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Investigator Handbook
Investigator Handbook
Prepared by The Office of Research Integrity - IACUC
HISTORICAL PERSPECTIVES ON ANIMALS AND THEIR USE IN RESEARCH
The Humane Movement
Origins and Development in Britain
The earliest efforts to achieve more humane treatment of animals in England concentrated on outlawing such practices as bullbaiting, cockfighting, and the abuse of domestic animals. In l796, John Lawrence argued that legislation was needed to protect animals and, in l800, there was an unsuccessful attempt to get Parliament to outlaw bullbaiting. In l809, Lord Erskine attempted to get a more general anti-cruelty law enacted, but the bill failed in the House of Commons after being passed by the Lords. In l822, however, Richard Martin succeeded in getting Parliament to enact a law outlawing cruelty to horses, cattle and asses.
This legislative activity arose mainly out of a growing feeling of revulsion on the part of the upper and middle classes against the abuse of domestic animals. The industrial revolution with its consequent urbanization and crowding may have increased the abuse of domestic animals; it certainly made the abuse more visible.
Arthur Broome founded Britain's first effective humane organization, the Society for the Prevention of Cruelty to Animals (later the RSPCA), in l824, two years after passage of the Martin Act. The RSPCA's effectiveness was due in large part to its powerful support among the British royal family (Queen Victoria was a patron) and the upper classes. During its first few decades, the society agitated successfully against many forms of animal abuse and cruelty, and as a result, the Martin Act was amended in l835 to extend protection to all domestic animals and to outlaw bear, bull and badger baiting and dogfights and cockfights. In l855, the use of dogs as draught animals was outlawed.
Although Arthur Broome had proposed as early as l827 that experiments involving animals be submitted to a board of medical scientists for ethical review, it was not until the l860s that the RSPCA turned its full attention to the vivisection issue. Because British medicine was slow to accept animal experimentation, developments on the continent rather than in England initially spurred the British humane movement to become involved in the issue. In the l860s, the RSPCA opposed the use of unanesthetized horses for surgical procedures in French veterinary schools, and in l863 the society adopted a policy opposing all painful animal experiments.
Scientists of the period were also concerned about the ethics of animal research. The British physiologist Marshall Hall proposed that his fellow physiologists form a society which would monitor research, aid in the development of the science, and prevent needless repetition of experiments on animals. As animal experiments became more common, sentiment for some kind of ethical standards among British scientists increased. In l87l, the British Association for the Advancement of Science produced a set of guidelines intended to minimize animal suffering in legitimate experiments and to discourage illegitimate experimentation. Events of the next few years, however, took the initiative for regulation of animal experiments out of the hands of scientists.
In the l870s, the availability of anesthesia (the anesthetic effects of ether were discovered in l847) led to the assumption that painful experiments were few and were being performed only by skilled scientists and only when no other alternative would produce the desired information. Publication of the Handbook for the Physiological Laboratory in l873 cast serious doubt on these assumptions. The Handbook made little mention of anesthesia and suggested that its detailed descriptions of technical procedures were intended for beginners. In l874, a public demonstration of an experiment on a dog in England led to a public outcry and an attempt to prosecute, under the l822 Humane Act, both the French experimenter and the British scientists who had arranged the demonstration. The prosecution failed, leaving in doubt whether the law applied to animal experiments. The RSPCA, which had brought the case against the scientists, began to agitate for new, stronger legislation.
At about the same time, the British press was giving wide coverage to reports of painful experiments being performed by physiologist Moritz Schiff in Italy; Schiff's work was protested by upper-class Italians and English residents in Italy. In l875, Frances Power Cobbe, a British woman who had been active in the campaign against Schiff in Italy, returned to England and attempted to get the RSPCA to sponsor legislation to restrict animal experiments. When the RSPCA did not act decisively enough for Cobbe, she founded a group specifically devoted to the cause of antivivisection, the Victoria Street Society.
