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

Bioethics Commission Requests Comment on Ethical Considerations in the EVD Response

At its meeting on November 6, 2014, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) began its consideration of the complex ethical landscape of U.S. public health emergency response to the Ebola virus disease (EVD). The Bioethics Commission is currently considering three areas of specific ethical concern: U.S. public policies that restrict association or movement; the ethics of placebo-controlled trials in the context of public health emergencies; and the ethical considerations relevant to collecting, storing, and sharing biospecimens during a public health emergency.

Before making any recommendations, the Bioethics Commission would like to consult with the broadest possible range of individuals and groups. The Commission is therefore interested in receiving comments from individuals, groups, and professional communities regarding the three areas of ethical concern outlined above in the context of public health emergency response generally and the EVD epidemic specifically, including:

• Ethical and scientific standards for public health emergency response;

• Ethical and scientific standards that guide the use of quarantine or other movement restrictions during public health emergencies;

• The impact of quarantine or other movement restrictions on the availability or willingness of health workers to volunteer to contain the epidemic in disease-affected areas;

• The impact of quarantine or other movement restrictions on public fear and anxiety about potential threats to public health;

• How U.S. public policy and public health response to the current EVD epidemic might or should affect public attitudes to, and further U.S. policy and public health response to, other current and future public health issues and emergencies;

• Ethical and scientific standards for placebo-controlled trials during public health emergencies;

• Ethical and scientific standards for collection, storage, and international sharing of biospecimens and associated data during public health emergencies.

The Bioethics Commission invites public commentary from any interested party. Please submit comments by February 6, 2015. Please email comments to info@bioethics.gov.

For more information on this request, please visit Bioethics.gov.

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PRIM&R Conference Update: Research Ethics and Incidental and Secondary Findings

Recently, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) facilitated a didactic workshop session at the Public Responsibility in Medicine and Research (PRIM&R) Advancing Ethical Research Conference. This past Saturday, December 6, Bioethics Commission staff led the workshop IRB Primer: Incidental and Secondary Findings. The presentation provided an overview of the Commission’s recommendations regarding discoveries that lie outside the original aim of a test or procedure, and introduced educational materials to inform and support institutional review board (IRB) members, who often review protocols that include concerns about the ethical management of these findings.

Elizabeth Pike began with a brief introduction to the Bioethics Commission’s report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. She emphasized the Commission’s main message: The ethical management of incidental and secondary findings requires that practitioners in all contexts anticipate and communicate. Practitioners should anticipate the incidental and secondary findings that can arise from a particular test or procedure and communicate how those findings will be managed to a potential recipient. She also noted the role of IRBs in reviewing research, and provided an overview of definitional issues, including what makes findings “incidental” or “secondary,” as well as the types of tests and procedures that commonly produce these findings.

Misti Ault Anderson then discussed the role of researchers. She highlighted various options researchers have to facilitate the ethical management of incidental and secondary findings, including informed consent processes, access to additional expertise, and opportunities to obtain participant preferences and disclose findings in accordance with these wishes.

Finally, Karen Meagher presented on the ethical considerations pertinent to IRB members when evaluating protocols in which incidental and secondary findings can arise. This overview included relevant ethical principles, such as respect for persons and beneficence, that IRBs can apply when evaluating researchers’ plans for ethical management of incidental and secondary findings. By considering a variety of options, PRIM&R attendees were able to envision multiple ways in which researchers can meet their responsibilities to participants, including different ways to establish clear communication.

In the second part of the session, staff members facilitated small group activities including the analysis of hypothetical research case studies involving large-scale genetic sequencing, testing of biological specimens, and imaging. Small groups considered the case studies, and reported out to the larger group about how researchers might design ethical protocols regarding the management of incidental and secondary findings, generating a lively group discussion. One attendee noted how IRBs also benefit from planning ahead, as thinking through difficult decisions before they arise is preferable to reacting after an incidental or secondary finding has been discovered, when available options might be limited or the timing of decisions more urgent. Session attendees enriched discussion by sharing their own past experiences and insights gained from a wide variety of professional backgrounds in research ethics.

