The Regulatory Support unit provides assistance to investigators before protocols are submitted to regulatory agencies. Our goal is to interact closely with investigators to help them meet regulatory requirements. Several faculty members in the Center for Clinical Research are members of Institutional Review Board (IRB) review committees and have extensive knowledge of requirements regarding human subjects. The CTRI ombudsman, Michael Ziegler, MD, is available to assist junior investigators with requirements for conducting studies involving human subjects.
Training in human research protection is provided to faculty and staff through the Human Research Protections Program (HRPP), through the Collaborative Institutional Training Initiative (CITI) training module, and via an online course on Research Aspects of HIPAA (Health Insurance Portability and Accountability Act of 1996).
Experienced staff in the HRPP can provide guidance with FDA applications. The CTRI has staff with regulatory experience who can prepare and submit documents to the IRB, including proposals, consent forms, adverse event reports, annual and final reports, and 4-year renewals. Research Coordinator and Administrator Training is available to Clinical Coordinators and administrative staff on the Research Compliance Program (RCP) Intranet. If you are a UCSD employee and cannot access the RCP Intranet, please contact the RCP at firstname.lastname@example.org.
Michael Caligiuri, PhD
Professor, Department of Psychiatry
Director, UCSD Human Research Protections Program
phone: (858) 657-5155