21 CFR 50 Subpart D – Protecting Children in Clinical Trials

Under the Common Rule and the regulations that govern the FDA, researchers must follow 21 CFR 50 subpart D to protect the health and safety of children in clinical trials. These regulations require investigators to follow specific guidelines when conducting research on children, including the establishing of risk-benefit categories and the requirements for obtaining parental assent.

The regulations also address additional protections for children and prisoners in human research, and apply to all non-exempt federally-funded human subject research. The regulations also outline the approval process for these trials. These regulations are an essential part of the human subject research process. To learn more about the regulations and the process, visit the FDA’s website.

The requirements for compliance with 21 CFR 50 subpart D are similar to those set forth in 45CFR 46. An investigator must propose a category of research and provide a scientific background for the study. He or she must also describe the mechanisms of obtaining the parental consent or the assent of a minor. These mechanisms must be adequate for obtaining informed consent.

The regulations also detail the rights and responsibilities of child participants in clinical trials. The regulations govern clinical investigations under the FD&C Act for research and marketing purposes. They also cover human drugs and biological products, medical devices and foods with health or nutrient claims. In addition, the regulations cover food additives and electronic products.