Thorough preparation of animal use-protocols facilitates the review process and reduces the chance of delay in initiating projects. Investigators with questions about protocol preparation are encouraged to contact the IACUC Office.
General information: Animal-use protocol
The animal-use protocol is a detailed description of the proposed use of laboratory animals. The following topics should be considered in the preparation of the protocol by the researcher and its review by the IACUC:
- A clear and concise sequential description of the procedures involving the use of animals that is easily understood by all members of the committee
- Availability or appropriateness of the use of less invasive procedures, other species, isolated organ preparation, cell or tissue culture, or computer simulation (see Appendix A, Alternatives)
- Justification of the species and number of animals proposed; whenever possible, the number of animals and experimental group sizes should be statistically justified (e.g., provision of a power analysis; see Appendix A, Experimental Design and Statistics)
- Unnecessary duplication of experiments
- Nonstandard housing and husbandry requirements
- Impact of the proposed procedures on the animals' well-being
- Appropriate sedation, analgesia, and anesthesia (indices of pain or invasiveness might aid in the preparation and review of protocols (see Appendix A, Anesthesia, Pain, and Surgery)
- Conduct of surgical procedures, including multiple operative procedures
- Post-procedural care and observation (e.g., inclusion of post-treatment or post-surgical animal assessment forms)
- Description and rationale for anticipated or selected endpoints
- Criteria and process for timely intervention, removal of animals from a study, or euthanasia if painful or stressful outcomes are anticipated
- Method of euthanasia or disposition of animals, which includes the planning for care of long-lived species after study completion, adequacy of training and experience of personnel in the procedures used, and roles and responsibilities of the personnel involved
- Use of hazardous materials and provision of a safe working environment
Once approved by the IACUC and subsequently funded by the granting agency, the protocol becomes a public document. Accordingly, investigators should anticipate that the protocol may be reviewed by the general public.
Resources
Everything you need to know about satisfying IACUC protocol requirements
Top 10 reasons that IACUC submissions are not approved
1. Not enough information
The protocol does not clearly express either the rationale behind the experiments, the justification for the use of live animals, or the details of the procedures used. Be sure to review all sections of the protocol narrative application and provide ALL requested information.
2. Too much information
The Experiment section must provide an overview of the project as a whole, including the rationale for the experiments, a summary of the experimental groups and what procedures will be performed on them, and the timeline for those procedures. Details about the procedures should be included in the procedures themselves and it should be clear exactly what will happen to each of the animals and why.
3. The Summary of Research is too technical
The Summary of Research is meant to be a lay summary of the project as a whole. It should be clearly understandable to people with little or no background or experience in your area of expertise. Leave out jargon and technical terms. Provide an explanation of what you plan to do that is suitable for a newspaper article or non-scientific cocktail party chatter.
4. The consideration of alternatives to the use of live animals has not been documented
The IACUC understands that review of the scientific literature is an ongoing part of the research process; however, it must be documented in the protocol in order to meet the requirements of USDA Animal Care Policy #12. The IACUC protocol application form has been specifically designed to guide researchers in appropriately documenting the consideration of alternatives.
5. Animal numbers are not adequately justified
The number of animals requested for the experiments must be adequate to achieve the research goals of the study. Researchers must provide an explanation for how the number of animals was determined. Wherever possible, statistical power analyses should be employed.
6. Inconsistencies in the narrative
All sections of the protocol must be consistent. Procedures and agents mentioned in the Experiments section must be described in detail in the procedures; animal numbers and pain categories must be consistent throughout the protocol, etc.
7. Animal welfare issues
If an equivalent procedure is reasonably expected to cause pain, distress, or discomfort in a human being, you MUST assume that it would also cause pain, distress, or discomfort in an animal and address these issues accordingly in the protocol narrative. Monitoring and assessment parameters must be described in detail, and relief from potential pain and distress must be provided unless there is a strong scientific justification for withholding it.
8. Modification Mishap #1: Proposed changes not incorporated into the protocol
IACUC policy requires that the protocol be updated with each approved modification, which means that the proposed changes must be incorporated into the relevant protocol tabs and section.
9. Modification Mishap #2: Doesn't fit within the existing approved narrative
Proposed changes that significantly alter the originally approved protocol may be more appropriately submitted as a new stand-alone protocol.
10. Misclassified Procedures
The procedure type that was selected does not match the procedure that will be completed. Very rarely will procedures be listed as ‘other’. Please contact the IACUC Office with questions.