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A guide to open science practices for animal research

Contributed equally to this work with: Kai Diederich, Kathrin Schmitt

Affiliation German Federal Institute for Risk Assessment, German Centre for the Protection of Laboratory Animals (Bf3R), Berlin, Germany

* E-mail: [email protected]

• Kai Diederich, 
• Kathrin Schmitt, 
• Philipp Schwedhelm, 
• Bettina Bert, 
• Céline Heinl

Published: September 15, 2022

• https://doi.org/10.1371/journal.pbio.3001810
• Reader Comments

Translational biomedical research relies on animal experiments and provides the underlying proof of practice for clinical trials, which places an increased duty of care on translational researchers to derive the maximum possible output from every experiment performed. The implementation of open science practices has the potential to initiate a change in research culture that could improve the transparency and quality of translational research in general, as well as increasing the audience and scientific reach of published research. However, open science has become a buzzword in the scientific community that can often miss mark when it comes to practical implementation. In this Essay, we provide a guide to open science practices that can be applied throughout the research process, from study design, through data collection and analysis, to publication and dissemination, to help scientists improve the transparency and quality of their work. As open science practices continue to evolve, we also provide an online toolbox of resources that we will update continually.

Citation: Diederich K, Schmitt K, Schwedhelm P, Bert B, Heinl C (2022) A guide to open science practices for animal research. PLoS Biol 20(9): e3001810. https://doi.org/10.1371/journal.pbio.3001810

Copyright: © 2022 Diederich et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: The authors received no specific funding for this work.

Competing interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: All authors are employed at the German Federal Institute for Risk Assessment and part of the German Centre for the Protection of Laboratory Animals (Bf3R) which developed and hosts animalstudyregistry.org , a preregistration platform for animal studies and animaltestinfo.de, a database for non-technical project summaries (NTS) of approved animal study protocols within Germany.

Abbreviations: CC, Creative Commons; CIRS-LAS, critical incident reporting system in laboratory animal science; COVID-19, Coronavirus Disease 2019; DOAJ, Directory of Open Access Journals; DOI, digital object identifier; EDA, Experimental Design Assistant; ELN, electronic laboratory notebook; EU, European Union; IMSR, International Mouse Strain Resource; JISC, Joint Information Systems Committee; LIMS, laboratory information management system; MGI, Mouse Genome Informatics; NC3Rs, National Centre for the Replacement, Refinement and Reduction of Animals in Research; NTS, non-technical summary; RRID, Research Resource Identifier

Introduction

Over the past decade, the quality of published scientific literature has been repeatedly called into question by the failure of large replication studies or meta-analyses to demonstrate sufficient translation from experimental research into clinical successes [ 1 – 5 ]. At the same time, the open science movement has gained more and more advocates across various research areas. By sharing all of the information collected during the research process with colleagues and with the public, scientists can improve collaborations within their field and increase the reproducibility and trustworthiness of their work [ 6 ]. Thus, the International Reproducibility Networks have called for more open research [ 7 ].

However, open science practices have not been adopted to the same degree in all research areas. In psychology, which was strongly affected by the so-called reproducibility crisis, the open science movement initiated real practical changes leading to a broad implementation of practices such as preregistration or sharing of data and material [ 8 – 10 ]. By contrast, biomedical research is still lagging behind. Open science might be of high value for research in general, but in translational biomedical research, it is an ethical obligation. It is the responsibility of the scientist to transparently share all data collected to ensure that clinical research can adequately evaluate the risks and benefits of a potential treatment. When Russell and Burch published “The Principles of Humane Experimental Technique” in 1959, scientists started to implement their 3Rs principle to answer the ethical dilemma of animal welfare in the face of scientific progress [ 11 ]. By replacing animal experiments wherever possible, reducing the number of animals to a strict minimum, and refining the procedures where animals have still to be used, this ethical dilemma was addressed. However, in recent years, whether the 3Rs principle is sufficient to fully address ethical concerns about animal experiments has been questioned [ 12 ].

Most people tolerate the use of animals for scientific purposes only under the basic assumption that the knowledge gained will advance research in crucial areas. This implies that performed experiments are reported in a way that enables peers to benefit from the collected data. However, recent studies suggest that a large proportion of animal experiments are never actually published. For example, scientists working within the European Union (EU) have to write an animal study protocol for approval by the competent authorities of the respective country before performing an animal experiment [ 13 ]. In these protocols, scientists have to describe the planned study and justify every animal required for the project. By searching for publications resulting from approved animal study protocols from 2 German University Medical Centers, Wieschowski and colleagues found that only 53% of approved protocols led to a publication after 6 years [ 14 ]. Using a similar approach, Van der Naald and colleagues determined a publication rate of 60% at the Utrecht Medical Center [ 15 ]. In a follow-up survey, the respective researchers named so-called “negative” or null-hypothesis results as the main cause for not publishing outcomes [ 15 ]. The current scientific system is shaped by publishers, funders, and institutions and motivates scientists to publish novel, surprising, and positive results, revealing one of the many structural problems that the numerous efforts towards open science initiatives are targeting. Non-publication not only strongly contradicts ethical values, but also it compromises the quality of published literature by leading to overestimation of effect sizes [ 16 , 17 ]. Furthermore, publications of animal studies too often show poor reporting that strongly impairs the reproducibility, validity, and usefulness of the results [ 18 ]. Unfortunately, the idea that negative or equivocal findings can also contribute to the gain of scientific knowledge is frequently neglected.

So far, the scientific community using animals has shown limited resonance to the open science movement. Due to the strong controversy surrounding animal experiments, scientists have been reluctant to share information on the topic. Additionally, translational research is highly competitive and researchers tend to be secretive about their ideas until they are ready for publication or patent [ 19 , 20 ]. However, this missing openness could also point to a lack of knowledge and training on the many open science options that are available and suitable for animal research. Researchers have to be convinced of the benefits of open science practices, not only for science in general, but also for the individual researcher and each single animal. Yet, the key players in the research system are already starting to value open science practices. An increasing number of journals request open sharing of data, funders pay for open access publications and institutions consider open science practices in hiring decisions. Open science practices can improve the quality of work by enabling valuable scientific input from peers at the early stages of research projects. Furthermore, the extended communication that open science practices offer can draw attention to research and help to expand networks of collaborators and lead to new project opportunities or follow-up positions. Thus, open science practices can be a driver for careers in academia, particularly those of early career researchers.

Beyond these personal benefits, improving transparency in translational biomedical research can boost scientific progress in general. By bringing to light all the recorded research outputs that until now have remained hidden, the publication bias and the overestimation of effect sizes can be reduced [ 17 ]. Large-scale sharing of data can help to synthesize research outputs in preclinical research that will enable better decision-making for clinical research. Disclosing the whole research process will help to uncover systematic problems and support scientists in thoroughly planning their studies. In the long run, we predict that the implementation of open science practices will lead to the use of fewer animals in unintentionally repeated experiments that previously showed unreported negative results or in the establishment of methods by avoiding experimental dead ends that are often not published. More collaborations and sharing of materials and methods can further reduce the number of animal experiments used for the implementation of new techniques.

Open science can and should be implemented at each step of the research process ( Fig 1 ). A vast number of tools are already provided that were either directly conceptualized for animal research or can be adapted easily. In this Essay, we provide an overview of open science tools that improve transparency, reliability, and animal welfare in translational in vivo biomedical research by supporting scientists to clearly communicate their research and by supporting collaborative working. Table 1 lists the most prominent open science tools we discuss, together with their respective links. We have structured this Essay to guide you through which tools can be used at each stage of the research process, from planning and conducting experiments, through to analyzing data and communicating the results. However, many of these tools can be used at many different steps. Table 1 has been deposited on Zenodo and will be updated continuously [ 21 ].

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Application of open science practices at each step of the research process can maximize the impact of performed animal experiments. The implementation of these practices will lead to less time pressure at the end of a project. Due to the connection of most of these open science practices, spending more time in the planning phase and during the conduction of experiments will save time during the data analysis and publication of the study. Indeed, consulting reporting guidelines early on, preregistering a statistical plan, and writing down crucial experimental details in an electronic lab notebook, will strongly accelerate the writing of a manuscript. If protocols or even electronic lab notebooks were made public, just citing these would simplify the writing of publications. Similarly, if a data management plan is well designed before starting data collection, analyzing, and depositing data in a public repository, as is increasingly required, will be fast. NTS, non-technical summary.

https://doi.org/10.1371/journal.pbio.3001810.g001

https://doi.org/10.1371/journal.pbio.3001810.t001

Planning the study

Transparent practices can be adopted at every stage of the research process. However, to ensure full effectivity, it is highly recommended to engage in detailed planning before the start of the experiment. This can prevent valuable time from being lost at the end of the study due to careless decisions being made at the beginning. Clarifying data management at the start of a project can help avoiding filing chaos that can be very time consuming to untangle. Keeping clear track of a project and study design will also help if new colleagues are included later on in the project or if entire project parts are handed over. In addition, all texts written on the rationale and hypothesis of the study or method descriptions, or design schemes created during the planning phase can be used in the final publications ( Fig 1 ). Similarly, information required for preregistration of animal studies or for reporting according to the ARRIVE guidelines are an extension of the details required for ethical approval [ 22 , 23 ]. Thus, the time burden within the planning phase is often overestimated. Furthermore, the thorough planning of experiments can avoid the unnecessary use of animals by preventing wrong avenues from being pursued.

