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

The Bioethics Commission and Ethics Integration at All Levels

This week, Research Analyst Elizabeth Fenton will present on behalf of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) at the Association for Practical and Professional Ethics Twenty-fourth Annual International Conference. The presentation is part of a four-day conference held by the Association for Practical and Professional Ethics (APPE), an organization founded to promote the advancement and teaching of practical and professional ethics. APPE’s annual conference has a number of different program tracks, including: bioethics, business ethics, environmental ethics, empirical ethics, media and journalism ethics, and research ethics.

Fenton’s presentation is part of the conference’s Bioethics track. Her presentation, “Bioethics Education: Presidential Bioethics Commission and Ethics Integration at all Levels and Across Disciplines,” highlights the Bioethics Commission’s pedagogical materials. Noting the need for improved resources to support ethics education, the Commission has committed to building a foundation of educational materials that can be used across a wide range of academic disciplines in a variety of settings using contemporary ethics issues. The educational materials produced by the Commission range from topic specific modules created to correspond to Commission reports, to primers for physicians, researchers, and patients; the Commission also offers Spanish translations for its materials related to its analysis of the unethical STD research conducted in the 1940s in Guatemala.

Fenton’s presentation will discuss the importance of integrating ethics into educational disciplines such as science, where ethical challenges frequently arise but where researchers might not have the skills or vocabulary needed to recognize or address them. Ethics integration promotes ethical conduct, professional responsibility, and engagement with the broader societal dimensions of research to enable thoughtful decision-making. The presentation will also highlight the need for further research to evaluate the best models for ethics integration.

“Ethics integration is very much a two-way street,” Fenton says. “It is a process in which experts in both ethics and science can become competent and literate in each other’s fields. When scientists develop a vocabulary for expressing ethical concerns, and ethicists have the scientific vocabulary to understand those concerns, both fields benefit.”

All educational materials developed by the Bioethics Commission are available for free on its website at www.bioethics.gov/education. Instructors are encouraged to access, use, and adapt the materials, provide feedback on their utility, and suggest improvements. We encourage comments or suggestions at education@bioethics.gov.

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New Educational Module from the Bioethics Commission on Community Engagement in Synthetic Biology

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted to Bioethics.gov a new educational module on community engagement in the context of synthetic biology. The module integrates material from the Bioethics Commission’s report New Directions: The Ethics of Synthetic Biology and Emerging Technologies (New Directions).

The aim of this module is to help instructors understand how community engagement can impact technological development and application of synthetic biology and other emerging technologies, as well as the importance of democratic deliberation for addressing the use of such technologies. The module identifies guiding ethical principles and describes how they promote engagement with the public and with affected communities.

Through discussion questions, scenarios, and exercises, the module guides instructors to help students consider the differences between public engagement, community engagement, and community-engaged research, and offers a timely example of the engagement process in synthetic biology. Illustrative examples that highlight potential benefits and challenges of community engagement include the production of algal biofuels, use of synthetic chemicals in consumer products, and development of drugs using synthetic biology techniques.

This module is the latest addition to the Bioethics Commission’s series of modules on community engagement, which includes background material and modules discussing community engagement in the contexts of human subjects research protection and privacy in whole genome sequencing. This module is also the first that the Bioethics Commission has developed based on its report New Directions.

All of the Bioethics Commission’s educational modules are based on ethical questions addressed by the Commission and 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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Rethinking the Global Response to Public Health Emergencies

Members of the Presidential Commission on the Study of Bioethical Issues (Bioethics Commission) are considering possible recommendations for future engagements in public health emergencies, including ethical approaches to conducting research in affected countries even in the midst of a crisis.

Yesterday’s deliberations touched on a wide range of issues generated by the ongoing Ebola epidemic in western Africa, from the ethics of using placebos in clinical trials, to the stigmatization of members of western African communities and health care workers who tended to the sick, to the need to improve the response to future outbreaks.

Commission members heard from a wide variety of speakers, including current and former government officials; leading experts in infectious disease, ethics, and global health; and people who belong to and work with communities both in western Africa and the U.S. who have been profoundly affected by the epidemic.

The day closed with a roundtable discussion at which Amy Gutmann, Ph.D., Chair of the Bioethics Commission, posed a simple question: “If there was one thing you think could be improved moving forward in the U.S. response to public health crises like Ebola, what would it be?”

