Responding to the IRB

If the CRC IRB requires further changes or information about your submission, you will receive either an email or a letter with the requested modifications. Before preparing and submitting a response to an IRB review, be sure to touch base with an IRB Analyst if you have any questions.

Please note, investigators have 60 days to respond to an IRB review before the submission is withdrawn from IRB review.

Steps to Responding

Step 1: Prepare a Point-by-Point Response

For each point raised in the IRB notification, provide a response. The best way to respond is to first restate the IRB comment and then, provide your response underneath.

You can provide your point-by-point response within the body of an email, as a separate email, or by using the Request for Modification Response Form. ALL of the points and questions raised by the IRB must be fully addressed.

Step 2: Make Necessary Changes to the Application and/or Study Documents, as Applicable

If you have made changes to your IRB application or any of the study documents, as a result of the IRB requests, be sure to note which changes you have made and to what documents.

For changes to your IRB application:

Be sure to highlight/shade where the changes have been made. You can also note where the change has been made within the body of your point-by-point response.

For changes to your study documents:

Be sure to submit a marked version of the documents. We recommend using track changes. The IRB can usually create a clean version of the document using the marked version you submit.

However, if you are submitting a marked PDF or PowerPoint document, please also submit a clean version of the revised document.

Step 3: Submit the Response to the IRB Analyst

After you have created your point-by-point response and have made the necessary changes to the study documents and/or IRB application, email your completed response to the IRB Analyst.

For student investigators, be sure to cc your faculty advisor on ALL email correspondence sent to the IRB.

Who Reviews Your Response Packet?

The IRB Analyst and/or IRB committee member will review your response.

If your submission was deferred at a full IRB Committee meeting, the response will need to go back to a convened meeting for review by the full IRB Committee.

If you have questions about who will review your response, please do not hesitate to contact the IRB analyst.