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Opening The Laboratory Door: National and International Legal Responsibilities for the Use of Animals in Scientific Research--An Australian Perspective

Katrina Sharman


2 Journal of Animal Law 67 (2006)
Publish Date:
2006
Place of Publication: Michigan State University College of Law
Printable Version

Opening The Laboratory Door: National and International Legal Responsibilities for the Use of Animals in Scientific Research--An Australian Perspective

 

Opening The Laboratory Door: National and International Legal Responsibilities for the Use of Animals in Scientific Research--

An Australian Perspective

 

Katrina Sharman*

 

 

‘One of the greatest delusions in the world is the hope that the evils in this world are to be cured by legislation.’ Thomas Brackett Reed (1839-1902)

 

When I first set out to write this article in the Spring of 2004, I sought to explore how the lives of laboratory animals could be improved within a legal system that classifies them as property, with no rights and no fundamental interests.  I thought then (and think now) that the use of animals in scientific research is one of the hardest issues to write about in animal law. As advocates for the voiceless, we are torn between striving for a system that prohibits the use of animals for scientific purposes and recognising that liberation from the laboratory may be a long time coming.

            Despite the ethical objections that advocates such as myself have towards the use of animals in research, certain of us feel a strong moral imperative to act for the silent victims locked behind laboratory doors today.  Although their fate has already been determined, animal welfare law arguably serves as a platform to reduce their suffering.

            In order to assess whether animal welfare laws could reduce suffering in the context of animal research, I conducted a case study of the legislative framework for animal research in my jurisdiction, New South Wales, Australia.  At the time I wrote the article, I believed that these laws could serve a useful purpose if they promoted accountability, the three R’s (replacement, refinement, reduction) and a genuine battleground for the hearts and minds engaged in debating ‘the animal research question’.  In the time that has elapsed since then, I have decided that while these principles appear to be tenets of a system that takes animal protection seriously; as a practical matter they rarely stand up to scrutiny.  Worst still, they are often used as shields to justify ongoing experimentation on animals, diverting attention from important moral and scientific inquiries into why animals are being used as test models in the first place.

            In the initial version of this article, I also explored the question of whether creating tighter regulatory systems for animal research in industrialised countries would push animal research offshore into less regulated environments.  On the assumption that it would, I argued emerging international animal research norms, or minimum standards, should be fostered to remove the worst aspects of scientific use of animals and to promote the development of alternatives.  As I now question the ability of seemingly tight animal research laws to provide meaningful protections to many animals in my own jurisdiction, I am more reluctant to propose those laws as the basis for a global model.

            Two years after completing the first version of this article, I remain undecided as to whether this is an area in which we should seek incremental legal change in recognition that the animal model is not going away in the near future; or whether we should focus our energies on educating the public about alternatives and lifting the veil to disclose the extent of ‘unnecessary suffering’ involved in animal research. As animal lawyers, with no clients to instruct us, I expect we will explore our own hearts and minds, and no doubt those of others, before we take a stance on this issue.  I hope that my article (as revised) will help generate debate about the best legal solutions for animals. 

 

I. Introduction

 

While the deliberate infliction of harm on animals is sanctioned in a wide range of industries in modern society, the horrors that take place behind laboratory doors in the name of science, education and progress raise some of the most difficult and confronting questions in animal law.  Despite the increased availability of alternatives, laws and policies continue to be used as shields by those who gas, burn, confine, clone, infect, mutilate, force-feed, starve, poison and kill healthy animals in nations everywhere.[1]  Although regulatory regimes for animal research are constantly evolving, few (if any) species are safe from the reach of the scientist.[2]  Some jurisdictions have refused to accord the most basic protections to certain species, while others simply have no laws relating to the protection of animals in research.[3]

            In today’s political climate, animal advocates who seek to challenge research on ethical or moral grounds are often mischaracterised as animal rights ‘extremists’ or unrealistic, utopian visionaries.[4]  Meanwhile, those who seek to steer a more conservative or scientific course by questioning the reliability or necessity of animal test models must arm themselves with sufficient expertise to engage in a highly technical debate about current medical technologies, research successes and failures.[5]

            Irrespective of whether one approaches the issue from an ethical or scientific standpoint, in most industrialised countries that have established regulatory frameworks for animal research, the 'necessity' of the experiment has become the threshold question.  Consistently with the expansion of animal welfare, the public appears increasingly willing to subscribe to the idea that it is wrong to cause an animal unnecessary suffering but it is morally acceptable to conduct animal research if this is perceived to be in the interests of humans or animals.[6]

            Of course this threshold question only exists because the law classifies animals as property.  Since people or institutions own them, animals have no legal right to life, freedom or bodily integrity and the law says we may do what we like to them, provided that it is done within the confines of our anti-cruelty or animal research laws.  The concept of animals as property has become particularly pervasive in the laboratory with the advent of new areas of biomedical research such as genetic engineering, stem cell research, xenotransplantation and bioterrorism defence.[7]  Not only are these rapidly developing areas of science contributing to the increased use of animals in research;[8] they are serving to entrench animals’ property status by allocating them in some instances, to the special class of ‘intellectual’ property.

            As long as society refuses to accept the words of Ingrid Newkirk that 'When it comes to feelings like pain, hunger and thirst, a rat is a pig is a dog is a boy,'[9] the animal test model is likely to remain a feature of our national and global society. The important question that follows is whether animal research laws can ever be used to reduce the numbers of animals languishing behind the closed doors of laboratories today and most probably tomorrow.  For some the answer is clear; the only useful animal research law is one which prohibits research on animals, as anything less will entrench and sanction the extensive suffering which is currently considered necessary.[10]  Others assert that animal research laws can serve a useful purpose if they promote scrutiny, accountability, humane treatment of animals and a genuine battleground for the hearts and minds of those involved in debating the threshold question of whether each animal experiment should take place.

            In this article, I examine the elements of various legislative regimes for the use of animals in research with a view to assessing whether there is such a thing as a ‘good’ animal research law and if so, whether its features should be implemented on an international basis.  The first part of this article involves an examination of the Australian framework for animal research and a case study of the New South Wales legislative regime for the conduct of scientific research involving animals. 

            In the second part of this article, I briefly examine some of the international principles that are emerging to regulate the use of animals in scientific research on a global basis.  I assume that if animal research was to be prohibited or to become more tightly regulated in certain countries, a considerable proportion would be exported to less regulated environments.  However I argue that this should not be used as a justification for deferring meaningful animal protection laws in industrialised countries.  To the contrary, those countries should impose special responsibilities on persons and corporations carrying out animal research in less regulated environments.

 

II. Animal Research in Australia

 

Australia's approach to managing the use of animals in scientific research is one of enforced self regulation.  This means that the government is responsible for overseeing and enforcing industry compliance in all jurisdictions.[11]  Unlike the United States and a number of other countries, Australia has no national legislation which regulates the conduct of scientific research on animals. Instead the legislative regime has two components.  Firstly, each State and Territory has its own legislation, which regulates matters such as licensing, monitoring and enforcing prescribed conditions of animal research.  Secondly, each set of legislation is underpinned by a national code of practice, known as the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes (‘the Code’).[12]  The Code seeks to supplement State and Territory laws by defining the responsibilities of researchers and institutions that are authorised to carry out research.  It contains general principles for the care and use of animals used for scientific purposes and guidelines for the humane conduct of scientific activities and for the care of laboratory animals, including their environmental needs.[13]

            New South Wales is the only state that has enacted separate legislation concerning the use of animals in scientific research.[14]  The remaining States and Territories have incorporated scientific procedure provisions into their animal welfare or anti-cruelty statutes.[15]  It seems anomalous that laws which sanction patently cruel activities should be located in anti-cruelty statutes.  However this is less surprising when one acknowledges that in Australia, as in many other countries, the swords and shields which allow us to use animals for food, sport and entertainment are often embedded in our anti-cruelty and animal welfare statutes.