In response to increasing public pressure and debate, a few prominent scientists struggled to form a lobby to support research and to set standards for regulating animal experiments. Although there were still deep divisions of opinion about the inherent worth of the experimental method, part of the scientific community (including the editorial staff of the medical journal Lancet) felt that some regulation might be justified if it ensured the competence of experimenters and established that judgment of competency would be made by qualified professionals. A group of scientists, led by Thomas H. Huxley and Charles Darwin, drew up a bill to regulate painful experiments and to license experimenters through the government's Home Office. A version of the scientists' bill was introduced in Parliament within a few days of the introduction of a regulatory bill supported by Cobbe and the more militant antivivisectionists. Cobbe's version of the bill restricted animal experiments to premises registered annually with the Home Office, required anesthesia for all experiments except by special license, prohibited the use of curare as an anesthetic, and established small monetary penalties for violations.
Faced with competing bills, the government formed a Royal Commission to study the issue. The report eventually issued by the commission concluded that animal experiments should not be outlawed but that some kind of regulation was called for. In l876, after active lobbying by scientists and antivivisectionists, parliament passed a bill regulating use of animals in experiments. The l876 Cruelty to Animals Act established yearly licensing requirements for all experimenters and restrictions on experiments involving extreme pain or unnecessary duplication.
Origins and Development in the U.S.
The early American colonists' attitudes towards animals reflected attitudes prevalent in England and Europe at the time. Sports such as bearbaiting, dogfighting and cockthrowing were as popular in the colonies as they had been in the Old World, and new versions of these sports were developed to take advantage of native American species such as the opossum and the raccoon. The conditions of the new land further engendered an exploitive attitude towards animals. In the early years of settlement when food crops often failed, the native fauna was viewed as a food source. In addition, many of the wild animals which inhabited this seemingly vast and dangerous wilderness were hunted to reduce predation on the colonists' domestic stock.
Despite this environment, colonial Massachusetts passed the earliest known humane law in l64l. This law, part of the "Body of Liberties," forbade cruelty to domestic animals and was enforced in court cases. There are other records of prosecutions for cruelty to animals under public nuisance statutes in the colonies and later in the states, but no other specific anti-cruelty laws were enacted for almost two centuries.
At about the same time that England enacted the Martin Act, increasing concern for the welfare of domestic animals prompted attempts to pass anti-cruelty laws in the U.S. In l829, New York state passed a bill forbidding cruelty or misuse of horses, cows and sheep. Massachusetts passed a similar law in l835, followed by Connecticut and Wisconsin in l838. It was not until l92l, however, that all U.S. states and territories had such laws.
In the mid-l9th century, Henry Bergh founded the ASPCA, an American version of the Society for the Prevention of Cruelty to Animals and began to work for more comprehensive anti-cruelty laws. In l867, he succeeded in getting New York to enact a law which extended protection to all animals, prohibited baiting and fighting, provided for humane treatment of impounded animals, and forbade cruelty during transport. Enforcement of the law was accomplished by agents of the local humane societies who were deputized by county sheriffs to make arrests and bring prosecutions. The New York law eventually became the model for similar laws in most other states.
Despite the passage of anti-cruelty laws, abuse of domestic animals continued. Meat animals being transported to markets or to meat packers were particularly vulnerable. When the first federal anti-cruelty law was enacted, in l873, it was specifically directed at the meat packing industry. This act (the "28-hour Law") regulated the number of hours during which cattle could be confined during shipment and mandated the provision of food, water and opportunity to rest. In l906, this law was replaced with a stronger version with better provisions for inspection and enforcement by the U.S. Department of Agriculture.
In the first half of the 20th century two issues dominated animal welfare concerns. These were the enactment of humane slaughter laws and the extension of anti-cruelty laws to cover laboratory animals.
The U.S. lagged behind Europe in the enactment of humane slaughter laws even though American meat packing companies and individual inventors were responsible for developing several devices which made humane slaughter possible. A Hormel employee developed the use of carbon dioxide as a pre-slaughter anesthesia for swine, and the Seitz Company devised a method for keeping cattle calm and quiet so that the captive bolt pistol could be used more humanely. Nevertheless, meat industry opposition still slowed adoption of legislation, and the federal law regulated only meat packers who supplied the federal government. After enactment of the federal Humane Slaughter Act in l958, most states also adopted some kind of humane slaughter regulation.
