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

Roundtable Discussion: Improving Public Dialogue of Bioethics

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) closed its discussion of democratic deliberation in bioethics and bioethics education with a roundtable discussion involving Commission members and presenters.

Amy Gutmann, Ph.D., Chair of the Bioethics Commission, kicked off the session by asking the panelists to share their thoughts on what the Bioethics Commission can do to improve the quality of public dialogue and deliberation on bioethics and the quality of bioethics education.

Following are highlights from the discussion:

Margaret Little, Ph.D., director of the Kennedy Institute of Ethics and associate professor in the philosophy department at Georgetown University, suggested that the Bioethics Commission help launch a series of experiments to promote informed deliberation on bioethics, both at universities and in communities. “This is a great model that is used in many places. Right now, there is an energy prize for $5 million to a community that reduces its carbon footprint,” Little noted. “So this is something with incentives and an aspirational mandate.”

“Watching is one thing; doing is another,” said James Fishkin, Ph.D., the Janet M. Peck Professor of International Communication and director of the Center for Deliberative Democracy at Stanford University. He urged the Bioethics Commission to undertake an exemplary project using democratic deliberation to spur public engagement in bioethics. “If you do it right, other commissions can follow in your footsteps,” he added.

F. Daniel Davis, Ph.D., the director of bioethics at the Geisinger Health System and former executive director of the President’s Council on Bioethics under President George W. Bush, said that there’s a need to make ethical knowledge more practical and less theoretical. He cited work he is doing with surgical residents, assessing their emotional intelligence as a way to reduce medical errors. The goal, he said, is to get the residents not only to recognize ethical issues but also to “operationalize that ethical knowledge and do so in a virtuous way.”

Jason Schwartz, Ph.D., M. Bioethics, the Harold T. Shapiro Fellow in Bioethics at the University Center for Human Values, Princeton University, asked the Bioethics Commission to think broadly in terms of the government entities that address bioethics issues. “Call attention to the fact that bioethics may not be the domain of bioethics alone,” he said, noting that many bodies that do not have bioethics in their name or mandate deal with bioethics issues. For example, bioethics is a factor in the how the Food and Drug Administration weighs the risks and benefits of pharmaceuticals, and in how vaccines are prioritized for development. “Ethical dimensions are largely ignored or cast aside or reshaped if they are exclusively technical or scientific questions,” Schwarz said.

Steven Joffe, M.D., M.P.H., the Vice Chair of Medical Ethics, Emanuel and Robert Hart Associate Professor of Medical Ethics and Health Policy and director of Penn Fellowship in Advanced Biomedical Ethics at University of Pennsylvania, emphasized the importance of promoting respectful public dialogues. As a model, he suggested presidential debates in which questions are asked by citizens sitting in a circle. “The citizens equip themselves incredibly well time after time after time. And those sorts of discussions, engaging the public about bioethical issues, I think, would be…incredibly powerful to promote the conversations we want to have.”

Connie Ulrich, Ph.D., R.N., F.A.A.N., an associate professor of bioethics and nursing in the Department of Biobehavioral Health Sciences at the University of Pennsylvania School of Nursing, cited a need for better communication. “Training and communication would absolutely help in bioethics education, so we can help people feel more confident to address the issues that they face.”

The Commission is scheduled to meet again on September 2 in Washington, D.C. For details, go to www.bioethics.gov.

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Bioethics Education from Three Viewpoints

This afternoon, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) turned its attention to three approaches for teaching bioethics.

Emphasis on Empirical Methods

Steven Joffe, M.D., M.P.H., the vice chair of Medical Ethics, Emanuel and Robert Hart Associate Professor of Medical Ethics and Health Policy and director of Penn Fellowship in Advanced Biomedical Ethics at University of Pennsylvania, made the case for including empirical scholarship in the education of bioethicists. He identified two broad roles for empiricism in bioethics: to inform ethical analysis and to move from a moral vision to ethical behavior and effective, justifiable policy.