Implementing open scientific practices at the beginning of a project does not mean that the idea and study plan must be shared immediately, but rather is critical for making the entire workflow transparent at the end of the project. However, optional early sharing of information can enable peers to give feedback on the study plan. Studies potentially benefit more from this a priori input than they would from the classical a posteriori peer-review process.

Most people perceive guidelines as advice that instructs on how to do something. However, it is sometimes useful to consider the term in its original meaning; “the line that guides us”. In this sense, following guidelines is not simply fulfilling a duty, but is a process that can help to design a sound research study and, as such, guidelines should be consulted at the planning stage of a project. 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 [ 24 ]. 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. It is currently available in 33 languages and the responsible team from Norecopa, Norway’s 3R-center, takes requests for translations into further languages.

The UK Reproducibility Network has also published several guiding documents (primers) on important topics for open and reproducible science. These address issues such as data sharing [ 25 ], open access [ 26 ], open code and software [ 27 ], and preprints [ 28 ], as well as preregistration and registered reports [ 27 ]. Consultation of these primers is not only helpful in the relevant phases of the experiment but is also encouraged in the planning phase.

Although the ARRIVE guidelines are primarily a reporting guideline specifically designed for preparing a publication containing animal data, they can also support researchers when planning their experiments [ 22 , 23 ]. Going through the ARRIVE website, researchers will find tools and explanations that can support them in planning their experiments [ 29 ]. Consulting the ARRIVE checklist at the beginning of a project can help in deciding what details need to be documented during conduction of the experiments. This is particularly advisable, given that compliance to ARRIVE is still poor [ 18 ].

Experimental design

To maximize the validity of performed experiments and the knowledge gained, designing the study well is crucial. It is important that the chosen animal species reflects the investigated disease well and that basic characteristics of the animal, such as sex or age, are considered carefully [ 30 ]. The Canadian Institutes of Health Research provides a collection of resources on the integration of sex and gender in biomedical research with animals, including tips and tools for researchers and reviewers [ 31 ]. Additionally, it is advisable to avoid unnecessary standardization of biological and environmental factors that can reduce the external validity of results [ 32 ]. Meticulous statistical planning can further optimize the use of animals. Free to use online tools for calculating sample sizes such as G*Power or the inVivo software package for R can further support animal researchers in designing their statistical plan [ 33 , 34 ]. Randomization for the allocation of groups can be supported with specific tools for scientists like Research Randomizer, but also by simple online random number generators [ 35 ]. Furthermore, it might be advisable when designing the study to incorporate pathological analyses into the experimental plan. Optimal planning of tissue collection, performance of pathological procedures according to accepted best practices, and use of optimal pathological analysis and reporting methods can add some extra knowledge that would otherwise be lost. This can improve the reproducibility and quality of translational biomedicine, especially, but not exclusively, in animal studies with morphological endpoints. In all animal studies, unexpected deaths in experimental animals can occur and be the cause of lost data or missed opportunities to identify health problems [ 36 , 37 ].

To support researchers in designing their animal research, the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) has also developed the Experimental Design Assistant (EDA) [ 38 , 39 ]. This online tool helps researchers to better structure in vivo research by creating detailed schemes of the study design. It provides feedback on the entered design, drawing researcher’s attention to crucial decisions in the project. The resulting schemes can be used to transparently share the study design by uploading it into a study preregistration, enclosing it in a grant application, or submitting it with a final manuscript. The EDA can be used for different study designs in diverse scenarios and helps to communicate researcher plans to others [ 40 ]. The EDA might be particularly of interest to clarify very complex study designs involving multiple experimental groups. Working with the EDA might appear rather complex in the beginning, but the NC3R provides regular webinars that can help to answer any questions that arise.

Preregistration

Preregistration is an effective tool to improve the quality and transparency of research. To preregister their work, scientists must determine crucial details of the study before starting any experiment. Changes occurring during a study can be outlined at the end. A preregistered study plan should include at least the hypothesis and determine all the parameters that are known in advance. A description of the planned study design and statistical analysis will enable reviewers and peers to better retrace the workflow. It can prevent the intentional use of the flexibility of analysis to reach p -values under a certain significance level (e.g., p-hacking or HARKing (Hypothesizing After Results are Known)). With preregistration, scientists can also claim their idea at an early stage of their research with a citable individual identifier that labels the idea as their own. Some open preregistration platforms also provide a digital object identifier (DOI), which makes the registered study citable. Three public registries actively encourage the preregistration of animal studies conducted around the world: OSF registry, preclinicaltrials.eu, and animalstudyregistry.org [ 41 – 45 ]. Scientists can choose the registry according to their needs. Preregistering a study in a public registry supports scientists in planning their study and later to critically reevaluate their own work and assess its limitations and potentials.

As an alternative to public registries, researchers can also submit their study plan to one of hundreds of journals already publishing registered reports, including many journals open to animal research [ 8 ]. A submitted registered report passes 2 steps of peer review. In the first step, reviewers comment on the idea and the study design. After an “in-principle-acceptance,” researchers can conduct their study as planned. If the authors conduct the experiments as described in the accepted study protocol, the journal will publish the final study regardless of the outcome. This might be an attractive option, especially for early career researchers, as a manuscript is published at the beginning of a project with the guarantee of a future final publication.

The benefits of preregistration can already be observed in clinical research, where registration has been mandatory for most trials for more than 20 years. Preregistration in clinical research has helped to make known what has been tested and not just what worked and was published, and the implementation of trial registration has strongly reduced the number of publications reporting significant treatment effects [ 46 ]. In animal research, with its unrealistically high percentage of positive results, preregistration seems to be particularly worthwhile.

Research data management

To get the most out of performed animal experiments, effective sharing of data at the end of the study is essential. Sharing research data optimally is complex and needs to be prepared in advance. Thus, data management can be seen as one part of planning a study thoroughly. Many funders have recognized the value of the original research data and request a data management plan from applicants in advance [ 25 , 47 ]. Various freely available tools such as DMPTool or DMPonline already exist to design a research data management plan that complies to the requirements of different funders [ 48 , 49 ]. The data management plan defines the types of data collected and describes the handling and names responsible persons throughout the data lifecycle. This includes collecting the data, analyzing, archiving, and sharing it. Finally, a data management plan enables long-term access and the possibility for reuse by peers. Developing such a plan, whether it is required by funders or not, will later simplify the application of the FAIR data principle (see section on the FAIR data principle). The Longwood Medical Area Research Data Management Working Group from the Harvard Medical School developed a checklist to assist researchers in optimally managing their data throughout the data lifecycle [ 50 ]. Similarly, the Joint Information Systems Committee (JISC) provides a great research data management toolkit including a checklist for researchers planning their project [ 51 ]. Consulting this checklist in the planning phase of a project can prevent common errors in research data management.

Non-technical project summary

One instrument specifically conceived to create transparency on animal research for the general public is the so-called non-technical project summary (NTS). All animal protocols approved within the EU must be accompanied by these comprehensible summaries. NTSs are intended to inform the public about ongoing animal experiments. They are anonymous and include information on the objectives and potential benefits of the project, the expected harm, the number of animals, the species, and a statement of compliance with the requirements of the 3Rs principle. However, beyond simply informing the public, NTSs can also be used for meta-research to help identify new research areas with an increased need for new 3R technologies [ 52 , 53 ]. NTSs become an excellent tool to appropriately communicate the scientific value of the approved protocol and for meta-scientists to generate added value by systematically analyzing theses summaries if they fulfill a minimum quality threshold [ 54 , 55 ]. In 2021, the EU launched the ALURES platform ( Table 1 ), where NTSs from all member states are published together, opening the opportunities for EU-wide meta-research. NTSs are, in contrast to other open science practices, mandatory in the EU. However, instead of thinking of them as an annoying duty, it might be worth thoroughly drafting the NTS to support the goals of more transparency towards the public, enabling an open dialogue and reducing extreme opinions.

Conducting the experiments

Once the experiments begin, documentation of all necessary details is essential to ensure the transparency of the workflow. This includes methodological details that are crucial for replicating experiments, but also failed attempts that could help peers to avoid experiments that do not work in the future. All information should be stored in such a way that it can be found easily and shared later. In this area, many new tools have emerged in recent years ( Table 1 ). These tools will not only make research transparent for colleagues, but also help to keep track of one’s own research and improve internal collaboration.

Electronic laboratory notebooks

Electronic laboratory notebooks (ELNs) are an important pillar of research data management and open science. ELNs facilitate the structured and harmonized documentation of the data generation workflow, ensure data integrity, and keep track of all modifications made to the original data based on an audit trail option. Moreover, ELNs simplify the sharing of data and support collaborations within and outside the research group. Methodological details and research data become searchable and traceable. There is an extensive amount of literature providing advice on the selection and the implementation process of an ELN depending on the specific needs and research area and its discussion would be beyond the scope of this Essay [ 56 – 58 ]. Some ELNs are connected to a laboratory information management system (LIMS) that provides an animal module supporting the tracking of animal details [ 59 ]. But as research involving animals is highly heterogeneous, this might not be the only decision point and we cannot recommend a specific ELN that is suitable for all animal research.