By prompting audience consideration of the ethical issues that arise when considering research that might produce incidental and secondary findings, staff members demonstrated how professionals can make use of Bioethics Commission educational resources in support of important ongoing work in research ethics.

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New Education Materials from the Bioethics Commission on Privacy Now Available

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted to Bioethics.gov a new series of educational modules on privacy. The materials on privacy increase the breadth of topics covered by the Bioethics Commission’s educational resources; previous topics include community engagement, compensation for research-related injury, informed consent, and vulnerable populations. The new series includes a background module and one module to accompany the Bioethics Commission report Privacy and Progress in Whole Genome Sequencing.

The “Privacy Background” module describes a brief history of privacy; provides definitions of privacy and related concepts; relates privacy to the Bioethics Commission’s guiding ethical principles; identifies how U.S. case law, U.S. statutory protection, and the European approach have contributed to legal notions of privacy; explains privacy concerns and protections for health information; and addresses challenges to the de-identification of health-related data.

The “Privacy in Privacy and Progress in Whole Genome Sequencing” module describes the technique of whole genome sequencing and presents the privacy concerns related to whole genome sequencing. It identifies the ethical principles involved in reconciling individuals’ privacy and scientific progress in whole genome sequencing and explains the legal and policy considerations associated with protecting the privacy of individuals who contribute whole genome sequencing data and information to support scientific research.

All of the educational modules produced by the Bioethics Commission are based on the contemporary ethical issues addressed by the Commission, and are designed to provide instructors with foundational information, ethical analysis, discussion questions, problem-based learning scenarios, exercises, and additional resources to support ethics education and the integration of bioethical analysis into coursework across disciplines.

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

 

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Bad Blood Author James H. Jones Visits the Bioethics Commission

The staff of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) was pleased to welcome James H. Jones, Ph.D., to the office on November 21, 2014 for a discussion of his book Bad Blood: The Tuskegee Syphilis Experiment, A Tragedy of Race and Medicine. First published in 1981 (Revised edition, 1993), Bad Blood is a historical account of a non-therapeutic scientific experiment conducted by the U.S. Public Health Service (PHS) from 1932 to 1972 in rural Alabama.[1] Bad Blood received the American Public Health Association’s Arthur Viseltear Award for the best book on the history of public health and was selected by the editors of The New York Times “Book Review” as one of the 12 “Best Books” published in 1981.

During his visit, Jones discussed how his research on Alfred C. Kinsey and the social hygiene movement in 1970 led him to discover records of the Tuskegee Study stored at the National Archives. The stated goal of the experiment was to document the effects of untreated syphilis in African American males living in and around Macon County, Alabama. Researchers identified several hundred men who had syphilis, failed to inform them that they had the disease, lied to them, and then provided them with iron tonic and aspirin instead of available syphilis treatment. Jones walked the staff through the timeline of the experiment, explaining not only how the study was conducted and by whom, but also why he believes it was able to go on for 40 years. Jones argued that several factors played a role in the study’s duration, including a series of internal promotions that allowed the same personnel to work on the project for so long. He said that such continuity meant that the PHS officers were never able to review the experiment with “fresh eyes.” Rather, they were “held hostage by their own success,” and as a result the experiment was never critically reexamined.

