Dr. Amy Gutmann – 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 Bioethics Commission Sharpens Focus on Ebola Challenges https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/02/05/bioethics-commission-sharpens-focus-on-ebola-challenges/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/02/05/bioethics-commission-sharpens-focus-on-ebola-challenges/#respond Thu, 05 Feb 2015 14:24:46 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1524 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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What is Democratic Deliberation? A Q&A with Bioethics Commission Chair Amy Gutmann https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/09/10/what-is-democratic-deliberation-a-qa-with-bioethics-commission-chair-amy-gutmann/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/09/10/what-is-democratic-deliberation-a-qa-with-bioethics-commission-chair-amy-gutmann/#respond Wed, 10 Sep 2014 16:46:11 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1410 Amy Gutmann, Ph.D., Chair of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission), has written eloquently about the idea of democratic deliberation. We asked her to explain this principle and discuss how it has influenced the work of the Bioethics Commission.

Blog.Bioethics.gov (B.B.G): What is democratic deliberation?

Amy Gutmann (A.G.): The best any democracy can do in the face of disagreement on complex issues is to have deliberation among a wide range of experts and involved citizens in a way that is transparent to the public. Open and robust dialogue is at the very heart of deliberative democracy, and I’ve worked hard to imbue the work of the Bioethics Commission with that principle.

Deliberative democracy is the opposite of sound-bite democracy. Democracies do better when people discuss – robustly and respectfully argue about – their differences. It’s the give-and-take of viewpoints with an aim of finding common ground and reaching mutual respect among citizens where that common ground is not possible. The common good of democracy includes living respectfully with our differences, while continually aspiring to create a society–and world–that is just for all.

B.B.G.: What is the purpose of the Bioethics Commission and how does democratic deliberation play a role?

A.G.: First and foremost, the Bioethics Commission is here to provide advice and guidance to President Obama to help him and his administration navigate the challenging questions that arise in our evolving and very complex era of biomedicine. Advances in biomedical research and related areas of science and technology can often create a range of ethical dilemmas. The Bioethics Commission seeks to identify and promote policies and practices that ensure that scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner.

Good policy is based on good advice. The Bioethics Commission’s job is to offer practical public policy advice grounded in scientific evidence and in debate on philosophical and ethical principles. The best advice we can give comes from respectful deliberation based on the best evidence available after a thorough review of the ethical implications. The Commission’s work is fully transparent and is conducted in public in a manner in which experts and members of the public can engage in high level and productive discussion.

B.B.G.: There are many ethical principles on which to ground the Bioethics Commission, why democratic deliberation?

A.G.: My commitment to learning, to service, and to open and respectful deliberation is in many ways an homage to my parents. My mother was a natural teacher, but she had no choice but to put her dream on hold–since she could not afford a college education and had to support her family during the Great Depression. My father escaped Hitler’s Germany in 1934, and also saved the lives of his family by urging and enabling them to join him shortly thereafter in India.

My parents were extraordinary people with great values, foresight, generosity, and courage, who had a powerful faith in America as the land of opportunity.

I bring those values and their example to bear at the Bioethics Commission. And I believe that it has served us well. From synthetic biology to reviewing the ethical considerations of conducting clinical trials of medical countermeasures with children we have tackled some incredibly complex issues. It is a challenge that we embrace and the democratically deliberative process is key to finding common ground and an ethically sound path forward.

B.B.G.: Can you say a little about how the Commission balances a commitment to transparency and the need for a free exchange of ideas among its members that may be more likely to occur in a non-public setting?

A.G.: All deliberations of the Bioethics Commission occur at our public meetings. Some subcommittee work is done before those public meetings, but the subcommittees must present and report to the Commission as a whole and the Commission as a whole must discuss those findings before any recommendations can be deliberated.

B.B.G.: How do you think the Commission is doing as a deliberative body and what role can an “advisory commission” have in deliberative democracy?

A.G.: The Bioethics Commission Members need not – and do not – all agree on everything all of the time.  Instead, we clearly identify critically important ethical and scientific issues and we reach consensus on what advice to offer on how to navigate these issues of public importance.  On this advice, the Bioethics Commission has consistently reached consensus through our public deliberations.

