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• W2016804769 abstract "There are many hundreds of peer-reviewed medical and scientific journals in circulation, many of which publish research involving the use of animals. Clearly, publication of research is crucial for researchers, funders, and universities and as such, journals are in an ideal position to influence scientific conduct and disseminate good practice via their editorial policies. Reduction, refinement, and replacement (the 3Rs) in terms of animal research was a phrase coined by Russell and Burch in 19591Russell WMS Burch RL The Principles of Humane Experimental Technique. Metheun & Co. Ltd, London1959http://altweb.jhsph.edu/pubs/books/humane_exp/het-toc#Google Scholar and some 50 yr later, it remains the cornerstone of animal welfare principles for researchers.2Balls M Animal experimentation and the three Rs: time for honest answers to some leading questions.Altern Lab Anim. 2009; 37: 229-232PubMed Google Scholar Most people probably do not realize that the Declaration of Helsinki, which we all associate with standards of ethical conduct of research in humans, also contains a statement safeguarding the welfare of animals used in research. Most journals publishing research involving animals fail to provide editorial policies on the use and the reporting of animal-based research. The editorial policies of a random sample of 288 English language peer-reviewed journals that publish original research involving the use of animals were recently evaluated.3Osborne NJ Payne D Newman ML Journal editorial policies, animal welfare, and the 3Rs.Am J Bioeth. 2009; 9: 55-59Crossref PubMed Scopus (70) Google Scholar The aim was to identify how many of the journals had editorial policies regarding the use of animals and if these policies are designed to promote the principle of the 3Rs within the scientific community. The authors found that 47% of journals publishing original research involving animals had no editorial policy relating to the use of animals. Of those journals that did have policies, most stated only that the research be undertaken in accordance with standard regulatory requirements. This rather half-hearted approach is not surprising, since the International Committee of Medical Journal Editors (ICMJE) mentions animal experimentation in only a single sentence within its 1200-word document on uniform requirements for manuscripts submitted to biomedical journals: ‘When reporting experiments on animals, authors should indicate whether the institutional and national guidelines for the care and use of laboratory animals were followed’.4International Committee of Medical Journal Editors Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. 2008http://www.icmje.org/#protectGoogle Scholar It is clear, however, that national guidelines vary considerably between countries and in some countries guidelines differ even between institutions. Brazil, for example, has only recently developed recommendations for animal studies at a national level.5Tréz TA Refining animal experiments: the first Brazilian regulation on animal experimentation.Altern Lab Anim. 2010; 38: 239-244PubMed Google Scholar A revised European directive designed to harmonize animal research legislation across Europe has been agreed by the European Council, and it is likely that the UK government will implement the directive, with new regulations coming into force at the beginning of 2013. For researchers in the UK, there will be little change, as the UK has tough regulations and one of the best records of animal welfare in the world. An international collaboration of organizations including Understanding Animal Research (UK), Americans for Medical Progress (USA), National Association for Biomedical Research (USA), and the European Coalition for Biomedical Research (EU) contribute to the website www.animalresearch.info to provide publically accessible information about the role of animal research in the advancement of medicine. The Medical Research Council (MRC) is actively encouraging scientists to speak about their animal research, arguing that openness about animal research will foster understanding and trust, as animal research remains one of the most controversial areas of science. Scientists using animals in their research, particularly those who are publically funded, have a responsibility to fully report how they design, conduct, and evaluate their experiments, to ensure that money and animals are not wasted. The National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) is an independent scientific organization, established by the UK government, which funds 3Rs research through support from research funders including the MRC and the Wellcome Trust, the Home Office, and several industrial sponsors. Work funded by the NC3Rs has shown that many publications reporting animal research lack key information on study design, conduct, and analysis, which limits their value in informing future scientific studies and policy.6Kilkenny C Parsons N Kadyszewski E et al.Survey of the quality of experimental design, statistical analysis and reporting of research using animals.PLoS One. 2009; 4 (doi:10.1371/journal.pone.0007824): e7824Crossref PubMed Scopus (556) Google Scholar