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.

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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.

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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.

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How often will routine monitoring occur?

An individual protocol may be selected for routine monitoring once every 12 months.

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What happens once a study is selected for a post approval monitoring visit?

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 PAM Reviewer 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 post approval monitoring visit.

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How long will the visit take?

If your documents are complete and organized, the review will take about 30 minutes to an hour.  If an investigator is not prepared, the review may take several hours.

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How should research teams prepare for the monitoring visit?

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.

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Are the PAM Reviewers 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.