INSTITUTIONAL REVIEW BOARD (IRB)
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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.
Federal Agencies Guidelines and Regulations
(21 CFR 600) Biological Products
(21 CFR 812) Investigational Device Exemptions
New Clinical Trial Registration Rule
FDA Centers
Clinical Trial Registration
ClinicalTrials.gov Protocol Registration System
A public registry option for trials that require registration by law or as a condition for publication for ICMJE. To include a trial on this registry you will need to apply for an individual account. Use “University of Central Florida” when asked for your affiliation or facility.
International Committee of Medical Journal Editors (ICMJE)
For information on registration requirements for publication.
Resources: Lay Language for Consent Forms
“The Common Rule” Agencies
- Central Intelligence Agency
- NASA
- National Science Foundation
- National Institutes of Health
- U.S. Agency for International Development
- U.S. Department of Agriculture
- U.S. Department of Commerce
- U.S. Department of Defense
- U.S. Department of Education
- U.S. Department of Energy
- U.S. Department of Homeland Security
- U.S. Department of Housing & Urban Development
- U.S. Department of Justice
- U.S. Department of Transportation
- U.S. Department for Veteran Affairs
- U.S. Environmental Protection Agency
- U.S. Food and Drug Administration
- U.S. Product Safety Commission