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Regulations & References

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Regulations and other References

  • NIH Office for Human Research Protections Institutional Review Board Guidebook, 1993
  • Code of Federal Regulations (CFR)
  • 45 CFR 46 Protection of Human Subjects
  • 21 CFR 50 Protection of Human Subjects
  • 21 CFR 54 Financial Disclosure
  • 21 CFR 58 Good Laboratory Practice

Regulatory Agencies

  • US Dept. of Health & Human Services Office for Human Research Protections
  • US Food & Drug Administration Clinical Trials/Human Subjects Protection