Jones also highlighted different logical points in time when the project could have been reviewed and shut down, including during World War II and the Civil Rights Movement. His story came full circle as he described how Albert Leisinger, Jr., the Deputy Archivist of the United States enabled Jones to gain access to the records of the Tuskegee Study, and how he, in turn, gave copies of the documents that he found to Fred Gray, the iconic Civil Rights attorney who worked to bring justice to the victims of the study. The Tuskegee Study remains a somber reminder of the importance of research ethics. It shattered many African-Americans’ trust in the medical community. “There is a deep, deep wound in the African American community,” said Jones. He recalled his conversations with nurse Eunice Rivers, the African-American nurse who was the chief liaison between the PHS officers and the subjects. She helped make the experiment possible by assembling the men for the “annual round ups” at the hospital, where they were examined and their disease progression was monitored.   When the men died, she negotiated, often using burial stipends as incentives, to convince families of the deceased to agree to autopsies. Jones recalled what nurse Rivers told him during his last interview with her. As he was walking out the front door of her home, nurse Rivers took his hand and sobbed, “ Oh, Dr. Jones we should have told those men they had syphilis; and God knows we should have treated them.” Jones also described President William J. Clinton’s formal apology to the nation in April 1997 for the Tuskegee Study, and Jones expressed the hope that it was an important step toward restoring African-Americans’ faith in the medical profession.

The discussion with Jones coincides with the anniversary of the Bioethics Commission’s human subjects protection charge from the President. On November 24, 2010, in the wake of the revelations about PHS-supported research on sexually transmitted diseases in Guatemala, President Barack Obama requested that the Commission analyze what happened in Guatemala in the 1940s, and conduct a review of current Federal human subjects research protections. The request resulted in two reports: “Ethically Impossible” STD Research in Guatemala from 1946 to 1948 and Moral Science: Protecting Participants in Human Subjects Research. The unethical research done in both Tuskegee and Guatemala are examples of the harm that can occur without adequate human subjects protections in place. By shedding light and examining the mistakes of the past, the ethics community can move toward facilitating morally sound scientific practice now and in the future.

 

[1] http://www.cdc.gov/tuskegee/index.html

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The Bioethics Commission’s Neuro Double-Header

Since President Obama’s April 2013 launch of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has worked to ensure that ethics is an integral part of the conversation when discussing neuroscience. This past week, the Bioethics Commission was busy discussing its work at two annual neuroscience conferences in the Washington, D.C. area: the International Neuroethics Society (INS) Annual Meeting and the Society for Neuroscience (SfN) Annual Meeting.

Bioethics Commission Member Stephen L. Hauser, M.D., represented the Commission at INS on November 14, where he took part in the panel “The BRAIN Initiative & the Human Brain Project: An Ethical Focus.” Dr. Hauser was joined by fellow panel participants Walter Koroshetz, BRAIN Initiative, and Henry Markram, Human Brain Project, for a discussion on the ethical issues surrounding neuroscience research. Following the panel, each participant gave a brief interview for the University of Cambridge’s podcast The Naked Scientists.

“There are a whole host of issues that the Commission and society at large needs to undertake and tackle. These include such areas as brain privacy, particularly as our imaging tools become more sophisticated; cognitive enhancement; things like personality, sociability, violent impulses, etc.” said Hauser during his podcast interview. “What we need to have is a two-fold mission: first, to communicate clearly the true value of the therapies that we now have available; and second, anticipate and prepare for those that will perhaps be transformational but that are not yet currently available,” he explained. To listen to the full podcast, visit http://bit.ly/1xxVEmu.

The Bioethics Commission then went on to participate in SfN’s Annual Meeting exhibition, visited by more than 31,000 attendees. The exhibition, which took place November 16-19, 2014, allowed the Commission to discuss its role in the BRAIN Initiative and related reports. The Commission promoted the reports Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings, because so many neuroscience researchers often deal with these issues, and Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society, the Commission’s first of two reports in response to President Obama’s BRAIN Initiative-related request.

It was wonderful to engage with so many neuroscientists eager to discuss ethics over the past week!

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A Look at How M.D. Anderson Cancer Center Uses Bioethics Educational Materials

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) loves hearing from educators who use our pedagogical materials in traditional and nontraditional settings. As a part of its initiative to promote and enhance bioethics education, the Bioethics Commission has produced a library of educational materials to accompany its reports. The Commission aims to contribute to the tools that educators and students can draw upon, with the overall goal of enhancing bioethics education. Happily, many attendees at the recent American Society of Bioethics and Humanities (ASBH) 2014 Annual Meeting reported incorporating these materials into their university lectures.

