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Rotunda during the day

The University of Virginia is committed to the protection of human subjects involved in research studies. In pursuit of this commitment, and to satisfy the requirements of federal regulatory agencies, the Post Approval Monitoring and Education Program (HRPP PAM & Ed) was initiated in 2002. The program is managed by two specialized groups which share the same mission: the IRB-HSR PAM & Ed and IRB-SBS PAM & Ed.

The purpose of the PAM program is to protect research participants and provide on-going support for researchers as they conduct human subject research. Further, the program provides internal oversight on compliance issues relating to the performance of human subject research, conducted under the University’s Federal Wide Assurance Agreement with the Office of Human Research Protections (OHRP). Additional goals are to ensure the quality and integrity of the research; identify educational needs and provide resources; ensure compliance with federal, state, local and institutional regulations.

Types of review include the Compliance Check-up, remote or on-site Post-Approval Monitoring Reviews (randomly selected or directed), and Consent Process Observation. The review process includes involvement from not only the compliance monitor, but also from the Principal Investigator, CRCs & other study team members, and PAM Advisory Committees. Based on the PAM review, the IRB-HSR or IRB-SBS may have additional recommendations or requirements for the study team. 

For more information regarding the review process, go to either the IRB-HSR PAM & Ed or IRB-SBS PAM & Ed pages.

IRB-HSR PAM & Ed          IRB-SBS PAM & Ed