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

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.”

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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.

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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.

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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.

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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

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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

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Capacity, Consent, and Progress: Recommendations from the Bioethics Commission

(This post also appears on PRIM&R’s Amp&rsand blog)

Earlier this year, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released the second part of its report on neuroscience and ethics—Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2). The report examines in depth several controversial topics that bring ethical issues to the fore, including cognitive enhancement, neuroscience and the law, and the ethical conduct of research with participants with impaired capacity for informed consent.

The challenge of impaired consent capacity has been a perennial issue in research ethics for decades yet it is nonetheless well-placed in a report about contemporary neuroscience. Neuroscientists commonly study the very diseases that can cause impairments in decision-making capacity, making informed consent difficult or impossible. These include head trauma, stroke, dementia, schizophrenia, and major depression, among others. Neuroscience research can promote progress towards understanding and alleviating these conditions, but that progress requires the participation of persons affected. Informed consent is a central tenet of research ethics and, in its absence—when working with participants whose capacity is impaired—researchers and IRBs need clear guidelines for whether and how to proceed ethically.

It is vital to find ways whenever possible to ethically and responsibly include individuals with impaired consent capacity in research, but researchers must also vigilantly protect participants from exploitation and abuse. In addition, researchers must guard against and mitigate stigma and harmful assumptions about individuals based on diagnoses or impaired consent capacity.

With all of this in mind, Gray Matters, Vol. 2 explains the long and complex history of national bodies crafting guidance about impaired consent capacity, describes the current regulatory framework to protect participants, and elucidates additional protections that can be employed when consent capacity is impaired or in question. These additional protections include using improved assessment techniques, respecting assent and dissent, engaging independent consent monitors, limiting acceptable levels of risk, requiring legally authorized representatives, honoring research advance directives, and ensuring meaningful stakeholder engagement. The Bioethics Commission made four recommendations in this area, emphasizing responsible inclusion, and calling for clearer requirements for identifying legally authorized representatives to provide permission on behalf of participants when consent capacity is impaired.

As a part of its continued efforts to distribute its findings and recommendations to relevant stakeholders, the Bioethics Commission has developed educational materials to accompany its reports. Included among the Gray Matters educational material is a primer for researchers on neuroscience and consent capacity. Researchers can use the primer to aid ethical decision making and ensure that they have considered and implemented appropriate safeguards. All of the Bioethics Commission’s materials are free and available at

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Update: The Growing Need for a Systematic Approach to Compensation for Research-Related Injuries

(This post also appears on the Penn Wharton Public Policy Initiative)News Image

In December 2011, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) released its report Moral Science: Protecting Participants in Human Subjects Research. In it, the Commission responded to a charge from the President to determine if federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the federal government. Although the Bioethics Commission noted the substantial protections for the health, rights, and welfare of research participants under the existing U.S. system, it also found room for improvement in several areas.

One such area identified by the Bioethics Commission was the treatment and compensation of participants who sustain research-related injuries. Over the last several decades, almost every developed country has instituted policies requiring researchers or sponsors to provide treatment and compensation for research subjects’ injuries. Despite recommendations from the Presidential Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in 1982, the National Bioethics Advisory Commission (NBAC) in 2001, and the Institute of Medicine (IOM) in 2002 that the federal government either explore the issue further or implement a system of its own, U.S. action has been minimal.

In Moral Science, the Bioethics Commission argued that the absence of such a system was ethically unjustified. Rooted in longstanding ethical principles the Bioethics Commission wrote that “treatment or compensation… is appropriate as an act of benevolent regard for an individual’s willingness to participate in an enterprise of important benefit to the public.”[1] Offering arguments based in justice, professional obligations, and utility, the Bioethics Commission recommended that the federal government evaluate the need for a national system of compensation for research-related injuries and study possible program mechanisms. Just over one year later, the Bioethics Commission took up this issue again in its report Safeguarding Children: Pediatric Medical Countermeasure Research. In this report, the Bioethics Commission reviewed the ethical considerations of conducting clinical trials of medical countermeasures—interventions used in the event of a terror attack—with children. When considering ethical requirements for these studies, the Bioethics Commission reaffirmed its ethical argument for research-related injury compensation from Moral Science and recognized the additional need in the context of pediatric MCM research.