            The establishment of eight sets of legislation regulating animal research is a product of Australia’s federal system and it’s Constitution which does not specifically mention animals, other than fish.[16]  In the absence of an express allocation of power to the Commonwealth, State and Territory governments have assumed responsibility for enacting and enforcing the bulk of animal welfare laws, including those that relate to the use of animals in research.

            Whilst there are certain common features of each jurisdiction’s legislation, one of the most fundamental differences is the way that 'animal' is defined.  An expansive definition of 'animal' would ensure that the protection offered by the legislation was extended to all vertebrates and cephalopods.  However under the current system, States and Territories only protect vertebrates and some even exempt fish.[17]  Certain States have taken a more progressive approach and extended the reach of their scientific procedure provisions to live pre-natal or pre-hatched creatures in the last half of gestation or development.[18]  In contrast to countries such as the United States, all Australian jurisdictions include rats, mice, birds and farm animals in their definition of ‘animal.’[19]  However the position is still unsatisfactory, in that animals can arguably lose the protection provided by the legislation simply by being transported across a State or Territory border.

           

A. A Macro View

 

If one was to adopt a macro view of the Australian legislation that regulates animal research, it would be possible to identify certain common features.[20]  These include:

1. a requirement that authorisation be obtained by individuals or research establishments (or both) before scientific research can lawfully proceed;[21]

2. the establishment of animal ethics committees to authorise and oversee the conduct of scientific research;[22]

3. an express or implied reference to the fact that the Code is to be considered part of the relevant State or Territory's legislative regime;[23] and

4. the inclusion of specific provisions relating to inspecting institutions and dealing with instances of breach of the relevant legislation.[24]

While this analysis suggests that the Australian legislative framework relating to animal research has a number of shared themes, any descent into the detail of the legislation demonstrates clear disparities.  For example, whilst all States and Territories empower an authorising body to impose conditions on the applicant in connection with any authorisation granted, the conditions that can be imposed vary considerably between jurisdictions.[25]  Of greater concern are the inconsistencies both on paper and in practice, between each State's and Territory's provisions relating to monitoring and enforcement.

            In short, a detailed examination of the legislation leads one to conclude that even if an animal is 'fortunate' enough to fall under the protective umbrella of an animal welfare law; its treatment will depend largely on the jurisdiction in which the proposed research is to be conducted.

 

B. Attempts to Create Robust Systems for Animal Research: The New South Wales Example

 

1. animal ethics committees

 

Theoretically, Animal Ethics Committees (AECs) are an important component of any legislative scheme designed to protect the use of animals in research, as they promote transparency and accountability in the research process.  AECs are designed to bring a public voice to the research table. New South Wales (NSW) laws are a good example of this because they require both an independent person and a person with a demonstrated commitment to animal welfare to be a member of every research establishment's AEC.[26]

            In NSW, AECs are empowered to carry out the crucial task of evaluating research proposals submitted to their research establishment.[27]  They must answer the threshold question of whether each research project is necessary.  Unfortunately there are a plethora of factors which may affect whether this process produces actual benefits for animals.  To cite a few examples; the quality of the research protocols provided for AEC members to consider; the willingness of AEC members to consider that material and voice their concerns; the depth of debate engaged in by AEC members about each research protocol and the individual philosophies held by the supposed animal welfare representatives. 

            In answering the question as to whether each experiment should take place, AEC members are encouraged to revert to a series of general principles set out in the Code.[28]  Unfortunately these principles appear to be so heavily weighted towards ensuring the smooth functioning of a system which utilises animals, that most attempts to challenge the justification of an experiment would constitute an exercise in futility.  For example, the introductory section of the Code suggests that an experiment may be justified if its aim is ‘to improve animal management or production.’[29]  This facilitates the carrying out of research aimed at increasing productivity (the food and fibre produced by each animal).  It also arguably serves as a platform for modern animal agriculture’s obsession with genetic modification, viewed by some as a search for ‘legless cows and featherless chickens.’[30]

            Other bases upon which scientific and teaching activities may legitimately be carried out according to the Code include ‘to obtain and establish significant information relevant to the understanding of humans and/or animals,’ ‘for the maintenance and improvement of human and/or animal health and welfare and ‘for the achievement of educational objectives.[31]  These categories are so broad that it is hard to think of an example of an experiment that would not fall within them.  The fact that the animal welfare and independent members of the AEC are required to deliberate within the confines of such principles clearly limits the extent to which they can meaningfully resist research proposals.

            Furthermore, while the Code does seem to require a balancing of the predicted scientific/educational value of a project with its effects on animal welfare and even emphasises the need for ‘particular justification’ for potentially severe or ethically contentious procedures, it is difficult to see how animals could emerge victorious from this cost benefit analysis given the widespread faith in the current test model and the classification of animals as mere legal ‘things’.[32]

            In addition to considering the justification for each research project, AECs must assess a detailed range of matters including the potential benefits of the project, the applicability of the principles of Reduction, Replacement and Refinement (The Three R’s), the likely impact on the animals involved, the applicability of the proposed regime for monitoring the animals and the available procedures for preventing and alleviating distress.[33]  Herein lies a further difficulty. Whilst the Code appears to be a comprehensive document, it prescribes principles as opposed to qualitative standards.  The words regularly, suitable, essential, adequate, wherever possible and necessary' appear frequently however they are never defined.[34]  This has clear implications for enforcement of the Code, especially in 'borderline' cases.  Furthermore, as AECs tend to work in isolation due to intellectual property and confidentiality issues, the malleability of the Code's principles raises the prospect of a serious lack of consistency in application.  In NSW, a detailed site inspection process has been introduced to address this problem; however as discussed below, inspections should not be seen as a panacea.[35]

            AECs in New South Wales have a number of other notable responsibilities, which include conducting regular inspections of research animals and facilities.[36]  AECs also have the power to terminate research and to call for the emergency care of animals.[37]  They are assisted in their functions by the development of state departmental policies dealing with matters ranging from conflicts of interest to technical guidelines for animal health and welfare.[38]

            Notwithstanding the importance and scope of their functions, AECs remain largely unaccountable to the public due to the secret nature of much of their business and the sanctions that apply for breach of confidentiality.  This creates a real likelihood of experiments being duplicated.  It also makes the system more translucent than transparent as it means that only certain trusted members of the public are permitted to participate in the decision making processes that affect so many lives.  In these circumstances, it is extremely difficult for an ‘outsider’ to accept that the system is working to protect the welfare of animals in any meaningful way.