The following are highlights from the panel’s recommendations:

“Throughout this whole outbreak…I always thought: wouldn’t it be nice to have an empowered and independent Surgeon General who could have spoken to the public in a clear, concise way. Somebody who was not micromanaged by the White House or other agencies could have been a game-changer.”
– Peter Hotez, M.D., Ph.D., Dean of the National School of Tropical Medicine at Baylor College of Medicine and President of the Sabin Vaccine Institute

“At the end of the day you can have the best public health system, but you have to build it on the backs of an educated community…As part of the (Ebola) crisis we are facing now, there are about five million kids across three countries who are in danger of missing a whole year of school and that has not been factored into most of the response we have seen. I think that the important intersection between education and health is part of a long-term sustainable solution (to public health challenges).”
– Chernor Bah, Chair of the Youth Advocacy Group at the Global Education First Initiative, and a former child refugee from Sierra Leone who has worked in all three countries affected by the recent Ebola epidemic

“Everyone needs a civics lesson about what states’ rights allow and what the federal government can do. The CDC was lambasted in the early days of the (Ebola case in Dallas) because they did not come in and save the day, without knowing that (legally) they would need to be invited (by Texas authorities) to do so.”
– Howard Markel, M.D., Ph.D., the George E. Wantz Distinguished Professor of the History of Medicine at the University of Michigan

“We need to stress in all messaging to the public the vital importance of structural factors, including inequities in health care in the U.S. and globally, to the spread and prevention of disease. I think that not only will improve people’s health, but it also is the best way to challenge stereotypes and myths about disease.”
– Dorothy E. Roberts, J.D., the George A. Weiss University Professor of Law & Sociology at the University of Pennsylvania

“We need to be better incorporate communications strategies and health literacy into public health strategies. During epidemics, we need to take that as seriously as we do surveillance and make it a key part of the public health response.”
– Seema Yasmin, M.D., a Professor of Public Health at the University of Texas at Dallas, and Staff Writer, Dallas Morning News

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Bioethics Commission Finalizing Work on Neuroscience

On July 1, 2013, President Obama requested that the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) review the ethical considerations of neuroscience research and its application as part of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative.

Specifically, the President instructed the Bioethics Commission to “identify proactively a set of core ethical standards – both to guide neuroscience research and to address some of the ethical dilemmas that may be raised by the application of neuroscience research findings.”

Today, during its public meeting in Washington, D.C., the Bioethics Commission worked to wrap up its work on neuroscience and related ethical issues and to finalize its recommendations to the President.

The Bioethics Commission has held (counting today’s gathering) nine public meetings in five cities — Washington, D.C., Salt Lake City, Atlanta, Philadelphia, and San Francisco — that have focused on neuroscience. They have featured extensive discussions with experts from a wide array of disciplines, including neuroimaging, cognitive neuroscience, neurology, computational neurobiology, nanotechnology, psychiatry, ethics, philosophy, computer science, behavioral health, engineering and law. The Commission also has heard detailed public comments from affected communities, including advocates for patients with Alzheimer’s disease, Parkinson’s disease, depression and bipolar disorders.

The Bioethics Commission provided its initial recommendations to President Obama last year in volume one of its Gray Matters report, in which it stressed the importance of integrating ethics early and throughout neuroscience research.

Today’s deliberations will inform the Bioethics Commission’s recommendations for Gray Matters, Volume two, which will focus on three areas: cognitive enhancement and other neural modifications, capacity and the consent process, and neuroscience in the legal system.

Bioethics Commission Chair Amy Gutmann noted that these three areas “illustrate the ethical tensions and societal implications that can arise as neuroscience and technology advance.”

“Our Commission is well situated to clear a path for productive discourse and conduct policy making on these topics,” she added.

The Commission expects Gray Matters, Vol. 2 to be released this spring.

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Back Live for Day 2 of the Bioethics Commission Meeting in D.C.

We are back live and blogging in Washington, D.C. for day 2 of the 20th public meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission).

