Modifying (Amending) an Existing Protocol

Changes to previously approved research will generally require additional review by RCS or the IRB. If a change requires either a modification (also known as ‘amendment’) to the current study or the submission of a new study, approval for the proposed changes must be secured prior to implementation.

If you must make a change to an approved study to eliminate immediate potential hazards to participants, you may do so without prior approval. If you make changes to eliminate immediate potential hazards, contact RCS as soon as possible for further instructions.

To determine what types of changes require submission prior to initiation, see the Guidance on Amending Previously Approved Research with specific guidance on amendment exempt, expedited, or full board research.

If a modification/amendment submission is necessary, a modification submission is prepared based on review type:

• Exempt– For studies previously determined to qualify for exemption, investigators will need to first self-assess to determine if the study appears to continue to qualify for exemption.
  • If the study continues to qualify for exemption, a modification/amendment is prepared using the same Exempt Review Application and relevant Category Worksheet(s). Provide responses in the application based on the proposed changes to the research. RCS will review the study to determine that the study continues to qualify for exemption; a determination letter will be issued.
  • If the study no longer appears to qualify for exemption, an Initial Review Application and applicable protocol materials will need to be prepared and submitted to RCS for IRB review.

  The Exempt Review and Amendment Review Applications include a submission checklist on the back page to guide researchers in identifying additional materials required for submission. See below for instructions on how to prepare a submission.

  Note: Personnel only modifications (regardless of review type - exempt, expedited, full board) do not need an application.

  If you have questions, please contact Research Compliance Services.

  Submitting Application Materials

  All study materials are submitted to Research Compliance Services (RCS) who will facilitate the review process. All application materials are submitted using the RAP system. The materials and instructions for submitting a modification/amendment depend on the type of study you are modifying:

  • Legacy studies are those studies established prior to the implementation of the IRB module of the Research Administration Portal (RAP). All legacy studies were migrated to the RAP portal on May 12, 2021. For more information about migrated studies please see our Transitioning Studies page.
  • RAP studies are those studies established and managed using the IRB module of the Research Administration Portal (RAP).
    • If your study was approved through the RAP, you will submit your modification request through the IRB module using RAP versions of the application forms.

    Legacy and RAP versions of the application and forms are available on the Applications, Forms, and Guidance page.

    To submit a study modification,

    • click below to access the RAP
    • select “IRB Module” from the navigation bar
    • select the “Active” tab
    • select the study you wish to modify
    • select “Create Modification/CR”
    • select "Modification/Update"
    • select the modification scope (select all that apply)
      • Study team member information - this selection will only allow you to update the information in the Local Study Team Members section. It will not allow you to update the PI, your study documents or any other sections.
      • Other parts of the study - this selection will allow you to change your study documents (e.g., research plan, recruitment, consent form), the PI, and other sections of the RAP application aside from the Local Study Team Members section.
        • System Limitations:
          1. The modification scope cannot be changed once you make a selection and click continue. If you make a mistake when selecting the scope, please discard your modification and create another.
          2. Only one modification of each type can be created at one time. For example, if you have a study team member modification open, that modification will need to be approved or discarded before you can create another modification to update personnel. However, you will still be able to create a separate modification to change other parts of the study and you will still be able to create and submit a continuing review (CR) or reportable new information (RNI).

        Legacy Submissions and the RAP - Making your Study Complete/Whole

        Legacy studies are those that were not created in the IRB module of the research administration portal (RAP). If your study identification is all numbers with no letters, it is a legacy study (e.g., 01012015.099). If your study identification starts with "STUDY", it is a RAP study (e.g., STUDY99000999 ).

        Because not all information for legacy studies was able to be migrated to the RAP, the first submission using the RAP for a legacy study will take some extra time and consideration. To make the study complete/whole in the RAP, information must be updated and all currently approved study materials uploaded. The only way to add/change information to the parent study in the RAP make the legacy study complete/whole is through a modification. When submitting a continuing review, you must submit a modification simultaneously if your legacy study has not been completed in the RAP (i.e., if you have not previously updated the legacy study information and uploaded legacy study materials via a RAP modification).

        For additional information/guidance on migrated studies and the RAP:

        • Transitioning studies to the RAP
        • Guidance on how to make your study complete/whole for additional instructions.

        Use the following resources for support:

        • RAP Investigator Manual for instructions on submitting new studies through the IRB Module of the RAP.
        • We have created many step-by-step RAP guidance documents to support you! Find these available in the RAP Guidance section of our Guidance Library and in the Help Center within the IRB Module of the RAP.
        • See additional guidance for Students and Faculty Advisors for additional instructions for submission.
        • See our training catalog for workshops and other learning opportunities to support you.
        • Contact Research Compliance Services with any questions.