“Common Rule”

Department of Health and Human Services (DHHS)

• 45 CFR 46
• Excerpts from Subpart A:
  • Exempt Research Categories
  • Expedited Review Categories
  • Criteria for IRB Approval of Research
  • General Requirements for Informed Consent
  • Waiver of Elements of Informed Consent
  • Waiver of Documentation of Informed Consent
• Subpart B: Additional Protections for Pregnant Women, Human Fetuses & Neonates Involved in Research
• Subpart C: Additional DHHS Protections Pertaining to Biomedical & Behavioral Research Involving Prisoners as Subjects
• Subpart D: Additional DHHS Protections for Children Involved as Subjects in Research

DHHS Office of Civil Rights

• Health Insurance Portability and Accountability Act (HIPAA) Privacy Regulations

DHHS Office of Human Research Protections (OHRP)

• Policy and Guidance

Department of Defense

• Directive on Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research

 Department of Navy

• Human Research Protection Program (DON HRPP) General and Training and Education Guidance

 Department of Education

• Family Educational Rights and Privacy Act (FERPA)

 Food and Drug Administration

• 21 CFR 56 Institutional Review Boards