CONTINUING REVIEW OF NON-EXEMPT RESEARCH PROTOCOLS
Studies approved by the convened IRB must be reviewed if they continue longer than one year past the date of IRB approval. These documents will assist you in applying for continuing review of ongoing research protocols.
Under the revised Common Rule, the following no longer requires continuing review:
- Most expedited studies. The IRB may require continuing review for some expedited studies.
- Studies approved by the convened IRB that have completed subject intervention/interaction, where the activity is limited to either the final analysis of identifiable data/biospecimens or involves accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
Expedited studies not subject to annual reviews will receive annual survey reminders with information regarding researcher responsibilities & project termination.
AMENDMENTS TO PREVIOUSLY APPROVED RESEARCH
If a principal investigator needs to add researchers or make other changes to their protocol, they must file an amendment to their previously approved research. Please see these documents on how to file an amendment.
It is critical that principal investigators report any adverse events occurring in the course of their research. Please review these documents to ensure that the university is aware of any such events.
The principal investigator must formally close their research when the study is finished. Please use these documents to assist in closing a research study.
- Final Report Form (Note: This document is described as a progress report or a final report, but investigators should only use it for their final report.)
- Final Report Submission Checklist
Questions about these processes? Please contact the IRB office at firstname.lastname@example.org or (773) 442-4675.