Editorial

Animal Research and Publication Ethics

The Veterinary Journal 2001, 162, 81–83doi: 10.1053/tvjl.2001.0636, available online at http://www.idealibrary.com on

The Veterinary Journal, as an international journal ofveterinary research, publishes original articles inwhich animals may have been employed in con-trolled clinical trials or laboratory experiments.Animals are used in biomedical research whenthere are no alternative means of studying thepathogenesis, treatment or prevention of disease,or in the safety or efficacy testing of veterinary orhuman medicines. Scientists working with animalsmust appreciate the sensitivity of the ethical debatethat surrounds animal experimentation and beaware of the need to operate to the highest possiblestandards in caring for the animals and causingthem the very minimum of distress. This awarenessis a basic humane and moral necessity, but it is alsoof scientific importance as the inclusion of a suffer-ing or distressed animal can markedly affect itsphysiology and therefore the validity of a study.

Guidelines for scientific research journalspublishing papers involving the use of animals have been recommended by the Fund for theReplacement of Animals in Medical Experiments(FRAME) as part of the acceptance criteria for sub-mitted manuscripts (www.frame.org.uk/guide-lines.htm). This Journal supports FRAME’s idealsand has established its own ground rules, clearly setout in our Instructions to Authors, which state thatany paper will be rejected where there is reason tobelieve that experimental animals may have beensubjected to unnecessary (or avoidable) pain ordistress. The purpose of this editorial is to provideadvice to our authors and to explain how TheVeterinary Journal implements its policy.

Over 40 years’ ago, Russell and Burch (1959)proposed the three Rs of animal research – replace-ment, reduction and refinement; a concept thathas survived the test of time. The replacement of ani-mals is the hardest challenge of all. Certainlyprogress has been made, particularly with the useof multimedia material to replace animal experi-ments in teaching programmes, for example inphysiology and pharmacology. There has also been

1090-0233/01/020081 + 03 $35.00/0

considerable success in research and testing. Butalthough tissue culture and cellular models pro-vide valuable means of assessing specific effects atthe cell or molecular level, they cannot totallyreplace whole animals. There are two main reasonsfor this. Firstly, a model must be as compelling andstatistically sound as existing validation systems; thisis particularly important when considering toxicityand safety studies for human medicines and for vet-erinary drugs used in animals destined for humanconsumption. The thalidomide catastrophes of the1960s show how seriously a lack of sufficient rigourin safety testing can impact on human health.Secondly, the living animal is highly complex andthe whole is not simply a sum of its parts, which lim-its the value of in vitro alternatives. Sophisticatedmathematical models are being developed for par-ticular diseases or conditions, and the arrival of vir-tual controls and placebos offer interestingpossibilities (Higgins, 2001). However, as animalsare likely to be used in medical and veterinaryresearch for the foreseeable future, work must con-tinue to find ways to replace them where possible.The US Department of Agriculture Animal WelfareInformation Center has published a directory ofresources on alternatives and animal use (Larson etal., 1998), and there is a regularly updated websitewhich provides comprehensive sources of informa-tion for improved animal care and use in research,teaching and testing (www.nal.usda.gov/awic).

Reduction of animal use should be increasinglyachievable with better study design and statisticalinput to ensure the minimum number of animals isused to reach a valid conclusion. But improveddesign can lead to the need for additional studiesin order to pursue further lines of investigation, sothe absolute number of animals used in experi-ments may not decrease markedly, at least in the short term. There has also been a dramaticincrease in the use of transgenic animals and thistrend is set to continue. The Veterinary Journal will continue to ask its referees to comment on the

© 2001 Harcourt Publishers Ltd

82 THE VETERINARY JOURNAL, 162, 2

statistical methods employed, and if these suggestpoor experimental planning or the use of unneces-sary animals, specialist reviewers will be consultedbefore the paper is accepted.

Refinement means making improvements in theconditions of experimental animals from birth todeath, including, inter alia, the development andimplementation of better housing, management,breeding, veterinary care, anaesthetic use andmethods of euthanasia (Jennings et al., 1998;Morton et al., 1993). The refinement of animal pro-cedures to make them more humane should be anintegral part of all scientific research and thisJournal requires and expects its contributors to havean awareness of the need for refinement in animalhusbandry and to work within a system thatdemands close monitoring and the routine imple-mentation of changes for the better care of animals.

