Share

Extended IRB Approval

EXTENDED IRB APPROVAL

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, and effective October 2012, the HRPP has implemented procedures for granting IRB approval for an extended period of up to 3 years.

STUDIES ELIGIBLE FOR EXTENDED IRB APPROVAL

Research...

  • involving no more than minimal risk to participants (Expedited level of review as defined by 45 CFR 46.102),
  • not subject to federal oversight (as clarified below), and
  • not subject to UCI Conflict of Interest Oversight Committee (COIOC) review.

STUDIES NOT ELIGIBLE FOR EXTENDED IRB APPROVAL

  • 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, directly or indirectly, including federal training and program project grants
    • Research directed or overseen by a federal agency that has signed on to the Common Rule, including every agency within Department of Health and Human Services
    • Student projects for which a faculty sponsor uses federal funding to support the project
    • Federal no-cost extensions
    • Studies subject to FDA oversight
    • 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.
  • Research subject to UCI COIOC review
  • Studies involving greater than minimal risk
  • Studies with contractual obligations or restrictions precluding eligibility to this policy (e.g., a non-federal sponsor or funder of the research which requires annual review).
  • Studies involving direct intervention or intervention with prisoners or parolees as subjects
  • Studies funded by the California Institute for Regenerative Medicine (CIRM)
  • Studies invovling single IRB (sIRB) / Reliances

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 report 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.

NOTE: If the research involves federal or CIRM funding, funding cannot be released until continuing IRB approval is granted.

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

suggestions and comments