Office of Responsible Research Practices
The Ohio State University

Guidance for the Preparation of an Animal Use Protocol

The following guidance is offered to assist you in completing an Animal Use Protocol (AUP).

If you experience problems, or have questions, please use the resources available to you, including the IACUC support staff or ULAR protocol consultant.

Technical Problems or General Information:
IACUC Office
Anthony Yonkura:  292-4494 or Yonkura.1@osu.edu

Protocol Content or Setup Questions:
ULAR Protocol Consultant
Angela Phillips:  292-3633 or Phillips.270@osu.edu

Part 1: The Protocol Form
Part 2: Answering Questions During Review

Part 1: The Protocol Form

Protocol Identification
When selecting the “Academic Unit”, you are selecting the endorsers in your department that will be viewing your protocol during the pre-review process.

Rationale for Using Animals
In this section, the IACUC is looking for you to discuss why alternatives to live animal cannot be used.  For example:  Describe why computer models, tissue culture, or perhaps clinical studies cannot be used to complete the objectives of your Protocol Aims.  Simply stating that you need live animals is not an appropriate response.

Protocol Groups
In this section, you are creating the “breakdown” of your animals.  The groups you create in this section will also be used in upcoming sections (such as Protocol Activities and Justification for Number of Animals Requested).

Each species must be in a separate protocol group. Animals of the same species that undergo different protocol activities (procedures) should be in separate protocol groups. However, when there are different experimental groups (in the same species) that will undergo essentially the same activities, they may be combined in a single protocol group.

Assign a short, descriptive title to each protocol group. It should be easy for the reader to relate the protocol groups to the number of animals requested in the Justification for Numbers section. If protocol groups are actually comprised of several experimental groups, simply identify these within the Activity Timeline. These same experimental groups may be referenced again in the Justification for Numbers section to support the total number of animals requested under the (larger) single protocol group.

Try to minimize the number of groups you create.  This will help simplify the completion of upcoming sections.

Animal Sources
If “Obtained Internally: Breeding” is selected for a particular group, then a number must be present in the breeding portion of the upcoming section “Justification for Number of Animals Requested” (for that group).

If “Obtained Internally: Breeding” and any other source is selected for the same group, then a number must be present in both the breeding portion and the non-breeding portion of the upcoming section “Justification for Number of Animals Requested” (for that group).

Housing Locations
If non-ULAR housing is being requested, please visit the IACUC Guideline Housing Requirements for Animals for more information.

Activity Timeline
In this section, the Committee is looking for a sequential order for when protocol activities are taking place.  The Timeline is designed to indicate what protocol activities will happen, and when, to each group of animals.  For each group, you should include the series of treatments to be carried out starting with arrival/enrollment in the study, to final disposition. Do not include a detailed description of the procedures.  This information will be collected in the protocol activities section.

Along with the sequence of activities, the Committee is also looking for the time between each procedure and if procedures are to be repeated.  Example:  For chronic experiments, include how long animals will survive following a procedure as well as their final disposition.

The endpoint for all experiments needs to be clearly defined.  If death (without intervention) is being used as an endpoint, then the Committee expects a scientific justification to be included in this section explaining why this endpoint is needed.

Protocol Activities
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.Select they type of Protocol Activity that best describes the procedure that is to be performed. Provide procedure descriptions in each of the Activities. Use the IACUC Guideline links that are provided for descriptions of commonly used procedures.  This section should correlate with what you included in Activity Timeline.

The Committee does not require 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 procedures (activities) to the experimental groups.

The Committee needs to have information on all details relating to injections of drugs, virus vectors, etc. including routes of administration, volumes, site of blood draw, number of bacteria/viruses, etc.  This information should be provided in the agent lists within each of the Protocol Activities.

The current standard of practice is that analgesics are to be given to animals following any survival surgery procedure.  You can contact the Veterinary Staff for assistance in choosing the correct analgesic and dose for your particular species and situation. You must provide scientific justification if you choose not to use an analgesic.  Please note, past history alone is not acceptable.

It is good practice to add a sentence that indicates if post-surgical pain is recognized you will consult with a clinical veterinarian to discuss disposition or treatment 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.

