Proposal for an Accord between Animal Advocates and the Biomedical Research Community

From ANIMAL PEOPLE,  April 2012:

Animal advocates hopeful of reaching an accord with the biomedical research community recognize that some biomedical research, testing, training and education using animals will continue in the foreseeable future. The biomedical research community has already agreed in principle that scientific use of animals should be subject to rigorous scientific review including serious consideration of non-animal alternatives and, if approved and funded, conducted in a manner which ensures that the smallest possible number of animals are involved, of species with the lowest potential for pain and suffering, and that such animals should be provided with optimum housing, handling, and care. However, we have identified areas in which both animal welfare and science might be improved in the practices of scientific institutions, in the regulation of animal use by public agencies, and in the federal Animal Welfare Act’s definition of “animal.”
If the practices and regulations outlined below were changed or amended so that scientific use of animals were to be conducted in an improved and strict manner regarding the welfare of animals, we believe that animal advocates would agree not to interfere with such research or specifically object to it through targeted campaigns. Such agreement would be made in full recognition of the ethical dilemma presented by the use of animals in experimentation, testing, training,  and education and without relinquishing animal advocates’ philosophical concerns regarding scientific use of animals or their right to protest against or expose the existence of scientific use of animals that does not meet agreed upon standards of animal welfare.

BELOW, LEFT: Kim Bartlett, member of the drafting committee.
In December of 2010, the Institute of Medicine was commissioned by the National Institutes of Health to assess whether chimpanzees are or will be necessary for biomedical and behavioral research. The IoM report was released on December 17, 2011. We agree with the following five points made by David Jentsch in his analysis posted on <http://speakingofresearch.com/2011/12/17/afterthoughts-on-iom-report-on-the-use-of-chimps-in-scientific-research/> “Afterthoughts on IoM report on the use of chimps in scientific research”:
“We believe discussions on the science and ethics of animal research are inextricably linked and both should be part of any public discussion on animal research. An honest, open and civil discussion on both the science and ethics of animal research that includes animal advocates, animal welfare organizations, scientists, patients and their families, patient advocacy groups, public health officials and the medical leadership of the country” is needed, and to which list of interested parties we would add professional ethicists and bioethicists trained in animal ethics;  and
“The IoM panel clearly demonstrated the power of a comprehensive and critical analysis that accounts for progress in research, changes in technologies, models, and questions. However, proceeding in critical analysis on a species-by-species basis is problematic for a number of reasons. We argue that a more general appraisal of the ethics and science of animal research is warranted”; and
”As illustrated by the IoM report and surrounding discussion, the ‘species-wise’ approach ignores the more basic and important questions that are at the heart of the issue (the ethical dimension) and that this deserves a much more thorough and broader public discussion based upon empirical data and facts”;   and
“There is no reason to think that changes in the technology, questions, and need for certain projects that contributed to a reduction in the requirement for chimpanzees in research might not also apply to other types of animals…”;  and
“We believe that conducting a broader review of animal research could significantly advance public understanding of the role that it plays in medical and scientific progress. In many ways, such an exercise is long overdue. The report’s conclusions clearly show the value of a rigorous, thoughtful, and public review of even the most controversial type of research. But public interest in animal studies extends far beyond chimpanzee research” …
Reaching an accord with animal advocates will require the biomedical research community to agree to the following principles for humane research and to take actions necessary to assure compliance with these principles, including commitments to support changes in the federal Animal Welfare Act and its regulations, as well as changes in policies and guidelines of research funding agencies including but not limited to the Public Health Service:

REFINEMENT,  REDUCTION,
AND REPLACEMENT

If alternative yet equally effective methods of experimentation or testing are available, they must be employed in preference to any experiment conducted with an animal.
Procedures that are likely to cause pain, fear, or distress to animals must not be allowed if (a) there exist other research methods or models through which the knowledge sought might reasonably be obtained, and (b) the research cannot be performed on consenting human subjects.
Animals with the lowest potential for pain and suffering should be used in preference to animals with greater potential to experience pain and suffering, based on objective criteria (e.g., the possession of a central nervous system, nociceptors, opioid receptors, etc.).
All institutions that conduct research and testing with animals should consider it an ethical obligation to refine research methodologies and reduce and seek to ultimately replace animals whenever possible. These efforts should be supported and funded by both the research-funding agencies and the research institution’s administration.

CLINICAL RESEARCH ON ANIMALS

As one alternative to research on laboratory animals, we encourage the biomedical research community to engage in clinical research on animals afflicted with naturally-occurring diseases and disorders in need of treatment, in partnership with veterinarians, especially board-certified veterinarians and veterinary specialty clinics.

