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

Barbara F. Mishkin, J.D.
Submitted by: Mortimer Mishkin, Building 49, Room 1B80, Bethesda, MD 20892-4415

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: Barbara F. Mishkin holds a J.D. from the American University and M.A. in Philosophy, Behavioral Neuroscience, Anthropology from Yale University. She is a partner in the Washington, D.C. office of Hogan & Hartson L.L.P. and a member of the firm's Health Group.

From 1974 to 1978, she worked as the Assistant Director for the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

From 1978 to 1980, she worked as the Assistant Director and then, Director for the HEW Ethics Advisory Board.

From 1980 to 1983, she worked as the Deputy Director for the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.

Contribution/Impact: Barbara F. Mishkin’s early contributions to the 1974 NIH regulations for the protection of vulnerable populations are evident today in the current regulations. Improvements by the three advisory committees that she served as senior staff person reflect her continuing contributions to the process of deliberating, drafting, and editing national reports and recommendations for the protection of human subjects. Today, After 33 years in the field, Barbara is viewed nationally as the preeminent, “go-to” lawyer for matters relating to IRBs and the protection of human subjects.

Leadership: In a 1978 staff report to the National Commission, Barbara reviewed the regulations of 20 federal agencies funding research involving human subjects, and recommended adoption of a single set of federal regulations. As Deputy Director of the President’s Commission, Barbara was responsible for all of its research-related activities. In 1984, Barbara drafted what became the D.C. Health Care Decisions Act. Appointed to be the American Bar Association’s co-Director of the ABA/AAAS National Conference of Lawyers and Scientists, she led the group’s studies of scientific misconduct and violations of research regulations.

Justification for award: As an attorney, Barbara F. Mishkin enhances the protection of human subjects by auditing IRBs and persuading institutional administrators and general counsel of the need to provide more resources to enhance regulatory compliance. She is an active participant in conferences and on committees dedicated to the protection of human subjects and scientific integrity.

For additional information: Mortimer Mishkin
Tel: 301-496-625 x 201