595. Determining Dates for Full Committee and Expedited Reviews

Updated July 19, 2021

The IRB approves new projects, continuing reviews, and project amendments only after determining the research complies with the DHHS criteria for IRB approval at 45 CFR 46.111 and when applicable, the additional requirements of Subparts B, C, and D; and of other federal agencies; or would comply with these requirements if specific, minor conditions requested by the IRB are met.

The IRB documents all approval dates in IRBNet as outlined below. The date of approval is calculated, consistent with applicable law, regulations, and guidance.

Package-level Dates

The Effective Date applies at the package level and is documented for each package.

Project-level Dates

The Initial Approval Date applies to new projects only. The Initial Approval Date depends on review type (i.e., Expedited versus Full Board) and the IRB Action at the first and subsequent reviews.

The Project Expiration Date designates the due date for completion of the next IRB review. The Project Expiration Date is calculated by adding the specified approval period to the Initial Approval Date. The expiration date is updated following each continuing review. It is the last day the project is approved.

The Effective and Project Expiration Dates appear in IRB approval letters and minutes.

Regardless of review type, IRB Actions other than Approved require at least two packages in IRBNet. The following sections for new projects refer to the new project package as Package-1 and the second package submitted and reviewed as Package-2, containing the investigator's response to the revisions requested by the IRB (i.e., response/follow-up package).

Dates for New Projects: Full Committee Review

Dates for Convened IRB Action: Approved

For new projects approved at the first review by the convened IRB, dates are determined and documented as follows.

• The Effective Date for Package-1 is the date the convened IRB approved the new project
• The Initial Approval Date is documented in Package-1 and is the date the convened IRB approved the project (the same date as the Effective Date).
• The Project Expiration Date is documented in Package-1.
• For reporting purposes, the Package-1 Effective Date is considered both the review and the approval dates.

Dates for Convened IRB Action: Approved with Conditions

New projects approved with conditions at the first review by the convened IRB will have at least two packages, a new project and response/follow-up package, with dates documented as follows.

Dates for New Project (Package-1): Approved with Conditions

• The Effective Date for Package-1 is the date the convened IRB determined the research would be approvable and defined the required specific/minor conditions.
• Initial Approval and Expiration Dates remain blank in Package-1.
• For reporting purposes, the Package-1 Effective Date is the first review date.

Dates for Response/Follow-Up (Package-2): Approved

• The Effective Date for Package-2 is the date a designated IRB member confirmed the conditions for approval were satisfactorily met and is both the effective date of the initial approval and the date the IRB determined the research may commence.
• The Initial Approval Date is documented in Package-2 and is the date the convened IRB determined the research would be approvable and defined the required specific/minor conditions (the same date as the Package 1 Effective Date ).
• The Project Expiration Date is calculated from the Initial Approval Date and is documented in Package-2.

NOTE: The Package-2 Effective Date auto-generates in IRB approval letters and as a notification in IRB minutes as the Effective Date for the Expedited Review of the Response/Follow-Up package (or other subsequent packages). No expedited review category is noted.

Dates for Convened IRB Action: Deferred

New projects deferred at the first review by the convened IRB will have at least two packages, new project and revisions package. The outcome of the Package-2 review dictates the Package-2 Effective and Initial Approval Dates and whether a third package is needed (e.g., the revisions package is approved with conditions). Dates are determined and documented for Package-1, Package-2, and Package-3 (if necessary) as follows.

Dates for New Project (Package-1): Deferred

• The Effective Date for Package-1 is the date the convened IRB deferred approval.
• Initial Approval and Expiration Dates remain blank in Package-1.
• For reporting purposes, the Package-1 Effective Date is the first review date.

Dates for Revisions in Response to Deferral (Package-2): Approved

• The Effective Date for Package-2 is the date the convened IRB approved the revisions package.
• The Initial Approval Date is documented in Package-2 and is the date the convened IRB approved the project (the same date as the Package-2 Effective Date).
• The Project Expiration Date is calculated from the Initial Approval Date and is documented in Package-2

NOTE: The Package-2 Effective Date (i.e., effective date for initial approval) auto-generates in IRB approval letters and as a notification in IRB minutes as the Effective Date for the revisions package.

Dates for Revisions in Response to Deferral (Package-2): Approved with Conditions

• The Effective Date for Package-2 is the date the convened IRB determined the research would be approvable and defined the required specific/minor conditions.
• The Initial Approval and Expiration Dates remain blank in Package-2.

Dates for Response/Follow-up (Package-3): Approved

A third package is required if the revisions package (i.e., Package-2) is approved with conditions. Dates for Package-3 follow Dates for Response/Follow-Up (Package-2): Approved above.

Dates for Convened IRB Action: Disapproved

• The Effective Date for Package-1 is the date the convened IRB disapproved the project. Package-1 becomes the terminal package for the study.
• Initial Approval and Expiration Dates remain blank in Package-1.
• For reporting purposes, the Package-1 Effective Date is the review date.

Dates for New Projects: Expedited Review

Dates for Expedited Review Action: Approved

• The Effective Date for Package-1 is the date the expedited reviewer approved the new project.
• The Initial Approval Date is documented in Package-1 and is the date the expedited reviewer approved the project (the same date as the Effective Date).
• The Project Expiration Date is documented in Package-1.
• For reporting purposes, the Package-1 Effective Date is the review and the approval date.

