scientists, policymakers, legal experts, and community members work together to improve the legal and societal response to the opioid crisis. Similar efforts could involve interactions between stakeholders in the mental-health and legal communities.

    Third, expanded partnerships with legal stakeholder groups such as the Department of Justice (DOJ) and the National Institute of Justice may prove fruitful. BRAIN Initiative-funded research is discovering how deficits in human decision-making, including addictive decision-making, can be understood and improved. The Department of Justice has in recent years emphasized better decision-making as the center piece of its offender re-entry programs. Expanding partnerships in this arena could lead to swift and significant improvements in policy outcomes.


  1. Neuroscience and education

    What do we know?

    Educational neuroscience, also called “mind, brain, and education,” is a burgeoning field of study and practice fueled by the recognition that understanding how the brain learns will lead to better teaching and learning. This goal has not been straightforward to achieve, in part because educators do not have access to state-of-the-art neuroscientific tools. Another challenge is that the educational marketplace has ample products marketed as being “brain- based,” when in fact they were not grounded in sufficient research. Other issues center around neurodiversity. That is, which types of educational/learning differences should be treated as “disorders” or “deficiencies” to be addressed by the education system, and which educational/learning differences should be accepted and celebrated?

    What could we learn? Neuroethics research opportunities

    In the United States, 76 million students are enrolled in over 10,000 school districts in more than 98,000 schools. These 76 million brains are being modified daily by their teachers, peers, and school environments. Even modest improvements in how shaping a child’s brain for the better from neuroscientifically informed educational methods could be significant and have long-lasting effects across the lifespan of that individual. But as in other areas discussed in this Neuroethics Roadmap, outcomes could also be harmful. Gene-editing for cognitive improvement is one widely agreed “no-go” technology. But what about medications and/or electrical stimulation to boost test score performance? Schools and educational leaders need knowledge and tools to readily discriminate between effective and ineffective applications of neuroscientifically informed educational methods. More research is needed before these decisions can be made to assess, and potentially improve, educational outcomes. In the interim, before research results are available, neuroethics research is useful, since data remains preliminary, and brain-related rhetoric may not properly reflect underlying scientific uncertainty.

    Potential next steps: Implementable goals

    First, NIH should engage in neuroethics dialogue with educational neuroscience and coordinate with NIH and other scientists at other agencies that fund education-relevant research. While progress to date in educational neuroscience has been mixed, there is reason to believe that in the future, brain biomarkers may play an important role in better matching individual students with the most supportive learning environments for their needs. Direct integration of brain data into educational practice will raise a host of neuroethics concerns similar to those raised in other sectors.

    A second step is to partner with educational stakeholders and institutions at the federal, state, and local levels to explore synergies between neuroethics and educational neuroscience. Neuroscientific perspectives may have implications for policies related to special education, including autism. For example, an NIH-funded study found that differences in white-matter fiber tract development at 6 months old in at-risk infants can predict whether, at 24 months, those infants will develop autism spectrum disorders. While the data remain preliminary, it is likely that in the coming years we will see more examples of biomarker-based predictions with educational relevance. If that occurs, it raises questions about potential stigma (should a 6-month year old infant be labelled as autistic?), resource inequities (who will pay for intensive interventions at such a young age?), and privacy (with whom will this infant’s brain data be shared?). Neuroethics is well positioned to address these questions.


  1. Neuromarketing

    What do we know?

    Increasingly, marketing firms see neuromarketing as a viable addition to their work. A variety of neuromarketing tools are currently used, although the effectiveness of specific approaches remains debated. Neuromarketing techniques include gathering brain data during consumer decision-making – with the presumed goal of probing, and then controlling, unconscious processes to increase revenue via targeted branding, selling practices, or product design and placement. Whether this goal is achievable remains to be seen amid considerable hype of the promise.

    Neuroethics scholars have identified potential concerns about neuromarketing. These include practical issues about actually doing the research (e.g., what if the study uncovers incidental brain findings affecting health and attaining informed consent?) as well as deeper conceptual worries such as excessive corporate power to manipulate consumers. Does collecting brain data to manipulate consumers (described by some scholars as a “hard” attack on consumer autonomy) differ in ethically relevant ways from the traditional “soft” attacks on consumer autonomy emerging from traditional tools such as focus groups? Public opinion on the ethics of neuromarketing is contextual, with more perceived support for non-profit organizations using neuromarketing than for-profit firms doing the same. Neuromarketing has attempted self-policing with regards to ethics (Thomas A et al, Ethics and Neuromarketing: Implications for Market Research and Business Practice, 2016). In 2012, the newly formed Neuromarketing Science and Business Association (NMSBA) adopted a code of ethics for its members, but it is unclear how stringently and uniformly this code is enforced.

