Regulatory issues surrounding the use of companion animals in clinical investigations,trials, and studies

Laboratory animal veterinarians sometimes encounter animals with rare conditions and may subsequently become involved in the performance of related animal research outside the laboratory, in homes, in veterinary clinics, or in universities to which owners have donated their animals for study. Similarly, veterinarians may monitor animal companion vaccination studies, performed to optimize preventive health care or minimize physiological variability and research confounders associated with a preventive medicine program for dogs and cats utilized for research procedures. These nontraditional uses of dogs, cats, and other companion animals in research have spurred the establishment of regulations to ensure that the animals benefit from clinical veterinary products and techniques. Included and described are the 2002 Public Health Service Policy, the Animal Welfare Act (AWA), the Federal Food, Drug, and Cosmetic Act, and the regulations of the US Department of Agriculture in response to the AWA. The complexities of clinical research with companion animals outside standard biomedical research facilities are discussed.     

Animal reuse: balancing scientific integrity and animal welfare

Research scientists and IACUC members are faced with the difficult task of balancing the necessity of using animals for experimental research and their mandate to protect the welfare of those animals used in that research. One way to reduce the number of research animals would be to reuse them, but the regulations do not specifically address this topic. To learn more about the reuse of research animals, the authors conducted an online survey of animal facilities involved in preclinical studies. Their results suggest that animal reuse is a common practice in the field.     

Animal Research Ethics in Africa: Is Tanzania Making Progress?

The significance of animals in research cannot be over‐emphasized. The use of animals for research and training in research centres, hospitals and schools is progressively increasing. Advances in biotechnology to improve animal productivity require animal research. Drugs being developed and new interventions or therapies being invented for cure and palliation of all sorts of animal diseases and conditions need to be tested in animals for their safety and efficacy at some stages of their development. Drugs and interventions for human use pass through a similar development process and must be tested pre‐clinically in laboratory animals before clinical trials in humans can be conducted. Therefore, animals are important players in research processes which directly and indirectly benefit animals and humans. However, questions remain as to whether these uses of animals consider the best interests of animals themselves. Various research and training institutions in Tanzania have established some guidelines on animal use, including establishing animal ethics committees. However, most institutions have not established oversight committees. In institutions where there may be guidelines and policies, there are no responsible committees or units to directly oversee if and how these guidelines and policies are enforced; thus, implementation becomes difficult or impossible. This paper endeavours to raise some issues associated with the responsible use of animals in research and training in Tanzania and highlights suggestions for improvement of deficiencies that exist in order to bridge the gap between what ought to be practised and what is practised.     

实验动物与生物安全

实验动物是从事科学研究、教学、生产、检定等的重要工具和支撑条件.随着科学技术的飞速发展,科学研究中使用的实验动物和实验用动物的种类、品系越来越多,生物安全问题已经明显地威胁到生物多样性、生态环境和人类健康.本文分析了实验动物的潜在生物安全危害,探讨了实验动物生物安全管理方面存在的问题并就应对实验动物生物安全提出了一些建议.     

Training for best practices for agricultural programs

As with other areas of animal research, ensuring the proper training and qualifications of the individuals working with agricultural animals for use in research, teaching, and testing is critical to both animal welfare and the successful outcome of the study or teaching exercise. The author provides guidance for the development of appropriate training programs for organizations that use agricultural animals in research.     

产生人抗体的转染色体动物研究进展

现已证明,应用抗体治疗疾病是一种非常成功的方法。单克隆抗体的生产使免疫治疗达到一个新水平,但鼠源单抗在治疗人体疾病方面有很多问题,而人源化抗体可以解决这些问题。目前抗体人源化已由鼠嵌合抗体发展到了转基因动物表达完全人抗体阶段,而人类人工染色体(HAC)载体的发展和微细胞介导的转染色体技术使得产生携带人类免疫球蛋白基因位点的转染色体动物成为可能。通过HAC将人的免疫球蛋白基因转入后,这类转染色体动物可以产生大量人源化多克隆抗体,这对预防及治疗疾病,甚至防御生物武器都有很重要的作用。转染色体技术可以使动物携带大而复杂的人类基因或基因簇,这些转基因动物有助于研究人类基因组在体内的功能作用,并用于各种疾病研究和生产药物蛋白。     

Spontaneous otitis media in Wistar rats: an overlooked pathology in otological research

The rat is commonly employed in otological research, but spontaneous ear infections can confound the results of experimental procedures--wasting time, money, and animals. The authors focus on the incidence of spontaneous otitis media in Wistar rats. They compare disease incidence in animals housed in standard cages with those housed in barrier units, showing that 20% of their conventionally housed animals developed spontaneous otitis media, whereas only 5% of their animals housed in isolated units were infected. These results underscore the importance of strict control of the shipping, housing conditions, and manipulation of animals to be used in otological research.     