The U.S. humane movement first took up the issue of laboratory animal welfare in the last quarter of the l9th century. Henry Bergh, founder of the ASPCA, was an antivivisectionist and in the l870s tried to get New York state to enact legislation to restrict animal experiments. His attempts failed largely because of opposition from the state medical society. In l883, the American Antivivisection Society was founded in Philadelphia, but, in general, the American antivivisectionist movement lacked local initiative and relied heavily on English examples.
In the l880s and '90s, there were several unsuccessful attempts to get restrictive legislation along the lines of the British l876 Act enacted at both the state and federal levels. In l896, for example, a bill was introduced in Congress to regulate the use of animals in experiments in the District of Columbia, already an important center of medical research. The bill, opposed by the National Academy of Sciences, the American Medical Association and other prominent medical and scientific organizations, was defeated.
Public acceptance of animal research was strengthened by medical advances such as the development of diphtheria antitoxin in l894. The American antivivisection movement may also have incurred adverse publicity from its association with unorthodox medical views such as opposition to vaccination, and repudiation of the germ theory of disease. After the turn of the century, humane leaders backed away from the issue of antivivisection and emphasized cooperation with biomedical scientists rather than restrictive legislation. The Hearst Press strongly supported antivivisectionist causes, especially between the l920s and the l940s, but even with this powerful ally, the humane movement failed to get the state of California to regulate the use of animals in research.
The growth of biomedical research into the mid-20th century was accompanied by increased demands for research animals. In the late l940s, the National Society for Medical Research began to work for local and state laws which would require animal shelters to release unclaimed dogs and cats to research institutions for use in biomedical experiments and education. In l949, Minnesota passed the first "pound release" law, and other states quickly followed. The enactment of the pound release laws ended a forty-year period during which there was relatively little conflict between humane organizations and the biomedical research community. Some humane organizations felt that surrendering animals from shelters violated the protective ethic on which shelters had been founded, that of providing humane care and protection to stray or unwanted animals. An attempt to negotiate a quiet compromise between humane and research interests over the issue failed when the National Society for Medical Research publicized a scheduled meeting with the American Humane Association. In response to this breakdown in negotiations (and to the perception among some humane workers that established humane organizations were not taking a strong enough stand on this issue), two new organizations were formed. These organizations--the Animal Welfare Institute, founded by University of Michigan physiologist Robert Gesell, and the Humane Society of the United States--initially focused on the humane treatment of laboratory animals.
Throughout the l960s, humane groups called for federal regulation of research animal use. These efforts were encouraged by the report of the Littlewood Commission on the effects of regulation of animal experimentation in Britain. The commission found that nearly a century of government regulation had not hampered the development of biomedical research. The final push towards federal legislation in the U.S., however, came mainly as a result of two incidents which galvanized public opinion.
The first incident involved a missing pet, Pepper, a dalmatian. While searching for their lost dog, Pepper's owners saw a newsphoto of a dalmatian resembling Pepper being transported by a dog dealer who supplied animals for research. Frantic attempts to trace and recover Pepper eventually involved a New York Congressional representative who was angered when a New York animal dealer refused to help the owners trace their missing pet. The search for Pepper ended inconclusively, but it led to introduction of bills in Congress in l965 to regulate the trade in dogs for research.
While these bills were being considered, an article appeared in Life magazine showing the shocking conditions of animals being kept by dealers who provided animals for research. This article created a public outcry and demands for congressional action.
These incidents provided the impetus for passage of the l966 Laboratory Animal Welfare Act. Originally the law provided for licensing and regulation of animal dealers and for humane treatment of dogs and cats while being transported by dealers or held at research institutions. It covered some (but not all) other common laboratory animals, only if dogs and cats were present in the same facility and did not regulate care of animals during actual experiments. The act, which is now known as the Animal Welfare Act, was later amended and broadened. The most recent amendment was passed by Congress in l990.
The Current Climate for Animal Research
Over the past three decades, animal research has become a major public issue, as animal rights groups have vigorously pressed their position in the media, in legislative hearings, and in civil litigation. These groups argue that the use of animals in research is inherently abusive to animals, that research on animals cannot be extrapolated to humans, and that alternatives exist which render animal research obsolete and unnecessary. A prominent part of many animal rights presentations are gory videotape and picture displays purporting to show how animals are abused in research. These are characterized as typifying all animal research.
