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Viewpoint
Reforming the politics of animal research Lisa Hara Levin,1 William A Reppy2 1
Medical Department, AC&C of New York City, New York, New York, USA 2 School of Law, Duke University, Durham, North Carolina, USA Correspondence to Dr Lisa Hara Levin, Medical Department, AC&C of New York City, 11 Park Place, Suite 805, New York, NY 10007, USA; [email protected] Received 21 August 2012 Revised 25 September 2014 Accepted 23 January 2015 Published Online First 25 February 2015
ABSTRACT An unfortunate tension exists between the biomedical research and animal welfare/rights communities. We believe that despite the mistrust between these groups, there are individuals on both sides of the controversy who seek to better understand the other. We recommend an update of institutional policies that will better inform the public about the use of non-human animals in biomedical research and improve a dialogue on such use between concerned individuals who either support or oppose non-human animal-based biomedical research. Such interactions may well determine the longevity of using non-human animals as experimental subjects.
THE FRAMEWORK OF FEDERAL ‘PROTECTION’ OF ANIMALS USED IN RESEARCH IN USA
▸ http://dx.doi.org/10.1136/ medethics-2014-102404
To cite: Levin LH, Reppy WA. J Med Ethics 2015;41:563–566.
In 1966, serious public concern was stirred in USA by a LIFE magazine article that depicted horrible cruelty to animals destined for use in the country’s medical research laboratories.1 A sad illustration of such inhumanity was a prior story of a family’s Dalmatian, who had been stolen by an animal dealer and removed to a New York research laboratory, where she died.2 The US Congress legislatively responded with the Laboratory Animal Welfare Act (LAWA),3 which outlawed the theft/sale of owned companion animals to research laboratories and regulated the humane care and handling of certain animals used in these environments. The US Department of Agriculture, lead by a presiding Secretary, was designated as the administering body of the LAWA via its Animal and Plant Health Inspection Service. An amendment to LAWA in 1970 included a name change to the Animal Welfare Act (AWA). But, arguably the most impressive legislative advances for laboratory animal welfare were passed by the Congress in 1985: the Improved Standards for Laboratory Animals Act,4 as an AWA amendment, and; the Health Research Extension Act,5 administered by the Director of the National Institutes of Health (NIH). Both required the establishment of Institutional Animal Care and Use Committees (IACUCs) at all facilities performing biomedical research on animals. Both statutes creating IACUCs were implemented by administrative regulations. IACUCs are expected to evaluate animal research protocols and oversee laboratory performance with regard to animal welfare. While two sets of regulations might seem redundant, they do feature some differences. A 2002 amendment to the AWA6 permanently excluded, as regulated ‘animals,’ rats, mice and birds specifically bred for use in laboratories, thus, terminating any contention that they were protected by the AWA.
The Health Research Extension Act, alternatively —with rules detailed in the ‘Public Health Service Policy for the Humane Care and Use of Laboratory Animals’ (PHS Policy)—includes all vertebrate animals used in federally funded research. This would include research funded by the NIH, a PHS agency. The acceptance of federal funding also requires that researchers comply with the regulations set out in the Guide for the Care and Use of Laboratory Animals.7 The Guide is published by the Institute for Laboratory Animal Research and is based upon the historically important 3Rs: Refinement, Reduction, and Replacement of the use of animals in research.i Some research facilities are exempt from the AWA and PHS Policy. These include private corporations and other non-federally funded facilities restricting their investigations to those using rats, mice and birds. Many in this group have established IACUCs (with self-determined responsibilities) and voluntarily seek laboratory animal welfare accreditation through the Association for Assessment and Accreditation of Laboratory Animal Care International. The structural composition of an IACUC depends on its adherence to either the AWA (three members minimum) or PHS policy (five members minimum). Both will include a veterinarian experienced in laboratory animal medicine and a member unaffiliated with the facility. The AWA goes one step further, by characterising the unaffiliated member as one who represents the animal welfare interests of the lay community. PHS adherents will add as IACUC members a scientist active and knowledgeable in animal-based research and an individual principally working in a non-scientific area. Unlike the recent European Union (EU) Directive 2010/63,8 which mandates an ethics committee review of all animal research protocols prior to their authorisation, neither of the two US regulatory schemes has specifically incorporated an ethics review requirement into its IACUC model. It is the ‘ethical monoculture’ of scientist-stacked IACUCs with “vested interests in continuing animal research” that may impair IACUCs ability to meet public concern for animal welfare.9 Given the abundant mutual suspicions and recriminations exchanged between the US research and animal-protection communities, it is clear that some intervention must be performed to eliminate or at least substantially reduce these problems. We
i
William Russell and Rex Burch recommended this humane approach in 1954 following their 2-year tour through laboratories in the United Kingdom. The 3Rs philosophy is presented in their book entitled The Principles of Humane Experimental Techniques (London: Methuen, 1959).
Levin LH, et al. J Med Ethics 2015;41:563–566. doi:10.1136/medethics-2012-101043
563
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Viewpoint recommend an update of institutional policies so that they would better inform the public about the use of non-human animals in biomedical research. It is likely that this type of exposure would prompt a dialogue on such use between individuals who either support or oppose non-human animal-based biomedical research. An admirable example of such a policy system successfully implemented is the Boyd Group,10 a think tank based in the UK, whose hybrid membership of scientists, philosophers, and animal protectionists has produced and has all the promise of continuing to produce valuable consensus opinions on laboratory animal welfare. We believe that increased institutional transparency and an earnest diplomatic approach to scientist-animal protectionist dialogue may well determine the longevity of using non-human animals as experimental subjects.
