Does research involving children include special requirements?
Yes. Subpart D of the HHS regulations at 45 CFR part 46 provides additional protections for children participating in human subjects research. Investigators conducting HHS-supported research must comply with the requirements of subpart D, as well as other subparts. The IRB must determine that all requirements of subparts A and D have been met. If the research involves pregnant minors, then the requirements of subpart B must be met and if the research involves incarcerated minors then the requirements of subpart C must be met. Subpart D’s additional protections include: • requiring IRB review of some research activities involving children that would be exempt if the research subjects were adults; • use of parental permission and child assent instead of the procedures for obtaining informed consent used for research involving adults; • conditions for IRB approval of proposed research activities in three categories depending on the level of risk and other specified features of the propose
