What an IRB Is:

IRB reviews research to determine whether it is:

• Ethical
• Legal
• Scientifically sound enough to justify involving humans

Specifically, the IRB evaluates:

• Study purpose and design
• Risks vs. potential benefits
• Informed consent language
• Recruitment methods
• Data security and confidentiality
• Protections for vulnerable groups (e.g., veterans, trauma survivors, justice-involved individuals)

IRB review is typically required when:

• Research involves living human subjects
• Data are collected through interaction or intervention (interviews, surveys, therapy, observation)
• Identifiable private information or biospecimens are used
• Research is conducted for publication, presentation, or funding
• Research is federally funded (NIH, DoD, VA, etc.)

Even non-clinical studies, like interviews, program evaluations, or trauma narratives, may require IRB review.

An IRB is not:

• A funding agency
• A publisher
• A rubber stamp
• A legal defense shield
• A guarantee that research will be approved

Payment to an IRB NEVER guarantees approval.

IRBs exist because of past abuses in research, including:

• The Tuskegee Syphilis Study
• Human experimentation without consent
• Exploitation of marginalized groups

These failures led to federal protections now codified in:

• 45 CFR 46 (The Common Rule)
• The Belmont Report, which established three ethical principles:
  • Respect for persons
  • Beneficence
  • Justice

For an organization like Combat Support Institute (CSI):

• Veterans are a vulnerable population
• Trauma-informed care requires extra ethical care
• Research often intersects with justice, health, and policy
• Ethical oversight protects participants, researchers, and CSI’s credibility

An IRB ensures CSI’s work is trusted, publishable, and defensible.