 

2. authorisation of research establishments and the role of the animal research review panel

 

The legislative regime for the use of animals in scientific research in New South Wales has a second tier of public participation which takes the form of the Animal Research Review Panel (the Panel).  Panel members are appointed by the NSW Minister for Primary Industries on the basis of nominations received from industry, government and animal welfare groups.[39]  Of the twelve panel members, two are appointed as nominees of the Royal Society for Prevention of Cruelty to Animals and a further two, as nominees of the Animal Societies Federation (NSW), which is a coalition of animal rights and welfare groups.

            The tasks of the Panel are broad in scope.  However for the purposes of this article, the most significant are its role in evaluating applications for the accreditation of research establishments (including the specification of conditions of accreditation) and the opportunity for panel members to accompany departmental inspectors (who are qualified veterinarians) ‘behind closed doors’ on site inspections of research establishments.[40]

            The New South Wales method for conducting site inspections is based on methods used by the Canadian Council on Animal Care and the Association for the Assessment and Accreditation of Laboratory Animal Care.[41]  Site inspections, which tend to occur on a triennial basis, may take up to 2 weeks depending on the size of the institution, the number of sites involved and the type of research being conducted.[42]  There are three phases to the site inspection.  Firstly, written material is provided by the institution to the site inspection participants.  This material includes:

lists of research protocols considered by the AEC and also the people issued with research authorities, AEC minutes, the AEC annual report and records of inspections conducted, information about the procedures of the committee and the institutional policy on the committee's operation and decisions.[43]

The second phase of the inspection involves a visit to the research institution to view its holding facilities and animals.  Following the physical inspection, the inspection team attends a scheduled meeting of the AEC for the purpose of assessing its normal operating procedures and reporting on any issues of concern noted during the site inspection.[44]  A meeting is also generally held with the head of the institution during the course of the inspection.[45]

            The final phase of the site inspection process involves preparation of a report by the inspection team.  That report includes an evaluation of the AEC and an overall assessment of the well-being of the animals and their facilities amongst other issues.[46]  The report may involve the identification of additional conditions to be placed on an institution's accreditation.  It may also include non-compulsory recommendations for improved standards of animal care and management.  Once the report has been considered by the Panel, it is sent to the institution and a written response is requested explaining the nature of the actions taken to implement the terms of the report.  If concerns remain, the Panel may revisit an institution to assess the extent to which conditions have been implemented.[47]

            The three-phase site inspection process is clearly an important component of a system of enforced self regulation because it makes research institutions more accountable to the government.  Although the result is not a transparent system, the system does promote accountability and certain information about the process is available via the Panel's Annual Report, which is a publicly available document presented to the Minister for Primary Industries on an annual basis.[48]

            In summary, the concept of granting specified animal welfare advocates and independent persons a role in authorising and inspecting research institutions is important because it helps lift the veil of secrecy and the corresponding distrust which surrounds the activities of such institutions.  Panel members who attend site inspections play a role in assessing and reporting back to the Department of Primary Industries (DPI), on the extent to which the relevant institution has complied with its accreditation conditions.  While advocates for animals are rarely inclined to concede the necessity of animal research, some may agree that their nominees on the Panel give them a voice in the regulatory process. That voice may result in marginal improvements in the lives of those living behind laboratory doors today.

 

3. complaints and enforcement

 

Any analysis of a legislative scheme for animal research would not be complete without an assessment of whether the system has 'teeth'.  Effective enforcement requires proper mechanisms for detecting breaches of the legislative scheme and a willingness to take remedial action, such as the suspension or revocation of research licenses or the prosecution of more serious offences.

            The Animal Research Act establishes a formal complaints mechanism, which is triggered by the receipt of a written complaint to the Director-General of NSW DPI.  Complaints may be made about independent researchers where animal research is carried out in the following circumstances: without appropriate authorisation; outside the terms of a research authority; without the approval or in contravention of the terms of the authority specified by the AEC; in contravention of the Code; for a purpose other than the previously specified research purpose; on animals obtained from an unlicensed supplier; or by a person that has been previously been 'disqualified' from obtaining a research authority or accreditation as a result of a conviction under certain provisions of the Animal Research Act or the Prevention of Cruelty to Animals Act 1979 (NSW).[49]  A complaint may also be triggered if the independent researcher is a director of a  'disqualified corporation' which is an establishment that cannot obtain accreditation to carry out research because it has been convicted of an offence under the equivalent provisions in the Animal Research Act or the Prevention of Cruelty to Animals Act 1979 (NSW).[50]

            Where a person is carrying on any of the above activities on behalf of a research establishment, a formal complaint may also be made about that establishment.[51]  Additionally, a formal complaint about a research establishment may be lodged with the Director-General if: the establishment does not have a duly constituted AEC; the establishment has not complied with a condition of its accreditation; or if the establishment is a 'disqualified corporation'.[52]

            The legislation provides that all complaints are to be referred to the Panel for investigation.[53]  Following that investigation, the Director-General may take action to cancel or suspend the authority held by the subject individual or research establishment.[54]  Alternatively, the Director-General may issue a caution or dismiss the complaint.[55]  These sanctions are arguably too lenient, given that the circumstances giving rise to a complaint could cause pain, suffering or an excruciating death to a large number of animals.  However any suggestion that the penalties under the complaints mechanisms are too weak, disregards the fact that certain activities giving rise to a formal complaint may be applauded if they were carried out in accordance with the procedures set out in the legislation.  It also fails to consider that the prospect of suspension or cancellation of a research licence or accreditation may have a greater deterrent effect than the imposition of a fine, as the decision has clear and immediate personal and commercial implications for the individual or institution involved.

            The ARRP Annual Report for 2003-04 indicates that the Panel did not deal with any complaints during the relevant reporting period.[56]  Although it is possible that the institutions regulated by the Act were fully compliant, ‘perfect records’ such as this lead one to query whether the complaints system is failing to detect breaches when they occur.

            In addition to the formal complaints mechanism, the Animal Research Act creates a number of separate offences, which provide for the imposition of fines.  These offences include the offence of: unlawfully carrying out animal research, unlawfully carrying on of the business of animal research,[57] failing to comply with inspection requirements,[58] obstructing inspectors in their duties,[59] giving false or misleading information under the Act,[60] and failure by a research establishment to keep records or to provide an annual report to the Director-General in the approved form.[61]  Significantly, the legislation provides a maximum penalty of 12 months imprisonment in relation to the first two of these offences.[62]

            The Director-General (or a person authorised by the Director-General) has the sole discretion to commence proceedings under the Animal Research Act.[63]  Whilst this appears to be a consequence of the way in which the legislative scheme is structured and the fact that animals generally lack legal standing, it is clearly a limiting factor in enforcement, as the Act's sanctions will be rendered meaningless if there is little willingness to prosecute.[64]  Proceedings under the Act have been commenced in relation to the supply of animals for research purposes, but not for other matters.[65]  In other models of enforced self-regulation (such as the Australian tax system) such low levels of prosecutions would raise serious questions about the adequacy of monitoring and enforcement.  Given that animal research affect lives and not dollars in the first instance, I would argue that at the very least, these same questions should be asked.

 

III. In Search of International Norms

 

In the first part of this article, I argued that while the Australian system of enforced self-regulation for animal research is open to challenge, in theory it provides certain safeguards for laboratory animals.  A number of these protective mechanisms are shared with regimes for regulating animal research in other industrialised countries.  However there are notable disparities between legislative schemes regarding key issues such as the definition of 'animal', the functions and powers of animal ethics committees, opportunities for public participation and the mechanisms for monitoring and enforcement.

