Public Health – blog.Bioethics.gov https://bioethicsarchive.georgetown.edu/pcsbi/blog 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 Looking Back at the Bioethics Commission’s Blog https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/12/05/looking-back-at-the-bioethics-commissions-blog/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/12/05/looking-back-at-the-bioethics-commissions-blog/#respond Mon, 05 Dec 2016 16:00:04 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=2125 Throughout its tenure, the Bioethics Commission has maintained an active digital presence to connect with a global audience. A major component of this has been through its blog. This final blog post reflects on the role the blog has played in disseminating the Bioethics Commission’s work.first-blog

Former Bioethics Commission Executive Director Valerie Bonham launched the commission’s blog on November 15, 2010, announcing that the staff would be liveblogging during Meeting Three in Atlanta. From that meeting onward, Bioethics Commission staff continued to blog live from the Bioethics Commission’s meetings, held throughout the country in cities including Washington DC, Philadelphia, Salt Lake City, San Francisco, Chicago, and Boston. Meeting posts highlighted salient points of discussion as they occurred during the public meetings. For example, during Meeting Three, a blog post outlined the members’ deliberations regarding the risks and benefits of synthetic biology. During Meeting Eighteen, which focused on ethical issues in neuroscience, a blog post highlighted some of the discussion about the ethical challenges in neuroscience research. The Bioethics Commission also used blog posts to distill complex topics that arose during meetings. During Meeting Twelve, which focused on pediatric medical countermeasure research, a blog post presented a simplified structure of some of the federal regulations concerning pediatric research.

The commission’s blog also highlighted and explained the impact of the commission’s work. For example, during the commission’s tenure, a notice of proposed rulemaking (NPRM) to revise the Common Rule—the regulations that govern the ethical conduct of federally supported human subjects research—was published in the Federal Register on September 8, 2015. Elements of the commission’s work were included in this notice. In September and October 2015, the Bioethics Commission released a series of blog posts that described some of the relevant inclusions in the NPRM, and explained their significance.

The Bioethics Commission also used the blog to share its outreach activities and initiatives with a broad readership. For example, when Bioethics Commission staff attended the annual meeting of the American Society of Bioethics and Humanities in October 2015, a blog post highlighted the commission’s outreach efforts, and included answers to frequently asked questions that staff members fielded while at the conference. When the Bioethics Commission presented at the White House BRAIN conference, a blog post shared Executive Director Lisa M. Lee’s remarks. On June 8, 2016, Col. Nelson Michael gave an interview with the bioethics news site BioEdge, and the Bioethics Commission staff wrote a two-part blog post on some of the issues Col. Michael raised regarding democratic deliberation and ethics education. Blog posts were also written to describe publications in academic journals by Commission members and staff. A blog post shared a commentary written by Bioethics Commission Vice Ch
air Dr. James Wagner, who wrote about the importance of early ethics education.

During its tenure, the Bioethics Commission produced over 65 educational materials, and used the blog to picture1announce the availability of new educational materials, including user guides, primers, classroom discussion guides, and deliberative scenarios. Blog posts also helped outline how to use the educational materials. Blog posts also highlighted topics including innovations in ethics education, and the importance of civic engagement. The Bioethics Commission also used the blog to announce and promote its podcast series Ethically Sound, a 10-episode series that focuses on some of the ethical issues raised in the commission’s reports.
Readers can access previous blog posts, educational materials, the podcast series Ethically Sound, along with all of the Bioethics Commission’s reports and related materials at bioethics.gov. On behalf of the Bioethics Commission, we thank our readers for their continued interest in the work of the commission.

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Ethically Sound Episode 10: Charting a Path Forward https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/11/21/ethically-sound-episode-10-charting-a-path-forward/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/11/21/ethically-sound-episode-10-charting-a-path-forward/#respond Mon, 21 Nov 2016 16:00:01 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=2052 The tenth and final episode of the Bioethics Commission’s podcast series, Ethically Sound, is now available. Today’s episode, “Charting a Path previewscreensnapz001Forward,” focuses on the Bioethics Commission’s two most recent public meetings, during which the Bioethics Commission reflected on the impact of past, present, and future of national bioethics advisory bodies.

