Nicolle Strand – The blog of the 2009 - 2017 Presidential Commission for the Study of Bioethical Issues Mon, 09 Jan 2017 23:23:29 +0000 en-US hourly 1 Bioethics Commission Closes Meeting with Roundtable Discussion Wed, 31 Aug 2016 19:27:37 +0000 This afternoon, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) closed its meeting with a roundtable discussion of the impact of bioethics advisory bodies past, present, and future.

Amy Gutmann, Ph.D., Chair of the Bioethics Commission, asked each panelist to identify one important idea or action that encapsulated their thoughts for the day.

Highlights from the discussion include:

Jonathan Montgomery, LL.M., HonFRCPCH, Chair, Nuffield Council on Bioethics, focused on curating topics so as not to reiterate too heavily what past commissions have already discussed.

Eugenijus Gefenas, M.D., Ph.D., Chairperson, Bureau of the Intergovernmental Bioethics Committee, UNESCO, observed that continuity of name and staff of commissions would improve continuity, even across administrations.

Rebecca Dresser, J.D., Daniel Noyes Kirby Professor of Law, Washington University in St Louis, said: “Get out of the bioethics bubble.” She emphasized the experience and knowledge necessary for well-rounded composition of commissions.

Harold T. Shapiro, Ph.D, President Emeritus, Professor of Economics and Public Affairs, Princeton University, said that external review is necessary for quality work product.

Ruth Macklin, Ph.D., Distinguished University Professor Emerita at the Albert Einstein College of Medicine, urged diversity of membership and the importance of including a variety of perspectives.

Robert Cook-Deegan, M.D., Professor, School for the Future of Innovation in Society, Arizona State University, suggested the importance of using relevant expertise to deliberate.

Alexander M. Capron, L.L.B., Scott H. Bice Chair in Healthcare Law, University of Southern California, said “bioethics is a field of inquiry,” and emphasized that individuals should bring their own knowledge and experience from their disciplines to the table.

Thomas H. Murray, Ph.D., President Emeritus, The Hastings Center, said that commissions should “develop robust communication strategies for key audiences,” emphasizing the important role that commissions play in outreach and education.

Members and panelists then engaged in a discussion about what topics will be relevant for a future commission to take up, how they should deliberate, and what their role in society and politics should be. Check out in the next few weeks to watch the archived webcast or read the transcripts.

Thanks for joining us today.

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Presenters’ Additional Reflections on Bioethics Advisory Bodies Wed, 31 Aug 2016 17:58:54 +0000 Presenters at today’s Bioethics Commission meeting continued their discussion on the impact of bioethics advisory bodies. Future efforts in bioethics and health policy can take into account lessons learned from the experiences of advisory bodies before them.

In the third session of the day, the Bioethics Commission heard from a variety of speakers considering the past, present, and future impact of such groups. Presenters included Ruth Macklin, Distinguished University Professor Emerita in the Department of Epidemiology and Population Health at the Albert Einstein College of Medicine and Harold T. Shapiro, President Emeritus and current Professor of Economics and Public Affairs at Princeton University. In addition, the commission heard from Rebecca Dresser, Daniel Noyes Kirby Professor of Law at Washington University in St Louis, and Eugenijus Gefenas, Chairperson, Bureau of the Intergovernmental Bioethics Committee for the United Nations Educational, Scientific and Cultural Organization (UNESCO).

Ruth Macklin previously presented before the Bioethics Commission during Meeting 6 on the topic of international research ethics. Today, she spoke of her time on the Advisory Committee on Human Radiation Experiments (ACHRE) (1994-1995) under President Clinton. She also spoke about her membership as a staff consultant on NBAC, and the challenges of writing reports while commission members were changing their minds about recommendations. She spoke about maintain intellectual and moral integrity, when writing on behalf of others’ views.

Harold T. Shapiro drew from his time as Chair on the National Bioethics Advisory Commission under President Clinton (1995-2001) and as a member of the Council of Advisors on Science and Technology under President George W. Bush. He noted that we need to be specific about what bioethics is, what topics are important, and what kind of experts are needed to deliberate. He emphasized that whatever structure a bioethics commission takes, the important factor is that the leadership has access to people who can make change.

