OPRS and IRB responsibilities do not end when an application is reviewed and approved. OPRS and the IRB provide ongoing oversight for all projects until they have been officially closed with a Final Project Report.
Post Approval Monitoring is the program OPRS/IRB uses to confirm that the research is being conducted as approved, ensuring compliance with the federal and institutional regulations, policies, and guidelines for the protection of research subjects.
The PAM program has three goals:
All studies, even those determined to qualify for exempt status, are subject to PAM. Receiving notification that a study has been selected for PAM does not imply that wrongdoing has occurred or is suspected in the conduct of the study.
Studies are selected randomly, for cause, or as a result of a request by a PI, research staff, or department leadership.
OPRS determines one of two monitoring methods:
OPRS has provided the worksheets and tools used to conduct monitoring visits. Researchers are encouraged to use these worksheets to conduct their own monitoring throughout the study or to prepare for a monitoring site visit.
Behavioral Sciences Self-Assessment Worksheet
Biomedical and Health Sciences Self-Assessment Worksheet