AN IMPORTANT HISTORY LESSON Slightly more than a decade ago, a battle over the scope of the AWA took place. It is a story covering the tactical transformation of the US research community from belligerence to accommodation and reveals an attempt at diplomacy between the research and animal protection camps. We offer this important history lesson as a prelude to strategies we will later recommend to reform the politics of animal research. A lawsuit had been brought to determine the scope of discretion vested in the Secretary of Agriculture by a statute, 7 U.S.C. § 2132 (g), to exclude rats, mice and birds from the protection given to research animals by AWA. Protections specified in the AWA applied by statute to a “dog, cat, monkey (non-human primate mammal), guinea pig, hamster, rabbit or such other warm-blooded animal, as the Secretary may determine is being used…for research….” By regulation dating from 1971, the Secretary did exclude rats, mice and birds from AWA protection even though these animals constituted approximately 95% of all animals used in regulated laboratories. Litigation over whether this exclusion violated the quoted statue had begun in 1989, and for years the research community stood in implacable opposition to giving AWA protection to rats, mice and birds. For example, it was argued that these animals were already protected by animal care guidelines issued by the US PHS, thereby making the relief sought in the AWA litigation ‘redundant.’11 But attitudes were changing. A 1999 survey of nearly 500 IACUC members—two-thirds of whom were researchers— found that almost 75% of the respondents supported the making of rules to extend AWA protection to rats, mice and birds.12 And in 2000, the American Association for Laboratory Animal Science, while not taking a position on the legal issue in the pending lawsuit, stated: “The political and economic rationale that led to the exclusion in the AWA of the vast majority of animals used in research is ethically indefensible.13” The federal government proceeded to settle the case by way of a stipulated judgement ordering the US Department of Agriculture to make rules bringing rats, mice and birds under AWA protection within a reasonable time. A letter from Secretary Glickman to the research community indicated that federal lawyers thought the animal activists had a strong legal case that might result in the trial court itself imposing a shorter timetable for bringing rats, mice and birds under the AWA.14 Although Congress amended the AWA so that the agreed-on regulations never took effect, the incident of the research community making common ground with animal activists concerning the scope of AWA invites future conversations between concerned representatives of both camps who do not hold rigidly immoveable positions on new issues that arise. Decisions that will control how far into the future animals will be used in 564
research ought to be affected by such interactions in years to come.
NIH EXPRESSES FEAR OF PRO-ANIMAL TERRORISTS In April, 2011, a posting on the NIH Office of Extramural Research site15 warned the scientific community of “increasing calls to action from animal rights activists” that would involve “intimidation, threats and violence” and “inciting acts of terrorism [t]hreatening the safety of scientists and students at their home and at their institutions….” Research institutions, the NIH posting advised, needed to be “prepared for the unexpected” and were urged to use NIH resources to help “build a preparedness program.” The NIH message concluded with the recommendation that researchers and their institutions “will take the time to build a plan but will never have the need to use it.” The NIH official who posted this 2011 perspective reposted it in the spring of 2012, due to her belief that it “was particularly important,” and again deserved her readership’s attention.16 Given that May 2012 marked the 10th anniversary of excluding all rats, mice and birds bred specifically for research— estimated as representing over 90% of all research animals— from the humane protections afforded by the AWA,17 this repost can be viewed as ironically timely. We respectfully assert that these two NIH postings could have offered more than mere ‘hope’ that a particular research institution would not be the subject of a criminal attack by an animal rights fringe group. It might have noted that the creation of an institutional defence plan should include a thoughtful consideration of that institution’s publicly stated policies concerning the use of experimental animals. Indeed, NIH’s IACUC guidebook lists as the first of “four key elements of institutional preparedness” against unexpected events including “laboratory break-ins” the maintaining of an “animal program of impeccable integrity” supported by “an integrated communication plan.18”
A POLICY OF PROGRESS We are not (so far as we know) acquainted with any animal activists who engage in criminal acts against research institutions; and we believe that the author of the NIH postings quoted above would view would-be terrorists as delusional or out of touch with reality. Like the IACUC guidebook, we assume that the expressed policies of a research institution concerning its use of animals are something such activists would consider in picking out a target for a criminal attack. Here we lay out briefly three such policies that an institution could publicly adopt. The governing board of the institution would embrace these policies not to appease potential criminals but, rather, because they are morally right and reflect the views of a majority of the shareholders of a corporate research facility and of the faculty, staff, students and alumni of a university. The institution would also recognise that an incidental effect of adopting the policies would be to make it a less attractive target of criminal violence. The three policies are: (1) to avoid the use of animals in experiments whenever a non-animal alternative procedure is available, while aspiring to the ultimate elimination of using animals in research; (2) to embrace transparency regarding animal-based research, providing the public with detailed information about the institution’s use of animals, and; (3) to be willing to negotiate with responsible representatives of the animal rights/welfare community about problems they have concerning animals at the institution. The primary issue involved in formulating a policy in favour of alternative research procedures that do not inflict pain or Levin LH, et al. J Med Ethics 2015;41:563–566. doi:10.1136/medethics-2012-101043