 

 

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Discussion Highlights on Ethical Issues Related to Neuroscience https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/12/18/discussion-highlights-on-ethical-issues-related-to-neuroscience/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/12/18/discussion-highlights-on-ethical-issues-related-to-neuroscience/#respond Wed, 18 Dec 2013 21:48:47 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1072 In a roundtable discussion that ended today’s meeting, Amy Gutmann, Ph.D., President of the University of Pennsylvania and the Chair of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission), emphasized that “we have two big buckets here, one is the ethics of neuroscience research, and the other is the potential applications and ethical implications of the research findings themselves.” She asked each of the meeting presenters for their advice on what the Bioethics Commission should recommend as it examines the ethical issues related to neuroscience.

“I’d like to recommend that there be serious financing incentives and accountability to develop ethics scholarship in neuroscience, and to do it in a way that is very mindful…so the scholarship is structured in a way so that it itself is educational.”  – Mildred Z. Solomon, Ed.D. President of the Hastings Center

“[Bioethics] is the only field where everyone seems to think they are qualified…because everyone believes they are ethical…and they believe that’s all that’s needed.” – Paul Root Wolpe, Ph.D. of Emory University

“As a working scientist, there is already a very large regulatory burden on us, and we now in the case of my institution have several people who are full time doing nothing but the paperwork associated with any one experiment. And I would urge you, if you make recommendations, to give some thought to…the regulatory burden.” – Christof Koch, Ph.D. of the Allen Institute for Brain Science

Bioethics Commission members responded:

“I think it’s really important to recognize that ethical considerations do not equate to regulatory burdens.” – Amy Gutmann, Ph.D. President of the University of Pennsylvania and the Chair of the Bioethics Commission

“We know there are scientists that will be ethical failures…How do we prepare for [ethical failure]…how do we disincentivize it? What sort of sanctions should be in place? What sort of protections for research subjects…should be in place? We can’t pretend like it’s not going to happen; it’s going to happen. What do we do about that?” – Anita L. Allen, J.D., Ph.D. Vice Provost for Faculty at the University of Pennsylvania and the Henry R. Silverman Professor of Law and Professor of Philosophy and a member of the Bioethics Commission

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Integrating Ethics and Neuroscience Through Education https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/12/18/integrating-ethics-and-neuroscience-through-education/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/12/18/integrating-ethics-and-neuroscience-through-education/#respond Wed, 18 Dec 2013 17:13:56 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1056 Today’s meeting of The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) began with a session on how ethics are integrated into science education in general, and into neuroscience education in particular.

The Commission members heard first from Mildred Z. Solomon, Ed.D. President of the Hastings Center. Dr. Solomon emphasized that scientists are professionals, and that as such, they should “consider the purposes and implications of their work.”

Science and technology hold great power in our society, Dr. Solomon said, and therefore “self-reflection is important.” She noted that scientists, as experts, are best positioned to constrain the hyperbole that can arise from the misinterpretation of neuroscience findings, but also pointed out that bioethicists and scientists need one another: Ethicists might miss problems or estimate incorrectly the magnitude of ethical issues. On the other side, scientists cannot engage closely with ethicists unless they “develop the ability to discriminate between ethical and normative questions.”

Dr. Solomon proposed a model of “transformational learning,” the type of shared learning experience that is “something you do for yourself,” with basic bioethics literacy for early researchers and undergraduates and deeper engagement for professionals. She proposed actions including an Ethical, Legal and Social Implications (ESLI) program for brain science, such as that associated with the Human Genome Project; a learning community approach to bioethics; annual symposia on bioethics; bioethics intensives for neuroscientists; surveys that can be utilized to examine the efficacy of bioethical education; and for BRAIN awardee institutions to build the capacity to address ethical questions into their grant work.

Steven E. Hyman, M.D., of the Broad Institute of Massachusetts Institute of Technology and Harvard University, spoke to the Bioethics Commission about the importance of encouraging young neuroscience students to think about “the purpose of their work in the deepest sense.” He commented that the young scientists he works with “are so deeply engaged in the intellectual and technological aspects of their work that often they do not find themselves able to lift their heads to engage in ethical reflections.” By engaging students with ethical questions early in their scientific careers, Dr.  Hyman proposed a goal of achieving “curiosity about ethics concerns, and habits of ethical reflection.”

