The blog of the Presidential Commission for the Study of Bioethical Issues

Bioethics Commission Makes Recommendations on Existing and Novel Methods to Maintain and Improve Neural Health

In its recently published report, Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2), the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) focused on three controversial topics that illustrate some of the ethical and societal tensions that surround rapidly advancing neuroscience research and its applications. One of those topics was cognitive enhancement. The Bioethics Commission expanded the conversation about cognitive enhancement to include all forms of neural modification. It considered not only novel neurotechnologies like brain stimulation devices and brain training tools, but also any methods, behaviors, and conditions that alter the brain and nervous system.

For example, some lifestyle and public health interventions can benefit neural health and might be safer and more effective than novel neural modifiers such as transcranial direct current stimulation (tDCS) devices. The Bioethics Commission’s first recommendation addresses the prioritization of such existing strategies to maintain and improve neural health:

In addition to developing new drugs and devices to maintain and improve neural health, funders should prioritize and support research on existing, low-technology strategies, such as healthy diet, adequate exercise and sleep, lead paint abatement, high-quality educational opportunities, and toxin-free workplaces and housing.

Existing treatments for neurological disorders also are valuable and can be improved. Emerging neural modification interventions have the potential to reduce the burden of neurological disorders on individuals and society. Safe and effective treatments can help improve the lives of millions of individuals living with neurological disorders in the United States. The Bioethics Commission’s second recommendation is to prioritize treatment of neurological disorders:

Funders should prioritize research to treat neurological disorders to improve health and alleviate suffering. This research should consider individual, familial, and public health burdens as well as potential risks, benefits, and long-term effects of specific interventions.

Although the Bioethics recommended prioritizing the study of both traditional and novel interventions for the prevention and treatment of neurological disorders, it also recognized the need for research to better characterize novel neural modification techniques such as stimulant drugs and brain stimulation devices. Limited evidence exists for the benefits and risks of novel neural modifiers and more data is needed on the prevalence of use of these interventions for enhancement purposes. Therefore, the Bioethics Commission’s third recommendation is to study novel neural modifiers to augment or enhance neural functioning:

Funders should support research on the prevalence, benefits, and risks of novel neural modifiers to guide the ethical use of interventions to augment or enhance neural function.

Overall, the Bioethics Commission considered a variety of forms of neural modification and recommended that funders prioritize research on existing, low-technology and public health interventions and treatments for neurological disorders, and support research to better understand novel methods of cognitive enhancement and their use. By broadening the cognitive enhancement conversation to include all forms of neural modification, the Bioethics Commission aims to expand the scope of current dialogue.

Gray Matters, Vol. 2, and all other Bioethics Commission reports, are available at

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Bioethics Commission Releases Final Neuroscience Report as Part of BRAIN Initiative: Focuses on Controversial Topics that Must be Addressed if Neuroscience is to Progress and be Applied Ethically

The Presidential Commission for the Study of Bioethical Issues today released Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2), the second of its two volume report in response to President Obama’s BRAIN Initiative related charge. The President requested that the Bioethics Commission consider the ethical issues associated with neuroscience research and the application and implications of neuroscience research findings. Gray Matters, Vol. 2takes an in-depth look at three controversial topics at the intersection of neuroscience and society that have captured the public’s attention—cognitive enhancement, consent capacity, and neuroscience within the legal system. In the first volume, Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society, released in May 2014, the Bioethics Commission emphasized the importance of integrating ethics and neuroscience early and explicitly throughout the research endeavor. Programs that integrate neuroscience and ethics will be well-positioned to answer new and remaining ethical questions, consider societal implications of neuroscience research, educate the public, and implement policy recommendations. The three topics addressed in Gray Matters, Vol. 2 illustrate the ethical tensions and societal implications of advancing neuroscience and technology, and bring into heightened relief many important ethical considerations.

Contemporary neuroscience research offers us the opportunity to better understand the human brain and support the development of new or more effective diagnostic tools, treatments, preventions, and cures for neurological disorders and psychiatric conditions that affect tens of millions of individuals in the United States, and more than a billion globally. In addition, it has the potential to lead to a deeper understanding of our cognition, emotion, imagination, behavior, memory, learning, and social interactions.

Amid public and scholarly debate surrounding cognitive enhancement, consent capacity, and neuroscience within the legal system, Gray Matters, Vol. 2 seeks to clarify for the public the current scientific landscape, clear a path to productive discourse to navigate difficult issues as they arise, and identify common ground where it exists.

