- 1. Complete and consistent drugs and compounds table (Part H1)
All drugs, compounds, and medications that will be administered to an animal should be reflected in the ‘Drugs and Compounds’ table on the protocol application. The table asks for the dose, route and site administered, frequency and duration of administration, needle gauge, and purpose of the drug. Revisions are commonly requested due to a drug missing from the table that is mentioned elsewhere in the protocol, or the information provided about a specific drug is incorrect.
- 2. Complete CITI Training and the Medical History Forms (MHF)
All personnel listed in the protocol must complete the required CITI Training modules and submit the Medical History Forms (MHF) to the Laboratory Animal Program office before they can be approved to participate in a protocol. PIs should try to ensure that all personnel, including themselves, have met all the requirements before application submission. This will help reduce IACUC processing time.
For information on how to complete the CITI Training, please visit the IACUC Training page.
To learn more about the Medical History Forms, please review the Occupational Health and Safety Program page.
- 3. Clarify the method(s) of euthanasia
Investigators should review the AVMA Euthanasia Guidelines, even if euthanasia is not expected as a part of the protocol. IACUC cannot approve a protocol without verifying that the methods of euthanasia listed are appropriate, including any secondary methods as necessary.
- 4. Send all relevant documents to the IACUC
Any documents referenced in a protocol (Standard Operating Procedures, tables, graphs, flowcharts, etc.) should be attached to the application submission. Any applicable permits or approvals, such as IBC approval, should be sent to IACUC once the PI has received them.
- 5. Keep animal numbers consistent
Verifying that all animal numbers are consistent throughout the protocol can save time in the long run. The sum of the animal numbers listed in Part B5 of the application should equal the total maximum number of animals. Using a table to illustrate the number of animals per group or per procedure can also help keep the numbers consistent.
- 6. Describe the sterilization and disinfection methods
IACUC reviewers will want to know how supplies, equipment, and/or tools will be sterilized or disinfected. Common revisions include clarifying the method of sterilization of tools between animals, listing consistent agents throughout the protocol, or using the word sterilized and disinfected appropriately.
- 7. Confirm pharmaceutical or nonpharmaceutical grade drugs
The Guide requires that all nonpharmaceutical drugs be described, justified, and IACUC approved. In some cases, it may be necessary to use nonpharmaceutical drugs, but the justification will need to be listed on the application for IACUC review. It is also important to note that once a pharmaceutical grade drug is diluted, it is no longer considered pharmaceutical grade.
- 8. Clear and comprehensive methodology
The methodology section (Part F) should describe all activities of the study in a clear and concise manner that walks reviewers through the protocol from the beginning of the animal’s acquisition until the endpoint of the study. It is critical to remember that IACUC members come from a variety of backgrounds, including scientists, non-scientists, and ethicists. Details within the methodology section must address the three (or four) Rs: Reduce, Replace, Refine (Reuse).
Furthermore, the methodology section should be consistent with other sections of the application. For example, if a drug or compound is mentioned in the methodology, it should also be listed in Part H, experimental groups should total the same number as listed as Part B, etc.
Finally, while depth is required in this section, be mindful that the over-use of jargon, acronyms, and even standard techniques may distract reviewers.
- 9. Describe restraint time and the justification
Physical restraint is defined as manual or mechanical limitation of some or all of an animal's normal movement. Investigators may find it useful to review the SIU animal physical restraint policy. The IACUC reviewers will want to know how many times an animal will be restrained, for how long, and what the reason is for the restraint.