1. HRPO review is conducted after any contract or agreement has been established, and after an IRB has reviewed and approved the research study, but before the research activity begins.
2. Submit to the DAF COHRP the appropriate items as outlined in the next section (What is submitted to the HRPO for review?), via the organization email at usaf.pentagon.af-sg.mbx.afmsa-sge-c@health.mil.
   1. Only provide final, IRB / EC approved documentation (no drafts or tracked changes documents will be accepted unless requested by the HRPO Office).
   2. If the activity has an existing HRPO review from another DoD HRPO (e.g., Defense Health Agency, Army, Navy), submit a copy of the existing HRPO determination to usaf.pentagon.af-sg.mbx.afmsa-sge-c@health.mil before continuing. Duplicate HRPO reviews are generally not conducted.
   3. Contact the DAF COHRP for a DOD SAFE submission upload link for secure transmission of very large files (up to 8 GB). DoD SAFE (Note: This site is restricted and requires a common access card; users without a common access card will receive a website error message) also supports zip files.
3. The DAF COHRP will receive your submission, assign it a tracking number, and review it as soon as possible.
4. If additional information is required for the HRPO to make a determination that the research meets all applicable DoD and DAF requirements, you will receive an email outlining each requirement. Address any issues or missing information identified, and provide responsive documentation to the DAF COHRP organization email above.
5. Once any issues are resolved, and it is determined that the research meets all applicable DoD and DAF requirements, a Concurrence determination will be issued. This determination documents that DoD and DAF human research protection requirements are met - once all approvals and requirements are met (e.g., DAF Survey Office approval, safety boards, etc.) the research may begin.

Contact the DAF COHRP for additional guidance and instruction for submission of activities after the initial approval of the research.

For studies that an IRB or EC determined are “not research” or “research that does not involve human subjects”, submit:

• Protocol, Institutional Review Board submission form, or other document that will guide the conduct of the activity
• Any other documents submitted to and reviewed by the office that made the “not research” or “not human subjects” determination
• Documentation of the non-DoD institution’s review and determination

For exempt human subjects research studies, submit:

• Research protocol or IRB submission form
• Any other documents submitted to and reviewed by the office that made the exempt determination
• Documentation of investigators’ training in the protection of human subjects (may be training certificates or documentation of institutional policy requirements for training)
• Documentation of the non-DoD institution’s review and determination (must include the exemption category / categories and sub-categories)

For all non-exempt human subjects research studies, submit:

• Research protocol
• IRB submission form (if separate from protocol)
• Recruitment material(s) (e.g., flyers, posters, emails, Facebook ads, etc.)
• Informed consent document(s) or justification for waiver of consent/documentation of consent
• Study instruments (e.g., surveys, interview scripts, case report forms)
• Product information (e.g., investigator’s brochure, package insert for drug being tested)
• Any other documents submitted to, reviewed, and approved by the IRB
• Documentation of investigators’ training in the protection of human subjects (may be training certificates or documentation of institutional policy requirements for training)
• Documentation of Federalwide Assurance (FWA) coverage for all engaged investigators (Individual Investigator Agreements and Institutional Agreements for IRB Review should be provided as appropriate when collaborating with other organizations)
• Documentation of IRB review and approval must include:
  • IRB’s risk determination (minimal risk / greater than minimal risk)
  • Type of IRB review (expedited / full board and, if expedited, what category the study was found to meet)
  • Time period until next review / study expiration
  • Any additional determinations that are relevant

1. EDO review is conducted prior to the start of any activity that is or might include HSR, when conducted solely by a DAF institution or DAF-affiliated investigator.
2. Submit to the DAF COHRP the appropriate items as outlined in the next section (What is submitted to the EDO for review?), via our organization email at usaf.pentagon.af-sg.mbx.afmsa-sge-c@health.mil. Contact the DAF COHRP for a DOD SAFE submission upload link for secure transmission of very large files (up to 8 GB). DoD SAFE (Note: This site is restricted and requires a common access card; users without a common access card will receive a website error message) also supports zip files.
3. The DAF COHRP will receive your submission, assign it a tracking number, and review it as soon as possible.
4. If additional information is required for the EDO to make the necessary determinations, you will receive an email outlining each requirement. Address any issues or missing information identified, and provide responsive documentation to the DAF COHRP organization box above.
5. Possible outcomes:
   1. If the activity is not research or research that does not involve human subjects, and thus does not require further review, then we will provide the appropriate final determination. Likewise, if sufficient information is available to determine the activity is HSR, and meets requirements for Exemption from full / IRB review, a final determination will be provided. Note that we may require additional information to make these determinations in the course of our review.
   2. If the activity requires IRB review, then we will let you know the options that may be available for this. The IRB will likely require use of its own protocol template to perform this review. Note that the DAF CORHP is not an IRB and cannot conduct a full "IRB Review."
   3. If the EDO determines this activity is research involving human subjects, additional Human Research Protection Program documentation will be required IAW DoDI 3216.02, paras 3.3. and 3.4., regardless of whether the research is Exempt or non-Exempt. More information about HRPPs and implementation of such programs can be found on our website, under DoD Human Research Protection Programs and Assurances.

• Activity-related documents:
  • Any existing CONOPS or other documentation describing the purpose and procedures of the activity
  • Recruitment materials (e.g., flyers, posters, emails, Facebook ads, etc.)
  • Consent Information (i.e., information provided to participants in order to obtain their agreement to take part in the study)
  • Any other participant-facing materials
  • Study instruments (e.g., surveys, interview scripts, case report forms)
• Human Research Protection Program Plan
  • Any institution that conducts or supports HSR must provide an HRPP to address regulatory requirements for the protection of study subjects
    • See the DoD Human Research Protection Programs and Assurances page for more information and template documents
  • This may include both the investigator’s institution, and any outside DoD institutions that are supporting the research