Institutional Review Board

 

Post Approval Monitoring

Overview

PAM is conducted by the IRB Office to review active protocols and ensure research is being conducted in accordance with what is written and approved within each protocol. The IRB will monitor Expedited and Full Board research projects. The PAM reviewers will ensure that scientific, ethical, and regulatory requirements are followed, and will provide researchers the tools to achieve and maintain compliance, while identifying areas that need improvement for the continuing advancement of OSU research.

 

 

Receiving notification that a study has been selected for a PAM visit does not imply that wrongdoing is suspected in the conduct of the study. PAM visits of randomly selected protocols help the IRB to assess research compliance, as well as act as an educational tool for the PIs, Research Team, and the IRB Office. It is an opportunity to discuss the protocol and its progress, and to review the procedures pertinent to the protection of human research participants.

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Federal policies governing human subject research (Title 45 CFR Part 46) gives the IRB authority and responsibility for continuing oversight of approved protocols. All OSU research teams must identify, evaluate, and respond to any non-compliance issues and unexpected events to protect the rights, safety, and welfare of research participants and the integrity of the research data.

 

Any questions or concerns regarding the PAM Program should be addressed to irb@okstate.edu.