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

New Bioethics Commission Educational Materials and Improved Website Access

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has released new educational materials and unveiled a reorganized webpage to facilitate easier access to all of its educational resources.

New materials include Users Guides that provide field-specific directories to Bioethics Commission educational materials, Public Health Case Studies that provide public health professionals and educators with opportunities to explore ethical issues that might arise in the course of their work, and Classroom Discussion Guides that provide prompts and questions that instructors at various educational levels can use to integrate ethics into their classes. These new resources add to a collection of educational materials that the Bioethics Commission has developed and made available to support the integration of bioethics into many disciplines in traditional and nontraditional educational and professional settings.

The Users Guides are designed to help professionals and educators quickly identify the most relevant materials for their needs. Guides are currently available for Researchers, Human Subjects Researchers, Public Health Professionals, Legal Educators, Public Policy Educators, and Science Educators. Future blogs will highlight the new Public Health Case Studies and Classroom Discussion Guides.

The updated education webpage facilitates access to Bioethics Commission educational materials by grouping them by categories. Categories include Users Guides for professionals in various fields, Primers for professionals and the public, Teaching Tools for educators and professional training instructors, and Videos for all audiences.

All Bioethics Commission educational materials are free and available at www.bioethics.gov/education. The Bioethics Commission encourages feedback on its materials via email to education@bioethics.gov.

 

 

 

 

Share this article

Modernizing Human Subjects Research Protections: A Blog Series on Recent Proposed Revisions to the Common Rule

Last week, 16 federal departments and agencies released a notice of proposed rulemaking (NPRM) to revise the Common Rule – the regulations that govern the ethical conduct of federally supported human subjects research. This highly anticipated NPRM arrived more than four years after the July 2011 release of an advanced notice of proposed rulemaking (ANPRM) that sparked substantial commentary and debate.

In its 2011 report, Moral Science: Protecting Participants in Human Subjects Research, the Bioethics Commission analyzed current protections for research participants, concluding that the regulations generally appear to protect people from avoidable harm or unethical treatment, but also offering recommendations for improvement. Indeed, the Bioethics Commission commented directly on the ANPRM in Moral Science (Recommendation 13).

The Bioethics Commission later addressed genetic research in Privacy and Progress in Whole Genome Sequencing; pediatric research in Safeguarding Children: Pediatric Medical Countermeasure Research; incidental findings in research in Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts; and research with participants with potentially impaired consent capacity in Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society. Analysis and recommendations relevant to research ethics exist throughout the Bioethics Commission’s work.

The NPRM cites several of the Bioethics Commission’s reports, and acknowledges that “in preparing the NPRM, the deliberations of the [Bioethics Commission] were taken into account.” (NPRM, p. 397) Moreover, the NPRM’s ethical rationale in support of proposed regulatory changes often closely parallels the Bioethics Commission’s analyses of similar issues. Over the next several weeks, we will be highlighting the impact of the Bioethics Commission’s work on the NPRM, and the relationship between the Bioethics Commission’s recommendations and the proposed revisions to the Common Rule in a series on this blog called “Modernizing Human Subjects Research Protections.”

Share this article

Bioethics Deliberation and Education in Safeguarding Children

In the most recent post for the “Deliberation and Education” series, we examined the role of deliberation in the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) fourth report Privacy and Progress in Whole Genome Sequencing. While not specifically citing democratic deliberation in its recommendations in Privacy and Progress, the Bioethics Commission actively demonstrated the principle by inviting experts from the public and private sectors to inform their public deliberations on the topic. The fifth post in the series will examine deliberation and education in the Commission’s fifth report: Safeguarding Children: Pediatric Medical Countermeasure Research.

At the request of the Secretary for Health and Human Services, the Bioethics Commission conducted a careful and transparent review of the ethical considerations of conducting medical countermeasure (MCM) research with children.

Safeguarding Children, published in March 2013, is the Bioethics Commission’s response to this request. In this report, the Commission made six recommendations concerning MCM research with children, differentiating between pre-event (before exposure to an agent) and post-event (after exposure) research. The Commission identified four ethical principles to guide their discussion of pediatric research protections: respect for persons, beneficence, justice, and democratic deliberation. The Commission recognized that in research, one example of democratic deliberation is community engagement—the process of including community members in an ongoing public exchange of ideas. Democratic deliberation can also be present in various aspects of institutional research review and approval. The Commission referenced community engagement and democratic deliberation in its recommendations for both pre- and post-event research.

