Response to a Letter of Action

If your application to the IRB has gone to the convened board and the IRB has requested modifications, justification, or clarification you will need to submit a response to the IRB. The response should include the following:

  • A point-by-point response to the IRB’s comments. Please describe how you addressed each of the IRB’s requirements. If you do not wish to make a certain revision, provide a rationale for not making the change. If you intend to include new modifications to the study when responding to the committee’s requirements, describe the modifications clearly and separately in the response memo. You may also include any general comments about the response in the memo. The memo should be ink-signed by the PI or electronically signed by the PI in IRBNet using the “Sign this Package” feature.
  • If the Committee requires revisions to documents that have previously been reviewed, submit the revised document in a format that identifies the changes made. A WORD document using the “Tracked Changes” feature works well. Use the clean version submitted in the package that was just reviewed and track the new changes required by the Committee. If you wish to request additional modifications, include this information at the end of the response memo, and track the additional changes you are requesting.
  • When submitting revised documents please also include a “clean” (changes accepted) copy of each revised document.

Note: If the Committee did not request a document to be revised, do not re-submit the document with your response unless the document will be used as part of your response to a requested change.

The response should be submitted to the IRB by close of business on of the due date listed on the letter. The response package should include the response memo, marked and clean copies of all revised documents, and a copy of the original letter of action.

Step-by-Step Instructions

UC Davis Demonstration Video: How do I submit a response to a Letter of Action?

  1. Create and save your response memo as well as marked (tracked changes) and clean versions (changes accepted) of revised study documents.
  2. Enter your user name and password at irbnet.org.
  3. Click the project title to open the protocol.
  4. From the left hand menu click “Create New Package.”
  5. To upload documents click “Designer” from the left hand menu. There are two ways to upload documents:
    • Click “Attach New Document.” Locate the document(s) needed and hold the  “Ctrl” button on the keyboard while selecting all document(s). When finished, click “Open,” OR
    • Drag and drop files to the bottom right corner of the screen.
  6. Once documents are uploaded use the IRBNet Document Type and Description Guide to choose the correct IRBNet Document Type from the drop down menu for each document.
  7. To stack new a version of a document on previously reviewed versions, drag and drop the new version of the document onto the version from previous packages.
  8. To edit the Initial Review Application click the pencil icon at the far right. Using the “Jump To” feature, go to the information screen that requires updating and enter the changes. Click “Next” until all information has been completed. Click “Save and Exit.”
  9. Edit other project information, as appropriate.
  10. Collect necessary signatures.
  11. From the left hand menu click “Submit this Package.”
  12. When prompted select review type “Response/Follow-up.”
  13. Complete the steps to submit you response to the IRB.

The IRB will respond to your submission. Click here for a list of possible IRB actions.