Dr. John D. Arras – 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 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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Aristotle would be proud: `Prudent vigilance’ for synthetic biology https://bioethicsarchive.georgetown.edu/pcsbi/blog/2010/11/16/aristotle-would-be-proud-prudent-vigilance%e2%80%99-for-synthetic-biology/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2010/11/16/aristotle-would-be-proud-prudent-vigilance%e2%80%99-for-synthetic-biology/#respond Wed, 17 Nov 2010 02:20:44 +0000 http://blog/?p=39 Since there are so many unknowns about synthetic biology, should the federal government follow Europe’s approach to genetically modified food? That is, not allow research to go forward until it’s proven safe?

That question was posed by Dr. John D. Arras, a member of the Presidential Commission for the Study of Bioethical Issues, during its hearing today in Atlanta.

Arras, the Porterfield Professor of Biomedical Ethics and Professor of Philosophy at the University of Virginia, was presenting one of the Commission’s draft recommendations. The group will make final recommendations in a month to President Obama on federal oversight of synthetic biology.

Arras – and the Commission – do not back the European GM approach. Instead, they are now supporting a call for ongoing assessments of synthetic biology in order to stay abreast with any developments in the field.

“Synthetic biology is a new and very energetic field,’’ Arras said. “We are witnessing very rapid development. It’s very difficult to predict ahead of time what sorts of benefits will arise, or what sort of risks. We are speculating largely in the dark. We are facing a great amount of uncertainty. What is the proper attitude toward risk when the future is shrouded in uncertainty?’’

He continued: “Especially, what is the proper attitude in dealing with events which are in low probability range, but high in impact? We can think about organisms let loose in the environment, reeking havoc out there. This is a very serious risk, but hard to predict what the likelihood of that is. The same thing goes for risks under the heading of bioterrorism, bad actors doing terrible things. We know they are out there, but hard to get a handle on the quantity of the risk.’’

Arras posed two approaches to dealing with such unknown risk:

“One way of handling risk is to be proactive: Go full speed ahead, worry about risk later. This supports the values of scientific freedom and focuses on the benefits that derive from it,’’ he said. “The other extreme – the cautionary proposal – we’ve seen in Europe when it comes to genetically modified foods. In that case, there must be a promise of mitigation before one goes forward with research.’’

His conclusion? Neither route. He chose a middle road.

Arras, the philosopher he is, called it the Aristotelian Approach.

Following the footsteps of Aristotle meant: clearly define the issue, consider all accepted views on the subject, and present findings based on deduction and practical considerations.


We call it prudent vigilance,’’ Arras said of the views of fellow Commission members. “We recommend having ongoing assessments as the risk develops. We argue that research goes forward but with lots of safeguards.’’

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