• Research involving children must not present greater than minimal risk.
  • The VA medical facility Director must approve participation in the proposed research that includes children.
  • Research involving biological specimens or data obtained from children is considered to be research involving children even if de-identified. If the biological specimens or data were previously collected, they must have been collected under applicable policies and ethical guidelines.
  • The IRB must have the appropriate expertise to evaluate VA research involving children and must comply with the requirements of 45 CFR 46.401 – 46.404 and 46.408.