            While the diversity of laws, cultures, traditions and religions inhibits the international harmonisation of animal research laws to some degree, certain principles have emerged which seek to define the responsibilities of researchers and institutions that carry out animal research.[66]  The development of these principles has been facilitated by the burgeoning field of animal health and welfare and the globalisation of animal research.  Both the scientific community and industry have been at the forefront of the development of these standards, motivated by changing public perceptions about animals and commercial incentives.[67]

 

A. Emerging International Principles for the Use of Animals in Scientific Research

 

Although there is not yet an international treaty or declaration which sets out the principles for the use of animals in research, the following principles could be viewed as norms or ‘best practice standards’ as they appear in a number of international, regional and national legislative instruments and guidelines.[68]  It should be noted that many of these principles are subject to the same deficiencies raised in the previous section of this article.

 

Principle

Explanation

Justification for Research

Animals may be legitimately be used for the purpose of scientific research, where such research can be said to contribute to, inter alia, improved human and animal health.[69]

Reduction

Scientists should use the minimum number to obtain scientifically valid results.[70]

Refinement and Pain Minimisation

The suffering of animals should be reduced through procedural refinements such as the use of sedation, analgesia or anaesthesia or the provision of improved living conditions which minimise the distress of animals.[71]  The species of animals used for scientific research should be carefully considered.[72]

Replacement

Scientists should be encouraged to adopt alternatives to the use of animals models such as mathematical models, computer simulation, in vitro biological systems clinical and epidemiological studies, microbiological studies and autopsy.  Scientific researchers have an ethical duty to promote, research and endorse alternatives.[73]

Sentience

All animals should be considered sentient. Scientists should adopt a precautionary principle and assume that procedures that would cause pain in human beings cause pain in all species. On that basis, proper care of animals and the avoidance or minimisation of pain and suffering should be considered an ethical imperative.[74]

Housing and Care

Animals kept for scientific purposes should be housed and cared for in accordance with certain minimum conditions of movement, food, water and care throughout their lives, although this does not absolve carers of their ethical duty to identify and implement higher standards.[75]

Qualifications and Training

Scientific procedures must always be carried out by qualified persons with appropriate experience in conducting procedures on animals.  Training in humane animal care should be provided to both animal researchers and animal carers on an ongoing basis.[76]

National Obligations

Each nation, or an appropriate tier of government within that nation should enact detailed legislation relating to the acquisition of research animals, the process of obtaining authorisation to carry out procedures or maintain animals for research purposes, transportation of animals, animal housing, environmental conditions, nutritional requirements, veterinary care and record keeping requirements applicable to each institution.  In enacting such legislation, legislators should have recourse to current qualitative international standards.[77]

Each nation, or an appropriate tier of government within that nation should enact detailed legislation which provides for independent monitoring to avoid excessive or inappropriate use of research animals and to ensure appropriate care of animals for the entire period that the animal remains in the custody of a research institution.  The provisions relating to monitoring should identify appropriate sanctions to be regularly enforced by a government inspectorate.  Lay persons should be given a meaningful role in the monitoring process, possibly through the establishment of animal ethics committees.[78]

 

The following principles for the protection of animals in scientific research do not appear to be widely accepted by the international community at the time of writing; however they should also arguably be incorporated into any international, regional, national legislation or codes of conduct that seek to regulate animal research.[79]  Certain of these principles have been drawn from international legislative instruments concerning clinical research on human beings including the Nuremberg Code (1947), the Universal Declaration of Human Rights (1948), the Declaration of Helsinki and the International Ethical Guidelines for Biomedical Research Involving Human Subjects.[80]

 

Principle

Explanation

Definition

of animal

The protection offered by animal research legislation should be extended to all living creatures, or at least to all vertebrate animals.[81]

Harmonisation

of techniques

In order to avoid duplication of animal research, each nation should where practicable, recognise the results of research carried out in other nations and should certainly seek to facilitate data exchange within its own jurisdiction.[82]  Each nation should also be willing to contribute to the international harmonisation of testing and training strategies.

Unlawful research

Each nation, or an appropriate tier of government within that nation should at a very minimum ensure that its animal research legislation prohibits certain types of animal tests.  Examples of such tests include tests where the animal is likely to experience severe or ongoing pain, the draize test,[83] the LD50 toxicity test[84] any test which aims to determine the toxicity of a cosmetic, household or industrial preparation against a predetermined level of mortality.[85]

Serious consideration should also be given to prohibiting the use of animal models in emerging fields of research such as stem cell research, cloning, xenotransplantation and bioterrorism defence on the basis (at least) that many of the emerging international norms in animal research are unlikely to be effectively applied to reduce the suffering of animals involved in these fields of research.[86]

If governments are not willing to prohibit such tests, they must ensure that a separate process for authorising such research has been established, to ensure greater scrutiny of the justification for the tests and the conditions in which they are to be conducted.[87]

Role of AECs

AECs with clearly defined powers, should be established at institutional, local, regional or national levels to approve proposals for animal research on the basis of their scientific merit and ethical acceptability.[88]  AECs should include equal numbers of researchers, veterinarians, animal welfare advocates and lay persons.[89]  Regulatory authorities should promote uniform standards across committees within each country and should arrange for independent bodies to regularly review AEC performance and report any assessment to the public.

Independence

of AECs

Whilst institutions have a responsibility to allocate sufficient resources to ensure that the AECs function properly, AECs must be independent of the applicant for animal research, the research sponsor or any other kind of undue influence.[90]  All members of AECs should be required to declare any conflicts of interest they have in relation to any particular research proposal.[91]  Equally, any financial or other material benefit available to committee members for participating in the committee should not be contingent on the outcome of their review.[92]

 

B. The off Shore Phenomenon--Conducting Animal Research in Less Regulated Countries

 

For this purpose of this article, I have assumed that where scientific procedures in a researcher's home country are heavily regulated, there will be significant incentives to send that research offshore.  Although I have not sought to identify particular instances of this phenomenon, the history of clinical testing serves as sufficient warning that individuals and corporations must be guided by specific principles when conducting research in developing countries that are more susceptible to unethical or exploitative research.[93]  A failure to identify and impose such principles will expose animals in countries that lack animal protection laws to the prospect of intense suffering at the hands of the scientist. The kinds of principles that may be adopted can be broadly grouped into four categories.

 

1. funding obligations relating to animal ethics committees

 

Valid scientific and ethical review requires appropriately trained people and resources, which may be absent in many developing countries.[94]  In relation to the ethics of clinical research in developing countries, the Working Party of the Nuffield Council on Bioethics stated that:

It is a fundamental ethical principle that those involved in research in developing countries, including research teams, pharmaceutical companies and governments, should not take advantage of the vulnerabilities created by the poverty or a lack of infrastructure and resources.[95]

If one accepts that this ethical principle should apply to research involving all animals, it follows that any sponsor of research in a developing country (‘external sponsor’) should contribute sufficient resources to the ethical review process, to ensure that AECs are established and that participants in those AECs can conduct their duties in a meaningful and impartial manner.[96]  Given that the receipt of funds from an external sponsor may raise questions about the ability of the AEC to perform its tasks independently, the costs of establishing and maintaining AECs should be directed to a central fund held by the local or national government in the host country and earmarked for the support of AECs.  This proposal was raised by the Working Party of the Nuffield Council on Bioethics in the context of establishing ethical review committees for (human) healthcare in developing countries.[97]  However it seems to me that it should apply equally to research involving animals in those countries.

