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

Bioethics Commission Sharpens Focus on Ebola Challenges

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) is conducting an in-depth review of U.S. engagement in the global response to the current Ebola epidemic.

In her opening remarks, Amy Gutmann, Ph.D., chair of the Bioethics Commission, noted that the panel is seeking insights into three critical issues: the ethics of placebo-control trials in the context of public health emergencies; the ethics of U.S. public policies that restrict association or movement; and the ethical considerations relevant to collecting and storing biospecimens during a public health emergency and sharing them for future research.

“I believe that the overarching theme of all of these discussions is that major infectious disease epidemics are a matter of U.S. concern for both ethical and prudential reasons,” Gutmann said. “We are obligated to engage in such devastating outbreaks from a global justice perspective, and also—considering the ability of infectious diseases to travel in our interconnected world—it is prudent for us as a country to address epidemics at their source.”

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Bioethics Commission, Live from Washington, D.C.

We are live and blogging in Washington D.C. for the 20th public meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission). The Bioethics Commission is meeting today, February 5, from 9 a.m. to 5:30 p.m. ET, and tomorrow, February 6, from 9 a.m. until 11:30 a.m. ET.

At this meeting, the Bioethics Commission will continue considering the implications of a public health emergency response, with a focus on the current Ebola epidemic, a topic first discussed at the Commission’s Nov. 2014 public meeting. Tomorrow, members will resume consideration of ethical issues associated with neuroscience research and the application of neuroscience findings, as requested by President Obama. They also will discuss recommendations associated with the Ebola response.

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

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The Bioethics Commission’s Meeting 20 Milestone

This February will mark an important milestone for the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission); the Bioethics Commission will hold its 20th public meeting. The 2-day meeting will be held February 5-6, 2015, in Washington, D.C. Since President Obama issued the Executive Order establishing the Commission on November 24, 2009, it has convened quarterly each year in order to publically discuss and deliberate various bioethical topics. As a Federal Advisory Committee, the Commission conducts all meetings and deliberations in public.

The Bioethics Commission held its first public meeting July 8-9, 2010 in Washington, D.C. to discuss its first topic, synthetic biology and the ethics of new technologies. The Commission has since covered a wide breadth of topics including privacy and genomic sequencing, ethical treatment of research participants, ethical duties of returning incidental findings, and the ethical conduct of neuroscience research. This year Commission meetings have focused on neuroscience; bioethics education and deliberation; and public health emergency response, with a focus on the current Ebola virus disease (EVD) epidemic.

During its quarterly meetings, Commission members hear from experts relevant to the topic being deliberated. After meeting 20, the Commission will have heard from more than 200 speakers. These speakers have come from across the U.S. and the world, and represent a variety of disciplines and interests including science, technology, law, medicine, and affected communities. Presentations from these experts provide Commission members with background information and lay the foundation for their deliberations. The roundtable discussions that occur during the public meetings serve to inform the recommendations published in each report. After meeting 20, the Commission will have engaged in more than 135 hours of public discussion and deliberation to inform its recommendations.

The Bioethics Commission does not rely on one ethical framework to guide its deliberations and recommendations. Instead, the Commission often draws upon broader ethical principles to inform its conversations and resulting analyses and recommendations. Some key bioethical principles that have run throughout many of the Commission’s reports include beneficence, democratic deliberation, respect for persons, as well as justice and fairness.

At meeting 20 the Bioethics Commission will continue to discuss the ethical considerations of neuroscience research, as well as public health emergency response in the context of the current EVD epidemic. Details, including the meeting location and agenda, will be posted to Bioethics.gov on the Meeting page. Meetings are always open to the public, and guests are encouraged to attend. For those unable to attend, all meetings are webcast live and archived at Bioethics.gov/meetings. See you February 5-6, 2015!

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Why the Bioethics Commission Asks for Public Comment

Public comments play a critical role in the Presidential Commission for the Study of Bioethical Issues’ (Bioethics Commission) deliberations. Public input is essential for processing and analyzing challenging bioethical topics.

The Bioethics Commission is currently seeking public comment on the ethical considerations of U.S. public health emergency response with a focus on the current Ebola virus disease (EVD) epidemic. At its meeting on November 6, 2014, the Bioethics Commission began its consideration of this topic, and the Commission plans to continue this discussion at its next public meeting February 5-6, 2015 in Washington, D.C. Before making any recommendations, the Commission will consult with a broad range of individuals and groups.

The collection of a wide variety of public comments is one aspect of the Bioethics Commission’s practice of democratic deliberation. The Commission’s call for public comments serves as a way for the public to provide their input on current topics. Public comment comes from a variety of sources, including but not limited to individuals, scientists, organizations representing affected communities, and federal agencies. In addition, Commission meetings are always open to the public, and attendees are encouraged to submit written comments at meetings.

The Bioethics Commission has issued requests for comments for each topic it has examined since its start. For its current request, the Commission is considering three specific areas related to the current EVD epidemic: the ethical foundations of U.S. 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 and storing biospecimens during a public health emergency and sharing them for future research.

For more information, and to view the request for comments as it appears in the Federal Register, visit the Bioethics Commission’s website. Please email comments by February 6, 2015 to info@bioethics.gov.

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Using the Bioethics Commission’s Pedagogical Materials on Informed Consent and Incidental Findings to Engage Students Undergoing Personalized Genetic Testing

Recently, some U.S. educational institutions have used personalized genetic testing (PGT) as a pedagogical tool for teaching human genetics, allowing students to generate real-world experiences with technology relevant to course content. In a recent article published in the Journal of Microbiology & Biology Education, Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) staff members Tenny Zhang and Misti Ault Anderson assert that PGT also can be an effective tool for incorporating ethics into the biology classroom. Experiencing PGT first-hand represents a chance for students to reflect upon and discuss the many facets of genetic testing, including the interpretation, limitations, and potential impacts on individuals and society.

PGT in the educational setting provides an opportunity to integrate ethical considerations into the science classroom since genetic testing can raise a number of ethical concerns, including ensuring informed consent, protecting privacy, and promoting accessibility, among others. Integrating discussion about ethics into biology courses that offer PGT can help students to make direct and personal connections between the science learned in class and related bioethical challenges, and encourage consideration of the broader ethical implications of genetic testing.

While it has not taken a position on the use of PGT in the classroom itself, the Bioethics Commission has consistently emphasized in its work the need for ethics education across various disciplines, educational levels, and settings. As part of its ongoing effort to support bioethics education, the Bioethics Commission developed educational materials to facilitate ethics integration.

The Bioethics Commission’s topic-based modules, which are designed to be flexible to support multiple approaches to implementation and can be adapted into existing curricula in various educational settings, can provide a helpful resource to instructors using PGT in classrooms. Report-specific modules about informed consent in the context of whole genome sequencing (Informed Consent in Privacy and Progress) and incidental findings (Informed Consent in Anticipate and Communicate) are relevant to PGT and might help encourage students to consider the ethical complexities of genetic testing. The Conversation Series primer on incidental findings for consumers helps them to understand what incidental findings might arise in the direct-to-consumer (DTC) context and prepares them to ask the DTC provider relevant and important questions.

The full article by Zhang and Anderson, “Personalized Genetic Testing as a Tool for Integrating Ethics Instruction into Biology Courses,” can be read here.

For more information on all of the Bioethics Commission’s educational efforts, please watch the video, Promoting and Providing Materials for Bioethics Education, here.

All Bioethics Commission pedagogical materials are publicly accessible at www.bioethics.gov.

The Bioethics Commission encourages feedback on its materials at education@bioethics.gov.

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

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