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