» 2010 Annual Report

The ACE Committee has been using a wide range of approaches to draw attention to issues of concern. The Committee has sponsored programs at EB, revised the Society’s position statements on animal research issues, and sought to participate in national policy discussions about animal welfare oversight.

The most development in animal welfare policy this year with the greatest potential for impact on APS members was the release of the pre-publication version of the Guide for the Care and Use of Laboratory Animals. This manual, which is published by the Institute for Laboratory Animal Research (ILAR) of the National Academy of Sciences, is a widely-used reference document concerning laboratory animal care. Institutions that conduct research funded by the U.S. government are expected to follow the Guide, as are those whose animal facilities are accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC), International. The current edition of the Guide was published in 1996 and will remain in force until the new edition is finalized. At that time, NIH’s Office of Laboratory Animal Welfare (OLAW) and AAALAC will announce their timetables implementing the requirements of the new Guide.

During the revision process, the ACE Committee submitted comments to the ILAR committee charged with updating the Guide, and some of these comments were incorporated in the new edition. One of those recommendations was that institutional animal care and use committees (IACUCs) should make the determination whether a surgical procedure is major or minor based upon the actual impact on the animal. In recent years, the ACE Committee has been urging the USDA and OLAW to reconsider what constitutes a major surgery and to exclude from that classification minimally-invasive procedures such as laparoscopies that do not produce significant pain, distress, or physiological impairments. Members of the ACE committee have raised this topic at national conferences on IACUC issues. In addition, ACE Chair Bill Yates and former ACE Committee member Linda Toth co-authored an editorial (“Is it Time to Redefine ‘Major Operative Procedures?’”) that appeared in the January issue of the Journal of the American Association of Laboratory Animal Sciences (JAALAS). The ACE Committee also provided comments to OLAW when it released a new FAQ in February 2010 that classified laparoscopic procedures as major surgeries. OLAW subsequently revised this FAQ to permit IACUCs to decide whether laparoscopic procedures are major or minor surgery depending upon their outcome, which is consistent with the language in the new Guide.

Permitting certain minimally invasive procedures to be deemed minor surgeries will serve both animal welfare and science. This will allow animals that have not experienced significant pain, distress or impairment to be included in another research project, which will decrease the total number of animals needed. However, the ACE Committee has discovered that addressing regulatory issues often involves many layers of complexity. In this case, OLAW’s FAQ and the new Guide are not the only regulatory authorities. The Animal Welfare Act, which applies to most mammals except purpose-bred rats and mice, also prohibits multiple major surgeries. Therefore, the ACE Committee will also try to encourage the USDA to revisit its approach.

The ACE Committee has been concerned about various tactics being used to obstruct research and intimidate researchers. To inform the membership about these trends, the ACE Committee sponsored a symposium at Experimental Biology 2010 entitled Trends in Animal Rights Activism and Extremism. The purpose of the symposium was to help researchers understand what the threats are and what they (and their institutions) can do to protect themselves and their work. A summary of this symposium is available at http://the-aps.org/pa/policy/animals/AnimalRightsExtremism.htm.

At EB 2010 the ACE Committee also sponsored a forum where researchers whose IACUCs are grappling with difficult issues could discuss them with colleagues. Although attendance was sparse, the forum was enthusiastically received. The committee plans to hold a similar event next year and will do more to inform the membership about it.

During the past year, APS has provided expert opinion to Congress and the NIH concerning the ongoing need for non-purpose bred dogs and cats in physiological research. 

This summer the ACE Committee asked Council to approve a new position statement on the importance of animal research and an update to the APS Guiding Principles for the Care and Use of Animals in Research. The new position statement describes the important role that animals play in medical discovery:

Animal Research is Essential to the Search for Cures

Humane research involving animals provides unique insights into biological structure and function. These insights offer major benefits to both human and animal health. The American Physiological Society is strongly committed to ensuring that research animals are treated humanely and that their use is regulated appropriately.

Biomedical research today involves a wide array of approaches that make use of computers, molecules, cells, tissues, organs, and whole animals. Each approach addresses different elements of a research question. Together, they offer a full complement of ways to learn about living systems. Animal studies are particularly crucial for understanding how the body functions in health and disease. Basic and translational research involving animals is a necessary component in the search for causes, preventions, treatments, and cures for disease.

The ACE Committee also requested a significant update of the APS Guiding Principles for the Care and Use of Animals in Research. This statement of the Society’s commitment to humane animal care was first adopted by the APS Council in 1953. It has been reviewed and revised periodically since then as U.S. animal welfare laws and policies have changed. The revisions approved by Council in July 2010 represent the first major changes to this document since 1991. They are intended to clarify certain elements of the Guiding Principles and make them easier to apply in practical situations. In addition, because the Guiding Principles are based upon U.S. animal welfare requirements, the update adds provisions to address the fact that other countries have different animal welfare requirements. This change was needed because of the increasing number of physiologists from around the world who are joining the APS and submitting articles for publication in APS journals. The update includes a change in the title, noting that these principles apply to vertebrate animals, and that they apply to training as well as research. The updated version of the APS Guiding Principles took effect September 1:

APS Guiding Principles for the Care and Use of Vertebrate Animals in Research and Training

As noted in the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, “Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.”  The use of animals is also justified to provide scientific, veterinary, and medical training that is not possible through other mechanisms.

Investigators should consider the appropriateness of the experimental procedures, the species of animals used, and number of animals required. Prospective approval of procedures on animal subjects should be obtained from an institutional animal care and use committee (IACUC) or similar oversight body as required under the relevant regulatory authorities. This review should also consider whether the use of animals in a given protocol could be replaced by other experimental approaches such as in vitro studies or computer modeling.

Only animals that are lawfully acquired shall be used in research and teaching. The procurement, transport, maintenance, and use of animals must in all cases comply with federal, state and local laws and regulations. In the United States, animal research may be subject to the Animal Welfare Act, the Public Health Service Policy on Humane Care and Use of Laboratory Animals, or other guidelines established by funding agencies. The PHS Policy requires institutions to use the Guide for the Care and Use of Laboratory Animals to develop and implement an institutional animal care and use program.

Analgesics and other techniques should be used to minimize discomfort and pain except when the intervention would compromise experimental goals. Appropriate anesthetics must be used to eliminate sensibility to pain during all surgical procedures. Drugs that produce muscle paralysis are not anesthetics. They must never be used alone for surgical restraint, only when animals are under anesthesia.

If the study requires the death of an animal, humane endpoints should be identified, and an approved method of euthanasia stipulated in the American Veterinary Medical Association’s Guidelines of Euthanasia should be used. Death is acceptable as the endpoint of a study only where euthanasia would compromise scientific outcomes and an IACUC or similar oversight body has approved the exception.

Animals used in research and education must be housed, fed, and maintained in a manner appropriate for their species and their condition. They should also be given appropriate veterinary care.

Personnel who care for or perform procedures on animals must receive training for these tasks. When students or trainees use animals in educational activities or for the advancement of science, such work shall be conducted under the direct supervision of an experienced teacher, investigator, or veterinarian.