Calculation of Approval and Expiration Dates

Calculation of Initial Approval Date

The IRB calculates the date of initial IRB approval in the following manner:

  • When a research study is approved at a convened meeting, the date of the convened meeting is the date of IRB approval.
  • When the research study is approved subject to modifications at a convened meeting, the date of IRB approval is the date that the requested changes are verified by the Chair, Vice Chair, or his/her designee.
  • When a research study is reviewed and approved through an expedited review process, the date that approval is extended by the Chair, Vice Chair, or his/her designee is the date of IRB approval.

Calculation of Expiration Date

Initial Approval

The IRB calculates the date of expiration in the following manner:

  • When a research study is fully approved at a convened meeting, the date of expiration is based on the date of the convened meeting (minus one day). For example, if the committee meeting date is 10/17/10, then the date of IRB expiration is 10/16/11 for an annual approval or 4/16/11 for a six month approval.
  • When a research study is approved subject to modifications, the date of expiration is one year from the date of the convened meeting (minus one day). It is not calculated from the date that the Chair, Vice Chair, or his/her designee verifies the requested changes and grants final approval. For example, if the committee approves a research study subject to modifications on 10/17/10 and the response is verified by the Chair, Vice Chair, or his/her designee on 10/20/10, then the date of IRB approval is 10/20/10 and the expiration is 10/16/11 for an annual approval or 4/16/11 for a six month approval.
  • When a research study is reviewed and approved by expedited review, the date of expiration is based on the date that the Chair, Vice Chair, or his/her designee verifies any requested changes and grants final approval (minus one day).

The approval period expires at 11:59 p.m. on the date set forth in the IRB approval letter.

Modification Dates

The IRB calculates the date of modification approval in the following manner:

  • When a modification is approved through an expedited review mechanism, the modification approval date is the date that the Chair, Vice Chair or his/her designee reviews and approves the modification.
  • When a modification is reviewed at a full board meeting and is approved at the meeting, the modification approval date is the date of the IRB meeting.
  • When a modification is reviewed at a full board meeting and is approved subject to modifications, the modification approval date is the date that the response is verified by the Chair, Vice Chair, or his/her designee.

Expiration dates are maintained as the date assigned upon initial or continuing review unless the IRB determines that there has been a significant change to the risk/benefit ratio which would require a more frequent continuing review. If this change occurs, the IRB will notify the principal investigator of the study of the new expiration date. The new date must never exceed the original expiration date.

Maintenance of Anniversary Date (Expedited Submissions Only)

OHRP recognizes the logistical advantages of keeping the IRB approval period constant from year to year throughout the life of each project. When continuing review occurs annually and the IRB performs continuing review within 30 days before the IRB approval period expires, the IRB may retain the anniversary date as the date by which the continuing review must occur.

Extended Approval Periods (approved 8.15.2014)

Certain types of non-exempt research may be granted a three year approval. In order to be eligible for the extended approval period, the research must present no more than minimal risk to human subjects as determined by the convened IRB or through an expedited review mechanism, and must not include any of the following:

  • Federal funding, including federal training and program project grants and federal no-cost extensions
  • Subawards issued to University of Pittsburgh where the prime award is federal
  • FDA regulated
  • Prisoners as subjects

Expiration dates are maintained as the date assigned upon initial or continuing review (not at the time of a modification). If during the course of the three year approval period, changes occur that affect the eligibility of the study to continue with an extended approval, the study will immediately become subject to annual review.

The IRB reserves the right to make exceptions to this policy, and inclusion/exclusion of any research project under this procedure will be at the IRB’s discretion.

During the extended approval period, principal investigators retain responsibility for all regulatory requirements including submission of modifications, reportable events, suspension and/or terminations.

Members of the Regulatory Affairs Division will periodically monitor a random sample of studies to confirm continued eligibility for the three year approval period. Studies found to not meet the criteria will be subject to annual review.