Like any large bureaucracy, USAFA is required to comply with numerous regulations. However, the DoD has accepted federal regulations that reduce the red tape on some types of human subjects research. 32CFR 219.101
identifies six categories of human subjects research that are exempt from HRPP oversight. Here is what DoD requires of a Principal Investigator (PI): “Prior to start of an activity that is or may be research involving human subjects
, obtain written determination from an appropriate [Exempt Determination Official] EDO or an Institutional Review Board (IRB) per paragraphs 6.a.(1)(a)1. and 10.d. of enclosure 2, and the PI’s [Institutional Official] IO/AIO [Authorized Institutional Official] per paragraph 6.a.(2). PIs are not authorized to make such determinations
for their own activities (DoDI3216.02_AFI40-402, Enclosure 2, 11.c.
Follow the instructions below to submit a COMPLETE package to the USAFA HRPP.
If you are submitting research that is exempt because it is educational research (32CFR 219.101(b)(1)), submit your completed package to the Exemption Determination Officer (EDO). Please contact the EDO at 333-3277 for submission instructions.
If you are submitting research that is exempt because it qualifies under one of the other categories (i.e. NOT educational research), read the following submission instructions.
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 ensure ALL investigators are current in their annual human subjects protection training. Refer to USAFA HRPP Training Instructions or step-by-step instructions.
3. You review the resumes of your investigators to ensure they have the appropriate experience to execute the study in compliance with HRPP requirements. As PI, you are responsible for any breaches in human subjects protection that occur. NOTE: If you have never conducted human subjects research before, you CANNOT be a PI; you must find an experienced researcher to be the PI and mentor you as the Associate Investigator (AI).
4. You complete the USAFA HRPP Determination Request AND secure the required signatures.
5. You submit your completed exemption request package to the HRPP Organizational Box, email@example.com by the monthly submission deadline with “Exempt Research Submission” in the subject line. If you do not use the correct subject line, your submission might not be viewed. This package must include the completed HRPP Determination Request with all signatures, evidence of resource approval, and current training certificates for all researchers. Note: the IRB office does not keep partial submissions “on file.” Please submit a complete packet. If a complete packet is not submitted, the HRPP Support Personnel will return what you submitted.
6. Once a complete submission is received by the HRPP, it will be sent for review and determination. If the reviewer requires clarification or additional information from the researcher, the IRB member will contact you directly. Be sure to “reply all”, when corresponding directly with your reviewer.
7. There are three possible determinations your reviewer can make:
a. NOT research involving human subjects.
The study does not meet the regulatory definition of research involving human subjects per 32CFR 219.102
. In this case, the determination is sent to you and you are free to start your study.
b. Human subject research eligible for exemption from the requirement for IRB review.
This study meets the definition of research involving human subjects and meets a least one of the six exemptions per section 219.101(b).
i. HRPP Support Personnel will inform you of the determination.
ii. Your study will be posted on the HRPP SharePoint site one week after the IRB submission deadline and 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 your AIO and exists outside of the IRB review process.
iii. Once the two week comment time has elapsed, the IRB determination, resource approvals, and any ME comments that were posted on the HRPP SharePoint site, will be staffed to the AIO to obtain his/her decision to permit/not permit the research to be done at USAFA.
iv. 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.
c. Human subjects research ineligible for exemption from the requirements for IRB review. This study meets the definition of research involving human subjects but does not meet any of the six exemptions per section 219.101(b). In this case, the research requires full IRB review. The determination is sent to you with instructions for submitting full protocol research.
8. Amendments are required for modifications that might affect risk to subjects or the exemption category, such as changes in procedures, data collection instruments, data plans, and investigators. Amendments are not required for modifications that will not affect risk to subjects or the exemption category, such as adding a class, increasing subject numbers, extending the time period.
9. No annual reports are required; the research is closed by HRPP Support Personnel.
10. Per DoDI3216.02_AFI40-402, Enclosure 2, 11.f.
, you must retain all your research records (e.g., protocol, IRB correspondence, and data) for at least three years after the research ends or for the length of time specified in applicable regulations, or institutional or sponsor requirements, whichever is longer. You must transfer research records to another PI or keep them with you and provide new contact information if you leave USAFA before the 3 years is over. In either case, you must inform the HRPP office that you are leaving USAFA.
11. The USAFA HRPP office maintains all administrative records for three years after closure and then destroys them appropriately.
12. Your files are subject to audit by USAFA HRPP and SGE-C.
13.You send any publications or presentations resulting from your study to the HRPP Organizational Box, email@example.com with ”Publication or Presentation” in the subject line. Please reference your protocol number and title.