Rebecca Dresser previously spoke before the Bioethics Commission during Meeting 17 regarding ethical and societal implications of neuroscience, commenting on research protections for participants who might have impaired consent capacity. Today, she considered her time on the President’s Council on Bioethics under President George W. Bush, offering her own insights about what can happen when bioethics is conducted in the national spotlight, especially when the debates have partisan political aspects. She learned that people of different views can engage in civil debate, despite diverse backgrounds and moral commitments. “Deliberation in bioethics should expand to include the voices of as many possible of those now excluded,” she said.

Eugenijus Gefenas reflected on his experience on UNESCO’s Intergovernmental Bioethics Advisory Committee. He observed “Europe is a good example of capacity building for bioethics committees,” because the countries are different in terms of economics and size. He described some challenges that national bioethics advisory bodies face, including the difficulty of directly implementing recommendations and of measuring impact.

Next up: a roundtable discussion with all of our presenters from today’s meeting. Stay tuned!

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Presenters Reflect on National Bioethics Advisory Bodies Wed, 31 Aug 2016 15:00:45 +0000 In the second session of the day, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) heard from a series of speakers reflecting on the past, present, and future impact of national bioethics advisory bodies. Presenters included Robert Cook-Deegan, Professor at the School for the Future of Innovation in Society at Arizona State University; Alexander M. Capron, Scott H. Bice Chair in Healthcare, Law, Policy and Ethics; Thomas H. Murray, President Emeritus of the Hastings Center; and Jonathan Montgomery, Chair of the Nuffield Council on Bioethics.

Robert Cook-Deegan served on as a member of the Biomedical Ethical Advisory Committee (1987-1990). He observed that the position of the Biomedical Ethical Advisory Committee in Congress as opposed to the executive branch might have contributed to its failure. He noted that an important goal of bioethics commissions should be political impact—for example, the President’s Commission in its Defining Death report influenced state laws. “If a Commission is sanctioned by the US government…there should be something that connects it to the political apparatus, there should be something that you’re doing that matters.”

Alexander M. Capron previously spoke before the Bioethics Commission in 2010 during Meeting 2 regarding the oversight of emerging technologies. Today, he reflected on his time on Chair of the Biomedical Ethics Advisory Committee (1987-1990), and as a member of the National Bioethics Advisory Commission (1995-2001). He emphasized that our Commission has set a good example, showing the ways in which ethical issues move from the research stage to the impact in clinical practice and society. He also noted that topics in public health ethics deserve further examination by bioethics bodies.

Thomas H. Murray, who presented before the Bioethics Commission during Meetings 3 (on emerging technologies), 14 (on integrating ethics throughout the research process), and 21 (in memoriam of John Arras), recalled his time as a member of the National Bioethics Advisory Council (NBAC). He noted the importance of a diversity of perspectives, including ideological and religious variation. He also stated: “Our reports influenced how IRBs, regulators, and researchers think about a variety of issues,” emphasizing the impact that bioethics commissions can have on shaping the debate for generations to come. He complimented our Commission on thoughtful work and excellent use of democratic deliberation to address complex issues.

Jonathan Montgomery previously presented before the Bioethics Commission during Meeting 15 on the Nuffield Council’s efforts to address the social implications of novel advances in neuroscience as the commission deliberated about the ethical and social implications of the President’s BRAIN Initiative prior to releasing its report Gray Matters. At today’s meeting, he discussed his experience on the Nuffield Council of Bioethics in the United Kingdom. He emphasized that Nuffield is not beholden to anyone in terms of the topics they select, which affords them more freedom to explore controversial issues. “It’s crucial that we are courageous,” he said. Respecting the public’s opinion does not mean accepting it without scrutiny.

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Kathleen Sebelius Addresses Bioethics Commission Wed, 31 Aug 2016 13:36:28 +0000 To start off the meeting, former Secretary of Health and Human Services Kathleen Sebelius addressed, via video presentation, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) and reflected on its tenure during the administration of President Barack Obama.