The Bioethics Commission offers 14 recommendations to guide the ethical progress of neuroscience research and its applications. The recommendations call for attention to fundamental ethical concerns regarding, for example, justice and stigmatization of groups and individuals; research to clarify persistent questions and fill gaps in our current state of knowledge; accurate communication about the ethical and practical implications and application of neuroscience research results; clarity around legal requirements and new guidance where needed; and the need to support and advance innovative multidisciplinary research and scholarship at the critically important intersection of neuroscience, ethics, and society.

The report is available at Additional posts about the Bioethics Commission’s recommendations will be highlighted here on throughout this spring.

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New Features Now Available at

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has added two new design features to its website, The purpose of the new features is to make it even easier to use the website, which continues to grow as the Bioethics Commission produces new materials and conducts quarterly meetings.

The new additions include filter toolbars for both the Education and Meetings pages. These filters will allow users to search for specific topics and materials on each page. On the Education page, users can search for educational modules by topic, Bioethics Commission report, or study guides and other resources. The Meetings page offers filters according to meeting year, location, and topic. For those already accustomed to the original layout, the filters are offered in addition to the original navigation tools. New material will be added as it always has, but the filters serve as an additional option should users wish to conduct a more targeted search.

The Education and Meeting pages are two of the fastest growing parts of the website, and each is expected to expand throughout the coming years. As part of its commitment to furthering bioethics education, the Bioethics Commission continues to produce educational modules to accompany its reports. All modules and materials are made publicly available online on the Education page. The Meetings page will also grow in 2015, as the Commission continues its process of democratic deliberation and continues to hold quarterly meetings. The Commission recently hit a meeting milestone in February when it held its 20th public meeting. Information, including agendas, transcripts, blog coverage, and presenter materials, from all 20 meetings are available at

The Bioethics Commission hopes that you find these additions useful!

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Celebrating the Cerebellum (and All Other Parts of the Brain)

March 16-22, 2015 is Brain Awareness Week, an international recognition of all things brain! First organized by the Dana Foundation, the goal of the 20 year-old initiative is to educate the public on the science, progress, and impact of neuroscience research. Brain Awareness Week involves partner organizations from around the world, and includes activities such as lectures, exhibitions, and presentations.

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has an interest in neuroscience and emerging technologies, playing an active role in President Obama’s Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. Launched on April 2, 2013 as a White House “Grand Challenge,” the BRAIN Initiative seeks to better understand the human brain through advances in science and technology. The Initiative involves public and private partnerships working together on emerging research and technological advances in neuroscience. Since the start of the BRAIN Initiative, the Bioethics Commission has worked to ensure that ethics is an integral part of the neuroscience conversation.

In August 2013, President Obama charged the Bioethics Commission with reviewing the ethical issues associated with neuroscience research and its applications. Specifically the President asked the Bioethics Commission 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.” On May 14, 2014 the Commission released Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1). Gray Matters, Vol. 1, the first of two Commission reports produced on the topic, underscores the importance of integrating ethics throughout neuroscience research.

Volume 2, Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society, will be released soon. The report will contain recommendations on three topics: neuroscience and the law, neural modification, and consent capacity.

The Bioethics Commission is pleased to participate in this White House Grand Challenge. By integrating ethics early and throughout neuroscience research, scientists can prevent the need for interventions to correct ethical mishaps. Gray Matters, Vol. 1 is available for download on our website. Check back soon for Gray Matters, Vol. 2.

For more information on Brain Awareness Week, including ideas on how to commemorate the occasion, visit the Dana Foundation’s website.


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Bioethics Commission Makes Recommendations on Research Ethics in Public Health Emergencies

In its recently published brief, Ethics and Ebola: Public Health Planning and Response, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) considered what lessons might be drawn from U.S. engagement in the global response to the Ebola epidemic. The brief examined two areas of human subjects research ethics that have been particularly controversial in the current Ebola epidemic: clinical trial design and the use of placebos; and the collection, use, and international sharing of biospecimens for research.

Public health emergencies add ethical complexity to the conduct of clinical research and yet the Bioethics Commission recognizes the importance of such research—especially when an emergency presents the best, or only, opportunity to conduct research on potential preventive or therapeutic interventions, as is the case for Ebola. As large clinical trials are planned or already underway in western Africa to investigate experimental Ebola vaccines and therapies, the Commission considered whether it is ethically appropriate to conduct randomized placebo-controlled trials to evaluate these interventions. The Bioethics Commission considered two perspectives on this question, one against and one in support of placebo-controlled trials in the current Ebola epidemic, as well as possible middle grounds, while underscoring ethically relevant aspects of conducting clinical research in the Ebola epidemic that might help to resolve tensions between these two viewpoints, such as the role of different levels of supportive care and responsiveness to the needs of communities in which the research is conducted.

