Institutional Review Board
Post Approval Monitoring
FAQ's
What is Post Approval Monitoring?
Post Approval Monitoring is an examination of the research facility and study documents to assure that human subjects are protected, and the investigator is in compliance with applicable University and Federal regulations. Conducting post approval monitoring will help to ensure that appropriate applications and supporting documents are executed as approved, any changes or adverse events are reported, and the consent forms are approved.
What are some of the benefits that an investigator may gain from the PAM process?
Some of the possible benefits that may be gained from a review include but are not limited to an increased understanding of the regulations that guide all of our research projects, increased communication concerning updates to Federal and University regulations, access to resources and the opportunity to discuss the study with the research team.
How are the research protocols selected?
All non-exempt studies that have received approval from the OSU IRB may be randomly selected for a routine monitoring visit as long as they are open and active.
How often will routine monitoring occur?
An individual protocol may be selected for routine monitoring once every 12 months.
What happens once a study is selected for a routine audit?
The PI will receive notification from the IRB that their study has been selected for monitoring. An initial visit will be scheduled. At this initial visit, the auditors will describe the monitoring process and discuss the study with the research team. The research team will also have the opportunity to ask questions and address any issues during the auditing visit.
How long will the audit review take?
If your documents are complete and organized, the review will take about one hour. If an investigator is not prepared, the review may take several hours.
How should research teams prepare for the audit review?
When the visit is scheduled, the IRB Office will provide the research team with a Self-Assessment eForm via email. This self-assessment tool is the same form used during the audit review. Research teams should ensure their study records and materials are present and organized, and that they have any preliminary questions answered prior to the visit. The Self-Assessment eForm is available on the IRB website and is available for everyone to use.
What will happened during an audit review?
The PI will have received a letter via email before this visit outlining what will occur. The auditors will arrive at a scheduled time that is pre-arranged with the PI. The auditors will review research records and materials for the specific protocol. The PI and Faculty Advisor and required to be onsite during an audit review. Research teams are encouraged to ask questions throughout the visit. At the end of the review, the auditors will meet with research team to briefly discuss the visit and ensure any questions are answered.
What Results can study teams expect from the monitoring visit?
The PI will receive a follow-up letter within 5 business days of the audit review visit. This letter will provide PI with an overview of the findings of the visit and any potential follow-up actions that may be needed.
What if the PI is unable to attend the scheduled PAM meeting?
The preferred option would be to meet at a mutually agreeable time for both the PAM auditors, the PI and the Faculty Advisor. The IRB Office will try to accommodate all schedules to ensure the PI and Faculty Advisor are present during the audit review.
Are the PAM Auditors authorized to view my research records?
The IRB has the authority to ensure that research conducted under its jurisdiction is designed and conducted in a manner that protects the rights, welfare and privacy of human participants in research. Specifically:
- The IRB may disapprove, modify, or approve studies based upon consideration of human participant protection aspects.
- The IRB reviews, and has the authority to approve, require modification in, or disapprove all research activities that fall within its jurisdiction.
- The IRB has the authority to conduct continuing review as it deems necessary to protect the rights and welfare and privacy of human participants in research, including requiring progress reports from investigators and reviewing the conduct of the study.
- The IRB may suspend or terminate approval of a study not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to research participants.
- The IRB has the authority to conduct post approval reviews on any applications for any reason. Review may consist of a review of documents and/or review of the activities to determine whether the research is being conducted in accordance with the IRB’s requirements and the approved application.
- The IRB has the authority to observe or have a third party observe the informed consent process and/or audit the progress of any study in its jurisdiction as it deems necessary to protect the rights and welfare of human participants in research.