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.
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.
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 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
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 email@example.com 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: firstname.lastname@example.org 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 email@example.com
“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 firstname.lastname@example.org.
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.