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Post-Approval Monitoring and Education
The Office of Research Ethic’s Post-Approval Monitoring (PAM&Ed) program is committed to promoting ethical human subjects research that is conducted in compliance with relevant federal regulations, state laws, and Iowa State policies. Working together with Principal Investigators (PIs) the PAM&Ed program aims to proactively identify and address potential compliance concerns through monitoring and targeted education. PAM&Ed is also a designed to help Principal Investigators (PIs), research teams, and Iowa State in preparation for external audits by funding, regulatory, or accreditation agencies.
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PAM&Ed monitoring is conducted by the Post-Approval Monitor (PAM), a member of the Office of Research Ethics staff. The PAM works closely with the IRB but is not a member of the committee. Through observation and document comparison, the PAM verifies that study procedures and practices are conducted in accord with the IRB protocol. If necessary, the PAM assists the PI in addressing deviations from the IRB approved protocol.
During PAM&Ed monitoring, the various areas of a research project (e.g., study procedures, informed consent process, confidentiality measures, and general lab/record keeping) are all subject to review. Questions included in the PI Self-Assessment (non-exempt) or PI Self-Assessment (exempt) can help PIs evaluate their own research and identify potential noncompliance issues before they become serious and/or require reporting to regulatory or funding agencies.
Post-Approval Monitoring Program Description contains additional information about the PAM&Ed program objectives, types of monitoring, scope, and the monitoring process.
The PAM&Ed program offers a variety of educational opportunities.
- Monitoring visits allow for sharing of 1:1, targeted, individualized information. PIs are encouraged to as questions throughout the monitoring process and beyond.
- Regular IRB Basics/IRB 101 presentation/webinars hosted by OVPR throughout year
- Targeted presentations to labs, research teams, or classes upon request.