Michele Russell-Einhorn is an expert in the field of research administration, cancer center scientific review, and the protection of human subjects in research. She is currently the Senior Director of the Office for Human Research Studies at the Dana-Farber Cancer Institute and is responsible for the management and support of scientific review and institutional review board review, as well as other regulatory matters, involving all cancer relevant research involving human subjects conducted at the five Harvard clinical institutions under the umbrella of the Dana-Farber/Harvard Cancer Center.
Trained as a lawyer, she has over 30 years of professional experience including service as the Conflicts of Interest Attorney for the National Institutes of Health; Director of Regulatory Affairs for the U.S.D.H.H.S Office for the Protection from Research Risks (OPRR) and its successor office, the Office for Human Research Subjects (OHRP); Director in the Global Pharmaceuticals Practice at PWC; as well as the Associate General Counsel for the J. Craig Venter Institute.
She is a co-chair of the U.S.D.H.H.S. Secretary’s Advisory Committee on Human Research Protections, Subcommittee on Subpart A; as well as a founder and leader of the IRB Directors Group of the National Comprehensive Cancer Center. She served as the Co-Chair for three years and a core planning committee member for five years of the annual Ethics in Research Conference sponsored by Public Responsibility in Medicine and Research; and, a member of the Vanderbilt University Steering Committee for an NIH Grant on Alternative IRB Models. She participates each year as a faculty member at the American Association of Cancer Research, AACR Translational Cancer Research for Basic Scientists Workshop and the Tufts Center for Drug Development, Annual Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation.
She is a speaker at numerous conferences on various topics relating to research involving human subject protections, bio-repositories and FDA regulations; and, is adjunct faculty in the Northeastern University Masters of Regulatory Affairs Program.