Animal Care Courses: Helping Fulfill the Mandate of Animal Care Committees in Canada

Animal Care Committees (ACCs) at Canadian universities and research centers operate under the aegis of the Canadian Council on Animal Care (CCAC) and its guidelines for the humane care and treatment of animals in teaching, research, and testing. All Canadian universities have at least one active committee. The committees are expected to assume an educative role beyond the provision of information concerning housing, maintenance, and appropriate conditions for the treatment of animals in research. This includes critical examination of the serious ethical issues involved in animal research within the context of the principles and practices endorsed by the CCAC. One-day animal care courses provided by ACCs at three Canadian universities are described. Comparisons are made between the content and structure of curricula and the ways these relate to the teaching and research mandate in each institution, focusing particularly on the teaching of ethics in each course. The implications for heightening awareness of ethical issues in animal research and improving the effectiveness of these courses are discussed.     

Animal care courses: helping fulfill the mandate of animal care committees in Canada

Animal Care Committees (ACCs) at Canadian universities and research centers operate under the aegis of the Canadian Council on Animal Care (CCAC) and its guidelines for the humane care and treatment of animals in teaching, research, and testing. All Canadian universities have at least one active committee. The committees are expected to assume an educative role beyond the provision of information concerning housing, maintenance, and appropriate conditions for the treatment of animals in research. This includes critical examination of the serious ethical issues involved in animal research within the context of the principles and practices endorsed by the CCAC. One-day animal care courses provided by ACCs at three Canadian universities are described. Comparisons are made between the content and structure of curricula and the ways these relate to the teaching and research mandate in each institution, focusing particularly on the teaching of ethics in each course. The implications for heightening awareness of ethical issues in animal research and improving the effectiveness of these courses are discussed.     

Publication: an ethical imperative.

Publication of medical research is both a monitor of the researcher''s ethics and an audit of the local or regional ethics committee that approved it. Selectivity of publication or of the intention to publish lessens this audit. Opinions differ about what is ethically allowable in clinical and benchtop medical research. Ethical permission and ethical monitoring of medical research are subject to a hierarchy of pyramidal controls, starting in hospital and ending with the local, institutional, or regional ethics committee. Currently, such committees function with widely varying degrees of efficiency and quality of output, and with differing viewpoints on many ethical issues. Without an a priori insistence by institutional ethics committees that there be an intention to publish all medical research involving human subjects, ethics committees cannot routinely be subject to the scrutiny or audit which they themselves demand of researchers.     

Barriers and challenges in clinical ethics consultations: the experiences of nine clinical ethics committees

Clinical ethics committees have recently been established in nearly all Norwegian hospital trusts. One important task for these committees is clinical ethics consultations. This qualitative study explores significant barriers confronting the ethics committees in providing such consultation services. The interviews with the committees indicate that there is a substantial need for clinical ethics support services and, in general, the committee members expressed a great deal of enthusiasm for the committee work. They also reported, however, that tendencies to evade moral disagreement, conflict, and 'outsiders' are common in the hospitals. Sometimes even the committees comply with some of these tendencies. The committees agree that there is a need to improve their routines and procedures, clarify the committees' profile and field of responsibility, to make the committees well-known, to secure adequate operating conditions, and to develop organizational integration and support. Various strategies to meet these challenges on a local, regional or national level are also explored in this paper.     

The new system of review by multicentre research ethics committees: prospective study

ObjectiveTo assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed.DesignProspectively collected data from a multicentre study was examined with respect to the ethics review process. Administrative, financial, and time elements of the review process were audited.SettingA single multicentre research ethics committee and 125 local ethics committees from six regions of England.ResultsOnly 40% of local ethics committees considered our study in the manner specified in the 1998 directive. Less than a third of committees replied within the 21 day period stipulated, although committees acting by executive subcommittee replied more quickly than those not acting by executive subcommittee. There was a tendency for executive subcommittees to approve studies in a shorter time. Local ethics committees asked for a large number of non-local changes to the application. The financial cost of applying to multiple ethics committees remains high, mainly because multiple copies of research applications are being requested.ConclusionsThe new system of approval by multicentre research ethics committee for multicentre studies was introduced to reduce administrative costs, speed up the process of reviews by multiple research ethics committees, and standardise the conclusions of the local research ethics committees. Since its introduction an improvement has been seen, but the system is not yet universally functioning as intended. Ethics review still remains a hindrance to the financial resources and commencement of national studies. We strongly support the structure of review by multicentre research ethics committees but suggest that the system has yet to achieve its aims.     

