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

Bioethics Commission FAQs from ASBH

Last week the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) attended the American Society for Bioethics and Humanities (ASBH) annual meeting, held in San Diego, California October 16-19. Along with leading multiple presentations, the Bioethics Commission was pleased to host a booth in the conference’s exhibition hall. The exhibit featured Commission reports as well as new communications materials. Several hundred copies of “Ethically Impossible” STD Research in Guatemala from 1946 to 1948, Safeguarding Children: Pediatric Medical Countermeasure Research, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings, and Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society flew off the table so quickly that we ran out of copies before the end of the conference’s second day. If you were not able to get a hard copy of your favorite report, all materials are available for free download on our website.

ASBH 2014 Booth

ASBH provided an opportunity to interact with many colleagues from across the bioethics community; many attendees reported using our educational resources in their classrooms. The Bioethics Commission welcomes feedback and likes to hear how its materials are being used, so if you have used our materials and are interested in sharing your experience, please email education@bioethics.gov!

The Bioethics Commission received many great questions at our exhibit. Here are some of the most commonly asked questions:

What is the Bioethics Commission currently working on?
The Commission is continuing its work on neuroscience. At its next public meeting on Nov. 5-6 in Salt Lake City, Utah, the Commission will be deliberating recommendations on neuroscience and related ethical issues. Gray Matters, Vol. 2, thefollow up to the May 2014 report Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society, is expected to be released in spring 2015 and will address important ethical issues related to applications and implications of neuroscience research.

In addition to neuroscience research and related ethical issues, the Bioethics Commission will begin discussions on its next topic – a self-directed topic – the role of deliberation and education in bioethics– at the November meeting. The Commission 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.

How does the Bioethics Commission choose the topics that it works on?
The Executive Office of the President may ask the Bioethics Commission to study a particular topic or answer a particular question and report back; Gray Matters and “Ethically Impossible” are examples of two reports that came at the request of the President. In addition, the Commission may accept suggestions of issues for consideration from executive departments and agencies and the public, as it deems appropriate in support of its mission.

How does the Bioethics Commission promote public bioethics?
All Commission deliberations occur in public during its quarterly meetings. Anyone who is interested may attend these public meetings, or watch the meeting via live webcast. These meetings allow for the unique opportunity to witness the live deliberations of a national bioethics commission—public bioethics in action. The Commission welcomes input from anyone wishing to provide public comment on any issue before it, and is particularly interested in receiving comments and questions during meetings that are responsive to specific sessions. Written comments are accepted in advance of each meeting; please address written comments by email to info@bioethics.gov. In addition, the Commission posts regular updates to its blog—blog.bioethics.gov—and to Twitter.

How do you get to be on the Bioethics Commission?
Each Commission member is selected by the Executive Office of the President and serves for the term of the Commission.

Are there any staff employment opportunities available?
Currently there are no openings for staff positions. When opportunities come up, we post all of our vacancies on our website under Employment Opportunities.

How do I get in touch with the Bioethics Commission?
The best way to contact the Commission is via email. All correspondence is reviewed and logged. For public comments and questions please email info@bioethics.gov; for comments on or questions about educational materials please email education@bioethics.gov.

What happens to the commission after President Obama’s term is over?
Like all federal advisory bodies, the Bioethics Commission must be renewed every two years. The Executive Order under which the Commission currently operates expires in September 2015. Even if President Obama again extends his order and issues an additional continuance for the Commission, it is expected that this Commission, in its current form, will complete its work at the close of President Obama’s term in January 2017. At that time, it is also expected – though not guaranteed – that the next president will establish his or her own bioethics commission.

Where can I access reports published by previous bioethics commissions?
The Presidential Commission for the Study of Bioethical Issues is a separate commission from those established by previous presidents, and therefore does not maintain archives for previous commissions. Our website provides links to various archived material from past commissions, including some links to previous commissions’ reports. Most of these archives are maintained by either Georgetown University or George Washington University.

Thanks to all who stopped by our booth this year!

 

 

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The “Brains” Behind the Bioethics Commission and Why a Multidisciplinary Approach is the Smartest Approach

Last month the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) was excited to take part in the first-ever White House BRAIN Conference. As a part of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, President Obama asked the Bioethics Commission to review the ethical issues associated with neuroscience research. In May, the Commission released Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society, the first of two volumes the Commission will produce in response to the President’s request. Vol. 2 is slated for release in spring 2015. The Bioethics Commission is pleased to play a key role in ensuring the incorporation of ethical considerations into neuroscience research, but just who are the brains behind those who advise about BRAIN?

“Our Commission is as multidisciplinary as a commission could be,” said Commission Chair Amy Gutmann, Ph.D., in a video from the Bioethics Commission. The newly posted video highlights the multidisciplinary nature of the group, and why it is critical that its members hail from a variety of fields.

