Office of Research

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 7/19/10)
Audio, Video & Photography  (version 11/26/12)
CITI Training Requirements (version 2/3/09)
Confidentiality of IRB Records (version1/28/13)
Deception or Concealment (version 6/8/11)
Expedited Categories
Exemption Categories
GHS Submissions for Clemson Researchers (version 11/16/10) 
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
Researchers Not Affiliated with Clemson (version 4/6/09)
Responsibilities - Principal Investigator
Responsibilities - Research Team Members
Students as Research Participants
Translators/Interpreters as Research Team Members (version 3/5/13)
Verbal Consent Scripts (version 1/23/12)

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
PPRA (Protection of Pupil Rights Amendment): 34 CFR 98

For Federal Guidance, please go to Resources