As a trusted partner to the industry’s top sponsors and leading research institutions, our highest priority is ensuring that our client’s trials and studies comply with all regulations: ensuring the protection of the rights and welfare of human research participants.
About Federal Wide Assurance (FWA)
An FWA is documentation stating that your institution will comply with federal regulations, maintain ethical research policies, and follow procedures to protect your research participants.
WCG IRB is registered with the Office for Human Research Protections (OHRP and FDA) as IRB00000533.
This registration enables us to be the IRB of record for HHS-supported or conducted research involving human participants under the FWA of a submitting organization.
Our Canadian board’s registration number is IRB00002354.
In addition to IRB registration, WCG IRB complies with:
- AAHRPP Standards
- U.S. Food and Drug Administration Regulations 21 CFR Parts 50 and 56
- U.S. Department of Human Health Services Regulations 45 CFR 46
- International Conference on Harmonisation (ICH) E6 Good Clinical Practices (GCP)
- Canadian Food and Drug Regulations Part C, Division 5
- Canadian Tri-Council Policy Statement (TCPS 2)
- Environmental Protection Agency 40 CFR Part 26
- Applicable federal and state laws