HomeOrganizationsAFMSA/SGE-CNew IRBS and Researchers

New IRBs and Researchers

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

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

  • Protocol, Institutional Review Board (IRB) submission form, or other document that will guide the conduct of the research
  • Any/all 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:

  • Research protocol or IRB submission form
  • Any/all 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/all 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 DoD HRPO Review Issues

Common Acronyms

Acronym Definitions
AFMSA/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 Private Investigator
SAV Staff Assistance Visit
SGHARP Surgeon General's Human and Animal Research Panel
USD(P&R) Under Secretary of Defense for Personnel and Readiness
Air Force Medicine

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