5.2 Pre-Award Required Assurances
The University of Utah promotes, through policy and process, the highest standards of regulatory compliance in all areas of sponsored projects, including but not limited to: protection of human subjects (IRB); appropriate use of animals in research (IACUC); appropriate handling of radioactive, hazardous and toxic materials and wastes; biosafety; conflict of interests and integrity in research. In addition, the reporting of research results, compliance with federal and international laws, assurance that charges to sponsored projects are allowable and allocable, and documentation of cost sharing are critical issues in university audits. Listed below are the regulatory areas of concern.
It is important that PI’s inform the University if their projects may include any areas covered by these compliance issues. To facilitate this, it is important that the second page of the document summary sheet, which pertains to these compliance issues, be filled out completely and accurately.
Faculty, students or staff planning to conduct any kind of research involving human subjects (surveys, clinical studies, basic research, chart reviews, etc.) must get approval from the Institutional Review Board (IRB) to comply with Federal Regulations (45 CFR 46).
No human subject research may be started if the IRB has not approved a project or if the one-year renewal has not been approved.
All clinical investigations, funded externally, are sponsored activities (not to be considered a gift or donation) and are subject to IRB approval.
The University of Utah IRB Federal Wide Assurance (FWA) Number is:
Any project involving the use of an animal, in particular vertebrate animals, must have the approval of the IACUC Committee.
This committee is charged with ensuring the humane use of animals in research and compliance with national policies, procedures and regulations. The services provided include; review of animal use protocols, assistance in ensuring appropriate housing and facilities for animals, and training of investigators and other individuals involved with housing a research involving animals. IACUC approval is not necessary in the case of insects.
The University of Utah PHS Animal Welfare Number is:
USDA Registration Number (Animal Subjects):