591. IRB Requested Revisions: Investigator Response and IRB Review

Updated July 13, 2021

When the IRB approves a project/package with conditions or defers IRB review, the Principal Investigator (PI) must submit the requested changes/revisions in a timely manner (e.g., within 30 days). Failure to meet the deadline will lead to administrative closure of the project/package and require resubmission and review.

Investigator Responses to IRB-Requested Changes/Revisions

Investigators whose studies require minor or substantive revisions following IRB review have three options for responding to the IRB's requested revisions:

1. completing the revisions as requested;
2. making revisions that render the stipulations irrelevant (e.g., removing the procedure that required the revisions); or
3. justifying (in writing) why the revisions are inappropriate.

Investigators responding to an IRB notification that revisions are necessary to secure IRB approval must create a new package in IRBNet: response/follow-up or revisions package.

Revising Documents Previously Submitted for Review

When requested revisions apply to a document previously submitted for review, the person preparing the response package should:

• locate the application/document (available from the Designer page in IRBNet);
• save it to her/his/their computer with a new date or name;
• incorporate the requested changes into the downloaded, updated application/document; and
• from the Designer page in the newly created response/follow-up or revisions package, replace the existing document with the revised and updated version.

Adding New Documents Requested by the IRB

When the revisions require submission of a new document, the person preparing the response package should add the application or document to the newly created response/follow-up or revisions package.

Applications/documents that are not revised need not be uploaded again.

NOTE: For new projects, investigators may be asked to record project numbers on consent materials. The version date on the consent form would not be updated but the version with the project number should be uploaded to the response package in IRBNet.

IRB Review of Revisions

For revisions that may be approved by expedited procedures (i.e., revisions are minor or directed, or revisions are for research eligible for review by expedited procedures), Research Integrity staff who are IRB members will review the revised or new materials. Research Integrity staff may determine the changes are satisfactory, request refinements to the revised or new documents, or refer the revisions to the primary reviewer or IRB Chair for verification the changes are satisfactory. If additional revisions or information are required before the IRB can to confirm the revisions are satisfactory, Research Integrity staff will notify the PI and the designated contact person about the revisions/information that remain to be completed to secure IRB approval.

For revisions that require Full Committee Review, the revisions package will be placed on the agenda for review at the next IRB meeting. If the convened IRB requests substantive clarifications or modifications that are directly relevant to the regulatory criteria, the project must be returned to a convened meeting of the IRB for regulatory review. These substantive clarifications or modifications cannot be reviewed and determined by expedite review. Standard procedures are followed for assigning and notifying the reviewer and for full committee review of a new project. The IRB's response to the revisions depends on the outcome of the review.

Upon verification that the requested revisions have been satisfactorily addressed, the standard procedure is followed for notifying the investigator and contact person of IRB approval.