Baruch Human Research Protection Program (HRPP) Office (formerly IRB)
Continuing Reviews, Amendments, and Final Reports
Continuing Review of Active Protocols (Renewals) - Approved research is subject to continuing IRB review at least yearly, or more
frequently if specified by the IRB [45 CFR 46.109(e)]. This review must take place
before the approval expiration date; any lapse in approval will result in suspension of
subject recruitment/enrollment and, if the research is DHHS-sponsored, notification of the funding agency.
Investigators should allow sufficient time for development and review of renewal submissions.
Continuing IRB review occurs as long as the research remains active only for long-term follow-up of subjects, even when the research is permanently closed to the enrollment
of new subjects and all subjects have completed all research-related interventions.
Continuing IRB review of research also occurs even when the remaining research activities are limited to the analysis of identifiable data. However, the analysis of deidentified data does not require continuing review.
Changes in Approved Research (Amendments) - A PI shall seek IRB approval before making any change in approved research unless the change is necessary to eliminate an immediate hazard to the subject.
The PI shall submit an amendment form specifying the changes requested, a revised consent form (if applicable), and a copy of the approved protocol with the proposed changes highlighted, directly to local IRB office. The IRB Chair or Vice
Chair shall advise the PI in writing of the IRB’s decision regarding the proposed
change.
IRB-approved amendments to ongoing research do NOT extend the original approval expiration date.
Completion of Research (Final Report) - The PI shall promptly notify the IRB when an approved
research project is completed. The PI shall submit a final progress report to the
IRB that includes, for the last year of the research, all of the information to be submitted with applications for continuing review of protocols.
SUBMITTING AMENDMENTS, CONTINUING REVIEWS, OR FINAL REPORTS (PLEASE NOTE THAT THIS OPTION IS NOT CURRENTLY AVAILABLE ON IRB MANAGER)
1. Click on the HOME icon on the top left of the webpage. A list of the protocols you've submitted should appear on your homepage. If this does not occur, please contact the IRB Administrator.
2. Choose the protocol (by IRB number) you want to submit an amendment, continuing review, or final report for. Click on the protocol number.
3. Under ACTIONS choose xforms
4. Choose the form you wish to submit to the IRB.
Note these instructions are for PI's who have submitted applications between 2006-present. New PI' s or PI's that haven't submitted an IRB application between 2006-present should use these log-on instructions.
