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• Once a study has received initial IRB approval, any new change /modification to the study or consent form is considered a modification, and the proposed modification must be submitted to the IRB for review.
• The NIH IRB must approve the modification before any change can be initiated or before updated materials can be used except when necessary to eliminate apparent immediate hazards to a subject.
• You are responsible for ensuring timely submission to the IRB of all modifications.

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The process for adding non-NIH participating sites (pSites) in the electronic IRB system is described in the manuals available on the IRBO websiteIRBO webpage with eIRB Training and User Guides.  When the NIH IRB is the Reviewing IRB, and you are adding a participating site, whether to initiate multi-site research or to expand an existing multi-site protocol, make certain the modification includes the following documentation:

• Submit Basic Site Information using the eIRB submission form.

• Upload supporting documents in the eIRB system including the following:

      1. pSite Protocol Addendum (using the IRBO template);

      2. pSite Consents/ Assents (if applicable);

      3. pSite Recruitment materials (if applicable) which is is documentation confirming that the pSite’s institutional requirements have been met and that local context information provided has been approved by the relying institution; this can be documented via a letter, email, memo,  etc.;

     4. pSite HRPP Clearance (via letter or email)

• Any other documents or information that the IRBO requests.

If required Human Research Protection Program (HRPP) training is not up to date/current or if I am adding a new AI, will the modification undergo IRB review?

• The IRB Coordinator will send back return modifications if the PI or any investigator is delinquent with their required HRPP training.
• If any investigators are added to the study after IRB approval, they need to complete the required training as indicated in Policy 301, Education Program and be added by submitting a modification form.

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1. Analyst Pre-Review: The IRBO Analyst conducts a pre-review of all documents submitted via the NIH electronic IRB system and verifies the submission meets minimum standard to be considered complete for pre-review. The analyst verifies all sections in the modification form are properly completed. All necessary updates to the consent, recruitment documents and questionnaires/data collection instruments should be attached as applicable. Revised documents should be named properly. Ensure there is consistency with all documents submitted.
2. Potential withdrawal: For any missing or incomplete documents, the submission is considered "incomplete" and will be returned to the study team to address the Pre-review request for clarification. It is the responsibility of the study team to respond to requests for clarifications clarification or corrections from the IRBO. At its discretion, the IRBO may administratively withdraw submissions from IRB consideration when the PI is non-responsive to requests from the IRB or from IRBO staff for 30 calendar days. The investigator will be notified by the IRBO if the submission is administratively withdrawn.
3. Addressing Pre-review Requests for Clarifications: Before your submission is reviewed by the IRB, the Analyst may ask you to make some changes that will be sent as a Request for Clarification.
   • When you are responding to these request:
     1. Respond to study information questions directly in the NIH electronic IRB system.
     2. Provide written responses, when appropriate.
     3. If a tracked document is provided by the IRBO Analyst…use it!
     4. Review the changes, accept the changes, and upload a clean version of the document into the application.
     5. If you don't want to accept changes…provide a justification.
     6. Make sure you address/respond to ALL requests for clarifications/changes.
     7. Return to the IRB in a timely manner.
4. Analyst Pre-Review of Request for Clarification/Study Team Responses - Responses which you submitted submit are reviewed by the IRB Analyst. Once the analyst confirms that required corrections have been made/addressed and all supporting documents are available, the submission is assigned a review level (Expedited or Full Board) review.
5. IRB Review - When conducting its review, the convened NIH IRB, or expedited reviewer must review the submission materials in order to determine that all regulatory and policy requirements for approval of research are met, or whether more information is needed to make a determination.

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• At Full Board Review the Board votes as per below:
  • Approved
  • Modifications required to secure approval
  • Deferred
  • Disapproved
  IRB Approval - If the modification is approved, the NIH IRBO will issue the NIH IRBApproval letter addressed to the PI. The letter is sent via the NIH electronic IRB system. The outcome letter indicates the approval date, review level of the modification (Full Board vs Expedited Review). Any action item(s) such as required re-consent of subjects, will be stated in the modification approval letter.

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