Colleen M. Gallagher, Ph.D., M.A., L.S.W., F.A.C.H.E., visited our booth at ASBH to tell us that she has used Bioethics Commission educational materials as a part of her curricula. Gallagher, the Chief and Executive Director of the Section of Integrated Ethics in Cancer Care and an Associate Professor, teaches clinical and research interns, fellows and trainees completing certificates in ethics at the University of Texas M.D. Anderson Cancer Center in Houston, TX. She has used modules such as the Study Guide to “Ethically Impossible” STD Research in Guatemala from 1946 to 1948 and Vulnerable Populations in Safeguarding Children: Pediatric Medical Countermeasure Research for courses on research ethics and clinical trials.

“The Study Guide to ‘Ethically Impossible’ helps to guide conversations with our interns on the importance of balancing public health concerns with the needs of the individual,” said Gallagher. She had also used the format from the Study Guide to “Ethically Impossible” to discuss other cases of ethical misconduct in research.

Gallagher said she finds the division of Bioethics Commission educational material into specific topic areas, such as informed consent and vulnerable population, to be especially useful when discussing public health and social policy issues with her classes. “Ethics is very philosophical, and there’s often a lack of consistent methodologies available. The materials created by the Bioethics Commission break down ethics into topic areas with specific case studies and examples,” explained Gallagher. She then had students apply the issues raised in Commission reports and educational modules to population health concerns where they live. Many of her students are professionals who are continuing their educations online. Gallagher, noting the need for a variety of materials and modalities when teaching online courses, said she appreciates the range of resources produced by the Bioethics Commission. She also appreciates the ease with which her students can access the materials for free online.

All Bioethics Commission educational materials are available for free use at bioethics.gov/education. If you have used Commission materials in your lectures, classes, or seminars and would like to provide feedback, please email education@bioethics.gov.

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Deliberation and Education in Bioethics: Overview

In the final session of its nineteenth public meeting, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) heard from a panel of experts on deliberation and bioethics education, a theme that has been central throughout the Commission’s work since it was established by President Obama in 2009.

In introducing the new project this morning, Bioethics Commission Chair Amy Gutmann, Ph.D., noted that while all of the Commission’s reports to date have been topic-specific, its commitment to public bioethics and to related educational and deliberative efforts has been a constant. “Recognizing that education is required for informed deliberation, and deliberation enhances education at all levels, this new report will integrate deliberation and education as overarching themes of the Commission’s work, and focus on their symbiotic relationship as twin pillars of public bioethics,” Gutmann said.

Daniel Levin, Ph.D., associate professor of political science at the University of Utah, started the discussion by addressing the role of deliberation in public bioethics forums—such as the national meetings of the Bioethics Commission—in informing public understanding of bioethics.

Levin noted that public forums such as the Bioethics Commission are important to ensuring that policy discussions on complex and important issues that concern the public—but in which the public isn’t necessarily engaged—are transparent and serve the public.

Research has shown that Americans are “conflict avoidant” and do not like to engage in discussions of controversial issues, Levin said.  However, he added, “Americans are concerned about the process itself, especially that special interests not be allowed to have undue influence, and they believe that the political process should be transparent.”

Next, Diana E. Hess, Ph.D., professor of curriculum and instruction at the University of Wisconsin-Madison and senior vice president of the Spencer Foundation, examined the relationship between democratic deliberation and both public and medical education.

“People need to be taught how to engage in high-quality deliberation,” Hess said, starting in high school and throughout the course of their education, on complex issues, including issues related to bioethics.

She noted that anyone –not just physicians and bioethicists—may at some point in their life be faced with a bioethical decision, such as how to deal with care at the end of life.  “You’ve got a responsibility to prepare people not just to participate in public policy discussions,” Hess told the Commission.  “What is education for? We want to create a better society, but we want people to have better lives.”