Ultimately the Bioethics Commission recommended that the full range of trial designs that protect and promote the welfare of participants and are capable of yielding credible and reliable data on the safety and effectiveness of the interventions should be considered:

Research during the Ebola epidemic should provide all participants with the best supportive care sustainably available in the community in which the research is conducted. Trial designs should be methodologically rigorous and capable of generating results that are clearly interpretable, acceptable to the host communities and, to the extent possible, minimize delays to completing the research. Properly designed placebo-controlled trials can meet these conditions, and innovative designs, such as adaptive randomization, ought to be considered as a means of addressing these research goals. Research teams should actively engage with affected communities while planning research to determine the trial design that best reflects these ethical and scientific requirements.

The Bioethics Commission also considered the ethical and practical challenges of collecting and sharing biospecimens in the context of a communicable disease outbreak like Ebola. The analysis concluded that researchers and other stakeholders should work to ensure equitable access to the benefits that result from research using shared biospecimens and emphasized the importance of ethical acquisition of samples, informed consent, and strong privacy protections.

The Bioethics Commission recommended that the United States should play a leading role in establishing best practices for sharing the benefits of research using biospecimens:

The U.S. government should ensure that Ebola virus related biospecimens are obtained ethically, including addressing the challenges of obtaining informed consent during a public health emergency and ensuring adequate privacy protections. The U.S. government should also, in collaboration with partners, facilitate access to the benefits that result from related research to the broadest group of persons possible. This can be achieved by engaging in dialogue with global partners and working collaboratively with local scientists whenever possible to develop effective strategies for ensuring equitable distribution of the benefits of research both in the United States and abroad.

A public health emergency can magnify and complicate ethical concerns associated with research, both clinical and non-clinical, and challenge research protections for vulnerable participants. In Ethics and Ebola, the Bioethics Commission navigated these dilemmas by considering practical realities and applying core ethical principles, including beneficence and justice and fairness. It emphasized the importance of broad and inclusive public engagement and democratic deliberation in advance of public health emergencies to anticipate and address the ethical, societal, legal, and practical challenges that emerge in such crises.

Ethics and Ebola: Public Health Planning and Response, and all other Bioethics Commission reports, are available at

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Using the Least Restrictive Limits in Public Health Emergencies

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) recently released Ethics and Ebola: Public Health Planning and Response. In this brief, the Bioethics Commission examined U.S. engagement in the global response to the Ebola epidemic with the goals of 1) determining what lessons might be learned from the U.S. response and 2) creating recommendations to support proactive response to public health epidemics.

The Bioethics Commission considered in detail the U.S. public health emergency response with regard to the ethical use of liberty-restricting public health measures that involve monitoring or restricting movement and association, such as quarantine, and the impact of such measures on western African and U.S. health care workers. The Commission’s analysis of the use of restrictive measures highlighted the importance of the principle of least infringement, which holds that the least restrictive measures—grounded in the best available scientific evidence—should be taken to protect the public health and health care workers. Specifically, the Bioethics Commission recommended that:

Governments and public health organizations should employ the least restrictive means necessary—on the basis of the best available scientific evidence—in implementing restrictive public health measures, such as quarantines and travel restrictions, intended to control infectious disease spread. In addition, governments and public health organizations should be prepared to communicate clearly the rationale for such measures and provide ongoing updates to the public about their implementation, with particular attention to the needs of those most directly affected.

The Bioethics Commission stressed the importance of ethical preparedness and planning, with an emphasis on transparency and consensus in decision making through democratic deliberation, a process that fosters public engagement. The Commission emphasized using deliberative democratic processes to provide citizens with sound scientific and ethical justifications for public health policies. Drawing on the principles of least infringement, beneficence and non-maleficence, reciprocity, justice and fairness, and the harm principle—in addition to lessons from the current Ebola epidemic and other public health crises, including HIV/AIDS, SARS, and tuberculosis—the Bioethics Commission concluded that public health officials should implement the least restrictive measures that are effective in controlling disease transmission during a public health emergency.

