Modification Request
A modification request is required if you plan to make any changes to your research or deviate from the protocol after approval or exemption has been granted. Such changes include, but are not limited to:
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Change of principal investigator.
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Addition of personnel.
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Removal of personnel.*
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Increase in planned number of enrolled participants.*
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Changes to the inclusion/exclusion criteria.
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Minor changes to the study instruments (surveys, questionnaires, etc.).*
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Substantive changes to the study instruments.
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Changes to the informed consent documents or procedures.
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Changes to recruitment materials.
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Change of research or agency location.
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Changes in funding sources.
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Change to procedures that do not affect participants.*
* Minor changes to the nature of exempt research (such as those with an *) do not require a modification request.
Cases in Which New Application May Be Needed
If your planned changes include 1) the addition of a new study population (or group of participants) and 2) changes in procedures (including changes to study instruments), they may not qualify for a modification and you may have to submit a new IRB application. If unsure whether your changes qualify as a modification, contact the HRPP office for guidance.
Note that changes may not be implemented before your modification request has been approved by the IRB. If you implement changes before IRB approval, you will be out of compliance.
To request a modification of your current approval, complete and submit a Modification Request form to the HRPP office. Remember to submit your request with ample time for the IRB to approve it before you plan to make the changes.
Note that if your research has been approved as exempt and your modification disqualifies it from its exemption, you must file an initial research protocol with your modification. The modification request and initial research protocol will be reviewed as expedited or by the full committee, as appropriate.