The Honorable Kathleen Sebelius served as the U.S. Secretary of Health and Human Services under President Barack Obama from 2009 to 2014, and as the Governor of Kansas from 2003 to 2009. She is the President and CEO of Sebelius Resources LLC, which provides strategic advice to companies, investors, and non-profit organizations. Sebelius serves as a Senior Advisor to The Aspen Institute, where she co-chairs the Aspen Health Strategy Group, and as a member on the Board of Directors for companies including Dermira, Grand Rounds, and Humacyte. She earned a Master of Public Administration degree from the University of Kansas and a Bachelor of Arts degree from Trinity Washington University.

During her time as Secretary of Health and Human Services, Secretary Sebelius was instrumental in the establishment of the Presidential Commission on the Study of Bioethical Issues by Executive Order in November 2009; she conducted the swearing-in of the Commission’s Members in 2010. In 2012, she issued the charge that led to the release of the Commission’s fifth report, Safeguarding Children: Pediatric Medical Countermeasure Research.

In her remarks, Former Secretary Sebelius reflected on her unique perspective as a U.S. Presidential Administration official who has charged the Bioethics Commission with a project. The former secretary noted the importance of working on tough issues and working across borders. She observed that Bioethics Commission has served an important national role in crucial issues in science and technology policy.

Sebelius May 2012

Bioethics Commission Chair Amy Gutmann and Vice Chair James Wagner greet then- Secretary of Health and Human Services Kathleen Sebelius at their 9th Meeting in May of 2012 during the Bioethics Commission’s deliberations about pediatric medical countermeasure research.

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Bioethics Commission Meeting 26: Live from Philadelphia, PA Wed, 31 Aug 2016 13:10:59 +0000 Welcome to Philadelphia, PA for the 26th public meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission). The Bioethics Commission’s meeting is today, August 31, 2016, from 9 a.m. to 3:45 p.m. ET.

At today’s meeting, the Bioethics Commission will continue the discussion it began in Meeting 25, reflecting on the structure, operations, and impact of bioethics advisory committees. The Bioethics Commission welcomes a variety of esteemed speakers who will shed light on different perspectives pertinent to bioethics advisory committee activities, setting the stage for the future of such groups.
For the full agenda of today’s meeting, click here.

You can follow the proceedings of the Bioethics Commission’s meetings here at this blog, and on the live webcast at the Bioethics Commission’s website All transcripts and the webcast will be archived and available following the meeting.

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Member Discussion of the Intersection of Deliberation and Education Tue, 17 Nov 2015 20:07:04 +0000 This is the last session of the Bioethics Commission’s twenty-third meeting. During this session, Members discussed what to recommend at the intersection of deliberation and education. In previous meetings, the Bioethics Commission has heard from experts in education that using deliberation as an educational tool builds the skills that will help students become informed and active participants in their communities. Bioethics education can be an important forum for introducing deliberative methods into diverse educational settings. Commission Members also heard from organizers of and participants in deliberative activities about the important educational function of these activities, which foster a more informed and engaged public. The mutually reinforcing functions of deliberation and ethics education create a virtuous circle, as deliberation facilitates education, and bioethics education builds skills of deliberation.

Members discussed two potential recommendations during this session. First, developments in health, science, and technology, some of which the Bioethics Commission has considered during its tenure, raise significant bioethical questions that need robust and informed public discussion and deliberation. Individuals involved in education and deliberation should use the tools in both of these domains to facilitate greater public engagement with these questions. Ultimately, Members agreed that this recommendation would be an important contribution to the fields of education and to bioethics and policy making.

Second, national bioethics commissions have an important role to play in supporting public bioethics education and contributing to national discourse and deliberations on health, science, and technology policy. Members proposed that future bioethics commissions and other bioethics organizations should continue to explore and advance their educational and democratic role, and should develop and promote accessible educational tools to enable teachers at all levels to integrate deliberation and bioethics education into their classrooms. Members agreed that this would be a valuable send-off to help guide future national bioethics commissions in their work.

