IRB Study Modifications

All amendments or modifications to an approved study should be submitted to the IRB for review and approval. Study amendments or modifications may be submitted to the IRB for review by completing an IRB Modification Form in the iRIS electronic compliance platform. Changes in research procedures or consent/assent form(s) should not be initiated without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject.

Examples of modifications that require IRB review include, but are not limited to, changes in:

• Investigator Brochure or the Master Study Protocol
• Informed consent and/or assent documents
• Advertising material (flyers, emails, posters, social media posts, etc.)
• Study tools (surveys, questionnaires, etc.)
• Study participant population (quantity, age range, etc.)
• Location where research will be conducted
• Study design or study procedures
• Study personnel (addition, removal, updated roles)
• Recruitment procedures
• Completion date of the study

Investigators must promptly notify the IRB in writing of any changes in protocol status, such as discontinuation or completion of a study.

Submission Checklist

A complete submission increases the chance of approval. The following information should be included in an IRB study modification request:

• Adding new personnel to the study:
  • All study personnel and their role in the study must be defined in the personnel section of Modification Form. Individuals will need to have an iRIS account before they can be added to a study. Visit the iRIS page for more information on creating an iRIS account.
  
  
  • A current CV/biosketch/resume of all personnel being added to the study.
  
  
  • CITI certificates of completion for all required CITI modules from all personnel being added to the study. The required CITI training modules are defined in the Modification Form and can also be determined by visiting the CITI page.
  
  
  • HIPPA training certification. This is required for study personnel who will access medical records and Protected Health Information (PHI).


• If the modification pertains to changes to the study title, a rationale for this change must be provided, including any changes to specific aims of the project.


• If the change pertains to a change in the study design or procedures, a detailed description of the changes must be provided.


• Changes to previously approved and stamped documents require the submission of a version of the revised document that includes highlighted or tracked changes and a “clean” version of the revised document that is ready for use once it is stamped for approval.