恒河猴在生殖生物学中的应用进展

目的非人灵长类动物在生殖生物学研究领域是一种非常重要的实验动物。人类利用非人灵长类动物与人的生物学等方面相似的特征,开展了生殖生物学、生理学、药理学、毒理学以及生育调节等方面的研究工作,为生殖生物学基础研究以及人类健康和疾病问题的基础研究和临床前研究提供了理想的动物模型。随着生命科学的发展,对非人灵长类实验动物质量提出了更高的要求,人们认识到实验时,应用健康的优质非人灵长类动物的重要性。本文简要概括了非人灵长类动物恒河猴的生物学特性,阐述了非人灵长类动物恒河猴在生殖生物学中的应用研究。     

Does the Animal Welfare Act apply to free-ranging animals?

Despite the long-standing role that institutional animal care and use committees (IACUCs) have played in reviewing and approving studies at academic institutions, compliance with the Animal Welfare Act (AWA) is not always complete for government natural resource agencies that use free-ranging animals in research and management studies. Even at universities, IACUCs face uncertainties about what activities are covered and about how to judge proposed research on free-ranging animals. One reason for much of the confusion is the AWA vaguely worded exemption for "field studies." In particular, fish are problematic because of the AWA exclusion of poikilothermic animals. However, most university IACUCs review studies on all animals, and the Interagency Research Animal Committee (IRAC) has published the "IRAC Principles," which extend coverage to all vertebrates used by federal researchers. Despite this extended coverage, many scientists working on wild animals continue to view compliance with the AWA with little enthusiasm. IACUCs, IACUC veterinarians, wildlife veterinarians, and fish and wildlife biologists must learn to work together to comply with the law and to protect the privilege of using free-ranging animals in research.     

无菌动物及其在微生物与宿主互作机制研究中的应用

无菌动物是指通过现代技术手段在其体内外的任何部位均检测不出细菌、真菌、放线菌、支原体、衣原体、螺旋体、立克次氏体、病毒、原生动物和寄生虫的动物。无菌动物因其不携带任何微生物,可转化为携带特定微生物的动物,同时因其免疫系统处于休眠状态,对微生物感染异常敏感,可建立多种悉生动物模型,用于特定微生物感染实验和致病机制研究。此外,无菌动物作为关键工具,是研究菌群与疾病关系的核心,在微生物与宿主健康、疾病和感染机制研究过程中,起着不可替代的作用。本文将对无菌动物及其在微生物与宿主互作机制研究中的应用进行简要综述。     

Report of the Working Group on Animal Distress in the Laboratory

Finding ways to minimize pain and distress in research animals is a continuing goal in the laboratory animal research field. Pain and distress, however, are not synonymous, and measures that alleviate one may not affect the other. Here, the authors provide a summary of a meeting held in February 2004 that focused on distress in laboratory animals. They discuss the difficulties associated with defining 'distress,' propose methods to aid in recognizing and alleviating distressful conditions, and provide recommendations for animal research conduct and oversight that would minimize distress experienced by laboratory animals.     

Future directions in small animal imaging

The adaptation and development of imaging technologies for use in small animals has the potential to be a refinement with profound effects on how basic cancer research using animals is conducted. The authors describe how NCI funding is helping to advance research in this area.     

A moderate Buddhist animal research ethics

Though there is a burgeoning interest in applied Buddhist ethics, Buddhist animal research ethics remains an underdeveloped area. In this paper I will explore how some central Buddhist ethical considerations can usefully engage our use of other animals (henceforth, animals) in science. As the scientific use of animals is broad, I will narrow my focus to laboratory science. I will show that, though a Buddhist abolitionism would not be unmotivated, it is possible to reject it. While doing so, it will be important to resist emphasizing elements of Buddhist thought that merely provide reasons to adopt the dominant ethical framework governing laboratory animal research ethics, known as the 3Rs. Though I will suggest how a Buddhist animal research ethics can sometimes permit the use of animals in harmful research, it will also require ethical constraints that resonate with some of the more progressive elements in ‘Western’ bioethics.     

动物实验中的兽医作用

实验动物是现代医学研究中的重要基础和条件,随着我国实验动物科学的迅速发展和实验动物和动物实验质和量的不断提高,对实验动物兽医的需求越来越大,对实验动物兽医的要求和期望也越来越高,本文简要阐述了兽医在动物实验中的作用.文章就实验动物兽医应该具备的资质、实验动物兽医的基本职责以及实验动物健康与兽医管理等方面进行了讨论,明确了实验动物兽医的各项基本职责及任务.兽医在实验动物的管理以及动物实验的过程中有着非常重要的作用,在动物实验中应充分发挥兽医的作用.     