“High-quality, high-impact bioethics requires interdisciplinarity, translation to policy and practice, and grounding in nuanced appreciation of relevant empirical realities,” Joffe said.

Teaching Bioethics through Humanities

Margaret Little, Ph.D., is the director of the Kennedy Institute of Ethics and associate professor in the philosophy department at Georgetown University. Little described how novel approaches to bioethics education, such as the Kennedy Institute’s Conversations in Bioethics series, Massive Open Online Courses (MOOCs), and its Ethics Lab, can help prepare students and the broader public to engage in dialogue and deliberation on topics in bioethics with significant public policy implications.

Each of these approaches has unique advantages. Through the university-wide conversations series, for example, students can gain exposure to experts with both deep knowledge and unique personal experience. Through MOOCs, “anyone with an internet connection can access the world’s experts on a variety of topics,” Little noted. And in the Ethics Lab, students use newly acquired knowledge to design real-world tools and interventions.

Bioethics Education through a Clinical Lens

Connie Ulrich, Ph.D., R.N., F.A.A.N., an associate professor of bioethics and nursing in the Department of Biobehavioral Health Sciences at the University of Pennsylvania School of Nursing, explored the value of nursing to public discourse on ethical issues, the ethical issues that nurses encounter that require bioethics education, and the role of bioethics education in preparing the next generation of nursing professionals.

Ulrich said that nurses face complex and challenging ethical issues in clinical care, partly because of the time they spend directly with patients and their families. Yet only about half of nurses surveyed reported having had ethics education in their basic or advanced professional program, and 23 percent said they’d had no ethics education at all. This lack of preparedness can make nurses feel less confident and less likely to take action when faced with an ethical issue.

“Ethics preparedness can strengthen nurses’ ability to work collaboratively with other health care providers, build confidence to speak about ethics concerns related to patient care, and garner respect as valued members of the caregiving team,” Ulrich said.

Next, the Bioethics Commission will wrap up today’s meeting with a roundtable discussion.

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How to Elevate Bioethics Deliberations to a National Level

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) continued its discussion about democratic deliberation in bioethics and turned its attention to how bioethics issues are treated in the national dialogue, and the role of national bodies like the Bioethics Commission in fostering democratic deliberation on bioethics. The Bioethics Commission heard from F. Daniel Davis, Ph.D., the director of bioethics at the Geisinger Health System and former executive director of the President’s Council on Bioethics under President George W. Bush, and Jason Schwartz, Ph.D., M. Bioethics, the Harold T. Shapiro Fellow in Bioethics at the University Center for Human Values, Princeton University.

Davis noted that during his three-year tenure as director of a national bioethics advisory body, he never heard the term “democratic deliberation.” But he believes that active citizen participation in bioethics issues is important and should be encouraged. At Geisinger, he said, he has been involved in several efforts to engage patients and elicit their views on research issues that affect them. For example, Geisinger in 2006 established a biobank after conducting a survey to assess community attitudes toward genetic research and approaches to patient consent.

Schwartz spoke to how previous national bioethics bodies in the United States have sought public engagement as part of their deliberative process. There has been, he said, significant variation in how commissions have approached this objective. Some commissions merely provided public notice of their meetings and made their meeting minutes available to the public. In 1994, the National Advisory Committee on Human Radiation Research went much further, actually holding meetings in affected communities and reaching out to interview individuals and families who had participated in radiation research. The National Bioethics Advisory Committee had three public members, a requirement written into its charter.

Both Davis and Schwartz encouraged the Bioethics Commission to consider applying democratic deliberation to its own work as a way to increase public engagement in bioethics issues.

“It has to be more than just doing it in public,” Davis said. He noted that he’s attended commission meetings with 400 people in attendance, as well as others with only 10 attendants. “I worry about what it means to do ethics in public when there are only 10 people in the audience.”

