Note – this policy is approved under the UM IP3R Program
8.4(a) General Principles for Multi-Year Approval
At initial submission (‘new studies’) or at the time of continuing review (‘on-going studies), eligible studies may receive a three year approval (including the year of initial or continuing approval). If the study is undergoing expedited review, the reviewer (the IRB Chair or designee) may recommend such multiyear approval to the convened IRB for its approval. If the study is not undergoing expedited review but instead is being reviewed by the convened IRB, that panel may grant the three-year approval at its discretion.
To be eligible for the three year approval, the study must fit the criteria of the IP3R Program (c.f. Section 2.5 of these Policies). Some (but not all) of these criteria include that the study or associated training:
is not federally funded and/or subject to federal, state or local regulations that require continuing review at least annually
does not involve drugs, devices or biologics for which an IND/IDE is required and/or is not subject to FDA regulations requiring continuing review at least annually
poses no more than minimal risk as determined by the IRB and is approved for no less than one year via the standard IRB approval process
8.4(b) Process for Granting Multi-Year Approval
The process for granting multi-year approval shall occur as follows:
the expediting reviewers, or the convened IRB, shall notify the HSRO of the standard (i.e. up to one year) approval of the new or continuing study and the HSRO shall notify the principal investigator of this approval. This notification to the principal investigator shall occur so that the study may proceed in a timely manner without waiting for any subsequent deliberations as to whether the study shall receive multi-year approval
if an expediting reviewer (or a reviewing member of the convened IRB) believes that the study should be given three-year approval, he/she may so recommend to the convened IRB
by majority vote, the convened IRB may grant three-year approval to eligible studies upon recommendation of the expediting reviewer or a reviewing IRB member.
If three-year approval is granted by the IRB, the IRB shall notify the HSRO and the HSRO shall notify the principal investigator that the requirement for continuing review is waived for the approved duration. The HSRO shall also notify the principal investigator of the conditional properties of this three-year approval (see below).
8.4(c) Conditions for Continuance of Multiyear Study Approval
During a three-year approval period, the study must remain unchanged from that reviewed and approved by the IRB with the exception of amendments approved in accordance with Section 11 of these IRB policies. For any amendment proposed during a three-year approval period, however, the convened IRB (or the Chair or designee in the case of expedited review) shall determine whether the amendment makes changes that are compatible or incompatible with three-year approval of the study and whether such three-year approval should therefore be continued.
If an amendment is determined to be compatible with the three-year approval status of the study, that status may continue. If an amendment is determined by the IRB (or expediting reviewer) to be incompatible with the three-year approval status of the study, the study status shall revert to requiring continuing review at least annually. If this occurs, the IRB (or the expediting reviewer) shall determine the date of expiration of its approval which shall be no later than one year after the approval date of the amendment.
As for all studies, the Principal Investigator of any study that receives three-year approval is responsible for reporting to the HSRO any deviation from the approved protocol, any serious study-related adverse events or unanticipated problem involving risk to subjects or others that might occur. The IRB has the authority to revert the study status to require continuing review at least annually. In the event of a serious study-related adverse event, the study status shall revert to requiring continuing review at least annually. If the study status does revert to require annual review, the IRB shall determine the date of expiration of its approval which shall be no later than one year from the date of the serious adverse event or the date that the IRB changes the study status.
8.4(d) Principal Investigator Affirmation
At least annually, the principal investigator must affirm to the HSRO via ePROST that:
the study protocol is unchanged from that granted multi-year approval by the IRB
the risk to subjects is unchanged
no study-related, serious adverse events occurred
As for other studies requiring continuing review, notices shall be forwarded to the Principal Investigator from the HSRO warning that this Principal Investigator Affirmation is due. If the affirmation is not received prior to or on the day at which IRB approval would have expired had the study not been given three-year approval, the study shall be suspended for expiration of IRB approval.
8.4(e) Continuing Review
Studies granted three-year approval must receive continuing review at least once during every three years. As for other studies requiring continuing review, notices shall be forwarded to the Principal Investigator from the HSRO 90-, 60-, and 30-days prior to the day at which the three-year IRB approval will expire warning that a continuing report is due. The continuing report may be approved (if appropriate) by an expedited reviewer. This approval shall be for up to one year so that the study may proceed in a timely manner without waiting for any subsequent deliberations as to whether the study shall retain multi-year approval. The convened IRB may again permit 3-year approval upon recommendation of the expediting reviewer per IP3R policy. If the continuing report is not undergoing expedited review but instead is being reviewed by the convened IRB, that panel may grant the three-year approval at its discretion.