How regulation hamstrings animal research
US agencies change previously effective rules, give oversight to people unfamiliar with the benefits of animal research, and place unreasonable demands on researchers
Government agencies like to cite the dangers of animal rights activists. But the Research Animal Resource Centers (RARCs) and Animal Care Unit Committees (ACUCs) created in response to the US Animal Welfare Act (AWA) constitute a larger threat to progress in the health sciences than the actions of any such activists. The net outcome has been huge expenditures and, in many cases, increased numbers of animals needlessly killed.
Ignorance has set the course and fear has silenced most spectators. I?ve worked with more than 30 different mammalian species in my three decades as an experimental neuroscientist, and I?ve served as chair of the Wisconsin University Union, a faculty and staff organization devoted to the protection and enhancement of due process for university employees. And due process, when it comes to institutional ACUCs certainly requires protection.
RULES OF ENGAGEMENT
The AWA is not included in the local institution?s legal system that guides and guards individuals. Consequently, infractions against AWA rules are not handled according to the carefully tailored system of justice within the university. The treatment of Ei Terasawa exemplifies this.
Terasawa is a well known scientist, who, after some 20 years of research, has been banned from work with any kinds of animals for two years. The official letter with the decision to restrict her research offers no details. Instead it uses generalizations such as: ?pattern of protocol violations, lack of full cooperation with ACUC requirements or provisions, and a failure to recognize the importance of rules and regulations that govern the use of animals in research and teaching, contributed to the GS (Graduate School) ACUC?s recommendation. Collectively, this history has undermined both ACUC?s confidence in your ability to perform your responsibilities as a principal investigator authorized to use animals in research.?
Terasawa?s fate is not unique at UW. Nor is the acerbic tone of the sentencing letter. Other university matters follow a well developed system of due process and procedure. At UW, Chapter 9 of the UW, Madison, Faculty Policies and Procedures (FPP) and state laws regulate how accusations must be dealt with. Any accusation must be specified, evidence must be presented in detail and made available to the accused, the accused is assured the right of a defender, the right to appeal to another forum than the one that sentenced, etc. Terasawa?s case was not handled accordingly. Instead the ACUC and RARC fulfill the role as police, prosecutor, judge, jury, and warden. Bafflingly, the UW administration claims that her sentence or any other ACUC sentence is not a ?disciplinary action.? Consequently, the above processes do not apply.
The AWA states that members of the institutional ACUC be appointed by ?the Chief Executive Officer of the research facility.? But most Chancellors or Deans have little hands-on knowledge of animal research and little ability to assess the experience of a potential member. To assure expertise in ACUC the members should be elected by faculty or a similar entity of peers.
The AWA mandates at least one layperson in the ACUC: ?The secretary intends that such a person will provide representation for general community interests? (2.31, ii). It is amazing that, while the AWA demands that people involved in a project using animals are fully qualified (2.32), there is no demand on the layperson assigned to evaluate the projects. I asked the layperson at UW?s ACUC what his expertise was. He told me he was a middle school teacher and his kids had two guinea pigs as pets!
The AWA does stipulate that: ?at least one member shall be a Doctor of Veterinary Medicine.? While an improvement, laboratory veterinarians generally have no research experience, no knowledge of highly specialized animal experiments or experimental surgery. Furthermore, since the ACUC veterinarian is employed by RARC she/he is more interested in protocol matters, not in achieving scientific results.
This leaves the investigator facing a committee in which potentially the only member with the background, vocabulary and experience to comprehend the complexities associated with the procedure has little vested interest in interpreting or clarifying on behalf of the investigator. The result is barrages of questions from the ACUC and delays of protocols for months. Many of these questions show ignorance beyond imagination.
For example, one UW ACUC refused to accept the over-night water deprivation method in mice despite hundreds of scientific articles that use and have used this method. In another example the ACUC at another large university refused use of a cheek-pouch (submandibular) blood collecting method in mice. Although information about it is readily available on the WEB, the local ACUC had never heard about it and two months later the researcher is still waiting for approval.
Local RARCs and ACUCs don?t deserve all the blame. AWA is filled with unrealistic demands and rules. One example of this is the mandated question of unnecessary duplication, which requires: ?a written assurance that the activities do not unnecessarily duplicate previous experiments.? (2.31, iii).
Repetition is a hallmark of science and safeguards against error and fraudulence. For the result of research to have any kind of scientific validity, it has to be repeated. Is this an unnecessary duplication?
Furthermore, AWA creates unrealistic conditions. To conform with AWA, universities and research institutions must have centralized animal holdings. These serve as breeding ground for infections and in turn epidemics.
Moreover, the demand that all survival surgery be aseptic is ignorant of what every practicing veterinarian knows: There is a big difference between bacteria and pathogens. Bacteria are everywhere, pathogens are not. Animal species handle bacteria differently, too. It is ridiculous to demand sterility for surgery in rats, as is done by the ACUC and RARC, because rats have an excellent immune system.
AWA was written to reduce the use of animals in research. But applying these excessive rules kills more animals than before. In one lab I teach we do a simple two-bottle experiment with mice. Students measure intake of two sweeteners, sucrose and aspartame. Since mice don?t taste the sweetness of aspartame, in contrast to humans, the lab is an easy and clear demonstration of species differences in taste. After the lab the animals could easily go back to their animal room, since they have had no contact with any other animals, but RARC forces us to kill all the mice.
The way the AWA is applied, it kills rather than saves animals. The reason fewer animals are used in research is that many experiments have been made illegal by regulations, costs have increased astronomically, and fewer and fewer scientists are prepared to jump through the hoops presented by the AWA.
In the early 70s I developed a less traumatic surgical technique to record from taste nerves. The one used earlier necessitated sacrificing the animal, but after the new one the animals recover in a few days. We have published and used this technique in many species. And although I have done the surgery in my lab on more than 300 monkeys with few complications, ACUC now considers the lab unsuitable for primate work. The lab is especially equipped for taste research using electrophysiological technique and extensive equipment, which can not be transported anywhere else. ACUC would only accept terminal experiments, which is a waste of animals and money, around $5,000/monkey.
As most of the research funds originate from the tax-payers, it is time to have an open discussion of the cost of AWA and its enforcement. The rules of the AWA are grossly disproportionate to regulations that guide the regulation for food animals. I have visited agricultural pig facilities where the animals cannot lie down, because it is so crowded. The personnel have to use air filters, because of the dust in the air. For the pigs in the barn only some vague rules about animal cruelty apply. Contrast this with the extensive demands for space, air exchange, temperature, etc. detailed in the AWA. Why should not the demand for space for a pig produced for meat be the same as if it were destined for research? It is time to level the field.
I propose the following:
1. Level the differences in legislation between animals used in research ? the AWA ? and agriculture.
2. Unify the animal protocol forms across all research institutions.
3. Have the AWA demand expertise of all members of the local Animal Care Units.
4. Make the ACUCs a normal part of the committee system at the institution and elect its members from active researchers.
5. Mandate use of the institutional legal system and state laws to deal with AWA allegations.
Then we?ll have time to worry about the animal rights activists.
Göran Hellekant is professor of Animal Health and Biomedical Sciences at the University of Wisconsin, Madison?s School of Veterinary Medicine.
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