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Viewpoint death on sentient animals is probably cost. We do not expect an institution to immediately adopt a policy providing that it will always, no matter the cost difference, employ in lieu of a procedure involving animals an equally effective one that does not. The policy we endorse necessarily will have to use a flexible standard such as “provided any additional cost associated with the alternative procedure is not unreasonable.” However, we do expect that researchers will aggressively pursue investigations aimed at levelling the cost of animal and non-animal methods. Cost-effective non-animal models are increasingly available, and, as noted by laboratory-animal veterinarian Larry Carbone, there will be a day when animal-based technology ‘becomes obsolete.’19 The end of using animals as experimental subjects in biomedical research may not occur in our lifetimes. But as Carbone has cautioned, “A hundred years from now, people may look back with dread at the way we now treat animals” in our laboratories. Our duty to protect animals, while preserving and restoring human and animal health, invites cooperation with an intelligent and compassionate scientific community. A corollary of the primary policy against non-essential use of animals in research should be recognised: If the use of animals is necessary, the animal-based procedure that minimises pain and suffering without incurring unreasonable costs must be employed. In Carbone’s words, the goal is to ‘make it better’ for those animals that continue to be used in research. Our second proposed policy is transparency with respect to animals in research, agreeing with the IACUC guidebook (cited above) that a “communication plan with descriptions of research projects” is one of the “key elements of institutional preparedness” that will reduce the chances of criminal violence. Keeping information about experiments involving animals secret vis-à-vis the animal rights/welfare community obviously creates a substantial risk that animal activists—including the potential terrorist—will assume the worst: that needless suffering is being inflicted on animals. With respect to many experiments—those not involving what the law calls ‘trade secrets,’ such as the formula for a pharmaceutical in the design process—full public disclosure can be made, including the following facts: type and number of animals involved; the invasive nature of the experiment; measures taken to reduce suffering; disposition of the animals when the experiment is concluded; and; the basis for the institution’s conclusion that the experiment was not unnecessarily duplicative. Ordinarily, the IACUC’s review should also be posted. With experiments involving trade secrets, the disclosure may have to be less thorough; pertinent IACUC documents may need to be redacted before being publicised. The institution’s stated policy applicable to these experiments should be to make the maximum disclosure that protects the integrity of the trade secret involved. The third policy a research institution should consider publicly adopting upon the occasion of making plans to deal with potential attacks by terrorists is a willingness to negotiate with responsible members of the animal rights/welfare community. The antivivisectionist constituency of the Boyd Group maintains that its viewpoint must be considered, if the public is to have faith in the EU’s established ethical review process. While the Boyd Group believes that researchers engaged in an ethical review process will be reluctant to invite such pro-animal opinions, it nonetheless encourages the inclusion of “informed representatives of responsible organisations opposed to animal use.”20 A similar position is expressed by a working group of the Federation of European Laboratory Animal Science Associations, which recommends the inclusion of ‘lay’ Levin LH, et al. J Med Ethics 2015;41:563–566. doi:10.1136/medethics-2012-101043
perspectives.21 To recognise that sometimes the pro-animal position can be right—ethically, legally or both—results in efficiency for the institution, reducing legal fees and other expenses of a drawn-out battle by virtually immoveable adversaries. Increased respect for the institution by the pro-animal community should be an incidental benefit. We believe that these policies are supported by the recent animal welfare advance, Directive 2010/63, made in the EU. Adopted in September 2010 by the European Parliament and the Council of the EU, its requirements, which became effective 1 January 2013, have standardised welfare for all animals used in scientific procedures within EU member states. While it is too early to assess its effect on the ethical comportment of scientists, there are two features of the legislation that will increase institutional transparency regarding the scientific use of animals: (1) the requirement for an ethical review of scientific research involving animals, prior to project authorisation, and (2) the publication of non-technical reports summarising research studies using animals. Although American IACUCs may discuss ethical issues during their deliberations (PHS policy, in fact, directs attention—though using other words—to the 3Rs), they are reported to primarily focus on technical concerns, perhaps in some part due to AWA language ambiguity.22 Even an informal consensus on ethical review similar to the mandate of the EU Directive could do much to ensure that the public’s interest in laboratory animal welfare was served. The publication in language directed at lay readers of summaries of animal research in USA, though laudable and appropriate, is a requirement of funding bodies rather than a response to a legislative mandate like that of the EU. A 2002 House of Lords Select Committee report made clear that “[t]he availability to the public of regularly updated, good quality information on what animal experiments are done and why, is vital to create an atmosphere in which the issue of animal experimentation can be discussed productively.”23 Broad dissemination of such material in USA can only improve public understanding of scientific investigations using animals. The exemplary mode for disclosure would be that recommended in 2005 by a UK bioethics working group: “researchers should be more open to two-way dialogue to improve and sustain public trust.”24 We earlier referred to the Boyd Group, an estimable model for information exchange about issues and ideas involving animal research subjects. Based in the UK, with membership open to “veterinarians, scientists using animals, members of animal welfare organisations, antivivisectionists, members of bodies funding or directly engaged in research, philosophers and others,” the “Group’s objectives are to promote dialogue between these diverse people and organisations; and, where there is consensus, to recommend practical steps towards achieving common goals.” We suggest that a similar think tank situated in USA could stepwise achieve the progressive policies we have recommended here. Until such a resource can be developed, we propose inclusion of experienced animal advocates as unaffiliated members on IACUCs in USA. As one of us has elsewhere opined,25 it would be a “show of goodwill,” if animal research facilities would “voluntarily appoint individuals to their IACUC who are recognised within the local community as advocates for animals.” Perhaps, with the assistance of institutional public relations departments, these same individuals could “be encouraged to serve openly as a liaison between the research community and the concerned public, neither as a mouthpiece for the facility nor as spies for local animal activists, but as credible advocates for animals, seeking to function within an imperfect oversight mechanism that has built-in tensions and 565
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Viewpoint ambiguities.” We believe that all IACUC members are to some degree advocates of animal welfare, but the unaffiliated “member’s role is linked to community representation and is free of the potential for conflict of interest due to affiliation with the institution.” Balanced dialogue is an aim upon which scientists and animal protectionists can agree.
