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

Bioethics Commission Participates in White House BRAIN Conference

At the White House BRAIN Conference yesterday, Lisa M. Lee, Executive Director of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) joined other representatives from federal agencies to discuss the progress and the goals of the BRAIN Initiative.  Her remarks, as part of the panel “Current Activities, Long-Term Goals, and Critical Components for Success,” follow.

Dr. Holdren, colleagues, honored guests:

Thank you for the opportunity to update you on the Bioethics Commission’s progress and role related to this White House Grand Challenge.

We all know that advances in biomedicine, science, and technology come with a range of ethical considerations.

The Bioethics Commission is an independent advisory panel comprising a variety of disciplines including law, philosophy, medicine, science, and engineering. We seek to identify policies and practices that will ensure that scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner.

So, we were delighted last year when President Obama asked us to review the ethical considerations associated with neuroscience research as part of the BRAIN Initiative.

Earlier this year, we released the first of two reports in response to his charge. That report: Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society. We’ve heard that word a lot today—”integrative”—and that’s my message here.

In Gray Matters the Commission called for adequate and clearly demarcated funding to achieve its recommendation of integrating ethics explicitly and systematically throughout neuroscience research.

Such integration allows us to incorporate ethical insights into the scientific process and to consider societal implications of neuroscience research from the very beginning.

Ethics integration – early and throughout research – can prevent the need for corrective interventions, and help build public trust in science. Integration prevents intervention.

We have collected public comments from professional organizations, affected communities and individuals and have engaged with the scientific community, all of whom bring to bear a variety of important perspectives on contemporary neuroscience.

We heard from many, including the Salk Institute, the Allen Institute, and the Kavli Foundation, and others.

In our first report, we actually recommended that BRAIN Initiative-related scientific advisory bodies include substantive participation by persons with relevant expertise in the ethical and societal implications of the neuroscience under consideration.

The Commission did not recommend a single model of integration – there are many good options and we reported on several of these. We did highlight DARPA’s exemplary work in this area. DARPA successfully combines several approaches to ethics integration including

  • Consulting with an independent panel of ethics experts,
  • Linking program managers with ethics mentors, and
  • Setting aside funds for ethics consultation.

In short – good science is ethical science. We point to DARPA’s example because we are keenly aware that ethics recommendations can be interpreted as just one more bureaucratic hurdle in the way of scientific discovery.

Clearly, DARPA’s integrated model has not hampered its progress or broken its bank.

Our commission works diligently to make practical recommendations— recommendations that both de-mystify ethics and facilitate good science. We know that so much can be gained from neuroscience research. And I think we all agree that we must ensure it does not come to a screeching halt because of one significant ethical lapse.

Thinking about these issues now and implementing our recommendations in a way that is compatible with your institution or agency can prevent that from happening.

Next, the Bioethics Commission is considering the implications of neuroscience research and its applications more broadly for our second report. We’re thinking about:

  • The ethical issues raised across stages of life – from infancy through old age,
  • And what neuroscience research might mean for various affected communities like those affected by Alzheimer’s disease, Parkinson’s disease, and mental illness.

These types of community engagement play a key role in our deliberations We expect to hold at least one additional public meeting – in November – before concluding our deliberations and making a final set of recommendations.

Since by now you’ve no doubt picked up our theme, that ethics integration – early and throughout research – prevents intervention, I will close simply by saying that, on behalf of the 11 Members of the Bioethics Commission, we are delighted to be a part of this initiative – from its very beginning.

Thank you.

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Neuroscience and Ethics: Integration Not Intervention

We’re pleased to take part in today’s White House BRAIN Conference. Check out our infographic that highlights our recommendations from Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society, the first of two reports on neuroscience and related ethical issues.

bioethics_integration

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New Education Materials on Compensation for Research-Related Injury

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted to Bioethics.gov a new series of educational modules on compensation for research-related injury. The materials on compensation increase the breadth of topics the Bioethics Commission’s educational resources cover; previous topics include community engagement, informed consent, and vulnerable populations. The new series includes a background module and two modules specific to Bioethics Commission reports: Moral Science: Protecting Participants in Human Subjects Research and Safeguarding Children: Pediatric Medical Countermeasure Research.

The “Compensation Background” module describes the goals of compensating individuals for research-related injury; provides ethical justification for compensation; discusses practical considerations, including informed consent and cost and feasibility; presents past U.S. historical context and advisory committee recommendations on compensation; and identifies current U.S. and international approaches to compensation. The module presents various models of compensation including insurance, personal insurance, specialty courts, and compensation funds.

The “Compensation in Moral Science: Protecting Participants in Human Subjects Research” module presents the Bioethics Commission’s examination of treatment and compensation for research-related injury. The module explains the ethical principles that support, and addresses challenges associated with, providing treatment or compensation for research-related injuries. The module describes international requirements and guidance concerning treatment or compensation for research-related injury; leads instructors through different models for compensating participants for research-related injuries and some of the strengths and weaknesses of each; and addresses the difference between compensation for research-related injury and reparations for past unethical research.

The “Compensation in Safeguarding Children: Pediatric Medical Countermeasure Research” module focuses on compensation for research-related injury in the context of pediatric medical countermeasure (MCM) research. The module outlines the ethical principles that support providing treatment or compensation for research-related injuries that arise from pediatric MCM research; describes the different arguments for treating or compensating injured adults and injured pediatric research participants; and addresses the various ways injured pediatric MCM research participants can seek treatment or compensation and the strengths and limitations of these approaches.

All of the learning modules are based on ethical questions addressed by the Bioethics 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 www.bioethics.gov/education. The Bioethics Commission encourages feedback on its materials at education@bioethics.gov.

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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 www.bioethics.gov/education.

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 education@bioethics.gov.

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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.

Blog.Bioethics.gov (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, Bioethics.gov. 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 www.bioethics.gov/education. The Bioethics Commission encourages feedback on its materials at education@bioethics.gov.

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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 (blog.bioethics.gov), take part in our webinars (Bioethicsgov) access and use our educational materials (bioethics.gov/education), 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 info@bioethics.gov. 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 www.bioethics.gov/education. Feedback on the materials is encouraged at education@bioethics.gov.

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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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About blog.Bioethics.gov

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.

Learn more about the Presidential Commission for the Study of Bioethical Issues.

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