If you are on the medical campus please see Med Campus IRB website
Amendments & Clarifications
Federal regulations require IRB’s to review and approve changes to approved studies prior to their implementation. In rare cases, changes might be implemented prior to IRB approval if the changes are necessary in order to eliminate immediate hazards to subjects. If a change is necessary in order to eliminate immediate hazards to subjects, investigators should contact the IRB immediately if possible.
However, for all other changes, investigators should seek IRB approval prior to implementing changes.
Any changes/alterations that occur prior to IRB approval are considered to be deviations and require reporting to the IRB. See the Deviation Policy for more information.
Changes to Expedited/Full Board Studies
Changes to Exempt Studies
Amendment Examples (not exhaustive)
- Changes in study staff. Study staff amendments are not required for Exempt studies
- Revisions to the Inclusion/Exclusion criteria
- Revisions to questions being asked in a study survey
- Changes in the time frame for a study assessment
- Changes in the contact information on the recruitment materials
- Changes in the method of obtaining informed consent
- Addition of new study location
- Increase in the number of subjects being enrolled etc.
- Removal of a study questionnaire/instrument
Amendment Review
Minor changes that pose no more than minimal risk can typically be reviewed via expedited procedures. This means that the amendment will be reviewed in the office by an IRB member. However, if the change is more significant and is greater than minimal risk, the amendment will need to be reviewed at a convened IRB meeting.
The approval of the amendment does not alter the dates of the study’s overall approval period.
When is an Amendment really a new study?
If the proposed amendment includes changes to two or more of the following criteria, the IRB would consider this to be a new study and the investigator would need to submit a new study application.
- Study population
- Study procedures
- Study purpose