Regulations and Requirements

Federal Regulations

DOE requires compliance with all applicable Federal requirements for the protection of human research subjects, including:

  • Department of Health and Human Services Office for Human Research Protections Requirements

All DOE-funded and conducted studies must comply with both:

a) 10 Code of Federal Regulations (CFR) Part 745External link (DOE’s implementation of 45 CFR Part 46, Subpart A (implemented by DOE as 10 CFR Part 745)

b) 45 CFR Part 46External link (all other subparts, as they relate to the study).

Food and Drug Administration Requirements (for Drug and Device-Related Studies Under FDA’s Purview)

a) 21 CFR Part 50, Protection of Human SubjectsExternal link

b) 21 CFR Part 56, CFR - Institutional Review BoardsExternal link

c) 21 CFR Part 812, Investigational Device ExemptionsExternal link

d) 21 CFR Part 312 Investigational New Drug ApplicationExternal link

e) 21 CFR Part 600, Biologic MaterialsExternal link

f) 21 CFR Part 361, Prescription DrugsExternal link

g) 21 CFR Part 54, Financial DisclosureExternal link

h) 21 CFR Part 58, Good Laboratory PracticesExternal link

Last modified: 4/11/2016 2:09:50 PM