ELNs are already established in the pharmaceutical industry and their use is on the rise among academics as well. However, due to concerns around costs for licenses, data security, and loss of flexibility, many research institutions still fear the expenses that the introduction of such a system would incur [ 56 ]. Nevertheless, an increasing number of academic institutions are implementing ELNs and appreciating the associated benefits [ 60 ]. If your institution already has an ELN, it might be easiest to just use the option available in the research environment. If not, the Harvard Medical School provides an extensive and updated overview of various features of different ELNs that can support scientists in choosing the appropriate one for their research [ 61 ]. There are many commercial ELN products, which may be preferred when the administrative workload should be outsourced to a large extent. However, open-source products such as eLabFTW or open BIS provide a greater opportunity for customization to meet specific needs of individual research institutions [ 62 – 64 ]. A huge number of options are available depending on the resources and the features required. Some scientists might prefer generic note taking tools such as Evernote or just a simple Word document that offers infinite flexibility, but specific ELNs can further support good record keeping practice by providing immutability, automated backups, standardized methods, and protocols to follow. Clearly defining the specific requirements expected might help to choose an adequate system that would improve the quality of the record compared to classical paper laboratory notebooks.

Sharing protocols

Adequate sharing of methods in translational biomedical sciences is key to reproducibility. Several repositories exist that simplify the publication and exchange of protocols. Writing down methods at the end of the project bears the risk that crucial details might be missing [ 65 ]. On protocols.io, scientists can note all methodological details of a procedure, complete them with uploaded documents, and keep them for personal use or share them with collaborators [ 66 ]. Authors can also decide at any point in time to make their protocol public. Protocols published on protocols.io receive a DOI and become citable; they can be commented on by peers and adapted according to the needs of the individual researcher. Protocol.io files from established protocols can also be submitted together with some context and sample datasets to PLOS ONE , where it can be peer-reviewed and potentially published [ 67 , 68 ]. Depending on the affiliation of the researchers to academia or industry and on an internal or public sharing of files, protocols.io can be free of charge or come with costs. Other journals also encourage their authors to deposit their protocols in a freely accessible repository, such as protocol exchange from Nature portfolio [ 69 ]. Another option might be to separately submit a protocol that was validated by its use in an already published research article to an online and peer-reviewed journal specific for research protocols, such as Bio-Protocol. A multitude of journals, including eLife and Science already collaborate with Bio-Protocol and recommend authors to publish the method in Bio-Protocol [ 70 ]. Bio-Protocol has no submission fees and is freely available to all readers. Both protocols.io and Bio-Protocol allow the illustration of complex scientific methods by uploading videos to published protocols. In addition, protocols can be deposited in a general research repository such as the Open Science Framework (OSF repository) and referenced in appropriate publications.

Sharing critical incidents

Sharing critical or even adverse events that occur in the context of animal experimentation can help other scientists to avoid committing the same mistakes. The system of sharing critical incidents is already established in clinical practice and helps to improve medical care [ 71 , 72 ]. The online platform critical incident reporting system in laboratory animal science (CIRS-LAS) represents the first preclinical equivalent to these clinical systems [ 73 ]. With this web-based tool, critical incidents in animal research can be reported anonymously without registration. An expert panel helps to analyze the incident to encourage an open dialogue. Critical incident reporting is still very marginal in animal research and performed procedures are very variable. These factors make a systemic analysis and a targeted search of incidence difficult. However, it may be of special interest for methods that are broadly used in animal research such as anesthesia. Indeed, a broad feed of this system with data on errors occurring in standard procedures today could help avoid critical incidences in the future and refine animal experiments.

Sharing animals, organs, and tissue

When we think about open science, sharing results and data are often in focus. However, sharing material is also part of a collaborative and open research culture that could help to greatly reduce the number of experimental animals used. When an animal is killed to obtain specific tissue or organs, the remainder is mostly discarded. This may constitute a wasteful practice, as surplus tissue can be used by other researchers for different analyses. More animals are currently killed as surplus than are used in experiments, demonstrating the potential for sharing these animals [ 74 , 75 ].

Sharing information on generated surplus is therefore not only economical, but also an effective way to reduce the number of animals used for scientific purposes. The open-source software Anishare is a straightforward way for breeders of genetically modified lines to promote their surplus offspring or organs within an institution [ 76 ]. The database AniMatch ( Table 1 ) connects scientists within Europe who are offering tissue or organs with scientists seeking this material. Scientists already sharing animal organs can support this process by describing it in publications and making peers aware of this possibility [ 77 ]. Specialized research communities also allow sharing of animal tissue or animal-derived products worldwide that are typically used in these fields on a collaborative basis via the SEARCH-framework [ 78 , 79 ]. Depositing transgenic mice lines into one of several repositories for mouse strains can help to further minimize efforts in producing new transgenic lines and most importantly reduce the number of surplus animals by supporting the cryoconservation of mouse lines. The International Mouse Strain Resource (IMSR) can be used to help find an adequate repository or to help scientists seeking a specific transgenic line find a match [ 80 ].

Analyzing the data

Animal researchers have to handle increasingly complex data. Imaging, electrophysiological recording, or automated behavioral tracking, for example, produce huge datasets. Data can be shared as raw numerical output but also as images, videos, sounds, or other forms from which raw numerical data can be generated. As the heterogeneity and the complexity of research data increases, infinite possibilities for analysis emerge. Transparently reporting how the data were processed will enable peers to better interpret reported results. To get the most out of performed animal experiments, it is crucial to allow other scientists to replicate the analysis and adapt it to their research questions. It is therefore highly recommended to use formats and tools during the analysis that allow a straightforward exchange of code and data later on.

Transparent coding

The use of non-transparent analysis codes have led to a lack of reproducibility of results [ 81 ]. Sharing code is essential for complex analysis and enables other researchers to reproduce results and perform follow-up studies, and citable code gives credit for the development of new algorithms ( Table 1 ). Jupyter Notebooks are a convenient way to share data science pipelines that may use a variety of coding languages, including like Python, R or Matlab, and also share the results of analyses in the form of tables, diagrams, images, and videos. Notebooks contain source code and can be published or collaboratively shared on platforms like GitHub or GitLab, where version control of source code is implemented. The data-archiving tool Zenodo can be used to archive a repository on GitHub and create a DOI for the archive. Thereby contents become citable. Using free and open-source programming language like R or Python will increase the number of potential researchers that can work with the published code. Best practice for research software is to publish the source code with a license that allows modification and redistribution.

Choice of data visualization

Choosing the right format for the visualization of data can increase its accessibility to a broad scientific audience and enable peers to better judge the validity of the results. Studies based on animal research often work with very small sample sizes. Visualizing these data in histograms may lead to an overestimation of the outcomes. Choosing the right dot plots that makes all recorded points visible and at the same time focusses on the summary instead of the individual points can further improve the intuitive understanding of a result. If the sample size is too low, it might not be meaningful to visualize error bars. A variety of freely available tools already exists that can support scientists in creating the most appropriate graphs for their data [ 82 ]. In particular, when representing microscopy results or heat maps, it should be kept in mind that a large part of the population cannot perceive the classical red and green representation [ 83 ]. Opting for the color-blind safe color maps and checking images with free tools such as color oracle ( Table 1 ) can increase the accessibility of graphs. Multiple journals have already addressed flaws in data visualization and have introduced new policies that will accelerate the uptake of transparent representation of results.

Publication of all study outcomes

Open science practices have received much attention in the past few years when it comes to publication of the results. However, it is important to emphasize that although open science tools have their greatest impact at the end of the project, good study preparation and sharing of the study plan and data early on can greatly increase the transparency at the end.

The FAIR data principle

To maximize the impact and outcome of a study, and to make the best long-term use of data generated through animal experiments, researchers should publish all data collected during their research according to the FAIR data principle. That means the data should be findable, accessible, interoperable, and reusable. The FAIR principle is thus an extension of open access publishing. Data should not only be published without paywalls or other access restrictions, but also in such a manner that they can be reused and further processed by others. For this, legal as well as technical requirements must be met by the data. To achieve this, the GoFAIR initiative has developed a set of principles that should be taken into account as early as at the data collection stage [ 49 , 84 ]. In addition to extensively described and machine-readable metadata, these principles include, for example, the application of globally persistent identifiers, the use of open file formats, and standardized communication protocols to ensure that humans and machines can easily download the data. A well-chosen repository to upload the data is then just the final step to publish FAIR data.

FAIR data can strongly increase the knowledge gained from performed animal experiments. Thus, the same data can be analyzed by different researchers and could be combined to obtain larger sample sizes, as already occurs in the neuroimaging community, which works with comparable datasets [ 85 ]. Furthermore, the sharing of data enables other researchers to analyze published datasets and estimate measurement reliabilities to optimize their own data collection [ 86 , 87 ]. This will help to improve the translation from animal research into clinics and simultaneously reduce the number of animal experiment in future.

Reporting guidelines

In preclinical research, the ARRIVE guidelines are the current state of the art when it comes to reporting data based on animal experiments [ 22 , 23 ]. The ARRIVE guidelines have been endorsed by more than 1,000 journals who ask that scientists comply with them when reporting their outcomes. Since the ARRIVE guidelines have not had the expected impact on the transparency of reporting in animal research publications, a more rigorous update has been developed to facilitate their application in practice (ARRIVE 2.0 [ 23 ]). We believe that the ARRIVE guidelines can be more effective if they are implemented at a very early stage of the project (see section on guidelines). Some more specialized reporting guidelines have also emerged for individual research fields that rely on animal studies, such as endodontology [ 88 ]. The equator network collects all guidelines and makes them easily findable with their search tool on their website ( Table 1 ). MERIDIAN also offers a 1-stop shop for all reporting guidelines involving the use of animals across all research sectors [ 89 ]. It is thus worth checking for new reporting guidelines before preparing a manuscript to maximize the transparency of described experiments.

