The National Research Act of 1974 mandated that the Department of Health and Human Services develop regulations for the protection of research subjects.

These regulations, as amended in 2001, are sometimes referred to at 45 CFR 46, a designation that describes their location in the Code of Federal Regulations (CFR).

The full text of the regulations with internal links is available for investigators to study. In brief, 45 CFR 46 does the following:

• Defines activities that are subject to regulation
  
• Details the composition and function of an IRB
  
• Describes expedited review procedures
  
• Lists the criteria for review of research
  
• Provides a detailed description of the informed consent process, including waivers
  
• Describes the process for documenting consent, including waivers
  

There are three subparts of the regulations that include additional protections for vulnerable populations:

1. Pregnant women, fetuses, and neonates
2. Prisoners
3. Children