The Bioethics Commission is continuing the discussion initiated at its November meeting in Salt Lake City focusing on issues arising at home and abroad from U.S. engagement in the global response to the current Ebola epidemic. Members today also resume consideration of ethical issues associated with neuroscience research and the application of neuroscience findings, as requested by President Obama.
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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Amnesia and Other Side Effects of Epidemics

If there is one medical condition that commonly occurs at the culmination of many infectious disease epidemics it is “amnesia.”

That was the message from Howard Markel, M.D., Ph.D., the George E. Wantz Distinguished Professor of the History of Medicine at the University of Michigan. He looked to previous fights against infectious diseases over the last 200 years to help the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) process the many lessons to be learned from the recent Ebola epidemic.

Markel said his fear is that precious little will be learned, or that what has been learned will quickly be forgotten.

“The most common final end to a pandemic is what I call profound amnesia,” he said. “SARS? What’s that? We are not yet at ‘Ebola? What’s that?’ But I guarantee you we will be there. And that’s the real problem.”

The Commission is grappling with the U.S. engagement in the global response to the current Ebola epidemic, and Thursday afternoon it sought insights from historical, sociological, and legal perspectives.

For the recent history of the fight against Ebola, the panel turned to Unni Karunakara, Dr.PH, a Senior Fellow at Yale University’s Jackson Institute for Global Affairs. Karunakara was involved in some of the early fights against Ebola during his time with Médecins Sans Frontières (Doctors Without Borders or MSF), where he last served as International President.

Karunakara said the confusion and suspicion that accompanied his early experiences confronting Ebola outbreaks in Africa quickly taught him that there is one thing that will always undermine the effectiveness of the effort.

“Ebola allows no time for mistrust,” he said. “Speed is of absolute importance in an outbreak response.”

Karunakara said MSF has learned that lesson well — for example, it now makes sure Ebola patients under its care can directly be observed from a safe distance by their relatives. That way, he explained, there is quite literally, transparency. But he said mistrust quickly became endemic in the recent Ebola outbreak when early on in the response authorities contemplated quarantines and enacted various restrictions on movement.

“We know that coercive policies are remarkably counter-productive,” Karunakara said. “Checkpoints and roadblocks meant to limit and control movement became a disincentive to seeking care. Fear of being quarantined has made people less forthright about having been in West Africa.”

Dorothy E. Roberts, J.D., the George A. Weiss University Professor of Law & Sociology University of Pennsylvania, believes some of the mistrust and suspicion surrounding the U.S. reaction to the Ebola epidemic stems from the fact that the disease tends to be viewed through the lens of racial stereotypes.

“The two things Americans associated with Ebola the most was Africa and fear,” she said. “The extent to which fear outweighed the scientific evidence of risk was determined by racial concepts and stereotypes and assumptions.”

Roberts said the racial view of disease has led many to think of Ebola as a disease of black people.

“There is a long history in the United States of understanding disease in racial terms and racial differences in terms of disease,” she said.

James W. Wagner, Ph.D., the Commission’s Vice Chair, wryly noted that the panel’s observations painted a bleak picture.

“What we have been hearing from you three is that the life cycle of an epidemic is to begin with denial and neglect and to end with amnesia,” he said. “And the middle is marked with disparities and human rights restrictions and misinformation.”

The Bioethics Commission is expected to deliberate possible recommendations tomorrow morning on the second day of its public meeting.

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Experiencing Ebola: First-Person Perspectives from the Diaspora and Health Care Workers

Among the many unfortunate outcomes of the recent Ebola outbreak is how public reaction played out in the affected communities, both in the countries themselves and also in the western African diaspora in the U.S.

As the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) continued its review of U.S. engagement in the global response to the current Ebola epidemic, it considered the experience of people who were quickly swept up in the tumult.

Oretha Bestman-Yates, who immigrated to the United States from Liberia in 1987 and now serves as president of the Staten Island (New York) Liberian Community Association, said Liberians in this country — even those who had been here for years — suddenly found themselves subject to suspicion and discrimination.

“I was directly hit by the stigmatization,” she said. “I even lost my job because I visited Liberia in July and my son, who was proud to call himself Liberian-American, now does not want to be associated with anything from Liberia. We were targeted by our neighbors…As you boarded a train or ferry people actually stood away from you because of your accent.”

