Post Approval Monitoring Program

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Post Approval Monitoring Program
by Louisa Gay Post Approval Monitoring Officer
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Discussion Areas

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

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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.

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

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

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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

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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)

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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.

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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.
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Who will be involved?

• Post Approval Monitoring Staff
• IRB Staff/Committee
• PIs and Lab/Research Staff

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Who will be selected?

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

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Upon Selection

• PIs 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

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Examples of Areas that will be Reviewed

• Protocol and Personnel
• Study Procedures
• Consent Documentation
• Record Keeping
• Video or voice recordings
• Laboratory (if applicable)

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After a visit

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

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Questions or Comments