Delia Y. Wolf, MD, JD, MSci
Harvard T.H. Chan School of Public Health
Dr. Wolf is the Assistant Dean for Regulatory Affairs & Research Compliance and Director for the
Office of Regulatory Affairs & Research Compliance (ORARC) at Harvard T.H. Chan School of Public Health. In her role as Assistant Dean, Dr. Wolf is responsible for the development and implementation of policies and procedures and ensuring faculty and institutional regulatory compliance in the areas of clinical research including conflicts of interest, data and information security, research integrity, intellectual property, animal research and bio-safety. She also oversees efforts in international research compliance, including review of institution collaboration agreements/MOUs, and global research ethics training.
In her role as the Director of ORARC, Dr. Wolf is responsible for establishing and implementing a comprehensive Human Research Protection Program, which includes IRB review, quality assurance, quality improvement, compliance, education and outreach to the research community in the US and abroad.
As a faculty member in the Department of Health Policy and Management, Dr. Wolf teaches two courses relating to legal and ethical issues in reviewing, conducting and overseeing human research.
She is a nationally recognized speaker and an accomplished teacher who has served as a faculty member at numerous national conferences sponsored by Public Responsibility in Research and Medicine (PRIM&R), the Association of Clinical Research Professionals (ACRP), and the Drug Information Association (DIA), among others. She is also a sought-after expert, who has been providing consultation to many institutions in the US for the establishment of research compliance programs. She served as a member of the WHO International Working Committee that developed the Operational Guidelines for the Establishment of Data & Safety Monitoring Boards.
Besides her medical degree from her native country China, Dr. Wolf earned a Master of Science in Clinical Investigation and a law degree (Juris Doctor) from Suffolk University Law School. She is a licensed attorney in the Commonwealth of Massachusetts and a Certified IRB Professional (CIP). Dr. Wolf also completed a fellowship in Medical Ethics from Harvard Medical School, where she concentrated on ethical issues in conducting clinical research at international sites. As a former clinical researcher, IRB chair and Director for a research compliance program at Massachusetts General Hospital and Brigham and Women’s Hospital for more than a decade, Dr. Wolf has extensive experience in conducting, organizing, developing, and overseeing the full spectrum of clinical research. Her research interests include legal, ethical, and practical issues in conducting and managing clinical research in different countries.