Since the 1970s, the U.S. has had a succession of national advisory bodies to provide Congress or the President with expert advice on topics related to bioethics. Other countries also benefit from advisory bodies that provide advice about bioethi
cal issues. During its twenty-fifth and twenty-sixth public meetings, the Bioethics Commission heard
from members of past bioethics advisory bodies, representatives of international bioethics bodies, as well as officials who have been advised by such bodies.

The podcast opens with a narrative from Alex Capron, Professor of Law and Medicine at the University of Southern California. Mr. Capron chaired the Biomedical Ethics Advisory Committee from 1987 to 1990, and served on President William J. Clinton’s National Bioethics Advisory Body from 1996 to 2001. Mr. Capron presented before the commission during Meeting 26, and reflected on his experiences with both of these advisory bodies. In the podcast, Mr. Capron recounts a challenging experience he faced while describing the disciplinary backgrounds of bioethics advisory body staff to policymakers unfamiliar with the interdisciplinary nature of bioethics.

The podcast also includes an interview with Bioethics Commission member Dr. Daniel Sulmasy, Kilbride-Clinton Chair in Medicine and Ethics at the University of Chicago. The interview was conducted by Hillary Wicai Viers, a former Communications Director with the Bioethics Commission staff. Dr. Sulmasy discussed the importance of looking to past commissions, the legacy of the current Bioethics Commission, and the pressing ethical issues that we could face in the future. Regarding the importance of looking to past bioethics commissions, Dr. Sulmasy said “The past is applicable because many of the most basic ethical questions are perennial. We may encounter new problems, but the most fundamental questions about human finitude, the meaning of human progress, the role of balancing relief of suffering versus other ethical principles, questions of cost, and justice are always with us.”

Episode 10, and all of the other Ethically Sound episodes, is now available on our website, as well as on our SoundCloud, YouTube and iTunes pages. Listeners can follow the podcast using #EthicallySound or by following us on Twitter @bioethicsgov. Stay tuned for our upcoming educational resource, a set of discussion questions to accompany the Ethically Sound series that can be used in a classroom or seminar setting. We welcome comments and feedback at info@bioethics.gov.

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Introducing “Ethically Sound Discussion Guide: Podcast Series Discussion Questions” https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/11/09/introducing-ethically-sound-discussion-guide-podcast-series-discussion-questions/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/11/09/introducing-ethically-sound-discussion-guide-podcast-series-discussion-questions/#respond Wed, 09 Nov 2016 18:29:05 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=2105 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has released a new educational resource, “Ethically Sound Discussion Guide: Podcast Series Discussion Questions.” safariscreensnapz001The discussion guide is based on the Bioethics Commission’s podcast series Ethically Sound. This 10-episode series is based on the 10 reports the Bioethics Commission produced during its tenure. Each podcast focuses on an ethical challenge the Bioethics Commission addressed in a specific report. Each episode opens with an introductory vignette from a speaker closely associated with the topic, and features an interview with a member of the Bioethics Commission.

The discussion guide includes a set of questions for each podcast designed to stimulate classroom or seminar discussion. The questions challenge students and those in professional training to think critically about why certain topics are important to consider, and how certain ethical challenges might be addressed. The questions are suitable for high school, undergraduate, and graduate-level students, as well as professionals in post-graduate training.

The discussion guide is the most recent addition to a series of educational materials designed to facilitate discussion around the topics addressed by the Bioethics Commission. Educators can access a set of classroom discussion guides to introduce students and professionals to the Bioethics Commission’s reports. Teachers and instructors can use our Guides to Deliberation to introduce students and those in professional training to democratic deliberation, an inclusive method of decision-making used to address open policy questions. Deliberative scenarios can help students and professionals use democratic deliberation to collaboratively address and propose a solution to a contemporary ethical challenge. Educators can use our user guides to find educational materials suitable for a particular field, discipline, or level of education.