            In addition to the above, animal protection organisations and the research community should conduct programs to train and monitor those persons involved in AECs to ensure that their responsibilities are understood and carried out effectively.  This would accord with the approach taken to developing capacity for the ethical review of human research in developing countries.[98]

 

2. ethical review process

 

As an additional safeguard, where research is being conducted overseas, each research proposal should be reviewed by animal ethics committees in both the external sponsor’s country and the host country.[99]  The proposal should be scrutinised to at least the same ethical standards as apply in the external sponsor’s country.[100]  In relation to investigator's responsibilities for human subjects in developing countries, Marcia Angell's wrote in the New England Journal of Medicine that:

our ethical standards should not depend on where the research is being performed . . . the nature of investigator's responsibilities for the welfare of their subjects should not be influenced by the political and economic conditions of the region.[101]

This principle should apply equally to animal research.

 

3. funding obligations relating to animal management and care

 

The obligations of the external sponsor should not be limited to facilitating the functioning of a meaningful ethical review process.  External sponsors should also be required to provide sufficient resources to ensure that research animals are managed and cared for in accordance with standards that are at least equivalent to those that apply in the external sponsor’s country.  This may involve making contributions to a general 'animal welfare fund' established for the purpose of providing sufficient animal housing, environmental conditions, nutritional requirements and veterinary care.  The fund could also be drawn upon to train local animal care organisations.[102]

 

4. ‘home’ government responsibilities

 

In addition to the principles set out above, where individuals and institutions would be required to seek approval for animal research if it were to be carried out in their own jurisdiction, legislative provisions should require ‘home country’ standards of care to apply as a minimum standard when that research is carried out overseas.  Such legislation may take the form of ‘report back’ provisions to an appropriate government authority or an applicable AEC. Although ultimate responsibility for observing and applying a home country’s standards lies with the researcher/institution involved, compliance could be facilitated if ‘home country’ legislation provided for research licences to be cancelled if minimum standards were found to be breached overseas.  In the absence of a law to this effect, institutions may adopt this approach as a matter of policy, for ethical reasons and to ensure consistency in the quality of research being carried out in their name.[103]

 

IV. Conclusion

 

Despite the increasing availability of alternative test models, millions of animals around the world today continue to be used for scientific purposes.  Their suffering is often sanctioned by laws which condone the infliction of harm, subject to compliance with a range of requirements, responsibilities and general principles.  In this paper I have suggested that while tight systems of regulation appear to reduce the suffering of animals within the context of ongoing research, each of these systems needs to be critically examined to determine their effectiveness as a means of preventing or reducing animal suffering.

            I have also suggested that while there is substantial variation between national regimes for regulating animal research, certain international norms appear to be emerging. Some animal advocates would view the development of these principles as a backward step, on the basis that they entrench and legitimise the use of animals as research models.  However this is not necessarily so, as international laws, like state laws, are subject to revision in accordance with our evolving community values and priorities.  The Declaration of Helsinki, for example, has been revised five times since 1964, when it was first formulated.[104] 

            There may also be a number of animal advocates who would be willing to support the adoption of these international principles on the basis that they are a step in the right direction.  Despite their ethical opposition to animal research, these advocates would argue that in this current climate of fervent scientific endeavour, our best hope is to offer animals a little justice through the adoption of these international principles.  That way we may find that next time we sit down at the table, either with our legislators or the scientific community, that our request to open the laboratory door a little further is regarded as a little less revolutionary.

 



Originally published in Favre, D., ed., International Animal Law Conference Publication, San Diego (Detroit: Animal Legal and Historical Center, 2004). Revised edition.  [The following article uses a generally accepted Australian legal citation method and is written in Australian Standard English--Eds.]

* Katrina Sharman is the Corporate Counsel for Voiceless, a non-profit organisation for animals in Australia. For further information visit www.voiceless.org.au.

[1] This list is not intended to identify all forms of harm inflicted upon animals used in research. Many animal protection organisations seek to educate people about the use of animals in research and specific examples of tests involving animals can be obtained from those organisation’s websites. For example in the EU, see the website of The British Union for the Abolition of Vivisection (BUAV) <http://www.buav.org/aboutus/index.html>; in the US, see the Physicians Committee for Responsible Medicine (PCRM) <http://www.pcrm.org/>; in Australia, see Australian Association for Humane Research Inc (AAHR) <http://www.aahr.asn.au/>.

[2] In New Zealand, ‘non-human hominids’ defined as gorillas, chimpanzees, bonobos and orangutans, have been accorded certain limited ‘rights’ relating to research and experimentation. See: Animal Welfare Act 1999 §85 (NZ) discussed in Peter Sankoff ‘Five years of the new animal welfare regime: Lessons learned from New Zealand’s decision to modernise its animal welfare legislation (2005), Animal Law Vol 11, 7.

[3] The US Animal Welfare Act does not apply to rates, mice, birds, fish or farm animals. It is thought that rats and mice account for approximately 90% of animals used in research in the US; 7 USC § 2132(g) (2000); Darian M. Ibrahim, Reduce, Refine, Replace: The Failure of the Three R's and the Future of Animal Experimentation, 2006 U. Chi. Legal F. 12; Until recently there was no law protecting animals used in research in Japan. Due to a recent revision of the Law Concerning the Protection and Control of Animals the welfare of animals used in experimentation is to be considered; however according to the animal protection group ALIVE almost no controls over animal experimentation have been included. See ALIVE, ‘Revision of the Animal Protection and Control Law Achieved’, Alive News August 2005 [9 March 2006] <http://www.alive-net.net/english/en-law/L3-action.html>.

[4] Consider Gary L. Francione, Rain without Thunder: The Ideology of the Animal Rights Movement, Temple University Press, 1996 (discussing whether animal rights is a ‘utopian’ theory).

[5] See for example the website of Americans, Europeans, Japanese for Medical Advancement, [10 March 2006] <http://www.curedisease.com/>.

[6] Caroline Flint, 'Speech to the Coalition for Medical Progress 3Rs event on 8 October 2003' (Paper presented at an event organised by the Coalition for Medical Progress), 10 November 2003, [10 March 2006] <http://scienceandresearch.homeoffice.gov.uk/animal-research/documents/carolineflint.pdf?version=1>.

[7] Darian M. Ibrahim, above n 3, 3.

[8] Darian M. Ibrahim, above n 3, 3 and 35.

[9] Ingrid Newkirk quoted in: Deborah Blum, The Monkey Wars, Oxford University Press (1994), 143.

[10] Consider Gary L. Francione, above n 4 (discussing different ideological approaches to animal protection).

[11] The legislative scheme regulating animal research in Australia also applies to the use of animals supplied for research purposes and the use of animals for teaching purposes.  However those issues are beyond the scope of this article.

[12]Australian Code of Practice for the Care and Use of Animals for Scientific Purposes, 7th edition (2004), Australian Government National Health & Medical Research Council, 2004 (herein ‘The Code’).

