Full Board Review

Studies that involve more than minimal risk require full board review at a convened meeting at which a quorum of IRB members is present. For the research to be approved, it must receive the approval of a majority of those members.

While federal regulations do not specifically list categories that require full board review, studies such as those listed below are normally sent to full board for review when part of the study design involves greater than minimal risk procedures:

  • studies involving clinical procedures with drugs, devices, or biologics, or innovative research into new medical or surgery procedures
  • studies 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
  • studies in which disclosed information could require mandatory legal reporting (e.g., child/elder abuse, etc.)
  • studies involving deception which raise the risk to subjects or others
  • studies in which the IRB staff, chair, member, or designee determines risk to subjects or others to be greater than minimal risk
  • studies using ‚Äúvulnerable populations”* and thus requiring extra protections
    *Children, prisoner, pregnant women and neonates