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

Just Published Hastings Center Report Highlights “Teaching Bioethics”

(This post also appears on Bioethics Forum.)

The topic “teaching bioethics” is highlighted and explored in the newly published issue of the Hastings Center Report, which contains a set of essays developed collaboratively by the Presidential Commission for the Study of Bioethical Issues and The Hastings Center. The set’s introductory essay acknowledges that basic bioethics literacy and training lag. But what are the best educational practices to prepare our scientists, health care providers – even those of us who are not in science or healthcare – who will most assuredly wrestle with bioethical issues at some point in our careers or our family lives?

The Bioethics Commission has made several recommendations since 2010 to improve bioethics education in the science and health professions, and The Hastings Center has also made bioethics education one of its strategic priorities. The collection of papers in the Sept.-Oct. issue of the Report and to be published across several future issues highlights the current status of best practices in bioethics education, describes the gaps that exist, and suggests approaches to fill them. Mildred Solomon, EdD, president and CEO of The Hastings Center, and Lisa M. Lee, PhD, MS, executive director of the Bioethics Commission, served as guest editors for the issue.

Last fall, the Bioethics Commission and the Center invited papers on several broad topics including: assessing the state of bioethics education (What work has been done? How do we evaluate it? What are potential measures? What is the research agenda?); incorporating professional, clinical, research, and public health ethics education into medical and STEM education at secondary, undergraduate, and graduate levels; methods for bioethics instruction (casuistry, decision-making frameworks, pedagogical innovations, interpreting the role of history); and best practices in bioethics education.

We encouraged manuscripts from individuals teaching in traditional and nontraditional settings and we received more than 80 manuscripts. With such an impressive response and with the need to stimulate work in this area so great, we are pleased that this Sept.-Oct. set of papers is just the beginning. The Report will publish a bioethics education essay in each of its issues throughout 2015.

“The papers… are meant to serve as a starting point for further reflection, writing, and debate,” Lee, Solomon, and Amy Gutmann, Ph.D., Chair of the Bioethics Commission, wrote in the set’s introductory essay.

To keep this conversation going Solomon and Lee will also offer a special session at the American Society for Bioethics and Humanities 16th Annual Meeting in San Diego on Friday October 17: “Bioethics Literacy Across the Lifespan.” They will describe transformative learning as an approach to ethics education in science technology, engineering, and mathematics and outline research needs for the development of evidence-based pedagogy.

“Developing and sharing a body of literature on best practices of teaching bioethics, and continuing the conversation at key conferences are two important steps in developing a community of practice. Ideally there will someday exist an online forum in which traditional and nontraditional educators across disciplines can share best practices, course materials, and other helpful information with one another,” Lee said.

In addition to working with The Hastings Center to produce this set of essays, the bioethics commission has committed to developing its own set of pedagogical materials, based on its contemporary analysis and its reports, to further support bioethics education. The materials can be found at

Comments on the set of essays in the Report, thoughts on the need for bioethics literacy, or feedback about the Bioethics Commission’s pedagogical materials are welcome at

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What is Democratic Deliberation? A Q&A with Bioethics Commission Chair Amy Gutmann

Amy Gutmann, Ph.D., Chair of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission), has written eloquently about the idea of democratic deliberation. We asked her to explain this principle and discuss how it has influenced the work of the Bioethics Commission. (B.B.G): What is democratic deliberation?

Amy Gutmann (A.G.): The best any democracy can do in the face of disagreement on complex issues is to have deliberation among a wide range of experts and involved citizens in a way that is transparent to the public. Open and robust dialogue is at the very heart of deliberative democracy, and I’ve worked hard to imbue the work of the Bioethics Commission with that principle.

Deliberative democracy is the opposite of sound-bite democracy. Democracies do better when people discuss – robustly and respectfully argue about – their differences. It’s the give-and-take of viewpoints with an aim of finding common ground and reaching mutual respect among citizens where that common ground is not possible. The common good of democracy includes living respectfully with our differences, while continually aspiring to create a society–and world–that is just for all.

B.B.G.: What is the purpose of the Bioethics Commission and how does democratic deliberation play a role?

