When the IRB returns submissions for changes either as Incomplete, Modifications Required, or Deferred, investigators are required to make the necessary revisions and submit the revised materials in eRA. This is called a Response submission.
A submissions is Incomplete when it lacks key documents or information, making it impossible for the IRB to review. Common missing information includes: incorrect or incomplete CITI training, missing protocol documents, and missing consent forms.
If a submission requires minor changes before approval can be issued, a reviewer will give it a Modifications Required determination. These modifications may be determined by an individual reviewer via expedited review or by Board members at a convened IRB meeting.
If substantial modification or clarification is required or if the IRB is unable to review the submission adequately due to insufficient information (e.g., the risks and benefits cannot be assessed with the information provided), a Deferral determination is given. The Response to Deferral submission must be reviewed at a convened IRB meeting.
The required documentation will vary depending upon the provisions provided by the IRB. Although not a mandatory submission, it is useful when investigators create and include a response Word document with the Response submission. This document should address each of the itemized provisions that were outlined in the communication letter.
For step-by-step instructions for creating and submitting a Response submission refer to the eRA Response Submission Guide.