A FINAL POINT Ethical principles are established to deal with the dilemmas inherent in an enterprise of animal research. However, the interpretation of these principles is entrusted to individuals, and the degree to which personal views intersect will determine how animal research ethics are situated at the institutional and public levels.26 Additionally, complex opinions about the sanctity of animal life do much to confound reasonable analysis. In Orwellian fashion, the prevailing human attitude ranks some species more equal than others. Scientists value rats and mice but may sometimes place greater value on non-human primates, due to that population’s large congruity with human DNA. Alternatively, this genetic resemblance is the basis for moral arguments against their use as experimental subjects in biomedical research.27 Two legal scholars, two centuries apart, have remarked that animal sentience equates to the capacity to incur pain and suffering at some level. Jeremy Bentham, the 18th-century jurist, wrote in his Introduction to the Principles of Morals and Legislation, “the question is not, Can they reason? nor, Can they talk? but, Can they suffer?”28 In the 21st century, legal scholar Gary Francione comments on our ‘moral schizophrenia’ when assessing the value of animal life.29 This condition of the human psyche alone provides justification for examining the moral correctness of our decisions to use non-human animals as research subjects and is the ethical driver behind our promotion of transparency. We appreciate the great efforts made by EU member countries with respect to their regulation of animal research. It is our opinion that the UK—with central regulation and local ethical review of animal research—provides a paradigm that USA may copy. While IACUCs in USA may already choose to perform ethics reviews as part of their deliberations, we have previously noted that this activity has never been required by the language of the AWA. Along with voluntary ethics reviews, we also envision IACUCs and broader institutional information networks that have more comprehensive avenues that enable investigators to explain their research to those who do not have an advanced scientific understanding. We concur with the thought that, while antivivisectionists will oppose any research performed using animals, some will look upon the 3Rs as a compromise, while they continue to campaign for a more extreme change in policy.30 We urge a research institution that adopts one or more of our recommended policies to publish it in a way that makes the policy easy to find by interested persons. A box on the home page of an institution’s website might draw the attention of web visitors if it contained (in large type font) the words ‘POLICIES ON ANIMALS.’ Enhancements to this box, such as a grouping of the more commonly used animals in research, might be a visual attractant. If adoption of pro-animal polices is to have the incidental effect of reducing the chances that an institution will be the target of violence by true terrorists, broad public dissemination that can reach such an individual should be the goal. Moreover, inviting collaboration with people having broad 566
intellectual backgrounds could result in sensible dialogue regarding the use of animals in research. Ideally, this would replace poorly informed debate, minimise invective and balance the world’s drive for scientific advance with the need to ensure animal protection. Contributors LHL’s professional background in biomedical research and animal welfare has allowed her to examine the historical and practical aspects of this manuscript’s content. WAR’s legal scholarship permits the very fine legal insight required to interpret and add to this manuscript’s content. LHL is the guarantor for the overall content of this manuscript. Competing interests None. Provenance and peer review Not commissioned; externally peer reviewed.
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Wayman S. Concentration camps for dogs. LIFE 1966;60(5):22–9. Phinizy C. The lost pets that stray to the labs. Sports Illustrated 1965;23(22):36–49. Public Law 89-544, 80 Stat. 350 (August 24, 1966). Public Law 99-198, 99 Stat.1645 (December 23, 1985). Public Law 99-158, 99 Stat 820 (November 20, 1985). Public Law 107-171, § 10301, 116 Stat. 134, 491 (May 14, 2002). National Research Council Institute for Laboratory Animal Resources. Guide for the care and use of laboratory animals. Washington DC: The National Academies Press, 2011. Council Directive of 22 September 2010. Official Journal of the European Union No L 2010 September 20: 276/33-79. (2010/63/EU). Hansen LA. Institution animal care and use committees need greater ethical diversity. J Med Ethics 2013;39:188–90. The Boyd Group. About the Boyd Group. http://www.boyd-group.demon.co.uk (accessed Nov 2012). Hendrix MJC. Guidelines work better than animal welfare law. Nature 2000;408:133. Plous S, Herzog HA. Should AWA coverage be broadened? Results from a survey of animal care and use committees. Lab Animal 1999;28:38–40. AALAS Position Statement: Inclusion of Rats, Mice and Birds Under USDA Oversight. AALAS Reference Directory. 2000:16–17. Letter from Dan Glickman to Chris Price, chair of Animal Care & Experimentation Society for the Study of Reproduction. SSR Newsletter 2001;18(1):7. Office of Extramural Research National Institutes of Health website. Be Prepared for the Unexpected. http://nexus.od.nih.gov/all/2011/04/14/be-prepared (accessed Apr 2011). Office of Extramural Research National Institutes of Health. Repost: Be Prepared for the Unexpected. http://nexus.od.nih.gov/all/2012/04/13repostbe-prepared (accessed Apr 2012). 7 USC §§2131–2159. Office of Extramural Research National Institutes of Health. The ARENA/OLAW Institutional Animal Care and Use Committee Guidebook. http://grants.nih.gov/ grants/policy/air/preparedness.htm (accessed Apr 2011 and Apr 2012). Carbone L. What animals want: expertise and advocacy in laboratory animal welfare policy. New York: Oxford University Press, 2004:239. The Boyd Group. Response to Home Office Review of the Ethical Process. March 2001. http://www.boyd-group.demon.co.uk (accessed Nov 2012). FELASA Working Group on Ethical Evaluation of Animal Experiments. Principles and practice in ethical review of animal experiments across Europe: summary of the report of a FELASA working group on ethical evaluation of animal experiments. Lab Anim 2007;41:143–60. Hansen, op. cit. House of Lords Select Committee. Animals in Scientific Procedures: Volume I—Report. London, UK: The Stationery Office, 24 Jul 2002. Perry P. The ethics of animal research: a UK perspective. ILAR J 2007;48(1):42–6. Levin LH, Stephens ML. Appointing animal protectionists to institutional animal care and use committees. Anim Welf Info Cent Newsl 1994/1995;5(4):1–2, 8–10. Ideland M. Different views on ethics: how animal ethics is situated in a committee culture. J Med Ethics 2009;35:258. Rosoff PM. I’ll be a monkey’s uncle: a moral challenge to human genetic enhancement research. J Med Ethics 2011;37:612. Bentham J. An introduction to the principles of morals and legislation. Oxford: Clarendon Press, 1907: Ch. 17, section 1. Francione G. Animals as persons: essays on the abolition of animal exploitation. New York: Columbia University Press, 2008:28. Nuffield Council on Bioethics. The ethics of research involving animals. 2005. http://nuffieldbioethics.org (accessed Nov 2012).