A.G.: First and foremost, the Bioethics Commission is here to provide advice and guidance to President Obama to help him and his administration navigate the challenging questions that arise in our evolving and very complex era of biomedicine. Advances in biomedical research and related areas of science and technology can often create a range of ethical dilemmas. The Bioethics Commission seeks to identify and promote policies and practices that ensure that scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner.

Good policy is based on good advice. The Bioethics Commission’s job is to offer practical public policy advice grounded in scientific evidence and in debate on philosophical and ethical principles. The best advice we can give comes from respectful deliberation based on the best evidence available after a thorough review of the ethical implications. The Commission’s work is fully transparent and is conducted in public in a manner in which experts and members of the public can engage in high level and productive discussion.

B.B.G.: There are many ethical principles on which to ground the Bioethics Commission, why democratic deliberation?

A.G.: My commitment to learning, to service, and to open and respectful deliberation is in many ways an homage to my parents. My mother was a natural teacher, but she had no choice but to put her dream on hold–since she could not afford a college education and had to support her family during the Great Depression. My father escaped Hitler’s Germany in 1934, and also saved the lives of his family by urging and enabling them to join him shortly thereafter in India.

My parents were extraordinary people with great values, foresight, generosity, and courage, who had a powerful faith in America as the land of opportunity.

I bring those values and their example to bear at the Bioethics Commission. And I believe that it has served us well. From synthetic biology to reviewing the ethical considerations of conducting clinical trials of medical countermeasures with children we have tackled some incredibly complex issues. It is a challenge that we embrace and the democratically deliberative process is key to finding common ground and an ethically sound path forward.

B.B.G.: Can you say a little about how the Commission balances a commitment to transparency and the need for a free exchange of ideas among its members that may be more likely to occur in a non-public setting?

A.G.: All deliberations of the Bioethics Commission occur at our public meetings. Some subcommittee work is done before those public meetings, but the subcommittees must present and report to the Commission as a whole and the Commission as a whole must discuss those findings before any recommendations can be deliberated.

B.B.G.: How do you think the Commission is doing as a deliberative body and what role can an “advisory commission” have in deliberative democracy?

A.G.: The Bioethics Commission Members need not – and do not – all agree on everything all of the time.  Instead, we clearly identify critically important ethical and scientific issues and we reach consensus on what advice to offer on how to navigate these issues of public importance.  On this advice, the Bioethics Commission has consistently reached consensus through our public deliberations.



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New Educational Modules on Vulnerable Populations

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted a new series of educational modules on vulnerable populations on its website, These include a background module on vulnerable populations, as well as report-specific modules on vulnerable populations in two Bioethics Commission Reports: Safeguarding Children: Pediatric Medical Countermeasure Research and “Ethically Impossible”: STD Research in Guatemala from 1946 to 1948.

The “Vulnerable Populations Background” module describes vulnerability and how the term “vulnerable populations” is traditionally defined; provides historical examples of research that exploited vulnerable populations; explores ethical principles applicable to research with vulnerable populations; and identifies various codes of conduct, guidelines, and regulations that shaped human subjects research protections generally, and protections for research with vulnerable populations specifically. To illustrate the history of human subjects research and the emergence of special protections for vulnerable populations, the module also includes a timeline of notable research and related events.

The “Vulnerable Populations in Safeguarding Children: Pediatric Medical Countermeasure Research” module focuses on children as a vulnerable population generally, and on pediatric medical countermeasure (MCM) research specifically. This module provides instructors with an explanation of the ways that children are vulnerable; current regulations for protecting children in pediatric research, including the Bioethics Commission’s ethical framework to guide national-level review of pediatric MCM research when appropriate; as well as scientific, practical, and ethical challenges of conducting MCM research with children.

The third module highlights the Bioethics Commission’s analysis on vulnerable populations in “Ethically Impossible”: STD Research in Guatemala from 1946 to 1948.” The experiments in Guatemala involved the intentional exposure of vulnerable populations—prisoners, soldiers, psychiatric patients, and commercial sex workers—to sexually transmitted diseases without their consent. For guided readings and discussion questions about vulnerable populations in the U.S. Public Health Service STD research studies in Guatemala, the module refers instructors to A Study Guide to “Ethically Impossible” STD Research in Guatemala from 1946 to 1948.

