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President Obama's bioethics commission March 1 named its International Research Panel to examine the standards for protecting human subjects in research, and members include representatives from Uganda, India, Brazil, Egypt, and China.
The Presidential Commission for the Study of Bioethical Issues formed the panel in response to the discovery last October of conduct in U.S.-funded studies during the 1940s in Guatemala, when prisoners and other vulnerable populations were intentionally injected with syphilis and other sexuality transmitted diseases. The international panel will report on regulations and standards both domestically and abroad; the commission also is conducting a fact-finding mission on what happened in Guatemala.
“A civilization can be judged by the way it treats its most vulnerable individuals. There is no position of vulnerability that is greater than to be a subject of a medical experiment,” Amy Gutmann, who chairs the bioethics commission and is the president of the University of Pennsylvania, said during the March 1 meeting. “What happened was clearly wrong--was clearly terribly wrong--and we want to get the facts out in the record for the public in Guatemala, and in the United States, and all over the world.”
The international panel includes 14 members. The majority come from outside the United States, and members' backgrounds include medical ethics, science, and clinical research, representing academia, government, and industry. Gutmann, who will lead the panel, said the international working group will meet at least three times in the next five months, with at least one meeting abroad. Obama's memorandum said he expected the commission to convene the panel beginning in January and complete its work in nine months.
Gutmann said the panel will focus on contemporary research and international ethics issues. She said nearly a decade has passed since the latest national bioethics report on questions about international research and domestic policies for human subjects research.
“Our review of contemporary scientific studies comes at a critical time,” she said. “The current system for protection of research subjects--largely based on policies developed three to four decades ago--may not be keeping pace.”
In addition to Gutmann, the members are:
• John Arras (United States), bioethics commission member; biomedical ethics and philosophy professor, director of 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), assistant executive secretary at the Uganda National Council for Science and Technology;
• Christine Grady (United States), bioethics commission member; deputy chief of the Department of Bioethics at the National Institutes of Health Clinical Center and head of the department's section on human subjects research;
• Dirceu Greco (Brazil), director of the Brazilian Ministry of Health department of STD, AIDS, and viral hepatitis; professor of internal medicine/infectious diseases at Universidade Federal de Minas Gerais (UMFG); and member of the National Commission on Research Ethics (CONEP) from 2007-2011;
• Unni Karunakara (India), former deputy director of health for the Millennium Villages Project at the Earth Institute at Columbia University; and currently assistant professor in the Heilbrunn Department of Population and Family Health at Columbia's Mailman School of Public Health;
• Nandini Kumar (India), member of the executive committee of the Forum for Ethics Review Committees in India, a national chapter of the forum in Asia/Pacific; and closely involved in finalizing the Indian Council of Medical Research Ethical Guidelines for 2000 and 2006;
• Sergio Litewka (Argentina), international programs director and research assistant professor for the University of Miami Ethics Programs; and project director for the Pan American Bioethics Initiative;
• Luis Lopez (Guatemala), board member of the Latin-American Forum of Committees for Ethical Research in Health; faculty member at the University of San Carlos; 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), former president of Merck Vaccines; expert on disease control in the developing world and vaccine development; and professor in the department of molecular biology and at the Woodrow Wilson School of Public and International Affairs at Princeton University;
• Nelson Michael (United States), bioethics commission member; director of the retrovirology division at the Walter Reed Army Institute of Research; and director of the U.S. Military HIV Research program;
• Peter Piot (Belgium), director of the London School of Hygiene and Tropical Medicine; former undersecretary-general of the United Nations and the founding executive director of UNAIDS; former associate director of the World Health Organization's Global Programme on AIDS; and co-discoverer of the Ebola virus in 1976;
• Huanming Yang (China), co-founder of BGI (formerly Beijing Genomics Institute) in 1999 and current president and professor of BGI; significant contributor to the Human Genome Project, the HapMap Project, and the 1000 Genomes Project; and recipient of Research Leader of the Year by Scientific American in 2002 and Award in Biology by the Third World Academy of Sciences in 2006; and
• Boris Yudin (Russia), head of the department of comprehensive problems of human studies at the Institute of Philosophy of the Russian Academy of Sciences; Russian representative on the steering committee on bioethics, Council of Europe; and vice chairman of the Russian Committee on Bioethics and the Commission of the Russian Federation for UNESCO.
Valerie H. Bonham, executive director of the bioethics commission, said there are 12 people working on the staff-led, fact-finding mission on Guatemala. She said they also have the assistance of bioethicists Jonathan D. Moreno of the University of Pennsylvania, who also is a senior fellow at the Center for American Progress, and Jeremy Sugarman of Johns Hopkins University. To date, Bonham said she and her colleagues have reviewed 477 boxes, with hundreds of thousands of pages in documents.
“Essentially what we are pursuing are fundamental questions of who knew about Dr. Cutler's Guatemala studies? What did they know? When did they know and what did they do about it? In probing these basic details, we are looking to explain in the context in which the research occurred,” Bonham said.
Bonham said she anticipates the fact-finding report on Guatemala to be released by the beginning of summer.
Commission member Anita L. Allen, law professor and bioethicist at the University of Pennsylvania, said after Bonham's presentation that the president made clear that he thought the 1940s inoculation studies were unethical.
“I want to confirm that the point of this comprehensive review, which I'm sure will be conducted with the utmost care, is not to excuse or to justify the experiments but rather to attempt to understand them--and understand them in context,” Allen said.
“Absolutely,” Bonham said. “But I don't think there's any question, with the judgment that President Obama has already given and as you all have discussed quite clearly here.”
Gutmann said, “Medical research's ultimate aim is to serve the public good. In order to do that, it also has to treat its subjects in an ethically responsible way. … The work before us demands very careful deliberation.”
More information, including archived video of the Presidential Commission for the Study of Bioethical Issues' Feb. 28 and March 1 meeting, is available at http://www.tvworldwide.com/events/bioethics/110228/.
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