Hello Potential Researcher,
You probably wonder why someone recommended that you submit your project to the USAFA Human Research Protection Program (HRPP). 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 this enclosure, and the PI’s [Institutional Official] IO/AIO [Authorized Institutional Official] per paragraph 6.a.(2) of this Enclosure. PIs are not authorized to make such determinations for their own activities (DoDI3216.02_AFI40-402, Enclosure 2, 11.c.
).” Any activity that may meet the definition of human subjects research (32 CFR 219.102) must be submitted
(excludes customer satisfaction and post program feedback directed solely at improving activities within the program). Course critiques, Chapel programs usage and satisfaction survey, and NCLS feedback forms are examples of excluded activities. Direct comparison of two different programs might be research and should be submitted for HRPP review.
NOTE: The AF has PROHIBTED AF IRBs from reviewing research that has an IRB determination from another organization; this includes a determination of not human subjects research. If your study has been submitted to any other HRPP or IRB for review, STOP, do not follow these instructions. Contact the USAFA HRPP at firstname.lastname@example.org
Follow the instructions below to submit a COMPLETE package to the USAFA HRPP.
1. Complete the USAFA HRPP Determination request.
The following are included in the form, but are NOT required for this type of submission:
institutional resources in place
mission element comments
resumes and PI experience with human subjects research
any signatures beyond the PI
2. Submit your completed form to the HRPP Organizational Box, email@example.com with “Not Human Subjects Research Submission” in the subject line. If you do not use the correct subject line, your submission might not be viewed.
3. Based on your responses on this form, the HRPP will make one of three determinations:
- NOT human subjects research. 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. This study need not be submitted to the USAFA HRPP again unless your procedures change (i.e. you weren’t using identifiable data, but now you are) or your intent changes (i.e. you were only using the results to develop your program, but now you believe your process could contribute to program evaluation literature).
- Humans 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). The determination is sent to you with instructions for submitting exempt research.
- 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). The determination is sent to you with instructions for submitting full protocol research.