All of the Bioethics Commission’s educational materials can be accessed and downloaded for free at www.bioethics.gov/education. The Bioethics Commission welcomes comments and feedback on its materials at info@bioethics.gov.

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Ethically Sound Episode 8: Ethically Impossible https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/10/31/ethically-sound-episode-8-ethically-impossible/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/10/31/ethically-sound-episode-8-ethically-impossible/#respond Mon, 31 Oct 2016 15:37:38 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=2045 Ethically Impossible,” the eighth episode of the Bioethics Commission’s podcast series Ethically Sound, is now available. Ethically Sound is based bioethics_twitter-v3-08on the 10 reports that the Bioethics Commission has produced during its tenure. The Bioethics Commission, established in 2009 by Executive Order, has addressed a wide variety of ethical challenges ranging from synthetic biology to neuroscience. This episode is based on the Bioethics Commission’s second report Ethically Impossible: STD Research in Guatemala from 1946-1948.

In what is now recognized as an infamous episode in the history of research ethics, the U.S. Public Health Service (PHS) conducted unethical sexually transmitted disease (STD) experiments in Guatemala from 1946 through 1948. The Guatemala STD experiments were carried out with ongoing oversight by PHS and with the approval and engagement of Guatemalan government officials. The research involved intentionally exposing and infecting several vulnerable Guatemalan research subject populations—prisoners, soldiers, and psychiatric patients—to disease, without their consent. When these studies were revealed in 2010, President Barack Obama extended an apology to the President and people of Guatemala. President Obama charged the Bioethics Commission to conduct an ethical analysis of the research that took place, and to review current federal regulations to protect research participants. The Bioethics Commission conducted a thorough fact-finding investigation, reviewed more than 125,000 pages of documentation related to these studies, and traveled to Guatemala to meet with Guatemala’s own investigation committee. The Bioethics Commission’s report presents an unvarnished ethical analysis of the research studies that occurred, and concludes that these studies involved “unconscionable basic violations of ethics.” The Bioethics Commission’s third report Moral Science: Protecting Participants in Human Subjects Research, addresses the second part of the president’s charge. The Bioethics Commission found that participants in federally-funded research studies were generally protected under current regulations, and recommended 14 changes to current practices to better protect research participants.

The podcast opens with a narrative from Dr. Paul Lombardo, Bobby Lee Cook Professor of Law at Georgia State University. Dr. Lombardo serves as a senior advisor to the Bioethics Commission, and traveled to Guatemala to help conduct this investigation. While recounting this experience, Dr. Lombardo said, “I returned to the United States with a more complete understanding of the meaning of the stories we tell about research ethics, not merely as a parochial academic concern, but within a larger historical frame where ill-treatment of research participants implicate the human rights of all people.”

The podcast also includes an interview with Commission member Dr. Anita Allen, the Henry R. Silverman Professor of Law and Professor of Philosophy at the University of Pennsylvania. Hillary Wicai Viers, former Communications Director with the Bioethics Commission staff, conducted the interview. Dr. Allen discussed why the Bioethics Commission conducted a fact-finding investigation, what the investigation entailed, and whether such morally reprehensible research could happen again. Dr. Allen said, “Going deeper into the history…was an important way for us to make sure that we [had] a complete historical picture of what had occurred, and also to increase our chances for understanding what we need to avoid, by way of research practices, moving forward.”

Episode 8 is now available on our website, as well as on our SoundCloud, YouTube and iTunes pages. In addition to this episode, listeners can access the first seven episodes of Ethically Sound. Listeners can follow the podcast using #EthicallySound or by following us on Twitter @bioethicsgov. Stay tuned for the ninth episode in our series, “Bioethics for Every Generation,” which will be available on November 7, 2016. We welcome comments and feedback at info@bioethics.gov.