The brief and all other Bioethics Commission reports are available at

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Bioethics Commission Releases Brief on Ebola and Ethics Preparedness for Public Health Emergencies

Today, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released a brief, Ethics and Ebola: Public Health Planning and Response, to the administration and the public on ethical preparedness for public health emergency response, with a focus on the U.S. response to the current Ebola epidemic in western Africa. The brief considers what lessons the U.S. response to the epidemic has for ethics preparedness for future public health emergencies, emphasizing the role of proactive democratic deliberation in developing responses that reflect public values in a pluralistic society and an increasingly interconnected world. The brief also considers two areas of particular controversy: 1) the ethical use of liberty-restricting public health measures, such as quarantine; and 2) the ethical conduct of research during public health emergencies.

In this brief the Bioethics Commission endorsed the ongoing participation of the United States in the global response to the Ebola epidemic for both ethical and prudential reasons. Public health crises like the Ebola epidemic often occur in countries and communities least equipped to manage and control them. The magnitude of suffering caused by these crises, and global inequalities in wealth and power that contribute to them, provide a strong moral imperative grounded in humanitarianism and justice to contribute to response efforts. In addition, given the capacity of infectious diseases to travel easily in an interconnected world, addressing epidemics at their source is justified on prudential grounds. Safeguarding national health security provides a strong pragmatic reason to respond to public health emergencies where they occur, and to support ongoing efforts to strengthen capacity and public health infrastructure in affected areas.

Strong international and U.S. federal public health infrastructures are essential for responding effectively to public health emergencies and their short- and long-term consequences. In Ethics and Ebola the Bioethics Commission recommended that the United States strengthen key elements of its domestic and global health emergency response capabilities, including leadership and global collaboration, and engage actively in effective public education and communication.

Ethics preparedness for emergency response, both at home and abroad, calls for an approach to policy making that prioritizes early public engagement, building consensus, and transparency. A proactive process of democratic deliberation before the onset of a crisis can inform and facilitate the development of public health policies that reflect shared values. However, democratic deliberation can be particularly challenging in the midst of a crisis, when information is changing rapidly, and policies and their implementation might need to be reconsidered. The Bioethics Commission recommended that ethical principles be integrated into public health decision making, and that qualified public health ethics expertise be readily available in an emergency to ensure that decision makers identify and respond to relevant ethical considerations in light of real-time available evidence.

In its next project the Bioethics Commission will consider in more depth the importance of democratic deliberation and public education in bioethics. The U.S. response to the Ebola epidemic in western Africa is a timely reminder of why broader public engagement in the ethical dimensions of health decision making is critical, both now and in anticipation of the future.

The brief is available at Look for additional blog posts about each of the brief’s recommendations to be posted to

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The Bioethics Commission and Ethics Integration at All Levels

This week, Research Analyst Elizabeth Fenton will present on behalf of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) at the Association for Practical and Professional Ethics Twenty-fourth Annual International Conference. The presentation is part of a four-day conference held by the Association for Practical and Professional Ethics (APPE), an organization founded to promote the advancement and teaching of practical and professional ethics. APPE’s annual conference has a number of different program tracks, including: bioethics, business ethics, environmental ethics, empirical ethics, media and journalism ethics, and research ethics.

Fenton’s presentation is part of the conference’s Bioethics track. Her presentation, “Bioethics Education: Presidential Bioethics Commission and Ethics Integration at all Levels and Across Disciplines,” highlights the Bioethics Commission’s pedagogical materials. Noting the need for improved resources to support ethics education, the Commission has committed to building a foundation of educational materials that can be used across a wide range of academic disciplines in a variety of settings using contemporary ethics issues. The educational materials produced by the Commission range from topic specific modules created to correspond to Commission reports, to primers for physicians, researchers, and patients; the Commission also offers Spanish translations for its materials related to its analysis of the unethical STD research conducted in the 1940s in Guatemala.

Fenton’s presentation will discuss the importance of integrating ethics into educational disciplines such as science, where ethical challenges frequently arise but where researchers might not have the skills or vocabulary needed to recognize or address them. Ethics integration promotes ethical conduct, professional responsibility, and engagement with the broader societal dimensions of research to enable thoughtful decision-making. The presentation will also highlight the need for further research to evaluate the best models for ethics integration.

“Ethics integration is very much a two-way street,” Fenton says. “It is a process in which experts in both ethics and science can become competent and literate in each other’s fields. When scientists develop a vocabulary for expressing ethical concerns, and ethicists have the scientific vocabulary to understand those concerns, both fields benefit.”