“Bioethics touches so many aspects of medicine, of science, and of society, and I think it’s magnificent the way that our Commission is so diverse in terms of the backgrounds and perspectives of the people who are on the Commission,” says Commission Member Stephen Hauser, M.D.

“We have many different perspectives on very complex problems,” says Gutmann, “and if you put them all together and deliberate together, and you deliberate in public, I think we maximize the information, knowledge, and understanding that we can bring to bear on any bioethical issue.”

To view the video “Who is the Bioethics Commission” and to learn more about the Bioethics Commission, please to visit our YouTube page.

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Bioethics Commission to Offer Presentations at ASBH This Week

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) is pleased to offer multiple presentations at the American Society for Bioethics and the Humanities (ASBH) Annual Meeting, scheduled for October 16-19 in San Diego, Calif. Over the course of the four day conference Bioethics Commission staff will highlight a number of bioethical issues, including bioethics literacy, incidental findings, and the integration of ethics into neuroscience research.

Executive Director Lisa M. Lee, along with Mildred Solomon, President and CEO of the Hastings Center, will present “Bioethics Literacy across the Lifespan” on October 17 at 10:45 a.m. According to Lee, the talk will focus on more than just ethics education. “Just like bioethics is multidisciplinary, bioethics education is also multidisciplinary. It is not just about a bioethicist teaching a scientist,” said Lee. “Everyone, from organizational leaders to primary school teachers, has a role in ethics education.” The talk comes on the heels of the recent release of the Sept.-Oct. issue of The Hastings Report. The issue, themed “Teaching Bioethics,” is co-sponsored by the Commission and highlights a collection of papers on bioethics education, the Commission’s newly announced project.

On October 16 at 4 p.m., Bioethics Commission Associate Director Michelle Groman, along with representatives of the New York State Task Force on Life and the Law, will lead the panel “Take it or Leave it: the Role of Bioethics Advisory Bodies in Effecting Policy Change.” The panel will use several case studies in order to examine how the features and structure of a bioethics commission, along with the political and social climate, can impact a commission’s influence on changes to policy and law. Jason Schwartz, a former Commission staff member and current research associate and lecturer in bioethics at the Princeton University Center for Human Values, will moderate.

In addition to Lee’s presentation, October 17 will feature a second presentation by Bioethics Commission staff. At 8 a.m., Research Analyst Nicolle K. Strand will present her paper “The Cost of Misinformation: Consumer Remedies for Misleading Genetic Test Results,” examining the potential legal solutions for consumers to respond to misleading genetic test results, and considering questions of compensation.

On October 18 at 11 a.m., Bioethics Commission Associate Director Kayte Spector-Bagdady, Senior Policy and Research Analyst Karen Meagher, and Executive Director Lisa M. Lee will lead the panel “Applying the Ethical Management of Incidental and Secondary Findings in Context,” moderated by Research Analyst Nicolle Strand. The panel will build on the Commission’s recommendations on the management of incidental and secondary findings, discussing staff work from philosophical, public health, and legal perspectives.

Finally, on October 19 at 8 a.m., Michelle Groman, Bioethics Commission Associate Director; Debra Matthews, former Bioethics Commission staff member and current Assistant Director for Science Programs at the Berman Institute of Bioethics; and William Casebeer, formerly of the Defense Advanced Research Projects Agency (DARPA), will lead the panel “Integrating Ethics and Neuroscience Research: Recommendations from the Presidential Bioethics Commission and Integration in Practice.” The panel will focus on the Commission’s recommendations for ethics integration throughout neuroscience research, as presented in its most recent report Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society. DARPA’s efforts to integrate ethics into neuroscience research, as well as the integration of ethics and science through all levels of education will be discussed.

With a busy schedule, the Bioethics Commission looks forward to an educational and informative meeting. Be sure to stop by our booth in the exhibit hall. See you at ASBH!

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The Bioethics Commission’s Work on Incidental and Secondary Findings and the Applications for Neuroscience

Today, Senior Policy and Research Analyst Elizabeth Pike will present on behalf of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) at the conference “Emerging Ethical and Legal Challenges in Chronic Neurological Conditions.” The presentation is part of a two-day conference held at the Cleveland Clinic’s Global Center for Health Innovation and at the Cleveland Convention Center. Its goal is to explore dilemmas that arise in outpatient settings relevant to clinicians, ethicists, and public health scholars, and to provide practical ethical frameworks and tools to navigate these dilemmas.

