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 ACTRI ombudsman, Michael Ziegler, MD, is available to assist junior investigators with requirements for conducting studies involving human subjects.
Experienced staff in the HRPP can provide guidance with FDA applications. The ACTRI 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. For help with IRB submissions, please submit a ACTRI Services Request using the button above.
Anthony Magit, MD, MPH