Post Approval Review Guidance
To provide a more thorough review of currently approved studies, the UWM IRB has developed a post approval review process. The purpose of the review is to enhance the protection of human subjects and the oversight of approved research. The reviews will be completed to verify that IRB approved procedures are being followed. In addition, the IRB will use the results to develop researcher education and improve IRB processes/procedures/guidance.
Any active full board or expedited study involving human subjects may be selected for review. A PI will have no more than 1 study reviewed per fiscal year. Studies may be selected for review for any of the following reasons:
- By request from a PI, SPI and/or coordinator
- Studies that involve more than minimal risk
- Studies involving medical devices, vulnerable populations, sensitive data
- Studies that are Federally funded
- Studies that were found to have non-compliance, a reportable event and/or deviation
- Randomly selected studies
General Procedures for Post Approval Reviews
- The IRB office will identify a study for review based on the reasons listed above.
- The IRB office will determine who will review the study – IRB member(s) and/or IRB staff. A post approval review event will be created in the study’s I-Manager page.
- The IRB office will contact the PI via email to schedule the review. The email will include:
- A description of what a post approval review is
- The reason why and/or how the study was selected
- How the post approval review will be conducted and by whom
- An attachment of the Post approval review checklist, so the PI understands what is being reviewed. This is the checklist the reviewers will use to guide their review.
- A list of items that will be discussed and/or reviewed:
- Current study procedures and activities
- Informed consent process and a review of signed consent forms (if applicable)
- Visit of data collection site (if possible) to view equipment, devices, etc.
- Review of subject data/records (paper and electronic)
- Training records of staff (if applicable)
- A request to select a date/time/location to meet (within 30 days of the request, when possible)
- A request to provide the current number of subjects enrolled
- On the selected meeting day, the PI will be requested to provide access to study records (including, but not limited to, signed consent forms, study records/data, training records of study staff, access to equipment, etc.) and be available to answer reviewer questions.
- The IRB will use a Post approval review checklist to review study documents and procedures. Throughout the meeting and with a summary at the end of the meeting, the reviewer(s) will verbally review positive observations, items that may require follow-up, and recommendations (that are optional) with PI, SPI, coordinator, etc.
- The IRB will write up a summary report of observations and any corrective actions. The report will be sent to PI and filed with IRB study records. If corrective actions are required, the PI will need to provide a corrective action plan within 4 weeks to specify how issues will be resolved. The plan will specify how an item will be resolved and a target date for completion (but not necessarily completed yet).
- After all corrective actions have been completed, the post approval review will be considered completed/closed. All review documents, emails, notes, etc. will be saved in the study’s I-Manager file.
- Post approval review results will be reported to the IRB and the IO at IRB meetings.
- # of reviews conducted
- # of positive findings
- # of corrective actions
- # of recommendations
- # of corrective actions, improvements, new guidance, etc. for the IRB