The Commission is scheduled to meet again on March 3, 2016 in Atlanta, G.A. For details, go to

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Member Discussion of Education Tue, 17 Nov 2015 19:39:37 +0000 Welcome back to our live coverage of the Bioethics Commission’s twenty-third meeting. During this session, Members discussed recommendations for bioethics education in their next report. Like deliberation, bioethics education is a topic that the Bioethics Commission has discussed at length in its public meetings. They have also developed over 50 educational tools related to the topics in their reports. These tools include case studies, teaching modules on key bioethics topics, classroom discussion guides, webinars, and videos, and they are all free and available online on our website at These materials are designed for teachers and students of bioethics in a variety of contexts, including traditional classroom as well as professional settings.

Members discussed four potential recommendations during this session. First, recognizing the critical role of schools in preparing citizens to participate in their communities and in fostering the values and skills that will help them to address the inevitable bioethical challenges they will face throughout life, they discussed recommending that educators at all levels, from pre-school to professional school, should incorporate into their curricula and courses ethics education tools, such as vivid real-world case studies aimed at the appropriate grade level, that focus on building moral character and ethical reasoning skills. It is upon this foundation that bioethics skill building will be developed. Members agreed that this will be an important recommendation to make. Members emphasized that most citizens as they age will face individual questions about medical decision making that have bioethical dimensions, regardless of their chosen profession.

Second, building on the Bioethics Commission’s recommendations in its past reports, including its first report on synthetic biology and its most recent report on neuroscience and ethics, Members discussed urging graduate and professional education, including in health, science, and technology fields, to include a strong bioethics component to help graduates understand and address the distinct ethical challenges that might arise in the practice of their chosen profession. Members agreed that this would be a valuable recommendation for their report.

Third, Members talked about recommending that education policy makers support professional development of teachers to prepare them to implement ethics and bioethics education and facilitate constructive conversations about complex bioethical questions. Since ethics education can benefit all students, regardless of age or ability, opportunities to participate in ethics education should be provided equitably.

Finally, Members agreed that both the processes and the outcomes of bioethics education should be evaluated to determine how particular programs can contribute to a more informed and ethically literate public. Educators and others involved in bioethics education should contribute to the development of appropriate evaluation tools for assessing how effective bioethics education is in developing related moral reasoning and decision-making skills.

The session concluded, and the Bioethics Commission will now turn to recommendations at the intersection of deliberation and education. Stay tuned!

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Member Discussion of Deliberation Tue, 17 Nov 2015 16:49:03 +0000 Today, the Bioethics Commission is developing recommendations for its work on deliberation and education. After years of modeling the use of democratic deliberation to arrive at solutions to complex and controversial bioethics and health, science, and technology policy questions, the Bioethics Commission is well-situated to make recommendations in this area.

Members discussed three potential recommendations during this session. First, they discussed strongly urging stakeholders at all levels to use democratic deliberation to inform policy decisions in health, science, and technology that have ethical dimensions. The Bioethics Commission’s own deliberations about medical countermeasure research with children serves as a vivid example of this process. In 2013 during their meetings about pediatric medical countermeasures, Members started with many different ideas about how to move ahead, and through effective deliberation, arrived at a path forward that was not only well-received by the key stakeholders, but was also implemented by major players in the field, including CDC and the Biomedical Advanced Research and Development Authority. During this discussion, Members emphasized that well-designed deliberations can help us formulate better answers to bioethical questions that our society can act upon, by pooling intelligence and insight across a range of backgrounds, expertise, and perspectives. Members agreed that this will be an important recommendation to make. Some Members commented that the report should emphasize the specifics and mechanics of how to conduct democratic deliberation, using vivid examples of deliberative processes at different levels, not just at the federal level.

Second, they discussed recommending that those involved in deliberative activities should use available empirical evidence about methods for deliberation, and ensure that deliberative activities are designed and conducted according to best practices. For example, participants in deliberation should give reasons for their arguments that are accessible to and respectful of fellow deliberators. In addition, the issues chosen for deliberation should raise questions that have not yet been definitively answered. Members discussed some of the important features that deliberative processes should share, including agreeing upon established facts, engaging a diverse range of individuals with different perspectives, and encouraging mutual respect.