The next speaker before the Bioethics Commission was Pat Levitt, Ph.D. of the  University of Southern California. Dr. Levitt noted that “people come to the table with a belief system, and we have to recognize that as scientists.” He stated three main areas that he feels “demand greater emphasis in ethics training:”

First, the challenge of “conveying promises of neuroscience discoveries leading to disease and disorder cures.” Neuroscience holds a special place, he said, because “we believe that through our capacity to gather an unending amount of information, we eventually will discover the signature patterns of mental and physical states.” Second, Dr. Levitt stated that the current emphasis on translational technologies might have led to “misrepresenting research ‘deliverables’ to trumpet discoveries that provide high science currency.” Finally, Dr. Levitt notes that neuroscience advances have led to evolution in the concept that human brain disease results from a developmental etiology. He concluded, “it is about training the current and next generation to recognize when they are participating in building a bridge too far, which is an issue of personal and disciplinary ethics, and when they are being true to both the promises and limitations of neuroscience.

The final speaker was Paul Root Wolpe, Ph.D. of Emory University. He noted that the bioethical issues inherent in neuroscience are more personal than those in other research areas. “I don’t care if you have my genome,” he said. “It isn’t the genome that most defines who I am. The sense of myself, my memories, my personality, my quirks…reside in my brain, not in my genome.”

Neuroscience has been experimenting in areas that have profound ethical implications.  “I keep thinking we’re going to hit a wall,” Dr. Wolpe said, “and be able to go no further, and neuroscience keeps pushing through that wall.” Because of this, Dr. Wolpe said, now is the time to think about the implications of neuroscientific advances. He recommended three courses of action: a re-prioritization so that there is funding to systemically consider ethical issues in neuroscience, encouraging a different orientation for graduate students to address ethical issues in neuroscience, and encouraging scientists to speak publicly about their research topics. “They are the ones,” Dr. Wolpe said, “who not only have the expertise, but who have a right to advocate for the science itself.”

In the discussion that followed, Amy Gutmann, Ph.D., President of the University of Pennsylvania and the Chair of the Bioethics Commission, pointed out, “you can’t begin ethics education at the professional level.” She emphasized that “science is a professional and a public calling,” and this makes it important to engage students in bioethical discussions early in their careers. Bioethical education is, she said, “going to be more effective and more stimulating if it’s taught to undergraduates who are less jaded than professionals.”

Overall, the session speakers emphasized the need for deep consideration of ethical issues in neuroscience. They stressed the importance of early education on bioethical issues to spark curiosity and to encourage deep thinking, without creating the perception that bioethical considerations could unduly fetter scientific pursuits. These points will help guide the Bioethics Commission as it considers the ethical issues inherent in neuroscience research and neuroscientific training.

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Beyond BRAIN: Bioethics Commission to Look Broadly at Ethical Issues in Neuroscience https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/12/18/beyond-brain-bioethics-commission-to-look-broadly-at-ethical-issues-in-neuroscience/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/12/18/beyond-brain-bioethics-commission-to-look-broadly-at-ethical-issues-in-neuroscience/#respond Wed, 18 Dec 2013 14:15:37 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1052 On July 1, 2013, President Obama requested that the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) review the ethical considerations of neuroscience research and its application. The impetus for this request was the launch of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative.

Dr. Amy Gutmann, the President of the University of Pennsylvania and the Chair of the Bioethics Commission, opened today’s meeting, the fifteenth public meeting of the Bioethics Commission with a clarifying note: that the deliberations of the Bioethics Commission will go beyond the scope of the BRAIN Initiative alone. “While we received our charge as part of the President’s BRAIN Initiative, our focus is wider than the Initiative…President Obama asked us to review the ethical consideration of neuroscience more broadly,” she said, “[including] considerations of both neuroscience research and the application of neuroscience research findings.”

Dr. Gutmann explained that the Bioethics Commission is not tasked with the review of institutional research protocols. As such, the Bioethics Commission will “consider how best to integrate ethics into neuroscience broadly – and the BRAIN Initiative specifically– but this Bioethics Commission will not be the ultimate locus of that integration.”