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Ethically Sound Episode 7: Moral Science https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/10/24/ethically-sound-episode-7-moral-science/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/10/24/ethically-sound-episode-7-moral-science/#respond Mon, 24 Oct 2016 15:00:46 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=2027 ethically_sound_moral-science-7-08Moral Science,” the seventh episode of the Bioethics Commission’s podcast series Ethically Sound, is now available. Ethically Sound is based on the 10 reports that the Bioethics Commission has produced during its tenure. Established in 2009 by Executive Order, the Bioethics Commission has addressed a variety of ethical challenges ranging from whole genome sequencing to public health planning and response. This episode is based on the Bioethics Commission’s third report Moral Science: Protecting Participants in Human Subjects Research.

In what is now recognized as an infamous episode in the history of research ethics, the U.S. Public Health Service (PHS) conducted unethical sexually transmitted disease (STD) experiments in Guatemala from 1946 through 1948. The Guatemala STD experiments were carried out with ongoing oversight by PHS and with the approval and engagement of Guatemalan government officials. They involved intentionally exposing and infecting 1,308 person from vulnerable Guatemalan populations—prisoners, soldiers, sex workers, and psychiatric patients—to disease, without their consent. When these studies were revealed in 2010, President Barack Obama extended an apology to the President and people of Guatemala, and charged the Bioethics Commission to conduct an ethical analysis of the research that took place, and to review current federal regulations to protect research participants. The Bioethics Commission addressed the first part of this charge in its report Ethically Impossible: STD Research in Guatemala from 1946-1948. Moral Science addressed the second part of this charge. The commission found that the kinds of unethical conduct that occurred during the studies conducted in Guatemala from 1946-1948 could not occur under today’s federal protections for research participants. Federal protections generally appear to protect people from avoidable harm or unethical treatment in research conducted or supported by the federal government. However, the commission also found that there is room for improvement in how federally-funded research studies involving human subjects are conducted. In Moral Science, the Bioethics Commission presented 14 recommendations regarding various aspects of protecting human subjects in federally funded research.

The podcast opens with a narrative from Dr. Jerry Menikoff, the Director of the Office for Human Research Protections (OHRP). Dr. Menikoff presented before the Bioethics Commission during its fifth public meeting, where he discussed the role of OHRP in protecting research participants. In this episode Dr. Menikoff shared how the protection of research participants became a central focus in his career, and recounted an eye-opening experience he had while serving on an institutional review board. Following the recollection, Dr. Menikoff said “Since then, making sure that people who are thinking about participating in clinical trials are given the information they need to make fully informed decisions has been an important part of my life’s work.”

The podcast also includes an interview with Bioethics Commission member Dr. Nita Farahany, Director of Science and Society at the Institute for Genome Sciences and Policy at Duke University. Hillary Wicai Viers, former Communications Director with the Bioethics Commission staff, conducted the interview. Dr. Farahany discussed the importance of ethics education for researchers, and how new technologies will shape protections for research participants. Regarding new technologies, Dr. Farahany said, “It’s essential for that kind of research to continue to afford the same kind of protection to human subjects.”

Episode 7 is now available on our website, as well as on our SoundCloud, YouTube and iTunes pages. In addition to this episode, listeners can access the first six episodes of Ethically Sound. Listeners can follow the podcast using #EthicallySound or by following us on Twitter @bioethicsgov. Stay tuned for the eighth episode in our series, “Ethically Impossible,” which will be available on October 31, 2016. We welcome comments and feedback at info@bioethics.gov.

 

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Ethically Sound Episode 6: New Directions https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/10/17/ethically-sound-episode-6-new-directions/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/10/17/ethically-sound-episode-6-new-directions/#respond Mon, 17 Oct 2016 15:00:43 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=2012 The Presidential Commission for the Study of Bioethical Issues bioethics_twitter-v3-08(Bioethics Commission) has
released the sixth episode, “New Directions“, in its new
podcast series Ethically Sound.  This podcast series is dedicated to bringing the Bioethics Commission’s body of work to a broad audience. The Bioethics Commission, established in 2009 by President Bara
ck Obama, has produced 10 reports, each of which focuses on key ethical considerations surrounding a particular topic. Today’s episode is based on the Bioethics Commission’s first report, New Directions: The Ethics of Synthetic Biology and Emerging Technologies.

