Funders and Regulatory Authorities
- PREPARE is highlighted by the UK Home Office in their Guidance Notes for Project Licence Applications (September 2022, page 12) as the answer to the question What published best practice guidance will you follow to ensure experiments are conducted in the most refined way? Similar text is to be found in the ASPel Project Licence Application online Template, a copy of which is available here on the website of the Department of Health, Northern Ireland (under point D7.9). These provide part of their collection of guidance for the regulated community on animal research and testing.
- PREPARE is cited in a Report by the Advisory Committee to the Director (ACD) of the NIH entitled "ACD Working Group on Enhancing Rigor, Transparency, and Translatability in Animal Research", published on 11 June 2021. The Report cites PREPARE as one of the ways to strengthen the critical elements across the life of a study, from planning to execution and publication, which will result in a higher quality knowledge base and will better inform future research.
- PREPARE is cited by the Senate Commission on Animal Protection and Experimentation of the central independent German Research Foundation (DFG) in its Guidance on the 3Rs and the validity of animal experiments (in German and in English. The Commission advises the statutory bodies of the DFG as well as policy-makers and government agencies. In its advisory capacity, it also makes its expertise available to researchers, universities and research institutions.
- PREPARE has been included in the Australian guidance Best Practice Methodology in the Use of Animals for Scientific Purposes, published by the National Health and Medical Research Council (NHMRC) in December 2017
- The Norwegian regulatory authorities cite PREPARE as guidelines for planning animal experiments and link to Norecopa's webpage on the 3Rs.
- The Swedish Central Ethical Committee on Animal Experiments (den centrale djurförsöksetiska nämnden), which adjudicates on appeals against decisions taken by regional ethical committees on animal experiments and evaluates animal experiments after they have been conducted, uses the PREPARE guidelines in its evaluation process.
- On 20 February 2020 the National Committee in Greece issued a Recommendation stating that the PREPARE guidelines should be followed when designing an experimental protocol, pointing out that PREPARE focuses on a large number of factors which, although rarely referred to in scientific work, can affect the validity and outcome of animal studies, as well as the health and safety of all concerned.
- The UK Concordat on Openness describes endorsement of PREPARE in its annual report for 2022. In 2020, they noticed that signatories of the Concordat were mentioning in their contributions to the report for that year that they were following the PREPARE guidelines. For their annual reports in 2021 and 2022, signatories were expressly asked whether they work to PREPARE. In 2022, 80 signatories (including research organisations, learned societies with publications and funders) stated that PREPARE was endorsed and actively supported by them, and 46 organisations stated that they also use the PREPARE guidelines to underpin the ARRIVE reporting guidelines. Nineteen research organisations have also developed specific practices for ensuring that the guidelines are followed by their researchers.
- PREPARE was highlighted in the January 2018 edition of the newsletter of the National Centre for the 3Rs (NC3Rs) in the U.K.
- PREPARE has been endorsed by ANZCCART (Australian and New Zealand Council for the Care of Animals in Research and Teaching)
- The Swedish Board of Agriculture's 3R Center cites the PREPARE guidelines on their webpage about preparing for animal research.
- The primer on research involving animals produced by the UK Research Integrity Office (UKRIO) in February 2019 described PREPARE as 'current best practice for laboratory animal science'. Version 2 of this primer, published in 2020, states that 'institutions can support researchers to consider all the topics which may influence the outcome of their studies and aid collaboration by promoting the PREPARE guidelines published in 2017, a good practice checklist for use when planning experimental procedures on animals'.
- EFPIA published an Industry Statement on Experimental Design in 2019, which supports the use of PREPARE as one of three resources for planning, reporting and publishing in vivo studies.
- The UK organisation FRAME's website recommends PREPARE when animal research cannot be avoided, as an aid in dissemination of the highest quality and reproducible research, to eliminate needless repetition of experiments and waste of animal lives and funding. FRAME's Review of experimental design training provision for biosciences PhD students at UK universities points out that it would be beneficial to provide specific training in design to early career researchers that are applying for personal licences, mentioning PREPARE specifically.
- The Quality Principles in Systemic Phenotyping of genetically altered mouse models, published by INFRAFRONTIER, the European research infrastructure for the generation, phenotyping, archiving, and distribution of model mammalian genomes In the the detailed supplementary file, recommend that the PREPARE guidelines should be used in training and when designing phenotyping experiments.