    What could we learn? Neuroethics research opportunities

    Similar to guidance for research on the use of neuroscience by the military, more research is needed to understand how and whether neuromarketing firms are adhering to appropriate ethical standards. For instance, how many firms are members of the NMSBA, and how are member firms interpreting the organization’s code of ethics? How are firms outside of NMSBA navigating informed consent, incidental findings, data privacy, and other ethically relevant issues? Data on these types of questions is hard to find but will be vital to informing neuroethics guidance in this industry. For instance, it could be that industry self-regulation is working and has derived consensus on shared norms and practices. But also possible are gaps in protections for participants in neuromarketing studies.

    Potential next steps: implementable goals

    The neuroscience research community needs to establish exchange of ideas with neuromarketing stakeholders and should consider development of a certification that this has occurred (akin to “Consumer Reports Certified”). Neuromarketing firms and practitioners are aware of the neuroethics concerns part of their work. These ethical issues overlap substantially with neuroethics issues in other societal domains. Yet there is currently little crosstalk between neuromarketing and the NIH-associated neuroethics community.


Neuroscience has captured the imagination of the non-scientific public and scientists alike because of the rich implications of its findings. As we have shown throughout this report, neuroethics is integral to the neuroscientific endeavor based upon unique ethical issues that arise in conjunction with assumptions and beliefs about the role of the mind and the brain’s connection to it. Neuroethics helps guide neuroscience advances and discoveries toward positive social outcomes – in medical or non-medical settings. In turn, the numerous impacts of neuroscience and neurotechnologies on individuals and populations have significant and broad-reaching ethical implications. In this chapter, we provide suggested concrete steps for integrating neuroethics into the study and practice of current and future neuroscience research.

Guidance for researchers: The critical role of neuroethics in neuroscience research

What do we know?

Neuroethics should be integrated into the entire life cycle of a neuroscience research project – from hypothesis to research design and conduct to dissemination of results and translation of knowledge. Many entities have long-recognized the importance of this interdependence, including at the highest levels of government. For more details, see Chapter 1. Neuroethics Past, Present, and Future.

While neuroethicists can work independently from neuroscientists, neuroethical expertise is most relevant with shared intimate knowledge of the science and its context. Including an ethicist in a research team can lead to fruitful inquiry and provide an opportunity for ethicists to not stall, but accelerate, good neuroscience by anticipating and addressing ethical issues before they arise. Such ongoing interactions mitigate potential roadblocks that ethical missteps create if not considered early and often.

What could we learn? Neuroethics research opportunities

Integrating collaborative neuroethicists within research teams has been the subject of several BRAIN Initiative-funded neuroethics research project grants (R01s). For example, one project explored the ethics of research involving brain organoids. Researchers also investigated the informed-consent process associated with invasive brain interventions (such as deep-brain stimulation) for psychiatric conditions or opportunistic research occurring with epileptic patients implanted with electrodes.

What is the best way for neuroethical questions to surface in neuroscientific settings? Neuroscientists need the ability to identify ethical quandaries in the context of their work. Although tides are changing, most neuroscientists do not know enough about neuroethics to navigate these waters. As a result of mandatory training, however, most neuroscientists are indeed aware of basic issues related to the responsible conduct of research. We have learned through such efforts to educate neuroscientists about neuroethics (particularly in preliminary conversations through the NIH BRAIN Neuroethics Working Group) that neuroscientists typically welcome a resource to help them explore the ethical, social, and legal implications that may arise uniquely because their subject of study is the brain. The Neuroethics Questions and the Neuroethics Guiding Principles (see Chapter 1. Neuroethics: Past, Present, and Future) help to serve this role. In addition, the international brain community has committed to addressing neuroethical issues in formal and informal ways. In a special issue on neuroethics in the journal Neuron, each of seven large-scale brain research projects demonstrates how they are currently or are planning to integrate neuroethics into their research projects.

Neuroethics scholarship and training

Do neuroscientists have enough training to understand ethical implications of their research? Are there established practices for professional conduct in highly innovative areas in which neurotechnological capabilities are surfacing rapidly?

What do we know?

Culture change is a key component to fully integrating neuroethics into neuroscientific practice. The next step will be to establish formal opportunities for established scientists and trainees conducting neuroscience research to learn about neuroethics, and for neuroethicists to learn more about neuroscience. Some of this training may fit well into core principles already articulated by the BRAIN 2025 report, stating the need for crossing boundaries to promulgate interdisciplinary research. To facilitate these interactions, the NIH Neuroethics Working Group has published a set of Guiding Principles as values to undergird neuroscience research (see Chapter 1. Neuroethics: Past, Present, and Future).

To motivate true scholarly partnerships, institutional support and incentives are needed– a structure, with resources supplied for both groups. Dedicated support may encourage such collaboration and give collaborating ethicists time to engage in co-developing neuroscience. These efforts could also help meet the BRAIN Initiative’s goal of breaking down “silos” between fields of study.