Lisa Lehmann, M.D., Ph.D., M.Sc., director of the Center for Bioethics at Brigham and Women’s Hospital and associate professor of medicine and medical ethics at Harvard Medical School, rounded out the panel by focusing on the importance and value of ethics education in the education of medical professionals.

Lehman said bioethics education can foster the “moral courage” needed for medical professionals to “put ethical principle into action.”  She defined moral courage as “the courage to do what’s right for patients, despite the professional risks … even if it conflicts with the law.”

However, she agreed with Hess that all members of society should have some bioethics education, so that they can make informed decisions such as whether to be an organ donor, for example.

Gutmann asked the panel if the example of quarantines during an Ebola outbreak might be the kind of case study that could help with bioethics education.  She noted that such a case study brings science, law, and ethics together.

Hess replied that it is a “close to perfect case study.”  She said that it is both highly authentic and that it has a lot of conflicting core values.

The Bioethics Commission’s next public meeting is scheduled for Feb. 5-6, 2015. The Commission plans to meet in Washington, D.C.

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Deliberation and Bioethics Education: A Case Study of Public Health Emergency Response

This morning, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) turned its attention to its next report topic: deliberation and bioethics education.  The Bioethics Commission advises President Obama and his administration on issues arising from advances in biomedicine and related areas of science and technology and, in so doing, educates the nation on bioethical issues.  This new project will focus on the symbiotic relationship between deliberation and education as twin pillars of public bioethics.  Education is required for informed deliberation, and deliberation enhances education at all levels.

The Bioethics Commission dove into its new project this morning with back-to-back sessions examining a case study in public health emergency response. Guest speakers Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH), andLawrence O. Gostin, J.D., LL.D., university professor and director of Georgetown University’s O’Neill Institute for National & Global Health Law and director of the World Health Organization Collaborating Center on Public Health Law & Human Rights,  brought up compelling ethical topics related to the timely debate of restriction of movement provisions in response to an epidemic.

“There are very few examples that are stronger than a global public health crisis to focus our minds and drive home the importance of public education and proactive deliberation,” explained Bioethics Commission Chair Amy Gutmann, Ph.D.

Gostin launched the discussion by describing the various sets of ethical standards that should come into play as issues like quarantine and restriction of movement are considered.  Quarantine and restriction of movement is just one of the difficult ethical issues that have been brought up by the current Ebola virus disease outbreak in several western African countries.

In particular, Gostin cautioned against blanket quarantines. “When we think carefully, we should use good science and good constitutional law, both of which would require an individualized assessment of risk before limiting individual liberty,” he said.

Gostin also stressed the importance of public trust to effective public health enforcement.  “Whatever decisions policymakers make, they need to be made in partnership and shared understanding with those who are most affected,” Gostin said. “If AIDS taught us anything, it taught us that the first response is social mobilization.”

Next, Fauci discussed how science should inform ethical guidance for public health decision-makers managing Ebola in the United States.  Fauci has played a leading role in the national response to Ebola. He has testified before Congress and has been interviewed by national news media on the importance of a science-based approach to containing the Ebola epidemic in western Africa and minimizing risk in the United States.

Fauci also helped care for a Dallas area nurse who was infected with Ebola while caring for a patient with Ebola.  This involvement, he said, puts him at low risk for infection, and, in some states, would mean that he would be quarantined. He cited a recent public health conference in New Orleans that banned participation of health care workers who had traveled to West Africa – “and those are the very people you want there.”

Blanket quarantines, he said, are not based on scientific evidence, but arise from a desire to assuage public fear.  The real danger, he added, is that blanket quarantines and restrictions can undermine efforts needed to contain outbreaks such as Ebola because they discourage health care workers from providing care to those who are infected.

What’s most needed, Fauci said, is public education.  He contrasted the public response to the early days of the AIDS epidemic with the current reaction to Ebola.  In AIDS, “we had a growing, insidious epidemic and very few people were paying attention to it.  Here we have two cases, and we have mobilized everyone, including the President of the United States.”  He added, “The lesson learned is you’ve got to keep educating the public over and over again.”