Identifiers

Persistent identifiers for published work, authors, or resources are key for making public data findable by search engines and are thus a prerequisite for compliance to FAIR data principles. The most common identifier for publications will be a DOI, which makes the work citable. A DOI is a globally unique string assigned by the International DOI Foundation to identify content permanently and provide a persistent link to its location on the Internet. An ORCID ID is used as a personal persistent identifier and is recommendable to unmistakably identify an author ( Table 1 ). This will avoid confusions between authors with the same name or in the case of name changes or changes of affiliation. Research Resource Identifiers (RRID) are unique ID numbers that help to transparently report research resources. RRID also apply to animals to clearly identify the species used. RRID help avoid confusion between different names or changing names of genetic lines and, importantly, make them machine findable. The RRID Portal helps scientists find a specific RRID or create one if necessary ( Table 1 ). In the context of genetically altered animal lines, correct naming is key. The Mouse Genome Informatics (MGI) Database is the authoritative source of official names for mouse genes, alleles, and strains ([ 90 ]).

Preprint publication

Preprints have undergone unprecedented success, particularly during the height of the Coronavirus Disease 2019 (COVID-19) pandemic when the need for rapid dissemination of scientific knowledge was critical. The publication process for scientific manuscripts in peer-reviewed journals usually requires a considerable amount of time, ranging from a few months to several years, mainly due to the lengthy review process and inefficient editorial procedures [ 91 , 92 ]. Preprints typically precede formal publication in scientific journals and, thus, do not go through a peer review process, thus, facilitating the prompt open dissemination of important scientific findings within the scientific community. However, submitted papers are usually screened and checked for plagiarism. Preprints are assigned a DOI so they can be cited. Once a preprint is published in a journal, its status is automatically updated on the preprint server. The preprint is linked to the publication via CrossRef and mentioned accordingly on the website of the respective preprint platform.

After initial skepticism, most publishers now allow papers to be posted on preprint servers prior to submission. An increasing number of journals even allow direct submission of a preprint to their peer review process. The US National Institutes of Health and the Wellcome Trust, among other funders, also encourage prepublication and permit researchers to cite preprints in their grant applications. There are now numerous preprint repositories for different scientific disciplines. BioASAP provides a searchable database for preprint servers that can help in identifying the one that best matches an individual’s needs [ 93 ]. The most popular repository for animal research is bioRxiv, which is hosted by the Cold Spring Harbor Laboratory ( Table 1 ).

The early exchange of scientific results is particularly important for animal research. This acceleration of the publication process can help other scientists to adapt their research or could even prevent animal experiments if other scientists become aware that an experiment has already been done before starting their own. In addition, preprints can help to increase the visibility of research. Journal articles that have a corresponding preprint publication have higher citation and Altmetric counts than articles without preprint [ 94 ]. In addition, the publication of preprints can help to combat publication bias, which represents a major problem in animal research [ 16 ]. Since journals and readers prioritize cutting-edge studies with positive results over inconclusive or negative results, researchers are reluctant to invest time and money in a manuscript that is unlikely to be accepted in a high-impact journal.

In addition to the option of publishing as preprint, other alternative publication formats have recently been introduced to facilitate the publication of research results that are hard to publish in traditional peer-reviewed journals. These include micro publications, data repositories, data journals, publication platforms, and journals that focus on negative or inconclusive results. The tool fiddle can support scientists in choosing the right publication format [ 95 , 96 ].

Open access publication

Publishing open access is one of the most established open science strategies. In contrast to the FAIR data principle, the term open access publication refers usually to the publication of a manuscript on a platform that is accessible free of charge—in translational biomedical research, this is mostly in the form of a scientific journal article. Originally, publications accessible free of charge were the answer to the paywalls established by renowned publishing houses, which led to social inequalities within and outside the research system. In translational biomedical research, the ethical aspect of urgently needed transparency is another argument in favor of open access publication, as these studies will not only be findable, but also internationally readable.

There are different ways of open access publishing; the 2 main routes are gold open access and green open access. Numerous journals offer now gold open access. It refers to the immediate and fully accessible publication of an article. The Directory of Open Access Journals (DOAJ) provides a complete and updated list for high-quality, open access, and peer-reviewed journals [ 97 ]. Charité–Universitätsmedizin Berlin offers a specific tool for biomedical open access journals that supports animal researchers to choose an appropriate journal [ 49 ]. In addition, the Sherpa Romeo platform is a straightforward way to identify publisher open access policies on a journal-by-journal basis, including information on preprints, but also on licensing of articles [ 51 ]. Hybrid open access refers to openly accessible articles in otherwise paywalled journals. By contrast, green open access refers to the publication of a manuscript or article in a repository that is mostly operated by institutions and/or universities. The publication can be exclusively on the repository or in combination with a publisher. In the quality-assured, global Directory of Open Access Repositories (openDOAR), scientists can find thousands of indexed open access repositories [ 49 ]. The publisher often sets an embargo during which the authors cannot make the publication available in the repository, which can restrict the combined model. It is worth mentioning that gold open access is usually more expensive for the authors, as they have to pay an article processing charge. However, the article’s outreach is usually much higher than the outreach of an article in a repository or available exclusively as subscription content [ 98 ]. Diamond open access refers to publications and publication platforms that can be read free of charge by anyone interested and for which no costs are incurred by the authors either. It is the simplest and fairest form of open access for all parties involved, as no one is prevented from participating in scientific discourse by payment barriers. For now, it is not as widespread as the other forms because publishers have to find alternative sources of revenue to cover their costs.

As social media and the researcher’s individual public outreach are becoming increasingly important, it should be remembered that the accessibility of a publication should not be confused with the licensing under which the publication is made available. In order to be able to share and reuse one’s own work in the future, we recommend looking for journals that allow publications under the Creative Commons licenses CC BY or CC BY-NC. This also allows the immediate combination of gold and green open access.

Creative commons licenses

Attributing Creative Commons (CC) licenses to scientific content can make research broadly available and clearly specifies the terms and conditions under which people can reuse and redistribute the intellectual property, namely publications and data, while giving the credit to whom it deserves [ 49 ]. As the laws on copyright vary from country to country and law texts are difficult to understand for outsiders, the CC licenses are designed to be easily understandable and are available in 41 languages. This way, users can easily avoid accidental misuse. The CC initiative developed a tool that enables researchers to find the license that best fits their interests [ 49 ]. Since the licenses are based on a modular concept ranging from relatively unrestricted licenses (CC BY, free to use, credit must be given) to more restricted licenses (CC BY-NC-ND, only free to share for non-commercial purposes, credit must be given), one can find an appropriate license even for the most sensitive content. Publishing under an open CC license will not only make the publication easy to access but can also help to increase its reach. It can stimulate other researchers and the interested public to share this article within their network and to make the best future use of it. Bear in mind that datasets published independently from an article may receive a different CC license. In terms of intellectual property, data are not protected in the same way as articles, which is why the CC initiative in the United Kingdom recommends publishing them under a CC0 (“no rights reserved”) license or the Public Domain Mark. This gives everybody the right to use the data freely. In an animal ethics sense, this is especially important in order to get the most out of data derived from animal experiments.

Data and code repositories

Sharing research data is essential to ensure reproducibility and to facilitate scientific progress. This is particularly true in animal research and the scientific community increasingly recognizes the value of sharing research data. However, even though there is increasing support for the sharing of data, researchers still perceive barriers when it comes to doing so in practice [ 99 – 101 ]. Many universities and research institutions have established research data repositories that provide continuous access to datasets in a trusted environment. Many of these data repositories are tied to specific research areas, geographic regions, or scientific institutions. Due to the growing number and overall heterogeneity of these repositories, it can be difficult for researchers, funding agencies, publishers, and academic institutions to identify appropriate repositories for storing and searching research data.

Recently, several web-based tools have been developed to help in the selection of a suitable repository. One example is Re3data, a global registry of research data repositories that includes repositories from various scientific disciplines. The extensive database can be searched by country, content (e.g., raw data, source code), and scientific discipline [ 49 ]. A similar tool to help find a data archive specific to the field is FAIRsharing, based at Oxford University [ 102 ]. If there is no appropriate subject-specific data repository or one seems unsuitable for the data, there are general data repositories, such as Open Science Framework, figshare, Dryad, or Zenodo. To ensure that data stored in a repository can be found, a DOI is assigned to the data. Choosing the right license for the deposited code and data ensures that authors get credit for their work.

Publication and connection of all outcomes

If scientists have used all available open science tools during the research process, then publishing and linking all outcomes represents the well-deserved harvest ( Fig 2 ). At the end of a research process, researchers will not just have 1 publication in a journal. Instead, they might have a preregistration, a preprint, a publication in a journal, a dataset, and a protocol. Connecting these outcomes in a way that enables other scientists to better assess the results that link these publications will be key. There are many examples of good open science practices in laboratory animal science, but we want to highlight one of them to show how this could be achieved. Blenkuš and colleagues investigated how mild stress-induced hyperthermia can be assessed non-invasively by thermography in mice [ 103 ]. The study was preregistered with animalstudyregistry.org , which is referred to in their publication [ 104 ]. A deviation from the originally preregistered hypothesis was explained in the manuscript and the supplementary material was uploaded to figshare [ 105 ].