INSTITUTIONAL ANIMAL CARE AND USE COMMITTEES

All facilities which use animals for research, testing, or education in the U.S. are currently required to establish Institutional Animal Care and Use Committees (IACUCs)–called ethics committees in some countries– which are comprised of representatives from inside and outside the biomedical research community. In addition to the current requirement for one public member of the IACUC who is “intended to provide representation for general community interests in the proper care and treatment of animals” [Improved Standards for Laboratory Animals amendment to the Animal Welfare Act of 1985], there must be added a second public member who is professionally trained in bioethics. If a bioethicist is not available, a professional ethicist should be sought. If no professional ethicists are available to serve on IACUCs, persons may be chosen who have some degree of professional training in ethics (e.g., members of the clergy, jurists, or academic philosophers). In addition to considering ways in which proposed uses of animals may be refined, reduced, or replaced with alternatives, IACUCs must consider the ethics of proposed uses of animals, including a harm versus benefit analysis of the proposed work, so that the use of animals is approved only when any harm done to the animals is greatly outweighed by the anticipated benefits of their use.

RIGHT: Gil Michaels, member of the drafting committee. Michaels is a lifelong supporter of animal causes.

    An internal mechanism to address grievances brought by dissenting members of the committee must be required.
All research institutions must have a person designated as a public liaison official whose role it is to provide a greater degree of transparency regarding use of animals,  and to whom concerns and complaints about IACUC decisions or procedures as well as concerns regarding the conduct of research or the housing,  handling,  and care of animals may be addressed by members of the public,  including animal welfare organizations.
Systems of 24-hour video surveillance should be designed and installed within research facilities to record and archive all activities involving care and use of animals,  including all experimental and veterinary procedures.  These video recordings must be routinely monitored by a person who reports to the IACUC and audited at regular intervals for compliance with all applicable laws and regulations by a qualified independent agency (such as USDA APHIS) which is legally empowered to report non-compliance with applicable laws and regulations to regulatory and government agencies via reports that will be available publicly through Freedom of Information Act filings.
The committee must carefully consider whether research involving animals addresses questions of importance that cannot be answered using methods that do not require animals, as well as the 3Rs of reduction, refinement, and replacement.  The consideration of ethics must be central to discussions about the use of animals in research protocols.  The welfare of the animals or,  conversely,  the toll taken on the welfare of the animals,  should be the focus of the ethical considerations involved in designing and approving scientific research with animals.

PAIN SCALE

There is a need for development and compulsory adherence to a pain scale classifying the severity of pain inflicted on animals (from little or none up to severe),  the prohibition of experiments that would cause high degrees of unrelievable pain, and the requirement that IACUCs consider the expected degrees of pain in evaluating protocols and stipulate appropriate levels of analgesia and/or anesthesia at specific levels of anticipated pain.  Compulsory guidelines would specify the types of experiments and levels of pain that would not be permissible regardless of potential benefit in scientific knowledge that might be obtained through the conduct of such an experiment or procedure.  We agree with Dr. John S. Church, in his article “Understanding Pain and its Relevance to Animals,” <www.afac.ab.calreports/understandingpain.pdf>,  that “Pain scales can be used to educate people about the two alternatives of refinement and replacement, and the need to reduce animal pain. Furthermore, a pain scale has further practical applications: 1) in reviewing procedures which are of concern from an animal welfare standpoint; 2) in developing policies on the use of animals in educational institutions; and 3) as a basis for collecting quantifiable data on animal experimentation, so that meaningful data can be collected on trends in reduction and control in animal pain.”

ANESTHESIA,  EUTHANASIA, AND PAIN MANAGEMENT

Animals’ pain, physical discomfort, maladaptive behaviors, fear and anxiety must be prevented and/or minimized by considerate and scientifically sound experimental design and appropriate use of anesthetic, analgesic, and/or tranquilizing drugs.
Any experiment or test that inflicts trauma should be conducted with a fully anesthetized animal. If the procedure is designed to cause irrecoverable traumatic injury, the animal should be euthanized following the procedure and before regaining consciousness.

