Compliance and Training

The Office of Compliance and Training within OHSRP is responsible for coordinating review and management of Reportable Events that occur during the conduct of Intramural Research Program (IRP) human subjects research (HSR) activities.  We are also available to answer questions about event reporting in general and about completing Reportable New Information Forms in PROTECT.

Other responsibilities of the Office of Compliance and Training include:

  • Addressing administrative aspects of monthly meetings of the Research Compliance Review Committee (RCRC), which is a duly convened NIH IRB with nine specific members that reviews research related events that rise to the level of possible serious and/or continuing noncompliance
  • Reporting the following IRB determinations to the HHS Office of Human Research Protections (OHRP) and the FDA: unanticipated problems, serious and/or continuing noncompliance, and suspension or termination of research by the NIH Institutional Review Board (IRB)
  • Conducting noncompliance investigations, as needed
  • Quality Assurance (QA)/Quality Improvement (QI) reviews of NIH IRB activities
  • Responding to questions related to the training required for investigators who conduct human subjects research overseen by the NIH IRB
  • Creating HSR related educational materials for NIH investigators and staff and coordinating monthly OHSRP Education Series sessions

Please see our Compliance and Training FAQs for additional information on these topics:

  • Functions of the Office of Compliance and Training
  • Event reporting requirements
  • Responding to participant complaints
  • Required training for investigators conducting human subjects research
  • Requirements for obtaining informed consent from potential study participants

We welcome ideas from the IRP community for future educational materials and training sessions, so send us your ideas!   Please also feel free to contact us with any questions via the link to our mailbox below.


For questions and additional information, please contact:

Compliance and Training Team

Margaret Sanders, RN MSN MA CIP

Director, Compliance & Training

Brenna Hansen, BSN MSHS RN OCN®

Compliance & Training Analyst

Dorinda Metzger, MS

Compliance & Training Analyst