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Johns Hopkins Bloomberg School of Public HealthCAAT
 

Animals and Alternatives in Testing: History, Science, and Ethics

Joanne Zurlo, Deborah Rudacille, and Alan M. Goldberg

Chapter 5

Animal Experimentation: Ethics and Law

The universities do not teach all things, so a doctor must seek out old wives, gypsies, sorcerers, wandering tribes, and such outlaws and take lessons from them.

- Paracelsus (1493-1541)

In 1831, British physiologist Marshall Hall proposed five principles that he believed should govern animal experimentation. First, an experiment should never be performed if the necessary information could be obtained by observations; second, no experiment should be performed without a clearly defined and obtainable, objective; third, scientists should be well-informed about the work of their predecessors and peers in order to avoid unnecessary repetition of an experiment; fourth, justifiable experiments should be carried out with the least possible infliction of suffering (often through the use of lower, less sentient animals); and finally, every experiment should be performed under circumstances that would provide the clearest possible results, thereby diminishing the need for repetition of experiments.

Hall also proposed the founding of a scientific society to oversee publication of research results and recommended that "the results of experimentation be laid before the public in the simplest, plainest terms" (Rupke, 1987). Hall was castigated by those who disapproved of animal experimentation, both within and without the medical community. He died in 1857, with many of his recommendations formally instituted over a century later in the British Animals (Scientific Procedures) Act and the U.S. Animal Welfare Act.

Laws Regulating Animal Experiments

The first law written specifically to regulate animal experimentation was Great Britain's 1876 Cruelty to Animals Act. This act was a much weakened version of the original, extremely bill, which came close to passage in 1875. The 1876 law, which implicitly approved animal experimentation at the same time that it set up a system of licensing and certification, was replaced by the Animals (Scientific Procedures) Act of 1986, which specifically states that "The Secretary of State shall not grant a project license until he is satisfied that the applicant has given adequate consideration to the feasibility of achieving the purpose of the programme to be specified in the license by means not involving the use of protected animals" (Animal Welfare, UFAW, Vol. 1, No. 2, 1992).

In the United States, the 1966 Animal Welfare Act, amended in 1970, 1976, 1986, 1989, and 1991, set standards for the transportation and husbandry of laboratory animals, excluding rats, mice, and birds. On January 8, 1992 the U.S. District Court in Washington, DC ruled that the U.S. Department of Agriculture had been violating the Animal Welfare Act by not enforcing its provisions as they relate to these animals. The case is currently on appeal (see Appendix D: United States Animal Welfare Timeline, and Appendix E: Great Britain Animal Welfare Timeline).

The U.S. Public Health Service Guide for the Care and Use of Laboratory Animals and the Health Research Extension Act of 1985 regulate all research funded by the National Institutes of Health (NIH) and require the submission of regular reports on protocols involving animals. The guide has been revised five times and is being updated once again this year. The NIH also requires accreditation by the American Association of Laboratory Animal Care (AAALAC) or the operation of an institutional animal care and use committee. However, since AAALAC requires an animal care and use committee as well, almost all institutions conducting vertebrate research or testing are now subject to review.

Institutional Animal Care and Use Committees

Under the 1985 amendment to the U.S. Animal Welfare Act, Institutional Animal Care and Use Committees (IACUC) have been established to review all protocols for procedures involving live warm-blooded animals, whether or not pain or distress is likely to occur. If these procedures are acceptable, the IACUC provides institutional approval. In addition, the IACUC must evaluate procedures every year and inspect facilities.

Each research facility must set up an IACUC composed of at least five members, one of whom is a Doctor of Veterinary Medicine, who are responsible for the activities involving animals at the institution. The committee must also include at least one practicing scientist experienced in research involving animals, one member whose primary concerns are nonscientific (i.e., a lawyer, cleric, or ethicist), and one individual who is not affiliated with the institution in any way except through his or her membership on the committee. However, most committees have more than five members, and in academic institutions, it is common to have student representatives as well.

The establishment of animal care and use committees in universities, industrial laboratories, and other research facilities has certainly had an impact on the use of animals in these places. IACUCs are charged with reviewing both the ethical and procedural issues related to animal use, including the choice of animal, numbers of animals, the degree of pain and discomfort animals will experience, and whether or not the investigator has considered the use of replacement, refinement, and reduction alternatives to whole animals in constructing the protocol (Fig. 11).

Figure 11. University of California (Berkeley) Animal Care and Use of Committee Protocol Review Process

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Although grumbling has been heard about the "bureaucratization" of science, some researchers are willing to admit that the IACUCs have not only improved conditions for laboratory animals but have also raised the calibre of the research itself. During a recent discussion at an IACUC symposium sponsored by the Office of Research Subjects at the Johns Hopkins University School of Public Health, the chairman of the University of Maryland School of Medicine's Animal Care and Use Committee, Michael Lipsky, commented that the animal care and use committee in that institution has facilitated a great deal of interaction and cooperation between researchers in different departments and disciplines. Because the members of the animal care and use committees are familiar with work of every investigator in the institution using animals, they are able to act as liaisons between researchers who might not otherwise connect, resulting in an extremely fruitful exchange of information and expertise.

It would be naive to assume, however, that animal care and use committees are universally popular and well-respected. Although science in the United States is very carefully peer-reviewed, there is increasing public demand for accountability, both ethical and economic. This is sometimes resented and perceived as an infringement of academic freedom. However, as institutions and researchers come to understand the role of the committees, this perception is diminishing.

