Federal Regulations and Resources

All Studies

• 45 CFR 46 (45 Code of Federal Regulations 46: Federal policy on the protection of human subjects from the Department of Health and Human Services)
• Belmont Report
• Office for Human Research Protections (OHRP)

Studies Using Investigational Drugs, Devices, or Biologics (also includes Medical Device Data Systems)

• 21 CFR 50
• 21 CFR 56
• 21 CFR 312 (IND studies)
• 21 CFR 812 (IDE studies)
• 21 CFR 880 (Medical Device Data Systems)

Campus, State, and Federal Policies

• California Research Subjects Bill of Rights description including English/Spanish documentation (Medical Experimentation)
• California Department of Public Health Guidelines for Human Stem Cell Research
• FERPA: Family Educational Rights and Privacy Act
• HIPAA: University of California Health Insurance Portability and Accountability Act of 1996 guidelines
• UCSB Research Circular D.2: Campus policy on the Use of Human Subjects
• University of California Policy on Protection of Human Subjects
• University of California Research Data Policy

Additional Resources

• NIH FAQs "Human Subjects Research - Human Specimens, Cell Lines or Data"
• OHRP - Guidance on Research Involving Coded Private Information or Biological Specimens
• OHRP International Compilation of Human Research Standards
• Genomic Data Sharing - Institutional Certification Process
• NIH 2023 Data Sharing & Management Policy - Considerations for participant data