All of the vulnerable populations modules are based on the contemporary issues addressed by the Bioethics Commission and aim to provide instructors with foundational information, ethical reasoning, applications, questions, discussion points, and additional readings to support ethics education and integrate bioethical analysis into existing curricula across disciplines.

Future modules on vulnerable populations will integrate other reports from the Bioethics Commission.

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

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Celebrating a Social Media Milestone: 1,000 Followers on Twitter! #Publicbioethics

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has just reached 1,000 followers on Twitter. This social media milestone is the perfect opportunity to take a moment and thank all of you who follow us (@Bioethicsgov), read our blog (, take part in our webinars (Bioethicsgov) access and use our educational materials (, attend our meetings, provide comments on any of our projects, and otherwise engage with us in what Edmund Pellegrino called “doing ethics in the public square.”

Advances in biomedical research and related areas of science and technology can create a range of ethical dilemmas, and the President established our commission to advise him and his administration as the country navigates the challenging questions that arise. For example: Can the U.S. government ethically conduct pediatric research on medical countermeasures, like an anthrax vaccine? Our nation must protect children enrolled in research studies while also doing its best to develop the knowledge needed to save children’s lives during a possible emergency. Another example: How do we protect individual privacy but share highly personal genomic and neuroscientific data widely enough in order to make important scientific progress?

The Bioethics Commission seeks to identify and promote policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner. We report to the President, but our work is not for the President’s eyes only – far from it. We are fully transparent and conduct our meetings and deliberations in public. In so doing, we help educate the nation on bioethical issues. But that is just part of how we engage in public bioethics.

To engage the community, our public meetings are held at various sites nationwide, webcast live, and bring our members and a wide variety of subject-matter experts together for information sharing and open deliberation. These sessions play an integral role in shaping our final reports and recommendations.

Comments from the public also play an important role in our deliberations. Through the Federal Register we call for comments related to each of our projects; and we encourage comments at any time through All comments are reviewed and logged, including those written and submitted during each of our public meetings; they are just part of a process that ensures a variety of perspectives are included during our deliberations.

Social media, such as Twitter, seemed a natural next step as we continue to explore what public bioethics is and can become. This commission is proud to be the first U.S. Bioethics Commission to engage the public via Twitter. For more about how this commission works, we hope you will watch this video.

And thanks again for following us on Twitter! Proud to be 1,000 strong.



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Commission to Formally Take up Issue of Bioethics Education: Builds Growing Body of Educational Materials

At Wednesday’s public meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission), Amy Gutmann, Ph.D., Commission Chair, announced that the Commission’s next topic would integrate education and deliberation.

“I am pleased to announce that we will begin work on a new project in the coming months: a report that will integrate two overarching themes of our work – education and deliberation. We will focus on their symbiotic relationship as twin pillars of public bioethics. Education is required for informed deliberation, and deliberation enhances education at all levels,” Gutmann said. “We are well positioned to make an important contribution in this area, and I look forward to working with all of you on it.”

The Bioethics Commission has noted the need for bioethics education improvement in many of its reports. A formal report with recommendations, plus continuing to develop easily accessible and free materials based on the Commission’s own analysis are efforts to help meet that need. The Commission believes that given the multidisciplinary nature of science and research, bioethics education should be available to a wide variety of disciplines at the undergraduate, graduate, and professional levels.

It has been almost a year since the Bioethics Commission introduced its first educational modules based on contemporary issues addressed by the Commission. Since it posted that first round Commission staff has produced more than 15 modules and primers based on five Commission reports.

The materials are free for use by educators and professionals in traditional and non-traditional settings across a variety of fields. Additional modules in the Bioethics Commission’s pipeline will add to the growing body of pedagogical materials the Bioethics Commission has developed to support bioethics education. New modules will explore topics such as vulnerable populations, compensation for research-related injury, privacy, and research design in light of contemporary biomedical and scientific challenges. Like previous modules, future materials will facilitate teaching and discussion.

Vulnerable populations in human subjects research will be addressed by drawing from Bioethics Commission reports “Ethically Impossible” STD Research in Guatemala from 1946 to 1948 and Safeguarding Children: Pediatric Medical Countermeasure Research. “Ethically Impossible” examined the ethical violations that occurred during research on sexually transmitted diseases in Guatemala in the 1940s. In Safeguarding Children, the Commission advised the U.S. government on the ethical considerations involved in evaluating and conducting pediatric research on medical countermeasures responding to a bioterrorism attack.