Over the coming months, the Bioethics Commission will review different ethical issues associated with neuroscience research and how ethics might be integrated into neuroscience training and practice. The Bioethics Commission will then, Gutmann said, “make ethical and practical recommendations that will inform the conduct of the BRAIN Initiative.”

Today’s meeting will build upon previous discussion of the ethical issues related to neuroscience. The Bioethics Commission will hear from experts on how to integrate ethics into every step of neuroscientific training and practice. They will also discuss the topic of  private sector partners in the BRAIN Initiative, to understand how they go about identifying and addressing ethical issues. Finally the Bioethics Commission will hear from international neuroscience research initiatives, to hear how groups already pursuing large neuroscience research projects are dealing with ethical issues in their work.

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A Discussion on the Ethics of Incidental Findings https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/04/30/a-discussion-on-the-ethics-of-incidental-findings/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/04/30/a-discussion-on-the-ethics-of-incidental-findings/#respond Tue, 30 Apr 2013 21:16:38 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=653 In a roundtable discussion, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) today discussed how incidental findings should be handled in the context of research, the clinic, and direct-to-consumer testing. What are the responsibilities of researchers to act on incidental findings? What is the duty of a clinician to her patient, a researcher to his participant, or a company to its consumer? Some of these relationships seem to be blurring as businesses take on research and as clinicians enroll their patients in studies. The Commissioners and the speakers at the meeting also emphasized the humanity of the patients involved, and the need for compassion and personal autonomy in future decisions on this issue.

“I view my main role here as reminding you, despite being research centered, we are humans…not to forget to pay attention to that human side.” – Sarah Hilgenberg, M.D., F.A.A.P., Department of Pediatrics, Stanford University.

“These relationships don’t come with a platonic ideal of what these relationships are or are not, they evolve due to policies, cultural understanding.” – Amy Gutmann, Ph.D., Chair of the Bioethics Commission, President of the University of Pennsylvania.

“There is still a primary duty in each domain that is different: research’s duty is to discover new knowledge, the company’s duty is to its shareholders, and the clinician’s duty is to patients.” – Alex John London, M.A., Ph.D., Professor of Philosophy at Carnegie Mellon University.

“The way that the technology is proceeding is that it may be cheaper to do whole genome sequencing than one or two tests at a time. When all these results are obtained, they will become part of the clinical record. So it is not possible to try and withhold any information, there is a very important case to be made that in those circumstances [where] there may be no incidental findings.” – Raju Kucherlapati, Ph.D., Professor in the Harvard Medical School Department of Genetics.

“In a clinical setting, that may not be the time when you want to hear [that piece of information], you may wish to hear that information later…we built a system where nothing is incidental.” – Joanna Mountain, Ph.D., Senior Director of Research, 23andMe.

“Real autonomy starts with information, people knowing what their options are.” Robert C. Green, M.D., M.P.H., Associate Professor of Medicine at Harvard Medical School.

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When an Incidental Finding Saves a Life https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/04/30/when-an-incidental-finding-saves-a-life/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/04/30/when-an-incidental-finding-saves-a-life/#respond Tue, 30 Apr 2013 15:53:40 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=645

Sarah Hilgenberg, M.D., tells her story.

During today’s meeting of the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission), a panel of experts discussed the ethical considerations associated with incidental findings that arise during research.

Alex John London, M.A., Ph.D., Professor of Philosophy at Carnegie Mellon began by noting “The researcher may have a duty to act in the best interest of the participant, and this may involve revealing findings to the patient that were outside the scope of the study and linking them up with clinicians, as well as keeping information confidential.”

In this case, the incidental finding may have saved a life. Peter Bendettini, Ph.D., chief of the section on functional imaging methods at the Laboratory of Brain and Cognition at the National Institute of Mental Health, noted that only 2% of brain scans have an incidental finding of clinical significance, but to those 2%, the incidental findings may have life-changing consequences.

For example, eleven years ago, Sarah Hilgenberg, now an M.D. in pediatrics, was just beginning a promising career in medicine. “I was high on life, feeling physically, emotionally and intellectually fulfilled,” she said. As she completed her orientation camping trip for the Stanford University School of Medicine, a friend asked her to participate in some research he was conducting on learning and memory. The research involved a functional magnetic resonance imaging (fMRI) scan.

