The blog of the Presidential Commission for the Study of Bioethical Issues

International panel named to review scientific trials

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.

Share this article

2 Comments to International panel named to review scientific trials

  1. Nancy Mich's Gravatar Nancy Mich
    March 1, 2011 at 11:53 am | Permalink

    Dear Commission:

    My comment has to do with Human Subjects Protections particularly in the context of “classified” research.

    The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1976 in their Report and Recommendations : Research Involving Prisoners, on the issue of “informed consent” in Recommendation (3) part (C) of the report states:


    The Commission must be aware that classified research on human subjects is conducted, and “generally accepted” regulations do not always apply.

    The recommendations by the ACHRE that would have removed the waiver of ‘informed consent’ when ‘national security’ research is conducted were never adopted by any of the agencies that conduct classified research. Therefore, informed consent is not a universal guarantee, especially ‘high risk’ and dangerous, secret research. Maintaining the secrecy of the research is also a high priority which causes further risk to the subject.

    There is no agency for an unwitting human subject to report a grievance to. There is no agency to investigate unethical research conduct.

    The unfortunate human subject of classified research not only has no ‘consent’, but there is no agency or organized body to investigate egregious behavior of researchers.

    This is entirely unacceptable. An involuntary human subject therefore much become a scientist and procure facilities to prove they are being subjected to unethical research and this impossible, and too much to require. A person with cancer for example is not expected to become an oncologist to get treatment. The lack of oversight in classified research creates a situation that victimizes the victim and must change.

    My concern is that the Commission has not even brought up this most serious topic and situation of undue risk.

    There needs to be an organization constructed to oversee classified research and protections. This organization, must investigate ALL complaints by people who suspect they are being subjected to experimentation without their consent.

    This cannot be ignored especially given the enormous interest by national security agencies in the rapid advancement of converging technologies so powerful as to threaten not only a reinterpretation of what it means to be human, free will, but the policies based on the common understanding our democracy, free will.

    More immediately as far as research is concerned are technologies that affect, control and seek to understand the central nervous system – nanotechnologies, small molecule technologies, brain-computer interface and so on.

    It is past time that this loophole in human protections is addressed and closed.

    Thank you,

  2. Nancy Mich's Gravatar Nancy Mich
    March 1, 2011 at 12:28 pm | Permalink

    I would like the Commission to please address the recommendations made by the ACHRE under Clinton, the last time henious secret human experimetns came to the public’s attention. Namely, informed consent and transparency. These recommendations were never adopted. The protections are therefore inadequate both for government funded research, when :”clsassified” and non-government funded.


  1. By on March 2, 2011 at 10:03 pm

Leave a Reply

Read the comment policy before posting your comment.


This is a space for the members and staff of the Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

Learn more about the Presidential Commission for the Study of Bioethical Issues.


You can receive updates about our blog via email subscription, RSS feed, or follow the Bioethics Commission on Twitter.