There are federal policies and regulations that have specific requirements regarding review of proposed animal activities. This includes:
Note that the AAALAC accreditation has no regulatory authority but institutions can assure the PHS that they are complaint with the PHS policy.
Provide a basic overview of the proposed study so that everyone on the committee can understand it, regardless of their level of scientific knowledge. This overview should also help them understand the societal implications of the proposed study. When writing the IACUC submission, it’s important to note that this section cannot be a summary of the aims listed in the grant application.
Researchers must also consider the potential value of the study and how it will contribute to the enhancement of human or animal health and the good of society. The potential benefits of the study should outweigh any pain, discomfort, or distress experienced by the animals.
The PI must provide the reasoning behind their selected animal model. It is their responsibility to select the optimal species for the project with consideration of financial and housing restraints. Generally, monetary costs are not an adequate justification and should not be a significant factor in choosing an animal model. The rationale used should be scientifically based and relate back to the goal of the study. Essentially, the PI must prove to the reviewers that the animal model selected will address the hypothesis and research questions proposed. The PI should also explain why they didn’t choose an animal lower on the phylogenetic scale.
In this section of the IACUC submission, PIs should consider the three Rs: Replacement, reduction, and refinement.
This section is heavily scrutinized by IACUC as there is an ethical requirement to use the least number of animals possible. The experiment should be designed so that the most amount of info can come from the least number of animals while considering attrition. Additionally, the AWRs require proof that the new project is not duplicating previous studies to prevent unnecessary use of animals.
A flow chart helps to explain the animal numbers. This is especially true if the study has a complicated breeding scheme or is a combination of several studies in one. The IACUC will specifically look for how the group sizes were determined, what statistical parameters and power calculations were used to achieve statistically valid results. If statistical analysis is not possible, the AWRs allow other methods such as published literature that used the same or similar animal models. For in vitro studies using animal tissue, the justification can be based on the amount of tissue or cells needed.
Breeding colonies should be the right size to provide enough animals for the experiment without producing too many extras that will be needlessly euthanized. Further, IACUC will want an explanation for any unwanted phenotypes created. The PI should include any other potential uses for unwanted genotypes, for example, they can be used for training staff or in a pilot study.
Researchers should investigate the possibility of sharing individual experimental animals or animal tissues between compatible research groups as long as the experiments are not inhumane or scientifically conflicting. Additionally, it may be useful to consult with experts regarding the statistical analysis required for animal numbers or any database searches to identify potential alternatives. This can be beneficial as it provides the IACUC with information they want from the start, saving time in the long run.
The name, class, and schedules of administration of any anesthetics, analgesics, sedatives, or tranquillizers used should be described. It is a good idea to include a range of dosage to allow for flexibility during the procedure. Note that many institutions may already have a preferred formulary of recommended anesthetics and analgesics developed by an attending veterinarian. If a PI prefers to use an anesthetic that is not on that list, it’s best to meet with the attending veterinarian to find an option that meets both the scientific needs and clinical recommendations.
The submission process varies with the institution. The actual submission can be done online through a portal or a text document. After submission, there could be a pre-review process to ensure that all sections are completed, and all documents required are included. Many IACUCs will have a Veterinarian do the prereview to be sure that the procedures are properly described, appropriate drugs are being used, and intervention plans are addressed.
After the pre-review, the submission moves to the review process. The outcome of the review can include approval, requirement of modifications to secure approval, and approval withheld. In some cases, the IACUC will approve a submission as a pilot study. This happens when there are new procedures proposed. The approval is for a limited time on a small number of animals. Once the pilot study is reviewed, the PI can submit a protocol for the full study.