Studies reporting research on live rodents and non-human primates which had been carried out in publicly funded research establishments in the UK and USA were surveyed.6Kilkenny C Parsons N Kadyszewski E et al.Survey of the quality of experimental design, statistical analysis and reporting of research using animals.PLoS One. 2009; 4 (doi:10.1371/journal.pone.0007824): e7824Crossref PubMed Scopus (556) Google Scholar Of the 271 publications, only 59% stated a hypothesis or objective of the study and the number and characteristics of the animals used. Most of the papers surveyed did not use randomization (87%) or blinding (86%), to reduce bias in animal selection and outcome assessment. Only 70% of the publications that used statistical methods described their methods and presented the results with an indication of variance. Power calculations are now the norm in clinical trials, but most animal research studies do not include any statements about power. The veterinary research journals also recognize the need for a more robust approach to study design.7Festing MF We should be designing better experiments.Vet Anaesth Analg. 2003; 30: 59-61Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar, 8Higgins AJ Moving with the times.Vet J. 2008; 175: 1-2Crossref PubMed Scopus (1) Google Scholar, 9Schulz KF Assessing allocation concealment and blinding in randomised controlled trials: why bother?.Equine Vet J. 2005; 37: 394-395Crossref PubMed Scopus (12) Google Scholar, 10Christley RM Statistical significance, power and sample size—Part 2.J Small Anim Pract. 2008; 49: 321-322Crossref PubMed Scopus (4) Google Scholar While the authors of scientific publications have the primary responsibility to describe their methods and results in a transparent manner, journal editors and reviewers also share this responsibility. The NC3Rs have produced a set of guidelines on the reporting of results of animal studies, in consultation with scientists, statisticians, journal editors, and research funders, including the MRC, the Biotechnology and Biological Sciences Research Council, the Wellcome Trust, and the Royal Society. These guidelines, called the ARRIVE (Animals in Research: Reporting In Vivo Experiments) Guidelines, are based on the CONSORT statement for clinical research and have been published simultaneously in several key journals.11Kilkenny C Browne WJ Cuthill IC Emerson M Altman DG Improving bioscience research reporting: the ARRIVE guidelines for reporting animal research.PLoS Biol. 2010; 8: e1000412doi:10.1371/journal.pbio.100041212Crossref PubMed Scopus (4690) Google Scholar, 12Kilkenny C Brown WJ Cuthill IC Emerson M Altman DG Animal research: reporting in vivo experiments: the ARRIVE guidelines.J Gene Med. 2010; (doi:10.1002/jgm.1473)PubMed Google Scholar, 13Kilkenny C Brown WJ Cuthill IC Emerson M Altman DG Animal research: reporting in vivo experiments: the ARRIVE guidelines.Exp Physiol. 2010; (doi:10.1113/expphysiol.2010.053793)Google Scholar, 14Kilkenny C Brown WJ Cuthill IC Emerson M Altman DG Animal research: reporting in vivo experiments: the ARRIVE guidelines.J Physiol. 2010; (doi:10.1113/jphysiol.2010.192278)Google Scholar, 15Kilkenny C Brown WJ Cuthill IC Emerson M Altman DG Animal research: reporting in vivo experiments: the ARRIVE guidelines.Br J Pharmacol. 2010; (doi:10.1111/j.1476-5381.2010.00872.x)Crossref Scopus (2834) Google Scholar, 16Kilkenny C Brown WJ Cuthill IC Emerson M Altman DG Animal research: reporting in vivo experiments: the ARRIVE guidelines.Lab Anim. 2010; (doi:10.1258/la.2010.0010021.)PubMed Google Scholar The Research Councils and the Wellcome Trust have incorporated adherence to the guidelines into a revised version of ‘Responsibility in the use of animals in bioscience research: expectations of the major research council and charitable funding bodies’.17Richardson C Flecknell PA Anaesthesia and post-operative analgesia following experimental surgery in laboratory rodents—are we making progress?.Altern Lab Anim. 2005; 33: 119-127PubMed Google Scholar The British Journal of Anaesthesia (BJA) takes its responsibilities with regard to animal welfare very seriously and, as the Editor responsible for many of the basic science studies submitted to the journal, I have certainly rejected a number of studies due to concerns about animal welfare. Indeed, reviewers will have noted that they now have to answer the question ‘Do you have any concerns related to the use of animals in the study being reported?’