Schwartz agreed. “Trying to systematically understand the concerns, the hopes, the worries of citizens at-large seems a good thing,” he said.

After a short break, we will hear from three speakers who will explore how to bring theory on public engagement with bioethics into practice.

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Lessons from Democratic Deliberations

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) launched its discussion about democratic deliberation in bioethics this morning by focusing on how to connect theory to practice. The Bioethics Commission heard from James Fishkin, Ph.D., the Janet M. Peck Professor of International Communication and director of the Center for Deliberative Democracy at Stanford University, and Scott Kim, M.D., Ph.D., a senior investigator in the Department of Bioethics at the National Institutes of Health.

Fishkin has worked extensively to apply the theory of democratic deliberation to create informed public policy discussions. During this morning’s session, Fishkin shared his experience conducting 70 democratic deliberation polls in 22 countries, most recently in Tanzania. He explained that he combines a random sampling of the public with specific conditions designed to facilitate free and respectful group deliberation.

In Tanzania, for example, Fishkin worked with the government to recruit 400 citizens to attend a two-day educational meeting, where they were briefed extensively on natural gas policy and participated in group discussions. They were polled both before and after the meeting. Results showed that attending the meeting significantly affected their views.

Fishkin explained that simply giving people information is not sufficient to engage them on a policy issue. Open discussion among people of diverse viewpoints in an environment of mutual respect is essential, he said.

“Democratic deliberation is not populism,” Fishkin said. “Democratic deliberation is an attempt to convene the people under conditions where they really think about the tradeoffs and competing values.”

Kim noted that measuring public values on moral and ethical issues—including bioethical issues—is challenging. He described how he and his colleagues applied democratic deliberation to assess public opinion on surrogate decision-making by family members of people with Alzheimer’s disease.

Similar to what Fishkin found, Kim said that participating in democratic deliberation had a strong effect on people’s views.

“The process is seen as fair and trustworthy by participants,” Kim said. Indeed, he noted that people who participated in democratic deliberation said that they were willing to abide by the group’s decision, even if it did coincide with their personal views.

Up next, the Bioethics Commission will discuss democratic deliberation in bioethics at the national level.

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The Bioethics Commission Remembers Commission Member John D. Arras

john-arras_portrait

Today, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) remembered one of their own. Dr. John Arras, a member of the Bioethics Commission and the Porterfield Professor of Biomedical Ethics and Professor of Philosophy and Public Health Sciences at the University of Virginia, passed away on March 9, 2015.

“He enlivened our deliberations and contributed far more than his share to our painstaking work,” said Dr. Amy Gutmann, the Chair of the Bioethics Commission in a tribute posted to the Bioethics Commission’s website. “We are grieving the tremendous loss of a great teacher, scholar, and member of our bioethics family, and we already miss him greatly,” she wrote.

Dr. Thomas Murray, President Emeritus of The Hastings Center and a close friend and colleague of Dr. Arras, also offered remarks. “Over the course of his career, John wrote incisively on many issues… He also contributed mightily to the critical evaluation of method and theory in bioethics,” said Murray in a commentary published in the Hastings Center Report. “John loved to teach, and we can be grateful for generations of students and colleagues who learned from him,” he expressed.

President Obama appointed Arras to the Bioethics Commission in 2010 and he served until his death in March. He was 69 years old.

“I can only add to this that as a lover of learning, and seeker of justice for all, John Arras was as good as we can ever hope to get,” said Gutmann.

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Bioethics Commission Meeting 21: Live from Philadelphia

We are live from Philadelphia, blogging the 21st public meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission). The Bioethics Commission is meeting today, May 27, from 9 a.m. to 4:30 p.m. EDT.

At this meeting, the Bioethics Commission will discuss the role of deliberation and education in bioethics. The Bioethics Commission is exploring the idea of teaching deliberation as a tool to promote ethical literacy.