[13] Ibid.

[14] Animal Research Act 1985 (NSW) and Animal Research Regulations 1995 (NSW).

[15] Animal Welfare Act 1992 (ACT) Part 4;  Animal Welfare Act (NT) Part 5; Prevention of Cruelty to Animals Act 1985 (SA) Part 4;  Animal Care and Protection Act 2001 (Qld) Chapter 4; Animal Welfare Act 1993 (Tas) Part 4; Prevention of Cruelty to Animals Act 1986 (VIC) Part 3; Animal Welfare Act 2002 (WA) Part 2.

[16] Section 51(xxv) of the Constitution allocates certain powers to the Commonwealth to regulate fisheries in Australasian waters, although the Commonwealth, States and Territories have adopted a cooperative approach to jurisdiction and supervision over marine fisheries for the past century. See: ‘The Development of Australian Fisheries Management’ [11 March 2006] <http://members.trump.net.au/ahvem/Fisheries/National/Dev_AFM3.html#Jurisdiction>.

[17] A more expansive definition of ‘Animal’ is included in the Code which includes ‘fish, amphibians, reptiles, birds and mammals, encompassing domestic animals, purpose-bred animals, livestock, wildlife, and also cephalopods such as octopus and squid’.  This broad definition is commendable and should be incorporated in all State and Territory anti-cruelty/animal welfare legislation by amendment; The Code, above n 12, 3. Fish are not included in the definition of ‘animal’ in the anti-cruelty/animal welfare legislation applicable in South Australia or Western Australia. See: Prevention of Cruelty to Animals Act 1985 (SA), s3(b);  Animal Welfare Act 2002 (WA), s5(1). 

[18] Animal Care and Protection Act 2001 (Qld) ss 11(1)(b) and 11(3).

[19] 7 USC§2132(g)(2000); Darian M. Ibrahim, above n 3, 12; David Favre, 'Overview of the US Animal Welfare Act' (May 2002), Animal Legal & Historical Center, Michigan University DCL College of Law, <http://www.animallaw.info/articles/ovusawa.htm>.

[20] I acknowledge with thanks, Keith Akers, for making the following unpublished thesis available for consideration in connection with this section of the paper: Keith Akers, 'Australian Law on the Use of Animals in Scientific Procedures, Chapter 3 (in draft form)' of a Ph.D. to be submitted to the School of Law at Deakin University, Melbourne. Unpublished. 2004.

[21] Animal Welfare Act 1992 (ACT) ss 25 and 37;  Animal Welfare Act (NT) ss 29 and 43; Animal Research Act 1985 (NSW) ss 18 and 25; Prevention of Cruelty to Animals Act 1985 (SA) s 16; Animal Care and Protection Act 2001 (Qld) s 51;  Animal Welfare Act 1993 (Tas) ss 27 and 29; Prevention of Cruelty to Animals Act 1986 (VIC) s 26; Animal Welfare Act 2002 (WA) s 6.

[22] Animal Welfare Act 1992 (ACT) s 50 and Animal Welfare Regulations 2001 (ACT) r 7;  Animal Welfare Act (NT) s 41; Animal Research Act 1985 (NSW) ss 13-16; Prevention of Cruelty to Animals Act 1985 (SA) ss 23-25; Animal Care and Protection Act 2001 (Qld) ss 52(2)(b) 73(3)(g);  Animal Welfare Act 1993 (Tas) s 30(2); Prevention of Cruelty to Animals Act 1986 (VIC) s 28; Animal Welfare Act 2002 (WA) s 9(1)(a).

[23] References to the Code include but are not limited to: Animal Welfare Act 1992 (ACT) s 41(d) and Animal Welfare Regulations 2001 (ACT) r 3;  Animal Welfare Act (NT) s 48(d); Animal Research Act 1985 (NSW) s 4 and Animal Research Regulations 1985 (NSW) r  4; Prevention of Cruelty to Animals Act 1985 (SA) ss 3 and 25(1)(a); Animal Care and Protection Act 2001 (Qld) ss 49 and 91;  Animal Welfare Act 1993 (Tas) s 30; Prevention of Cruelty to Animals Act 1986 (VIC) ss 25 and 26(2)(b); Animal Welfare Act 2002 (WA) ss 6(b) and 8(b) and Animal Welfare Act 2002 (WA) r 2 and r 5.  Institutions that receive funding from the National Health & Medical Research Council (NHMRC) are required to certify compliance with the Code in addition to being subject to the applicable state/territory law in their jurisdiction.  However these institutions only account for a proportion of those that use animals for scientific purposes. See: National Health & Medical Research Council ‘Statement of Compliance’, [10 March 2006] <http://www.nhmrc.gov.au/ethics/animal/issues/index.htm#state>.

[24] Above, n 15.

[25] Animal Welfare Act 1992 (ACT) s 30;  Animal Welfare Act (NT) s 34; Animal Research Act 1985 (NSW) s 26; Prevention of Cruelty to Animals Act 1985 (SA) s 19; Animal Care and Protection Act 2001 (Qld) s 56;  Animal Welfare Act 1993 (Tas) s 30; Prevention of Cruelty to Animals Act 1986 (VIC) s 26(2); Animal Welfare Act 2002 (WA) s 11.

[26] The composition of AECs in New South Wales is drawn from the Animal Research Act 1985 (NSW) and the Code. See: Animal Research Act 1985 (NSW) s 13(5) and the Code, above n 12, clause 2.2.2.

[27] Animal Research Act 1985 (NSW) s 14(1).

[28] Animal Research Act 1985 (NSW) s 16 and the Code, above n 12, clause 1.1.

[29] The Code, above n 12, clause 1.1.

[30] D. Fraser, The new perception of animal agriculture: Legless Cows, featherless chickens and a need for genuine analysis, J Animal Sci, 2001, 79:634-641.

[31] The Code, above n 12, clause 1.1.

[32] Consider: Steven Wise, Rattling the Cage: Towards legal rights for animals (Perseus Books) 2000; Gary Francione, Animals Rights & Animal Welfare, 48 Rutgers L Rev 397 (1996) (discussing the classification of animals as legal things).

[33] Animal Research Act 1985 (NSW) s 16 and the Code, above n 12, clauses 2.2.16. In relation to the ‘Three R’s’, see Russel & Burch, The Principles of Humane Experimental Technique (Methuen 1959) discussed in Section III(a) below.

[34] See the Code, above n 12, clauses 2.2.17, 2.2.29, 3.2.1, 3.3.1, 3.2.3, 3.3.5, 3.3.16, 3.3.38, 4.5.3, 4.5.7, 5.2.1 (‘regularly’); 1.14, 1.17, 2.2.15, 2.2.40, 3.2.1, 3.3.28, 3.3.46, 4.4.12, 4.4.22, 4.4.25, 4.4.26, 5.2.1, 6.1.1, 6.1.2 (‘suitable’); 1.1, 1.4, 1.11, 1.26, 2.2.1, 2.2.15, 2.2.42, 4.4.16, 4.7.1, 5.2.6, 5.8.1 (‘essential’); 1.26, 2.1.1(xiv); 2.2.16(xiii); 3.3.27, 3.3.35, 3.3.41, 4.2.4, 4.4.4, 4.4.9, 4.4.16, 4.4.24, 4.5.3, 4.5.8, 5.4.4, 6.4.10, Appendix 1; Schedule 2 (‘adequate’); 1.8, 1.27, 3.3.46, 5.2.2, 5.3.2, 5.9.5, 5.9.6 (‘wherever possible’); 1.9, 2.2.6, 2.2.16(iii) and (vii), 2.2.117, 2.2.40, 3.3.14, 3.3.17, 3.3.18, 3.3.25, 3.3.29, 3.3.41, 3.3.44, 3.3.55, 3.3.67, 3.3.78, 4.3.5, 4.3.1, 4.4.19, 4.4.21, 5.1.1, 5.1.5, 5.2.1, 5.5.2, 5.7.1, 5.8.1, 6.2.2, 6.4.11, Appendix 1; Schedule 2.