New Directions was written in response to a charge from President Obama, after the announcement that researchers at the J. Craig Venter Institute had created the world’s first self-replicating synthetic genome in a bacterial cell. This news resulted in intense media coverage and hyped claims about the implications of this research. President Obama asked the Bioethics Commission to review the developing field of synthetic biology and to identify appropriate ethical boundaries that would both maximize public benefits and minimize risks. The Bioethics Commission considered a diverse range of perspectives on the direction and implications of synthetic biology throughout its public deliberations. Taking into consideration both the tremendous promise and the potential risks that could arise from developments in synthetic biology, the commission put forth 18 recommendations that outline important ethical considerations for synthetic biology. The recommendations include a call for increased federal oversight of research in synthetic biology, and a recommendation for incorporating ethics training for researchers in fields such as engineering and materials science, who might become involved in synthetic biology research.

The podcast opens with a narrative from Eleonore Pauwels, Senior Program Associate within the Science and Technology Innovation Program at the Woodrow Wilson Center. Ms. Pauwels shared her reaction to the announcement from the Venter Institute, and her perspective on how ethical issues would need to be addressed in this emerging technology. She said, “Today we still face an unresolved question: How do we develop a culture of inclusive public deliberation and decision-making that could guide integration of synthetic biology and all new technologies into society?”

The podcast also includes an interview with the Vice Chair of the Bioethics Commission and former President of Emory University, Dr. James Wagner. Hillary Wicai Viers, former Communications Director with the Bioethics Commission staff, conducted the interview. Dr. Wagner discussed the relevance of the commission’s report for current and future developments in synthetic biology, and how this first report set the tone for the rest of the commission’s body of work. Dr. Wagner noted that the ethical principles established in this report were foundational to subsequent projects, as well. He said, “We found ourselves in subsequent reports also recommending that there needs to be greater education in the area of bioethics, and education of our public to understand the current state of the art. We found ourselves coming back to those [ethical principles] over and over again in subsequent works that we did, whether it was work in neuroscience or work in genome sequencing.”

Episode 6 is now available on our website, as well as on our SoundCloud, YouTube and iTunes pages. In addition to this episode, listeners can access the first five episodes of Ethically Sound. Listeners can follow the podcast using the hashtag #EthicallySound or by following us on Twitter @bioethicsgov. Stay tuned for the seventh episode in our series, “Moral Science,” which will be available on October 24, 2016. We welcome comments and feedback at info@bioethics.gov.

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Ethically Sound Episode 5: Gray Matters https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/10/10/ethically-sound-episode-5/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/10/10/ethically-sound-episode-5/#respond Mon, 10 Oct 2016 14:00:14 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1937 The fifth episode of the Bioethics Commission’s podcast series Ethically Sound, “Gray Matters,” is now available. The Bioethics Commission has released 10 reports on a variety of ethically challenging topics. Ethical issues in neuroscience were the focus of the reports Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Volume 1), and Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Volume 2).

The two Gray Matters reports responded to a charge from President Barack Obama, in conjunction with the announcement of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, a White House Grand Challenge. President Obama asked the Commission to “consider the potential implications of the discoveries that we expect will flow from studies of the brain.” In Gray Matters Volume 1, the Bioethics Commission recommended early and explicit integration of ethics into neuroscience research. In Gray Matters Volume 2, the Commission focused on three “cauldrons of controversy” in neuroscience: cognitive enhancement, research involving participants with impaired consent capacity, and the use of neuroscience in the legal system.