Rethinking the oversight conditions of human–animal chimera research

New discoveries are improving the odds of human cells surviving in host animals, prompting regulatory and funding agencies to issue calls for additional layers of ethical oversight for certain types of human–animal chimeras. Of interest are research proposals involving chimeric animals with humanized brains. But what is motivating the demand for additional oversight? I locate two, not obviously compatible, motivations, each of which provides the justificatory basis for paying special attention to different sets of human–animal chimeras. Surprisingly, the sets of animals that actually get flagged for special scrutiny by research and funding guidelines do not correlate with either of the sets of animals that arise when we think about what is motivating additional oversight. What this shows is that existing research policies and funding guidelines are disconnected from their motivation: the rationale for flagging certain types of human–animal chimeras as requiring special oversight is ignored in execution.     

Influence of pet ownership on opinions towards the use of animals in biomedical research

Abstract

The present study investigated the relationship between pet ownership and opinions on the use of animals in medical research. A questionnaire was answered by 484 schoolteacher students and 156 pre-school teacher students from Uppsala University, Sweden. Animal use was found to be of significant importance for developing treatments for human disease by 59 percent of respondents, but 15 percent did not agree. Forty-four percent thought that it was morally acceptable to use animals in biomedical research, while 25 percent did not. A significantly higher proportion of those who reported experience in the use of animals in research from university teaching morally accepted and understood the importance of using animals in biomedical research, compared with students without this background. Fifty-eight percent of the students were pet owners and the most common species owned were the cat and the dog. A lower proportion of pet owners (39%) found it acceptable to use pet species in biomedical research than did non-pet owners (52%).     

Development of a Chinese-Indian hybrid (Chindian) rhesus macaque colony at the California National Primate Research Center by introgression

Background  Fullbred Chinese and Indian rhesus macaques represent genetically distinct populations. The California National Primate Research Center introduced Chinese founders into its Indian-derived rhesus colony in response to the 1978 Indian embargo on exportation of animals for research and the concern that loss of genetic variation in the closed colony would hamper research efforts. The resulting hybrid rhesus now number well over a thousand animals and represent a growing proportion of the animals in the colony.
Methods  We characterized the population genetic structure of the hybrid colony and compared it with that of their pure Indian and Chinese progenitors.
Results  The hybrid population contains higher genetic diversity and linkage disequilibrium than their full Indian progenitors and represents a resource with unique research applications.
Conclusions  The genetic diversity of the hybrids indicates that the strategy to introduce novel genes into the colony by hybridizing Chinese founders and their hybrid offspring with Indian-derived animals was successful.     

The role of organizational culture in compliance with the principles of the 3Rs

In order for their research to be legitimate, scientists carrying out research using animals must comply with rules and regulations. The 3Rs (replacement, reduction and refinement) are one set of guidelines that help to promote the ethical use of animals for research. An important question is whether implementing the principles of the 3Rs in legal regulations, such as a Directive of the European Parliament and of the Council on the protection of animals used for scientific purposes, will increase compliance with the principles of the 3Rs in research organizations. Previous work suggests that organizational culture is just as important for directing behavior as are formalized rules and regulations. This article introduces the concepts of compliance and organizational culture and discusses their consequences on the implementation of the principles of the 3Rs.     

Is Giardia a significant pathogen in production animals?

Although Giardia duodenalis is recognised worldwide as the most important parasitic cause of gastro-intestinal disorder in human patients, the relevance of infection in production animals is prone to debate. Since the 1980s, clinical disease has been associated with giardiasis in production animals, both in natural conditions and in experimental studies. However, most Giardia research is focussed on the relevance of production animals as a reservoir for zoonotic transmission. In this study, the current knowledge on clinical relevance of giardiasis in production animals is reviewed, along with the diagnosis, treatment and control of infection. Furthermore, future research objectives are discussed.     

Public Attitudes toward the Use of Animals in Research: Effects of Invasiveness,Genetic Modification and Regulation

ABSTRACT

This study describes an online public engagement experiment aimed at investigating how acceptance of animal-based research is affected by: (a) the presence of regulations that govern the use of nonhuman animals in laboratories, (b) the invasiveness of procedures, and (c) the use of genetically modified (GM) animals. To meet these aims, participants were asked if they were willing to accept the use of pigs in different scenarios involving agricultural research. Two-thirds of the 681 participants were female and the majority (58%) were young (19–29 years old) with college or university level education (62%). Participants came from 26 different countries, with the United States, Canada, and the United Kingdom being the top three countries represented. Participants who self-identified as being vegetarians, familiar with animal welfare, animal advocates, environmental advocates, and familiar with animal research were significantly more likely to be opposed to animal-based research. Older participants were significantly less likely to oppose animal-based research. Support significantly decreased when animal-based research involved an invasive procedure or GM animals. Support for invasive research significantly increased when regulation was in place, but regulation had less effect on acceptance of GM animal use. Comments provided by participants illustrated different decision-making strategies regarding different types of animal-based research. Given the increasing use of GM animals in research, more effort is required to understand people's concerns regarding this type of animal use and to determine how these concerns should be reflected in policy.