Policy and Regulatory Information

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

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

• SLU FWA #: 00005304
• SLU IRB #1: IRB00000158
• SLU IRB #2: IRB00003984
• SLU IRB #3: IRB00005627

SLU IRB Standard Operating Policies and Procedures

• IRB Review Fee Schedule
• IRB Assurance of Compliance
• IRB Membership Composition
• IRB Member Conflict of Interest Assurance
• FDA Certification - Electronic Signature Acceptance
• eIRB PDF Clarification Document
• eIRB Approval Letter Clarification Document
• eIRB Acknowledgment Letter Clarification Document