Pike’s presentation will focus on the Bioethics Commission’s December 2013 report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. She will discuss how the Commission’s work on incidental and secondary findings can be applied specifically to neuroscience, and will reference two cases first presented at the Commission’s thirteenth public meeting on April 30, 2013. Sarah Hilgenberg and Carol Krucoff, both received incidental findings as a result of neuroimaging, one in a research setting and one in a clinical setting. Their cases help illustrate the practical, legal, and ethical implications of incidental and secondary findings. These implications vary depending on the context in which they arise and demonstrate the importance of preparing for both incidental and secondary findings when engaging in neuroscience clinical care or research.

Attendees at today’s conference include neurologists, neurosurgeons, psychiatrists, lawyers, advance care nurses, physician assistants, ethicists, psychologists, health services specialists and social workers. It is part of the larger “23rd Annual International Epilepsy Symposia” currently taking place in Cleveland, Ohio through October 11, 2014.

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Bioethics Commission Anticipates and Communicates in Webinar on Incidental and Secondary Findings

Two staff members of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) will lead the October 2014 webinar for Public Responsibility in Medicine and Research (PRIM&R). Elizabeth Pike, J.D., L.L.M., Senior Policy and Research Analyst, and Nicolle K. Strand, J.D., M. Bioethics, Research Analyst, will present “Anticipate and Communicate for IRBs: Ethical Management of Incidental and Secondary Findings” on Tuesday, October 7, 2014 from 1-2:30 p.m. The webinar will focus on helping IRB members and staff interpret the Bioethics Commission’s December 2013 report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. The webinar is free and open to both PRIM&R members and nonmembers; those wishing to attend the webinar are encouraged to register early online on the PRIM&R website.

The Bioethics Commission has defined incidental findings as discoveries that lie outside the original aim of a test or procedure; secondary findings are also not the primary target of the testing but, unlike incidental findings, they are actively sought. Anticipate and Communicate contains specific recommendations for the clinical, research, and direct-to-consumer settings as well as broader recommendations for the management of incidental and secondary findings to help anticipate and communicate unanticipated findings from research.

Pike will open the webinar with a summary of the 2013 report’s analysis and recommendations, focusing specifically on the research context. She will highlight the practical, ethical, and legal challenges to managing incidental and secondary findings in research and will discuss the role IRBs can play in implementing the Bioethics Commission’s recommendations.

In addition to the report, the Bioethics Commission has also released a number of educational materials for practitioners as well as recipients on incidental and secondary findings, and Strand will describe how IRBs can use the educational materials. Specifically, Strand will demonstrate how to use the Bioethics Commission’s IRB primer to conduct training sessions for IRB members to help prepare them as they assess plans on the management of these findings. In addition, Strand will describe a piece designed for research participants from the Bioethics Commission’s “Conversation Series”—a one-page description of incidental findings that might arise in research and how to prepare for them—and will demonstrate how researchers could use this additional resource as a part of the consent process.

Pike and Strand look forward to a robust question and answer session following the presentations.

All educational materials produced by the Bioethics Commission are available for free at http://bioethics.gov/education.

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“Engaging the Future Responsibly” with the Bioethics Commission

Tomorrow, Misti Ault Anderson, M.S., M.A., research analyst at the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission), will offer a plenary speech on ethics integration at all levels of education at the 16th International Conference on Ethics Across the Curriculum. The conference, sponsored by the Society for Ethics Across the Curriculum, will be held October 3-4 in Scottsdale, Arizona. The theme of this year’s conference is “Engaging the Future Responsibly,” with topics ranging from ethics in engineering and technology, to health sciences and graduate education.

Noting the need for improved educational materials to support ethics instruction in traditional and nontraditional educational settings, the Commission has committed to building a foundation of educational materials that can be used across a wide range of academic disciplines. Over the past five months, the Commission released three additional sets of educational materials, including a conversation series and primers on the ethical management of incidental findings in various contexts, and educational modules on vulnerable populations and compensation for research-related injury. These materials add to the Commission’s growing library of educational resources. In addition, the Commission recently announced its next report will focus on deliberation and education.

Anderson will point out that this commission is the first national level bioethics commission in the United States to develop educational materials around the contemporary issues addressed in its reports, many of which include recommendations encouraging increased and improved ethics education. The Commission’s expanding collection of educational materials reflects its commitment to support ethics education actively. All educational materials developed by the Commission are available for free on its website at www.bioethics.gov/education. Instructors are encouraged to access and use the materials, provide feedback on their utility, and suggest improvements. Comments or suggestions should be sent to education@bioethics.gov.

“Empirical research is still needed on approaches to integrating ethics at all levels of education, including undergraduate, graduate, and professional training,” said Anderson. “The Bioethics Commission encourages the academic community to advance this research, with the goal of strengthening ethics education across the curriculum because engaging the future responsibly starts with educating current and future professionals about ethical responsibility.”

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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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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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