About the IRB and Authority of the IRB​

  • The IRB is an autonomous administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities.  ​
  • The authority of the IRB is defined in The Code of Federal Regulations (45 CFR 46), and additional regulations imposed by the Food and Drug Administration (FDA). The IRB has the authority to review, approve, disapprove and require modifications to research.  ​
  • PNWU holds a Federal Wide Assurance (FWA00014453) with the Department of Health and Human Services (HHS), which describes the principles and guidelines under which the PNWU IRB must review and approve the conduct of research involving human subjects under the oversight of the Institutional Official. The PNWU IRB applies the ethical principles embodied in the Common Rule (45 CFR 46) and the Belmont Report with regard to the protection of human research subjects. Renewal of the FWA is required every 5 years. Any updates made to the FWA begins a new 5-year effective period. ​