Human Subjects Protection – 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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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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Ethically Sound Episode 1: Safeguarding Children https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/09/12/ethically-sound-episode-1-safeguarding-children/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/09/12/ethically-sound-episode-1-safeguarding-children/#respond Mon, 12 Sep 2016 14:00:57 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1921 Since the Bioethics Commission was established via Executive Order by President Obama, the Bioethics Commission has released 10 reports on a variety of ethically challenging topics, and has provided recommendations on topics ranging from synthetic biology to neuroscience to whole genome sequencing. In an effort to share the Bioethics Commission’s work with a wide variety of audiences, we are issuing a new podcast series called Ethically Sound.  Today’s episode, the first in the series, focuses on the Commission’s report Safeguarding Children: Pediatric Medical Countermeasure Research, which addressed the ethically challenging topic of when and how to test pediatric medical countermeasures for possible bioterrorism agents. When and how, for example, should we test an anthrax vaccine, approved for adults, in children?

The Ethically Sound: Safeguarding Children podcast centers around the question: How can we best protect children in the event of a bioterrorism attack? At the time this report was written, a vaccine for anthrax had only been tested in adults, but not in children. The Commission was asked to provide recommendations on how this vaccine could be safely tested in children, and when the vaccine would be ethically permissible to test.

The podcast opens with a narrative from Dr. Suzet McKinney, who is the Executive Director of the Illinois Medical District Commission. Dr. McKinney discusses how her public health training taught her that vaccines were largely beneficial, but the thought of an anthrax vaccine that had not been tested in children was a cause for concern. “If there were an anthrax bioterrorism attack in the US and the government determined a need to immunize children with a vaccine that had not been tested and deemed safe, experience tells me that even the most aggressive and comprehensive efforts to educate parents about the risks and potential benefits will be met with anxiety, fear, protest and apprehension… even I would have difficulty agreeing to an untested anthrax vaccine for my own child in the absence of a real, credible threat of attack.”

Hillary Wicai Viers, a former Communications Director with the Commission, interviewed Commission Member Col. Nelson Michael, the Director of the U.S. Military HIV Research Program at Walter Reed Army Medical Institute of Research. Col. Michael discussed his military background, and how the Commission came together to address a particularly sensitive topic. When asked about the most challenging aspect of this topic, Col. Michael said, “Research with children is ethically different from research with other groups, especially when the research in question promises really no direct prospect of benefit for the participants. This was really the heart of our matter. [While] competent adults can volunteer and give their consent and can accept risks and benefits for doing research, children really can’t do that legally or ethically. [As] a consequence, that really posed lots of dilemmas for us as a deliberate group.”

The podcast is available to interested listeners on our website, on our SoundCloud, and will launch shortly on YouTube and iTunes pages. Listeners can also follow the podcast using the hashtag #EthicallySound or following us on twitter @bioethicsgov. Stay tuned for the second episode on our series, “Ethics and Ebola,” which will be available on September 19. We welcome comments and feedback at info@bioethics.gov.

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The History of Bioethics Series – National Bioethics Commissions https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/01/27/the-history-of-bioethics-series-national-bioethics-commissions/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/01/27/the-history-of-bioethics-series-national-bioethics-commissions/#respond Wed, 27 Jan 2016 16:33:35 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1783 This is the first post in our “History of Bioethics” series in which we will examine some of the seminal events that shaped the landscape of bioethics and its practice in the world today. This first blog will focus on the creation of the national bioethics advisory bodies in the United States and their different iterations throughout the years.

From our History of Bioethics Commissions page…

The current advisory group, the Presidential Commission for the Study of Bioethical Issues, established by a 2009 Executive Order from President Barack Obama, continues the more than 40-year history of bodies established by the President or Congress to provide expert advice on topics related to bioethics. These groups have differed in their composition, methods, and areas of focus, yet they all have shared share a common goal – to promote the careful examination and analysis of ethical considerations that underlie our nation’s activities in science, medicine, and technology.

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78) is generally viewed as the first national bioethics commission. Established as part of the 1974 National Research Act, the National Commission is best known for the development of the Belmont Report, a document that laid out the ethical principles and guidelines for research involving human subjects. This document has been used as a basis for further federal regulations in the area of human subjects protections.

The Presidential Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1978-83), also established by Congress, produced reports on foregoing life-sustaining treatment and access to health care, among other topics. Its 1981 report Defining Death was the basis of the Uniform Determination of Death Act, a model law that was enacted by most U.S. states.

The Advisory Committee on Human Radiation Experiments (1994-95) was created by President Bill Clinton to investigate human radiation experiments conducted from 1944 -1974 as well as radiation intentionally released into the environment for research purposes. The committee considered the ethical and scientific standards for evaluating these events and provided recommendations aimed at ensuring that similar events could not be repeated.

Since the mid-1990s, each of the past three presidents has established bioethics commissions to explore ethical issues in science, medicine, and technology. The National Bioethics Advisory Commission (1996-2001), created by President Clinton, examined topics including cloning, human stem cell research, and research involving human subjects. President George W. Bush established the President’s Council on Bioethics (2001-2009), which issued reports on stem cell research, human enhancement, and reproductive technologies, among other topics.