Levin LH, et al. J Med Ethics 2015;41:563–566. doi:10.1136/medethics-2012-101043
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Reforming the politics of animal research Lisa Hara Levin and William A Reppy J Med Ethics 2015 41: 563-566 originally published online February 25, 2015
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Viewpoint
Reforming the politics of animal research Lisa Hara Levin,1 William A Reppy2 1
Medical Department, AC&C of New York City, New York, New York, USA 2 School of Law, Duke University, Durham, North Carolina, USA Correspondence to Dr Lisa Hara Levin, Medical Department, AC&C of New York City, 11 Park Place, Suite 805, New York, NY 10007, USA; [email protected] Received 21 August 2012 Revised 25 September 2014 Accepted 23 January 2015 Published Online First 25 February 2015
ABSTRACT An unfortunate tension exists between the biomedical research and animal welfare/rights communities. We believe that despite the mistrust between these groups, there are individuals on both sides of the controversy who seek to better understand the other. We recommend an update of institutional policies that will better inform the public about the use of non-human animals in biomedical research and improve a dialogue on such use between concerned individuals who either support or oppose non-human animal-based biomedical research. Such interactions may well determine the longevity of using non-human animals as experimental subjects.
THE FRAMEWORK OF FEDERAL ‘PROTECTION’ OF ANIMALS USED IN RESEARCH IN USA
▸ http://dx.doi.org/10.1136/ medethics-2014-102404
To cite: Levin LH, Reppy WA. J Med Ethics 2015;41:563–566.
In 1966, serious public concern was stirred in USA by a LIFE magazine article that depicted horrible cruelty to animals destined for use in the country’s medical research laboratories.1 A sad illustration of such inhumanity was a prior story of a family’s Dalmatian, who had been stolen by an animal dealer and removed to a New York research laboratory, where she died.2 The US Congress legislatively responded with the Laboratory Animal Welfare Act (LAWA),3 which outlawed the theft/sale of owned companion animals to research laboratories and regulated the humane care and handling of certain animals used in these environments. The US Department of Agriculture, lead by a presiding Secretary, was designated as the administering body of the LAWA via its Animal and Plant Health Inspection Service. An amendment to LAWA in 1970 included a name change to the Animal Welfare Act (AWA). But, arguably the most impressive legislative advances for laboratory animal welfare were passed by the Congress in 1985: the Improved Standards for Laboratory Animals Act,4 as an AWA amendment, and; the Health Research Extension Act,5 administered by the Director of the National Institutes of Health (NIH). Both required the establishment of Institutional Animal Care and Use Committees (IACUCs) at all facilities performing biomedical research on animals. Both statutes creating IACUCs were implemented by administrative regulations. IACUCs are expected to evaluate animal research protocols and oversee laboratory performance with regard to animal welfare. While two sets of regulations might seem redundant, they do feature some differences. A 2002 amendment to the AWA6 permanently excluded, as regulated ‘animals,’ rats, mice and birds specifically bred for use in laboratories, thus, terminating any contention that they were protected by the AWA.