What could we learn? Neuroethics research opportunities

Use of the Neuroethics Guiding Principles and the NeQN set provides both neuroscientists and ethicists a springboard to discuss the design, conduct, and translation of neuroscience research. For example, in NeQN1, scientists are prompted to consider how the questions they choose to study in the lab might amplify existing biases. Thus, considering these questions might lead them to reconsider designing a tool that uses a skewed mix of research participants (such as all males) as a normal population – a decision that may confound results. Interpreting such results will have implications for defining fundamental qualities of personhood associated with the brain, so choosing an appropriate study population is vital. Using NeQN4 and Guiding Principle 2, scientists are prompted to consider how brain interventions might affect autonomy. Researchers can respond to this question by designing technologies that enable ways an affected individual could override the machinery. Alternatively, researchers might also evaluate a neurotechnological design as impractical, by running down a battery, for example.

All true partnerships are two-way streets. While neuroscientists can benefit from learning more about ethics, ethicists must also keep apprised of current principles and trends in scientific and engineering research to have a better sense of how to navigate the ethical challenges. Having neuroethicists collaborating at the formative stages of BRAIN Initiative-funded research study design facilitates not only ethical neuroscience, but also provides more opportunities to speak a common language. Finding common ground will undoubtedly add fresh perspectives to conceptualizing, conducting, and translating research for the broadest number of people.

When should neuroethics education be integrated?

Among the neuroethics-related short-term goals outlined in BRAIN 2025 are to i) establish training grants for human research/ethics and ii) to establish neuroscience/ethics training programs, meetings, and interactions to establish guidelines and principles for human neuroscience research.

Ideally, as noted in Gray Matters Volume 1, exposure to ethics, and neuroethics, should happen early and often in a scientist’s professional development:

“Early ethics education in academic settings is critical to prepare future scientists to integrate ethical considerations into their work – including future research in neuroscience. Professional development for experienced investigators is equally important and can serve multiple ends, contributing not only to their individual knowledge, but to the knowledge of the students and young scientists that they mentor as well. Ethics education has a better chance of informing action when it is continually reinforced and connected to practical experience. (11, p.28)


“One foundational approach to integration is pairing science and ethics education at all levels of education. Early ethics education in academic settings is critical to prepare future scientists to integrate ethical considerations into their work – including future research in neuroscience. Professional development for experienced investigators is equally important and can serve multiple ends, contributing not only to their individual knowledge, but to the knowledge of the students and young scientists that they mentor as well.” (11, p. 44)

Some of this work has already begun – the Neuroethics Working Group has hosted workshops on invasive and noninvasive neurotechnology involving human research participants as well as the aforementioned NIH Neuroethics Working Group Guiding Principles. The BRAIN Initiative has also established an internal NIH neuroethics program team and has offered neuroethics grants, including fellowships for postdocs, but has not yet developed training grants. Additional training grants would provide an opportunity for more formalized neuroethics training as well as for setting up exportable models of training for graduate students and postdocs. Such training grants might also set up a mentoring cascade in which faculty train/mentor postdocs who then train/mentor graduate students who then train/mentor undergraduate students.

Professional/Institutional support

Since the field of neuroethics is relatively young (about 15 years old, but with a growing community of experts­­), new approaches are needed to capture talent while also nurturing existing neuroethics scholars – and cultivating cross-fertilization with neuroscience experimentalists. The cultural shifts required to achieve these goals require both top-down and bottom-up methods. Thus, explicit funding opportunities for neuroethics research and for interdisciplinary scholarship are both essential. Research partners are most likely to contribute fully when each is considered an equal participant in the design and conduct of the research – not an “add-on” that is expected to volunteer expertise. To date, the BRAIN Initiative has awarded two rounds of neuroethics research project grants (R01s), and it has included/expanded neuroethics language in predoctoral and postdoctoral training programs.

This research has just begun and as awareness of these unique opportunities increases, the program. BRAIN-Initiative support for neuroethics grants should be further continued and expanded in order to anticipate future issues and challenges in BRAIN research as the science progresses.

Committing resources

As a public, taxpayer-funded investment, the BRAIN Initiative aims to promote innovative fundamental science and has a responsibility to assure that the research will be done with integrity and adheres to the highest ethical standards. The BRAIN 2025 report mentions neuroethics as a means to “maximize value” of the neuroscience research investment. In the first few years, leadership of the BRAIN Initiative has increasingly emphasized neuroethics as central – it is our conclusion that this emphasis should not only remain but could also grow over the course of the second half of the BRAIN Initiative. A renewed commitment from the BRAIN Initiative to neuroethical principles amid this ongoing work requires sufficient, dedicated resources to ensure scientific and ethical rigor.

For comparison, the Human Brain Project, (HBP) another similar, large research effort dedicates about 4 percent of its budget to ethics projects – similar to the proportion allocated for ethics in a wide array of biomedical investigations (as in the commitment of up to 5 percent for ELSI research in the Human Genome Project), Applying this focus, from its inception, the HBP continues to conduct a sophisticated and interdisciplinary ethical, societal, and philosophical exploration of how neuroscience could and would inform the question, “What makes us human?” This research endeavor has created a number of sophisticated mechanisms for neuroethics integration and partnerships between ethicists and scientists. For example, the HBP has an ethics advisory board, and each member of this board is partnered with a designated scientist from each project, an “ethics rapporteur.” The board and rapporteurs meet regularly to discuss updates about ethical concerns. The HBP’s Ethics and Society subproject features prominently at the annual HBP meeting and as part of the organization’s progress review.