The Presidential Commission for the Study of Bioethical Issues was established in November 2009 and is chaired by Dr. Amy Gutmann, President of the University of Pennsylvania and renowned political philosopher and educator. The Bioethics Commission has dealt with topics ranging from neuroscience, to Ebola, to whole genome sequencing, and more. All of the Bioethics Commission’s reports can be viewed and downloaded for free at Bioethics.gov. A major point of emphasis for the current Bioethics Commission is to educate and inform the nation about bioethics. So far, in its tenure, the Bioethics Commission has created and disseminated materials for a variety of audiences in traditional and non-traditional educational settings. To date over fifty education materials have been developed and are disseminated freely through the website.

Stay tuned to this blog for upcoming posts on the “History of Bioethics”!

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Modernizing Human Subjects Research Protections: Legally Authorized Representatives and Consent Capacity https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/10/09/modernizing-human-subjects-research-protections-legally-authorized-representatives-and-consent-capacity/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/10/09/modernizing-human-subjects-research-protections-legally-authorized-representatives-and-consent-capacity/#respond Fri, 09 Oct 2015 15:07:18 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1730 This is the last installment in a series of blog posts about recent proposed changes to the Common Rule, and how they relate to the work of the Bioethics Commission. The Common Rule currently requires permission from a legally authorized representative (LAR) to enroll participants who lack consent capacity in research. LARs consider and evaluate the merits of research participation on behalf of others—often loved ones—who lack consent capacity.

In Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2) the Bioethics Commission noted that the Common Rule does not specify who can serve as an LAR, what kinds of decisions an LAR can make, and what processes and procedures are required to establish an LAR. Rather, it indicates that these decisions be made according to “applicable law,” including state law. However, while some states have laws that outline LARs for clinical care, few states have laws that specifically address LARs for research, leaving researchers and IRBs with uncertainty. In Gray Matters, Vol. 2, the Bioethics Commission recommended that “federal regulatory bodies should establish clear requirements to identify who can serve as legally authorized representatives for individuals with impaired consent capacity to support their responsible inclusion in research.”

The recent notice of proposed rulemaking (NRPM), which proposes revisions to the Common Rule, recognizes this regulatory gap that was highlighted by the Bioethics Commission. It notes that a possible ramification of this gap is that in states without clear laws, enrolling participants with impaired consent capacity could be difficult or impossible. The NPRM proposes a revision to the Common Rule that would permit LAR requirements to meet an accepted common practice standard, such as an established state or local hierarchy. This proposed revision mirrors the Bioethics Commission’s recommendation and its suggestion that federal regulatory bodies could recognize previous efforts on this front, such as the priority list of potential LARs developed in 2009 by the Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP).

If the NPRM proposed revisions are implemented, new research regulations will reflect the Bioethics Commission’s recommendation for clarity in LAR requirements. Clear requirements for LARs facilitate the responsible inclusion of participants with impaired consent capacity in research, which is necessary to fulfill the promise of research that might one day ameliorate neurological disorders and psychiatric conditions.

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Modernizing Human Subjects Research Protections: A Plan for Return of Results https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/10/05/modernizing-human-subjects-research-protections-a-plan-for-return-of-results/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/10/05/modernizing-human-subjects-research-protections-a-plan-for-return-of-results/#respond Mon, 05 Oct 2015 18:30:08 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1728 The notice of proposed rulemaking (NPRM), issued in the Federal Register on September 8, 2015, proposes revisions to the Common Rule—federal regulations that govern the protection of human subjects in research—including changes to the criteria for institutional review board (IRB) approval of research. This is the next installment in a blog series about those changes and their relationship to the Bioethics Commission’s work on incidental and secondary findings.

Currently, the Common Rule requires IRBs to find that certain criteria have been met in order to approve research. The NPRM proposes an addition that IRBs should evaluate the appropriateness of a plan for returning individual findings discovered during research, when that plan is submitted as part of the protocol. The proposed rulemaking also addresses the potential challenges of returning individual research findings when it is unclear if the findings are clinically valid or actionable, or when the findings might have psychological or social ramifications.

The Bioethics Commission addressed return of individual research results in its December 2013 report, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. The Bioethics Commission recommended that IRBs review and approve plans for the disclosure and management of incidental findings—a recommendation echoed in the proposed changes to the Common Rule. The Bioethics Commission stressed the importance of this plan, recommending both that researchers develop a plan for managing incidental and secondary findings and that, during the informed consent process, researchers clearly communicate their plan to participants.

The NPRM cites to the Bioethics Commission’s report, recognizing the importance of the issue of return of individual research results, and the challenges highlighted by Anticipate and Communicate. The challenge of incidental findings and returning individual results in a research context is a perennial one for IRBs and researchers, and due to more advanced technologies and faster and deeper data analysis, the issue is growing. Anticipate and Communicate addresses these challenges head-on, and the Bioethics Commission is pleased to see that federal research regulations are evolving to address them as well.

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