HOW TO DO RESEARCH AT USAFA IF YOU HAVE OR WILL HAVE A DETERMINATION FROM ANY DoD INSTITUTIONAL REVIEW BOARD (IRB) OR HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OTHER THAN USAFA AND USAFA IS ENGAGED IN THE RESEARCH
This includes activities determined to be exempted and full protocol research
Follow the steps below:
1. You ensure USAFA will support your study by obtaining 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 CFR 219.101(b), the Authorized Institutional Official (AIO) must sign an Institutional Agreement for IRB Review (IAIR) that allows the other 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. Once the HRPP office obtains a complete submission, it will request permission from the Authorized Institutional Official (AIO) for your research to be conducted at USAFA.
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 send evidence of resource support with all documents submitted to the reviewing IRB/HRPP and the IRB/HRPP approval documentation to the HRPP Organizational Box, email@example.com by the monthly submission deadline.
6. Once the HRPP office obtains a complete submission, it will request permission from the AIO for your research to be conducted at USAFA.
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 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 firstname.lastname@example.org addressing reasons for disapproval and providing substantive information (e.g., new information) for why the AIO should reconsider his/her decision.
7. 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.
8. The USAFA HRPP office maintains all administrative records for three years after closure and then destroys them appropriately.