Application of open science practices can increase the reproducibility and visibility of a research project at the same time. By publishing different research outputs with more detailed information than can be included in a journal article, researchers enable peers to replicate their work. Reporting according to guidelines and using transparent visualization will further improve this reproducibility. The more research products that are generated, the more credit can be attributed. By communicating on social media or additionally publishing slides from delivered talks or posters, more attention can be raised. Additionally, publishing open access and making the work machine-findable makes it accessible to an even broader number of peers.

https://doi.org/10.1371/journal.pbio.3001810.g002

It might also be helpful to provide all resources from a project in a single repository such as Open Science Framework, which also implements other, different tools that might have been used, like GitHub or protocols.io.

Communicating your research

Once all outcomes of the project are shared, it is time to address the targeted peers. Social media is an important instrument to connect research communities [ 106 ]. In particular, Twitter is an effective way to communicate research findings or related events to peers [ 107 ]. In addition, specialized platforms like ResearchGate can support the exchange of practical experiences ( Table 1 ). When all resources related to a project are kept in one place, sharing this link is a straightforward way to reach out to fellow scientists.

With the increasing number of publications, science communication has become more important in recent years. Transparent science that communicates openly with the public contributes to strengthening society’s trust in research.

Conclusions

Plenty of open science tools are already available and the number of tools is constantly growing. Translational biomedical researchers should seize this opportunity, as it could contribute to a significant improvement in the transparency of research and fulfil their ethical responsibility to maximize the impact of knowledge gained from animal experiments. Over and above this, open science practices also bear important direct benefits for the scientists themselves. Indeed, the implementation of these tools can increase the visibility of research and becomes increasingly important when applying for grants or in recruitment decisions. Already, more and more journals and funders require activities such as data sharing. Several institutions have established open science practices as evaluation criteria alongside publication lists, impact factor, and h-index for panels deciding on hiring or tenure [ 108 ]. For new adopters, it is not necessary to apply all available practices at once. Implementing single tools can be a safe approach to slowly improve the outreach and reproducibility of one’s own research. The more open science products that are generated, the more reproducible the work becomes, but also the more the visibility of a study increases ( Fig 2 ).

As other research fields, such as social sciences, are already a step ahead in the implementation of open science practices, translational biomedicine can profit from their experiences [ 109 ]. We should thus keep in mind that open science comes with some risks that should be minimized early on. Indeed, the more open science practices become incentivized, the more researchers could be tempted to get a transparency quality label that might not be justified. When a study is based on a bad hypothesis or poor statistical planning, this cannot be fixed by preregistration, as prediction alone is not sufficient to validate an interpretation [ 110 ]. Furthermore, a boom of data sharing could disconnect data collectors and analysts, bearing the risk that researchers performing the analysis lack understanding of the data. The publication of datasets could also promote a “parasitic” use of a researcher’s data and lead to scooping of outcomes [ 111 ]. Stakeholders could counteract such a risk by promoting collaboration instead of competition.

During the COVID-19 pandemic, we have seen an explosion of preprint publications. This unseen acceleration of science might be the adequate response to a pandemic; however, the speeding up science in combination with the “publish or perish” culture could come at the expense of the quality of the publication. Nevertheless, a meta-analysis comparing the quality of reporting between preprints and peer-reviewed articles showed that the quality of reporting in preprints in the life sciences is at most slightly lower on average compared to peer-reviewed articles [ 112 ]. Additionally, preprints and social media have shown during this pandemic that a premature and overconfident communication of research results can be overinterpreted by journalists and raise unfounded hopes or fears in patients and relatives [ 113 ]. By being honest and open about the scope and limitations of the study and choosing communication channels carefully, researchers can avoid misinterpretation. It should be noted, however, that by releasing all methodological details and data in research fields such as viral engineering, where a dual use cannot be excluded, open science could increase biosecurity risk. Implementing access-controlled repositories, application programming interfaces, and a biosecurity risk assessment in the planning phase (i.e., by preregistration) could mitigate this threat [ 114 ].

Publishing in open access journals often involves higher publication costs, which makes it more difficult for institutes and universities from low-income countries to publish there [ 115 ]. Equity has been identified as a key aim of open science [ 116 ]. It is vital, therefore, that existing structural inequities in the scientific system are not unintentionally reinforced by open science practices. Early career researchers have been the main drivers of the open science movement in other fields even though they are often in vulnerable positions due to short contracts and hierarchical and strongly networked research environments. Supporting these early career researchers in adopting open science tools could significantly advance this change in research culture [ 117 ]. However, early career researchers can already benefit by publishing registered reports or preprints that can provide a publication much faster than conventional journal publications. Communication in social media can help them establish a network enabling new collaborations or follow-up positions.

Even though open science comes with some risks, the benefits easily overweigh these caveats. If a change towards more transparency is accompanied by the implementation of open science in the teaching curricula of the universities, most of the risks can be minimized [ 118 ]. Interestingly, we have observed that open science tools and infrastructure that are specific to animal research seem to mostly come from Europe. This may be because of strict regulations within Europe for animal experiments or because of a strong research focus in laboratory animal science along with targeted research funding in this region. Whatever the reason might be, it demonstrates the important role of research policy in accelerating the development towards 3Rs and open science.

Overall, it seems inevitable that open science will eventually prevail in translational biomedical research. Scientists should not wait for the slow-moving incentive framework to change their research habits, but should take pioneering roles in adopting open science tools and working towards more collaboration, transparency, and reproducibility.

Acknowledgments

The authors gratefully acknowledge the valuable input and comments from Sebastian Dunst, Daniel Butzke, and Nils Körber that have improved the content of this work.

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• Published: 10 July 2020

Guidelines for planning and conducting high-quality research and testing on animals

• Adrian J. Smith   ORCID: orcid.org/0000-0002-8375-0805 1  

Laboratory Animal Research volume  36 , Article number:  21 ( 2020 ) Cite this article

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There are important scientific, legal and ethical reasons for optimising the quality of animal research and testing. Concerns about the reproducibility and translatability of animal studies are now being voiced not only by those opposed to animal use, but also by scientists themselves.

Many of the attempts to improve reproducibility have, until recently, focused on ways in which the reporting of animal studies can be improved. Many reporting guidelines have been written. Better reporting cannot, however, improve the quality of work that has already been carried out - for this purpose better planning is required.

Planning animal studies should involve close collaboration with the animal facility where the work is to be performed, from as early a stage as possible. In this way, weaknesses in the protocol will be detected and changes can be made before it is too late. Improved planning must focus on more than the “mathematical” elements of experimental design such as randomisation, blinding and statistical methods. This should include focus on practical details such as the standard of the facility, any need for education and training, and all the factors which can improve animal welfare.

The PREPARE ( Planning Research and Experimental Procedures on Animals: Recommendations for Excellence ) checklist was developed to help scientists be more aware of all the issues which may affect their experiments. The checklist is supported by comprehensive webpages containing more information, with links to the latest resources that have been developed for each topic on the list.

Introduction

There is now widespread international acceptance for the 3R-concept ( Replacement, Reduction, Refinement [ 1 ]) when planning research or testing which may involve the use of animals or animal tissue:

Replacement where possible with non-animal methods

Reduction of the number of animals to the minimum which achieves a valid result, and

Refinement of the care and use of those animals which must be used, to maximise animal welfare and data quality.

The three Rs are now part of animal research legislation in many countries [ 2 ]. In Europe, the European Union Directive 2010/63 explicitly states that Replacement is the ultimate aim [ 3 ]. An assessment of the need to use animals at all must therefore be the first stage of the process when planning preclinical research or testing. The large range of alternatives now available is beyond the scope of this paper, but there are many sources of information of this topic (e.g. [ 4 ]).

If animal use is unavoidable, attention must be paid to a long list of known variables which may affect the data collected from them. Unlike test-tube ingredients, animals are complex individuals, differing in their genetic make-up, microbial composition, and behavioural responses to their environment and procedures to which they are subjected. Again, a review of all these factors is beyond the scope of this paper, but information on the effects of these variables is available (e.g. [ 5 ]).

In addition to the legal and scientific incentives, there are good ethical reasons for aiming for the highest possible quality of animal-based research and testing. This is particularly important to remember within basic research in academia, where scientists may be rewarded for the publication of new knowledge rather than for the application of their research results.

In most cases, animal research and testing is performed to learn more about another species, usually humans, rather than to shed more light on the species being used as a model. This work must, therefore, be valid, robust and translatable. As Ritskes-Hoitinga & Wever [ 6 ] remarked: ‘we need a cultural change in which researchers are rewarded for producing valid and reproducible results that are relevant to patients, and for doing justice to the animals being used’. Ensuring translatability is difficult enough in itself [ 7 ], and it is totally dependent upon well-planned studies.

Quality does not come automatically: it necessitates detailed planning from day one, to take into account the effects of the internal and external parameters which affect the animals’ response to a procedure. In addition, the animal facility must have a large number of routine procedures in place, both to maintain the stability of the environment and to tackle any emergencies which may arise. Many scientists who do not work on a regular basis within an animal facility are probably unaware of the number and subtlety of many of these factors. Input from the facility’s veterinary staff will be central to this process.