The role of ethics in experimental marine biology and ecology

Although most countries have ethical guidelines for research involving human subjects and other sentient animals, the ethical issues associated with field research have received little attention. Most experimental marine biologists and ecologists operate without ethical guidelines or scrutiny, despite intermittent community concern about their activities. We offer suggestions on how marine biologists and ecologists can protect the future of research involving the field collection and experimental manipulation of organisms by developing mechanisms to address community concerns that such research is ethically responsible. We urge experimental marine biologists and ecologists to take pre-emptive initiatives by encouraging: (1) institutional animal ethics committees to broaden their terms of reference to include environmental ethics; (2) scientific societies to develop codes of ethics to guide the environmental research conducted by their members; (3) editorial boards of journals to require the research they publish to conform to an appropriate code of ethics, and (4) management agencies that issue permits for field research to establish an ethics committee to advise them on the ethical issues raised by specific research proposals. We conclude that the resultant administrative burden on scientists would be low but that the penalties of operating without such protection can be high.     

The refining influence of ethics committees on animal experimentation in Sweden

Mandatory scrutiny of projects by animal ethics committees was introduced in Sweden in 1979. The present study investigated the minutes of meetings held between 1989 and 2000 at which consideration of applications for experimental work in animals resulted in requests for modification (n = 3607). 18.1% of the applications received were approved only after modifications. The majority of the changes requested may be classified as 'Refinement'. The most common requests were for improvement of project design, euthanasia method and housing and husbandry. There was a relative increase in modifications requested by the committees related to anaesthesia, choice of licensed supervisor and the need for licenses or informed consent from animal owners during the period investigated. There was a relative decrease in modifications related to euthanasia, housing and husbandry, and general endpoint assertions. The results suggest that the work of the committees may be perceived as an ongoing process, since several of the applications for which modification was requested were projects that had been approved on a previous occasion but were now up for renewal. In order to have maximal influence on the refinement of scientific protocols it is important that the scientists in the committees are continuously updated on developments in laboratory animal science.     

Human Research Ethics Committees: Examining their Roles and Practices

considerable time and resources are invested in the ethics review process. We present qualitative data on how human research ethics committee members and health researchers perceive the role and function of the committee. The findings are based on interviews with 34 Australian ethics committee members and 54 health researchers. Although all participants agreed that the primary role of the ethics committee was to protect participants, there was disagreement regarding the additional roles undertaken by committees. Of particular concern were the perceptions from some ethics committee members and researchers that ethics committees were working to protect the institution's interests, as well as being overprotective toward research participants. This has the potential to lead to poor relations and mistrust between ethics committees and researchers.     

A sample postapproval monitoring program in academia

The primary goal of an animal care and use program (ACUP) should be to ensure animal well-being while fostering progressive science. Both the Animal Welfare Act (and associated regulations) and the Public Health Service (PHS) Policy require the institutional animal care and use committee (IACUC) to provide oversight of the animal program through continuing reviews to ensure that procedures are performed as approved by the committee. But for many committees the semiannual assessment does not provide an opportunity to observe research procedures being performed. Furthermore, IACUC members are typically volunteers with other full-time commitments and may not be able to dedicate sufficient time to observe protocol performance. Postapproval monitoring (PAM) is a tool that the IACUC can use to ensure that the institution fulfills its regulatory obligation for animal program oversight. When performed by attentive and observant individuals, PAM can extend the IACUC's oversight, management, training, and communication resources, regardless of program size or complexity. No defined PAM process fits all institutions or all situations; rather, the monitoring must match the program under review. Nonetheless, certain concepts, concerns, and conditions affect all PAM processes; they are described in this article. Regardless of the style or depth of PAM chosen for a given program, one thing is sure: failure of the IACUC to engage all available and effective oversight methods to ensure humane, compassionate, efficient, and progressive animal care and use is a disservice to the institution, to the research community and to the animals used for biomedical research, testing, or teaching.     