Since the release of these reports, several developments have highlighted the importance of the Bioethics Commission’s recommendations to study and evaluate different approaches to designing a system for compensation. These developments include:

  • New evidence that suggests that, without government intervention, some private institutions have yet to develop their own compensation policies. As of 2012, there has been no substantial change in research-related injury compensation policies among U.S. institutions since 2000 despite the calls for change from NBAC, the IOM and the Bioethics Commission during that time. In addition, over ten percent of U.S. research institutions actually changed their consent forms to include exculpatory language as of 2012 despite having had none in 2000.[2]
  • A 2013 strengthening of India’s legal protections for injured research subjects that prompted the National Institutes of Health (NIH) to halt as many as 40 clinical trials in light of what many industry experts considered to be an “unstable regulatory climate.”[3],[4] Despite making a reluctant return to India when the law was further clarified, the NIH faces continued legal challenges to providing appropriate compensation.[5],[6] The situation in India is not an isolated incident. On other occasions, the lack of a systematic compensation system has forced U.S. research teams abroad to work around existing regulations or in some cases, even stop clinical trials.[7]
  • A 2013 study demonstrating the possibility that costs of treatment for research-related injury might be shifted to local health care systems within developing countries where research takes place. The study of NIH HIV/AIDS clinical trials in Africa found that although many investigators use portions of their funding to cover treatment or reparation for research-related injuries, data from one African country suggest that “overburdened and under-resourced health systems may be forced to provide care and treatment for injuries caused by research when sponsors fail to do so.”[8]
  • A 2013 revision to the World Medical Association’s Declaration of Helsinki adding that “appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.”[9] The revision represents growing consensus on the issue of research-related injury compensation within the international community. The update has resulted in rising acknowledgement among scholars and physicians that the United States remains an outlier on this issue.[10]

In Moral Science, the Bioethics Commission presciently observed that, among other ethical arguments, general utility supports such a system, noting “if there is a growing commitment toward harmonization of policies and recognition of equivalent protections, the fact that federally sponsored human subjects research differs substantially in this policy toward compensation for humans subjects who are harmed in the course of research could prove a significant barrier [to recruitment of participants].”[11]

As the United States remains one of the few industrialized countries without a strong legal infrastructure providing for research-related injury compensation, recent events further highlight the strategic and ethical imperative for federal action. Amidst continued attention within the international community, the need for a systematic approach to compensation continues to grow.


[1] Presidential Commission for the Study of Bioethical Issues (PCSBI). (2011, December). Moral Science: Protecting Research Participants in Human Subjects Research. Washington, DC: PCSBI, p. 58.

[2] Resnik, D.B., et al. (2014). Research Related Injury Compensation Policies of U.S. Research Institutions. IRB 36 (1), 12-19.

[3] Gupta, Y.K. et al. (2014). Compensation for Clinical Trial-Related Injury and Death in India: Challenges and the Way Forward. Drug Safety, 37 (12), 995-1002.

[4] Krishnan K. and J.P. Koshy. (2013, 11 July). US agency NIH scraps nearly 40 clinical trials in India. Livemint. Retrieved on June 24, 2015 from

[5] Reardon, S. (2014). NIH makes wary return to India: Some clinical trials funded by US agency resume, but strict regulations have put off others. Nature, 506 (7487), 143-144.

[6] Marwick, C. (1998). Compensation for Injured Research Subjects. Journal of the American Medical Association, 279 (23), 1853-1855.

[7] Pike, E.R. Recovering from Research: A No-Fault Proposal to Compensate Injured Research Participants. American Journal of Law and Medicine, 38 (1), 42-43.

[8] Mamotte N., Wassenaar D. and N. Singh. (2013). Compensation for Research-Related Injury in NIH-Sponsored HIV/AIDS Clinical Trials in Africa. Journal of Empirical Research on Human Research Ethics, 8 (1), 45-54.