While the BRAIN Initiative is well underway and now into its second phase, there is still significant opportunity to create additional formal mechanisms to enhance neuroethical inquiry in neuroscience research that will last beyond the formal structure of the BRAIN Initiative. These may include but are not limited to:

  • In parallel with the importance of ethics in the Human Genome Project, BRAIN funding for neuroethics should be increased from its current 1.8% to a 5% of the annual budget
  • Using career-development awards to help support neuroethics researchers
  • Employing institutional awards to stimulate hiring people with neuroethics expertise
  • Funding grants for brain science akin to the NIH Centers of Excellence in Genomic Science
  • Associating center awards supporting neuroethics research with researchers; look at NIH portfolio for opportunities (the Neuroethics Working Group already does this)
  • Including neuroethics attention/training in relevant training grants
  • Require a neuroethics section on each BRAIN application, in which the applicant describes the neuroethical issues raised by the proposed research.
  • Facilitating the matching of a bioethics mentor on certain BRAIN projects to recognize and integrate neuroethics issues would be recognized and brought to the fore and enhance the project

Next-generation focus

Neuroscientists need knowledge beyond what they receive during scientific training to be able to recognize neuroethical issues as well as to conceive neuroethical inquiry in consultation with focused neuroethicists. Focusing on trainees and the next generation of leaders in neuroscience is already happening in the biomedical arena. For example, in collaboration with the International Brain Initiative, professional societies such as the International Brain Research Organization and the Institute of Electrical and Electronics Engineers have partnered with neuroethicists on neuroethics-focused educational modules for in-person and online learning. The International Brain Initiative’s Neuroethics Workgroup is currently designing a neuroethics short course to be shared and offered across the seven existing and emerging large-scale brain projects. Given the vitality of neuroethics training and awareness to the BRAIN Initiative, NIH and other BRAIN-Initiative partners should consider adding additional neuroethics training opportunities within existing responsible conduct of research (RCR) training requirements for neuroscientists. Alternatively, or in addition, the BRAIN Initiative could offer neuroethics-training opportunities associated with funded research at both the trainee- and established-investigator levels, some of which is already being done via administrative supplements. The Neuroethics Working Group has also held several public workshops at which experts considered issues related to BRAIN Initiative-funded research on invasive and noninvasive neural devices) as well as with ex-vivo models of the human brain.

Beyond the formal structure of the BRAIN Initiative, scientists might work with their local institutions to develop in-house programming featuring integrated neuroethics discussions. Such forums could generate exportable models for informal and formal neuroethics education. Several dedicated neuroethics centers and programs throughout the world, including many in the United States, have modeled undergraduate- and graduate-student neuroethics training and also host neuroethics short courses and regular programming. Some of these institutions offer neuroethics in the context of interdisciplinary training, while others have dedicated neuroscience-training programs. The BRAIN Initiative could offer incentives to academic institutions to offer neuroethics training for neuroscientists, or to join neuroethics training programs between neuroscience and humanities departments, bolstering neuroethics as a part of the neuroscientific enterprise. One opportunity for research might be to survey these institutions for successful strategies for developing neuroethics training programs for neuroscientists. For example, in one case, an undergraduate neuroscience-and-society course offered to neuroscience majors not only increased knowledge of neuroethics, but also improved overall moral judgment and reasoning skills. Additional research and evaluation would be valuable to inform future programming and to identify the full benefits of neuroethical education for neuroscientists. Given the international make-up and reach of neuroscience research, research within (and sponsored by) the United States benefits from multinational and multicultural participation and leadership. This point is especially important given the need for cross-cultural neuroethics educational models that acknowledge the varied cultural aspects of both ethics and science.

Global stage for neuroethics

What do we know?

In an era of global science/neuroscience, publishing, and communication – in which both knowledge and the fruits of science transcend geographic boundaries – it has become increasingly apparent that addressing a variety of value frameworks and perspectives is essential for fulfilling the goals of the BRAIN Initiative. Ethical values, assumptions about the role of science, and the types of science that should be pursued actually dictate what science gets pursued. This pattern has become clear in the case of the not-so-gradual move of most NHP research outside of the United States and Europe. Differing values about the conduct of research – along with which and how much data can be collected – have a profound impact on collaboration and data sharing. Questions such as NeQN2 and Guiding Principle 3 (see Chapter 1. Neuroethics: Past, Present, and Future) encourage researchers to carefully consider standards of data collection, as well as to consider potential violations of neuroprivacy.

What could we learn? Neuroethics research opportunities

NeQN3 encourages scientists to consider ethical issues that arise from innovative models of neural circuitry. One example is that posed by brain organoids/assembloids that are genetically engineered to model human brain development, cortical regions, and diseases. While closer approximations to human brains afford richer opportunities to gain deeper insights into the human brain and behavior, these models will also raise concern about the appropriateness of their use given their similarity or similar capacity to human brains. A similar debate has arisen in the context of the use of CRISPR-modified NHPs to study autism.

