HOW TO PROCEED IF YOUR RESEARCH HAS BEEN SUBMITTED TO ANY NON-DoD INSTITUTIONAL REVIEW BOARD (IRB) OR HUMAN RESEARCH PROTECTION PROGRAM (HRPP) AND USAFA IS ENGAGED IN THE RESEARCH
This includes activities determined to not be human subjects research, exempted research, and full protocol research
Like any large bureaucracy, USAFA is required to comply with numerous regulations. The AF has PROHIBITED AF Institutional Review Boards (IRB) from reviewing research that has an IRB determination from another organization (DoDI3216.02_AFI40-402 Enclosure 2, 6.a.(6)). If the reviewing IRB is not DoD, the Principal Investigator (PI) must obtain component-level review (DoDI3216.02_AFI40-402 Enclosure 2, 4.b.) and institutional permissions.
Follow the steps below:
1. You ensure USAFA will support your study by providing the resources necessary for you to execute it. Refer to Procedures to Obtain Resources and Survey Approval for detailed instructions on how to secure appropriate approvals.
2. . If the research is not exempt per 32 CFR219.101(b), the Authorized Institutional Official (AIO) must sign an Institutional Agreement for IRB Review (IAIR) that allows the other non-DoD organization to be the IRB/HRPP of record. This must be signed before the other IRB reviews the research or amendment to include USAFA. You send evidence of resource support and a short description of your study to the HRPP Organizational Box, firstname.lastname@example.org with “IAIR Required” in the subject line. If you do not use the correct subject line, your submission might not be viewed.
3. USAFA HRPP Support Personnel will staff the IAIR for AIO signature and return the signed IAIR to you.
4. You will secure signatures from the reviewing IRB/HRPP and return the signed IAIR to USAFA HRPP Support Personnel. The reviewing IRB is free to review on behalf of USAFA.
5. You obtain component-level review. Please email the Air Force Surgeon General’s office at: email@example.com for information on component-level review.
6. Once you receive component-level approval, you still need to obtain USAFA AIO permission to conduct the research at USAFA. You send the component-level review approved protocol, component-level review approval letter, all USAFA resource approvals, and the IRB/HRPP approval documentation to the USAFA HRPP Organizational Box, firstname.lastname@example.org with “Non-DOD reviewed and USAFA engaged” in the subject line by the monthly submission deadline.. If you do not use the correct subject line, your submission might not be viewed.
Your study will be posted on the HRPP SharePoint site one week after the USAFA IRB submission deadline and it will be available for two weeks to allow Mission Elements (ME) time to review and provide comments prior to the AIO signing the permission memo. This posting is required by the USAFA AIO and exists outside the IRB/HRPP process.
HRPP Support Personnel will staff the research protocol, IRB approval, resource and component-level approvals and any comments obtained during the two-week posting to the AIO to obtain his/her decision to permit/not permit the research to done at USAFA.
If the AIO permits the research, the HRPP Support Personnel will forward the signed AIO Permission memorandum to the PI and the research can begin. If the AIO does not permit the research, the PI may appeal the decision by sending a memorandum to the HRPP Organizational Box email@example.com addressing reasons for disapproval and providing substantive information (e.g., new information) for why the AIO should reconsider his/her decision.
7. If at any point in the process, you decide to discontinue the pursuit of research at USAFA, please notify the USAFA HRPP Support Personnel of your decision with an email to the HRPP Organizational Box.
8. Once the signed permission memo has been sent to you, the USAFA HRPP Support Personnel close the protocol. All your future communication is with the reviewing IRB/HRPP.
9. The USAFA HRPP office maintains all records for three years after closure and then destroys them appropriately.