You may follow the proceedings of the Bioethics Commission’s meeting here at this blog, and on the live webcast. The webcast and transcripts from the meeting will be archived and available following the meeting at www.bioethics.gov.

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New Educational Module from the Bioethics Commission on Informed Consent in Neuroscience Now Available

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted to Bioethics.gov a new educational module on informed consent. The module accompanies the Bioethics Commission’s two-volume report Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1) and Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2). The new Gray Matters module adds to the informed consent resources already produced by the Bioethics Commission. Additional materials on informed consent include a background module and four report-specific modules that accompany the Bioethics Commission reports Ethically Impossible: STD Research in Guatemala from 1946 to 1948, Privacy and Progress in Whole Genome Sequencing, Safeguarding Children: Pediatric Medical Countermeasure Research, and Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings. Other topics covered by the Bioethics Commission’s educational modules include research design, privacy, community engagement, compensation for research-related injury, and vulnerable populations.

The Informed Consent in Gray Matters module provides a brief introduction to the concept of consent capacity; elaborates an ethical justification for responsibly including individuals with impaired consent capacity in neuroscience research; describes the current regulatory framework regarding human subjects research involving participants with impaired consent capacity; and describes additional ethical safeguards to protect vulnerable populations, including adults with impaired consent capacity.

All of the educational modules produced by the Bioethics Commission are based on the contemporary ethical issues addressed by the Commission, and are designed to 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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Engaging Parents and Children Throughout Pediatric Research: A New Report from the Nuffield Council on Bioethics

Today the Nuffield Council on Bioethics (Nuffield Council), an independent bioethics advisory body in the United Kingdom, released Children and Clinical Research: Ethical Issues. The report marks the culmination of a two-year inquiry, during which the Nuffield Council received input from over 500 stakeholders – including the U.S. Presidential Commission for the Study of Bioethical Issues (Bioethics Commission).

The Bioethics Commission addressed the ethics of research with children in its March 2013 report Safeguarding Children: Pediatric Medical Countermeasure Research. In that report, the Bioethics Commission tackled the particularly complex ethical dimensions of conducting clinical trials of medical countermeasures (MCMs) – that is, clinical products and interventions used in response to chemical, biological, radiological, and nuclear terror attacks – with children. Through six recommendations to guide the ethical conduct of pediatric MCM research, the Bioethics Commission sought to navigate the tension between protecting individual children from undue risk in research and protecting all children, to the extent possible, through the fruits of research.

Throughout its analysis in Safeguarding Children, the Bioethics Commission recognized the critical importance of pediatric research to address children’s health needs. It expressed “an unwavering commitment to safeguard all children from unacceptable risks in research and through research that promotes their health and well-being.” (p. 105) The Nuffield Council echoed this commitment at the very outset of its report, “challeng[ing] the idea that clinical research is something from which children need to be protected and essentially excluded,” and articulating a “belief that children will be best protected from ill health, disease and the impacts of disability through a greater commitment to evidence-based care.” (p. vii)

The Bioethics Commission and Nuffield Council also fundamentally agree that pediatric research protections can be strengthened through engagement with trial participants, their families, and other stakeholders. The Bioethics Commission recognized the critical role of community engagement in pediatric MCM research to “build transparent, meaningful, collaborative, and mutually beneficial relationships among those considering or conducting research and the relevant communities.” (p. 79) Several of the Nuffield Council’s recommendations support similar engagement, for example, through the consideration of young persons’ and parents’ views in designing research. As the Nuffield Council’s Director, Hugh Whittall, explained, “by speaking to children and their families, researchers can design studies which are more suited to their needs, and ultimately more acceptable.”

In Safeguarding Children, the Bioethics Commission called for an ongoing conversation about the ethical conduct of pediatric research. Today the Nuffield Council has added its valuable voice to the discussion.

