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Submission and Review

Once your application is completed you will submit it for review. This section will discuss the process of IRB submission, the possible review outcomes and how to respond. For specific information on how to use CAP, see the user guides linked in CAP.

Submitting your Application

Once you've completed the application and are ready to submit you will click the "Submit to ORS" button at the bottom of the page. If you have a faculty sponsor, only they will be able to submit to ORS. Students will instead click "Submit to Faculty Sponsor." If the project has a proxy, remember that, while a proxy can edit the application, the PI will be the only person who can click to submit.

The Review Process

Once the application is submitted to ORS it will be pre-reviewed by ORS staff. Pre-review is to ensure that all parts of the application are completed before the IRB reviews. If there are clarifications needed, the application will be returned to you and you will receive an email saying that additional action is required before the application can be reviewed by the IRB. 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.

When the pre-review process is completed, the application will take different paths depending on the level of review.

Exemptions will be checked by an IRB member to see if the project described meets the exemption criteria. If it does, you will receive an email confirming that the project has been confirmed exempt. You will be able to download an official letter from CAP with the exemption determination.

If the reviewer would like clarification they can send the application back as deferred with comments. You will need to respond to the comments exactly as described above in the pre-review process.

If the project does not meet the exempt criteria, the reviewer will note this in their comments and the review will continue through the expedited or convened review process.

Expedited Reviews are conducted by two members of the board, while convened reviews are conducted by the full board at the convened meeting which is held once a month. The potential outcomes of expedited and convened reviews are as follows:

Approval

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.

Conditional Approval

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.

Deferral

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.

Disapproval

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.

What if I don't agree with the Board's decision?

If the Board asks for a change that you do not agree with, you can use the comments to explain why. Additionally, investigators are welcome to contact the to discuss the feedback they’ve received.

Once your application is completed you will submit it for review. This section will discuss the process of IRB submission, the possible review outcomes and how to respond. For specific information on how to use CAP, see the user guides linked in CAP.

Submitting your Application

Once you've completed the application and are ready to submit you will click the "Submit to ORS" button at the bottom of the page. If you have a faculty sponsor, only they will be able to submit to ORS. Students will instead click "Submit to Faculty Sponsor." If the project has a proxy, remember that, while a proxy can edit the application, the PI will be the only person who can click to submit.

The Review Process

Once the application is submitted to ORS it will be pre-reviewed by ORS staff. Pre-review is to ensure that all parts of the application are completed before the IRB reviews. If there are clarifications needed, the application will be returned to you and you will receive an email saying that additional action is required before the application can be reviewed by the IRB. 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.

When the pre-review process is completed, the application will take different paths depending on the level of review.

Exemptions will be checked by an IRB member to see if the project described meets the exemption criteria. If it does, you will receive an email confirming that the project has been confirmed exempt. You will be able to download an official letter from CAP with the exemption determination.

If the reviewer would like clarification they can send the application back as deferred with comments. You will need to respond to the comments exactly as described above in the pre-review process.

If the project does not meet the exempt criteria, the reviewer will note this in their comments and the review will continue through the expedited or convened review process.

Expedited Reviews are conducted by two members of the board, while convened reviews are conducted by the full board at the convened meeting which is held once a month. The potential outcomes of expedited and convened reviews are as follows:

What if I don't agree with the Board's decision?

If the Board asks for a change that you do not agree with, you can use the comments to explain why. Additionally, investigators are welcome to contact the to discuss the feedback they’ve received.