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User guide to Home Office statistics of scientific procedures on living animals PDF

51 Pages·2017·1.04 MB·English
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User guide to Annual statistics of Scientific Procedures on Living Animals, Great Britain Contents Page 1 Introduction ........................................................................................ 2 2 Data coverage and source ................................................................. 3 3 Quality and methodology .................................................................. 5 4 Related statistics and reports… ........................................................ 8 Last updated: July 2019 1. Introduction This user guide accompanies the Home Office collection ‘Statistics of Scientific Procedures on Living Animals, Great Britain’. The statistics in the collection relate to regulated scientific procedures performed using living animals under the Animals (Scientific Procedures) Act 1986 (ASPA). The latest statistics, for 2018, can be accessed here. Uses of the statistics The expected uses of the statistics are listed below using the standard categorisation for Official Statistics (as shown in the United Kingdom Statistics Authority (UKSA) monitoring brief 6/2010, ‘The Use Made of Official Statistics’): a) Informing the general public’s choices: • about the state of the economy, society and the environment, e.g. via Parliament and the media. • about the performance of government and public bodies, e.g. via Parliament and the media. b) Government policy making and monitoring c) Resource allocation – typically by central and local government d) Supporting third sector activity, e.g. lobbying and funding applications e) Facilitating academic research. Users of the statistics As well as Parliament, the media, the general public and individual licensees, there is a wide range of organisations with an interest in these statistics; some examples are listed below (the list is illustrative and not meant to be exhaustive). Animals in Science Committee: https://www.gov.uk/government/organisations/animals-in- science-committee Animals in Science Regulation Unit, Home Office: https://www.gov.uk/guidance/research-and- testing-using-animals Cruelty Free International: https://www.crueltyfreeinternational.org/ European Commission: http://ec.europa.eu/environment/chemicals/lab_animals/reports_en.htm Federation of European Laboratory Animal Science Associations: http://www.felasa.eu/ Fund for the Replacement of Animals in Medical Experiments: http://www.frame.org.uk/ Institute of Animal Technology: http://www.iat.org.uk/ 2 2. Data coverage and source Legislation and purpose of collection The annual statistics publication relates to scientific procedures performed using living animals subject to the provisions of the Animals (Scientific Procedures) Act 1986. The 1986 Act requires licensing and oversight of all places, projects and personnel seeking to conduct scientific procedures on living animals, as well as publishing and laying before parliament, annual statistics on the use of protected animals in regulated procedures. These statistics meet the requirement of the European Directive 2010/63/EU3 and UK law, which requires member states to submit information on the use of animals for scientific purposes to the European Commission (see ‘Quality and methodology’ for more detail). Data source All scientific procedures carried out on living animals in the UK, subject to the 1986 Act, must be authorised under a project licence, granted by the Home Secretary. The statistics are collected via data returns submitted by project licence holders at the end of each year, or within 28 days of the termination of the licence when this occurs during the year. Data coverage Within the UK, the Home Office collects and publishes information on regulated procedures for Great Britain, while in Northern Ireland the Department of Health separately collects and publishes this information under devolved arrangements. Regulated procedures are defined in the 1986 Act as any procedure applied to a protected animal for an experimental or other scientific purpose, or for an educational purpose, that may have the effect of causing an animal pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice. Protected animals are defined in the 1986 Act as any living vertebrate other than man and any living cephalopod. As the 1986 Act indicates, the breeding of an animal is a regulated procedure if the animal is bred from, or is the descendant of, an animal whose genes have mutated or been modified. The annual statistics publication predominately focuses on experimental procedures and procedures counted under the creation and breeding of genetically altered ( GA) animals separately. Experimental procedures include all animals used in basic research, regulatory use, translational/applied research, protection of the natural environment, higher education and training, preservation of species and forensic enquiries. The creation and breeding of GA animals includes some animals that were bred with the intention of producing GA animals, but resulted in non-GA animals being born. In addition, some animals used for the creation of a new genetic line would also have been genetically normal animals e.g. those used for superovulation. These animals were not used in experimental procedures. 