Melody J. Sacatos, CIP

Manager of Protocol Development

Melody J. Sacatos, CIP, formerly head of Compliance for the Yale School of Medicine biomedical institutional review board (Human Investigation Committee), has extensive experience and skill in helping investigators navigate through internal and external review and approval authorities and in interpreting and applying federal regulations, state statutes, related policies and guidance, and best practices essential to the development of compliant and ethically sound research plans, including preparation of protocol and consent documents and investigational drug and device applications. She is a member of the Human Investigation Committee, the Pediatric Protocol Review Committee, and the Yale University Interdisciplinary Bioethics Center. She has co-authored posters on fulfilling sponsor-investigator responsibilities and identifying and implementing critical elements of a human subject protection program for academic medical center community research affiliates for the national association Public Responsibility in Medicine and Research. She also initiated the first ever annual state wide IRB educational and networking symposium, which has been successfully re-convened for the last three years.