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The ARRIVE Guidelines 2.0: Updated Guidelines for Reporting Animal Research Nathalie Percie Du Sert1*, Viki Hurst1, Amrita Ahluwalia2,3, Sabina Alam4, Marc T

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The ARRIVE Guidelines 2.0: Updated Guidelines for Reporting Animal Research Nathalie Percie Du Sert1*, Viki Hurst1, Amrita Ahluwalia2,3, Sabina Alam4, Marc T Percie du Sert et al. BMC Veterinary Research (2020) 16:242 https://doi.org/10.1186/s12917-020-02451-y GUIDELINE Open Access The ARRIVE guidelines 2.0: Updated guidelines for reporting animal research Nathalie Percie du Sert1*, Viki Hurst1, Amrita Ahluwalia2,3, Sabina Alam4, Marc T. Avey5, Monya Baker6, William J. Browne7, Alejandra Clark8, Innes C. Cuthill9, Ulrich Dirnagl10, Michael Emerson11, Paul Garner12, Stephen T. Holgate13, David W. Howells14, Natasha A. Karp15, Stanley E. Lazic16, Katie Lidster17, Catriona J. MacCallum18, Malcolm Macleod19, Esther J. Pearl1, Ole H. Petersen20, Frances Rawle21, Penny Reynolds22, Kieron Rooney23, Emily S. Sena19, Shai D. Silberberg24, Thomas Steckler25 and Hanno Würbel26 Abstract Reproducible science requires transparent reporting. The ARRIVE guidelines (Animal Research: Reporting of In Vivo Experiments) were originally developed in 2010 to improve the reporting of animal research. They consist of a checklist of information to include in publications describing in vivo experiments to enable others to scrutinise the work adequately, evaluate its methodological rigour, and reproduce the methods and results. Despite considerable levels of endorsement by funders and journals over the years, adherence to the guidelines has been inconsistent, and the anticipated improvements in the quality of reporting in animal research publications have not been achieved. Here, we introduce ARRIVE 2.0. The guidelines have been updated and information reorganised to facilitate their use in practice. We used a Delphi exercise to prioritise and divide the items of the guidelines into 2 sets, the “ARRIVE Essential 10,” which constitutes the minimum requirement, and the “Recommended Set,” which describes the research context. This division facilitates improved reporting of animal research by supporting a stepwise approach to implementation. This helps journal editors and reviewers verify that the most important items are being reported in manuscripts. We have also developed the accompanying Explanation and Elaboration document, which serves (1) to explain the rationale behind each item in the guidelines, (2) to clarify key concepts, and (3) to provide illustrative examples. We aim, through these changes, to help ensure that researchers, reviewers, and journal editors are better equipped to improve the rigour and transparency of the scientific process and thus reproducibility. Why good reporting is important introduced a range of initiatives to address the problem, In recent years, concerns about the reproducibility of from open access and open practices to enable the research findings have been raised by scientists, funders, scrutiny of all aspects of the research [4, 5] through to research users, and policy makers [1, 2]. Factors that study preregistration to shift the focus towards robust contribute to poor reproducibility include flawed study methods rather than the novelty of the results [6, 7], as design and analysis, variability and inadequate validation well as resources to improve experimental design and of reagents and other biological materials, insufficient statistical analysis [8–10]. reporting of methodology and results, and barriers to Transparent reporting of research methods and find- accessing data [3]. The bioscience community has ings is an essential component of reproducibility. With- out this, the methodological rigour of the studies cannot * Correspondence: [email protected] be adequately scrutinised, the reliability of the findings 1 Experimental Design and Reporting, NC3Rs, London, UK cannot be assessed, and the work cannot be repeated or Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Percie du Sert et al. BMC Veterinary Research (2020) 16:242 Page 2 of 7 built upon by others. Despite the development of the research process are not sufficiently aware of the specific reporting guidelines for preclinical and clinical consequences of incomplete reporting. There is some research, evidence suggests that scientific publications evidence that awareness of ARRIVE is linked to the use often lack key information and that there continues to of more rigorous experimental design standards [37]; be considerable scope for improvement [11–18]. Animal however, researchers are often unfamiliar with the much research is a good case in point, where poor reporting larger systemic bias in the publication of research and in impacts on the development of therapeutics and irrepro- the reliability of certain findings and even of entire fields ducible findings can spawn an entire field of research, or [33, 38–40]. This lack of understanding affects how trigger clinical studies, subjecting patients to interven- experiments are designed and grant proposals prepared, tions unlikely to be effective [2, 19, 20]. how animals are used and data recorded in the labora- In an attempt to improve the reporting of animal tory, and how manuscripts are written by authors or research, the ARRIVE guidelines (Animal Research: assessed by journal staff, editors, and reviewers. Reporting of In Vivo Experiments) were published in Approval for experiments involving animals is gener- 2010. The guidelines consist of a checklist of the items ally based on a harm–benefit analysis, weighing the that should be included in any manuscript that reports harms to the animals involved against the benefits of the in vivo experiments, to ensure a comprehensive and research to society. If the research is not reported in transparent description [21–30]. They apply to any area enough detail, even when conducted rigorously, the of research using live animal species and are especially benefits may not be realised, and the harm–benefit pertinent to describe comparative research in the labora- analysis and public trust in the research are undermined tory or other formal test setting. The guidelines are also [41]. As a community, we must do better to ensure that, relevant in a wider context, for example, for observa- where animals are used, the research is both well tional research, studies conducted in the field, and where designed and analysed as well as transparently reported. animal tissues are used. In the 10 years since publication, Here, we introduce the revised ARRIVE guidelines, the ARRIVE guidelines have been endorsed by more referred to as ARRIVE 2.0. The information included than a thousand journals from across the life sciences. has been updated, extended, and reorganised to facilitate Endorsement typically includes advocating their use in the use of the guidelines, helping to ensure that guidance to authors and reviewers. However, despite this researchers, editors, and reviewers—as well as other level of support, recent studies have shown that import- relevant journal staff—are better equipped to improve ant information as set out in the ARRIVE guidelines is the rigour and reproducibility of animal research. still missing from most publications sampled. This includes details on randomisation (reported in only 30– Introducing ARRIVE 2.0 40% of publications), blinding (reported in only approxi- In ARRIVE 2.0, we have improved the clarity of the mately 20% of publications), sample size justification guidelines, prioritised the items, added new information, (reported in less than 10% of publications), and animal and generated the accompanying Explanation and Elab- characteristics (all basic characteristics reported in less oration (E&E) document to provide context and ration- than 10% of publications) [11, 31, 32]. ale for each item [42] (also available at https://www. Evidence suggests that 2 main factors limit the impact of arriveguidelines.org). New additions comprise inclusion the ARRIVE guidelines. The first is the extent to which edi- and exclusion criteria, which are a key aspect of data torial and journal staff are actively involved in enforcing handling and prevent the ad hoc exclusion of data [43]; reporting standards. This is illustrated by a randomised protocol registration, a recently emerged approach that controlled trial at PLOS ONE, designed to test the effect of promotes scientific rigour and encourages researchers to requesting a completed ARRIVE checklist in the manu- carefully consider the experimental design and analysis script submission process. This single editorial intervention, plan before any data are collected [44]; and data access, which did not include further verification from journal staff, in line with the
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