Immediately after the test, her friend who was conducting the research appeared concerned. After consulting a neurologist, he revealed to Hilgenberg that she had an abnormality in her brain scan. She immediately received a diagnostic neurological evaluation, as well as a large dose of worry. While the doctors initially feared that she had a brain tumor, the final results revealed an arterio-venous malformation (AVM), a malformed connection between the arteries and veins which usually goes undetected, until it is found as an incidental finding. An AVM can be very dangerous, as increased blood pressure can cause them to bleed, with potentially fatal complications.

Hilgenberg underwent a long series of tests and surgeries, attending medical school at the same time. She said that the combination of medical school and her own medical condition was a powerful experience. “I was learning firsthand the material taught in class: the vulnerability of the body and, in particular, my brain”. However, due to the early intervention as a result of the incidental finding, Hilgenberg was cured of her AVM. She is now a successful physician, married, and the mother of a little girl.

Hilgenberg is grateful that she received information about the incidental finding. “A part of me thinks that he [the researcher] had no obligation to do this,” she told the Bioethics Commission. “But I am not sure that I would be here today to speak to you if he had not acted.” The chair of the Bioethics Commission, Amy Gutmann, Ph.D. agreed. “There is a kind of minimal standard for what human beings with a basic ethical sensibility will say to themselves ‘If I don’t do this, I won’t be able to sleep at night,’” Gutmann said.

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An Overview of Incidental Findings https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/04/30/an-overview-of-incidental-findings/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/04/30/an-overview-of-incidental-findings/#respond Tue, 30 Apr 2013 15:03:24 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=637 Today, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) addressed the role and impact of incidental findings in the clinic, in research, and in the new emerging businesses of direct-to-consumer testing. As Amy Gutmann, Ph.D., Chair of the Bioethics Commission, noted “Emerging medical technologies, changing cost structures, and evolving medical practice have made the likelihood of discovering incidental findings in different contexts a growing certainty.” The Bioethics Commission previously addressed incidental findings in its Privacy and Progress in Whole Genome Sequencing report, but became so interested in the scope of the topic, that it has decided to expand the discussion of incidental findings in a separate report.

Incidental findings include information gathered in a clinical, research, or direct-to-consumer medical setting that is beyond their stated aims or goals. The discovery of incidental findings can have practical, legal, and ethical considerations for the doctor, researcher, business, and most importantly, the recipient of the incidental finding.

Executive Director Lisa M. Lee, Ph.D., M.S., addressed the Bioethics Commission with an introductory presentation on the ethical issues associated with incidental findings. First, there are questions that arise with the discovery of incidental findings in different modalities.

In imaging studies such as X-rays or ultrasounds, Lee informed the Bioethics Commission that the potential for incidental findings is extremely high, with over 40% of scans resulting in incidental findings. For example, in angiography, 50% of angiograms will reveal a non-calcified nodule, but 99% of these nodules will be benign. Follow-up on these findings can produce a great deal of patient anxiety, and is both costly and potentially dangerous. Finally, in the case of research, Lee noted that much of the imaging used in research is of lower quality, and may not provide definitive information.

In biological samples, such as metabolic panels, clinicians and researchers are aware that as the number of tests increase, so does the potential for incidental findings. While health providers and researchers can anticipate a certain set of possible findings, Lee stated that once abnormal findings are found, they are difficult to ignore.

Secondly, Lee informed the Bioethics Commission that incidental findings could give rise to different issues depending on the context in which they are discovered. In the clinic, doctors have a fiduciary duty to patients to act in their best interest, and the question becomes whether returning the incidental findings will provide more benefit than harm. Due to concerns about liability, defensive medicine may lead to over-testing, and the discovery of further incidental findings. Insurance issues could also come into play as some incidental findings may be treated as pre-existing conditions.

In research, ethical issues also arise, with the constraints of the researcher to return the findings, whether they have adequate expertise, and what obligations the researchers owe to the research participants.

Finally, Lee described the emerging field of direct to consumer testing, in which the ethical issues lie at the intersection of medical and business ethics. They raise questions of the obligation that companies have to return incidental results, whether consumers themselves should be involved in the decision making process, and how the autonomy of the customer can best be respected.

