Skip to main content

Post-submission Process for Modifications

workflow graphic

PI submits the Modification in eIRB+

The IRB Review Process Begins:

Pre-Review:
The Modification submission is pre-reviewed by an IRB coordinator. The coordinator ensures that the submission is complete and meets the IRB’s requirements.  The investigator may be asked to make changes to the submission and/or study documents.

Once the pre-review is complete, the submission is routed to either a single reviewer for submissions that qualify for Expedited Review or to a convened panel for submissions requiring Full Board Review.

IRB Review:

The Modification will receive the one of the following determinations by the IRB:

  • Approved: The Modification is fully approved by the IRB.  No further action is required.
  • Modifications Required to Secure Approval: The Modification is approved on the condition that the PI meet specific conditions.  These conditions are specified in the determination letter issued by the IRB.

The PI’s response is reviewed by the IRB to ensure that the conditions for approval have been met.  When the conditions are met, an approval letter is issued with the effective date of the approval.  None of the modifications requested by the PI in the submission may begin until full approval is secured.

  • Deferred:  The Modification submission lacks sufficient information for approval.  For example, the IRB may require additional information regarding the risks and benefits, privacy and confidentiality protections, and/or the informed consent process.

The determination letter will specify the basis for the deferral and the information required.  The PI’s response is assigned to the same IRB panel that issued the Deferral. When the panel determines the conditions are met, an approval letter is issued.  None of the modifications requested by the PI in the submission may begin until full approval is secured.

  • Disapprove:  The Modification submission does not meet the federally mandated criteria for approval.

The determination letter will specify the basis for disapproval.  The PI may respond to the IRB and the response will be reviewed at a convened IRB meeting.  After the subsequent deliberation, a new determination is made by the IRB.  None of the modifications requested by the PI in the submission may begin unless full approval is secured.