Award for Excellence in Human Research Protection
2004 life-time achievement award recipient

Robert J. Levine, M.D.
Submitted by: Robert J. Levine, M.D., Professor of Medicine, Yale University, New Haven, CT

The following information was submitted on behalf of the candidate for the award. The Institute may have edited the text for presentation purposes. Health Improvement Institute has not verified, and does not guarantee, the completeness or accuracy of the information for any purpose.

Curriculum vitae: Dr. Robert J. Levine holds an M.D. from the George Washington University. He is a member of the IRB Leadership Group at Yale University and the founding editor of the IRB: A Review of Human Subjects Research.

From 1969 to 2000, he served as the Chairperson for the Institutional Review Board (Human Investigation Committee), Yale-New Haven Medical Center.

From 1974 to 1978, he served as Special Consultant at National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

He was the chair for World Medical Association Working Group for Revision of the World Medical Association Declaration of Helsinki and the President of the American Society of Law, Medicine & Ethics: Board of Directors.

Contribution/Impact: He began the productive process of the case study approach to the field of human subjects protection first through establishing and administering the Nellie Westerman Prize and subsequently through featuring a ‘case studies’ section of IRB: A Review of Human Subjects Research. His work as Special Consultant to the National Commission for the Protection of Human Subjects influenced the entire field of US national policies for the protection of human subjects. His work in a leadership role with such agencies as the Council for International Organizations of Medical Sciences and the World Medical Association has had a major impact on the development of international guidelines for the protection of human subjects. He served as membership on several committees, working groups, etc to develop or recommend policy for the protection of such populations as adolescents, children, prisoners and those having cognitive disabilities as well as persons living with AIDS, multiple sclerosis, osteoporosis and many others.

Leadership: Dr. Robert J. Levine served as the Chairperson for the Institutional Review Board (Human Investigation Committee), Yale-New Haven Medical Center from 1969 to 2000. He is a member of the IRB Leadership Group at Yale University. He is the founding editor of and the Chair of the editorial Board for A Review of Human Subjects Research. His leadership has been actualized through service as a Special Consultant to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and since through service on multiple federal advisory committees. Internationally, he has been assigned leadership roles in developing the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, the World Medical Association’s Declaration of Helsinki and the UNAIDS Guidance Document on multinational trials of preventive HIV/AIDS vaccines.

Justification for award: Dr. Robert J. Levine has worked in the field of protection of human subjects for over 35 years and since 1974 has made this the primary focus of his professional activities. He has contributed to the literature of the field of protection of human research subjects by publishing around 150 articles, one major monograph (Ethics and Regulation of Clinical Research) and by founding and for 21 years editing the only peer-reviewed journal devoted to human subjects protection, IRB: A Review of Human Subjects Research. He has made major contributions to the development of programs designed to educate IRB members, investigators and research administrators.

For additional information: Robert J. Levine, M.D.
Tel: 203-432-8807
Fax: 203-432-5036
Email: levinerj@att.net