The Health Research Extension Act, alternatively —with rules detailed in the ‘Public Health Service Policy for the Humane Care and Use of Laboratory Animals’ (PHS Policy)—includes all vertebrate animals used in federally funded research. This would include research funded by the NIH, a PHS agency. The acceptance of federal funding also requires that researchers comply with the regulations set out in the Guide for the Care and Use of Laboratory Animals.7 The Guide is published by the Institute for Laboratory Animal Research and is based upon the historically important 3Rs: Refinement, Reduction, and Replacement of the use of animals in research.i Some research facilities are exempt from the AWA and PHS Policy. These include private corporations and other non-federally funded facilities restricting their investigations to those using rats, mice and birds. Many in this group have established IACUCs (with self-determined responsibilities) and voluntarily seek laboratory animal welfare accreditation through the Association for Assessment and Accreditation of Laboratory Animal Care International. The structural composition of an IACUC depends on its adherence to either the AWA (three members minimum) or PHS policy (five members minimum). Both will include a veterinarian experienced in laboratory animal medicine and a member unaffiliated with the facility. The AWA goes one step further, by characterising the unaffiliated member as one who represents the animal welfare interests of the lay community. PHS adherents will add as IACUC members a scientist active and knowledgeable in animal-based research and an individual principally working in a non-scientific area. Unlike the recent European Union (EU) Directive 2010/63,8 which mandates an ethics committee review of all animal research protocols prior to their authorisation, neither of the two US regulatory schemes has specifically incorporated an ethics review requirement into its IACUC model. It is the ‘ethical monoculture’ of scientist-stacked IACUCs with “vested interests in continuing animal research” that may impair IACUCs ability to meet public concern for animal welfare.9 Given the abundant mutual suspicions and recriminations exchanged between the US research and animal-protection communities, it is clear that some intervention must be performed to eliminate or at least substantially reduce these problems. We
i
William Russell and Rex Burch recommended this humane approach in 1954 following their 2-year tour through laboratories in the United Kingdom. The 3Rs philosophy is presented in their book entitled The Principles of Humane Experimental Techniques (London: Methuen, 1959).
Levin LH, et al. J Med Ethics 2015;41:563–566. doi:10.1136/medethics-2012-101043
563
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Viewpoint recommend an update of institutional policies so that they would better inform the public about the use of non-human animals in biomedical research. It is likely that this type of exposure would prompt a dialogue on such use between individuals who either support or oppose non-human animal-based biomedical research. An admirable example of such a policy system successfully implemented is the Boyd Group,10 a think tank based in the UK, whose hybrid membership of scientists, philosophers, and animal protectionists has produced and has all the promise of continuing to produce valuable consensus opinions on laboratory animal welfare. We believe that increased institutional transparency and an earnest diplomatic approach to scientist-animal protectionist dialogue may well determine the longevity of using non-human animals as experimental subjects.
AN IMPORTANT HISTORY LESSON Slightly more than a decade ago, a battle over the scope of the AWA took place. It is a story covering the tactical transformation of the US research community from belligerence to accommodation and reveals an attempt at diplomacy between the research and animal protection camps. We offer this important history lesson as a prelude to strategies we will later recommend to reform the politics of animal research. A lawsuit had been brought to determine the scope of discretion vested in the Secretary of Agriculture by a statute, 7 U.S.C. § 2132 (g), to exclude rats, mice and birds from the protection given to research animals by AWA. Protections specified in the AWA applied by statute to a “dog, cat, monkey (non-human primate mammal), guinea pig, hamster, rabbit or such other warm-blooded animal, as the Secretary may determine is being used…for research….” By regulation dating from 1971, the Secretary did exclude rats, mice and birds from AWA protection even though these animals constituted approximately 95% of all animals used in regulated laboratories. Litigation over whether this exclusion violated the quoted statue had begun in 1989, and for years the research community stood in implacable opposition to giving AWA protection to rats, mice and birds. For example, it was argued that these animals were already protected by animal care guidelines issued by the US PHS, thereby making the relief sought in the AWA litigation ‘redundant.’11 But attitudes were changing. A 1999 survey of nearly 500 IACUC members—two-thirds of whom were researchers— found that almost 75% of the respondents supported the making of rules to extend AWA protection to rats, mice and birds.12 And in 2000, the American Association for Laboratory Animal Science, while not taking a position on the legal issue in the pending lawsuit, stated: “The political and economic rationale that led to the exclusion in the AWA of the vast majority of animals used in research is ethically indefensible.13” The federal government proceeded to settle the case by way of a stipulated judgement ordering the US Department of Agriculture to make rules bringing rats, mice and birds under AWA protection within a reasonable time. A letter from Secretary Glickman to the research community indicated that federal lawyers thought the animal activists had a strong legal case that might result in the trial court itself imposing a shorter timetable for bringing rats, mice and birds under the AWA.14 Although Congress amended the AWA so that the agreed-on regulations never took effect, the incident of the research community making common ground with animal activists concerning the scope of AWA invites future conversations between concerned representatives of both camps who do not hold rigidly immoveable positions on new issues that arise. Decisions that will control how far into the future animals will be used in 564
research ought to be affected by such interactions in years to come.
