Principal Investigator Responsibilities

The principal investigator of the research study is ultimately responsible for assuring compliance with the IRB’s policies and procedures, DHHS Federal Policy regulations, and FDA regulations; and for oversight of the conduct of the research study and the informed consent process.

Education in the protection of human research subjects is recommended for all investigators, and is required for investigators participating in federally-funded studies. While all investigators need education in the basics of human subjects research, some may wish to consider more intensive study if their work involves especially difficult topics or special populations.

General Responsibilities of Research Study Investigators

Principal Investigator Responsibilities Handbook