Modifications are categorized into minor changes and major changes. A minor modification may include:
- A proposed change in research-related activities that does not significantly affect an assessment of the risks and benefits of the study and does not substantially change the specific aims or design of the study.
A major modification may include:
- A proposed change in research-related activities that significantly affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study.
While each study can vary, below is a list with examples of common minor and major modifications to an approved IRB protocol.
Minor Modification Examples
- Changes to research staff
- Adding research activities independent from the main research protocol
- Removing study activities independent from the main research protocol
- New recruitment materials (e.g., flyer, script)
- Increase or decrease in proposed human research subjects’ enrollment
- Narrowing the range of the inclusion criteria
- Broadening the range of the exclusion criteria
- Alterations to study activity duration or procedure
- Updates or alternations to safety standards or participant protections
- Refined data security procedures or confidentiality practices
- Alternations in participant compensation or alteration of the payment schedule with proper justification
- Changes to improve the clarity of statements or to correct typographical errors, provided that such a change does not alter the content or intent of the statement
- The addition or removal of study sites
Major Modification Examples
- Broadening the range of inclusion criteria significantly affecting the risks and benefits of the study
- Narrowing the range of exclusion criteria significantly affecting the risks and benefits of the study
- Alterations in the dosage or route of administration of an administered drug
- Substantially extending the duration of exposure to the study activity, test material, or invention
- Inclusion of a new study device (e.g., electrocardiogram) not previously part of the originally approved study
- Deletion of laboratory tests, monitoring procedures, or study visits directed at the collection of information for safety evaluations
- Site-specific requirements that impact the originally approved study
- Addition of measures to avoid serious unexpected adverse events or other significant risks to the Informed Consent Disclosure
- An addition of a qualified investigator with a disclosable conflict of interest
- Changes, which, in the opinion of the IRB reviewer, do not meet the criteria or intent of a minor modification
Researchers can visit TC IRB’s Modifications page for specific instructions on how to submit a minor or major modification to an already approved protocol.