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ILAR Journal V32(4) 1990
Issues for Institutional Animal Care and Use Committees (IACUCs)

Fred W. Quimby, V.M.D., Ph.D., informally surveyed the veterinarians who serve on the institutional animal care and use committees (IACUCs) of five small and five large universities about procedures for implementing the standards in part 2 of the animal welfare regulations [Code of Federal Regulations, Title 9 (Animals and Animal Products), Subchapter A (Animal Welfare), Part 2]. Several of these veterinarians responded with questions about how the U.S. Department of Agriculture (USDA) interprets some portions of the regulations. The editorial panel submitted those questions to Regulatory Enforcement and Animal Care (REAC), Animal and Plant Health Inspection Service, USDA, and requested a response for publication in ILAR News. The questions (printed in italics) and the responses from REAC are presented below.

1. During its review of animal protocols, is the IACUC obliged to evaluate the methods and sources used by the principal investigator (PI) in his/her consideration of alternatives to procedures that may cause more than momentary pain, if that pain will be abrogated entirely by the use of analgesics or anesthetics?

To answer this question one must first clarify "procedures that may cause more than momentary or slight pain or distress." As the IACUC evaluates protocols, the following questions should be asked: Does the animal feel pain? Can the animal be expected to feel pain? Certainly during the recovery period following a surgical procedure, even when analgesics are used, the animal may be expected to experience pain. Conversely, when surgical procedures are performed and the animal is not allowed to recover from anesthesia, the only discomfort that the animal may experience is during the induction of anesthesia. Therefore, in general, most survival surgical procedures may cause more than momentary or slight pain or discomfort.

The "written narrative description of the methods and sources used to determine that alternatives were not available" is indeed not easy for the IACUC to evaluate. It is not the intent of this regulation that the IACUC evaluate the databases or sources cited. The intent is that the PI consider alternatives to procedures that may cause pain. Questions that should be asked are: Is there a nonsurgical or noninvasive model? Is there a model that does not require surgery? Is there an in vitro model? Suggested items that the investigator may wish to include in the narrative are the database(s) searched, the key words used in the search, selected references on animal models or alternatives, etc.

2. The PI has provided written assurance that "the activities do not unnecessarily duplicate previous experiments.'' Will that statement, signed by the PI, satisfy the requirements or is it necessary for him/her to provide evidence of a literature review?

It is stated in section 2.31 (d)(1)(iii) of the animal welfare regulations that it is the IACUC's responsibility to determine that the investigator has provided "written assurance that the activities do not unnecessarily duplicate previous experiments". A written assurance consisting of a statement signed by the PI will satisfy this regulation. It is up to the IACUC, however, to determine what type of information should be included in the investigator's assurance. This may vary based on the needs and experience of the Committee.

3. "The Secretary intends that such person (nonaffiliated member of the IACUC) will provide representation for general community interests in the proper care and treatment of animals". Can the nonaffiliated member receive compensation by the institution for the time involved in protocol review or is this a conflict of interest?

It is generally accepted that reimbursement for expenses does not constitute conflict of interest. Compensation for the member's professional time, however, may create potential for a conflict of interest. Nominal compensation that is not considered to be pay for service or to infer affiliation with the institution might not be regarded as a conflict of interest.

4. If the details of a test drug or proprietary procedure are required for a complete review of animal care and use, what obligation do members of the IACUC have to protect the privileged nature of these drugs or procedures?

It is stated in the Animal Welfare Act [AWA; U.S. Code, Title 7, Section 2143(6)(B)] that "no...part of this Act shall be construed to require a research facility to disclose publicly or to the Institutional Animal Committee during its inspection, trade secrets or commercial or financial information which is privileged or confidential.'' Furthermore, the AWA states [U.S. Code, Title 7, Section 2157(a)] that it is unlawful for any member of an IACUC to release any confidential information of the research facility, including trade secrets.

In most instances, it will be possible for the IACUC to review an animal study proposal of an experiment or project involving proprietary information without the risk of disclosure. This may be accomplished by the PI using generic descriptions if appropriate or blanking out the proprietary information from the proposal.

An example of this might involve an animal study proposal needed to test a new drug. It should be possible for the committee to review such a proposal without having knowledge of proprietary information such as the chemical formula, molecular structure, etc. It may be important, however, for the committee to know information such as the pH (if administered parenterally), target cell or site of action, and expected or potential side effects or outcome (based on similar compounds) in order to properly evaluate the proposal.

5. The standards indicate that animal health certificates should be signed by a licensed veterinarian. Previously we were under the impression that for interstate or intercontinental shipments of animals the signer must be accredited by the USDA. Have these regulations changed?

The regulations pertaining to interstate and international movements of animals have not changed. Many states and foreign countries have animal health regulations requiring certification that the animals are free of or are protected against specific diseases. These regulations protect against the introduction or spread of animal diseases. Ail states and countries have these regulations for domestic farm animals; however, not all have similar regulations for nonagricultural animals. Health certification for compliance with these regulations require the signature of an accredited veterinarian. Information regarding state or international animal health regulations can be obtained from the state veterinarian or other animal health officer in your state.

The animal welfare regulations require health certification to ensure the well-being and safety of dogs, cats, and nonhuman primates that are being transported. If the state or country receiving the animals does not require additional health certification for imported dogs, cats, or nonhuman primates, the health certificate may be signed by a licensed veterinarian who is not accredited.

6. May paralytics be used alone in mammals for immobilization if no pain is anticipated in the study?

Section 2.31(2)(1)(iv) of the animal welfare regulations states that painful procedures will be performed with appropriate analgesics unless justified and will not include the use of paralytics without anesthesia. The intent of this regulation is that when necessary, animals that might experience pain will be provided appropriate pain relief and any withholding of such medication should occur only when scientifically justified. The further intent of this regulation is that paralytics not be used in place of anesthetics for restraint.

It is well recognized that a paralytic agent can obscure or prevent an animal from demonstrating a pain response. Such agents, however, do nothing to change the animal's pain perception or distress. Consequently, when paralytic agents are used, appropriate anesthesia, analgesia, or tranquilizers must be administered if the procedure performed on the animal causes or can be expected to cause pain or distress. Paralytics may be used alone if the IACUC determines that the procedure does not cause pain or distress.

7. What is the appropriate unit to be registered? Can a large institution located in several different geographical areas be covered by a single registration?

It is stated in Section 2.30 (a)(e) of the regulations that "A subsidiary of a business corporation, rather than the parent corporation, will be registered as a research facility...'' We interpret this to mean that registration must be at the level of the lowest legal entity of the parent corporation. It will be up to the legal counsel of the facility to determine what that lowest legal entity is.

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