For many years, TVJ has adopted as its workingreference standard, the British Government’sAnimals (Scientific Procedures) Act 1986, which isgenerally recognized to be one of the most thor-ough and tightly regulated pieces of legislation onanimal research anywhere in the world. TheExecutive Board’s consensus view has been thatwork should not normally be published in theJournal if it would not be permitted under the 1986Act (Higgins, 1993). The Act regulates for the UKall experimental and other scientific proceduresapplied to protected animals, which may have theeffect of causing pain, suffering, distress orlasting harm. For further details, see www.homeof-fice.gov.uk/animact/aspag1.htm. At the heart ofthe 1986 Act is balance – the need to weigh anyharm to an animal (in terms of potential pain,suffering, distress and lasting damage or death)against the likely benefits of the research.

A cost-benefit (or cost-harms) analysis will con-tinue to form part of this Journal’s decision-makingprocess in assessing whether a paper reporting ani-mal work should be published. Authors should pro-vide the necessary justification routinely within thetext of their paper, but where this is not clearlystated or where there is doubt or concern, the arti-cle will be reassessed in terms of the Journal’s policyon animal use. Specifically, the Introductionshould explain clearly and in enough detail whythe work was necessary, what questions the authorswere seeking to answer and how the report con-tributes to advances in veterinary and/or scientificknowledge. The Materials and Methods sectionmust contain sufficient information about the sta-tistical approaches used in selecting the number of

animals, the appropriateness of the species, theprocedures employed and how pain was alleviatedand discomfort kept to a minimum. The Resultsand Discussion should show how the outcome ofthe research justified the use of the animals.Authors must also state that the work was approvedin advance by an ethical review system within theauthors’ institute or by some other appropriateauthority. Where the stringency of an institute’ssystem or the national legislation governing animaluse is unknown or does not approach the rigours ofthe UK requirements referred to above, an edito-rial judgment will be made, often following receiptof further advice from one or more referees spe-cializing in experimental animal welfare.

The issue of animal experimentation will remaincontentious and some people will always opposethe use of animals on moral or principled grounds.Scientists need to be aware of these views and toconsider carefully the ethics of causing animalspain, suffering or death in order to understandand alleviate the suffering of other animals orhumans. Likewise, the veterinary profession has aduty to lead the way in ensuring the principles ofhumane science are incorporated into animalresearch. This Journal takes the view that providinga critical cost-benefit/harms analysis has beenundertaken, that there has been a thoughtful appli-cation of the three Rs, and that stringent controls(including ethical review) are in place andenforced, it can be unethical not to employ animalsif their use is manifestly expected to lead toimproved health of the wider animal or humancommunity.

ANDREW HIGGINS

Editor

REFERENCES

HIGGINS, A.J. (1993). Science and suffering – the impor-tance of standards. British Veterinary Journal 149,401–02.

HIGGINS, A.J. (2001). The virtual patient – addressing theplacebo challenge. The Veterinary Journal 162, 333–4.

JENNINGS, M., BATCHELOR, G.R., BRAIN, P. F., DICK, A,ELLIOTT, H., FRANCIS, R.J., HUBRECHT, R.C., HURST,J.L., MORTON, D.B., PETERS, A.G., RAYMOND, R., SALES,G.D., SHERWIN, C.M. AND WEST, C. (1998). Report ofthe Rodent Refinement Working Party. LaboratoryAnimals 32, 233–259.

LARSON, J.A., CRISCIO, R. AND JENSEN, D’A.J.B. (1998).Directory of Resources on Alternatives and Animal Use in the Life Sciences. AWIC Resource Series No. 1,2nd Ed. Beltsville: United States Department ofAgriculture.

EDITORIAL 83

RUSSELL, W.M.S. AND BURCH, R.L. (1959). The principles ofhumane experimental technique. London: Methuen.

MORTON, D.B., ABBOT, D., BARCLAY, R., CLOSE, B.S.,EWBANK, R., GASK, D., HEATH, M., MATTIC, S., POOLE,T., SEAMER, J., SOUTHEE, J., THOMPSON, A., TRUSSELL,

B., WEST, C. AND JENNINGS, M. (1993). Removal ofblood from laboratory mammals and birds: firstreport of the BVA/FRAME/RSPCS/UFAW JointWorking Group on Refinement. Laboratory Animals27, 1–22.