Guidance for the Preparation of an Animal Use Protocol
One of the most critical components for carrying out animal research at The Ohio State University is the submission of an Animal Use Protocol (AUP). The following guidelines are offered to assist you in completing an AUP not only correctly, but in an easy and timely manner. Please remember that the Institutional Animal Care and Use Committee (IACUC) is composed of your colleagues. Though the IACUC members wish to help investigators and facilitate research, they must also minimize time spent in Committee meetings while maximizing compliance with federal regulations. You can help the IACUC, and yourself, by doing your best to follow these guidelines in preparing your AUP. These guidelines list the most common problems the IACUC is faced with in reviewing Animal Use Protocols.
Most importantly, please use the most recent AUP form, and read the instructions on the form. If you experience problems, or have questions, make use of the resources available to you. Use the important information provided at this website, visit the Frequently Asked Questions section, or contact the IACUC support staff.
ORRP Website
- Under Forms you can access:
- All relevant forms related to Animal Use Protocols. Be sure to read the information listed with each form to insure that you select the correct one for your proposal or proposed change to an existing AUP.
- Personnel forms that must be completed for the Principal Investigator (PI) as well as anyone in the laboratory that will work on this protocol, including students, technicians, and post doctoral fellows.
- Under Regulations and Guidelines you can access:
- A list of IACUC Guidelines for several commonly used procedures including:Anesthesia/Analgesia, Documenting Animal Numbers, Blood Sampling, Tail Clipping, Housing of Animals in Laboratory Areas, Monoclonal Antibody Production, Polyclonal Antibody Production, Post Operative Care, Survival Surgery in Rodents, Therapeutic Agents, Tumor Production, and many other relevant topics.
- Under Training Requirements you will find links to Animal Usage Orientation and Training and Occupational Health and Safety Training required for all personnel on the an AUP.
- Under Occupational Health Program you will find links to register the PI and all personnel in the Occupational Health Program.This is required prior to IACUC approval of a proposed AUP.
- Under Meeting Dates you will find submission deadlines for AUPs for the IACUC, as well as the College of Medicine Pre-Review Committee and the Veterinary Medicine Pre-Review Committee.
Common Mistakes
- Consideration of Alternatives to Use of Animals:
Do not simply state that you need live animals! State what alternatives to the use of live vertebrate animals and/or animal tissues were considered, detailing how each alternative was considered and rejected for scientific reasons. For example, describe results from other research systems (computer models, tissue culture, clinical studies) and what their shortcomings are. - Justification for Numbers of Animals Requested:
Make it EASY for the Committee to understand!- Explain reasons for group size (published results, statistical analysis based on previous established difference in measurements etc.). State which statistical tests are being applied (e.g., power analysis).
- Clearly define the number of animals (e.g. 5 animals/group x 3 treatments x 4 time points x 2 different sexes = 120 animals). Define the groups, including controls, treatments, time points, etc.
- When you have a complex protocol, in which the same animals or subsets of animals are used for multiple procedures, tables and/or flow charts can be useful to make things crystal clear to Committee members.
- If you have a breeding protocol, in which many animals will not be used after genotyping, please make sure that the total number of animals produced and the total number actually used in the experiments/observations, can be clearly understood.
- When describing the number of offspring used, separate your numbers into those that will be used exclusively for breeding and those that will be used in experiments.
- Make sure your numbers add up and that they are consistent with what you enter under Animal Source in the next section.
- When you use euthanized animals for organ culture, provide rough estimate for the number of animals (e.g. we will get 3x107 cells per liver and need 6x107 cells per experiment, for 15 experiments that means 30 animals).
- Animal Source
Please be sure to include the animals in one section only.For example, animals that are going to be purchased for use in breeding colonies should be placed in section 12 b only. In addition, in section 12 b the number of animals to be used should only include the experimental animals. Any offspring that will be later used as additional breeders should be included in the total number of expected offspring.
