Institutional Review Board for Health Sciences Research (IRB-HSR)

Managing Protocol After Initial Approval

Modifications to Approved Research

Process for Modifications

Learning Shot: Process for modifying IRB-approved protocols

If the study meets the criteria of Coded, Exempt, or Non-Engaged, IRB approval is NOT required for of the following types of modifications: 

Changes to Coded, Exempt or Not-engaged applications, together with a modification request form, should be submitted to IRBHSR-Mods@virginia.edu. The changes will be reviewed by the IRB to ensure the study continues to meet the criteria for Coded, Exempt or Not-Engaged. You will receive an email documenting the receipt of the change which will include a statement that your project continues to meet Coded, Exempt or Not-Engaged criteria. You should file this email with your project documentation. A pre-review is required for all modifications that require revisions to the protocol/IRB application and/or consent. Pre-review of modifications may take up to 10 business days from the time of submission to the time of return of comments to the study team. Additional time will be needed to submit final versions and obtain IRB approval.

Retiring the IRB protocol:
Information for retiring the IRB protocol does not apply to:

If your study does not fit any of the bullets above and contains both a sponsor’s protocol and an IRB Protocol, the IRB protocol can be retired. When you retire your IRB protocol, your study will contain only one active protocol: the sponsor’s protocol. To retire your IRB protocol, follow the instructions on the Modification Request Form. Once your IRB protocol is retired, you will no longer be required to make revisions to it; however, the study team will still be expected to follow the recruitment plan, consenting process, identification and notification of incidental findings, and Privacy Plan that have been outlined for the study. In addition, the Investigator's Agreement and any sustentative information not contained in the sponsor's protocol remains valid for the duration of the study.

Types of Modifications (see individual sections below for specifics):

Personnel Changes

Once hard copies are received and the approval has been processed   administratively (usually within 2 business days of receipt of the hard copies), the modification will be reviewed by the IRB -HSR Chair, Vice Chair or member designee.  Once approved, the PI will be sent the approval form and any other applicable documents.

5 Year Updates

The investigator is required to re-write the IRB protocol/application and consent in protocol builder and submit to the IRB if the study remains open to enrollment. The study documents will undergo a comprehensive review that will look at the many detailed aspects of the protocol/application and consent form (s), if applicable, and ensure that the core principles of research with human subjects are upheld; essentially the review will be identical to the review of a new study.  As with all new full board and expedited studies , a pre-review will be required.   If the initial review of the protocol/application required the review of the full board, the 5 year review will also require review by the full board.  See instructions below.

The IRB-HSR has taken several steps to assist the investigator in meeting this requirement.

Last Modified: Wednesday, 25-Oct-2017 14:31:36 EDT