In addition, compensation for participants who are injured as a result of their taking part in research will be highlighted in a second set of modules using Safeguarding Children and the report Moral Science: Protecting Participants in Human Subjects Research. In Safeguarding Children, the Commission considered the importance of compensation in the context of pediatric medical countermeasure research. In Moral Science, the Bioethics Commission assessed contemporary standards that protect participants in human subjects research, including those concerning treatment and compensation for research-related injury.

Community engagement rounds out the set of new modules and is based on New Directions: The Ethics of Synthetic Biology and Emerging Technology. Before releasing New Directions, the Commission engaged with a wide variety of stakeholders to identify the appropriate ethical boundaries within the field of synthetic biology to maximize public benefits while minimizing harm. This module will add to an existing set of resources on community engagement from Moral Science and the report Privacy and Progress in Whole Genome Sequencing. Additional module sets on privacy and research design are also planned to accompany the Commission’s reports Privacy and Progress and Safeguarding Children.

All of the educational materials released by the Bioethics Commission are versatile and can be used in many ways to integrate bioethics into course curricula, discussions, and professional development activities. This versatility underscores the Commission’s commitment to advancing bioethics education across the academic curriculum. Each module includes background information, learning objectives, discussion questions, suggested additional readings, and practice exercises to support instructors as they develop their presentations. For examples about how one module might be used to reach different class audiences, check out our webinar: “Multidisciplinary Implementation of Bioethics Commission Education Materials.”

All Bioethics Commission educational materials are freely available at Feedback on the materials is encouraged at

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Roundtable Discussion: Identifying Priority Ethical Questions in Neuroscience Research and Applications

An in-depth roundtable discussion involving both members and presenters wrapped up today’s Washington, D.C. meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission).

Today’s meeting was in response to President Obama’s request, as part of the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative, that the Bioethics Commission review the ethical issues associated with the conduct of neuroscience research and implications of its findings.

Amy Gutmann, Ph.D., Chair of the Bioethics Commission, kicked off the session by requesting that panelists, “pick one piece of advice you’d like us to take into account.”

The following are highlights from the discussion that ensued:

“We need to think about… things such as education plans to help physicians and practitioners think through what they’re going to do when they have a young person come in their office and say, ‘Hey, I’d like this cause it would help me get through my test.’…We look at [cognitive enhancement] too narrowly and we need to treat it as a complex issue. ” – Rear Admiral Peter J. Delany, Ph.D., LCSW-C, Director of the Center for Behavioral Health Statistics and Quality at the Substance Abuse and Mental Health Services Administration (SAMHSA).

“I think one might characterize bioethics as the effort to try to prevent that which should not be done and enable that which should be done. Traditionally, I think the emphasis has been much more on the former—preventing that which should not be done. But, particularly within the enhancement arena, I think there is a big opportunity to start playing the second role:  to try to enable that which should be done. By looking for opportunities for things that would be very valuable and seeing what it is that hinders advancement in that area, particularly… regulatory framework [which] might be unsuitable for enhancement medicine.” – Nick Bostrom, Ph.D., Professor in the Faculty of Philosophy, Director of the Future of Humanity Institute, and Director of the Programme on the Impacts of Future Technology at University of Oxford.

“I think it’s a bit unusual in that we have a melding of federal provisions and state provisions… To what extent should we be adding a more federal system that doesn’t look so much to state law [for guidance on informed consent]?” – Jerry Menikoff, M.D., J.D., Director, Office for Human Research Protections, U.S. Department of Health and Human Services.

“Giving people 20 page single-spaced consent forms, having research assistants read the 20 page forms to them—both of which are sort of standard practice—doesn’t work well for anybody, but they are going to work less well for [potential research participants with diminished or diminishing capacity to consent]. So this might be an area in which particularly to encourage experimentation on the part of investigators and [internal review boards] to come up with and to support creative ways of conveying information and getting consent from participants.” – Paul S. Appelbaum, M.D., the Elizabeth K. Dollard Professor of Psychiatry, Medicine & Law; Director of the Division of Psychiatry, Law, and Ethics; Director of the Center for Research on Ethical, Legal & Social Implications of Psychiatric, Neurologic & Behavioral Genetics in the Department of Psychiatry at Columbia University.

