What is submitted to the Human Research Protection Official for review?

For studies determined to be "not research" or "research that does not involve human subjects":

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

For exempt human subjects research studies:

• 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 category/categories of exempt research determined to be applicable)

For all non-exempt human subjects research studies:

• Research protocol
• IRB submission form (if separate from protocol)
• Recruitment materials (e.g., flyers, posters, emails, Facebook ads, etc.)
• Informed consent document 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 FWA coverage for all engaged investigators (Individual Investigator Agreements and Institutional Agreements for IRB review should be provided as appropriate when collaborating/subcontracting aspects of the research)
• 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

Common Acronyms