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Rotunda during the day

Welcome to the Post Approval Monitoring and Education (PAM & Ed) Program

The University of Virginia is committed to the protection of human subjects involved in research studies. In pursuit of this commitment, and to satisfy the requirements of federal regulatory agencies, the Post Approval Monitoring and Education Program (HRPP PAM & Ed) was initiated in 2002. 

The purpose of the PAM program is to protect research participants and provide on-going support for researchers as they conduct human subject research. Further, the program provides internal oversight on compliance issues relating to the performance of human subject research, conducted under the University’s Federal Wide Assurance Agreement with the Office of Human Research Protections (OHRP). Additional goals are to ensure the quality and integrity of the research; identify educational needs and provide resources; ensure compliance with federal, state, local and institutional regulations.

Types of review include the Compliance Check-up, remote or on-site Post-Approval Monitoring Reviews (randomly selected or directed), and Consent Process Observation. The review process includes involvement from not only the compliance monitor, but also from the Principal Investigator, CRCs & other study team members, and PAM Advisory Committees. Based on the PAM review, the IRB-HSR or IRB-SBS may have additional recommendations or requirements for the study team. 

PAM & Ed Research Education Program

The PAM & Ed Research Education Program includes:

 

Research Education Resources

Compliance Check-Up Tool

The optional Compliance Check-up Tool helps you to determine quickly if you are conducting research that matches your approved protocol and is compliant with federal regulations. The Compliance Check-up Tool is also useful to help you prepare for a post-approval monitoring review visit, which is a more in-depth look at your study processes. Working with Stephanie Keister, Post Approval Monitor and Educator, can help you identify and resolve any problem areas which can both protect your participants and prevent potential disruptions to your study.

Research Education Presentations

The PAM & Ed team is pleased to provide host informational presentations designed specifically to meet the needs of academic departments, programs, and UVA research groups. Presentations can be held in person or virtually. The content will highlight IRB services and resources that can aid in an efficient protocol submission process. Please contact [email protected] to discuss how a presentation can be customized to meet your specific needs. 

Educational Resource Development

The PAM & Ed Team can collaborate with you to develop a variety of educational resources, including course modules and instructional videos. Please contact the team at [email protected] to explore the resources that can be designed for your users. 

Post Approval Monitoring for IRB-HSR Studies- Microlearning Videos 

IRB-SBS YouTube Channel: 

Check out the IRB-SBS YouTube Channel for research education videos on a variety of topics.

 

Post approval monitoring is conducted in accordance with the Human Research Protection Program Standard Operating Procedures.

 

Suggestion Box

Share your thoughts on what you like or any feedback for improvements with us here. Your ideas will help us to shape future plans for UVA's Human Research Protection Program. 

Note, for urgent maters, please see the Compliance Helpline.

Contact the PAM & Ed Team