The Human Research Protection Program (HRPP) is a system of interdependent elements that work together to ensure research is conducted ethically and in compliance with appropriate regulatory requirements. An HRPP provides oversight to human research activities that an organization is involved in. This oversight protects participants in research studies associated with the DoD. See HRPPs and Assurances for detailed information on when and how to establish an HRPP.

An institution’s commander or director must establish an HRPP when personnel affiliated with the institution conduct (i.e., directly carry out actions related to) or support (i.e., provide funding or other assistance to) human research.

An Assurance of Compliance is required for any DoD institution or organization that conducts non-Exempt human research.

No. DoDI 3216.02, sections 3.5.a.6. and 3.9.f. both require approval of an institution commander or the DoD Component when enrolling DoD personnel as research subjects. This is a separate approval from the HRPP, and focuses on the appropriateness of the research in consideration of the unit’s mission and ongoing operations.

However, the Limited HRPP template incorporates terms for both the command or Component approval and the HRPP – both requirements are included in the same document.

It depends. An institution that will only supports human research, or conducts only exempt human research needs only an HRPP. Both an HRPP and an Assurance are required to conduct non-Exempt human research. A DAF institution that has an Assurance must also have an HRPP. Contact the DAF COHRP if you have questions about what oversight programs are needed for your institution.

The requirements for student research will depend on your status as an investigator, as well as who your research participants will be. First, DoD personnel who conduct human research for the pursuit of academic credit at a non-DoD institution are deemed to be conducting such research on behalf of the non-DoD institution (i.e., your school), and not as DoD personnel. If you will enroll no DoD personnel as human subjects in your research, nor otherwise make use of any DoD resources (funding, facilities, equipment, etc.) then the study is neither conducted nor supported by the DoD, and no additional human research protection program approvals from the DoD are required.

However, if you are acting as DAF personnel in conducting the research, if you enroll DAF personnel as human research subjects or obtain other DAF support for your study, then the research is either DAF conducted or DAF supported, and additional Exemption Determination Official (EDO) or Human Research Protection Official (HRPO) review and requirements will apply. Contact the DAF COHRP to discuss your situation if there are any questions.

Support includes:

• Collaboration between DoD and non-DoD institutions;
• Use of DoD facilities, DoD equipment (including DoD-provided email, web and telephone systems), DoD personnel (investigators or other personnel performing tasks identified in the research protocol);
• Access to DoD-affiliated personnel for recruitment as study participants; or
• Access to identifiable, private information about DoD-affiliated personnel such as data or specimens

Contact the DAF COHRP to discuss your situation if there are any questions.

Some general requirements include (not inclusive):

• Contracts for activities that are or might include human research must contain the the DFARS clause 252.235-7004. Sub-contracts awarded must also contain this clause. Activities that are funded or supported through non-contract processes (e.g., grants, CRADAs, etc.) must provide the same or similar language. See DoDI3216.02, section 3.6.b. for details.
• DoDI 3216.02, section 3.9.f. provides additional requirements for the involvement of DoD-affiliated personnel as study subjects. These include protection from influence by leadership personnel and restrictions on compensation while in on-duty status.
• 10USC980 limits the use of Consent waivers in research conducted or supported by the DoD.
• All human research that is conducted by a non-DoD institution and supported by the DoD must obtain HRPO review after the contract has been approved, but before the conduct of any human research activities.