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 in accordance with onsite Routine Audits and For Cause Audits. The PAM auditors 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 Routine Audit does not imply that wrongdoing is suspected in the conduct of the study. Routine Audits of randomly selected or specifically targeted 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.
Process
Protocols are selected randomly for Routine Audits. For Cause Audits are conducted when concerns regarding research compliance, approved protocol adherence, or human research participant safety is brought to the attention of the IRB and may be initiated by the IRB Office or the IRB Committee.
- PAM auditors will visit the laboratory or other facility where the research study takes place. The research PI and Faculty Advisor are required to be onsite during an audit.
- Research documentation and procedures on the selected protocol are reviewed and any deviation from the approved protocol is noted.
- The investigators are given the opportunity to make corrections by addressing issues and/or by submitting a modification form for the audited protocol.
Follow-up visits are conducted by the PAM auditors to document that any findings highlighted during the first visit have been corrected.
For Cause Audits are different from a Routine Audit review and are usually initiated by, but not limited to the following events:
- The IRB has cause that a non-compliance has occurred
- There are unanticipated problems involving risk to research participants or others
- Projects where continuing review or reports from other sources have indicated that
changes without IRB approval may have occurred or participants were consented inappropriately - Research participant or whistleblower complaint
- Complex projects involving unusual levels or types of risks to participants
- A study is conducted by a PI who previously failed to comply with IRB determinations
The PAM auditors will provide guidance to the PI and assist in addressing significant findings as appropriate. Upon completion of the For Cause Audit, the PI will be debriefed regarding found non-compliance issues, recommendations, and next steps.
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.