[9] World Medical Association (WMA). (2013). World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Journal of the American Medical Association, 310 (20), 2191-2194.

[10] Many who covered the revision to the declaration or who were quoted in articles that followed it expressed doubts about whether or not US regulators would enact changes following the statement from the WMA. For more see: Kurihara, C. and Takeo S. (2013). Discussion toward he 50th anniversary of the Declaration of Helsinki: Interview with Dr. Otmar Kloiber, Secretary General, World Medical Association. Rinsho Hyoka (Clin Eval), 41 (2), 351-372; Morris, K. (2013). Revising the Declaration of Helsinki. The Lancet, 381 (9881), 1889-1890; Lynch, H.F. (2013) Bill of Health: Revisions to the Declaration of Helsinki. Retrieved on July 2, 2015 from

[11] PCSBI, (2011, December), op cit, p. 62.


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Bioethics Deliberation and Education in New Directions

Two weeks ago, in the blog post “A Background on Deliberation and Education in Bioethics,” we discussed the role of deliberation and education in the recommendations issued by the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission). These principles remain a common thread throughout the Bioethics Commission’s work. This second post of the new “Deliberation and Education” series will examine the role that these two principles played in the Commission’s first report: New Directions: The Ethics of Synthetic Biology and Emerging Technologies.

Released in December 2010, New Directions was undertaken at the request of President Barack Obama, who asked the Bioethics Commission to review the developing field of synthetic biology and identify appropriate ethical boundaries to maximize public benefits and minimize risks. The Commission made 18 recommendations in the report, centering around five ethical principles: public beneficence; responsible stewardship; intellectual freedom and responsibility; democratic deliberation; and justice and fairness.

In order to promote responsible stewardship, the Bioethics Commission made a recommendation (#9) that included ethics education:

Ethics education similar or superior to the training required today in the medical and clinical research communities should be developed and required for all researchers and student-investigators outside the medical setting, including in engineering and materials science.

The Bioethics Commission recognized that integrating ethics education into the curriculum was necessary in order to cultivate responsible research practices. In addition, democratic deliberation appeared as its own principle with three corresponding recommendations (# 14-16):

Stakeholders are encouraged to maintain an ongoing exchange regarding their views on synthetic biology and related emerging technologies, sharing their perspectives with the public and with policy makers.

When discussing synthetic biology, individuals and deliberative forums should strive to employ clear and accurate language.

Educational activities related to synthetic biology should be expanded and directed to diverse populations of students at all levels, civil society organizations, communities, and other groups.

The three recommendations, which also include education, serve to guide democratic deliberation, a process the Bioethics Commission uses in its own decision-making.

Bioethics education and deliberation have served as a foundation for the Bioethics Commission since its very first report. These concepts appear throughout the Commission’s work, demonstrating their applicability across the biomedical, research, and clinical spheres.

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New Educational Module from the Bioethics Commission on Vulnerable Populations in Neuroscience Research Now Available

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted a new educational module on its website, The module on vulnerable populations 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). Additional educational materials on vulnerable populations include a background module, as well as report-specific modules that accompany the Bioethics Commission reports: Safeguarding Children: Pediatric Medical Countermeasure Research and “Ethically Impossible”: STD Research in Guatemala from 1946 to 1948. Other topics covered by the Bioethics Commission’s educational modules include community engagement, compensation for research-related injury, informed consent, privacy, and research design.

The Vulnerable Populations in Gray Matters module focuses on vulnerability specifically in the context of neuroscience research. The module provides instructors with a description of the ways in which individuals with impaired consent capacity might be vulnerable. It describes circumstances that might make potential participants vulnerable, including desperation and imprisonment, which merit ethical consideration in neuroscience research. It also addresses additional protections researchers can employ to protect potentially vulnerable populations in research, including those with impaired consent capacity.

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 The Bioethics Commission encourages feedback on its materials at

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This is a space for the members and staff of the Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

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