Overview

The role of the Institutional Review Board (IRB) is to ensure compliance with all Federal regulations, state and local laws, and University policies for the use of human participants in research. Applicable Federal regulations are mandated by the Department of Health & Human Services (DHHS) and the Food and Drug Administration (FDA).

For detailed information regarding specifics on Federal laws and regulations, please click on the links below.

Human Subject Federal Regulations

• Human Subject Regulations Decision Charts
• 45 CFR 46 / "The Common Rule"
• 21 CFR 50 and 56 / Protection of Human Subjects; Informed Consent; Standards for Institutional Review Boards for Clinical Investigations
  
• 21 CFR 812 / Investigational Device Exemptions
• Expedited Categories 45 CFR 46.110
• Exempt Research 45 CFR 46.101(b)
• Exempt Research at UCF (Word)
• FDA Regulations
• OHRP Home Page

Other Federal Regulations That May Apply to Human Subjects:

• Family Educational Rights & Privacy Act (FERPA)
• Protection of Pupil Rights Ammendment (PPRA)
• Certificates of Confidentiality
• OHRP Guidance on Engagement of Institutions
• International Research