Course Home   Chapter One   Chapter Two   Chapter Three   Chapter Four   Chapter Five   Chapter Six

The Animal Use Protocol

Most institutions have instituted an animal use protocol form, or animal care and use protocol, that investigators are required to complete and submit to the IACUC. There is great variation in the length, format, content, and use of these forms, and a form that serves one institution well may not necessarily prove successful at another institution. However, in general, many IACUCs have found that use of a protocol form helps research investigators to describe the information that the IACUC requires in order to review a proposal, and also helps the IACUC to achieve greater consistency in its review.

The protocol application form requires a great deal of information, including a non-technical description of the proposed research, justification of why animals are necessary for the project, justification of the number of animals requested, a complete description of all procedures using animals, and a statement describing the qualifications of the personnel performing the research.

Specific examples of information contained in a protocol form include:

Administrative Data

This section might include name and contact information for the principal investigator and other personnel involved in the study, as well as information about the project’s funding and other information.

Animal Requirements

This section would describe the animal species and numbers to be used in the study, along with information about their supplier and where they will be housed and cared for.

Transportation

Transportation of animals must conform to all institutional guidelines/policies and federal regulations. This section would describe efforts to comply with USDA regulations if animals are to be transported on public roads or out of state, as well as methods and containment if animals are to be transported between or within a facility.

Study Objectives

This section is particularly important to the non-affiliated and other lay members of the committee, and is sometimes called the lay summary. In it, the investigator is asked to briefly explain in language understandable to a layperson the aim of the study and why the study is important to human or animal health, the advancement of knowledge, or the good of society.

Rationale for Animal Use

This section explains the investigator’s rationale for using animals, including an explanation of why non-animal models are not satisfactory. In this section, the investigator also must justify the species to be used and the numbers of animals proposed.

Description of Experimental Design and Animal Procedures

This section explains the experimental design and specifies all animal procedures. This description should allow the IACUC to understand the experimental course of an animal from its entry into the experiment to the endpoint of the study. Issues specifically addressed in this section include the following:

  • Experimental injections or inoculations
  • Blood withdrawals
  • Surgical procedures
  • Radiation
  • Methods of restraint
  • Animal identification methods
  • Other procedures
  • Resultant effects, if any, that the animals are expected to experience (e.g., pain or distress)
  • Other potential stressors (e.g., food or water deprivation) and procedures to monitor and minimize distress
  • Experimental endpoint criteria (e.g., tumor size, percentage body weight gain or loss, inability to eat or drink, behavioral abnormalities, clinical symptoms, or signs of toxicity). The criteria to be used to determine when euthanasia is to be performed must also be listed. Death as an experimental endpoint must always be scientifically justified.
  • Veterinary care

 

Surgery

The IACUC requires a written description detailing any surgical procedure(s) to be performed, including pre-operative procedures (e.g., fasting), monitoring and supportive care during surgery, and post-operative care for all animals undergoing survival surgery. Issues that must be addressed in the IACUC protocol include analgesic use, postsurgical monitoring while recovering from anesthesia, supportive care (external heat support, analgesics, fluids, etc.) and wound care.

This section must also describe the personnel to be involved in the surgery and their qualifications, and must discuss whether survival surgery has been performed on the animal previously.

Pain or Distress Classification and Consideration of Alternatives

This section identifies the USDA Pain/Distress classification for the proposed study. [See USDA Pain Categories below.]  If any procedures fall into USDA’s Category D or E, causing more than momentary or slight pain or distress to the animals, the investigator must describe his/her consideration of alternatives and the determination that alternatives are not available. The methods and sources used in the search must be specified, and database references must include databases searched, the date of the search, period covered, and the keywords used in the search.

USDA PAIN CATEGORIES According to the AWRs, an annual report must be filed with the USDA. Among other things, the report must:

• State the common names and the numbers of animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yet used for such purposes.

CATEGORY B Examples:
o Breeding colonies of any animal species (USDA does not require listing of rats, mice, birds) that are held. Breeding colony includes parents and offspring.
o Newly acquired animals that are being held and have not been utilized in study procedures yet.
o Animals held under proper captive conditions or wild animals that are being observed.

