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).
• 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.
• When a research study is reviewed and approved by expedited review, continuing review is not required unless HRP staff documents a reason regarding why it is necessary. Studies that are still subject to continuing review include:
  • Studies approved under the Pre-2018 Rule that are open to enrollment or closed to enrollment but research procedures continue;
  • Studies that are FDA regulated clinical trials,
  • Studies which require review by RDRC or IBC;
  • Coordinating center applications for studies that are greater than minimal risk
  • Studies conducted in an international setting.

The approval period expires at 11:59 p.m. on the expiration 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 on modifications 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. In the event that a study was released from continuing review and a determination is made to change that determination, the expiration date will be one year from the approval of the modification.

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.