HOW TO PROCEED IF YOUR RESEARCH HAS BEEN SUBMITTED TO
INSTITUTIONAL REVIEW BOARD (IRB) OR HUMAN RESEARCH PROTECTION PROGRAM (HRPP)
This includes activities determined to not be human subjects research, exempted research and full protocol research
Let’s check to be sure you have the correct instructions to follow. Answer the following question.
Has the research been submitted to any non-DoD IRB/HRPP?
If the answer to the above is “no” and you have not submitted it to any IRB/HRPP, you need different instructions so click here. If you submitted to a DoD IRB/HRPP, click here. If the answer to the above is “yes”, continue reading.
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 Human Research Protection Official (HRPO) 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. You send evidence of resource support, all documents submitted to the reviewing IRB/HRPP and the IRB/HRPP approval documentation to the USAFA HRPP Organizational Box, firstname.lastname@example.org by the monthly submission deadline.
3. Once a complete submission is received, HRPP Support Personnel will send you the Institutional Agreement for IRB Review (IAIR) form to obtain appropriate signatures from the reviewing IRB.
4. Please email the Air Force Surgeon General’s office at: email@example.com for information on HRPO review.
5. Concurrent with 3 and 4 above, the HRPP Support Personnel will post the study 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 Authorized Institutional Official (AIO) signing the permission memo. This posting is required by the USAFA AIO and exists outside the HRPP review process.
6. After you receive HRPO approval and IAIR signatures, send all documents submitted for HRPO review, all HRPO required changes and approvals, and the signed IAIR to the USAFA Organizational Box firstname.lastname@example.org.
7. Permission from the USAFA AIO is required prior to initiating any research activities. The HRPP Support Personnel will staff the HRPO approved protocol, HRPO approval letter, resource approvals, any ME comments that were posted on the HRPP SharePoint site, and the IAIR to the AIO to obtain his/her decision to permit/not permit the research to be done at USAFA and for his signature on the IAIR, that allows the non-DoD IRB to be the IRB of record.
8. Once the signed IAIR and permission memo are received by HRPP Support Personnel, they will be forwarded to you and research activities can commence. All your future communication is with the reviewing IRB.
9. 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.
10. Once the permission memo has been sent to you, the USAFA HRPP Support Personnel close the protocol.
11. The USAFA HRPP office maintains all records for three years after closure and then destroys them appropriately.
12. If you provide evidence of resource support by the monthly submission deadline, the process to the signed permission memo is approximately 8 weeks.