Local Policies and Federal Regulations

CWRU IRB Policies and Procedures

The CWRU IRB continues to update its guidance documents.  This guidance is meant to serve as a tool for faculty, staff, and students who perform social science/behavioral studies, and low-risk biomedical research not conducted in a hospital setting.

CWRU Guidance

University Policy on Human Participants in Research (updated 2019-20)


Data Use Agreements and Material Transfer Agreements for all Human-related data and Human-derived samples


Federal Regulations and Guidelines

45 CFR 46
The Code of Federal Regulations (45 CFR 46) can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

21 CFR 56

The Code of Federal Regulations (21 CFR 56) can be found at https://www.ecfr.gov/cgi-bin/text-idx?SID=c89b6ebbaec8c08db37ef0932fb80b6c&mc=true&tpl=/ecfrbrowse/Title21/21cfr56_main_02.tpl

Case Western Reserve University Federalwide Assurance
CWRU has a Federalwide Assurance (FWA) with the U.S. Department of Health and Human Services Office of Human Research Protections OHRP.

CWRU FWA number: FWA00004428
CWRU IRB registration number: IRB00000683

The terms of our Federalwide Assurance can be found at http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html