Preparation of animals for use in the laboratory: issues and challenges for the Institutional Animal Care and Use Committee (IACUC)

Preparation of animals is important for optimization of animal welfare as well as to minimize interanimal variation, thereby strengthening the quality of data for in vivo studies. These issues are important in the work of institutional animal care and use committees (IACUCs), but they pose many challenges as well. This article provides IACUC members with a resource for use in determining whether and how preparation of animals for research affects the IACUC's responsibilities. The topics addressed are intended to serve as a starting point for consideration and discussion. Questions related to subject selection and acclimation of subjects to experimental housing and procedures are emphasized and should provide IACUC members with a framework for discussion of relevant questions. Guidelines are provided for promoting the acclimation of a number of species to experimental settings. Additional, potentially controversial points are also raised, including the effects on longitudinal data sets of changing subject preparation procedures. The roles of the IACUC in the research endeavor are multifaceted and continuously evolving. As empirical data are produced that affect additional aspects of animal care and use, it is important for these committees to be able to evaluate and, when appropriate, stimulate the implementation of improved procedures and strategies.     

Ethical review in biomedical research

Through the difficulties encountered during the previous centuries in order for an animal to be recognized as a sensitive being, we saw the evolution of society's attitudes change from antiquity to our present day. Over the past twenty years animal testing has first evolved within a progressive regulatory framework reinforced by an ethical thinking which has, since 1990, led to the establishment of the ethics committees. The dialogue between these committees and researchers has led to the recovery of principles previously ignored such as the 3Rs (Replace, Reduce, Refine). This in turn has led to the application of improving experimental conditions, the progressive decrease in the number of animals used through a wise use and the replacement of animals by in vitro techniques in the very preliminary stages of research. Progress remains to be done, but the evolution of European regulations being amended, the formalization in France of ethics committees and the establishment of the National Ethics Committee should further contribute to the improvement of animal welfare in experimental research.     

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.     

Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative ‘Pre‐Review’ Mechanism for a Study of Fexinidazole for Human African Trypanosomiasis

Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs for Neglected Diseases Initiative (DNDi), an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis (HAT). The project involved the implementation of a novel ‘pre‐review’ process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process.     

A guide to defining and implementing protocols for the welfare assessment of laboratory animals: eleventh report of the BVAAWF/FRAME/RSPCA/UFAW Joint Working Group on Refinement

The refinement of husbandry and procedures to reduce animal suffering and improve welfare is an essential component of humane science. Successful refinement depends upon the ability to assess animal welfare effectively, and detect any signs of pain or distress as rapidly as possible, so that any suffering can be alleviated. This document provides practical guidance on setting up and operating effective protocols for the welfare assessment of animals used in research and testing. It sets out general principles for more objective observation of animals, recognizing and assessing indicators of pain or distress and tailoring these to individual projects. Systems for recording indicators, including score sheets, are reviewed and guidance is set out on determining practical monitoring regimes that are more likely to detect any signs of suffering. This guidance is intended for all staff required to assess or monitor animal welfare, including animal technologists and care staff, veterinarians and scientists. It will also be of use to members of ethics or animal care and use committees. A longer version of this document, with further background information and extra topics including training and information sharing, is available on the Laboratory Animals website.     

A new approach to regulating the use of animals in science

Anderson was a member of the writing group for the recent revision of Australia's national Code of Practice for the use of animals in scientific research. Here he outlines the major features of the Code. These deal with animal experimentation ethics committees, with levels of pain and distress in subjects, with standards of care, and with the delineation of responsibilities among researchers, institutions, ethics committees, and caretakers. Anderson also describes how the Code is updated, and discusses its legal status, scientists' concerns, and the Code's future.     

Preparation of animals for research--issues to consider for rodents and rabbits

This article provides details to consider when preparing to use animals in biomedical research. The stress of transport and receipt of animals into a new environment mandate the need for a period of stabilization and acclimation. This allotment of time often occurs in conjunction with the quarantine period and permits a stress "recovery" period. Discussions in the article include specific effects of the environment on the animal, such as housing and environmental enrichment. Suggestions are offered regarding how to minimize the effects of procedures and equipment through the use of preconditioning techniques. Guidelines for these techniques and for acclimation should be instituted by the institutional animal care and use committee. Stress and distress are placed in perspective as they relate to the preparation of laboratory animals for research.     

Challenges faced by research ethics committees in El Salvador: results from a focus group study

Objective:  To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building.
Methods:  Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the National Ethics Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed.
Results:  Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision-making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight.
Conclusions:  Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research.     