Guidelines for planning and conducting animal-based studies help both scientists and animal facilities to discuss the issues mentioned above at an early stage, while it is still possible to make improvements in the protocol. Scientists may need to be reminded that the greatest source of variation is likely to come from the animals themselves, rather than from their treatments. Scientists may assume that the facility is dealing with these issues, but this is not always the case. The classic studies by Crabbe and coworkers, who set up standardised behavioural tests on inbred mouse strains in different laboratories simultaneously, showed how unforeseen variables can lead to significant differences in results [ 8 , 9 ].

Fortunately, the need for detailed planning guidelines is becoming clearer, because the quality of animal experiments is now increasingly being criticised, not just by opponents of animal research but also by scientists themselves (e.g. [ 10 , 11 , 12 , 13 , 14 ]). The use of strong words such as ‘research waste’ and ‘false results’ (e.g. [ 15 , 16 ]) is becoming commonplace.

Unfortunately, initiatives to solve the reproducibility crisis tend often to focus on just two of the issues: the more “mathematical” elements of experimental design, and better reporting (e.g. [ 17 ]). These issues are of course important, and include the following items, among others:

Publication bias (reporting only positive results)

Low statistical power

P -value hacking (manipulating data to obtain statistical significance)

HARKing (Hypothesising After the Results are Known)

Lack of randomisation and blinding

Norecopa has made a collection of literature references about these concerns [ 18 ].

However, those familiar with the workings of an animal facility can add many additional and important issues to this list, which may be less conspicuous but which are equally critical to the validity of an experiment. These may be grouped into:

Artefacts caused by internal factors such as genetic diversity and subclinical infections

Artefacts caused by external effects such as transport, cage conditions, re-grouping of animals, food deprivation and the procedure itself

The need for contingency plans to reduce or avoid these and other risks in the facility

Reporting does not improve the standard of experiments

Good reporting is of course important, to allow readers to evaluate the scientific quality of the publication and the strength of the conclusions drawn by the authors. Insistence on better reporting is not new. When Laboratory Animal Science as we know it today was under development in the second half of the last century, focus was placed at an early stage on the low standard of reporting in the scientific literature. In a classic paper, Jane Smith and colleagues [ 19 ] examined the descriptions of laboratory animals, and the procedures for which they were used, in 149 scientific papers published in 8 major journals from 1990 to 1991. The percentages of papers not reporting basic details about the animals were alarmingly high (e.g. sex: 28%; age: 52%; weight: 71%; source: 53%), and 30% of the papers did not mention how many animals were used. The percentages were even higher for environmental factors such as room temperature (72%), photoperiod (72%), relative humidity (89%) and the number of animals per cage (73%).

Many reporting guidelines have been written since the 1980s, to encourage improvements. These include both general guidance (e.g. [ 20 , 21 , 22 , 23 , 24 ]) and guidelines written for specific types of experiment (e.g. [ 25 , 26 , 27 , 28 ]).

It is vitally important to remember that better reporting of an experiment which has already been performed cannot improve the quality of that experiment. A good salesman may manage to sell more burnt cakes if he describes them well (and if he is a good psychologist), but they will still be burnt and they will not taste better. To improve a cake, one must go back to the kitchen and modify the ingredients and/or the baking conditions. In the case of animal studies, just as in the kitchen, the quality of the result is dependent upon planning and conducting, not reporting.

This has been well demonstrated by the way in which the ARRIVE ( Animal Research: Reporting of In Vivo Experiments ) guidelines for reporting animal experiments [ 23 ] have been received and implemented. A new version of ARRIVE was developed in 2019 [ 29 ], because, as the authors point out, despite endorsement by more than a thousand journals, only a small number of these journals actively enforce compliance. Indeed, a Swiss study revealed that 51% of researchers using journals that had endorsed ARRIVE had even never heard of them [ 30 ]. The authors of ARRIVE concluded that most journals are unlikely to be able to provide the resources needed to ensure compliance with all the items on the original checklist. The new version of the ARRIVE guidelines has a shorter checklist of ‘essential’ items, to try and increase compliance. This situation demonstrates clearly how important the planning stage is for the quality of scientific papers.

Scientists should contact the animal facility as soon as they have concrete plans of conducting animal studies. Collaboration between scientists and facility staff will be needed to discuss all stages of the study, up to and including the end of the study which involves depopulation, decontamination and waste disposal. An essential part of this process is attention to the needs of the facility staff. This includes, among other things, their education and training, personal protection, their workload, and means of ensuring adequate staffing levels at all times during the study.

Preparation for preclinical studies: a modern definition of the 3Rs

The concept of the three Rs (Replacement, Reduction and Refinement) developed by Russell and Burch over 60 years ago [ 1 ] was written in an era when the most pressing need was to reduce the inhumanity of animal experiments. Technology at that time did not offer the same potential to replace such experiments as is available today - neither was there so much focus on reducing animal numbers by more sophisticated experimental design.

So today, preparation for robust, valid and humane preclinical studies should go beyond a mere search for more humane methods, using more contemporary definitions of the three Rs [ 31 ]:

Replacement is not just the use of methods which achieve a given purpose without procedures on animals, but also about total avoidance of animal use (Non-Animal Models, NAMs) by innovative approaches to scientific problems, for example by studies directly on human tissue

Reduction is about obtaining comparable information from fewer animals, or for obtaining more information from the same number of animals. Today, reduction also focuses on optimalisation of experimental design so that experiments are robust and reproducible

Refinement methods minimise pain, suffering or distress, but also improve animals’ well-being, since modern research demonstrates that this affects the quality of the data collected from the animals. Modern technology can be harnessed to refine the methods and equipment we use on animals.

Animals that are in harmony with their surroundings will provide more reliable scientific data in an experiment, because the parameters measured will reflect the treatment they are given, rather than being affected by stress. It is indeed true that ‘happy animals give better science’ [ 32 , 33 ].

For these reasons, scientists must be given comprehensive guidelines for planning any experiments which may involve the use of animals, or material taken from animals.

The PREPARE guidelines

Based on the authors’ experiences over the past 30 years in designing and supervising animal experiments, comprehensive guidelines for planning animal studies have been constructed, called PREPARE ( Planning Research and Experimental Procedures on Animals: Recommendations for Excellence ) [ 34 ].

PREPARE contains a checklist, which serves as a reminder of items that should be considered before and during the study, see Fig. 1 . This checklist is available in over 20 languages.

The PREPARE checklist (available at https://norecopa.no/PREPARE/prepare-checklist ). From Smith, AJ, Clutton, RE, Lilley, E, Hansen KEAa, Brattelid, T. PREPARE: Guidelines for planning animal research and testing. Laboratory Animals, 2018;52:135–141. DOI: https://doi.org/10.1177/0023677217724823 . Published under Open Access, Creative Commons licence CC BY-NC 4.0

Many of these items will need their own sets of checklists or standard operating procedures, in the same way that pilots, however experienced, use many checklists, even on routine flights, before, during and after the flight. Many of these checklists will be produced by the animal facility itself. Scientists should, however, check that these are in place, and discuss their contents with the facility.

Importantly, and unlike many reporting guidelines, the PREPARE checklist is supported by a website which provides more information on each of the 15 main topics on the checklist ( https://norecopa.no/PREPARE ). The website gives more complete guidance in the form of text and links to quality guidelines and scientific papers. This website is continually updated as new knowledge develops.

The PREPARE guidelines contain, of course, many of the elements found in reporting guidelines. However, PREPARE contains additional material about issues that can have dramatic effects on the scientific validity of the research, as well as on health and safety, and animal welfare.

Contingency plans and resources

Human nature is such that we tend to believe that accidents only happen to others. If this belief is followed in an animal facility, it will not only put the outcome of a scientific study at risk, but it will also endanger the health and lives of both the animals and personnel who are directly or indirectly involved in the study. As indicated above, it is important to ensure the quality of the whole process from obtaining the animals to disposal of waste and decontamination after the study.

A competent animal facility is one that “hopes for the best but is prepared for the worst” . Facilities with comprehensive and realistic contingency plans will be well placed to tackle disasters, including lockdown situations in connection with a pandemic. There are many resources available that describe the general principles involved, but these must be tailored to the local conditions at each facility. Building a contingency plan from scratch is a time-consuming affair, but it is an excellent insurance policy for the day when a threatening situation arises. Those lacking such a plan should begin with a risk assessment of the facility and its activities, and start by writing contingency plans for the most important of these scenarios.

In its simplest terms, risk assessment is the consequence of a threat multiplied by the likelihood of it occurring. The consequences of the threat include the level of tolerance of the event occurring, which may be anything from “totally unacceptable” to “acceptable within certain limits”. Assessments should be performed at several levels, since threats and their consequences may differ, depending upon where and when they occur, for example:

at the facility level (e.g. the consequences of flooding or fire)

at the room level (e.g. the consequences of power outages to vital equipment)

in connection with specific types of research (e.g. risk of human infection)

It is wise to construct a contingency plan based upon the assumption that ‘what can go wrong will go wrong at some time’ [ 35 ], and that this will happen when it is least convenient, for example during public holidays when staffing levels may be low.

Clearly, both the design of animal studies and the production of contingency plans must involve close collaboration between management, scientists and technical staff, including external suppliers of equipment and services.

