Full Board Review
For those projects that do not fit into the above two categories, a full board review by the IRB is required. This normally involves research within any of the protection participant (human subject) populations. These include fetuses, pregnant women, children, and prisoners. This also applies in some cases to severely vulnerable populations such as the mentally impaired or the elderly. See OHRP Federal Regulations.
Full Board review requires 30-40 business days for initial IRB review. The IRB highly recommends the application be submitted at least one 1 1/2 months before the proposed start date of the study.
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)
- when incomplete disclosure, misleading information or deception involves greater than moderate risk to participants
- the IRB staff, board member, or designee determines risks are greater than minimal
- vulnerable populations (Children, prisoner, pregnant women and neonates, per federal regulation)