The Role of a Hospital Ethics Consultation Service in Decision-Making for Unrepresented Patients

Despite increased calls for hospital ethics committees to serve as default decision-makers about life-sustaining treatment (LST) for unrepresented patients who lack decision-making capacity or a surrogate decision-maker and whose wishes regarding medical care are not known, little is known about how committees currently function in these cases. This was a retrospective cohort study of all ethics committee consultations involving decision-making about LST for unrepresented patients at a large academic hospital from 2007 to 2013. There were 310 ethics committee consultations, twenty-five (8.1 per cent) of which involved unrepresented patients. In thirteen (52.0 per cent) cases, the ethics consultants evaluated a possible substitute decision-maker identified by social workers and/or case managers. In the remaining cases, the ethics consultants worked with the medical team to contact previous healthcare professionals to provide substituted judgement, found prior advance care planning documents, or identified the patient’s best interest as the decision-making standard. In the majority of cases, the final decision was to limit or withdraw LST (72 per cent) or to change code status to Do Not Resuscitate/Do Not Intubate (12 per cent). Substitute decision-makers who had been evaluated through the ethics consultation process and who made the final decision alone were more likely to continue LST than cases in which physicians made the final decision (50 per cent vs 6.3 per cent, p = 0.04). In our centre, the primary role of ethics consultants in decision-making for unrepresented patients is to identify appropriate decision-making standards. In the absence of other data suggesting that ethics committees, as currently constituted, are ready to serve as substitute decision-makers for unrepresented patients, caution is necessary before designating these committees as default decision-makers.     

我国实验动物科学带来的动物伦理及福利问题

实验动物是在一定条件下人工饲养繁殖,具有特定的生物学特性,用于科学研究的动物。实验动物是生命科学研究不可缺少的支撑条件,是为人类的健康和发展作出贡献和牺牲的生命体。实验动物科学包括实验动物和动物实验两个方面,是生命科学的重要分支。随着人类社会、经济和文化的发展,动物福利和动物伦理问题已经全面渗透到了实验动物科学乃至生命科学的各个领域之中。在我国,实验动物科学带来的伦理问题主要表现为：缺乏相应的法律法规,对虐杀实验动物的现象缺乏管理,违背实验动物伦理的技术操作现象依然存在,动物保护主义者和实验动物科学工作者之间的矛盾,等等。动物伦理学在中国出现的社会原因是：改革开放后经济的快速发展促使人们的观念转变,与国际的交往促进了东西方文化的交融,同时也是近十几年来教育的结果。近年来,我国实验动物科学领域内关于伦理问题和动物福利的研究进展迅速,实验动物纪念碑的出现和＂3R＂研究概念的传入是其主要表现。改善实验动物的生活条件,杜绝虐杀实验动物的现象,规范动物实验的技术操作,尽快制定和完善相关的法律法规,是进一步努力的目标;而落实组织措施,成立动物伦理委员会及专家组,加强与国际上的交流,推动＂3R＂研究的进展,扩大对社会的宣传,支持爱护动物的行为,注重与动物保护组织的理解及沟通等,是为达到这一目标应采取的措施。     

Do Committees Ru(i)n the Bio‐Political Culture? On the Democratic Legitimacy of Bioethics Committees

Bioethical and bio-political questions are increasingly tackled by committees, councils, and other advisory boards that work on different and often interrelated levels. Research ethics committees work on an institutional or clinical level; local advisory boards deal with biomedical topics on the level of particular political regions; national and international political advisory boards try to answer questions about morally problematic political decisions in medical research and practice. In accordance with the increasing number and importance of committees, the quality of their work and their functional status are being subjected to more and more scrutiny. Besides overall criticism regarding the quality of their work, particular committees giving political advice are often suspected of being incompatible with democratic values, such as respect for affected parties, representation of diverse values and transparency in the decision-making processes. Based on the example of the German National Ethics Council, whose inauguration caused a still ongoing debate on the aims and scopes of committees in general, this paper discusses: (1) the requirements of modern democratic societies in dealing with complex scientific-technical problems; (2) the composition and organisation of committees working as political advisory boards; and (3) the appointment procedures and roles of laymen and experts, and here in particular of ethicists, who may legitimately be taken on by a committee. I will argue that bioethics committees do not necessarily endanger democratic values, but can considerably improve their realisation in democratic decision-making procedures--if, and only if, they do not act as substitutes for parliamentarian processes, but help prepare parliamentarian processes to be organised as rationally as possible.