The Covid-19 pandemic has demonstrated the importance of being adequately prepared. Animal facilities have had to quickly write contingency plans to tackle situations which were barely imaginable before the outbreak. This work has demanded enormous time and energy, at the expense of conducting research, and it has left many facilities with the unpleasant task of having to euthanise large numbers of healthy animals. Clearly, it is easier to tackle these situations, however improbable they may seem, if the majority of the issues which may arise have already been discussed, and plans made to tackle them.

At the time of writing, some specific advice on contingency plans for the Covid-19 pandemic is beginning to emerge, and existing advice on disaster planning is being re-examined (see [ 36 ]).

Collaboration between scientists and animal care staff

There are many good reasons for early and close collaboration between scientists and the staff at the animal facility where they hope to carry out the work. This collaboration should include dialogue with the animal carers and technicians, not just with the managers. Some of the reasons include the following:

the staff have a moral right to know what will happen to animals in their care.

they will be more motivated to look for ways of refining the study. This will improve both animal welfare and the scientific quality, including reliability of the data being collected from the animals.

the animal care staff know the possibilities, and the limitations, of the animal facility best. They are less likely to play limitations down for fear of the study being transferred to another facility.

they often possess a large range of practical skills and are good at lateral thinking from one study to another - they may be able to suggest a refinement which they have already seen in another species.

they know the animals best

the animals know them best

lack of involvement of the animal care staff creates anxiety, depression and opposition to animal research, as well as limiting creativity which might improve the experiments

A mutually respectful dialogue between technical and academic staff will also help resolve issues quickly which may otherwise cause disagreements later, such as the division of labour and responsibilities all stages of the study. It will also help to avoid the loss of important data due to misunderstandings about who was to collect it.

Culture of care and challenge

To facilitate this dialogue, steps should be taken to foster a culture of care among all members of the staff and research teams. This is actively encouraged in European legislation [ 3 ]. Animal research will inevitably, from time to time, involve studies where sentient creatures exhibit pain, suffering and distress. It is therefore vital to consider the mental health of those caring for these animals or observing this, to avoid compassion fatigue. In Europe, an International Culture of Care network has been established, to share experiences in implementing such a culture [ 37 ].

Closely related to a culture of care is the concept of a Culture of Challenge [ 38 ]. This is all about ‘looking for the acceptable, rather than choosing the accepted’. Comments such as “we have always done it that way” or “we do it as often as necessary” should automatically start a discussion about how to change these habits.

It can be hoped that the current focus on poor reproducibility in animal studies can be turned into an initiative to ensure better planning of all stages, rather than focusing on improving reporting. Otherwise, we are in danger of wasting time, discussing the quality of the lock on the door of the stable from which the horse has already escaped [ 39 ].

Availability of data and materials

This review paper does not include original data. Figure  1 is from a previous paper, published under Open Access, Creative Commons licence CC BY-NC 4.0.

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Acknowledgements

The author acknowledges the contributions of the co-authors of the PREPARE guidelines and other colleagues within Laboratory Animal Science over many years, which led to the development of the PREPARE guidelines and many of the principles mentioned in this paper.

The work of Norecopa has been supported by a large number of sponsors ( https://norecopa.no/sponsors ). No specific funding was obtained for the production of this paper. The author thanks the Universities Federation of Animal Welfare (UFAW), U.K., for funding the open access publication of the paper from which Fig.  1 is taken.

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Correspondence to Adrian J. Smith .

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• NATURE INDEX
• 04 November 2022

US agency seeks to phase out animal testing

• Rachel Nuwer 0

Rachel Nuwer is a freelance writer based in New York City.

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Biomedical advances mean there might be sound alternatives to using animals such as mice for testing. Credit: Paul Chinn/The San Francisco Chronicle/Getty

The future of drug development might be animal-free — or, at least, involve far fewer animals than is currently the norm. Last June, the US Food and Drug Administration (FDA) set out proposals for the New Alternative Methods Program that will focus on replacing, reducing and refining the use of laboratory animals through the adoption of cutting-edge alternative methods. The aim is to produce findings that are more relevant to humans, streamline product development and reduce costs.

The shift, which has been years in the making, would be undertaken across all of the FDA’s centres, including ones that oversee the approval of new pharmaceuticals, medical devices, veterinary medicines, cosmetics and more. FDA scientists are conducting their own research in service of this goal and are collaborating extensively with colleagues in industry, academia and other sectors of the US government. Any methods eventually adopted in place of research involving animals would be rigorously vetted and “fully validated and based on the best science”, says Namandjé Bumpus, chief scientist at the FDA. Bumpus and her colleagues have not received any pushback from researchers about making this shift, she adds, or heard any concerns from the scientific community about cutting back on the use of animals.

Although there is no set timeline, FDA officials say the programme is a priority. It would be funded from US$5 million it has requested as part of its 2023 budget to develop a ‘comprehensive strategy’ on alternative testing methods. According to Paul Locke, an environmental-health scientist and lawyer at Johns Hopkins University in Baltimore, Maryland, who specializes in alternatives to animal testing, the FDA is taking a necessary step towards ensuring that the US government stays up to speed with the latest science. “I’m really excited about what the FDA’s doing here,” he says. “They’ve put a stake in the ground and said, ‘Hey, we want to be there using these tools, they’re consistent with our mission and they’re consistent with what twenty-first-century science looks like.’”

Biomedical advances fuel alternatives

Animal-based testing has been the gold standard for research for decades, and it remains an important requirement for establishing the safety and efficacy of products being brought to market today. But key differences exist between humans and the rodents, rabbits, non-human primates and other animals that researchers depend on for testing, and as biomedical understanding has advanced, scientists have begun to come up against the limitations of using other species as proxies for humans. “A mouse or a rat doesn’t always handle or process medicines and chemicals in the same way humans do,” Bumpus says. “Developing more in vitro systems that are based on human cells, human tissues and human models could, in some instances, be more predictive.”

The FDA’s interest in moving towards new approaches also reflects the current thinking of the biomedical community at large. In 2014, the United Kingdom, for example, announced plans to reduce the use of animal tests in scientific research, aiming to replace those tests with ‘scientifically valid alternatives’ where possible. In 2021, the European Parliament voted in favour of plans to phase out animal testing in research.

“A key for bringing about change is to do so among the multiple major regulatory agencies,” says David Strauss, director of the FDA’s Division of Applied Regulatory Science. “Drug-development programmes are global, and companies want to market their products in many countries around the world.”

That sentiment is echoed by Bumpus. “There’s a lot of energy around this across the globe,” she adds.

Animal-rights advocates have been calling for an end to animal testing for years; now, methods being developed in labs around the world have made this a realistic possibility for the future. “We think we’re at a potential tipping point,” says Strauss. The technologies include, for example, induced pluripotent stem cells — cells that scientists program to have the potential to turn into any cell type found in the body — and ‘organs-on-a-chip’, which are small devices containing living human tissues that mimic an organ, organ system or even an entire body 1 . Developments in artificial intelligence and machine learning are also allowing scientists to harness existing data to build computer models that can make predictions about a new drug’s safety and efficacy.

More funding needed

In addition to being more relevant to humans, says Locke, once these types of technology are qualified and validated for specific uses, they will probably be faster and cheaper than using animals, allowing products to be brought to market more rapidly and efficiently. These are still early days, however, and so far, the FDA has only a handful of successful animal-testing-replacement stories it can point to.

Funding for developing and validating alternative methods is also an issue, Locke adds — both internally at the FDA, and externally for scientists whose labs depend on federal funds to pioneer new approaches. The FDA is not primarily a funding agency, and the US National Institutes of Health, which is the largest public funder of biomedical research in the world, currently has no programme dedicated to developing alternatives to animal testing. “If we had a legitimate funding programme to push these technologies forward, it would accelerate their progress greatly,” Locke points out.

For now, despite the promising alternatives to animal testing, federal regulators have approved only a few cutting-edge methods, and such techniques will not completely replace animal testing any time soon. But they do hold great promise, Locke says, especially if other government agencies and countries join the FDA in its effort.

“There’s a lot of moving pieces here,” he says. “The FDA has started the ball rolling, but we need more work to make sure we can use these new methodologies appropriately.”

doi: https://doi.org/10.1038/d41586-022-03569-9

Sung, J. H. et al. Anal. Chem. 91 , 330–351 (2019).

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WHY ANIMAL RESEARCH?

The use of animals in some forms of biomedical research remains essential to the discovery of the causes, diagnoses, and treatment of disease and suffering in humans and in animals., stanford shares the public's concern for laboratory research animals..

Many people have questions about animal testing ethics and the animal testing debate. We take our responsibility for the ethical treatment of animals in medical research very seriously. At Stanford, we emphasize that the humane care of laboratory animals is essential, both ethically and scientifically.  Poor animal care is not good science. If animals are not well-treated, the science and knowledge they produce is not trustworthy and cannot be replicated, an important hallmark of the scientific method .

There are several reasons why the use of animals is critical for biomedical research: 

••  Animals are biologically very similar to humans. In fact, mice share more than 98% DNA with us!

••  Animals are susceptible to many of the same health problems as humans – cancer, diabetes, heart disease, etc.

••  With a shorter life cycle than humans, animal models can be studied throughout their whole life span and across several generations, a critical element in understanding how a disease processes and how it interacts with a whole, living biological system.