[35] Refer to page 6 of this paper.

[36] Animal Research Act 1985 (NSW) s 16 and the Code, above n 12, clause 2.2.29.

[37] Animal Research Act 1985 (NSW) s 16 and the Code, above n 12, clauses 2.2.33.

[38] NSW Department of Primary Industries, Animal Research Review Panel New South Wales Annual Report 2003/04 (2005), 19. See also: Animal Ethics Infolink (NSW) [10 March 2006] <http://www.animalethics.org.au>.

[39] Animal Research Act 1985 (NSW) s 6.

[40] Animal Research Act 1985 (NSW) ss 10 and 19.

[41] Lynette Chave, 'Audits of animal research institutions-the NSW experience', (2003) 'Animal welfare and animal ethics committees: where are the goalposts now? ANZCCART-Proceedings of a Conference held at the Gold Coast International Hotel, Queensland October 17-19, 2002, Australian and New Zealand Council for the Care of Animals in Research and Teaching, 18-22.

[42] Lynette Chave, above n 41, 2. See also: Animal Research Review Panel New South Wales Annual Report 2003/04, above n 36, 9 and 18.

[43] Animal Research Review Panel New South Wales Annual Report 2003/04, above n 38, 10.

[44] Lynette Chave, above n 41, 19; Animal Research Review Panel New South Wales Annual Report 2003/04, above n 38, 10.

[45] Lynette Chave, above n 41, 19; Animal Research Review Panel New South Wales Annual Report 2003/04, above n 38, 12.

[46] Lynette Chave, above n 41, 19.

[47] Animal Research Review Panel New South Wales Annual Report 2003/04, above n 38, 11.

[48] For access to past Annual Reports of the Animal Research Review Panel, see: NSW Animal Agriculture, ‘Animal Ethics Infolink’ [11 March 2006] <http://www.animalethics.org.au/reader/annualreports>.

[49] Animal Research Act 1985 (NSW) ss 22 and 28.

[50] Animal Research Act 1985 (NSW) ss 17 and 28.

[51] Animal Research Act 1985 (NSW) s 22.

[52] Animal Research Act 1985 (NSW) ss 17 and 22.

[53] Animal Research Act 1985 (NSW) ss 23 and 28A.

[54] Animal Research Act 1985 (NSW) ss 24 and 28B.

[55] Ibid.

[56] Animal Research Review Panel New South Wales Annual Report 2003/04, above n 38, 19.

[57] Animal Research Act 1985 (NSW) ss 46-47.

[58] Animal Research Act 1985 (NSW) s 50.

[59] Animal Research Act 1985 (NSW) s 53.

[60] Animal Research Act 1985 (NSW) s 55.

[61] Animal Research Regulations 1995 (NSW) r  26(2).

[62] Above, n 53. Under these provisions, individuals may face a fine, or imprisonment for twelve months or both.

[63] Animal Research Act 1985 (NSW) s 57.

[64] Consider Cass R. Sunstein, ‘Can Animals Sue?’ (discussing the issue of legal standing and animals) in: Sunstein & Nussbaum, Animal Rights: Current Debates and New Directions (2004), Oxford University Press, chapter 11.

[65] NSW Agriculture, ‘Complaints’, Animal Research Review Panel Annual Report 1997/98, 25; Lynette Chave, Leader-Animal Research, Animal Welfare Branch, NSW Department of Primary Industries, pers comm, 13 March 2006.

[66] Consider: Council for International Organizations of Medical Sciences (CIOMS), 'International Guiding Principles for Biomedical Research Involving Animals (1985), (herein 'CIOMS Guidelines') [11 March 2006] <http://www.cioms.ch/1985_texts_of_guidelines.htm>.

[67] For example, the International Council for Laboratory Animal Science (ICLAS), was established on the initiative of the United Nations Educational, Scientific and Cultural Organisation (UNESCO) in 1956 to promote high standards of laboratory animal quality, care and health. Since that time, its goals have included promoting world-wide harmonisation in the care and use of laboratory animals and coordinating the development of laboratory animal science as a matter of priority in developing countries. The scientific members of ICLAS represent a diverse community of nations from South Africa to Thailand to the Baltic States. Consider: <http://www.iclas.org/>; Darian M. Ibrahim, above n 3, 8-9.

[68] This argument is based on a survey of the following instruments: International Council for Laboratory Animal Science's International Guiding Principles for Biomedical Research Involving Animals (1985), above n 66; Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes as amended by Directive 2003/65/EC (herein ‘EU Directive’), Official Journal L 358 , 18/12/1986 P. 0001-0028 <http://europa.eu.int/eur-lex/lex/LexUriServ/LexUriServ.do?uri=CELEX:31986L0609:EN:HTML>; the World Society for the Protection of Animal's Universal Declaration for the Welfare of Animals (2003), World Society for Protection of Animals, Universal Declaration for the Welfare of Animals (2000) (herein 'WSPA Declaration') [19 March 2006] < http://ww2.wspa-international.org/action/declaration/index.html>; The Code, above n 12; Animal Welfare Act 7 USC § 2132-2159 (2000).

[69] CIOMS Guidelines, above n 66, Basic Principles I and III; WSPA Declaration, above n 68, Articles 8(a); EU Directive, above n 68, Article 3; The Code, above n 12, clause 1.1-1.3.

[70] CIOMS Guidelines, above n 66, Basic Principle IV; EU Directive, above n 68, Article 7; WSPA Declaration, above n 68, Article 8(b); The Code, above n 12, clauses 1.9-1.13; Animal Welfare Act 7 USC § 2143(3)(b) (2000); Consider Darian M. Ibrahim, discussing Russel & Burch, The Principles of Humane Experimental Technique (Methuen 1959), and the implementation of the principle of replacement in the US Animal Welfare Act, above n 3, 4 and 14.

[71] CIOMS Guidelines, above n 66; EU Directive, above n 68, Articles 5, 7 and 8; Basic Principle VII; WSPA Declaration, above n 68, Article 8(b); The Code, above n 12, clauses 1.14-1.28; Animal Welfare Act 7 USC § 2143(a)(3)(B) and (3)(C)(v) (2000); Consider Darian M. Ibrahim, discussing Russel & Burch, The Principles of Humane Experimental Technique (Methuen 1959), and the implementation of the principle of refinement in the US Animal Welfare Act, above n 3, 5 and 14.

[72] CIOMS Guidelines, above n 66, Basic Principle IV; EU Directive, above n 68, Article 7(3); WSPA Declaration, above n 68, Article 8(b); The Code, above n 12, clauses 1.14-1.15.

