Federalwide Assurance (FWA) & IRB Registration Numbers

Federalwide Assurance (FWA)

Pursuant to Section 491 of the Public Health Service Act 42 U.S.C 289, and to human subject protections regulations 45 C.F.R 46.103, the University of Miami has a Federalwide Assurance (FWA) approved by the Office of Human Research Protections in the Department of Health and Human Services. The University’s FWA number is FWA00002247 and expires August 31, 2025.

Through its Federalwide Assurance, the University has agreed to conduct the review of human research in accordance with all requirements of Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46). The University of Miami has not “checked the box," permitting the UM IRBs to exercise additional flexibility. The various Standard Operating Procedures available in the IRB Library delineate the ways in which the UM IRB may deviate from the federal regulations.

IRB Registration Numbers

There are five IRBs at the University of Miami for the review of research involving human subjects. These IRBs are as follows:

  1. Medical Sciences IRB-A (IRB00005621)
  2. Medical Sciences IRB-B (IRB00005622)
  3. Medical Sciences IRB-C (IRB00006078)
  4. Social and Behavioral Sciences IRB (SBS-IRB) (IRB00000260)
  5. UM Central IRB (IRB00010711)

In addition, the University has executed IRB Authorization Agreements with external IRBs including, but not limited to:

  • National Cancer Institute Adult Central IRB (NCI-CIRB) (IRB00000781)
  • National Cancer Institute Pediatric Central IRB (NCI-CIRB) (IRB00004296)
  • Florida Department of Health IRB (IRB00000456 & IRB00005334)
  • Western IRB (WIRB) (IRB00000533)
  • Fred Hutchinson Cancer Research Center IRB