In its fourth recommendation, the Bioethics Commission included community engagement in its recommended ethical framework for national-level review of pre-event research that poses more than minimal risk without a prospect of direct benefit. Through this framework, the Commission sough to specify a rigorous set of conditions necessary to determine whether research is conducted in accordance with “sound ethical principles”—a regulatory requirement for this exceptional type of research.

The Bioethics Commission determined that community engagement would be particularly important in a post-event scenario, when it’s necessary to educate the public about research, allow them to inform the researchers about their concerns, and encourage the public to utilize the results of the research. The Commission recommended that, for post-event research:

… Institutional review boards must also ensure that…provisions are made to engage communities throughout the course of research.

Both recommendations described here reflect the Bioethics Commission’s emphasis on the importance of democratic deliberation and its practical implementation. By engaging the community throughout the research process—be it pre- or post-event—researchers can ensure that the public remains aware of what is occurring, while the community can guarantee that its voices and concerns are being heard.

Safeguarding Children and all other Bioethics Commission reports are available at bioethics.gov.

Share this article

Roundtable: Brainstorming Ideas on Education and Deliberation

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

Amy Gutmann, chair of the Bioethics Commission, kicked off the session by asking the panelists to share their thoughts on how the Bioethics Commission could strengthen bioethics education and deliberation about important bioethical issues.

The following are highlights from the discussion:

Sir Roland Jackson, the Executive Chair of Sciencewise, commented that including diverse and expert voices is critical for good deliberation. “If you’re trying to encourage a deliberative process among the people who have the power and influence that matter, you need a wider group to deliberate,” he said.

Marion Danis, from the Department of Bioethics at the National Institutes of Health, noted that the citizenry would benefit from engaging with policymakers and lawmakers on a consistent basis, as opposed to strictly during election season. She asked the Bioethics Commission to “find a way to get governmental and organizational leaders to be more respectful of the efforts people have put in, and not just listen to people when they are trying to get elected.”

Florence Evans, a participant in a deliberative polling exercise, told the Bioethics Commission that, during her participation in What’s Next, California, the purpose of the deliberation was never made completely clear. She emphasized that for deliberation to be successful, participants need to understand the purpose of the exercise, and be able to answer the question: “to what end?”

Lisa M. Lee, Executive Director of the Bioethics Commission, emphasized the importance of starting ethics education from an early age. As she noted, ethical literacy is important for all of us in many contexts, because “all of us need skills to help us resolve ethical issues whether we are a plumber, physician, scientist or a surrogate decision maker.”

Seth Mnookin, Associate Director of the MIT Graduate Program in Science Writing, commented that for patients, honest, frank discussions with health care workers are a primary tool to aid medical decision-making. He urged similar face-to-face interaction between citizens and experts, noting, “Since we’re not about to have geneticists and chemists and physicists go out en masse and engage people one-on-one, I wonder if there is some way to take advantage of the fact that there is a very good ratio of citizen interactions with people who have a lot of scientific and medical training.”

Like Dr. Lee, Sue Knight, Curriculum Author of Primary Ethics Limited in Australia also emphasized the importance of starting ethics education early, noting, “education for ethical deliberation has to involve education in the processes of ethical reasoning.”

Robert Ladenson, Emeritus Faculty Associate at the Center for the Study of Ethics in the Professions at the Illinois Institute of Technology, encouraged the Bioethics Commission to focus on how deliberation and education can complement and strengthen one another, and emphasized that “it’s going to be very important in pursuing both of these efforts not to lose sight of the other.”

Carol Ripple, Associate Director for Education Research and Engagement at the Duke University Social Science Research Institute, urged the Bioethics Commission to “encourage the idea of really identifying core competencies through education and through deliberation that you’re really looking to develop among  a particular audience and purpose.”