. The BJA has the aim of, as far as reasonably possible, promoting alternatives to animal use and ascertaining that procedures that are performed on animals are conducted with skill and compassion with particular regard for anaesthesia and pain management, as might be expected of an anaesthesia journal. The BJA updated its author guidelines a couple of years ago, after seeking opinion from several veterinary experts, to include a policy on the use of animals in research studies submitted to the journal. Studies that involve the use of animals must clearly indicate that Institutional approval was obtained and state the Home Office Licence number or local equivalent that the studies were performed under. It is recognized that animal welfare legislation can vary between countries, and so the BJA uses the UK standards as a baseline and reserves the right to reject manuscripts judged not to meet these standards, even when local approval has been granted. What is acceptable to the public in another country may not be acceptable here. A good example of this is the use of companion animals and equines in experimental studies. Manuscripts describing research on cats and dogs or horses other than for the benefit to health of other animals are unlikely to be acceptable to most people in the UK unless the authors can provide clear justification for their use from a scientific standpoint. Authors should note that Editors routinely ask for assessment of manuscripts by a veterinary expert. The methods of effective and appropriate anaesthesia and analgesia in research studies using animals should be the best available to ensure the welfare of the animals involved. Attention to these requirements helps fulfil two of the objectives set out by Russell and Burch1Russell WMS Burch RL The Principles of Humane Experimental Technique. Metheun & Co. Ltd, London1959http://altweb.jhsph.edu/pubs/books/humane_exp/het-toc#Google Scholar in their 3Rs concept of humane use of animals in research. Reducing the potential for pain and distress is a clear refinement and provision of safe and effective anaesthesia that does not interfere with specific research objectives also reduces the numbers of animals used. Authors must also state how they assessed and monitored the adequacy of anaesthesia. The use of intraperitoneal pentobarbital in rats, for example, is not a good choice for surgical intervention, as the safe dose has a narrow range and unpredictable duration. Indeed, a larger dose is often used for killing an animal at the end of a procedure. Whichever agent is used, an appropriate plane of anaesthesia for the intervention must be achieved. This is vitally important when neuromuscular blocking agents are used. Manuscripts describing interventional studies on animals must detail a rescue analgesia protocol for any animal which appears to be in pain. A survey of published animal studies in 2005 found that only 20% of rats and mice in the papers that were surveyed received additional postoperative pain relief.18NC3Rs/BBSRC/Defra/MRC/NERC/Wellcome Trust Responsibility in the use of animals in bioscience research: expectations of the major research councils and charitable funding bodies. NC3Rs, London2008http://www.nc3rs.org.uk/document.asp?id=1319Google Scholar The method of killing the animal after the experiment is completed should also be detailed. Carbon dioxide is a controversial agent for killing rodents, and although still an approved method, it is currently under review.19McIntyre A Lipman N Controversy exists on the use of carbon dioxide for the euthanasia of rodents.J Am Assoc Lab Anim Sci. 2006; 45: 7PubMed Google Scholar The use of animal models of pain to investigate analgesia techniques must be conducted with extremely careful regard to animal welfare. This journal will only rarely publish studies where an analgesic agent has been compared with a placebo in an animal model of pain. The contribution of animal research to better health for both men and animals is incontrovertible, and the BJA is committed to the publication of research studies which use animal models, but we must demand the same rigorous attention to detail as in clinical trials. Failure to describe research methods and to report results appropriately has potential scientific and ethical implications for the entire research process and the reputation of those involved. Inclusion of essential information in published research involving animals is vital to assuage scientific and ethical concerns. Experiments involving animals should be appropriately designed, correctly analysed, and then transparently reported, to both increase the validity of the results and maximize the scientific gain. A minimum amount of relevant information must be included in scientific publications to ensure that the methods and results of a study can be reviewed, analysed, and repeated. The BJA has updated its guidelines for authors on the use of animals in research. We will now also refer to the ARRIVE guidelines (Table 1) as the basis for the process of reviewing manuscripts of research involving animals. These guidelines are nothing more or less than is expected for clinical research and as such can only increase the integrity of the research this journal publishes.Table 1The ARRIVE guidelinesItemRecommendationTitle1Provide as accurate and concise a description of the content of the article as possibleAbstract2Provide an accurate summary of the background, research objectives, including details of the species or strain of animal used, key methods, principal findings, and conclusions of the studyIntroductionBackground3(a) Include sufficient scientific background (including relevant references to previous work) to understand the motivation and context for the study, and explain the experimental approach and rationale(b) Explain how and why the animal species and model being used can address the scientific objectives and, where appropriate, the study’s relevance to human biologyObjectives4Clearly describe the primary and any secondary objectives