Marshfield Clinic Research Institute Institutional Review Board (MCRI IRB) is a division of the Marshfield Clinic (MC). As a research ethics board, MCRI IRB is duly constituted, has written procedures for initial and continuing review of clinical trials; prepares written minutes of convened meetings, and retains records pertaining to the review and approval process; all in compliance with the regulations of the United States Food and Drug Administration (FDA) as described in 21 CFR Parts 50 and 56, the US Department of Health and Human Services (DHHS) regulations 45 CFR Part 46 as applicable, the International Conference of Harmonization (ICH) E6, Good Clinical Practice Guidelines along with local applicable laws.
MCRI IRB is registered with the DHHS for Human Research Protections (OHRP) with registration number IRB#00000673 as well as Food and Drug Administration (FDA). This registration expires July 8, 2018. Marshfield Clinic Research Institute’s Federal-Wide Assurance number is FWA00000873. The FWA expires February 11, 2020.
In March 2015, Marshfield Clinic was awarded a full three-year accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
Verification of AAHRPP Accreditation can be obtained on the AAHRPP website located at http://www.aahrpp.org.