[73] CIOMS Guidelines, above n 66, Basic Principle II; EU Directive, above n 68, Articles 7 and 23; WSPA Declaration, above n 67, Articles 8(c) and 8(d); The Code, above n 12, clause 1.9; Animal Welfare Act 7 USC § 2143(e)(3) and (3)(b) (2000); Consider Darian M. Ibrahim, discussing Russel & Burch, The Principles of Humane Experimental Technique (Methuen 1959), and the implementation of the principle of replacement in the US Animal Welfare Act, above n 3, 6-7 and 14.

[74] CIOMS Guidelines, above n 66, Basic Principle II; The Code, above n 12, ‘Scope of the code’, 1-2.  Additionally, Principle 12 of the Declaration Of Helsinki refers to the fact that the welfare of animals used for research must be respected. See: World Medical Association 'Declaration Of Helsinki, Ethical Principles for Medical Research Involving Human Subjects', Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 [19 March 2006] <http://www.wma.net/e/policy/b3.htm> (herein 'The Helsinki Declaration').

[75] CIOMS Guidelines, above n 66, Basic Principle X; EU Directive, above n 68, Article 5; WSPA Declaration, above n 68, Article 8(b); The Code, above n 12, Section 4, 33; Animal Welfare Act 7 USC § 2143 (2)(a) (2000).

[76] CIOMS Guidelines, above n 66, Basic Principle XI; EU Directive, above n 68, Articles 7 and 14; The Code, above n 12, clause 2.1.1(iii), 2.2.16(iii), 3.3.26, 3.3.45, 4.5.12, 5.2.7, 6.2.1(ii), 6.5.5(iv); Animal Welfare Act 7 USC § 2143(b)(5)(d) (2000).

[77] CIOMS Guidelines, above n 66, Special Provisions 2.  This principle is incorporated to varying degrees in the legislative instruments surveyed and set out above, n 68.

[78] CIOMS Guidelines, above n 66, Special Provisions 3.2.  This principle is incorporated to varying degrees in the legislative instruments surveyed and set out above, n 68.

[79] It has been recognised that certain legislative instruments relating to animal research are in need of reform due to scientific developments and changing perceptions of animal welfare.  For example the EU Directive is currently under review and is expected to be available in draft late in 2006.  Certain of the principles identified in this section may be the subject of discussion when existing law and policy instruments are revised. See Europa, Revision of Directive 86/609/EEC on the protection of Animals used for Experimental and other Scientific purposes, European Commission ‘Environment’ [11 March 2006] <http://europa.eu.int/comm/environment/chemicals/lab_animals/revision_en.htm>; RDS, ‘Revision of European Directive 86/609-an update’, <http://www.rds-online.org.uk/pages/page.asp?i_ToolbarID=5&i_PageID=1994>.

[80] Consider: Nuffield Council on Bioethics, 'The ethics of clinical research in developing countries', Nuffield Council on Bioethics (1999), 7. [16 March 2006] <http://www.nuffieldbioethics.org/go/ourwork/developingcountries/publication_305.html>.

[81] It is noted that the EU Directive covers all vertebrates, including free living larval and/or reproducing larval forms but excluding foetal or embryonic forms. EU Directive, above n 68, Article (2)(a); The Code does not refer to ‘sentience’ in its definition of an ‘Animal’ but the definition is comparatively broad, above n 17.

[82] EU Directive, above n 68, Article 22.

[83] For example, the Animal Research Act 1985 (NSW) ss 26(3) to (8) requires additional review and consent procedures to be complied with before research of this nature can proceed.

[84] Ibid.

[85] For example, the Prevention of Cruelty to Animals Regulations 1997 (VIC) r 12(2) requires additional review and consent procedures to be complied with before research of this nature can proceed.

[86] Consider Darian M. Ibrahim, above n 3, 32-41 (discussing difficulties applying the ‘Three R’s’ to new and emerging technologies; Some countries have sought to apply additional obligations on researchers involved in certain of these technologies, however an analysis of the merits of that approach is beyond the scope of this paper. Consider for example, the Code, above n 12, clauses 3.3.45-3.3.77.

[87] European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes, opened for signature 18 March 1986 by member States and by the European Community and for accession by non-member States (entered into force 1 October 1991), Article 9.

[88] Consider Council for International Organizations of Medical Sciences (CIOMS Geneva), 'International Ethical Guidelines for Biomedical Research Involving Human Subjects, (2002), (herein 'CIOMS Human Subject Guidelines'), Guideline 2, <http://www.cioms.ch/guidelines_nov_2002_blurb.htm>.

[89] The Code, above n 12, clause 2.2.2.

[90] Adapted from The Helsinki Declaration, above n 74, principle 13.

[91] Adapted from CIOMS Human Subject Guidelines, above n 88, guideline 2.

[92] Ibid.

[93] The conduct of large scale trials in developing countries to see whether zidovudine (AZT) treatment for HIV infected women prevented perinatal transmission of HIV is discussed in: Nuffield Council on Bioethics, above n 80.

[94] Nuffield Council on Bioethics, above n 80, 5.

[95] Nuffield Council of Bioethics, 'The ethics of research related to healthcare in developing countries', The Nuffield Council on Bioethics (2002), 90. [19 March 2006]  <http://www.nuffieldbioethics.org/go/ourwork/developingcountries/publication_309.html>.

[96] Consider Nuffield Council of Bioethics, above n 95, chapter 8. (discussing the ethical review of human research in developing countries).

[97] Nuffield Council of Bioethics, above n 95, 106-07.

[98] Nuffield Council of Bioethics, above n 95, 108-09.

[99] This principle was proposed by the Nuffield Working Party in relation to ethics committees established to review human research in developing countries. See: Nuffield Council of Bioethics, above n 95, 107.

[100] Adapted from CIOMS Human Subject Guidelines, above n 88, guideline 3.

[101] Marcia Angell, 'Investigator's responsibilities for human subjects in developing countries' (2002) 342 New England Journal of Medicine (13), 967-69, quoted in: Nuffield Council of Bioethics, above n 95, 89.

[102] Adapted from Nuffield Council of Bioethics, above n 95, 106-07.

[103] A variation of this practice appears to have already been adopted by institutions in (at least) Australia. For example, the Animal Welfare Committee at Monash University in Melbourne, Australia has released a policy which states that 'When Monash University and an overseas institution are jointly involved in a research project involving animal use overseas, approval by a Monash University AEC is necessary before Monash University staff and research workers can proceed.' Monash University Animal Welfare Committee, ‘Monash University Policy on the Conduct of Field Work; including Off-Campus, Overseas, and Collaborative Research Projects involving Monash University Personnel’ (revised 14 September 2005) [19 March 2006]

 <http://www.monash.edu.au/research/ethics/animal/regguide/muawc.html>; also consider ‘Projects conducted in other countries in association with Australian institutions’, the Code, above n 12, 2.2.45-2.2.46.

[104] The Declaration of Helsinki was revised in 1975 in Tokyo, 1983 in Venice, 1989 in Hong Kong, 1996 in South Africa and 2000 in Edinburgh. A Note of Clarification on Paragraph 29 was also added by the WMA General Assembly in Washington 2002 and in Tokyo in 2004. See The Helsinki Declaration, above n 74.

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