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Bioethics Commission recommends establishing clear requirements for identifying legally authorized representatives for research participation

On March 26 the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released the second volume of its two-volume report on neuroscience and ethics, Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2). In Gray Matters, Vol. 2, the Bioethics Commission recognized the challenging tension between the need for rigorous research on debilitating neurological diseases and psychiatric conditions, and the need to protect research participants who might be vulnerable because of impaired consent capacity.

Neuroscience research offers promise to find ways to prevent, treat, and cure neurological disorders, psychiatric conditions, and brain and nervous system injuries that inflict great individual and societal burden. Clinical research involving affected individuals is necessary to achieve this worthy goal. However, some potential research participants might have impaired capacity to provide fully informed consent before enrolling in research—an important ethical tenet in the protection of research participants. The Common Rule (the federal policy that governs research supported by 18 federal departments and agencies) requires permission from a legally authorized representative (LAR) if research participants cannot provide their voluntary informed consent. However, federal regulations and state laws lack clarity about who can legally serve as an LAR when a prospective research participant lacks consent capacity. This uncertainty can stall important research.

In Gray Matters, Vol. 2 the Bioethics Commission makes four recommendations regarding research involving human participants whose consent capacity might be absent, impaired, fluctuating, or in question. In its ninth recommendation, the Bioethics Commission called for the establishment of clear requirements for identifying LARs for research participation. The Commission recommended that:

State legislatures and federal regulatory bodies should establish clear requirements to identify who can serve as legally authorized representatives for individuals with impaired consent capacity to support their responsible inclusion in research.

Current laws for designating an LAR to facilitate decisions about medical care vary by state. For example, they differ in describing how LARs should make decisions on behalf of patients in the clinical context and who can serve as an LAR. Very few of these state laws address decisions about enrollment in research.

Within the current legal and regulatory framework, uncertainty and lack of clarity remain regarding ethically acceptable research involving participants with potentially impaired consent capacity. Using an LAR is one important way to facilitate inclusion of participants with impaired consent capacity in research, ensuring the just distribution of the benefits that might accrue to those affected by the disorder under study. Using an LAR also can help protect participants from exploitation, because loved ones or caregivers who have been designated as LARs are often the best proxy for representing participant interests. Federal regulatory bodies could endorse an existing list of who can serve as an LAR—for example, the Secretary’s Advisory Committee on Human Research Protections’ (SACHRP) recommended list—and explicitly permit researchers and institutional review boards to rely on that list. Alternatively, state legislatures that have not already done so could draft their own priority lists for LARs for research, eliminating the need to rely on lists included in laws pertaining to medical treatment. The Bioethics Commission acknowledged that clarity in identifying LARs will promote the ethical conduct of vital research by helping researchers and IRBs remain accountable to a clear set of ethical and legal standards for enrolling participants with impaired consent capacity in research.

Gray Matters, Vol. 2 and all other Bioethics Commission reports are available at Bioethics.gov.

 

 

 

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New Education Materials from the Bioethics Commission on Research Design Now Available

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted to Bioethics.gov a new series of educational modules on research design. The materials on research design increase the breadth of topics covered by the Bioethics Commission’s educational resources. Previous topics include privacy, community engagement, compensation for research-related injury, informed consent, and vulnerable populations. The new series includes both a background module, and a module to accompany the Bioethics Commission’s Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1).

The Research Design Background module provides a brief introduction to research design; relates research design to guiding ethical principles; describes practical and ethical considerations in research design generally; identifies design components and ethical considerations in randomized controlled trails for biomedical research with human participants specifically; and explains the relevant regulatory requirements and guidelines that promote ethical research design.

The Research Design in Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society module emphasizes the importance of integrating ethics early and explicitly throughout the research endeavor, including in the determination of research design; explains how foundational domains of ethical conduct support ethical research design; and provides examples of approaches to ethics integration in neuroscience research design.

All of the educational modules produced by the Bioethics Commission are based on the contemporary ethical issues addressed by the Commission, and are designed to 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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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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