Studies that involve more than minimal risk require review at full board IRB meeting. The research requires approval from a majority of those members.
IRB duties are described in the Federal Regulation for Protection of Human Subjects (45 CFR 46).
See Also
Examples of Full Board Research
Research involving greater than minimal risk procedures and:
- clinical procedures with drugs, devices, or biologics, or innovative research into new medical or surgery procedures
- taking place internationally (particularly countries with little or no provisions for protection of human subjects) where subjects may be at physical, psychological or legal risk
- disclosure of information that could require mandatory legal reporting (e.g., child/elder abuse, etc.)
- deception
- the IRB staff, board member, or designee determines risks are greater than minimal
- vulnerable populations (Children, prisoner, pregnant women and neonates, per federal regulation)