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• Confirm that all required materials (e.g., the required documentation and information collected in the NIH electronic IRB system), are submitted in a timely manner.
• Verify the completeness of all submissions to the NIH IRB consistent with the requirements of NIH Policy 205, Requirements for IRB Submissions^{Image Removed}. If your submission is incomplete, it will be returned.
• Specific information regarding your responsibilities when submitting modifications is found in the following questions, based on whether your protocol is exempt or non-exempt human subjects research.

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• The IRB Coordinator will send back 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^{Image Removed} and be added by submitting a modification form.

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• The protocol and consent document must be in clean Microsoft Word format. (However, if you are submitting a tracked pdf that the sponsor has provided for IRB submission, this may be included with tracked changes noted.)
• When submitting documents to the NIH electronic IRB system, each electronic regulatory file must have a consistent format, including naming of folders and files, to ensure required information is maintained and easily accessible.
• For proper nomenclature study teams are required to use when submitting documents to the NIH IRB. Refer to the section of the OHSRP website which outlines required nomenclature for protocols, consent forms and other study documents titled How to Name Documents for Submission to the IRB.^{Image Removed}

What is the process when changes to the protocol require approval by other committee(s) as part of a modification submission?

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• If the proposed change to the research adversely impacts risk/benefit or if the changes are more than a minor change, the modification is sent to full board. This could include research that was previously expedited.
• If the proposed change to the research is a minor change that does not adversely impact risk/ benefit, it may be considered for expedited review.
• If your level of review does not follow the above parameters, please contact the IRBO Analyst.

Levels of Review:

What happens when my modification to my non-exempt research study undergoes Full Board Review?

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