It is also important to consider the inevitable use of lab-generated technologies for purposes beyond their original intent. (see Chapter 5 of this report). This possibility is recognized in Guiding Principles 4 and 5 (see p. see Chapter 1. Neuroethics: Past, Present, and Future), but needs additional attention. In contrast, the Human Brain Project has a sophisticated network of neuroethicists who have collaborated with scientists to create a variety of opinion-pieces on key topic areas. These international groups (sometimes including individuals from up to 20 countries) accomplish the difficult task of harmonizing and reconciling differing views.

One recent Human Brain Project Opinion covered the topic of dual-use research, referring to uses and applications of research beyond the initially conceived hypothesis (mentioned within NeQN5 and in Guiding Principle 5). These Opinions are drafted and published by the Human Brain Project with input from an interdisciplinary group of ethicists, philosophers, and social scientists, including from the project itself. These well-researched reports are generally informed by both science as well as public-engagement research on specific topics.

NeQ2 asks researchers to explore ethical standards of biological material and data collection as well as how they relate to those of global collaborators. As the culture around data collection is moving toward one of sharing and openness, researchers around the globe will need to be aware of also-shifting tides of acceptability and regulation of non-human animal research, particularly as these models attempt to become closer approximations of human disease and suffering.

Public engagement: Meaningful and bidirectional

The modern consensus on how to approach and achieve public engagement for scientific pursuits is quite different from past strategies that focused on increasing public knowledge of science. The latter, mostly unidirectional methods mirror the information-deficit model of science communication – a model that has fallen from favor in both the science-communication and educational communities. Instead is the recognition that individuals within the public arena make conscious choices about what they want to know and learn, as well as how those efforts align with personal and societal values.

What do we know?

Both scientists in training and non-scientists alike take great interest in neuroscience, based upon the anticipation that advances and discoveries in brain research will affect how we understand ourselves as well as how we engage with the world. Neuroethics is thus a common entry point to neuroscience for everyone. Meaningful public engagement is critical to the success of neuroscience, as articulated by two of the BRAIN Initiative’s Neuroethics Guiding Principles:

  • Principle 6: Identify and address specific concerns of the public about the brain
  • Principle 7: Encourage public education and dialogue

The BRAIN Initiative also communicated the importance of public involvement and engagement, “Stakeholders should be engaged through a variety of additional mechanisms, including academic research in bioethics, training programs for a broad array of practitioners and students in the medical professions, conferences targeted to audiences with different levels of scientific expertise, and media outreach.” The return on investment from publicly funded research rests on the strength of the public’s trust in individual scientists and with the scientific enterprise. Like many new technologies and scientific advances, neuroscience advances are frequently subject to hyperbole. Importantly, we cannot only blame the media for such hype. Scientists must appreciate their own responsibility to communicate their work to general audiences clearly and effectively – while retaining its genuine interest and excitement.

What could we learn? Neuroethics research opportunities

Communicating science with non-scientists via a deficit model that assumes the public is wholly ignorant of science is not only dismissive but also unlikely to be successful. Skilled communication and effective engagement will likely require resources to connect scientists with experts in public engagement. While it is not uncommon for public engagement to be explicitly required as a component of conducting research projects, rarely are sufficient resources devoted to rigorous interdisciplinary collaborative work in this area. Scientists of tomorrow (and today) must be prepared to address the reality that science is being communicated, formally and informally, through a relentless 24-hour, 7-day media cycle. In summary, scientists should learn to be adept at public scholarship and engagement.

Some important considerations for the BRAIN Initiative related to engagement opportunities, particularly in neuroethics, include principles and lessons learned from the societal experience with human-genome editing. As noted in the 2017 National Academies of Science, Engineering, and Medicine’s Human Genome Editing: Science, Ethics, and Governance:

“We need to engage the public in a more open and honest bidirectional dialogue about science and technology and their products, including not only their benefits but also their limits, perils, and pitfalls. We need to respect the public’s perspective and concerns even when we do not fully share them, and we need to develop a partnership that can respond to them.

The authors of this report noted that high-quality engagement is marked by systematic exploration of the full range of risks and benefits of technology that go beyond simply those that are technical and medical, but that include perspectives and knowledge from all interested and affected parties. Other important considerations include assessing quality outcomes from engagement work that explores policy and regulatory issues – those that consider both facts and values, as well as how anticipated societal effects will affect the things people value. Legitimate engagement practices are those participants view as transparent, fair, and competent, and which truly interrogate the values and interests of the people who will be using these technologies or otherwise affected by them. On a practical note, engagement work cannot be done successfully without administrative efficiency, which requires dedicated resources. To this end, the BRAIN Initiative could consider supporting neuroethics research that assesses public opinion as well as develops best practices for public engagement around neuroethics issues.