This episode of Ethically Sound opens with a narrative from Dr. Stephen Morse, Associate Director of the Center for Neuroscience and Society at the University of Pennsylvania. Dr. Morse discussed a case where neuroscience was used as the basis of an insanity defense in a murder trial, as the defendant had a cyst in his left frontal lobe that the defendant’s legal counsel argued had impaired his judgment. When discussing the two positions taken by the prosecution and the defense, Dr. Morse said, “The defense took the position that the prosecution was afraid of the expert evidence having to do with the brain tumor.”

The podcast also features Bioethics Commission member Dr. Stephan Hauser, Director of the University of California, San Francisco Weill Institute for Neurosciences, and Chair of the Department of Neurology. Hillary Wicai Viers, former Communications Director with the Bioethics Commission staff, conducted the interview. Dr. Hauser discussed the array of ethical challenges that the Bioethics Commission addressed in its reports, including the importance of integrating ethics into all stages of neuroscience research. Dr. Hauser said, “Well-designed, ethical neuroscience research will pave the way for progress that has the potential to benefit so many [people].”

Episode 5 is now on our website, as well as on our SoundCloud, YouTube and iTunes pages. In addition to this episode, listeners can access the first four episodes “Safeguarding Children,” “Ethics and Ebola,” “Anticipate and Communicate,”and “Privacy and Progress.” Listeners can follow the podcast using #EthicallySound or by following us on Twitter @bioethicsgov. Stay tuned for the sixth episode in our series, “New Directions,” which will be available on October 17, 2016. We welcome comments and feedback at info@bioethics.gov.

 

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Exploring Democratic Deliberation https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/09/28/exploring-democratic-deliberation/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/09/28/exploring-democratic-deliberation/#respond Wed, 28 Sep 2016 14:09:38 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1959 Bioethics Commission member Col. Nelson Michael was interviewed in June by BioEdge, a bioethics news site, about the Commission’s capstone report Bioethics for Every Generation: Deliberation and Education in Health, Science and Technology. In a previous post, we discussed Col. Michael’s discussion of lifelong bioethics education. This post will focus on Col. Michael’s discussion of democratic deliberation, which the Commission recommends in its report.

Democratic deliberation is a method of decision-making that brings diverse voices to the table, and promotes mutual respect and reason-giving in order to identify areas of agreement to facilitate solutions to challenging problems. The goal of reaching consensus on a way forward distinguishes deliberation from debate, which involves participants trying to persuade others that their arguments are correct and more compelling than their fellow participants’ arguments. While participants are encouraged to use facts and reasons to support their various positions during the deliberative process, democratic deliberation is intended to be a mutually respectful process, with all participants entering the deliberation with an open mind and a willingness to consider other perspectives.

Xavier Symons, the BioEdge interviewer, asked Col. Michael about the criticism that democratic deliberation “smother[ed] substantial debate in focus groups and reports,” citing the debates and public deliberation that occurred when the Human Fertilisation and Embryology Authority (HFEA) in the United Kingdom considered the ethical implications of transferring a healthy nucleus from a mother’s egg to a donor egg in order to avoid certain mitochondrial diseases. Col. Michael responded by noting that “the discussions were facilitated using democratic deliberation…this distinguished those conversations from the kind of debates we are more accustomed to. Democratic deliberation is not foolproof—limitations and challenges exist with every method of decision making. However…deliberation has many advantages. It provides a morally and practically defensible way for addressing hyperpartisan gridlock. It also promotes mutual respect rather than fueling the sharp polarization and heightened differences that make consensus and legitimate outcomes nearly impossible in our current context.”

