Modifying (Amending) an Existing Protocol

Changes to previously approved research will generally require additional review by RCS and/or the IRB. 

Timing 

  1. Current/New Study: 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.
    • To determine what types of changes require submission prior to initiation, see the sections in this webpage below, and refer to the Guidance on Amending Previously Approved Research page and its specific guidance on amendments to exempt, expedited, or full board research.
  2. Immediate Potential Hazard: 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.

Modifications by Review Type

If a modification/amendment submission is necessary, a modification submission is prepared based on the 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 using the Exempt Self-Assessment Tool. See the Modifying Exempt Research webpage for more information about modifying exempt research.
    • 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 application 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.
  • Expedited and Full Review – Studies previously determined to require expedited or full review, must submit a Modification (Amendment) Review Application for any changes to previously approved research. The IRB must determine that all approval criteria specified in the federal regulations continue to be satisfied. If all criteria are satisfied, the IRB will issue an approval for the proposed changes. See Amending Expedited Research webpage for more information about expedited research, and the Amending Full Board Research webpage for more information about full-board research.
    • The application includes 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 a Modification

All study materials are submitted to Research Compliance Services (RCS) through the RAP system. All current applications and forms are available on the Applications, Forms, and Guidance page. 

Steps for Submitting Modification

  1. click on the button below to access the RAP
  2. select “IRB Module” from the navigation bar
  3. select the “Active” tab
  4. select the study you wish to modify
  5. select “Create Modification/CR”
  6. select "Modification/Update"
  7. 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:
      • 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.
      • 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).
  8. complete the electronic application pages and upload your materials where prompted. See the Modify Study (RAP Instructions) for additional details and screenshots. 

RAP Portal

 

Funding Modifications

When researchers receive new funding or when their existing funding changes (e.g., new EPCS number, budget changes related to increased participant compensation), a modification is needed to update the funding details and any associated documents impacted by this change. As an institutional control, we compare grant materials to the IRB materials to ensure they are consistent and the IRB submission fully covers the sponsored activity. When there are discrepancies between the funding and the IRB submission, those differences should be described in the funding and sponsorship form associated with the study in the RAP. 

Funding is currently associated with IRB projects through the EPCS number linked to your award. If your project is administered through Sponsored Project Services (SPS), your award should have an EPCS number. At times, an existing award may receive a new EPCS number that will need to be added to your IRB submission in the RAP even if nothing else about your IRB submission is changing. The modification process is more streamlined when only the EPCS number is changing. 

Option 1: Only the EPCS number is changing

If the only change is to add a revised EPCS number and all other aspects of the research and funding remain the same:

  • In the modification summary, note that you are adding a new EPCS number for an existing grant and confirm that everything else in the IRB submission remains unchanged.
  • Add the revised EPCS number to the existing funding source entry.
  • See our Quick Reference - Study Funding Sources guide for more information.

 

Option 2: New funding and/or changes to the research

If the award involves a new funding source and/or impacts other aspects of the study:

  • In the modification summary, describe what is changing.
  • Submit a Modification Application.
  • Add a new entry in the funding sources section (include the new EPCS number, a completed Funding and Sponsorship Form describing the funding you wish to add, and attach the human subjects portion of your grant proposal.
  • Upload revised study materials as needed for consistency with the changes proposed in the new funding.
  • See our Quick Reference - Study Funding Sources guide for more information.

 

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 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).

Additional Guidance

For additional information/guidance on migrated studies and the RAP see: Transitioning studies to the RAP and Guidance on how to make your study complete/whole for additional instructions.

Resources

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.