- Protocol Description
First, remember that the protocol you submit is a “stand alone” document. Do not refer to procedures in other protocols or publications or assume that they are so generally used that everyone will know what you will do. Describe all procedures. The Committee members do not have access to previous protocols, nor do they have time to look up references in the literature. Use the IACUC Guidelines section of the ORRP Website for descriptions of commonly used procedures.
- Pain or Distress
All 3 sections (Before, During, and After Surgery) do not have to filled in if it does not apply to your specific study. For example, if it is an acute study where the animal will not recover from anesthesia, Post surgical recognition of pain does not have to be considered. If there is no surgical procedure, you do not have to fill in the During Surgery box. Studies involving tumor development should consider During and After Surgery (implantation) signs of pain/distress.
The question is not what pain or distress will usually occur during the procedures you wish to perform, although this is clearly important, but whether are you prepared if things do not go as expected? If during your procedure pain or distress is experienced by animals what will you do? (example: incomplete anesthesia is recognized by xxxxx signs; it is corrected (alleviated) by increasing the anesthetic)
It is good practice to add a sentence that indicates if post-surgical pain is recognized you will consult with an attending veterinarian to discuss disposition of the animal. In some cases euthanasia may be appropriate, in others additional analgesics/antibiotics may allow you to keep the animal in the study.
- Consideration of Alternatives or Distressful Procedures
The key words MUST include the (potentially) painful or distressful procedure(s).
The search narrative has to specifically address your findings in respect to the (potentially) painful or distressful procedure. Were any alternatives discussed? If so, how do they relate to your study. If this is the standard for this type of research, indicate this.
- Early Removal Criteria
Early removal criteria are designed to recognize pain and distress in animals. They are particularly important to correctly identify moribund animals that can be euthanized and spared from suffering. Be specific and focus on the most meaningful criteria. It is your animal model and you have to inform the Committee about the parameters you will measure.Be sure to relate criteria to specific aspects of your protocol.
In considering weight loss, be sure to indicate the time period over which the weight loss is evaluated.
- Personnel Forms and Training
Personnel forms are required for everyone working on the protocol.This includes the PI, even if they will not have direct contact with the animals. They are still supervisors of the project.
The IACUC Support staff will be verifying that everyone involved in the care and use of animals have completed the requirements to participate in the work under the proposes AUP. You can save time and decrease the risk of your AUP being delayed in the review process by assuring that all the personnel on the protocol have completed the following requirements:
- PERSONNEL FORM: A separate IACUC Personnel Form must be completed and submitted for each individual on a protocol.
- ANIMAL HANDLER TRAINING: Each individual involved in the care and use of animals must obtain a basic level of competency in these areas through either participation in the classroom or in the online Animal Use Orientation Course. This training must be completed within the last three years.
- OCCUPATIONAL HEALTH AND SAFETY TRAINING: Each individual involved in an IACUC Animal Use Protocol must receive basic training in the use of hazardous chemicals and biological agents/materials through completion of the online Occupational Health and Safety Course. This training must be completed within the last three years.
- OCCUPATIONAL HEALTH RISK ASSESSMENT: Each individual involved in an IACUC Animal Use Protocol must have completed a current Occupational Health Risk Assessment via the Occupational Health Registry.
- CONFLICT OF INTEREST SCREENING/DISCLOSURE: The Principal Investigator and all Co-Investigators involved in an IACUC Animal Use Protocol must have a completed OSU Financial Conflict of Interest Screening/Disclosure Form on file with the ORRP.
The Committee is not interested in lengthy descriptions of in vitro experiments. (These requirements are contrary to most grant applications. Therefore do not simply copy your grant application into the AUP.) It should be easy for the reader to relate the experiments to the number of animals under section 12 of the AUP. You should briefly describe your aims and correlate it with your description under the Abstract and the Justification for Number of Animals Requested. It helps if you use common numbering systems in both sections.
The Committee needs to have information on all details relating to injections of drugs, virus vectors, etc. including routes of injection, volumes, site of blood draw, number of bacteria/viruses, etc.
The endpoints for all experiments need to be clearly defined. For chronic experiments, include how long will animals survive following a procedure, as well as their final disposition (e.g., euthanasia).Justify if death is an endpoint.
