Governing Regulations

Campus Institutional Review Board 483 McReynolds University of Missouri Columbia, MO 65211 573 882-9585 phone 573 884-0663 fax umcresearchcirb@missouri.edu

DHHS and FDA Regulated Research

Institutions accepting funds from federal sponsors must comply with the regulatory compliance requirements mandated by the agency. The University of Missouri-Columbia conducts federally sponsored human research and is therefore subject to the compliance requirements of the governing agency. The Campus Institutional Review Board (Campus IRB) is charged with assuring that all human subject research, regardless of sponsorship, conducted at the University of Missouri-Columbia complies with the federal regulations (45 CFR 46) of the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), the Belmont Report, State and Local Laws, and Campus IRB policies and procedures. A researcher may be subject to additional compliance requirements if they are conducting sponsored research from other agencies.

• 45 CFR 46
• 21 CFR §50

Federalwide Assurance (FWA)

The University of Missouri-Columbia entered into a Federalwide Assurance (FWA) agreement with the Department of Health and Human Services (DHHS) which defines MU's responsibilities and promise to comply with the governing regulations set forth by 45 CFR 46 and the ethical principles in the Belmont Report. MU assures DHHS that all research involving human subjects, regardless of the funding source, will be conducted pursuant to applicable federal guidelines.

MU's Federalwide Assurance number is: FWA00002876.

• Information on MU's Federalwide Assurance