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APPENDIX A. Federal Regulations

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  1. 32 CFR 219: Protection of Human participants (the Common Rule)
  2. 45 CFR 46: Subpart B: Additional Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization; Subpart C: Additional      Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Participants; and Subpart D: Additional Protections for Children involved as Participants in Research
  3. 21 CFR 50: Protection of Human participants (FDA)
  4. 21CFR 54: Financial Disclosures by Clinical Investigators (FDA)
  5. 21 CFR 56: Institutional Review Boards (FDA)
  6. 21 CFR 312: Investigational New Drug (IND) Application (FDA)
  7. 21 CFR 812: Investigational Device Exemption (IDE) (FDA)
  8. 45 CFR 160 & 164: Health Insurance Portability and Accountability Act (HIPAA) of 1996 (
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