Submission and Review

The IRB application is approved and the research can begin. Researchers must follow the research procedures described in the approved application.

If you would like to amend the research personnel, procedures, or materials, an amendment application must be submitted.

If there is an adverse or unexpected event, an adverse event report must be submitted.

To continue past the expiration of the approval (two years for expedited projects, and one year for convened review projects), a continuing review application must be submitted.

Once the project is completed a closure application should be submitted.

If the IRB determines that risks to participants are minimized but minor changes or clarifications are required in order for the research to satisfy the IRB’s criteria for approval, then the project will be conditionally approved.

You will receive an email with the list of conditions, which can also be found as comments in the application. See the CAP guide for help on responding to questions.

To resubmit, the PI (or proxy or faculty sponsor) must respond to all comments, but it is important that the relevant information is also included in the body of the application. Comments are not saved with the final application, and the application will be returned again if the updated information is not incorporated into the application. Once all comments have been addressed, the protocol is submitted to ORS using the same steps as an initial submission.

The responses to a conditional approval are reviewed through the expedited process. This means that typically a convened review project will not have to wait for the next meeting to have the responses reviewed, but, depending on the response from the PI, the reviewer could ask for the full board to review the responses as well.

If all conditions are satisfactorily met, the reviewer will approve the application.

If the IRB determines that it does not have sufficient information to determine if the project satisfies the IRB’s criteria for approval or that significant changes would be required to satisfy the IRB's criteria for approval, then the IRB may defer a protocol.

For convened reviews, this means that the application will need to be reviewed by the convened board again. Check the IRB schedule to make sure revisions are returned in time to be reviewed at the meeting of your choice.

The reviewer concerns will be listed in the deferral email, and can also be found as comments in the application. See the CAP guide for help on responding to questions.

To resubmit, the PI (or proxy or faculty sponsor) must respond to all comments, but it is important that the relevant information is also included in the body of the application. Comments are not saved with the final application, and the application will be returned again if the updated information is not incorporated into the application. Once all comments have been addressed, the protocol is submitted to ORS using the same steps as an initial submission.

In rare cases, the IRB may determine that a project does not meet the criteria for approval and there are serious concerns related to one or more criteria. In this case, the IRB may disapprove a project.

Disapproval requires the convened board, and cannot be done through the expedited process. In the case of disapproval, the PI would receive an email detailing the IRB's reasons for disapproval.