Raymond De Vries, Professor of Learning Health Science at the University of Michigan, noted that it is important for the Bioethics Commission to include a sociological perspective that understands the “structural, historical, social situation that explains where we are.”

John Gastil, Head and Professor of Communication Arts and Sciences and Political Science at Pennsylvania State University, asked that the Bioethics Commission prioritize a limited set of ideas and recommendations in its report and resist the urge to embrace a wide array of issues. “You are swimming in ideas,” he said. “I can’t imagine how great the temptation must be to go into all of these different places.”

That concludes the 22nd meeting of the Bioethics Commission. The Bioethics Commission is scheduled to meet again on November 17th in Washington, D.C. For details, go to www.bioethics.gov.

 

Share this article

Teaching and Evaluating Ethics Education, Fostering and Measuring Success

At today’s meeting, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) resumed its consideration of the many facets of effective deliberation and education surrounding bioethical issues by looking at two related issues: teaching ethics and deliberative skills, and fostering and measuring the efficacy of ethics-related education curriculum and deliberative processes.

In its 2014 report Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society, the Bioethics Commission called for the integration of ethics and science through education at all levels. Today, the Bioethics Commission heard about pre-professional bioethics education with presentations from Sue Knight, Ph.D. of Primary Ethics Limited and Robert F. Ladenson, Ph.D. of the Center for the Study of Ethics in the Professions.

Knight noted that it is possible to develop ethical literacy in students at all age levels. She said that while older students are able to engage more nuanced and morally complex situations, it can be surprising how very young children are able to identify ethical conduct. “Research shows that from the age of two and a half, children can distinguish between social convictions and moral laws,” Knight said.

Landenson has been seeking a greater focus at both the college and high school levels on deliberation and ethics by promoting an Ethics Bowl. Modeled on the Quiz Bowl format, student teams are assessed in their capacity to present and understand case studies in ethical quandaries. “The teams have to be able to listen to each other with an open mind,” said Landenson. “The team members have to be able to consider seriously different views and appreciate them, not in the sense of being persuaded, but in recognizing how a morally responsible person would hold that position.”

The next panel looked more broadly at what constitutes an effective approach to ethics education and, in a related discussion, what constitutes an effective deliberative process.

Carol Ripple, Ph.D., with Duke University’s Social Science Research Institute, said it can be a challenge to get educators involved in teaching ethics to step back and think about their impact because they are focused on developing their curriculum and “evaluation and measurement may be a distant thought.”

In a similar vein, Raymond De Vries, Ph.D, said there is also a growing interest today not just in convening deliberative bodies, but also in looking more closely at the nuts and bolts of a successful and meaningful deliberative process. He noted, among other things, that there are numerous pitfalls to be avoided in putting together a deliberative process to engage complicated bioethical issues. For example, he stressed, “I am worried about expert opinion overwhelming public opinion.”

John Gastil, Ph.D, said that one thing he has encountered in working with a wide variety of deliberative bodies is that size can matter—it can impact the ability of the body to carry out a functional set of discussions. For example, if the group is too large, he said, factions and coalitions can form that can cause a breakdown in the overall process. His magic number is 24.

“The reason that is a good number is that a 12 person jury gets a lot done but two dozen is what you need for more complex issues that we usually give people,” explained Gastil. “But it’s not so big that they can’t meet as a coherent entity and the group dynamics can be positive.”

Share this article

Fluency in Science and Ethics

Continuing its discussion of the role of deliberation and education in bioethics, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) turned to a broad consideration of how to improve fluency in science and ethics.

Lisa M. Lee, Executive Director of the Bioethics Commission, discussed the current state of bioethics education, particularly the growth over the last decade of Master’s degree programs in bioethics, and the role of bioethics education as a complement to existing training in other disciplines or professions.
Lee said that as bioethics programs proliferate around the country, the challenge is to make sure students are well trained, and the programs do more to create competency and fluency than just “teach topics.”

Seth Mnookin, associate director of the MIT Graduate Program in Science Writing, raised a difference set of concerns regarding the state of knowledge of important and frequently controversial issues in bioethics, particularly with regard to the desire for more deliberative discussions.

