Protocol Review Waiver
Certain specialized animal use activities may be exempt from standard Institutional Animal Care & Use Committee (IACUC) review processes. Principal Investigators (PIs) who believe that their study may qualify for an exemption must have their proposed project reviewed by the Animal Care & Use Office (ACUO) before beginning any work.
Photo credit: “The fruit fly—Drosophila melanogaster” by NASA’s Marshall Space Flight Center is licensed under CC BY-NC 2.0.
In accordance with the Animal Welfare Act and Public Health Policy on the Humane Care and Use of Laboratory Animals (PHS Policy), ALL research, instructional, training, and/or testing activities conducted under University auspices that use vertebrate animals or cephalopods MUST be reviewed and approved by the Institutional Animal Care & Use Committee (IACUC).
Certain projects – outlined in greater detail below – may not require IACUC review and approval; however, the project’s activities must first be reviewed by the Animal Care & Use Office (ACUO) to determine whether the proposed project is exempt from the U-M’s standard IACUC review process.
Activities That May Be Exempt from Standard IACUC Review Processes
Standard IACUC review and approval processes MAY not be required for animal use activities that include – but are NOT limited to – the following:
- Non-cephalopod invertebrates, such as insects.
- Embryos (e.g., unhatched amphibian and/or reptile eggs, bird eggs prior to the start of hatching, larval fish less than 7 days post-fertilization).
- Animal tissues or organs collected from animals euthanized under an existing IACUC approved protocol.
- Animal tissues or organs acquired from commercial sources (i.e., grocery stores or USDA-inspected slaughter facilities).
- Established cell lines and/or biological fluids categorized as standard inventory from a commercial supplier.
- Vertebrate animals that will be observed in a manner that does not materially alter the behavior of the animal.
- Whole-bodied dead animals or identifiable animal parts.
Institutional Animal Care & Use Committee Review Waiver Request Form
PIs who believe that their project may be exempt from standard IACUC review processes based on the criteria above should complete the IACUC Review Waiver Request Form. The Animal Care & Use Office, acting on behalf of the IACUC, will review all waiver requests to determine applicability.
Please note: No project activities may begin UNTIL a formal determination letter has been received. A separate waiver request form must also be submitted for EACH individual project proposed by the PI/Study Team.
Special Considerations
Although cephalopod use is NOT currently covered by the federal PHS Policy, the U-M Animal Care & Use Program is still responsible for ensuring that PIs who use these animals in their research adhere to appropriate animal welfare standards. As such, the IACUC Review Waiver Request Form should also be used to report any proposed research activity that may involve the use of cephalopods.
Custom-produced antibodies (using ascites) purchased commercially may require that the vendor have an active PHS Assurance per grant agency (e.g., NIH) requirements.
Some scientific journal editors may require an exemption letter prior to publishing studies that did not undergo a standard IACUC review. PIs who plan to publish data obtained from an exempt project should also complete the IACUC Review Waiver Request Form to obtain a formal exemption letter from the institution to support any potential publication(s).
Requesting a Protocol Review Waiver
PIs who believe that their project may be exempt from the U-M’s standard IACUC protocol review process should complete the IACUC Review Waiver Request Form.
The ACUO, acting on behalf of the IACUC, will review the waiver request to determine applicability and a formal determination letter will be sent within approximately two weeks of form submission.
Please note that a separate waiver request must be submitted for EACH individual project, and no project activities may begin UNTIL a determination letter has been received from the ACUO.
Related A-Z Documents
References and Resources
Questions?
If you have additional questions about requesting a protocol review waiver or are unsure about whether your project is subject to standard IACUC review processes, please contact the Animal Care & Use Office at (734) 763-8028 or [email protected].