Adverse Effects/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 and the reference point (e.g., weight at start of procedure, age matched litter mate, etc.).

Final Disposition
Any protocol group for which you list “euthanasia” as a final disposition will need to also be included in the upcoming Euthanasia question.

Euthanasia
If you have listed a protocol activity as non-survival surgery or euthanasia, then this section will not be displayed as the information is provided in the protocol activity sections.

For confirmation of euthanasia, “absence of cardiac or respiratory function” is not acceptable for rodents.  A physical method must be indicated.

Animal Use Locations
Ensure that all protocol activities and protocol groups are listed in a use location.  If you have two “Agent Administration” activities, then both activities must be listed in the section.

Consideration of Alternatives to Painful 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.

Justification for Number 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).  If you are using published results, include one or two references.
  • 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.  It is useful to start with the experiments to be carried out and then to work back to how many animals you will need to obtain through breeding.
  • 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.
  • When you use euthanized animals for organ culture, provide rough estimate for the number of animals (e.g. we will get 3×107 cells per liver and need 6×107 cells per experiment, for 15 experiments that means 30 animals).

Funding/Sponsor Information
If you select that you do have funding, be prepared to attach the “animal procedure” section of your grant application (e.g. For NIH funding, the IACUC is looking for the Animal Vertebrate section of the grant and any section describing the in vivo work with animals).  The full grant does not necessarily need to be uploaded.

External Collaboration
See the IACUC SOP “Collaborations with External Entities” or contact the IACUC office for guidance on what additional documents might be required.

Study Team Requirements
Everyone handling animals for the purpose of animal research must be listed on an IACUC protocol.  Be sure to indicate the specific activity each member of the team will perform on the AUP. To be on a protocol, there are several items that need to be completed. To save time and decrease the chance of the protocol being delayed in review, the IACUC encourages people to complete the following requirements as soon as possible:

  • Registering to eProtocol – In order for any individual to be listed on an Animal Use Protocol they must be provisioned an account in e-Protocol by completing the e-Protocol registration. Individuals who have not registered will not have access to e-Protocol and will not be available for selection as study team members in the system. Registration can be completed at: e-Protocol
  • Animal Usage Orientation and Occupational Health and Safety Training – Each individual involved in an Animal Use Protocol must obtain a basic level of competency in animal use and care and in the use of hazardous biological agents and materials associated with animal use. The online course that satisfies this requirement, Working with the IACUC, is provided by the Collaborative Institutional Training Initiative (CITI) Program. This training must be updated no less than every three years. To complete the online course, an aggregate score of at least 80% must be obtained on the course quizzes.
  • Registry into the Occupational Health Program – Each individual involved in an Animal Use Protocol must enroll in the Occupational Health Program by completing an initial risk assessment via the Online Risk Assessment Tool (ORAT).  Risk assessments should be updated as work-related responsibilities change.
  • Conflict of Interest (COI) Screening/Disclosure form –Each individual involved in an Animal Use Protocol must have a current OSU Financial Conflict of Interest Screening/Disclosure on file with the Office of Research Compliance.
  • Your Experience and Training Narrative – Each individual involved in an Animal Use Protocol must have a current Experience and Training Narrative describing their previous experience and/or training regarding specific species and activities to be performed in all of the protocols in which they are listed.  This will be considered complete when you write a brief narrative in the text box provided and hit the save button.

Part 2: Answering Questions During Review

When you are finished creating your protocol, you will then forward the protocol through the veterinary consultation and IACUC review processes.  Please find below a few tips on how to answer questions from the consulting or reviewing body:

Tip 1:  When the veterinary consultation and IACUC review are complete, your protocol may be sent back to you if there are questions or suggestions.  When this happens, the eProtocol system will send a notification to you via e-mail.  Use the link (which will be the protocol number) in the e-mail to go directly to your protocol’s home page.

Tip 2:  To find the questions, you must go into the actual protocol form (i.e. you need to hit the “Edit Protocol” button and find the questions in the protocol form).

Tip 3:  When responding to comments from the Veterinarians or the IACUC, be sure that you make the changes in the body of the document, not just in the reply box.  The dialog between PI and Vet/IACUC staff disappears after the protocol is approved and these responses will not be included in the document.

Last Reviewed: 04/2011