IRB Review—Outcomes and Approval Details

IRB Review—Outcomes and Approval Details

Outcomes of IRB Review

Normally, within 2-3 days after review of an application by the convened IRB, the OIRB sends the investigator a determination letter (and a copy by fax if a fax number was provided) that indicates the outcome. IRB review has five possible outcomes:

  • Approval—The determination letter for approved protocols is mailed to the Principal Investigator, along with the IRB Approval Form signed by the IRB Chair, and approved consent form if applicable. The research may begin.
  • Approval with Limited Modifications—The requirements for approval will be enumerated in the determination letter, as described below. The research may not begin until the requested items have been reviewed and approved by the IRB's designee and formal approval of the protocol has been issued. If the protocol is Approved with Limited Modifications, the determination letter will include specific, numbered, modifications upon which approval is contingent. None of the modifications can be related to the regulatory criteria for approval. To secure approval, the investigator must provide a written response that addresses each numbered item and specifies how each of the required modifications has been made. This response should be sent within 1 month of receiving the determination letter. The IRB reviews the investigator's response through an expedited procedure. If the response and modifications are satisfactory, the OIRB issues the Approval Form. The OIRB will notify investigators if there is any delay in the review process. The IRB will not issue an approval form until the "limited modifications" have been reviewed and approved.
  • Deferred for Response—The IRB cannot approve the protocol as submitted; the research may not begin until the response is reviewed and approved by the convened IRB and formal approval of the protocol has been issued. The letter will request that the investigator respond to specific questions.
  • Deferred—The entire protocol submission (protocol, grant/funding application, sponsors’ protocol, appropriate departmental approvals and informed consent document) was insufficient and will need to be rewritten, resubmitted, and re-reviewed by the convened IRB.
  • Disapproved—The IRB cannot approve the protocol as written.

Approval Period

For protocols reviewed through expedited or convened procedures, the IRB approval period begins on the approval date, regardless of whether additional modifications were required for formal approval. The approval period ends on the expiration date. On the expiration date, IRB approval is no longer valid; therefore, research activities must not take place on the expiration date unless continuing IRB approval is received before that date.

For convened review, the "approval date" is the date on which the IRB met and approved the protocol. For expedited review, the "approval date" is the date on which the designated reviewer approved the protocol.  In either case, the protocol is no longer approved on the "expiration date."

Most protocols are approved for a period of 1 year, but the IRB may specify a shorter period. In all cases, the IRB Approval Form indicates the approval date and the timing of continuing review (e.g., annual, quarterly).

Approval of Informed Consent Documents

If informed consent is to be documented, then the investigator will receive, along with the approval letter, one copy of the consent form for the study that will have been stamped with the IRB approval date and expiration date. The investigator makes copies of the informed consent document that bears the IRB-approval stamp and uses those copies for consenting study participants.

Page updated: May 8, 2013