Mnookin said one challenge of public engagement via deliberation involves deciding who should be included in the process. He noted that his research caused him to question the approach of bringing all opinions, even the most extreme, into a public dialogue. The desire to be inclusive, he noted, can have the effect of lending legitimacy to those who insist upon beliefs that directly contradict with objective facts.

“We should not pretend they are not there,” he said, of people with polarizing or extreme views, adding that it is important to ensure that those who are invited to join the discussion are willing to consider other points of view and acknowledge objective scientific evidence. Mnookin said the tension involves a need to create a thoughtful discussion around important scientific concerns versus “going out of your way to include people who are not willing to deliberate” because they are not likely to respectfully consider other points of view.

Share this article

Public Bioethics

In today’s opening session, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) turned its attention to facilitating public dialogue about bioethics. Democratic deliberation is a guiding principle of the Bioethics Commission. As outlined in its first report, New Directions: The Ethics of Synthetic Biology and Emerging Technologies, the Bioethics Commission believes that public discussion and debate promote outcomes that are inclusive, thoughtfully considered, and respectful of competing views. Learn more about the Bioethics Commission’s deliberative process in the video: “How does the Bioethics Commission work?

The Bioethics Commission heard from Dennis Thompson, Ph.D. of Harvard University; Sir Roland Jackson of ScienceWise; Marion Danis, M.D. of the National Institutes of Health Clinical Center, and Florence Evans, a participant in the “What’s Next California” deliberative polling exercise.

In Democracy and Disagreement, Thompson has argued that democratic deliberation can allow diverse groups separated by class, race, religion, and gender to explore an issue together in ways that allow their different views to stimulate a richer and more extensive discussion.

In this morning’s session, he pointed to the power of deliberative discussions to reach beyond the particular group or body involved, as people who participate become more interested in keeping the dialogue going in their everyday life.

“Deliberations can be propagated,” he said. “There is a study that found that citizens who participated in deliberative action are more likely to talk about the issues and engage with co-workers in ways they didn’t before, and this was an equal opportunity [engagement]. There was not a bias in favor of class and education.”

Jackson, whose organization, ScienceWise, is focused on fostering broader discussions of significant science and technology concerns in the UK, said it’s important to understand that consensus is not necessarily the goal of deliberative processes.

“These are not citizens’ juries or consensus conferences,” he said. “The richness of what comes back from deliberative dialogue is plural and conditional responses. It is then up to the decision maker, the policy maker, to draw on that to make their own conclusions.”

Danis described a specific approach to creating a deliberative process around health insurance policy decisions that uses a game board to facilitate discussions about the complicated array of trade-offs involved. She noted that the experience has demonstrated that “a structured public discussion regarding complex and contested priorities is possible, and the process can improve public understanding and foster meaningful dialogue.”

One challenge she has encountered involves moving the process to the next step—in which the information yielded from deliberative discussions influences policy decisions.

Evans shared her experience as a participant in “What’s Next California,” an innovative effort to draw more ordinary citizens into in-depth consideration and debate of pressing and controversial political issues facing Californians. Evans was impressed with how the deliberative approach prompted a more civil and respectful dialogue on such partisan topics.

“It was an amazing experience,” she said. “We were a bunch of strangers from a lot of different backgrounds…. But everyone was very respectful of each other… There were times when there were emotional responses that were highly charged but they did not dominate.”

After a short break, we will hear from two speakers who will explore fluency in science and ethics.

Share this article

Live from Washington

Welcome to Washington DC for the 22nd public meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission).

At today’s meeting, the Bioethics Commission will continue its discussion about the role of deliberation and education in bioethics. Check out the full agenda here.

Bioethics Commission Chair Dr. Amy Gutmann opened up the meeting by framing the discussion with illustrative examples of deliberation and its impact in action. She referenced the deliberative process of the Bioethics Commission and the real-world implementation of several of the Commission’s recommendations.

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

The Bioethics Commission is meeting today, September 2, 2015, from 9 a.m. to 4 p.m., ET.

Share this article

Bioethics Deliberation and Education in Privacy and Progress

Last week, we continued our “Deliberation and Education” series with the blog post “Bioethics Deliberation and Education in Moral Science.” Each post in this series explores the role of deliberation and education in the recommendations issued by the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission). This fourth post in the series will examine deliberation and education in the Bioethics Commission’s fourth report: Privacy and Progress in Whole Genome Sequencing.