All of these questions, the different ethical factors involved in each modality and context, will be discussed today, to provide more information and guidance to the Bioethics Commission.

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International panel named to review scientific trials https://bioethicsarchive.georgetown.edu/pcsbi/blog/2011/03/01/international-panel-named-to-review-scientific-trials/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2011/03/01/international-panel-named-to-review-scientific-trials/#respond Tue, 01 Mar 2011 15:46:23 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=110 Kicking off a five-month study of the ethics around contemporary human subjects clinical trials, the Presidential Commission for the Study of Bioethical Issues today named an International Research Panel to study the issue.

The international panel consists of 14 members, of which 10 are from outside the United States.

The announcement follows a request by President Obama to the commission that it report back to him on the effectiveness of current U.S. rules and international standards for the protection of human subjects in scientific studies. His request came in the wake of a revelation last October that a U.S. Public Health Service-supported research in Guatemala from 1946 to 1948 deliberately infected people with sexually transmitted diseases.

“It does not go without saying that a civilization can be judged by the way it treats its most vulnerable populations,” said Commission Chair Dr. Amy Gutmann in her opening remarks today. “There’s no position of greater vulnerability than to be a subject of a medical experiment.”

She continued: “We have a problem on our hands …. What happened in Guatemala, what happened in Tuskegee, in Willow Brook … whether these people look like us, or they don’t look like us, they are human beings with rights that doctors and scientists are expected to respect and should go by the highest standards.”

The international panel plans to meet three times, with at least one of the meetings held outside the United States. Here are the panel members and their countries of origin:

John Arras (US) is a member of the Presidential Commission for the Study of Bioethical Issues. He is the Porterfield Professor of Biomedical Ethics and Professor of Philosophy, Director of the Programs in Bioethics, and affiliated programs with the Center for Biomedical Ethics and Humanities in the School of Medicine at the University of Virginia.

Julius Ecuru (Uganda) is the Assistant Executive Secretary at the Uganda National Council for Science and Technology (UNCST).

Christine Grady (US) is a member of the Presidential Commission for the Study of Bioethical Issues. She is the Deputy Chief of the Department of Bioethics at the National Institutes of Health Clinical Center.  She also serves as the Head of the Department’s Section on Human Subjects Research.

Dirceu Greco (Brazil) is the Director of the Department of STD, AIDS and Viral Hepatitis of the Brazilian Ministry of Health. He is professor of Internal Medicine/Infectious Diseases at Universidade Federal de Minas Gerais (UMFG).  He was also chosen to serve as a permanent member of the National Commission on Research Ethics (CONEP) from 2007-2011.

Amy Gutmann (US) chairs the Presidential Commission for the Study of Bioethical Issues. She is President of the University of Pennsylvania and Christopher H. Browne Distinguished Professor of Political Science in the School of Arts and Sciences.

Unni Karunakara (India) was the deputy director of health for the Millennium Villages Project at the Earth Institute at Columbia University.  Currently he is an assistant professor in the Heilbrunn Department of Population and Family Health at Columbia’s Mailman School of Public Health.

Nandini Kumar (India) is a member of the executive committee of the Forum for Ethics Review Committees in India (FERCI), a National Chapter of the Forum for Ethics Review Committees in Asia Pacific (FERCAP).  She was closely involved in finalization of the Indian Council of Medical Research Ethical Guidelines of 2000 and of 2006.

Sergio Litewka (Argentina) is the International Programs Director and research assistant professor for the University of Miami Ethics Programs.  He is the project director for the Pan American Bioethics Initiative.

Luis Lopez (Guatemala) sits on the Board of Directors for the Latin-American Forum of Committees for Ethical Research in Health and is a faculty member at the University of San Carlos (USAC).  He also serves as a clinical trials assessor for the Guatemalan Ministry of Health, an editor for the Center for Health Science Research Magazine, and a legal representative for the Oxlajuj N’oj Foundation.

Adel Mahmoud (Egypt) is the former President of Merck Vaccines and an expert on disease control in the developing world and vaccine development.  He is a Lecturer with the Rank of Professor at The Department of Molecular Biology and The Woodrow Wilson School of Public and International Affairs at Princeton University.

