IRB Assurance and Registration
The Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) require Institutional Review Boards to register through a system maintained by DHHS.
Under 21 CFR part 56, subpart B, each Institutional Review Board (IRB) in the United States (U.S.) that reviews clinical investigations regulated by FDA and each IRB in the U.S. that reviews clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products must register.
- Institution/Organization Name: Mercer U
- IORG Number: IORG 0000578
Mercer University's IRB Approved Registration
- Mercer University's Human Subject IRB Registration Number: IRB 00000910
- IRB Registration (Adobe PDF)
Federal Wide Assurance
- Mercer University's Human Subject FWA Number: FWA 00000133
Under 45 CFR part 46, subpart E, IRBs must be registered with OHRP before the IRB may be designated on an FWA as reviewing proposed research for the FWA-holding institution.
The Federal Wide Assurance (FWA) is the only type of assurance currently accepted and approved by OHRP (Office for Human Research Protections). Through the FWA, an institution commits to DHHS that it will comply with the requirements in the DHHS Protection of Human Subjects regulations at 45 CFR Part 46. Mercer University is required to have an assurance because it receives federal funding for research involving human subjects.
Animal Welfare Assurance
Mercer University is an Assured institution and is required and responsible for assuring congruency between animal activities described in grant applications and all IACUC approved activities.
- Mercer University's Animal Assurance Number: A3725-01
- Revised Animal Welfare Assurance (Adobe PDF)
For further information, please contact the Office of Research Compliance
Phone: (478) 301-4101
Fax: (478) 301-2329