Many challenges are inherent in attempting public engagement in the modern world. We live in a global society in which information access and spread is rapid and distributed – sometimes without proper context. Thus, it is critical to consider engagement activities internationally, requiring a broad definition of stakeholders that extend beyond English-speaking countries. This is especially important given that individuals across the world may use neurotechnologies. The Internet, social media, and other creative electronic and in-person formats are powerful tools for public engagement, but they carry significant risk for distributing unvetted information and/or unsubstantiated claims, in a manner that is difficult to control.

A particularly vexing challenge is translating outcomes of science and related engagement activities into changes in policy and practice. Success requires controlling two key levers: i) support from those empowered to make decisions to incorporate public views and values; and ii) transparent, justifiable, and monitored pathways for those actions. Bias and ulterior motives can also be a concern: What about when decision makers use engagement activities toward achieving predetermined outcomes? In summary, effective public engagement is highly collaborative and requires input from individuals and groups responsible for funding, doing, and measuring such activities.

There are solid examples of what works, such as public-expert interactions that can produce meaningful communication about neuroscience as provided by the National Information STEM Education (NISE) Network, which balance understanding and engagement for various topics, assimilating and integrating the different ways public and scientific individuals and audiences interact. The NISE Network published a 2018 conference report, “Public Engagement with Neuroscience and Society,” which notes that sustained public engagement will benefit from leveraging existing strengths of the current neuroscience outreach ecosystem. Components include BRAIN Initiative-funded neuroscience research, a comprehensive educational content framework (e.g., BrainFacts from the Society of Neuroscience), museums with broad reach that use evidence-based engagement approaches, and employing as ambassadors volunteer experts (e.g., Brain Awareness Week and activities therein).

Next steps: implementable goals

Integrating neuroethics and neuroscience is happening, but to fully reap the benefits of the BRAIN Initiative, closer alignment is needed to ensure scientific and ethical rigor – and also to share both the sense of amazement and practical outcomes from this groundbreaking large-scale, cross-sector project. Key concepts toward achieving this goal include fostering side-by-side professional interactions between neuroethicists and neuroscientists, extending to neuroscientists knowledge and appreciation of neuroethical principles embedded in basic neuroscientific inquiry, offering formal neuroethics training at various career levels, continuing to support neuroethics research, and truly embracing public engagement as an opportunity to fortify the research investment. Specific possibilities include:

  • Establishing (continue to offer, via supplemental funding and neuroethics R01s) and expanding formal mechanisms and incentives to embed (neuro-)ethicists within neuroscience research projects
  • Supporting trainees and the next generation of leaders in neuroscience and neuroethics
  • Establishing formal opportunities for established scientists and trainees to learn about neuroethics – and for neuroethicists to learn about neuroscience
  • Using published principles and guidelines such as the NeQNs and Guiding Principles to provide both scientists and neuroethicists a springboard to discuss the design, conduct, and translation of neuroscience research
  • Establishing a neuroethics network resource, consisting of people to consider issues on an ongoing basis for a range of stakeholders (neuroscience researchers and trainees, IRBs, health care providers, non-scientific public)
  • Developing NIH BRAIN mechanisms for institutional support and incentives to conduct collaborative, interdisciplinary neuroscience research, perhaps through funding centers and/or joint applications
  • Create training grants and other funding strategies to explore more formalized neuroethics training, which may also yield exportable models of training for graduate students and postdocs
  • Partnering with public-engagement experts, including those using innovative methodologies
  • Investigating the relevant neuroethical concerns of BRAIN investigators and of the public
  • Developing and evaluating neuroethics educational programs and assessments
  • Identifying successful strategies and models for effective neuroethics engagement


Chapter 1: Understanding the Bases of Consciousness: Intersection of Neuroscience and Neuroethics

Moonshot: The BRAIN Initiative aims to “revolutionize our understanding of the human brain” through using new tools to measure biology at “the speed of thought.” Learning how to use these tools should help prevent and treat brain disorders – and ultimately, inform, influence, and challenge definitions of our human nature at the most fundamental level. BRAIN Initiative research is intimately tied to concepts such as consciousness, thought, agency, free will, and identity.

As a transformative project for the second phase of the BRAIN Initiative, we propose a large-scale, concerted interdisciplinary neuroscience/ethics centric project that would would result in neuroscience revolutionizing long-held philosophical notions of features once thought privileged to humans or comprising human-ness, specifically:

  • How could the enterprise of neuroscience challenge long-held assumptions about the meaning of such qualities such as sentience and the mind.
  • How would neuroscience successfully operationalize these terms, such as “mind” for study in the laboratory?

The public—including scientists--may assume a shared meaning of these terms, however, there may be very different interpretations depending on one’s world view. While there are many approaches to defining and understanding methodologies of neuroethics inquiry, one strength of neuroethics is that the field relies on a methodology to systematically (see Table) unearth cultural assumptions about such socially-laden terms. Neuroscience has also become part of the culture defining these terms: the “mind”, for example, is often being conceptualized as a neuroscientific phenomenon with neurological underpinnings.

