Susan Kornetsky

Site Regulatory Lead

Susan Kornetsky is the Director of Clinical Research Compliance. She directs an IRB administrative office, educates investigators regarding IRB regulations, assures institutional compliance with regulations pertaining to human research, protections and oversees quality improvement for human research protections. She has a Masters of Public Health and completed a Medical Ethics Fellowship at Harvard Medical School.  She is a past member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) and was co-chair of the Sub-committee on Children and serves on the Subpart A subcommittee.  She is a past Board member of the Association for the Accreditation of Human Research Programs (AAHRP), and past site visitor.  She was a member of the Institute of Medicine’s Committee on Clinical Research Involving Children.  She is currently Chair of the PRIMR Board of Directors. She was on the Council for Certification of IRB Professionals (CCIP) and served as a Council co-chair. She lectures at national and international meetings most recently teaching clinical research ethics in London, Turkey and Portugal.  She is a consultant for (OPRR) site visit teams. She lectures on research ethics and IRB regulations for Harvard Medical School. Topics of interest include pediatric research, boundaries between research and innovation, biobanking and the obligation to return research results to subjects.