Surrogate Responsibility

As a number of commentators have pointed out (Scientific Perspectives on Animal Welfare; Dodds and Orlans, 1982) the ultimate responsibility for the humane care and treatment of animal lies with scientists themselves. "It is impossible to police every laboratory in the country for 24 hours every day to ensure that proper treatment is given to these animals...Humane use of the animal is entirely in the hands of the investigators" (Dodds and Orlans, 1982). The vast majority of scientists acknowledge this responsibility and conduct experiments in a humane manner.

Recognizing the need to affirm investigator responsibility early in a student's scientific career, the government of The Netherlands has mandated that every doctoral student in the sciences take a course in the history and ethics of animal experimentation prior to graduation (van Zutphen, personal communication). This legislation may ultimately prove far more effective than restrictive covenants in sensitizing individual investigators and disseminating the three Rs approach. Studies in the social sciences have illustrated time and again that a change in both individual attitudes and group norms is essential for effective implementation of reform. If the culture of biomedical research promotes mindfulness and respect for animal life and well-being, the great majority of scientists and scientists-in-training will conform to these norms.

Richard C. Bartlett, President of Mary Kay Cosmetics and an active conservationist, and Frederick S. Carney, Professor of Ethics at Southern Methodist University, have written of the widespread employment of the concept of surrogate responsibility not only by parents on behalf of their children and by spouses and offspring on behalf of mentally incapacitated older persons, but also an increasing number of persons to identify, protect, and maintain threatened species and endangered ecosystems. Bartlett and Carney believe that this concept applies to laboratory animals as well. "The notion of surrogate responsibility...involves a profound respect for animals, a strong commitment to their welfare through proper care and use, and an avoidance or minimization of discomfort, distress and pain... It also calls for rigorous and continuing efforts to find in vitro alternatives to the use of animals" (Bartlett and Carney, 1992).

Bartlett and Carney also note the necessity of "an appropriate and effective institutional framework" in support of surrogate responsibility, including high national standards for the care and use of laboratory animals, monitoring of laboratory conditions, and the development of local review boards, which must approve in advance all use of animals in product safety testing. Professor Carney has stated that "in the United States the institutional animal care and use committee mandated by the 1985 amendment to the Animal Welfare Act would be sufficient, although open to future refinements in the light of ongoing experience and ethical reflection" (personal communication).

Clearly, the animal care and use committee has stimulated a greater degree of sensitivity within the scientific community to the ethical aspects of animal experimentation, just as the campaigns of animal advocates have stimulated a greater awareness among the public of all aspects of human use of animals, from food production to entertainment to the wearing of fur and leather (Fig. 12). Reasonable people may disagree about the morality of human use of animals, just as they disagree about other hotly debated topics in ethics such as capital punishment, abortion, and euthanasia.

Figure 12. Animals killed annually in the United States. EStimated numbers provided by the U.S. Congress Office of Technology Assessment, the Humane Society of the United States (1988), Animals' Agenda (1987), and the OTA (1985).

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In a democratic society, individuals have a right (and a responsibility) to express their convictions on these issues, contributing to the national discourse. However, individuals do not have a right to destroy property or to harass or otherwise threaten fellow citizens who hold different beliefs. The impotence of those who choose violence as a means of protest can and should be contrasted with the pragmatic and highly effective approaches of activists such as Henry Spira, whose Campaign to Abolish the LD50 and Draize Tests has instigated widespread institutional change.

"Many people perceive the movement for animal protection as negative and antiscience," Spira wrote recently. "To counteract this perception we have continually accentuated the fact that members of the science community are part of the nine out of ten people concerning protecting animals. We have attempted to turn walls in to bridges by promoting the shared goals of better science, efficiency, economy, and humanity" (Spira, 1993).

The bridges that Spira and others in the scientific and animal protection communities have built in the past decade will become better traveled as more people in both groups realize that good science and animal welfare are complementary -- not conflicting -- goals and that diplomacy yields far higher dividends than ad hominem attacks. Jerald Silverman, a laboratory animal veterinarian, commented recently that "we spend far too much of our time and effort trying to win the propaganda war of ethical animal use versus no animal use."

Silverman, like Spira, suggests focusing on common goals. "I argue that our goal should be to stop using animals while I readily admit that this is unrealistic in the foreseeable future. Nevertheless, if we do not try to make progress toward that goal, we deny the validity of scientific endeavor... We can therefore share a common goal, differing in our opinions as to the speed with which the goal can be reached...One of the intermediate steps toward reaching this goal must be to make the search for adjuncts and alternatives a well-funded scientific discipline. When funding is available, scientists and scientific acceptance will follow" (Silverman, 1993).

Spira and Silverman, activist and scientist, together point to an important truth -- that idealism tempered by pragmatism achieves measurable progress. The reductions in animal use for toxicity testing, which have been achieved over the past decade, are truly remarkable and have been spurred by scientific, economic, and political factors. Few would argue that the implementation of the three Rs on a broad scale has resulted in a decrease in public safety or poses dangers to human health. In fact, it is widely recognized that alternatives research has moved the science of toxicology forward and will continue to do so.

Whether one chooses to refer to these methodologies as adjuncts or alternatives may not be as important an issue as some would make it. Both science and activism seek the goal -- quantifiable results. If replacement, reduction, and refinement methodologies are able to produce (as they demonstrably have) quantifiable results, then both scientists and activists can, with clear consciences, work together in continued pursuit of that goal. As many have already discovered, the process itself yields rewards.