HOW TO DO RESEARCH AT USAFA IF YOU HAVE A DETERMINATION
FROM ANY DoD INSTITUTIONAL REVIEW BOARD (IRB) OR HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OTHER THAN USAFA
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 DoD IRB/HRPP?
If the answer to the above is “no” and you have not submitted it to any IRB/HRPP, youneed different instructions so click here. If you submitted to a non-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 IRBs 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 DoD, the USAFA IRB must accept the determination without any additional review, but Institutional permissions and agreements are still required.
Follow the steps below:
1. You ensure USAFA will support your study by obtaining the resources necessary for you toexecute 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 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.
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.
- 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
- Once the two week comment time has elapsed, the HRPP Support Personnel will staff the reviewed protocol, DoD IRB/HRPP determination, resource approvals, and any ME comments that were posted on the HRPP SharePoint site to the AIO to obtain his/her decision to permit/not permit the research to be done at USAFA. In addition, the AIO must sign an Institutional Agreement for IRB Review (IAIR) that allows the other DoD organization to be the IRB/HRPP of record.
- Following AIO signatures, the HRPP Support Personnel will send the IAIR to you to obtain signatures from the reviewing IRB/HRPP.
- Once the completed IAIR is received by HRPP Support Personnel, the AIO permission memo will be forwarded to you and research activities can commence.
4. Once the 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.
5. The USAFA HRPP office maintains all administrative records for three years after closure and then destroys them appropriately.
6. If you provide evidence of resource support by the monthly submission deadline, the process to the signed permission memo is approximately 6-8 weeks.