Chernor Bah, Youth Engagement Officer of A World at School and Chair of the Youth Advocacy Group at the Global Education First Initiative, discussed the epidemic from the perspective of communities in western Africa. Bah is a former child refugee from Sierra Leone and has connections through non-profits to all three countries affected by the epidemic.

He said there were unfortunate aspects of the international response that fed fears and paranoia in the affected countries that the Ebola infections were caused by some type of conspiracy. Bah said one response that was particularly jarring was the decision by certain countries to ban any flights from Sierra Leone and Liberia.

“That created a sense of isolation and also a sense of helplessness,” he said. “It allowed conspiracy theories to fester and it took so much time for the counter narratives to take root.”

A similar sense of isolation and stigmatization also affected U.S. health care workers who have worked the Ebola wards of western Africa. Patricia Henwood, Director of Global Health Initiatives in the Department of Emergency Medicine at the Hospital of the University of Pennsylvania, has served on two Ebola-related medical missions to Liberia. She spoke to the Commission the day after her 21 day isolation period from her most recent mission.

Henwood noted the surreal experience of working in the intense environs of Ebola treatment centers, “quietly crying in our facemasks and goggles while holding the hand of children as they draw their last breath,” and then returning to a growing wave of suspicion, inconsistent policies and calls for quarantines.

“At times it felt more of a challenge to manage the return to the U.S. than to do the Ebola work in West Africa,” she said. “We were touted as heroes when we worked in West Africa, but treated as pariahs when we returned home.”

The stories from the front-lines of the epidemic clearly moved members of the Commission. Christine Grady, R.N., Ph.D., Chief of the Department of Bioethics at the National Institutes of Health Clinical Center, teared up as she thanked the panel. “I just want to say I think you are all heroes and I wanted to shout out to the nurses because I am a nurse.”

Commission Chair Amy Gutmann said she has been impressed by how returning health care workers have been so “rationally passionate and passionately rational.”

As the fears in the United States appear to be dying down, Bah said he now finds it jarring how a disease that had so consumed American media and politicians just a few months ago is now largely ignored in the U.S., even as cases continue in Sierra Leone.

“Yesterday we had 21 cases in Sierra Leone,” he said. “We still have schools that have been closed down for a year. People are still dying every day, but we are speaking about Ebola as if it is in the past tense.”

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Learning the Lessons from Ebola to Inform Future Fights

As part of its review of  U.S. engagement in the global response to the current Ebola epidemic, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) sought insights from a panel of experts with decades of experience on the front lines of fighting infectious diseases.

Peter Hotez, M.D., Ph.D., Dean of the National School of Tropical Medicine at Baylor College of Medicine and President of the Sabin Vaccine Institute, said he hopes the Ebola epidemic will prompt health officials in the U.S. and around the world to get ready for what he believes could be even more disruptive and deadly encounters with infectious disease in the near future.

“It would be nice if for once the world could be proactive,” he said.

For example, Hotez said he has been advising the State Department and the White House that “the next shoe about to drop is in the Middle East and North Africa.”

“In ISIS-occupied Syria and Iraq we are already seeing refugees pouring across the border into Jordan, Lebanon, and Turkey. We are seeing rabies, huge amounts of Leishmaniasis. We are going to see Middle East Respiratory Syndrome. We have got to build capacity for the next big thing that is going to happen.”

Helene Gayle, President and CEO of CARE USA, observed that it has been the enduring frustration of public health veterans that preventative measures often are not widely embraced and thus struggle for attention and funding.

“Having spent most of my life trying to get people excited by non-events, which is what prevention is, we have to be realistic,” she said. “It is much more difficult to get people to care about something that they are preventing versus something they can change.”

Gayle said the lesson from her work at CARE is that if the U.S. wants to be more effective in its efforts to deal with threats like Ebola, it needs to establish trust and relationships in the affected countries.

“In our work in Sierra Leone and Liberia around Ebola, it has been with communities we have been working with for years,” she said. “We work in micro-finance, in agriculture productivity, so they already trusted CARE and our partners. We were not just there for Ebola. We were not just there for this disease that America now cares about.”