- A review paper by The US National Primate Research Center Consortium Rigor and Reproducibility Working Group concludes that 'adopting such guidelines consistently at the experiment preparation phase represents one potentially valuable step forward in ensuring that work that is carried out will be robust'.
- The 3R Center Rhein-Neckar states that PREPARE 'covers all stages of quality assurance, from the management of an animal facility or population to the individual procedures that are part of a study'.
- The International Society for Applied Ethology (ISAE) lists PREPARE under Educational Resources among 'potentially useful resources for those interested in studying applied ethology or looking for tools to aid in their research'.
- The Focus on Severe Suffering initiative from the RSPCA, UK, states that using the PREPARE guidelines 'help ensure that you have considered all aspects of a study which can affect its validity and reproducibility, as well as the animals’ welfare' (Disclosure: co-author of PREPARE, Elliot Lilley, was employed by the RSPCA at the time of publication of PREPARE, but has since left)
Journals and Guidelines for Publication
- The Author Guidelines for the ALTEX (Alternatives to Animal Experimentation) Journal state that 'ALTEX recommends following the PREPARE guidelines in planning studies using animals to ensure that the above requirements (Ed.: descriptions of experiments on animals) are met and the respective information is documented during the study'.
- The ASAB (Association for the Study of Animal Behaviour) and the ABS (Animal Behavior Society) have endorsed the use of the PREPARE guidelines, and in their guidelines for the treatment of animals in behavioural research and teaching they recommend that authors refer to these.
- The British Ecological Society (BES) has updated their policy on animal research ethics for all of their six BES journals: 'researchers should refer to the PREPARE guidelines when planning animal experiments'.
- In the manuscript submission guidelines for the Journal of Psychopharmacology, authors are 'strongly encouraged to consult the PREPARE guidelines when planning their experiments'.
- PREPARE is cited in the Instructions to Authors for the Journal of Pediatric Urology
- PREPARE is integrated in the EQIPD framework for research quality control. It is part of the toolbox for this framework, and is cited on the pages covering animal characterisation and use, and ethical evaluation and authorisation.
- PREPARE is endorsed in guidelines for preclinical tendon and ligament models: Beyond the 3Rs (replacement, reduction, and refinement) to 5W1H (why, who, what, where, when, how). (Little D et al., 2023)
- The Animal Welfare Body at Utrecht University describes PREPARE as a guideline for animal experiments, and states that 'using PREPARE is helpful for making a good work protocol design, which supports refinements of animal experiments'. Furthermore, they write: 'PREPARE is relevant for all stages of quality assurance, from individual procedures to managing an animal facility. The experts who are involved have experience in running animal facilities, collaborating with researchers, serving on advisory and regulatory committees and planning animal studies. The guidelines and checklists are developed upon the experiences of the authors during the last 30 years. PREPARE focuses on factors that can dramatically influence the validity and outcome of animal studies. Always use the PREPARE guidelines when planning a project that may involve animals. The guidelines should be used from day one of planning, in close collaboration with the animal facility where the project is executed'.
- The University of Leicester state: 'We, alongside the Home Office, recommend the use of the PREPARE checklist for preparing grant applications.'
- The University of Zurich recommends the PREPARE guidelines, in their guidance on study design.
- The University of Lausanne has a list of steps to follow before starting animal experiments, where it specifically mentions PREPARE
- Lund University in Sweden uses the PREPARE checklist in their requirements for scientists applying for permission to perform animal research.
- On a page entitled Optimising animal studies, the University of Edinburgh writes that 'PREPARE acts as an aide memoire for busy researchers and gives them advice on all the issues which may affect the scientific validity and translatability of their research, as well as the animals' welfare'.
- The League of European Research Universities (LERU) has published Good Practice in Communicating Animal Research at Universities, and points out that 'initiatives such as: the PREPARE guidelines on how to plan animal experiments...are designed to deliver more reliable and translatable research. In addition, these exercises may lead to a reduction of unnecessary animal experiments'.
Scientific papers and media articles
- Vibeke Fosse et al. (2023) present recommendations for robust and reproducible preclinical research in personalised medicine. They write: 'reporting in adherence with ARRIVE and other guidelines requires researchers to have planned for this when designing their experiments. The PREPARE Guidelines fulfil this purpose for the planning of preclinical studies involving animals'.