NIH EXPRESSES FEAR OF PRO-ANIMAL TERRORISTS In April, 2011, a posting on the NIH Office of Extramural Research site15 warned the scientific community of “increasing calls to action from animal rights activists” that would involve “intimidation, threats and violence” and “inciting acts of terrorism [t]hreatening the safety of scientists and students at their home and at their institutions….” Research institutions, the NIH posting advised, needed to be “prepared for the unexpected” and were urged to use NIH resources to help “build a preparedness program.” The NIH message concluded with the recommendation that researchers and their institutions “will take the time to build a plan but will never have the need to use it.” The NIH official who posted this 2011 perspective reposted it in the spring of 2012, due to her belief that it “was particularly important,” and again deserved her readership’s attention.16 Given that May 2012 marked the 10th anniversary of excluding all rats, mice and birds bred specifically for research— estimated as representing over 90% of all research animals— from the humane protections afforded by the AWA,17 this repost can be viewed as ironically timely. We respectfully assert that these two NIH postings could have offered more than mere ‘hope’ that a particular research institution would not be the subject of a criminal attack by an animal rights fringe group. It might have noted that the creation of an institutional defence plan should include a thoughtful consideration of that institution’s publicly stated policies concerning the use of experimental animals. Indeed, NIH’s IACUC guidebook lists as the first of “four key elements of institutional preparedness” against unexpected events including “laboratory break-ins” the maintaining of an “animal program of impeccable integrity” supported by “an integrated communication plan.18”
A POLICY OF PROGRESS We are not (so far as we know) acquainted with any animal activists who engage in criminal acts against research institutions; and we believe that the author of the NIH postings quoted above would view would-be terrorists as delusional or out of touch with reality. Like the IACUC guidebook, we assume that the expressed policies of a research institution concerning its use of animals are something such activists would consider in picking out a target for a criminal attack. Here we lay out briefly three such policies that an institution could publicly adopt. The governing board of the institution would embrace these policies not to appease potential criminals but, rather, because they are morally right and reflect the views of a majority of the shareholders of a corporate research facility and of the faculty, staff, students and alumni of a university. The institution would also recognise that an incidental effect of adopting the policies would be to make it a less attractive target of criminal violence. The three policies are: (1) to avoid the use of animals in experiments whenever a non-animal alternative procedure is available, while aspiring to the ultimate elimination of using animals in research; (2) to embrace transparency regarding animal-based research, providing the public with detailed information about the institution’s use of animals, and; (3) to be willing to negotiate with responsible representatives of the animal rights/welfare community about problems they have concerning animals at the institution. The primary issue involved in formulating a policy in favour of alternative research procedures that do not inflict pain or Levin LH, et al. J Med Ethics 2015;41:563–566. doi:10.1136/medethics-2012-101043
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Viewpoint death on sentient animals is probably cost. We do not expect an institution to immediately adopt a policy providing that it will always, no matter the cost difference, employ in lieu of a procedure involving animals an equally effective one that does not. The policy we endorse necessarily will have to use a flexible standard such as “provided any additional cost associated with the alternative procedure is not unreasonable.” However, we do expect that researchers will aggressively pursue investigations aimed at levelling the cost of animal and non-animal methods. Cost-effective non-animal models are increasingly available, and, as noted by laboratory-animal veterinarian Larry Carbone, there will be a day when animal-based technology ‘becomes obsolete.’19 The end of using animals as experimental subjects in biomedical research may not occur in our lifetimes. But as Carbone has cautioned, “A hundred years from now, people may look back with dread at the way we now treat animals” in our laboratories. Our duty to protect animals, while preserving and restoring human and animal health, invites cooperation with an intelligent and compassionate scientific community. A corollary of the primary policy against non-essential use of animals in research should be recognised: If the use of animals is necessary, the animal-based procedure that minimises pain and suffering without incurring unreasonable costs must be employed. In Carbone’s words, the goal is to ‘make it better’ for those animals that continue to be used in research. Our second proposed policy is transparency with respect to animals in research, agreeing with the IACUC guidebook (cited above) that a “communication plan with descriptions of research projects” is one of the “key elements of institutional preparedness” that will reduce the chances of criminal violence. Keeping information about experiments involving animals secret vis-à-vis the animal rights/welfare community obviously creates a substantial risk that animal activists—including the potential terrorist—will assume the worst: that needless suffering is being inflicted on animals. With respect to many experiments—those not involving what the law calls ‘trade secrets,’ such as the formula for a pharmaceutical in the design process—full public disclosure can be made, including the following facts: type and number of animals involved; the invasive nature of the experiment; measures taken to reduce suffering; disposition of the animals when the experiment is concluded; and; the basis for the institution’s conclusion that the experiment was not unnecessarily duplicative. Ordinarily, the IACUC’s review should also be posted. With experiments involving trade secrets, the disclosure may have to be less thorough; pertinent IACUC documents may need to be redacted before being publicised. The institution’s stated policy applicable to these experiments should be to make the maximum disclosure that protects the integrity of the trade secret involved. The third policy a research institution should consider publicly adopting upon the occasion of making plans to deal with potential attacks by terrorists is a willingness to negotiate with responsible members of the animal rights/welfare community. The antivivisectionist constituency of the Boyd Group maintains that its viewpoint must be considered, if the public is to have faith in the EU’s established ethical review process. While the Boyd Group believes that researchers engaged in an ethical review process will be reluctant to invite such pro-animal opinions, it nonetheless encourages the inclusion of “informed representatives of responsible organisations opposed to animal use.”20 A similar position is expressed by a working group of the Federation of European Laboratory Animal Science Associations, which recommends the inclusion of ‘lay’ Levin LH, et al. J Med Ethics 2015;41:563–566. doi:10.1136/medethics-2012-101043