“I think bad science hurts everyone doing science…  There are a lot of these grandiose hopes for what might be accomplished in the new BRAIN Initiative and DARPA Initiative and again it’s going to have to be iterative step wise. No one is going to get to make the Hail Mary pass just because they throw a lot of money at it. And that it’s not about money, it’s about stepwise progress and science will move at the speed that it does.” – Helen Mayberg, M.D., Professor of Psychiatry, Neurology, And Radiology, and the Dorothy C. Fuqua Chair, Psychiatric Neuroimaging and Therapeutics at Emory University School of Medicine.

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Who Can Consent to Neuroscience Research?

In the fourth series of the presentations from today’s public meeting on neuroscience and related ethical issues, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) addressed questions related to the capacity to consent to neuroscience research.

The Bioethics Commission heard from two experts in the field: Jerry Menikoff, M.D., J.D., the Director of the Office for Human Research Protections at the U.S. Department of Health and Human Services; and Paul S. Appelbaum, M.D., the Elizabeth K. Dollard Professor of Psychiatry, Medicine, & Law, and the Director of the Division of Psychiatry, Law, and Ethics in the Department of Psychiatry at the College of Physicians and Surgeons of Columbia University.

Menikoff focused on the guidance provided by the Office of Human Research Protections about research with those with diminished or diminishing capacity—such as those who have advanced Alzheimer’s disease—and their ability to consent to taking part in neuroscience research.

“Generally, a researcher has to obtain a legally effective informed consent of the subject or the subject’s legally authorized representative,” said Menikoff. However, he went on to explain that while the definition does not sound complicated, its implementation can be.

“If you conclude that they did have the capacity and it’s correct, you’re pretty good,” continued Menikoff. “Once you’ve concluded they do not have the capacity, we are now in the area, as you all know, where the rules are very unclear.”

Appelbaum—who is also a research psychiatrist at the New York State Psychiatric Institute and an affiliated faculty member at Columbia Law School, where he directs Columbia’s Center for Research on Ethical, Legal, and Social Implications of Psychiatric, Neurologic, and Behavioral Genetic—discussed how to assess decisional capacity in neuroscience research.

“There may be, but is not necessarily going to be, decisional impairment in people with neuropsychiatric illness,” said Appelbaum. “You can screen for incapacity reliably and validly.”

Appelbaum concluded, “Although we very much want to protect incapable subjects from making bad decisions, we need to balance that desire against the real societal interest of having people make their own decisions.”

With today’s discussions, including this session on capacity to consent, the Bioethics Commission is working to address President Obama’s request that it identify core ethical standards to guide neuroscience research and address potential ethical dilemmas arising from the application of neuroscience research.

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Identifying the Ethical Considerations in Neuroscience Research, Clinical Innovations and Applications

As it continued today’s meeting on neuroscience, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) turned its attention to potential clinical applications and innovations that may stem from neuroscience research. President Obama asked the Bioethics Commission to consider the ethical issues associated with neuroscience as part of the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative.

This panel included Steven L. Small, Ph.D., M.D., the Stanley van den Noort Professor and Chair of the Department of Neurology, Professor of Neurobiology and Behavior, Professor of Cognitive Sciences, and Director of the Neuroscience Imaging Center at the University of California, Irvine; Paul J. Ford, Ph.D., the Director of the NeuroEthics Program and Education Director for the Department of Bioethics at the Cleveland Clinic and Associate Professor at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University; and Helen Mayberg, M.D., a Professor of Psychiatry, Neurology, and Radiology and the Dorothy C. Fuqua Chair of Psychiatric Neuroimaging and Therapeutics at the Emory University School of Medicine.

Small offered an overview of the current science and began by highlighting the emergence of high performance computing that can crunch vast amounts of data, demonstrating the advances currently being made in the field. Small then identified areas he believes should become research priorities including brain circuit analysis, a field with the potential to help patients with epilepsy or those who have suffered a stroke or spinal cord injury; personalized medicine based on biomarkers or anticipating how an individual’s brain might react to a treatment; brain circuit alterations, using both invasive and non-invasive technologies; and brain computer interfaces. With these various technologies, Small listed several ethical concerns that must be considered, including irreversible changes, new understandings of data, and how these tools and the results they could produce might be used.

