OHRP

FDA

  • Food and Drug Administration
  • Frequently Asked Questions Regarding Protection of Human Subjects of Research
  • Human Subject Protection (Informed Consent): 21 CFR Part 50
  • IRB Regulations: 21 CFR 56
  • Information Sheets: Guidance for IRBs, Clinical Investigators, and Sponsors
  • Investigational New Drug Application: 21 CFR Part 312
  • Investigational Device Exemptions: 21 CFR Part 812

Ethical Principles & Codes

  • Belmont Report
  • Declaration of Helsinki (World Medical Association)
  • NIH Bioethics Resources on the Web
  • Nuremberg Code
  • National Bioethics Advisory Commission (NBAC)
  • Public Responsibility in Medicine and Research (PRIM&R)
  • The President’s Council on Bioethics

Good Clinical Practices

  • Good Clinical Practice in FDA-Regulated Clinical Trials
  • Good Clinical Practice Contacts
  • ICH E6: Good Clinical Practice: Consolidated Guidance
  • Medical Devices (Device Advice)

HIPAA

  • IRBs and the HIPAA Privacy Rule (NIH)
  • NIH Guidance on Protecting Personal Health Information in Research (NIH)
  • NIH Guidance on Research Repositories, Databases, and the Privacy Rule (NIH)
  • NIH Guidance on Clinical Research and HIPAA Privacy Rule (NIH)