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

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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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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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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