Post Approval Monitoring Program by Louisa Gay Post

Post Approval Monitoring Program by Louisa Gay Post Approval Monitoring Officer

Discussion Areas • What is Post Approval Monitoring • Why should we do this • Who will be involved • Logistics • Questions

Post-Approval Monitoring (PAM) • PAM is a program through which the IRB can ensure and document program integrity, compliance with regulations and guidelines, and adherence to protocol. • PAM can serve as a facilitator or conduit for information exchange between researchers, and between researchers and the IRB. • PAM can serve as the eyes and ears of the IRB.

PAM can provide assurance to regulatory agencies and VA TECH that Human Subjects experiments are monitored for compliance with approved IRB protocols.

Goals • Ensure Human Subject well being • Protect the Institution • Resource for the research community • Facilitate science • Ensure regulatory compliance

What PAM is NOT • NOT The Cops • NOT a replacement for the IRB • NOT required by the OHRP or the FDA • NOT a new regulation

Regulatory Basis • Department of Health & Human Services: 45 CFR 46 (DHHS); Office of Human Research Protections (OHRP) • FDA 21 CFR 50 & 56 • Health Insurance Portability & Accountability Act of 1996 (HIPAA)

DHHS: 46. 103 IRB Functions 1. Review: …The IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year … 2. Review of research: the IRB shall have the authority to observe or have a third party observe the consent process and the research.

3. …The IRB shall have the authority to approve, require modifications in, or disapprove all research activities… 4. The IRB shall investigate concerns involving the use of human subjects in research resulting from public complaints and/or from reports of noncompliance received from laboratory or research facility personnel or employees.

Who will be involved? • Post Approval Monitoring Staff • IRB Staff/Committee • PI’s and Lab/Research Staff

Who will be selected? • Any active protocol • Random selection • At the discretion of the IRB • For-Cause (ORC received a complaint)

Upon Selection… • PI’s will be contacted, and a visit scheduled • A Compliance visit takes approximately 45 minutes (longer if you are not prepared) • Findings are documented in the report • Discuss findings with PI and research staff

Examples of Areas that will be Reviewed • Protocol and Personnel • Study Procedures • Consent Documentation • Record Keeping • Video or voice recordings • Laboratory (if applicable)

After a visit • Final report: to PI, and IRB • Files of reports maintained by PAM • Follow up and support: - Training - Protocol modifications if needed

Questions or Comments