Nelson Michael (US) is a member of the Presidential Commission for the Study of Bioethical Issues. He is Director of the Division of Retrovirology at the Walter Reed Army Institute of Research and the Director, U.S. Military HIV Research program.

Peter Piot (Belgium) is Director of the London School of Hygiene and Tropical Medicine. He is the former Under Secretary-General of the United Nations and the founding Executive Director of UNAIDS. He is former Associate Director of the World Health Organization’s Global Programme on AIDS.  Dr. Piot co-discovered the Ebola virus in 1976.

Huanming Yang (China) co-founded BGI (formerly Beijing Genomics Institute) in 1999 and is currently President and Professor of BGI.  He and his collaborators have made a significant contribution to the Human Genome Project, the HapMap Project, and the 1000 Genomes Project.  Dr. Yang has received many awards and honors, including Research Leader of the Year by Scientific American in 2002 and Award in Biology by the Third World Academy of Sciences (TWAS) in 2006.

Boris Yudin (Russia) is head of the Department of Comprehensive Problems of Human Studies at the Institute of Philosophy of the Russian Academy of Sciences. He is the Russian representative on the Steering Committee on Bioethics, Council of Europe. He is Vice-Chairman, Russian Committee on Bioethics, Commission of the Russian Federation for UNESCO.

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The chair’s request: A single good idea https://bioethicsarchive.georgetown.edu/pcsbi/blog/2011/02/28/the-chair%e2%80%99s-request-a-single-good-idea/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2011/02/28/the-chair%e2%80%99s-request-a-single-good-idea/#respond Mon, 28 Feb 2011 22:38:28 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=105 At the end of a long meeting today, Dr. Amy Gutmann, President of the University of Pennsylvania and Chair of the Presidential Commission for the Study of Bioethical Issues, had one question for a group of experts on the ethics of genetics testing and neuro-imaging:

“What could we most productively take on as a commission? Is there one specific issue you would like us to take up, or one set of facts that you think is very important? What would that be?’’

Some of the answers:

Hank Greely, Deane F. and Kate Edelman Johnson Professor of Law, Stanford Law School: “Research use of collective data, everything from consent to incidental findings.”

Dr. Erik Parens, Senior Research Scholar at The Hastings Center: How to handle an avalanche of information “that would help rather than harm people.”

Dr. James P. Evans, Clinical Professor and Bryson Distinguished Professor of Genetics and Medicine at the University of North Carolina School of Medicine: “Forensic issues. I think the questions regarding forensics, including the newer use of searching databases for cold hits, are exceptionally timely. Your input would be influential.”

Dr. Martha Farah, Walter H. Annenberg Professor in Natural Sciences at the University of Pennsylvania: “Attention to the pipeline through which new neuro-imaging applications are developed. Who is taking on the cost of doing it? Who is doing the research? How is that pipeline influenced by who owns and develops the technology, and how does that shape or distort what gets produced and what gets used?”

Dr. Adina Roskies, Associate Professor in the Department of Philosophy at Dartmouth College: “I’m in line with Martha. Also, better means of interpreting the data.”

Dr. Stephen Morse, Ferdinand Wakeman Hubbell Professor of Law at the University of Pennsylvania Law School & School of Medicine: “Mine is vaguer, more foundational: How the new neuroscience will undermine the notion of what it is to be a human being.”

Susan Wolf, McKnight Presidential Professor of Law, Medicine & Public Policy at the University of Minnesota: “You’re not the Institute of Medicine, you’re not the National Academy of Sciences, what you do is public bioethics. One of the biggest issues is the question of the management of information. It’s going to be a total renegotiation of the line between research and clinical care.”

Dr. Ellen Wright Clayton, Director of the Center for Biomedical Ethics and Society at Vanderbilt University: “I also am concerned about management of data, but in a different way. In a clinical context, we are not going to be able to control access to data.”

The panel will reconvene on Tuesday morning. It has yet to decide whether to take up an inquiry on the ethics of genetic testing and neuro-imaging. Its focus on Tuesday will be a separate issue: the protection of human subjects in clinical trials overseas.

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