Statement of Compliance, Federalwide Assurance Information and Fee Schedule
Statement of Compliance
The University and Medical Center Institutional Review Board is duly constituted, allows only those IRB members who are independent of the investigators and the sponsor of the research to vote, has written procedures for initial and continuing review of research studies, prepares written minutes of convened meetings, and retains records pertaining to the review and approval process. Read ECU UMCIRB’s full statement of compliance here (PDF).
Federalwide Assurance Information
According to Department of Health and Human Services (DHHS) regulations 45 CFR 46.103, every institution engaged in human research supported or conducted by DHHS must obtain an assurance of compliance approved by the Office for Human Research Protections (OHRP). The Federalwide Assurance Signatory Official must be authorized to represent and commit the entire institution and all its components to a legally binding agreement.
- ECU’s FWA number is FWA00000658
- Vidant Health’s FWA number is FWA00029007
The OHRP has also developed an IRB registration system. Registration of an IRB or independent ethics committee (IEC) with the OHRP is voluntary. However, IRB/IEC registration is required for any institution or facility that receives federal funding. IRB registration is also mandatory for research that involves Food and Drug Administration articles that fall within its purview. The registration process is coordinated through the OHRP.
Both the Biomedical and Behavioral and Social Sciences IRBs at ECU are registered with the OHRP and the FDA. The registration numbers for those committees are:
- IRB00000705 East Carolina U IRB No. 1 (Biomedical)
- IRB00003781 East Carolina U IRB No. 2 (Behavioral and Social Sciences)
There are fees scheduled with research involving humans reviewed by the UMCIRB. Click here to review fees associated with human research at ECU (PDF).