Following the case study discussions, the Bioethics Commission went on to broaden its discussion to the goals and contributions of deliberation and bioethics education generally.

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Live from Salt Lake City

Welcome back to live blog coverage of the nineteenth public meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission).  The Bioethics Commission is meeting in Salt Lake City today, November 6, 2014, from 9 a.m. to noon MT.

Yesterday, the Bioethics Commission continued its review of ethical issues associated with neuroscience research and application and began deliberating on recommendations in response to President Obama’s request regarding the BRAIN Initiative.  Today the Bioethics Commission will begin discussing its new project – deliberation and bioethics education.

The Bioethics Commission will hear from two panels this morning.  For the first panel, guest speakers Anthony S. Fauci, M.D., of the National lnstitutes of Health and Lawrence O. Gostin of the World Health Organization Collaborating Center on Public Health Law and Human Rights will present on a case study of public health emergency response.  The second panel will provide an overview of deliberation and bioethics education, with remarks by Daniel Levin, Ph.D., associate professor of political science at the University of Utah; Diane E. Hess, Ph.D., professor of curriculum and instruction at the University of Wisconsin-Madison; and Lisa Lehmann, M.D., Ph.D., M.Sc., director of the Center for Bioethics at Brigham and Women’s Hospital.

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

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Bioethics Commission Discusses Law and Neuroscience

This afternoon, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) turned its attention to law and neuroscience as part of its deliberations on potential recommendations related to neuroscience that it may offer to the President.

Bioethics Commission Chair Amy Gutmann, Ph.D., began by focusing discussion questions around whether and how to use neuroscience technologies in the courtroom.

“What can neuroscience in its current capacity tell us about whether any individual is legally blameworthy for his or her actions?” Gutmann asked. “What is the potential for neuroscience to answer this question? What can it tell us about moral responsibility and blameworthiness, as distinct from legal responsibility and blameworthiness?”

Commission Member Nita A. Farahany, J.D., Ph.D., framed the discussion by noting the different legal contexts in which neuroscience research is being cited. For example, lawyers are bringing neuroscience research into the courtroom to substantiate claims about defendants’ competency to stand trial, as well as to challenge traditional notions about what a mental state is and how it should be measured. Neuroscience has also come up in sentencing as a way of determining the degree to which a person is morally responsible because of diminished capacity, and whether sentencing for such an individual should be weighted more toward retribution or toward rehabilitation. Finally, criminal courts have also looked to neuroscience as a predictor of a defendant’s future dangerousness.

Farahany said she has also seen neuroscience research cited in in certain civil cases. In the past, it has been difficult to prove whether a person is suffering pain from exposure to a toxic substance. Now, some civil plaintiffs are using neuroscience to do just that. In the arena of constitutional law, the U.S. Supreme Court has cited neuroscience research with regard to the culpability of juvenile defendants accused of capital crimes. Farahany noted that neuroscience is also beginning to highlight gaps in certain constitutional protections, such as freedom of speech and new technologies that reveal the brain’s visual imagery.

Farahany cautioned about overstating the capacity of neuroscience to inform law. “When we start using a science like neuroscience to predict behavior before it can do so, it can derail the credibility of science as a whole,” she said, citing “a duty to tread carefully in an area of nascent science.”

Commission Member John D. Arras, Ph.D., observed that some legal experts have questioned whether neuroscience upends the legal notion of people as ‘agents of action’ capable of making decisions in accordance with society’s rules and laws. This argument, he said, “strips people of their personhood and views them as things to be moved around and not responsible for their actions. That is something to worry about.”

Tomorrow the Bioethics Commission will shift its focus from neuroscience and related ethical issues to deliberation and bioethics education. The discussion will include a panel examining a case study of public health emergency response featuring Anthony S. Fauci, M.D., of the National lnstitutes of Health and Lawrence O. Gostin of the World Health Organization Collaborating Center on Public Health Law and Human Rights.

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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.

Learn more about the Presidential Commission for the Study of Bioethical Issues.

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