perspectives.21 To recognise that sometimes the pro-animal position can be right—ethically, legally or both—results in efficiency for the institution, reducing legal fees and other expenses of a drawn-out battle by virtually immoveable adversaries. Increased respect for the institution by the pro-animal community should be an incidental benefit. We believe that these policies are supported by the recent animal welfare advance, Directive 2010/63, made in the EU. Adopted in September 2010 by the European Parliament and the Council of the EU, its requirements, which became effective 1 January 2013, have standardised welfare for all animals used in scientific procedures within EU member states. While it is too early to assess its effect on the ethical comportment of scientists, there are two features of the legislation that will increase institutional transparency regarding the scientific use of animals: (1) the requirement for an ethical review of scientific research involving animals, prior to project authorisation, and (2) the publication of non-technical reports summarising research studies using animals. Although American IACUCs may discuss ethical issues during their deliberations (PHS policy, in fact, directs attention—though using other words—to the 3Rs), they are reported to primarily focus on technical concerns, perhaps in some part due to AWA language ambiguity.22 Even an informal consensus on ethical review similar to the mandate of the EU Directive could do much to ensure that the public’s interest in laboratory animal welfare was served. The publication in language directed at lay readers of summaries of animal research in USA, though laudable and appropriate, is a requirement of funding bodies rather than a response to a legislative mandate like that of the EU. A 2002 House of Lords Select Committee report made clear that “[t]he availability to the public of regularly updated, good quality information on what animal experiments are done and why, is vital to create an atmosphere in which the issue of animal experimentation can be discussed productively.”23 Broad dissemination of such material in USA can only improve public understanding of scientific investigations using animals. The exemplary mode for disclosure would be that recommended in 2005 by a UK bioethics working group: “researchers should be more open to two-way dialogue to improve and sustain public trust.”24 We earlier referred to the Boyd Group, an estimable model for information exchange about issues and ideas involving animal research subjects. Based in the UK, with membership open to “veterinarians, scientists using animals, members of animal welfare organisations, antivivisectionists, members of bodies funding or directly engaged in research, philosophers and others,” the “Group’s objectives are to promote dialogue between these diverse people and organisations; and, where there is consensus, to recommend practical steps towards achieving common goals.” We suggest that a similar think tank situated in USA could stepwise achieve the progressive policies we have recommended here. Until such a resource can be developed, we propose inclusion of experienced animal advocates as unaffiliated members on IACUCs in USA. As one of us has elsewhere opined,25 it would be a “show of goodwill,” if animal research facilities would “voluntarily appoint individuals to their IACUC who are recognised within the local community as advocates for animals.” Perhaps, with the assistance of institutional public relations departments, these same individuals could “be encouraged to serve openly as a liaison between the research community and the concerned public, neither as a mouthpiece for the facility nor as spies for local animal activists, but as credible advocates for animals, seeking to function within an imperfect oversight mechanism that has built-in tensions and 565
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Viewpoint ambiguities.” We believe that all IACUC members are to some degree advocates of animal welfare, but the unaffiliated “member’s role is linked to community representation and is free of the potential for conflict of interest due to affiliation with the institution.” Balanced dialogue is an aim upon which scientists and animal protectionists can agree.
A FINAL POINT Ethical principles are established to deal with the dilemmas inherent in an enterprise of animal research. However, the interpretation of these principles is entrusted to individuals, and the degree to which personal views intersect will determine how animal research ethics are situated at the institutional and public levels.26 Additionally, complex opinions about the sanctity of animal life do much to confound reasonable analysis. In Orwellian fashion, the prevailing human attitude ranks some species more equal than others. Scientists value rats and mice but may sometimes place greater value on non-human primates, due to that population’s large congruity with human DNA. Alternatively, this genetic resemblance is the basis for moral arguments against their use as experimental subjects in biomedical research.27 Two legal scholars, two centuries apart, have remarked that animal sentience equates to the capacity to incur pain and suffering at some level. Jeremy Bentham, the 18th-century jurist, wrote in his Introduction to the Principles of Morals and Legislation, “the question is not, Can they reason? nor, Can they talk? but, Can they suffer?”28 In the 21st century, legal scholar Gary Francione comments on our ‘moral schizophrenia’ when assessing the value of animal life.29 This condition of the human psyche alone provides justification for examining the moral correctness of our decisions to use non-human animals as research subjects and is the ethical driver behind our promotion of transparency. We appreciate the great efforts made by EU member countries with respect to their regulation of animal research. It is our opinion that the UK—with central regulation and local ethical review of animal research—provides a paradigm that USA may copy. While IACUCs in USA may already choose to perform ethics reviews as part of their deliberations, we have previously noted that this activity has never been required by the language of the AWA. Along with voluntary ethics reviews, we also envision IACUCs and broader institutional information networks that have more comprehensive avenues that enable investigators to explain their research to those who do not have an advanced scientific understanding. We concur with the thought that, while antivivisectionists will oppose any research performed using animals, some will look upon the 3Rs as a compromise, while they continue to campaign for a more extreme change in policy.30 We urge a research institution that adopts one or more of our recommended policies to publish it in a way that makes the policy easy to find by interested persons. A box on the home page of an institution’s website might draw the attention of web visitors if it contained (in large type font) the words ‘POLICIES ON ANIMALS.’ Enhancements to this box, such as a grouping of the more commonly used animals in research, might be a visual attractant. If adoption of pro-animal polices is to have the incidental effect of reducing the chances that an institution will be the target of violence by true terrorists, broad public dissemination that can reach such an individual should be the goal. Moreover, inviting collaboration with people having broad 566
intellectual backgrounds could result in sensible dialogue regarding the use of animals in research. Ideally, this would replace poorly informed debate, minimise invective and balance the world’s drive for scientific advance with the need to ensure animal protection. Contributors LHL’s professional background in biomedical research and animal welfare has allowed her to examine the historical and practical aspects of this manuscript’s content. WAR’s legal scholarship permits the very fine legal insight required to interpret and add to this manuscript’s content. LHL is the guarantor for the overall content of this manuscript. Competing interests None. Provenance and peer review Not commissioned; externally peer reviewed.
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Levin LH, et al. J Med Ethics 2015;41:563–566. doi:10.1136/medethics-2012-101043
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Reforming the politics of animal research Lisa Hara Levin and William A Reppy J Med Ethics 2015 41: 563-566 originally published online February 25, 2015
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