Answer: The regulations that apply to research with children are known as: Subpart D.
Explanation:
The regulations at 45 CFR part 46, subpart D set by the Department of Health and Human Services (HHS) allow Institutional Review Board (IRB)'s research institutions involve children in their investigations. In order to approve children's participation in the research, the HHS have established three categories:
45 CFR 46.404
Requirements to be met:
- Children need to be safe while they participate in the research.
- Parents or guardians must approve children's participation.
45 CFR 46.405
Requirements to be met:
- There is a minimum risk for children who participate in research.
- Inform that children obtain some direct benefit by participating in the research.
- Parents or guardians must approve children's participation.
45 CFR 46.406
Requirements to be met:
- There is a minimum risk for children who participate in research.
- Clarify that researchers might identify a disorder or condition in the children involved in the investigation, allowing in that way, the understanding of that disorder or condition.
- Parents or guardians must approve children's participation.