Ford turned the conversation to research participation, emphasizing a need to identify the factors that allow researchers to ethically select participants in scientific studies on clinical neuroscience innovations.  Specifically, Ford argued for ethical guidelines to allow for the inclusion of vulnerable patients in research, especially those who might benefit from participation. Ford also emphasized that in this type of research it is essential to view patients as collaborators. For example, he described research on Parkinson’s disease and deep brain stimulation in which a research participant asked for less control over an implanted neurological device than what researchers initially had assumed.  “If we hadn’t asked, we wouldn’t have known,” Ford reflected.

Mayberg concluded this panel’s presentations with “Research Design Considerations for Studies Using Invasive Brain Devices.”  She explored ways to ensure that research using invasive brain technologies was both ethical and scientifically rigorous.

“With brain imaging we have more information than we want,” said Mayberg. “And we are trying to reduce down the necessary and sufficient amount so that we can think about why we might want to invade the brain and tune it in some way, where we might do that, how we might do that, and who we might do that to.”

Additionally, Mayberg spoke about the need to be able to refine human subjects research that uses neurological implants, noting that a key step is identifying at what point researchers should end the study rather than continue to revise and iterate. “The question is how to know the difference. You need a framework to go in either direction.”

Up next, the Bioethics Commission discussed the issue of capacity to consent to research.

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Direct-to-Consumer Neurotechnology: Ethical Applications Today and Tomorrow

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) heard this morning from a panel of experts representing the neurotechnology sector and regulatory agencies on the ethical considerations in direct-to-consumer (DTC) sales of neurotechnologies. The Bioethics Commission is reviewing the ethical issues associated with the application of neuroscience research in response to President Obama’s request as part of the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative.

Starting off the conversation, John Reppas, M.D., Ph.D., the Director of Public Policy at the Neurotechnology Industry Organization, discussed the current state of the DTC neurotechnology market. Breaking direct-to-consumer neurotechnologies into two categories, Reppas discussed technologies that measure data and have back-end technologies to analyze data, as well as devices that send artificially generated signals into the brain or body.

“Measurement devices are considered quite safe,” said Reppas. “For this product class, the major real-world concern would center on data privacy and ownership, as well as how that data ends up being presented back to the consumer,” said Reppas.

For products that aim to change ongoing brain function to produce specific behaviors, like relaxation or more efficient learning, Reppas said that “the ethical imperative is to make sure that these products don’t have unanticipated long-term effects on user behavior or health.”

On the question of how these technologies should be regulated, Reppas argued that the neurotechnology sector has been safe and use of these technologies often changes once they’ve reached the market.

Carlos Peña, Ph.D., M.S., the Director of the Division of Neurological and Physical Medicine Devices in the Office of Device Evaluation at the Center for Devices and Radiological Health in the U.S. Food and Drug Administration (FDA) focused on the steps that the FDA takes to regulate new products, including past efforts to regulate neurological devices such as deep brain stimulators, neurodiagnostic devices, and therapeutic devices for migraines.

Picking up the conversation of FDA regulation, Freddie Ann Hoffman, M.D., CEO of the consulting firm, HeteroGeneity LLC and Former Deputy Director of the Medicine Staff in the Office of the Commissioner at the U.S. FDA, shared her expertise on past FDA regulatory requirements, specifically with regard to the Dietary and Supplement Health and Education Act. Hoffman focused primarily on the regulatory standards that exist for dietary supplements and drugs to help establish the framework into which neurotechnologies must fit.

“There are specific legal assumptions that surround these two categories,” explained Hoffman. “Dietary supplements are intended to supplement the diet of healthy, normal individuals for which no risk is really tolerable, versus drugs which are intended for use by a population for which the benefit has been proven to outweigh the risks.”

Wrapping up the panelist’s presentations, Deven McGraw, J.D., M.P.H., LL.M., focused on privacy issues. McGraw is a partner at Manatt, Phelps & Phillips, LLP and Former Director of the Health Privacy Project at the Center for Democracy and Technology. Discussing existing regulations to protect privacy, McGraw explained that DTC neurotechnology is not clearly regulated under the Health Insurance Portability and Accountability Act (HIPAA) privacy rule.

