Meeting Regulatory Compliance

Research involving human or animal subjects and specimens requires approval by the appropriate regulatory body.  The details of a clinical trial, including all tests and procedures used in the trial, are outlined in a research plan, usually called a protocol. Before a clinical trial can begin, the protocol must be approved by UCSF's Institutional Review Board.  

UCSF's Office of Ethics and Compliance coordinates and guides compliance efforts across the campus to ensure institutional compliance with applicable laws and regulations, to promote ethical behavior and research integrity, and to provide the tools, guidance, and oversight needed to adhere to all necessary regulatory requirements.  For information about the International Conference of Harmonization (ICH) guidelines, please see here.  For expert advice on regulatory issues, request a regulatory knowledge consultation