The biological and medical research communities have responded by pointing to the many advances in knowledge which have come from animal research and by arguing that research on animals is a necessary component for continued advancement. The scientific community further points out that animal use in research and teaching is strictly regulated to provide for humane treatment and to prevent abuse. The general public is thus being subjected to a conflicting array of arguments. Public sentiment welcomes the benefits to human and animal well-being that accrue from animal research but also opposes animal abuse.
The polarization and politicizing of the animal research issue has put institutions doing research on animals under constant challenge to justify their activities. It is clear that in this environment, breakdowns or inadequacies in animal care and use programs can have severe consequences. Some recent well-publicized examples illustrate this point.
In l982, Dr. Edward Taub, of the Institute of Behavioral Research in Washington, D.C., was charged with six counts of cruelty to animals, and custody of the 15 monkeys being used in his research was remanded to the NIH . The case against him had been developed by a student and animal activist, Alex Pacheco, working as a summer volunteer in his lab. Initially the matter was handled in the courts of Maryland. Dr. Taub was convicted on the six counts, but a court of appeals set aside the conviction on the grounds that since the laboratory was subject to the Public Health Service, the issue was a federal matter. The NIH’s Office of Laboratory Animal Welfare (OLAW - formerly OPRR) initiated an investigation.
Dr. Taub’s grant was suspended. Taub appealed the decision, but lost the appeal. His laboratory was never restored. The animals remained, by court order, in the custody of NIH for many years until all died or were euthanatized. Custody suits brought by PETA were taken all the way to the Supreme Court, which confirmed decisions of the lower court that PETA had no legal standing on which to base its claim for custody of the animals. The "Case of the Silver Spring Monkeys," as it was called in the media, lasted for a period of approximately 10 years.
At the University of Pennsylvania, the head trauma research unit was effectively shut down in the aftermath of a l983 break-in by animal-rights activists. Videotapes stolen from the laboratory were used to demonstrate how monkeys were "brutalized" in the experiments which were designed to study the recovery of inflicted damage that simulated rear-end auto crashes. Follow up investigations by the University and by the NIH showed the laboratory to be in violation of a number of NIH Policy requirements. Deficiencies included: a) inadequate personnel supervision and training; b) inadequate laboratory sanitation (smoking in the laboratory was specifically cited); c) deficiencies in aseptic surgical techniques; d) casual dress in the laboratory; e) substandard surgical recovery room; f) incomplete post-operative records; and g) inadequate supervision by a qualified veterinarian. The University of Pennsylvania was put on probation by the OLAW. The Head Injury Clinic was closed. The chief veterinarian was fired, and new training programs for investigators and staff were initiated.
The City of Hope Medical Center lost NIH funding for all research using animals after a l985 investigation revealed major deficiencies in its facilities and animal use program. The investigation was triggered in part by videotapes taken during a break-in at the City of Hope animal facility; these videotapes continue to be shown in animal rights media presentations. The NIH investigation identified a number of institutional problems, including: a) inadequate administrative organization and management of the animal use program; b) an ineffective animal use review procedure; c) inadequate housing and sanitation in the animal facility; d) inadequate record keeping; e) inadequate veterinary care; and f) inadequate supervision of anesthesia, analgesia, surgery, and postoperative care. The City of Hope made substantial changes in its animal use program and in l986 was able to submit a modified Animal Welfare Assurance Statement which allowed it to resume certain types of animal research.
Columbia University also lost funding for research using animals after a NIH investigation. The Animal Welfare Assurance Statement submitted by the University to the NIH in December l985 indicated, as required, that certain deficiencies existed and provided a plan for correction. One month later, the NIH conducted an unannounced site visit and three days after that suspended funding for all animal research except that involving rodents, and blocked future funding for all research involving animals. The deficiencies cited were a) inadequate overall management; b) an inadequate occupational health program; c) inadequate veterinary care; d) inadequate post-operative care; e) inadequate housing and sanitation in the animal facility; and f) inadequate personnel training program. The University corrected the deficiencies and six months later was able to submit an Assurance Statement acceptable to the NIH.
These examples make it abundantly clear that institutions desiring to continue research and teaching with animals must establish strong animal care and use programs and abide.