Per 32 CFR 219.109(e), Principal Investigators (PI)s are required to submit an annual report to the USAFA Institutional Review Board (IRB) within 364 days every year to continue the research until the research is closed with a final report.
1. About two months before the IRB approval for your research expires, you will receive an email from the HRPP Support Personnel with the IRB approval expiration date that provides a link to and requests you submit a Continuing or Final Report.
2. If you do not submit a Continuing or Final Report in the next month, HRPP Support Personnel will send you a second email.
Note: Reminders are a courtesy that your HRPP Administrative Support Personnel will make every effort to ensure.
However, an annual report within 364 days is the regulatory responsibility of the PI and NOT receiving a reminder will NOT result in an “extension” of the research beyond 364 days.
3. At the time you submit your continuing report, you should consider whether you wish to make changes to the research, such as removing or adding investigators or requesting more subjects. If you wish to amend the protocol for the next year, submit an amendment request with your continuing review report.
4. If you do not submit a Continuing or Final Report prior to the IRB approval expiration date, HRPP Support Personnel will notify you that IRB approval has lapsed and all research activities must cease until IRB approval is obtained. Your Department Head and Research Director will be copied on this email.
5. You submit your completed Continuing or Final Report form to the HRPP Organizational Box, email@example.com. A complete submission means all items have been completed, Informed Consent Documents (ICDs) have been appropriately accounted for (total # and the # properly/improperly executed), a copy of the current ICD is attached as a separate document, a copy of any presentations/publications that have resulted from this study is attached as a separate document, and the form is signed by the Principal Investigator (PI).
Note: The PI is responsible for maintaining all ICDs as required by regulation for all studies beginning on 01 April 2016.
6. Once a complete submission is received, HRPP Support Personnel ensure the report and most current protocol are included in the read-ahead for the next monthly IRB meeting
7. At the IRB meeting, the Board can make any of the following determinations:
a. Approve the report.
b. Require modifications to the report.
c. Disapprove the report.
8. If the report is approved, HRPP Support Personnel send you a letter that includes the determination and the next IRB approval expiration date (one year from the IRB meeting date).
9. If modifications are required, HRPP Support Personnel send you a letter with a change table. You will return the completed change table to the HRPP Organizational Box, firstname.lastname@example.org. Upon receipt, the HRPP Support Personnel will forward the completed change table to an IRB member to ensure all required modifications have been addressed appropriately. All additional information or clarifications required by the reviewer will be coordinated directly with you with a copy to the HRPP Organizational Box.
10. If the report is disapproved, HRPP Support Personnel send you a letter that includes the reason for the disapproval and information on how to appeal the decision. All research activities must cease if the report is disapproved and the IRB approval has expired.
11. If the report closes out the research, HRPP Support Personnel close the electronic and hard copy files when the report is approved.
12. The process from complete submission on the monthly submission deadline date to approval takes approximately 3 weeks if changes are not required.