- In their paper A guide to open science practices for animal research (2022), Kai Diederich et al. write: The PREPARE guidelines are a list of important points that should be thought-out before starting a study involving animal experiments in order to reduce the waste of animals, promote alternatives, and increase the reproducibility of research and testing. The PREPARE checklist helps to thoroughly plan a study and focuses on improving the communication and collaboration between all involved participants of the study (i.e., animal caretakers and scientists). Indeed, open science begins with the communication within a research facility.
- In the abstract (PD23) entitled More Realistic Budgeting in Grant Proposals would Benefit Research Quality and Animal Welfare for a presentation at the 2022 FELASA congress, Pieter Verbost et al. write that 'Points that need to be improved include standardization of adherence to the PREPARE and ARRIVE guidelines, preregistration and data sharing, and the system that rewards researchers.'
- Statistician Penny Reynolds (one of the ARRIVE v.2 co-authors), lecturing on reproducibility, demonstrates the need for both planning and reporting guidelines, and states that PREPARE 'identifies the key logistic and procedural task areas that are common to all preclinical studies' (2021). In a Commentary (2022) on preclinical research, reproducibility, and statistical design of experiments, she states that 'procedural change could be accelerated by statisticians becoming more aware of best-practice expectations though evidence-based planning (PREPARE) and reporting (ARRIVE) guidelines. These tools can direct early-stage study planning to ensure that procedures strengthening study validity can be incorporated'.
- In a paper entitled Improving rigor and reproducibility in nonhuman primate research, Bliss-Moreau et al. cite PREPARE and state: 'Adopting such guidelines consistently at the experiment preparation phase represents one potentially valuable step forward in ensuring that work that is carried out will be robust'.
- Following a systematic review of over 90 research papers to investigate compliance with the ARRIVE reporting guidelines, George et al. (2021) state that 'use of both sets of guidelines (ed. ARRIVE and PREPARE) will greatly increase the likelihood of translation success and adherence to the 3R’s principles'.
- In a review of hamster models of COVID-19 pneumonia, Gruber et al. (2021) state that PREPARE 'helps optimize study designs, including appropriate statistical methods to reduce the number of animals required for a particular purpose'.
- In a paper entitled Systematic review of guidelines for internal validity in the design, conduct and analysis of preclinical biomedical experiments involving laboratory animals, Vollert et al. (2020) point out that 'only a few specifically address rigorous planning and conduct of studies, which might increase validity from the earliest possible point', citing PREPARE as an example.
- PREPARE is highlighted in the paper Promoting and improving 3Rs practice: the Korean guidelines, published in BMB Reports in December 2017
- PREPARE has been endorsed by Ellegaard Göttingen Minipigs (magazine article about PREPARE).
- An Opinion piece in the journal Shock in March 2020 states that, 'at the beginning of a study, the investigator should consider consulting general best-practice planning checklists, such as PREPARE'.
- In a paper on the role of the environment and experimenter in the reproducibility of behavioural studies, Martina Nigri et al. (2022), citing PREPARE, state that 'authors should familiarize themselves with guidelines for preparing, conducting and reporting before even starting the experiments'.
- Writing about preregistration of protocols, Mira van der Naald et al. (2022) point out that PREPARE and preregistration improve research rigour and robustness by supporting scientists much earlier in the process than reporting guidelines do.
- In an overview of the ways in which publishing has changed over the years, Librarians Melissa Ratajeski and Rebekah Miller at the University of Pittsburg mention the PREPARE guidelines, writing:
'Literature searches are the first item on the PREPARE guidelines checklist for planning experiments. The intention of this checklist is not to prove regulatory compliance but rather to serve as a reminder to researchers of what should be considered 'vital for the success and validity of the experiment, for health and safety, and for animal welfare. Specifically, the literature searches are recommended to help in:
— 'identify[ing] possible non-animal alternatives to all or part of the proposed study';
— preventing unnecessary duplication of animal research;
— 'identify[ing] efforts to reduce animal numbers'; and
— finding and implementing refinements to painful and/or distressful procedures.
We encourage researchers to think of these literature searches as not simply being a requirement but as a means to conduct better science. Reviewing the literature retrieved by these searches can allow a researcher to stay abreast of novel techniques, methods and protocols, as well as to fully incorporate any alternatives found.'
- PREPARE is mentioned in a Norwegian-language article about the testing of new medicines (Tester medisiner på dårlige dyrestudier) in the magazine issued by the Norwegian National Research Ethics Committees in June 2018.