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 NOT ENGAGED IN THE RESEARCH

This includes activities determined to be not human subjects research, exempted research, and full protocol research.

Hello Researcher,

Like any large bureaucracy, USAFA is required to comply with numerous regulations. If the reviewing IRB is not DoD and USAFA is not engaged in the research, 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, usafa.irb@usafa.edu with “Has Non-DoD Determination and USAFA Not 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.

3. Permission from the USAFA AIO is required prior to initiating any research activities. The research 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 on the research 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.

4. The HRPP Support Personnel will staff the non-DoD approved protocol, 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 conducted at USAFA. The permission will stipulate that it is pending HRPO approval.

5. If the AIO permits the research, the HRPP Support Personnel will forward the signed AIO Permission memorandum to the PI. If the AIO does not permit the research, the PI may appeal the decision by sending a memorandum to the HRPP Organizational Box usafa.irb@usafa.edu addressing reasons for disapproval and providing substantive information (e.g., new information) for why the AIO should reconsider his/her decision. If the research is approved, the Permission memorandum is included in the documents sent to the AF-SG officer per #6 below.

6. You send all documents to the Air Force Surgeon General’s office at: usaf.pentagon.af-sg.mbx.afmsa-sge-c@mail.mil for Human Research Protection Official (HRPO) review.

7. After you receive HRPO approval, send all documents submitted for HRPO review and all HRPO required changes and approvals to the USAFA Organizational Box usafa.irb@usafa.edu with “Has Non-DoD Determination and USAFA Not Engaged” in the subject line.

8. Once HRPO approval is received by USAFA HRPP Support Personnel, they will send you a confirmatory email 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 usafa.irb@usafa.edu.

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.