The Bioethics Commission outlined steps that decision-making bodies can take to engage in democratic deliberation. Deliberation begins with an open question, for which there might be numerous possible paths forward. The Commission emphasized that it is preferable to conduct deliberations with enough time to affect policy decisions. For example, when the Commission considered whether testing an anthrax vaccine on children was ethically permissible, it did so at a time when the country was not facing an anthrax attack, which gave the Commission time to consult with experts, reflect on the empirical and moral dimensions, and make reasoned recommendations. However, the luxury of time is not always possible in emergency circumstances. The Commission encouraged public officials to anticipate as much as possible potential ethical challenges that could arise during emergency situations and address these challenges in advance, since deliberation might not be possible in the midst of a crisis. In order to fully consider the implications of the question at hand, deliberation calls for consulting experts and members of the public alike. Stakeholders from all walks of life, whether they are scholars in the field or community members and leaders, have an important perspective to contribute, and it is necessary to consider these varied perspectives to come to a solution. Participants in the deliberation are encouraged to openly discuss their various perspectives. While vigorous discussion can be a part of the deliberative process, participants must use accessible and explicit reasons to support their arguments, and must maintain a mutually respectful environment throughout the process. At the end of deliberation, participants develop a detailed plan of action that emerges from the deliberation, which includes addressing ethical duties towards those who are affected by the plan.

We have produced a series of educational materials related to democratic deliberation. The “Guide to Classroom Deliberation for Students and Teachers” introduces the deliberative process in a manner suitable for classroom environments. The Commission has also produced several deliberative scenarios that can be used as the basis for deliberation around an ethically challenging topic. The Commission has also produced “Five Steps for Effective Deliberation” in conjunction with the report Bioethics for Every Generation.

The Bioethics Commission’s educational materials and reports can be viewed and downloaded for free at www.bioethics.gov. The Bioethics Commission welcomes comments and feedback on its materials at info@bioethics.gov.

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Introducing New Primer Series: Spotting and Responding to Hype https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/08/03/introducing-new-primer-series-spotting-and-responding-to-hype/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/08/03/introducing-new-primer-series-spotting-and-responding-to-hype/#respond Wed, 03 Aug 2016 12:00:28 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1890 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has released a new series of primers on spotting and responding to science hype in the media. The three primers cover hype related to topics in new technology, public health and neuroscience. The primers introduce hype about scientific topics in the media, and provide users with ways to spot hype and evaluate scientific claims in media outlets. The primers draw on topics covered in three of the Commission’s reports: New Directions: The Ethics of Synthetic Biology and Emerging Technologies, Ethics and Ebola: Public Health Planning and Response, and Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society.

The primers are designed to help members of the public spot and respond to hyped claims in the media, which can often distort, exaggerate or misrepresent scientific information. The primers note that hype is generated from numerous sources, including scientists, communication and public relations professionals, and journalists. Each primer provides users with steps to spot hype as well as respond to hype when they counter such claims in news stories and blog posts. The primers also include examples of hyped claims that were found in news outlets.

The Commission has discussed hype in a number of its reports. In New Directions, the Commission recommended that individuals and deliberative forums should use clear language when communicating scientific information and avoid “sensationalist buzzwords” when describing topics in synthetic biology. The Commission also called for a private organization to fact-check claims that discuss advances in synthetic biology. In Ethics and Ebola, the Commission recommended that governments and public health organizations use the best available scientific evidence to inform decisions about using liberty-restricting measures (e.g., quarantines) and avoid bending to public pressure to inappropriately implement such measures. In Gray Matters, the Commission recommended that neuroscientists, attorneys, judges and members of the media avoid using or engaging with hype in relation to using neuroscience in the courtroom, noting that justice is threatened when unfounded neuroscience is used to make decisions in a courtroom.

This set of primers is the most recent addition to our “Conversation Series” collections of primers. Interested individuals can access our other “Conversation Series,” which discusses discussing incidental findings for consumers, research participants and patients. Users can also find informational primers about incidental findings and consent capacity.

Please stay tuned for information about forthcoming educational materials, including a classroom discussion guide and a deliberative scenario about incidental findings based on the Commission’s report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts.

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

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Capacity, Consent, and Progress: Recommendations from the Bioethics Commission https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/07/29/capacity-consent-and-progress-recommendations-from-the-bioethics-commission/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/07/29/capacity-consent-and-progress-recommendations-from-the-bioethics-commission/#respond Wed, 29 Jul 2015 17:48:26 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1680 (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 http://education.

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