“HIPAA generally is not going to apply in the context of DTC technology; it has very limited coverage,” said McGraw. “The DTC space is collecting a lot of health data…and is not going to be covered. Most medical devices are not covered, as well.”

McGraw went on to explain where there is currently authority to regulate these types of devices within the Federal Trade Commission (FTC). “It isn’t the case that this is a completely unregulated space. The data and the use of it are regulated to some extent by the FTC,” said McGraw. “The FTC has authority to prevent and seek redress for unfair acts or practices. They have very broad authority and they’ve used it to penalize some consumer-facing for-profit companies for failing to abide by a privacy policy.”

However, McGraw explained, “[the FTC] doesn’t set a comprehensive set of guardrails and rules on the data being collected on these devices.”

Following lunch, the Bioethics Commission will return to hear about clinical innovations through neuroscience research.

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Considering the Ethical Implications of Cognitive Enhancement

As part of the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative, President Obama asked the Presidential Commission for the Study of Bioethical Issues (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.” As the Bioethics Commission resumes its consideration of these ethical issues, it turned this morning to the ethical implications of cognitive enhancement specifically.

The session featured Peter Reiner, V.M.D., Ph.D., from the University of British Columbia’s National Core for Neuroethics, Kinsmen Laboratory of Neurological Research, and Brain Research Centre; Rear Admiral Peter J. Delany, Ph.D., LCSW-C, Director of the Center for Behavioral Health Statistics and Quality at the Substance Abuse and Mental Health Services Administration (SAMHSA); Adrian Raine, Ph.D., the Richard Perry University Professor of Criminology, Psychiatry, and Psychology at the University of Pennsylvania; and Nick Bostrom, Ph.D. a professor in the Faculty of Philosophy at the University of Oxford and founding Director of the Future of Humanity Institute.

Starting off the conversation with a presentation titled, “Cognitive Enhancement Past, Present and Future,” Reiner discussed the definition of cognitive enhancement. In doing so, he explained both the historic understanding and looked forward to how this definition is evolving.

“Cognitive enhancement is more complicated than it seems at first blush,” explained Reiner. “We’re already well on our way to enhancing ourselves with all sorts of drugs, devices and more.”

“I’d submit as we move forward we need to give a fair hearing to the public’s enthusiasms and fears, their utilitarian dreams and their visions for societal harmony for these are the norms to which our policies should hew,” Reiner concluded.

Delany, who oversees a SAMHSA program to collect, analyze, and disseminate critical public health data on substance abuse, mental illness, and related disorders, spoke briefly about how common cognitive enhancement is today, and how we might be able to reliably track both the prevalence of cognitive enhancement and results—both potential benefits and harmful outcomes.

Focusing on prescription drugs like Adderall and Ritalin, Delany explained that data show that people—especially college age students—who use cognitive enhancements also have increased use of other substances such as alcohol, marijuana or cocaine.

Raine later moved the discussion to the potential implications of nutrition as a cognitive enhancer and the possible use of nutritional supplements to alter behavior.

Citing extensive correlational studies about consumption of Omega-3 and a reduction in anti-social behaviors, Raine raised several ethical questions about the use of natural compounds, like fish oil, as a cognitive enhancer.

“To what extent is Omega-3 really different to drugs, medication?” asked Raine. “Our bodies don’t produce Omega-3. Yes, it’s natural, but in some ways it’s nothing short of a drug.”

“We wouldn’t give drugs to sedate prisoners. We wouldn’t give drugs to children to reduce their anti-social and aggressive behaviors. So why would we give Omega-3 to reduce such behaviors that aren’t wanted in society?” asked Raine.

Rounding out the morning’s first session, Bostrom addressed concerns in ensuring fair and equal access to cognitive enhancements, especially given the potential benefits both on an individual level and a societal level.

“There are already large inequalities in cognitive capacities—partly biological, partly because different people have different amounts of education, and so forth,” said Bostrom. “One question that one can ask about a hypothetical new cognitive enhancement intervention is whether it would increase or decrease that. That might partly depend on the system we have to access [the enhancement].”

Up next in this busy day, the Bioethics Commission will consider questions around direct-to-consumer neurotechnology.

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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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