Modifications
Table of Contents
Modifications
Investigators must continue to meet all requirements while conducting approved research.
This means they must get IRB approval before making any changes to the research that was previously approved.
If investigators ever need to change the research right away to remove an immediate risk to participants, they may do so without prior IRB approval — but they must report those changes to the IRB as soon as possible.
The IRB will assess:
- Risk/benefit balance
- Continued consent adequacy
- Participant safety
- Impact on scientific validity and ethical conduct
Modifications to an approved study fall into two categories: minor changes and major changes.
Minor Modifications
Minor modifications are changes that:
- Do not significantly affect the study’s risks or benefits, and
- Do not substantially change the study’s goals or overall design
Minor Modification Examples
- Changes to research staff
- New recruitment materials (e.g., flyer, script) that meet the IRB standards.
- Increase or decrease in proposed human research subjects’ enrollment if it does not increase the risks to subjects or affect the integrity of the study.
- Minor adjustments to data collection procedures (e.g., shortening a survey, adjusting interview timing)
- Revising recruitment methods that do not change who is being recruited
- Administrative changes such as updated sponsor or funding information
- Adding non-sensitive questions to an existing survey or form
- Narrowing the range of the inclusion criteria
- 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 Modifications
Major modifications are changes that:
- Significantly affect the assessment of risks or benefits, or
- Substantially change the study’s goals or overall design
Major Modification Examples
- Changing the purpose, goals, or specific aims of the study
- Substantial changes to the study design, such as adding a new study arm or switching methodologies
- Introducing procedures or questions that increase risk or involve sensitive topics
- Adding a new population (e.g., minors, pregnant individuals, vulnerable groups)
- Significantly altering the informed consent process or consent documents
- Changing the principal investigator (PI)
- Adding new drugs, devices, or biological samples to the study
- Large revisions to recruitment strategies that change who will be eligible or targeted