Federal Regulations
The core regulations in place for research involving human subjects include:
- DHHS Regulations for the Protection of Human Subjects 45 CFR 46 (The Common Rule)
- DHHS Final Revisions to the Common Rule
- DHHS HIPAA Privacy Rule 45 CFR 160, 162, and 164
- DHHS HIPAA and Research
- FDA Regulations for the Protection of Human Subjects 21 CFR 50
- FDA Regulations for Institutional Review Boards 21 CFR 56
- FDA Regulations Relating to Good Clinical Practice and Clinical Trials
- FDA Drug Regulations 21 CFR 312
- FDA Device Regulations 21 CFR 812
- Comparison of FDA and HHS Human Subject Protection Regulations
- ICH E6 Good Clinical Practice
- NIH Genomic Data Sharing Policy
- NIH HIPAA Privacy Rule
- NIH Single IRB Policy for Multi-site Research
Additional Regulatory Considerations
Research may be subject to additional regulations or guidelines. Use the checklists below to ensure unique considerations are following in the following research:
- Additional Criteria Checklist: Department of Defense
- Additional Criteria Checklist: Department of Education
- Additional Criteria Checklist: Department of Energy
- Additional Criteria Checklist: Department of Energy - PI Checklist
- Additional Criteria Checklist: Department of Justice
- Additional Criteria Checklist: Environmental Protection Agency
FWA and IRB Registration Information
- SLU FWA #: 00005304
- SLU IRB #1: IRB00000158
- SLU IRB #2: IRB00003984
- SLU IRB #3: IRB00005627