Any active study is subject to a post-approval review via our post-monitoring program (PMP). The purpose of the PMP is to assess the research activities conducted under the University’s Federal Wide Assurance Agreement with the Office of Human Research Protections (OHRP). This program assures human subject safety in research, provides education to research professionals, and identifies strengths and areas for improvement.

PMP reviews may be initiated for the following reasons:

• A protocol is randomly selected form a list of currently approved studies;
• The PI or PI’s department may wish to have research studies reviewed proactively;
• The IRB may request HSP staff conduct an observational visit for a specific protocol because the study is very complex or involves unusual levels or types of risks to participants; or
• Other reasons primarily related to subjects’ risk and safety.

Notification of a PMP visit is sent by Office of Human Subjects Protections (OHSP) via email to the Principal Investigator (PI) and Faculty Sponsor (if the PI is a student). HSP staff will work with the PI to establish a monitoring visit usually within thirty (30) days of notification.

During the visit, HSP staff’s review and evaluation will include (but is not limited to) the following areas:

• IRB records and documentation
• Compliance to IRB approved protocol
• Participant recruitment, selection, and payment procedures
• Participant enrollment and corresponding records
• Informed consent procedures and corresponding records
• Participant payment and corresponding records
• Data storage / retention practices
• Confidentiality and privacy practices and process

Once the PI and research team is notified of the PMP visit, they are encouraged to contact the HSP Office with any questions or concerns.