Dates for Expedited Review Action: Approved with Conditions or Deferred

New projects approved with conditions (or deferred) at the first expedited review will have at least two packages, a new project and response/follow-up package, with dates documented as follows.

Dates for New Project (Package-1): Approved with Conditions/Deferred

• The Effective Date for Package-1 is the date the expedited reviewer determined the research would be approvable and defined the specific/minor conditions required to finalize IRB approval, or deferred IRB approval pending receipt and review of the researcher's response to requested substantive revisions.
• Initial Approval and Expiration Dates remain blank in Package-1.
• For reporting purposes, the Package-1 Effective Date is the first review date.

Dates for Response/Follow-Up (Package-2): Approved

• The Effective Date for Package-2 is the date a designated IRB member confirmed the conditions for approval were satisfactorily met or the requested revisions rendered the research approvable and is both the effective date of the initial approval and the date the IRB determined the research may commence.
• The Initial Approval Date is documented in Package-2 and is the same date as the Package -2 Effective Date (i.e., the date a designated IRB member determined the conditions for approval were satisfactorily met).
• The Project Expiration Date is documented in Package-2.

NOTE: The Package-2 Effective Date auto-generates in IRB approval letters and as a notification in IRB minutes as the Effective Date for the Expedited Review of the Response/Follow-Up package (or other subsequent packages).

Dates for Expedited Review Action: Disapproved

Projects cannot be disapproved by Expedited Review. If the expedited reviewer determines disapproval may be warranted, the project is referred for review by the convened IRB. The dates are determined and documented after the subsequent IRB review and action.

Dates for Continuing Reviews

The Effective Date for continuing review packages is the date the convened IRB or expedited reviewer reviews and approves the continuing review package. If the review is approved with conditions, the response/follow-up package will result in a new Effective Date.

The University IRB maintains fixed annual renewal dates by basing Project Expiration Dates on the Initial Approval Date. Exceptions to fixed annual renewal dates occur when the continuing review is completed more than 30 days before the expiration date, or the continuing review is not approved by the expiration date.

Fixed Annual Renewal Dates

For continuing reviews completed less than 30 days before the expiration date: The new Project Expiration Date is calculated by adding the specified approval period to the existing Project Expiration Date, thereby maintaining a fixed annual renewal date.

Dates for Early Reviews

For continuing reviews completed more than 30 days before the expiration date: The new Project Expiration Date is calculated by adding the specified approval period to the Effective Date of the early continuing review.

Dates Following Lapse of IRB Approval

When continuing reviews are not approved by the expiration date, IRB approval expires.

When IRB approval expires, the IRB informs the researchers in writing that all research activities must cease (including enrollment of new participants) until the research is approved by Full Committee or Expedited Review, as applicable. If due to an over-riding safety concern or ethical issue it is in the best interests of individual participants for interactions or interventions to continue, the IRB may allow conditional continuation. The PI must submit a report explaining why the research should be continued to avoid harm to current participants that would result from stopping study procedures and a plan for continuation pending re-approval.

• The Effective Date for continuing review following lapse of IRB approval is the date the convened IRB or expedited reviewer reviews and re-approves the research.
• A new Project Expiration Date is calculated by adding the specified approval period to the continuing review package Effective Date.

Dates Following Suspension of IRB Approval or Research Activities

When IRB approval is suspended or the sponsor suspends research activities, the IRB informs the researchers in writing that the research activities must temporarily cease until the research is re-approved by the IRB. Re-approval generally requires Full Committee Review of amendments to minimize risks that prompted the suspension.

• The Effective Date following suspension of IRB approval or research activities, is the date the convened IRB reviews and re-approves the research (or subsequent amendment).
• A new Project Expiration Date is calculated by adding the specified approval period to the new Effective Date.
• The Initial Approval Date remains unchanged but is no longer used to calculate the Expiration Date in subsequent continuing reviews.

Dates for Amendments

Reviews of amendment packages do not affect Initial Approval or Project Expiration Dates.

Amendment Package: Approved

For amendment packages approved as submitted, the Effective Date is the date the convened IRB or expedited reviewer approved the amendment package.

Amendment Package: Approved with Conditions

Amendment packages approved with conditions whether by Expedited or Full Committee Review will take at least two packages, amendment and response/follow-up, with dates documented as follows.

Dates for Amendment Package: Approved with Conditions

• The Effective Date for an amendment package approved with conditions is the date the convened IRB or expedited reviewer determined the amendments would be approvable and defined the required specific/minor conditions.
• For reporting purposes, the Package-1 Effective Date is the amendment package review date.

Dates for Amendment Response/Follow-Up Package: Approved

• The Effective Date for the amendment response/follow-up package is the date a designated IRB member confirmed the conditions for approval were satisfactorily met.
• For reporting purposes, the amendment response/follow-up package Effective Date is the amendment package approval date.

Amendment Package: Deferred by Convened IRB

For amendment packages deferred by the convened IRB, approval is not finalized until the convened IRB approves the revisions package.

Dates for Amendment Package: Deferred by Convened IRB

• The Effective Date is the date the convened IRB deferred approval of the amendment package.
• For reporting purposes, the Package-1 Effective Date is the amendment package review date.

Dates for Amendment Revisions in Response to Deferral (Revisions Package): Approved by Convened IRB

• The Effective Date for the amendment revisions package is the date the convened IRB approved the amendment revisions package.
• For reporting purposes, the Effective Date for the amendment revisions package is the amendment package approval date.