Privacy and Progress, released in October 2012, is the Bioethics Commission’s first self-directed project. Recognizing that the increased use of genetic testing in research and the clinic could yield both major advances in healthcare as well as ethical dilemmas, the Commission sought to study the pressing privacy and data access issues raised by the emergence of low cost whole genome sequencing. In Privacy and Progress, the Commission sought to outline many of the key issues surrounding how to reconcile an individual’s need for privacy, consent, and respect with the need for gathering data from many individuals to advance scientific discoveries for the common good.

The Bioethics Commission made 12 recommendations centered around several themes: strong baseline protections while promoting data access and sharing; data security and access to databases; informed consent; facilitating progress in whole genome sequencing; and public benefit. While none of the recommendations specifically included democratic deliberation or education, democratic deliberation was specifically cited as one of the principles the Commission included in their ethical framework for considering the implications of scientific advances. The guiding principles included: public beneficence, responsible stewardship, intellectual freedom and responsibility, democratic deliberation, and justice and fairness. First described in detail in New Directions: The Ethics of Synthetic Biology and Emerging Technologies, the Commission applied these principles, along with the principle of respect for persons, to their examination of the science of whole genome sequencing. This ethical framework directed their analysis towards a focus on pursuing public benefit while minimizing both personal and public risk.

For Privacy and Progress, the Bioethics Commission focused its ethical analysis on issues of privacy associated with whole genome sequencing data. While not specifically citing democratic deliberation in its recommendations, the Commission actively demonstrated the principle by inviting experts from the public and private sectors to inform their public deliberations on the topic, a process it has engaged in since its establishment.

Privacy and Progress and all other Bioethics Commission reports are available at bioethics.gov.

Share this article

Bioethics Deliberation and Education in Moral Science

Last month, we introduced our new “Deliberation and Education” series with the blog post “A Background on Deliberation and Education in Bioethics.” This post highlighted the role of deliberation and education in the recommendations issued by the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission), and in a following post, we examined the role of these principles in the Bioethics Commission’s first report: New Directions: The Ethics of Synthetic Biology and Emerging Technologies. The third post in this series will examine deliberation and education in the Commission’s third report: Moral Science: Protecting Participants in Human Subjects Research.

The report came at the request of President Barack Obama, who asked the Bioethics Commission to conduct an assessment of research standards following the October 2010 revelation that the U.S. Public Health Service supported unethical research in Guatemala in the 1940s. The President gave the Bioethics Commission two assignments: to oversee a thorough fact-finding investigation into the specifics of the studies and to assure that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally. The Commission released “Ethically Impossible” STD Research in Guatemala from 1946 to 1948, in response to the first part of the President’s request, in September 2011. The second report, Moral Science, was released in December 2011.

In Moral Science, the Bioethics Commission made 14 recommendations, centering around a number of themes, including: improving accountability, creating a culture of responsibility, respecting equivalent protections, and promoting community engagement. While many of the recommendations were heavily centered around research or policy in order to create a culture of responsibility, the Bioethics Commission made a recommendation (#7) that included ethics education:

To ensure the ethical design and conduct of human subjects research, universities, professional societies, licensing bodies, and journals should adopt more effective ways of integrating a lively understanding of personal responsibility into professional research practice. Rigorous courses in bioethics and human subjects research at the undergraduate as well as graduate and professional levels should be developed and expanded to include ongoing engagement and case reviews for investigators at all levels of experience.

This recommendation reflects the Bioethics Commission’s emphasis on the importance of education, one that continues to be integrated into both the Commission’s later reports and in the creation of its expanding library of educational materials. By providing ethics education across the curriculum, the scientific community ensures that the clinical, research, and professional contexts are built upon solid ethical foundations, proactively preventing ethical lapses.

Moral Science and all other Bioethics Commission reports are available at bioethics.gov.

Share this article

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.

Subscribe

You can receive updates about our blog via email subscription, RSS feed, or follow the Bioethics Commission on Twitter.