Policies & Compliance
- Research Conduct
- Combatting Human Trafficking
- Federal Disclosure Requirements
- Research Handbook
- 1. Roles & Responsibilities
- 2. Standards for Conduct of Research
- 3. Overview of Sponsored Projects Administration
- 4. Funding Sources & Opportunities
- 5. Proposal Development
- 6. Budget Development
- 7. Procedures for the Submission of Proposals
- 8. Award Acceptance
- 9. Award Management
- 10. Research Related Regulations, Policies & Procedures
- 11. Other Conduct of Research Issues
- 12. Acronyms & Definitions
- 13. Glossary
- Procedure Library
- Regulations Library
Proposal Development
5.2 Pre-Award Required Assurances
The University of Utah is committed to maintaining the highest standards of regulatory compliance in all sponsored projects. Through established policies and review processes, the University ensures compliance with applicable federal, state, sponsor, and institutional requirements throughout the proposal and award lifecycle.
Regulatory areas of oversight include, but are not limited to:
- Protection of human subjects (IRB);
- Care and use of animals in research (IACUC/OACC);
- Biosafety and appropriate handling of hazardous, radioactive, or toxic materials;
- Conflicts of interest and commitment;
- Research integrity and professional conduct;
- Compliance with federal and international laws and regulations; and
- Financial accountability, including allowability and allocability of costs and documentation of cost sharing.
These areas are subject to internal and external audit and oversight. Principal Investigators (PIs) are responsible for disclosing any proposed research activities that may trigger regulatory requirements so that appropriate reviews and approvals may be obtained.
To facilitate this process, PIs must complete the compliance section of the Document Summary Sheet (DSS) fully and accurately. Early and transparent disclosure helps prevent delays in proposal submission, award acceptance, or project start-up.
5.2.1 Use of Human Subjects in Research
Any research involving human subjects, including but not limited to surveys, interviews, behavioral studies, chart reviews, clinical investigations, or biomedical research, must receive approval from the Institutional Review Board (IRB) in accordance with federal regulations (45 CFR 46).
No human-subjects research may begin until IRB approval has been obtained, and continuing approval must be maintained throughout the life of the project, including annual renewals when required.
All externally funded clinical investigations conducted at or through the University are considered sponsored activities and are subject to IRB review and approval.
The University of Utah IRB Federal Wide Assurance (FWA) Number is: FWA00003745
5.2.2 Use of Animals in Research & Testing
Any project involving the use of live vertebrate animals must receive prior approval from the Institutional Animal Care and Use Committee (IACUC).
The IACUC is responsible for ensuring humane and ethical treatment of animals and compliance with applicable federal regulations and policies. Services provided include review and approval of animal use protocols, oversight of animal care and housing, and training of investigators and research personnel.
Research involving invertebrate animals (e.g., insects) generally does not require IACUC approval, unless otherwise specified by the sponsor or regulatory guidelines.
The University of Utah PHS Animal Welfare Number is:
D16-00018 (A3031-01)
USDA Registration Number (Animal Subjects):
87-R-0001
