Washington, D.C. – Dr. Amy Gutmann, Chair of the Presidential Commission for the Study of Bioethical Issues, today announced the formation of an International Research Panel to consider the standards for protecting human subjects in scientific studies.
The announcement comes in direct response to a request from President Obama. The President asked the Commission to report on the effectiveness of current U.S. rules and international standards for the protection of human subjects in scientific studies supported by the Federal Government and to assure him that “the current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally.”
This request arose in the wake of revelations last October about U.S. Public Health Service supported research on sexually transmitted diseases in Guatemala from 1946 to 1948, which involved the intentional infection of vulnerable human populations.
The International Research Panel will consider the effectiveness of current federal rules and international standards governing research involving human subjects.
The International Research Panel includes experts on medical ethics, science and clinical research who bring wide experience from academia, government, and industry. They hail from many countries, including Argentina, Brazil, China, Egypt, Guatemala, India, Russia, Uganda, Belgium, and the United States. The Panel members will be acting in their individual capacities and are not official representatives of their home nations.
The members of the panel 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.
“The members of this International Research Panel will offer a valuable global perspective,” Gutmann said. “Their diverse backgrounds, extensive experience and understanding of global research, and their commitment to the highest ethical standards will be critical to informing the Bioethics Commission’s report to President Obama.”
The International Research Panel will convene in a series of meetings, or Consultation, that will examine:
- The dominant norms, and competing alternatives, driving the ethics of medical research in different global regions outside of the U.S.;
- The conflicts, if any, between U.S. norms and international standards;
- The challenges facing researchers conducting U.S.-funded research in global settings; and
- How best to address any major differences in regional norms for medical research.
The group plans to meet three times, with at least one of the meetings taking place outside the United States. The Consultation proceedings will be distributed publicly. Public comments on these proceedings will be solicited before the Bioethics Commission submits its final report to the President.
In addition, at the President's request the Bioethics Commission will include a thorough fact-finding investigation into the 1946-48 research. This historical investigation is being conducted by Commission staff, including several senior experts and consultants, and led by Valerie Bonham, the Commission's Executive Director.