Types of Neuroethics Research

Conceptual (normative) neuroethics research

  • Analysis of specific concepts such as privacy or personal identity
  • Philosophical research about normative questions (i.e., how do societies determine desirable or acceptable behaviors?)
  • Examples: How should we define and treat people with various levels of consciousness? Does fluctuating capacity from disease, a brain injury, or a brain intervention indicate a need to rethink informed consent?

Conceptual and normative neuroethics research may draw from existing literature and theories, as well as practices from law, philosophy, theology, and neuroscience.

Empirical neuroethics research

  • Systematic data collection to ascertain views, values, or practices of researchers, patients, research participants, or the public
  • May employ social-science methodologies such as quantitative surveys or qualitative interviews and could also include experimental designs to test the impact of interventions or other experimental manipulations.
  • Examples: The BRAIN Initiative has funded a number of neuroethics empirical projects[1].


One common term (although there are more terms) shared in philosophical and neuroscience discussions of sentience and the “mind”, is consciousness.  Consciousness and other phenomenon of “mind” are now being understood as complex properties of the brain that emerge from the functioning and coordinated interactions of many brain cells and that help define personhood.

When framed as an emergent property, consciousness is thought to represent a greater entity than the sum of its component biological parts[2]. Some neuronal substrates of elements of consciousness have been defined and tested in the lab. These investigations have involved anatomical approaches, pharmacological modulation and theoretical and mathematical models[3],[4],[5],[6] rendering consciousness an emergent feature with biologically tractable neuroscience including behavior[7],[8]. Advances from BRAIN Initiative investment presage the ability to understand how millions of cells connect and interact both biochemically and anatomically to create functional circuits. It is experimentally feasible to selectively alter cells within these circuits – and connections between them – in a specific and multigenic manner. It is not understood how such alterations might affect consciousness, nor is it known whether altering consciousness approaches moral limits to biomedical research. These are important and interesting questions.

Goal: Understanding consciousness as a point of study for how brain activity elicits causality at a systems level in a human is a bold moonshot. These higher-order properties have been the focus of extensive philosophical and neurobiological inquiry. The goal of this transformative research project is to explore to what extent a functional or operational definition of the emergent phenomena, like consciousness, can best be explored in the laboratory and in the process developing neuroethics and neuroscience tools to determine criteria for defining and understanding consciousness.

Ethicists and scholars from a variety of disciplines, including the humanities, would explore assumptions of what consciousness is, how it might be measured and operationalized in the laboratory – and how such measures could be applied in real-world settings – and more broadly, how these neuroscientific insights might inform societal views and policy in areas such as health care, law, and other realms.

This project builds upon already existing plans of BRAIN research to advance tool development to measure and intervene with brain activity but in a more precise and directed manner with the goal to understand how brain activity causes complex emergent behavioral outputs which is an important component of neuroethical concern and study. Using BRAIN priorities for research, this project would endeavor to identify molecular, biochemical and physiological differences/correlates of consciousness in selected brain region(s) and understand function via measuring these correlates in multiple experimental model systems. Moving scientific investigation strategically between model systems and relevant species could advance the goal of understanding core elements of human consciousness. Looking across models (e.g., the social behavior of bees, which is quantifiable and manipulatable, and other model systems including mammals and humans) could be used to assess the generality of study conclusions. In addition, computational modeling and application of synthetic biology approaches throughout the life of each subproject would be an integral component of this research.

Throughout the research project, neuroethicists and neuroscientists would work together in a laboratory setting to explore the neurobiological underpinnings of consciousness. As the research progresses, further innovative techniques and technologies might be developed to explore particular features of consciousness or perhaps investigate additional biomarkers of consciousness. Finally, these collaborative teams can explore how to best disseminate, insure proper use and apply study findings. 

Approach: These experiments can be explored systematically through interdisciplinary collaborations of neuroscientists, ethicists, synthetic biologists, bioengineers, artificial-intelligence experts, and others with relevant expertise and would include not only academic researchers, but also non-scientific participants. Such public engagement aligns with two BRAIN Initiative milestones that may warrant more robust attention in its second phase:

  1. Support for data-driven research to inform ethical issues arising from BRAIN Initiative research, ideally with integrated activities between ethicists and neuroscientists.
  2. Opportunities for outreach activities focused on engaging government leaders, corporate leaders, journalists, patients and their advocates, educators, and legal practitioners in discussion of the social and ethical implications of neuroscience research.

In addition to how understanding conscious states and levels can influence scientific questions and methodologies, the results of this transformative project could also help to inform fundamental issues related to an individual’s capacity to consent or assent, how health-care providers assess and facilitate quality of life and reduce suffering, and perhaps even how nonhuman animal personhood is defined and evaluated. Further defining ways to scientifically measure consciousness could help to define if and when it is appropriate to worry about organoids’ potential to exhibit consciousness, provide data to help understand when life has ceased and determine the extent to which AI merits moral consideration/status. This project will also demonstrate the value of integrating neuroethics throughout the lifecycle of a neuroscience research project. For example, interdisciplinary teams of neuroscientists and neuroethicists can interact with a range of stakeholders to systematically investigate (through both empirical and conceptual neuroethics research) the various assumed meanings and components of consciousness. These data can be used to extract terms used to study consciousness in the lab – in established human and non-human animal models as well as in other emerging models of brain circuitry.

