Expiration Dates

Exempt and limited review research have no Expiration Date: Eliminating Continuing Review for Certain Expedited Studies: This new section also includes a new subsection (46.109[f][1][i]) eliminating continuing review for all studies that are approved by expedited review (minimal risk studies), unless the reviewer explicitly justifies why continuing review would enhance protection of research subjects.

All other types of research:

The Approval Date is

    • The date the convened IRB or Expedited Reviewer makes the determination to approve the research.; or

    • The date the IRB confirms that the responsive materials met the requirements of a convened IRB or Principal Reviewer determination to approve the research.

The Approval Interval is the period of approval granted by the convened IRB or Principal Reviewer. (e.g., 1 year, 6 months, 3 months). The approval period expires at 12:00 AM on the expiration date set forth in the IRB approval letter (i.e. the Expiration Date is the first date that the study is no longer approved).

Initial review outcomes:

    • Reviewer Action = Approved: The approval period is one year (unless otherwise indicated) from the Approval date.

    • Reviewer Action = Approved with Contingencies: the approval period starts on the date the reviewer approves the contingencies, and expires no later than one year from the date it was originally approved with contingencies.

    • Reviewer Action = Needs Reply: if the Principal Reviewer’s motion is Needs Reply and the PI’s response is subsequently approved by the Principal Reviewer, the approval period will be one year from the approval date.

Continuing review outcomes:

    • The study Approval Date for continuing reviews is calculated identically as Initial Review as described above (Approved, Approved with Contingencies, Needs Reply).

    • The Expiration Date for continuing reviews is dependent on when the Continuing Review is submitted and when it is approved relative to the prior Expiration Date.