Contact the IRB-SBS

SBS
irbsbshelp@virginia.edu
Phone: (434) 924-5999
Fax: (434) 924-1992

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Regulations

• Federal Register- 21CFR312: Investigational New Drug Applications Title 21, Chapter FDA, Part 312
• Federal Register- 21CFR812: Investigational Device Exemptions Title 21, Chapter FDA, Part 812
• 45 CFR Part 46-Code of Federal Regulations- Public Welfare: Protection of Human Subjects
  • Subpart A   Federal Policy for the Protection of Human Subjects
  • Subpart B  Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research
  • Subpart C  Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
  • Subpart D  Additional DHHS Protections for Children Involved as Subjects in Research
    
•   21 CFR Part 50- Protection of Human Subjects
•   21 CFR Part 56- Institutional Review Boards