Broad participation that invites a diversity of thought, expertise, and experience is necessary for this exploration of consciousness to be successful. From the outset, team members that should include scientists, philosophers, ethicists, experts on artificial intelligence, synthetic biologists and computer scientists would create a cohesive set of questions and metrics with the goal of ultimately providing an operational understanding of consciousness and methods for measuring it.

 “Understanding the Bases of Consciousness: Intersection of Neuroscience and Neuroethics” is distinct from prior efforts in several ways:

  1. Neuroscientists, neuroethicists, philosophers, synthetic biologists, artificial-intelligence experts, and computer scientists will contribute integrally to development and benchmarking of scientific progress.
  2. The BRAIN Initiative has seeded progress of neuroscience research to the point where complex multimodal quantitative biological data in multiple experimental systems can be generated that directly provide insight into emergent systems properties.
  3. Methodologies for conducting these experiments are advancing rapidly and becoming easier to implement – making them vulnerable to malign intent and use. Staying at the forefront of this research and the knowledge arising from it may mitigate malign use.
  4. There is evolving societal recognition that understanding “ourselves” may enhance human flourishing through improved health. Consciousness is one component of this understanding.

 Referring to “A Theory of the Mind” as Chapter 1 recognizes the possibility of follow-up projects to explore agency, thought, identity, and other aspects of the various attributes that make humans distinctively human. It is an understanding of the totality of our unique nature that comprises the theory of the mind and will be achieved as additional “chapters” in the story of our human experience are explored.


1. Benzer S (1973) Genetic dissection of behavior. Sci Am 229(6):24-37.

2. Crick F & Koch C (1998) Consciousness and neuroscience. Cereb Cortex 8(2):97-107.

3. Fekete T, Van leeuwen C, & Edelman S (2016) System, subsystem, hive: Boundary problems in computational theories of consciousness. Front Psychol 7:1041.

4. Rees G, Kreiman G, & Koch C (2002) Neural correlates of consciousness in humans. Nat Rev Neurosci 3(4):261-270.

5. Tononi G & Koch C (2008) The neural correlates of consciousness: An update. Ann NY Acad Sci 1124:239-261.

6. Tononi G, Boly M, Massimini M, & Koch C (2016) Integrated information theory: From consciousness to its physical substrate. Nat Rev Neurosci 17(7):450-461.

7. Edelman GM, Gally JA, & Baars BJ (2011) Biology of consciousness. Front Psychol 2:4.

8. Boly M, et al. (2013) Consciousness in humans and non-human animals: Recent advances and future directions. Front Psychol 4:625.


NIH ACD BRAIN Initiative Neuroethics Subgroup

James Eberwine, PhD (co-chair)
University of Pennsylvania
Jeffrey Kahn, PhD, MPH (co-chair) 
Johns Hopkins University
Adrienne Fairhall, PhD
University of Washington
Elizabeth Hillman, PhD    
Columbia University
Christine Grady, MSN, PhD   
National Institutes of Health
Karen Rommelfanger, PhD 
Emory University
Insoo Hyun, PhD   
Case Western Reserve University
Andre Machado, MD 
Cleveland Clinic
Laura Roberts, MD    
Stanford University
Francis Shen, JD, PhD 
University of Minnesota
Ellen Gadbois, PhD (Executive Secretary)
National Institutes of Health


NIH Consultant: 
Alison Davis, PhD

NIH Staff:
Chanel Press, PhD
Aparna Singh, PhD


The following members of the Brain Neuroethics Subgroup have support from the NIH BRAIN Initiative Neuroethics funding:

Dr. Laura Roberts (RFA-MH-17-260)
Dr. Insoo Hyun (RFA-MH-18-500)
Dr. Francis Shen (PA-18-591)

The following members of the Brain Neuroethics Subgroup have support from the NIH BRAIN Initiative:

Dr. Adrienne Fairhall (RFA-NS-17-014, RFA-MH-16-700, RFA-NS-17-018)
Dr. Elizabeth Hillman (RFA-NS-17-004, RFA-MH-17-235, RFA-NS-17-018)
Dr. Andre Machado (RFA-NS-16-010, RFA-NS-15-008)

The following members have financial interest from pharmaceutical or medical companies/organizations:

Dr. James Eberwine (Illumina, Inc., Agilent Technologies, Inc., LBS technologies, Inc.)
Dr. Elizabeth Hillman (Leica Microsystems Inc.)
Dr. Andre Machado (Enspire DBS Therapy, Inc., Cardionomic, Inc., and Abbott Laboratories)
Dr. Laura Roberts is the owner of Terra Nova Learning Systems LLC, which develops science-based educational products and is supported by the NIH Small Business Innovation Research program.