Changes to an approved protocol or approved study materials such that subjects are treated differently than outlined or described in the original approved protocol, require submission of a modification for IRB approval. Once the modification has been approved, the modification changes may be implemented.
Investigators may not initiate any changes in research procedures or consent/assent form(s) without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject.
Modification must be submitted via the IRBIS system.
Examples of changes that require IRB review include, but are not limited to, changes in:
- Study personnel;
- Advertising materials (flyers, radio spots, etc.);
- Research procedures;
- Subject populations (e.g., age range);
- Location where research will be conducted;
- Consent/assent forms;
- Recruitment procedures; or
- Date for completion of study.
I’ve started my research and find that I need to make a change. What do I need to do?
Submit a modification explaining the proposed change. The change could be something as simple as adding a research team member or more significant such as changing the study procedures or changes to documents used with the participants (consent forms, questionnaires, recruitment materials, etc.). In all cases, you must have IRB approval of the change BEFORE implementing the change.