3 Counting rules The figures provided in the statistical report refer to the numbers of procedures (completed) rather than the numbers of animals used (for the first time), unless indicated otherwise. However, in most cases, the number of procedures corresponds to the number of animals used. In instances where the number of procedures is higher than the number of animals used, this is due to a re-use of animals. Each procedure (which may consist of several stages) is counted once for the year in which it was completed. A study involving procedures on a number of animals is counted once for each animal. Where an animal that has previously been used in a completed procedure is used again for a further procedure (‘re-use’) it is counted as a separate procedure, but the animal itself is not recounted. The circumstances in which the re-use of an animal is permitted are limited. Procedures on adult or free-living animals (including neonatal and juvenile mammals, and newly hatched birds) are counted. Details of procedures on immature forms (e.g. larvae, embryos) are not counted unless they have reached the free-feeding stage (e.g. zebrafish from five days post-fertilisation and tadpoles). Animals in the wild involved in rodenticide trials are also not counted. A rodenticide trial is the testing of any substance that is used to kill rats, mice, and other rodent pests. Information is collected on the number of project licences which undertake rodenticide trials. Exclusions The controls of the 1986 Act, and therefore the statistics in the annual release, exclude: • non-experimental agricultural practices; • non-experimental clinical veterinary practices; • practices undertaken for recognised animal husbandry; • the administration of any substance or article to an animal for research purposes in accordance with an animal test certificate granted under the Veterinary Medicines 1 Regulations 2013 . The annual statistics also exclude ‘genetically normal’ (i.e. non-GA) animals that were bred for scientific procedures but were killed or died without being used in procedures, and animals that 2 were subject to procedures for the purposes of genotyping . The Home Office published this data for 2017 here. 1 Statutory Instrument 2013/2033; see Part 1, Sect 3(2)(b) http://www.legislation.gov.uk/uksi/2013/2033/contents. 2 Genotyping is the process of investigating the genetic make-up of an animal. 4 3. Data quality and methodology Data quality The UK Statistics Authority has designated these statistics as National Statistics, in accordance with the Statistics and Registration Service Act 2007, signifying compliance with the Code of Practice for Official Statistics. NATIONAL STATISTICS STATUS National Statistics status means that our statistics meet the highest standards of trustworthiness, quality and public value, and it is our responsibility to maintain compliance with these standards. The designation of these statistics as National Statistics was confirmed in 2007 following a compliance check by the Office for Statistics Regulation. The statistics last underwent a full assessment against the Code of Practice in 2012. Since the latest review by the Office for Statistics Regulation, we have continued to comply with the Code of Practice for Statistics, and have made the following improvements: • Easier, more intuitive data entry with pop-up messages alerting suppliers to incompatible combinations of data being entered; • For the 2017 data onwards, data collected on ‘other’ species is subject to data quality checks which have allowed for further analyses of the animals returned under ‘other’ (non -Schedule 2) species categories; • Each year, we consult with colleagues in the Animals in Science Regulation Unit to ensure the collection remains suitable for its purpose. Quality assurance These statistics are compiled by statisticians within the Home Office. They undertake a wide range of quality assurance checks with the expert assistance of colleagues in the Animals in Science Regulation Unit, and with follow-up contact with data suppliers as needed. The checks include: • querying incomplete data, or invalid data/combinations of data, provided in returns • ensuring all returns are accounted for, and that no duplicate returns are provided • investigating returns which contain unusual data or unusual combinations of data • variance checks, i.e. investigating substantial changes in figures compared with the previous year Data quality issues Changes to data collection from 2014 Following the European Directive 2010/63/EU being transposed into UK law in January 2013, the 2014 collection underwent substantial changes. As a result, some inconsistencies were expected in the reporting of the 2014 information as project licence holders (i.e. data suppliers) became familiar with the new reporting requirements and data collection format . 5 Due to the change from counting ‘procedures started’ to ‘procedures completed’, all procedures started before 2014 but completed in 2014 should have been reported in both the pre-2014 and 2014 figures. There were some additional discrepancies with the 2014 data including a small number of duplicate returns and misclassifications of reported severity. Home Office statisticians have since reviewed their processes and quality assurance checks in light of these issues. Rounding Data may be rounded to simplify the presentation of the figures. However, all numeric and percentage calculations are based on unrounded data. Where data are rounded, they may not sum to the totals shown, or, in the case of percentages, to 100%, because they have been rounded independently. The rounding conventions used in the release, unless otherwise