The DAF COHRP must review and approve all full HRPPs prior to their taking effect, whether based on a template or institution-unique. Coordinate review and approval of an HRPP by contacting the DAF COHRP at usaf.pentagon.af-sg.mbx.afmsa-sge-c@health.mil. When submitting documentation to establish a new full HRPP, provide:

• The HRPP Plan Document. Contact the DAF COHRP to obtain a copy of the template. The DAF COHRP will provide assistance if there are any questions regarding its use, or substantive changes need to be made for your institution. The HRPP Plan must be signed by the institution commander.
• Any forms and templates proscribed by the HRPP Plan for use by HRPP staff and investigators.
• When appropriate, an Assurance of Compliance for the conduct of non-Exempt human research. Use the DoD Template for this document, obtained from the DAF COHRP. The Assurance must be signed by the institution commander as the Institutional Official, the Human Protections Director (HPD) and any Institutional Review Board (IRB) Chairs.
• Training for all HRPP personnel. Training must meet the requirements found in the Office of the Assistant Secretary of Defense for Research and Engineering Memorandum, Minimum Education Requirements for DAF Personnel Involved in Human Research Protection, August 16, 2012. Coordinate with the DAF COHRP to obtain training for HRPP personnel.

• Investigators must coordinate with an official DAF research review authority to obtain a determination for the proposed activity. The DAF COHRP can also provide assistance. DAF research review authorities include:
  • Exemption Determination Officials (EDOs): Review proposed DoD-conducted activities to determine whether they are HSR.
  • Human Research Protection Officials (HRPOs): Review proposed non-DoD conducted activities after the non-DoD entity’s research review authority.
  • Institutional Review Boards (IRBs): Can issue the above determinations, plus IRB reviews required for non-exempt human research.
• Investigators / Program Managers should coordinate Limited HRPPs with the commander of the institution providing support to human research or conducting Exempt human research.
• Limited HRPPs established using the Limited HRPP Template with no substantive changes are viewed as pre-approved by the DAF COHRP.
• Submit all completed Limited HRPPs to DAF COHRP for the record.
• Limited HRPPs that include substantive changes to the template must be submitted to DAF COHRP for approval prior to being in effect.

DoD institutions / organizations / commands engaged in DoD or component-supported research with human subjects are guided by the ethical principles set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research titled, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (The Belmont Report); DoD regulations for the Protection of Human Subjects (32 CFR 219); DoDI 3216.02_DAFI 40-402; where applicable, Food and Drug Administration regulations; 45 CFR 46 (Subparts B, C, and D under the authority of the DoD); and any other applicable federal, state and local laws.

The Assurance applies to research involving human subjects and activities that involve such research, even in part, regardless of whether the research is otherwise subject to federal regulation. The requirements of the Assurance apply to all programs within the institution and its DoD component, and are not restricted by funding source (intramural or extramural), funding appropriation, nature of support, program budget activity (e.g., P6 versus other), program title, or security classification.

Institutional Review Boards within DoD organizations must meet the requirements of the Common Rule, FDA regulations and any DoD component-specific additional requirements.

A DoD Assurance is approved as an element of an institution’s Human Research Protection Program. If your institution will conduct non-exempt human research, obtain and complete the Assurance Template from the DAF COHRP and submit it with your HRPP package for approval.