• State the common names and the numbers of animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use of pain-relieving drugs. Routine procedures (e.g., injections, tattooing, blood sampling) should be reported with this group.
CATEGORY C Examples:
o Procedures performed correctly by trained personnel such as the administration of electrolytes/fluids, administration of oral medication, blood collection from a common peripheral vein per standard veterinary practice (dog cephalic, cat jugular) or catheterization of same, standard radiography, parenteral injections of non-irritating substances.

• State the common names and the numbers of animals upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.
CATEGORY D Examples:
o Surgical procedures conducted by trained personnel in accordance with standard veterinary practice such as biopsies, gonadectomy, exposure of blood vessels, chronic catheter implantation, laparotomy or laparoscopy for which pain relief was provided.
o Blood collection by more invasive routes such as intracardiac or periorbital collection from species without a true orbital sinus such as rats and guinea pigs for which pain and distress was relieved.
o Administration of drugs, chemicals, toxins, or organisms that would be expected to produce pain or distress but which will be alleviated by analgesics.
o Prolonged restraint of an animal during which the distress will be mitigated by positive human contact and enrichment.

• State the common names and the numbers of animals upon which teaching, experiments, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests.  An explanation of the procedures producing pain or distress in these animals and the reasons such drugs were not used shall be attached to the annual report.
CATEGORY E Examples:
o Procedures producing pain or distress unrelieved by analgesics such as toxicity studies, microbial virulence testing, radiation sickness, and research on stress, shock, or pain.
o Surgical and postsurgical sequella from invasion of body cavities, orthopedic procedures, dentistry or other hard or soft tissue damage that produces unrelieved pain or distress.
o Chairing of nonhuman primates not conditioned to the procedure for the time period used.

NOTE: There is no USDA Category A.

Anesthesia, Analgesia, Tranquilization, Other Agents

For animals to be used in Category D procedures, the anesthetics, analgesics, sedatives, tranquilizers, or other methods of pain and distress relief that are to be used must be specified.

Method(s) of Euthanasia

Euthanasia is defined as the act of killing an animal by methods that induce rapid unconsciousness and death without pain or distress. The selection of specific euthanasia agents and methods depends on the species involved and the research objective. It must be described in the animal use protocol and approved by the IACUC. Generally, approved methods must be consistent with the AVMA Guidelines for the Euthanasia of Animals.

The IACUC must also be confident that the personnel performing euthanasia are sufficiently trained to perform euthanasia, including confirming the animal’s death.

Occupational Health & Safety / Hazardous Agents

Working in a laboratory presents a number of unique risks to personnel. Principal investigators are responsible for providing a safe working environment, identifying hazardous agents, instructing personnel in safe working practices and providing personal safety equipment for their laboratory.

All hazardous agents (chemical, physical and biological) must be declared in the animal use protocol submitted to the IACUC. Protocols involving hazardous agents are referred to the Institutional Biosafety Office/Committee to ensure that necessary precautions and safeguards are in place to protect the health of both the research staff and other animals in the facility.

Transgenic and Knockout Animals

This section describes any expected consequences resulting from genetic manipulation of the animals in the study. [See section on transgenic animals in next lesson “Difficult Issues in Protocol Review” for further discussion.]

Field Studies

If animals in the wild will be used, the investigator must describe how they will be observed, any interactions with the animals, whether the animals will be disturbed or affected, and any special procedures anticipated. Documentation must also be provided for any required federal permits.

Special Concerns or Requirements of the Study

Other special considerations might include special housing, equipment, or animal care (for example, special caging, water, feed, or waste disposal, environmental enhancement, etc.).

Principal Investigator Certifications

This section describes the Principal Investigator’s specific training and certifications that qualify him/her to perform the proposed study.

Concurrences

This section provides the IACUC with assurances from other stakeholders in the study — such as the Biosafety Office /Committee, animal facility manager, veterinarian, etc. – that all requirements outside the IACUC have been met for the proposed study.