IRB Policies and Regulations

UC Davis Policies

• UCD Health Research Policies and SOPs (intranet access required)
• Research Involving Human Subjects
  Policy and procedure manual, Section 240
• IRB Administration Standard Operating Procedures

UC Systemwide Policies

• UCOP Policies on Research (including human subjects)
• UC Contracts and Grants Manual
  Chapter 18, Sections 100 through 999
• Research Administration Records: Retention and Disposition Requirements 

California State Laws and Regulations

• California Health and Safety Code Section 24170-24179.5 (PDF) (Effective 4/03/2006)

Federal Laws and Regulations

• Federalwide Assurance UC Davis’ Federalwide Assurance Number (FWA#) is 00004557, and is approved up to April 19, 2028. The University of California, Davis (IORG0000251), in accordance with its Federalwide Assurance (FWA00004557) with the Department of Health & Human Services, adheres to all federal and state regulations related to the protection of human research subjects, including 45 CFR 46 (“The Common Rule”), 21 CFR 50, 21 CFR 56 for FDA regulated products, and the principles of The Belmont Report and Institutional policies and procedures. In addition, the International Conference on Harmonization, Good Clinical Practice (ICH GCP) principles are adhered to insofar as they parallel the previously mentioned regulations and policies.

• Terms of Assurance
• Office of Human Research Protections (OHRP)
  • DHHS-OHRP Regulations – 45 CFR 46
• U.S. Food and Drug Administration (FDA)
  • FDA Regulations – 21 CFR 56