All educational materials developed by the Bioethics Commission are available for free on its website at Instructors are encouraged to access, use, and adapt the materials, provide feedback on their utility, and suggest improvements. We encourage comments or suggestions at

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New Educational Module from the Bioethics Commission on Community Engagement in Synthetic Biology

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted to a new educational module on community engagement in the context of synthetic biology. The module integrates material from the Bioethics Commission’s report New Directions: The Ethics of Synthetic Biology and Emerging Technologies (New Directions).

The aim of this module is to help instructors understand how community engagement can impact technological development and application of synthetic biology and other emerging technologies, as well as the importance of democratic deliberation for addressing the use of such technologies. The module identifies guiding ethical principles and describes how they promote engagement with the public and with affected communities.

Through discussion questions, scenarios, and exercises, the module guides instructors to help students consider the differences between public engagement, community engagement, and community-engaged research, and offers a timely example of the engagement process in synthetic biology. Illustrative examples that highlight potential benefits and challenges of community engagement include the production of algal biofuels, use of synthetic chemicals in consumer products, and development of drugs using synthetic biology techniques.

This module is the latest addition to the Bioethics Commission’s series of modules on community engagement, which includes background material and modules discussing community engagement in the contexts of human subjects research protection and privacy in whole genome sequencing. This module is also the first that the Bioethics Commission has developed based on its report New Directions.

All of the Bioethics Commission’s educational modules are based on ethical questions addressed by the Commission and provide instructors with foundational information, ethical analysis, discussion questions, problem-based learning scenarios, exercises, and additional resources to support ethics education and the integration of bioethical analysis into coursework across disciplines.

All Bioethics Commission educational materials are free and available at The Bioethics Commission encourages feedback on its materials at

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Rethinking the Global Response to Public Health Emergencies

Members of the Presidential Commission on the Study of Bioethical Issues (Bioethics Commission) are considering possible recommendations for future engagements in public health emergencies, including ethical approaches to conducting research in affected countries even in the midst of a crisis.

Yesterday’s deliberations touched on a wide range of issues generated by the ongoing Ebola epidemic in western Africa, from the ethics of using placebos in clinical trials, to the stigmatization of members of western African communities and health care workers who tended to the sick, to the need to improve the response to future outbreaks.

Commission members heard from a wide variety of speakers, including current and former government officials; leading experts in infectious disease, ethics, and global health; and people who belong to and work with communities both in western Africa and the U.S. who have been profoundly affected by the epidemic.

The day closed with a roundtable discussion at which Amy Gutmann, Ph.D., Chair of the Bioethics Commission, posed a simple question: “If there was one thing you think could be improved moving forward in the U.S. response to public health crises like Ebola, what would it be?”

The following are highlights from the panel’s recommendations:

“Throughout this whole outbreak…I always thought: wouldn’t it be nice to have an empowered and independent Surgeon General who could have spoken to the public in a clear, concise way. Somebody who was not micromanaged by the White House or other agencies could have been a game-changer.”
— Peter Hotez, M.D., Ph.D., Dean of the National School of Tropical Medicine at Baylor College of Medicine and President of the Sabin Vaccine Institute

“At the end of the day you can have the best public health system, but you have to build it on the backs of an educated community…As part of the (Ebola) crisis we are facing now, there are about five million kids across three countries who are in danger of missing a whole year of school and that has not been factored into most of the response we have seen. I think that the important intersection between education and health is part of a long-term sustainable solution (to public health challenges).”
— Chernor Bah, Chair of the Youth Advocacy Group at the Global Education First Initiative, and a former child refugee from Sierra Leone who has worked in all three countries affected by the recent Ebola epidemic

“Everyone needs a civics lesson about what states’ rights allow and what the federal government can do. The CDC was lambasted in the early days of the (Ebola case in Dallas) because they did not come in and save the day, without knowing that (legally) they would need to be invited (by Texas authorities) to do so.”
— Howard Markel, M.D., Ph.D., the George E. Wantz Distinguished Professor of the History of Medicine at the University of Michigan

“We need to stress in all messaging to the public the vital importance of structural factors, including inequities in health care in the U.S. and globally, to the spread and prevention of disease. I think that not only will improve people’s health, but it also is the best way to challenge stereotypes and myths about disease.”
— Dorothy E. Roberts, J.D., the George A. Weiss University Professor of Law & Sociology at the University of Pennsylvania

“We need to be better incorporate communications strategies and health literacy into public health strategies. During epidemics, we need to take that as seriously as we do surveillance and make it a key part of the public health response.”
— Seema Yasmin, M.D., a Professor of Public Health at the University of Texas at Dallas, and Staff Writer, Dallas Morning News

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This is a space for the members and staff of the Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

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