of the study, or specific hypotheses being testedMethodsEthical statement5Indicate the nature of the ethical review permissions, relevant licences [e.g. Animal (Scientific Procedures) Act 1986], and national or institutional guidelines for the care and use of animals, that cover the researchStudy design6For each experiment, give brief details of the study design including:(a) The number of experimental and control groups(b) Any steps taken to minimize the effects of subjective bias when allocating animals to treatment (e.g. randomization procedure) and when assessing results (e.g. if done, describe who was blinded and when)(c) The experimental unit (e.g. a single animal, group, or cage of animals)A time-line diagram or flow chart can be useful to illustrate how complex study designs were carried outExperimental procedures7For each experiment and each experimental group, including controls, provide precise details of all procedures carried out. For example(a) How [e.g. drug formulation and dose, site and route of administration, anaesthesia and analgesia used (including monitoring), surgical procedure, method of euthanasia]. Provide details of any specialist equipment used, including supplier(s)(b) When (e.g. time of day)(c) Where (e.g. home cage, laboratory, water maze)(d) Why (e.g. rationale for choice of specific anaesthetic, route of administration, drug dose used)Experimental animals8(a) Provide details of the animals used, including species, strain, sex, developmental stage (e.g. mean or median age plus age range), and weight (e.g. mean or median weight plus weight range)(b) Provide further relevant information such as the source of animals, international strain nomenclature, genetic modification status (e.g. knock-out or transgenic), genotype, health/immune status, drug or test naïve, previous procedures, etc.Housing and husbandry9Provide details of:(a) Housing [type of facility, e.g. specific pathogen free (SPF); type of cage or housing; bedding material; number of cage companions; tank shape and material etc. for fish](b) Husbandry conditions (e.g. breeding programme, light/dark cycle, temperature, quality of water, etc. for fish, type of food, access to food and water, environmental enrichment)(c) Welfare-related assessments and interventions that were carried out before, during, or after the experimentSample size10(a) Specify the total number of animals used in each experiment, and the number of animals in each experimental group(b) Explain how the number of animals was arrived at. Provide details of any sample size calculation used(c) Indicate the number of independent replications of each experiment, if relevantAllocating animals to experimental groups11(a) Give full details of how animals were allocated to experimental groups, including randomization or matching if done(b) Describe the order in which the animals in the different experimental groups were treated and assessedExperimental outcomes12Clearly define the primary and secondary experimental outcomes assessed (e.g. cell death, molecular markers, behavioural changes)Statistical methods13(a) Provide details of the statistical methods used for each analysis(b) Specify the unit of analysis for each data set (e.g. single animal, group of animals, single neurone)(c) Describe any methods used to assess whether the data met the assumptions of the statistical approachResultsBaseline data14For each experimental group, report relevant characteristics and health status of animals (e.g. weight, microbiological status, and drug or test naïve) before treatment or testing (this information can often be tabulated)Numbers analysed15(a) Report the number of animals in each group included in each analysis. Report absolute numbers (e.g. 10/20, not 50%)(b) If any animals or data were not included in the analysis, explain whyOutcomes and estimation16Report the results for each analysis carried out, with a measure of precision (e.g. standard error or confidence interval)Adverse events17(a) Give details of all important adverse events in each experimental group(b) Describe any modifications to the experimental protocols made to reduce adverse eventsDiscussionInterpretation/scientific implications18(a) Interpret the results, taking into account the study objectives and hypotheses, current theory, and other relevant studies in the literature(b) Comment on the study limitations including any potential sources of bias, any limitations of the animal model, and the imprecision associated with the results(c) Describe any implications of your experimental methods or findings for the replacement, refinement, or reduction (the 3Rs) of the use of animals in researchGeneralizability/translation19Comment on whether, and how, the findings of this study are likely to translate to other species or systems, including any relevance to human biologyFunding20List all funding sources (including grant number) and the role of the funder(s) in the study Open table in a new tab H.F.G. is an Editor and Board Member of the British Journal of Anaesthesia. She has also received research funding from the BJA. I am grateful to the expert veterinary advice provided by Sue Barr, Ronald Jones, and Paul Flecknell." @default.
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