Third, they discussed recommending that scholars and others who use deliberative approaches should continue to assess the most effective methods of deliberation as a tool for policy making and public engagement in bioethics. For deliberation to be more widely used and supported as a form of public and political engagement, they felt that we need a better understanding of how different kinds of deliberation work and which work best in which contexts.

We will see you after the break at our next session!

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Implementing Innovations in Ethics Education Tue, 17 Nov 2015 15:34:05 +0000 The Bioethics Commission began its discussion on ethics education this morning by focusing on how ethics education might be implemented in different educational settings, particularly in schools. The Bioethics Commission heard from David Steiner, Ph.D., the Executive Director of the Johns Hopkins Institute for Education Policy and Professor of Education at Johns Hopkins University, and Laura Bishop, Ph.D., the head of academic programs at the Kennedy Institute of Ethics.

During this morning’s session, Steiner discussed current standardized testing protocols, which often exclude potentially controversial topics that have ethical dimensions. He explained that this exclusion often acts as a disincentive to teachers to introduce such topics into the classroom, preventing the cultivation of deliberative skills in students. This exclusion, Steiner said, “reduce[s] the likelihood that teachers will help students develop the deliberative skills required for democratic participation.” Steiner explained that the kinds of topics that are often excluded from testing and teaching include common issues in bioethics, such as, “death and dying, evolution…family problems…serious illnesses…treatments for serious illnesses…and suffering.”

Bishop went on to discuss the importance of integration bioethics into high school curricula, and efforts to train high school teachers to teach bioethics. She noted the obstacles that need to be overcome to ensure that ethics is integrated into high school curricula, including structural and logistical challenges, parental and teacher concerns about controversial topics, focus on test taking and meeting state standards, and lack of resources, including a lack of clear and fully developed formal curriculum materials, and a shortage of committed funds.

Including bioethics in high school curricula, Bishop explained, can help students learn how to “listen, hear, and understand peers and others who have opinions that are different from their own, and help students be able to articulate what they believe and why.” Bishop also noted that, “the exciting thing is [those learning bioethics in the classroom] also report an increased interest in the subject matter in which they have these bioethics discussions, they are more interested, they retain information, they can work in a facile way with new questions.”

Up next, the Bioethics Commission will discuss potential recommendations for democratic deliberation.

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Modernizing Human Subjects Research Protections: Changing the Landscape of Biospecimen Research Thu, 01 Oct 2015 17:43:24 +0000 In this fourth post in a new blog series, we zoom in on changes to the Common Rule—proposed in the notice of proposed rulemaking (NPRM) released earlier this month—that would alter oversight processes for biospecimen research.

In its current form, the Common Rule contains a regulatory gap, recognized throughout the Bioethics Commission’s work. Today, when biospecimens are collected for research purposes, their collection and associated analyses is considered human subjects research and are subject to IRB oversight, informed consent, and other protections required by the Common Rule. However, when biospecimens are collected for clinical purposes, but subsequently used for research, that research is not considered human subjects research under the Common Rule if they are stripped of traditional identifiers. The NPRM proposes changing that.

Over the past 3 years, technology has advanced rapidly, such that it is now possible to identify the donors of biospecimens, even when samples are stripped of traditionally recognized identifiers. As a result, the deidentification process no longer sufficiently protects biospecimen donors from privacy and security risks. In Privacy and Progress in Whole Genome Sequencing, the Bioethics Commission urged that informed consent be obtained for any and all genetic research, regardless of where or why the data were obtained. The NPRM echoes this suggestion, by proposing that the use of biospecimens in research, whether obtained in the context of a study, in the clinic, or any other setting, be considered human subjects research under the Common Rule.

The NPRM strikes a balance for this subsequent data use, allowing for broad initial consent for future research when data are collected for a non-research purpose—a path forward that is both practical and ethically sound, as recognized by the Bioethics Commission in Privacy and Progress.

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