William Foege, M.D., M.P.H., is a Senior Fellow for Health Policy at the Carter Center, a Senior Fellow in the Global Health Program at the Bill and Melinda Gates Foundation, and an Emeritus Presidential Distinguished Professor of International Health at Emory University. Foege was deeply involved in the battle against smallpox in the 1970s, and served as Director of the Centers for Disease Control and Prevention (CDC) from 1977-1983. He said among the lessons from his many years of experience, he learned that it’s very hard to get people to focus on problems affecting the poor. But he believes Ebola may be a prime opportunity to generate a new level of support for fighting the diseases of poverty and conflict and it should not be wasted.

“We should make the most out of Ebola,” he said. “Despite the fact that there are bigger problems, I always tell students that one of our jobs is to tie the fears of the rich to the needs of the poor. And Ebola has become a fear of the rich and we should use that to the maximum.”

Next up: The Bioethics Commission turns its attention to how the Ebola crisis has played out in Western African immigrant communities in the United States and among health care workers returning from working in affected countries.

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In Rush to Develop Ebola Therapies, a Debate Over Placebo Control

This morning the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) resumed consideration of U.S. engagement in the global response to the current Ebola epidemic by examining ethical issues that arise when conducting research during a public health emergency.

As experts move to accelerate development of drugs and vaccines against Ebola, a debate has emerged over whether these therapies should be evaluated with the placebo randomized control approach. This type of research involves clinical trials in which one group of volunteers receives the actual vaccine or drug candidate and another group receives a placebo.

Many clinicians consider the placebo-control approach to be the gold standard for determining the efficacy of a new treatment. But tension in western Africa today involves how scientists and policy makers should prioritize humanitarian and scientific concerns as they address both the immediate crisis and seek evidence that can be applied to future outbreaks.

Clement A. Adebamowo, B.M., Ch.B., F.W.A.C.S., F.A.C.S., Sc.D., a Professor of Epidemiology and Public Health at the University of Maryland School of Medicine, told members of the Bioethics Commission that the placebo-control approach provides very strong evidence. But Adebamowo, who was closely involved with Nigeria’s Ebola response as chair of Nigeria’s National Health Research Ethics Committee, said Nigerian health authorities have concluded there are instances in which other approaches may be warranted.

“We believe that these things should not be taken as doctrinaire positions,” he said. “That is why the Nigerian ethics committee issued the guidance statement saying we are going allow the use of therapies that have not completed the standard clinical trial development pathway in the context of this epidemic and share the data with all so we can rapidly evaluate the efficacy of these interventions.”

Luciana Borio, M.D., Assistant Commissioner for Counterterrorism Policy and Director of the Office of Counterterrorism and Emerging Threats at the U.S. Food and Drug Administration (FDA), said that there is an ethical case to be made for conducting a placebo-control trial even in the midst of a major disease outbreak like the Ebola epidemic in western Africa. While some have questioned the ethics of giving a placebo to research subjects at high risk of being exposed to Ebola, Borio said that one could argue that conducting a trial without a placebo control is unethical if it is not going to determine treatment efficacy.

“In the case of Ebola, (such a trial) would be scientifically invalid and a scientifically invalid study by definition cannot be ethical,” she said.

She said that western African countries have been very receptive to clinical trials with a placebo control and that the recent Ebola vaccine trial initiated in Liberia, which includes a placebo, has attracted a large number of volunteers.

“We have taken position that the best way forward is an adaptive randomized control trial,” she said. “We think that is the best way to protect patient safety now. We know that new Ebola outbreaks will occur and now is the time to do this right.”

There are other issues to consider, said Nancy Kass, Sc.D., the Phoebe R. Berman Professor of Bioethics and Public Health in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health and Director for Public Health at the Berman Institute of Bioethics.

Kass acknowledged that for a vaccine trial, without a placebo control, “how else can we learn that the vaccines work?” But she said for evaluating treatments, there could be other options.

“Ethics is often about thinking of a creative third option,” she said, “and that often requires getting a lot of people with a lot of different expertise in the same room who can think creatively.”

For example, Kass said that one option could be to hold a small pilot study with 40 patients where all get the treatment to see if the experimental treatment is overwhelmingly effective, a “home-run drug.”

“So if out of 40 people, 38 get up and walk away, you don’t need a placebo,” she said. “But if 38 people did not walk out, you actually have a lot more ethical justification for introducing a placebo.”

Next up: The Commission seeks perspective on the Ebola response from veterans of past fights against infectious disease outbreaks.

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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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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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