Extended IRB Approval for Studies Under the Pre-2018 Common Rule

UCI's Federalwide Assurance (FWA# 00004071) allows the UCI Human Research Protection Program (HRPP) flexibility in its application of human-subjects federal regulations to non-federally supported research. As such, for studies that were initially approved prior to January 21, 2019 (under the Pre-2018 Common Rule), the HRPP has implemented procedures for granting IRB approval for an extended period of up to 3 years.




  • Research subject to Federal Oversight: Projects receiving federal support; implemented at the direction of federal agencies; or otherwise subject to federal oversight are excluded from this policy. 
  • Examples of Federal oversight include:
    • Federal sponsorship/support, directly or indirectly, including federal training and program project grants
    • Student projects for which a faculty sponsor uses federal funding to support the project
    • Federal no-cost extensions
    • Studies subject to FDA regulations:
      • Invovles a drug
      • Clinical investigation of a medical device
    • Studies employing a Certificate of Confidentiality (issued by the NIH)
    • Studies for which the UCI IRB is serving as the IRB of record for any institution which applies the federal standards to all research regardless of source of funding.
  • Studies involving greater than minimal risk

The UCI IRB reserves the right to make exceptions to this policy, and the conduct of any research project under this procedure will be at the IRB’s discretion (e.g., prior noncompliance).

If the UCI IRB determines a study to be eligible for Extended IRB Approval, this determination will be referenced as part of the UCI IRB approval letter. Studies granted an extended approval period will remain subject to all post-approval submission requirements. The Lead Researcher (LR) will remain responsible for submitting:

  • modifications to the study (must receive IRB approval prior to implementation)
  • reports of adverse events, protocol violation/incidents, and other safety information meeting HRPP reporting criteria;
  • a continuing protocol application, at least 4-6 weeks prior to the study’s expiration date, if the study is still active; and
  • a closeout continuing protocol application when the study is complete.

Within 30 days of any change that may preclude continued eligibility for Extended IRB Approval, the LR is responsible for notifying the IRB via the submission of a modification request (if within six months of the most recent IRB approval) or a continuing protocol application (if beyond six months from the most recent IRB approval), so the study may be reviewed and reset to a one-year (no more than 365 days) approval cycle.

If you have any questions on this process, please contact the HRP staff.

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