University of Pennsylvania – 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 International panel named to review scientific trials Tue, 01 Mar 2011 15:46:23 +0000 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 Mon, 28 Feb 2011 22:38:28 +0000 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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Buzz over science: Oslo, Cronkite and Thu, 18 Nov 2010 01:36:10 +0000 A few years ago, Dr. Stephen L. Hauser accompanied a friend to Oslo. His friend had won a Nobel Prize.

Commission member Dr. Stephen L. Hauser, left.

“It was so impressive — the entire nation was transfixed by science,’’ Hauser told his fellow members of the Presidential Commission for the Study of Bioethical Issues.

“We were stopped in the streets, and asked which party are you with. The television was full of the discussion of the nature of these prizes,’’ he said.
Hauser, Chair of the Department of Neurology at the University of California, San Francisco, was speaking about one of the panel’s 19 recommendations on federal oversight in synthetic biology. The recommendation had to do with expanding educational activities related to synthetic biology for students at all levels, civil society groups, and communities.

“It would be just wonderful if a similar period was developed in the United States,’’ Hauser said, referring to Norway’s celebration over the Nobel Prizes. “Public education efforts are clearly central. … We need to find better ways to make science more interesting to the general public.’’

Dr. James Wagner, Vice Chair of the Commission and President of Emory University, which hosted the meeting, suggested putting in the recommendations a way to encourage the media to help promote public education of synthetic biology.

“The last time I can recall a vivid period of scientific focus was around the earlier days of the space program,’’ he said. “I think you would agree, one of the key players was the media, when we were listening and watching Walter Cronkite around the dinner table … using language such as heat shields. I think that encouraging literate, open science reporting could be a good recommendation.’’

Commission Chair Dr. Amy Gutmann, the President of the University of Pennsylvania, also had another idea: Create an independent, bioscience version of, which would include checking facts on synthetic biology and a host of other topics.

“When there are new innovations that come out with claims flying by the innovators themselves, or the media, or critics, sometimes even the educated public and even journalists who are covering this don’t have at their fingertips whether these claims can be borne out,’’ she said. “So one could go to this version of, and check the variety of claims made about synthetic biology and other new advances in the field of biology and technology.’’

She said such a Web-based service could have been used soon after the J. Craig Venter Institute announced on May 20 that it had injected a synthetic genome into a living organism.

Some said that Venter was “creating life.’’ Not so, Gutmann said.

“If there were a then, you could find out what the Venter Institute did was not creating life. There was a living cell in a genome, and that cell was taken over by new genome, but life existed prior to that experiment. As the rhetoric escalated, though, the notion of creating life took over.’’

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An ethical framework Tue, 16 Nov 2010 23:26:38 +0000 http://blog/?p=24 At the opening of the Presidential Commission for the Study of Bioethical Issues meeting today in Atlanta, the first discussion wasn’t about the issue at hand – synthetic biology.

Instead, it was about how to approach the issue.

It was the third meeting of the Commission for its assigned task to make a recommendation to President Obama about how the federal government should reap the benefits and minimize the risks of synthetic biology. The Commission should deliver that decision in roughly a month.

It has heard so far from 34 experts in a range of fields to talk about potential applications and potential risks in the field following the announcement on May 20th that the J. Craig Venter Institute had created the world’s first self-replicating synthetic genome in a bacterial cell of a different species. In other words, Venter and his colleagues showed they could design and construct new biological parts by inserting gene sequences not found in nature into existing organism.

So how has the Commission approached the issues?

Dr. Amy Gutmann, Commission Chair and President of the University of Pennsylvania, explained that the group has been looking at synthetic biology through the lens of five principles: public beneficence, responsible stewardship, intellectual freedom and responsibility, democratic deliberation, and justice and fairness.

Some of the principles are self-explanatory. She particularly focused on the second principle: responsible stewardship.

“This is a charge to scientists and public bodies alike to be trustees of the interests of those who can’t be represented here — to the children, future generations, the environment,’’ Gutmann said.

That, she said, had to be interpreted in the broadest sense, meaning that the Commission would look at the potential risks to the environment if something made by synthetic biology released into the natural world. But it also meant, she said, that if intellectual freedom were curbed, stopping research in life-saving vaccines, that would be detrimental to future generations.

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