BELOW, LEFT: Robert C. Jones
If an animal is subjected to surgery from which he or she is expected to survive, a pre-planned pain evaluation and pain management schedule must be developed that contains specific signs, behaviors, or physical parameters to be measured in the animal. This schedule must account for overnight and weekend hours.  Staff must ensure adequate and timely administration of pain relieving medications until the animal has recovered and the experience of pain is no longer a realistic possibility.
Professional staff must be available at all times to care for the animals.  The staff must make rounds for the purpose of ascertaining the state of each animal’s health and well-being. Animal care staff must be trained and authorized to dispense pain relieving or tranquilizing drugs as may be necessary. While it may be a standard operating procedure to phone the investigator or director regarding the need for such care, this action must not delay the provision of relief for the animal. Nursing care must be provided to all animals following surgery or other injurious interventions and to animals with chronic pathological conditions.
Euthanasia of irremediably suffering animals should be considered a major obligation, and delays must not be permitted in implementing decisions to euthanize.
The decision to euthanize a moribund animal must be made by the attending veterinarian and not the scientist(s) conducting the experiment or study; the attending veterinarian must be empowered to euthanize without seeking approval from the principal investigator. Staff carrying out euthanasia must be well trained to perform the procedure. The venue for conducting the euthanasia should be selected so as not to increase anxiety and fear. The method of euthanasia that is selected should ensure the quickest death possible, in accordance with guidelines published by the American Veterinary Medical Association. Animals should not be discarded without being monitored long enough after death to ascertain clear signs of cessation of life, such as rigor mortis.

DEFINITION OF ANIMAL

The definition of “animal” in the federal Animal Welfare Act must be amended to include all vertebrate animals, and research funding agencies must establish guidelines and regulations to provide for the welfare of invertebrates.
ACQUISITION
Animals used in experimentation and testing should be acquired from professional breeding facilities whose standards of housing and care are equal to those described herein for research laboratories. The use of dogs and cats from Class B dealers must be prohibited. The use of animals sold by members of the public should be prohibited, as this is detrimental to the ethic promoted by community animal shelters that companion animals should be considered members of the household and not disposable commodities.
We encourage veterinary schools to use dogs and cats from animal pounds and shelters to train veterinary students in surgical sterilization with such animals returned to bona fide animal shelters after the period of recovery for the purpose of adoption to the public. Dogs and cats from animal pounds and shelters may be used for procedures performed for the benefit of these animals, in the judgment of community animal control officials, but any such release of impounded animals must be subject to all applicable laws and regulations and information about such transactions must be available to the public. Release of dogs and cats from animal pounds and shelters for any purpose other than adoption into homes is detrimental to the increasing professionalization and growing public confidence in community animal control agencies. Laboratory use of impounded dogs and cats also presents public relations problems for scientific institutions.

ANIMAL CARE

Animal care staff must be trained to treat animals with care, respect, and in accordance with all applicable laws and regulations. Treatment of animals by staff must be monitored by the research facility and audited for compliance with all applicable laws and regulations by an appropriate agency. Failure to follow all regulations and guidelines and/or failure to treat animals with care and respect must result in disciplinary actions including immediate suspension and/or dismissal as well as any available legal remedies.
It is recognized, however, that animal care technicians often seek to improve the handling, housing, and care of animals in laboratories and their opinions and ideas should be given careful consideration. Whenever possible, animals should be humanely trained through positive reinforcement to cooperate with handlers instead of being forced into procedures such as blood draws.
Ongoing training regarding best practices must be provided. The staff must be trained to recognize signs of discomfort and distress in animals and be empowered to make their observations known to the attending veterinarian. For example, if staff identifies a moribund animal or an animal who is suffering irremediably, that animal should be euthanized without delay. An animal whose suffering is remediable should be provided with analgesia and/or sedation and given supportive care such as fluids, soft food, or custom bedding.

HOUSING

Animals used for scientific purposes should be maintained in ethologically appropriate physical and social environments. Housing should provide sufficient space and materials to permit the expression of basic species-specific behaviors, including species-typical movement, for examples: foraging, hiding or retreating to a safe/sheltered place, burrowing, and gnawing if the animals are rodents; climbing, perching, and swinging if the animals are primates; perching, scratching, and stretching if the animals are birds, and flight space for flying birds; and rooting and wallowing if the animals are pigs. Social animals must be housed with one or several compatible conspecifics (though in some cases, animals of other species are sufficient) to address their biological need for companionship.

RETIREMENT OF ANIMALS

Whenever feasible, animals should be permitted to retire to species-appropriate facilities provided by reputable institutions or organizations after termination of their assignment(s) to research, testing and education or, in the case of companion animals, they might be adopted into homes.
The funding agency and research institution should earmark funds for the lifelong retirement of animals used for scientific purposes.

This document was produced by a drafting committee consisting of Kim Bartlett, president of Animal People, Inc.;  Robert C. Jones, Assistant Professor of Philosophy, Director of the Center for Applied and Professional Ethics, California State University, Chico;  Gil Michaels, executive director of Animal Guardians;  and one person who wishes to remain anonymous.

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