stated, are as follows: Figure Rounding convention Over 1 million Presented as millions and rounded to two decimal places e.g. 2,121,582 = 2.12 million 10,000 to 999,999 Rounded to the nearest thousand e.g. 343,465 = 343,000 1,000 to 9,999 Rounded to the nearest hundred e.g. 8,465 = 8,500 10 to 999 Rounded to the nearest ten e.g. 47 = 50 Less than 10 Unrounded, whole numbers Percentages greater than 1% Rounded to the nearest percent e.g. 1.43% = 1% Percentages less than 1% Rounded to one significant figure e.g. 0.43% = 0.4%, and 0.043% = 0.04% The data in the data tables are unrounded. All percentages in the data tables are rounded to the nearest 0.1%. Revisions It is standard practice across all Home Office statistical releases to incorporate revisions to previous years’ data in the latest release. Corrections and revisions followth e Home Office’s statement of compliance with the Code of Practice for Official Statistics . During the production of the 2017 annual statistics, quality assurance checks revealed a small number of misclassifications within the 2014, 2015 and 2016 datasets. See Appendix A of the 2017 statistical report for details of all revisions to the 2014, 2015 and 2016 datam ade since 6 the 2016 release. In addition to the revisions listed in the 2017 statistical report, further revisions were made to the 2015 data. The generation of eight marmosets/tamarins, originally classified as ‘F0 wild caught’, were revised to ‘self-sustaining colony’ and 31 breeding procedures involving mice were removed. Following the publication of the 2017 annual statistics, a revision was made to one of the return of procedures. The genetic status of four rhesus monkeys, originally classified as ‘genetically altered without a harmful phenotype’ were revised to ‘not genetically altered’. The time series data tables published in the 2018 statistical report include any revisions that have been made to previously published data for the years 2014 to 2017. 7 4. Related statistics and reports Great Britain On 8 November 2018 the Home Office published ‘Additional statistics on breeding and genotyping of animals for scientific procedures, Great Britain 2017’. These experimental statistics were collected by the Home Office under the EU Directive (2010/63/EU) and cover the number of ‘genetically normal’ (i.e. non -genetically altered (non -GA)) animals that were bred for scientific procedures but were k illed or died without being used in procedures, and the number of animals (GA and non -GA) subject to tissue sampling for the purposes of genotyping. Previous releases dating back to 2001 for this statistical collection can be found on the GOV.UK website. Data was collected under different categories prior to 2014, meaning some of the data (e.g. for species, purpose, genetic status, severity) is not comparable or does not exist. Older editions of this statistical release may be found in the national archives. However, not all previous publications are available online. Annual publications giving detailed figures for scientific procedures under the Animals (Scientific Procedures) Act 1986 have been published as ‘Statistics of Scientific Procedures on Living Animals’ since 1987. Detailed figures for experiments on living animals under the Cruelty to Animals Act 1876 were published as ‘Statistics of experiments on living animals’ between 1977 and 1986. Less detailed information about experiments on living animals for the years prior to 1977 was published in the form of a ‘Return to an Address of the Honourable the House of Commons’. Forthcoming publications are pre-announced on the ‘Statistics: release calendar’ on the GOV.UK website. Northern Ireland Statistics for scientific procedures in Northern Ireland can be found on the Northern Ireland Department for Health website. The data for Northern Ireland are collected in the same manner and undergo similar quality assurance processes as the data for Great Britain, meaning the two datasets can be used for comparison. European Union Since 2014, all EU member states are required to submit information on scientific procedures to the European Commission (EC) in a common format. These national reports can be accessed on the EC website. Each member state is responsible for the collection and quality assurance of their data. As such, caution should be used if comparing datasets, as they may have been collected and/or quality assured in different ways and to varying standards. Reports from the EC on procedures on living animals in the EU can be found here. The latest (seventh) report provides an overview on the number of animals used in the EU in 2011 for experimental and other scientific purposes. The EC is due to publish the compiled EU data following the new format (i.e. 2014 onwards) in November 2019. Other related information A consolidated version of ASPA can be found on the GOV.UK website, as well as the guidance on the operation of ASPA. 8 Information about the work of the Home Office Animals in Science Regulation Unit can be found in their latest Annual Report. Information about the Animals in Science Committee can be found on the GOV.UK website. Information about the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) can be found on the NC3Rs website. Feedback and enquiries We welcome feedback on the annual statistics release. If you have any feedback or enquiries about this publication, please contact the Fire, Licensing and Public Order Analysis Unit, the Home Office Unit which produced the statistics, via

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