The Secretary amends the Department's regulations governing the protection of human research subjects to add special protections for children who are involved as subjects of research. These amendments to the Department's regulations are needed to secure additional protections for children who are involved as subjects of research. The regulations will, for research involving children as subjects, remove exemptions for certain kinds of research, modify the informed consent provisions, and further limit the risks to which children may be made vulnerable. These amendments will make the Department's policy regarding the protection of children as research subjects consistent with the regulations of the Department of Health and Human Services and the Federal Policy for the Protection of Children as practiced by other research agencies of the Federal government.