September 1, 2013
Statement of the Issue
UTD faculty who propose to engage in research activities involving animals are required to acquire approval of the research activity by the IACUC. Office of Research Compliance (ORC) supports the IACUC and serves as a liaison between the researchers and the Committee.
- NIH Guide for the Care and Use of Laboratory Animals
- Office of Research Compliance IACUC policies
- UTD Policy and Procedure, Institutional Animal Care and Use Committee (UTDPP1014)
- IACUC Quarantine Policy
- IACUC Breeding Policy
- NIH Grants Policy Statement – Part II: Terms and Conditions of NIH Grant Awards – Subpart A – Section 4.1.1 Animal Welfare Requirements
- Office of Laboratory Animal Welfare (OLAW)
- NIH and OLAW FAQs
- Public Law 99-158, Animals in Research
- United States Department of Agriculture (USDA)
- The IACUC review and approval process must be obtained prior to grant proposal submission or sponsoring agency deadlines. IACUC approval is often obtained prior to an award being funded.
- At the time of submission of a new, resubmission, revision, or renewal grant application status, indicate the IACUC approval as “pending,” if IACUC approval for the specific grant application is not available.
- For NIH grant applications, IACUC approval may be obtained “just-in-time” before the award is made. Nevertheless, the PI must consider the time involved in acquiring IACUC approval. An award will not be established by the Office of Sponsored Projects (OSP) without an IACUC approval. Investigators may initiate the process with the submission of an application to IACUC by submitting one of the following applications to ORC: (1) IACUC New Protocol Form, (2) IACUC Continuing Review form, or (3) IACUC Request for Revision Form.
- If a grant application is approved and is similar to an existing study with a current IACUC approval, the investigator is required to submit an amendment to include the new grant application to the currently approved protocol. ORC may provide an IACUC approval noting the amendment and approval of the grant application related to the existing protocol. An IACUC approval letter for an amendment will often have the same title.
- You may not use the “approval” status on grant applications with a current IACUC approval that is similar to the new grant application, unless the investigator has an amendment associated with the current IACUC approval. An approval to an amendment may have the same title and approval dates.
- During the submission of an annual progress report, you are required to include an IACUC approval letter in the file in order to be in compliance with the submission of the technical report.
- Animals may not be purchased, housed, or used for research activities without IACUC approval.
Acronyms and Definition
- AWA: Animal Welfare Act - The AWA was the first federal law in the U.S. regulating animals in research. The AWA applies to animal carriers, handlers, dealers, breeders, and exhibitors in addition to research laboratories, and sets minimum standards of care that must be provided for animals - including housing, handling, sanitation, food, water, veterinary care, and protection from weather extremes. The AWA has been amended numerous times over the years, the most recent in 2008.
- IACUC - According to U.S. federal law, institutions that use laboratory animals for research or instructional purposes must establish an Institutional Animal Care and Use Committee (IACUC) to oversee and evaluate all aspects of the institution's animal care and use program.
- OLAW - Provides guidance and interpretation of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training, thereby contributing to the quality of PHS-supported activities.
- USDA: - Animal Welfare Act regulations require institutions using animals in research to submit annual reports to the USDA and are subject to periodic inspections.