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
Acronym |
Definitions |
SGE-C |
USAF Research Oversight and Compliance Office |
AIO |
Authorized Institutional Official |
ASD(R&E) |
Assistant Secretary of Defense for Research and Engineering |
CFR |
Code of Federal Regulations |
DFARS |
Defense Federal Acquisition Regulation Supplement |
DHHS |
Department of Health & Human Services |
EDO |
Exempt Determination Official |
FWA |
Federalwide Assurance |
HARP |
Human and Animal Research Protection |
HRP |
Human Research Protection |
HRPO |
Human Research Protection Official |
HRPP |
Human Research Protection Program |
IAIR |
Institutional Agreement for IRB Review |
IIA |
Individual Investigator Agreement |
IO |
Institutional Official |
IRB |
Institutional Review Board |
PI |
Principal Investigator |
SAV |
Staff Assistance Visit |
USD(P&R) |
Under Secretary of Defense for Personnel and Readiness |