Regulations & Policies

1. Clemson University IRB Policies and Guidance Documents
2. HSSC (Health Sciences South Carolina) Cooperative Agreement - IRBs
3. Research Division Policies Impacting IRB Protocols
4. Federal Regulations

1. Clemson University IRB Policies and Guidance Documents

Advertising for Research Participants (version 6/6/09)
Audio, Video & Photography  (version 4/20/09)
CITI Training Requirements (version 2/3/09)
Deception or Concealment (version 4/6/09)
Expedited Categories
Exemption Categories
GHS Submissions for Clemson Researchers
Human Cell Lines Obtained from Commercial Sources
Interventions in Research Studies (version 4/6/09)
Investigator’s Manual
Photovoice (version 4/6/09)
Post-Approval Monitoring
Research Site Letters
Responsibilities - Principal Investigator
Responsibilities - Research Team Members
Researchers Not Affiliated with Clemson (version 4/6/09)
Students as Research Participants

2. HSSC (Health Sciences South Carolina) Cooperative Agreement - IRBs

HSSC Cooperative Agreement - Institutional Review Boards
HSSC IRB Cooperative Review SOPs

3. Research Division Policies Impacting IRB Protocols

Assignment of Principal Investigator / Project Director Role
Proposals and Awards with Compliance Considerations

4. Federal Regulations

DHHS Regulations for the Protection of Human Subjects: 45 CFR 46 
DHHS Regulations — Subpart B: Additional Protections for Pregnant Women, Human Fetuses & Neonates 
DHHS Regulations — Subpart C: Additional Protections for Prisoners as Research Subjects 
DHHS Regulations — Subpart D: Additional Protections for Children as Research Subjects 
FERPA (Family Educational Rights and Privacy Act): 34 CFR 99 
HIPAA (Health Information Portability and Accountability Act): 45 CFR 160, 162, 164