Initial Human Research Protection Program (HRPP) Submission

The initial submission requirements are determined by factors related to the personnel engaged in the research, where the research will be conducted, and whether an IRB or HRPP determination already exists. PERSONNEL ARE ENGAGED in the research if they interact or intervene with human subjects for research purposes (including obtaining informed consent) OR they obtain identifiable, private information about human subjects for research purposes. Providing subjects, facilities, equipment, or informing people about a study DOES NOT ENGAGE an organization or personnel in research. Handling pre-existing, anonymous data also DOES NOT ENGAGE a person in human subjects research. Choose the description below that best represents your research. USAFA contractors are NOT USAFA personnel; they are personnel outside USAFA. Visiting Professors/Researchers are USAFA personnel because they occupy a USAFA billet.

USAFA IS NOT ENGAGED IN THE RESEARCH

Only non-USAFA personnel will conduct the research at USAFA (i.e., USAFA is NOT engaged in the research). You should have a determination from another IRB/HRPP, but USAFA permissions and resource support are still required. Choose one of the statements below based on the type of IRB/HRPP that provided a determination.

I have a determination from a DoD IRB/HRPP (i.e., a DoD IRB/HRPP reviewed the research)

I have a determination from a NON-DoD IRB/HRPP (i.e., a non-DoD IRB/HRPP reviewed the research)

 

USAFA IS ENGAGED IN THE RESEARCH

Only USAFA personnel (no contractors) will be engaged in the research and the research will only be conducted at USAFA. In this case, the USAFA HRPP can provide the complete review of your research. Choose one of the statements below based on the intention of your project and the federal law that identifies exempt human subjects research categories.

I think my study is “Not Human Subjects Research” because I am handling pre-existing, anonymous data or my project is program evaluation rather than research.

I think my study is human subjects research and QUALIFIES AS EXEMPT because it falls under one of the categories of human subjects research, per 32 CFR219.101, that are exempt from HRPP oversight.  If you do not know the federal guidelines on what qualifies as exempt research, click here before you submit your research as exempt.

I think my study is human subjects research and DOES NOT qualify for exempt status

Only USAFA personnel will be engaged in the research (i.e., personnel outside USAFA (includes contractors) will not be engaged in the research) and the research will be conducted at USAFA and/or another site(s). In this case, USAFA will be the IRB that will review your research so you can choose the appropriate statement above to determine your submission requirements. HOWEVER, in addition to the above requirements, you will need to obtain written permission from each site where you intend to conduct the research and submit it with the other requirements.

Similar research will be conducted at multiple sites, but only USAFA personnel will be engaged in the research at USAFA (no contractors). Personnel from the other sites/organizations will be engaged in the research at their site/organization and not USAFA. Personnel OUTSIDE USAFA (includes contractors) will NOT be engaged in the research at USAFA and USAFA personnel will NOT be engaged in the research at other organizations. In this case, USAFA will be the IRB that will review your research for conduct only at USAFA so you can choose the appropriate statement above to determine your submission requirements. Do not include personnel from the other organization on the protocol as investigators. If you will provide anonymous data to personnel at the other organization(s), include this in the procedures section with their names and organizations and that obtaining anonymous, existing data does not engage the person in human subjects research.

USAFA personnel and personnel from other organizations will conduct research together. Personnel outside USAFA (includes contractors) will be engaged in research with USAFA personnel. In this case, it is important to determine which organization should review the research. If the research has already been reviewed by an HRPP/IRB, USAFA cannot perform a second review. Choose one of the statements below based on the researcher that initiated the project and the organization type.

The research initiator is from a DoD organization that is not USAFA(i.e., DoD IRB or HRPP has or will review this research).  In this case, the other DoD organization should review the research, but there are other requirements for its conduct at USAFA that are in the instructions at the link.

The research initiator is from a non-DoD organization (i.e., a non-DoD IRB or HRPP has or will review this research).  In this case, the non-DoD organization should review the research, but there are other requirements for its conduct at USAFA that are in the instructions at the link.

The research initiator is from USAFA. In this case, USAFA will be the IRB that will review your research.

I think my project is “Not Human Subjects Research” because I am handling pre-existing, anonymous data or my project is program evaluation rather than research.

I think my research qualifies as Exempt per 32 CFR219.101. If you do not know the federal guidelines on what qualifies as exempt research, click here before you submit your research as exempt.

I think my study is human subjects research and DOES NOT qualify for exempt status