The ethics of animal experimentation

Nothing so far has been discovered that can be a substitute for the complex functions of a living, breathing, whole-organ system with pulmonary and circulatory structures like those in humans. Until such a discovery, animals must continue to play a critical role in helping researchers test potential new drugs and medical treatments for effectiveness and safety, and in identifying any undesired or dangerous side effects, such as infertility, birth defects, liver damage, toxicity, or cancer-causing potential.

U.S. federal laws require that non-human animal research occur to show the safety and efficacy of new treatments before any human research will be allowed to be conducted.  Not only do we humans benefit from this research and testing, but hundreds of drugs and treatments developed for human use are now routinely used in veterinary clinics as well, helping animals live longer, healthier lives.

It is important to stress that 95% of all animals necessary for biomedical research in the United States are rodents – rats and mice especially bred for laboratory use – and that animals are only one part of the larger process of biomedical research.

Our researchers are strong supporters of animal welfare and view their work with animals in biomedical research as a privilege.

Stanford researchers are obligated to ensure the well-being of all animals in their care..

Stanford researchers are obligated to ensure the well-being of animals in their care, in strict adherence to the highest standards, and in accordance with federal and state laws, regulatory guidelines, and humane principles. They are also obligated to continuously update their animal-care practices based on the newest information and findings in the fields of laboratory animal care and husbandry.  

Researchers requesting use of animal models at Stanford must have their research proposals reviewed by a federally mandated committee that includes two independent community members.  It is only with this committee’s approval that research can begin. We at Stanford are dedicated to refining, reducing, and replacing animals in research whenever possible, and to using alternative methods (cell and tissue cultures, computer simulations, etc.) instead of or before animal studies are ever conducted.

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Animal Testing and Medicine

Rachel hajar.

Department of Cardiology and Cardiothoracic Surgery, Hamad Medical Corporation, Doha, Qatar

“The greatness of a nation and its moral progress can be judged by the way its animals are treated.” - Mahatma Gandhi

Animals have been used repeatedly throughout the history of biomedical research. Early Greek physician-scientists, such as Aristotle, (384 – 322 BC) and Erasistratus, (304 – 258 BC), performed experiments on living animals. Likewise, Galen (129 – 199 / 217 AD), a Greek physician who practiced in Rome and was a giant in the history of medicine, conducted animal experiments to advance the understanding of anatomy, physiology, pathology, and pharmacology. Ibn Zuhr (Avenzoar), an Arab physician in twelfth century Moorish Spain, introduced animal testing as an experimental method for testing surgical procedures before applying them to human patients.

In recent years, the practice of using animals for biomedical research has come under severe criticism by animal protection and animal rights groups. Laws have been passed in several countries to make the practice more ‘humane’. Debates on the ethics of animal testing have raged since the seventeenth century. Theodore Roosevelt in the nineteenth century stated, “Common sense without conscience may lead to crime, but conscience without common sense may lead to folly, which is the handmaiden of crime.”

Those against, contend that the benefit to humans does not justify the harm to animals. Many people also believe that animals are inferior to humans and very different from them, hence results from animals cannot be applied to humans. Those in favor of animal testing argue that experiments on animals are necessary to advance medical and biological knowledge. Claude Bernard, known as the father of physiology, stated that “experiments on animals are entirely conclusive for the toxicology and hygiene of man. The effects of these substances are the same on man as on animals, save for differences in degree”. Bernard established animal experimentation as part of the standard scientific method.

Drug testing using animals became important in the twentieth century. In 1937, a pharmaceutical company in the USA created a preparation of sulfanilamide, using diethylene glycol (DEG) as a solvent, and called the preparation ‘Elixir Sulfanilamide’. DEG was poisonous to humans, but the company's chief pharmacist and chemist was not aware of this. He simply added raspberry flavoring to the sulfa drug, which he had dissolved in DEG, and the company marketed the product. The preparation led to mass poisoning causing the deaths of more than a hundred people. No animal testing was done. The public outcry caused by this incident and other similar disasters led to the passing of the 1938 Federal Food, Drug, and Cosmetic Act requiring safety testing of drugs on animals before they could be marketed.

Another tragic drug fiasco occurred in the late 1950s and early 1960s with thalidomide. It was found to act as an effective tranquilizer and painkiller and was proclaimed a ‘wonder drug’ for insomnia, coughs, colds, and headaches. It was found to have an inhibitory effect on morning sickness, and hence, thousands of pregnant women took the drug to relieve their symptoms. Consequently, more than 10,000 children in 46 countries were born with malformations or missing limbs (phocomelia, from the Greek meaning ‘limb’). The drug was withdrawn in 1961 and 1968 after a long campaign.

The above-mentioned incidents and others illustrate the harm to humans from the use of substances that have not been first tested on animals and underline the importance of animal experimentation to avert or prevent human tragedy. The practice of using animals in biomedical research has led to significant advances in the treatment of various diseases.

Issues such as ‘cruelty’ to animals and the humane treatment of animals are valid concerns, and hence, the use of animals in experimentation is greatly regulated. This has led to the 3Rs campaign, which advocates the search (1) for the replacement of animals with non-living models; (2) reduction in the use of animals; and (3) refinement of animal use practices. However, total elimination of animal testing will significantly set back the development of essential medical devices, medicines, and treatment. By employing the 3Rs when continuing to use animals for scientific research, the scientific community can affirm its moral conscience as well as uphold its obligation to humanity to further the advancement of science for civilization and humanity.

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What are your thoughts on animal testing? Do you think it is ever justified? Why or why not?

In “ E.P.A. Says It Will Drastically Reduce Animal Testing ,” Mihir Zaveri, Mariel Padilla and Jaclyn Peiser write about the decision:

The E.P.A. Administrator Andrew Wheeler said the agency plans to reduce the amount of studies that involve mammal testing by 30 percent by 2025, and to eliminate the studies entirely by 2035, though some may still be approved on a case-by-case basis. The agency said it would also invest $4.25 million in projects at four universities and a medical center that are developing alternate ways of testing chemicals that do not involve animals. “We can protect human health and the environment by using cutting-edge, ethically sound science in our decision-making that efficiently and cost-effectively evaluates potential effects without animal testing,” Mr. Wheeler said in a memo announcing the changes. The E.P.A. has for decades required testing on a variety of animals — including rats, dogs, birds and fish — to gauge their toxicity before the chemicals can be bought, sold or used in the environment.

The article continues:

The practice of testing with animals has long prompted complex debates driven by passionate views on morality and scientific imperative. Reaction to Tuesday’s announcement was no different. “We are really excited as this has been something we’ve wanted for quite some time,” said Kitty Block, the president and chief executive of the Humane Society of the United States, an animal protection organization. “The alternatives are the future. They’re more efficient and save lives.” Kathleen Conlee, the vice president of animal research issues at the Humane Society, said the E.P.A.’s move is “broad-sweeping and significant.” “This is the first time a government agency has made such a commitment and timelined its specific goals along the way,” Ms. Conlee said. “There’s been a lot of positive action among other federal agencies, but we want to see all government agencies take this step.” Tracey Woodruff, a professor at the University of California, San Francisco’s school of medicine, said current alternatives to animal testing are somewhat useful. But Dr. Woodruff, who worked at the E.P.A. from 1994 to 2007, said only animal testing — a process honed over decades — was robust enough to gauge chemicals’ impacts on people of various ages, genetics and health backgrounds. “I definitely think we should be investing more in this research,” she said, referring to alternative testing. “But it’s really not ready for making decisions yet — at least the way that E.P.A. is making decisions.” Jennifer Sass, a senior scientist at Natural Resources Defense Council, an environmental advocacy group, said she was very concerned by the announcement. Dr. Sass said animals were still necessary to study chronic conditions, like cancer and infertility. Cells in a petri dish cannot yet replace whole living systems, she said. “The E.P.A.’s deadline is arbitrary,” Dr. Sass said. “Our interest isn’t in speed, it’s getting it right. We want proper animal testing because we don’t want harmful chemicals to end up in our food, air and water.”

Students, read the entire article, then tell us:

Do you support the decision by the E.P.A. to move away from requiring the testing of potentially harmful chemicals on animals? Or do you think animal testing is still necessary to regulate harmful substances that can have adverse effects on humans?

How important is it to you that the toxicity of chemicals and other environmental contaminants is rigorously studied and regulated? Why? Do you think not testing on animals hinders those efforts?

The Food and Drug Administration, the National Institutes of Health and the Department of Veterans Affairs are among the government agencies that still rely on animal testing. Do you think animal testing is important in these sectors or any others? Why or why not?

Do you think animal testing is ever justified? If so, what should be the criteria for when, how and on what animals testing is done?

Students 13 and older are invited to comment. All comments are moderated by the Learning Network staff, but please keep in mind that once your comment is accepted, it will be made public.

Natalie Proulx joined The Learning Network as a staff editor in 2017 after working as an English language arts teacher and curriculum writer. More about Natalie Proulx

We’re calling on the FDA to save animals by modernizing drug testing

In an era defined by scientific and technological innovation, testing drugs on dogs, rats, monkeys and other animals is not only becoming increasingly outdated but causes immense animal suffering. Despite publicly indicating a commitment to non-animal test methods, the U.S. Food and Drug Administration’s regulations and guidance documents for pharmaceutical companies are unclear and continue to emphasize the use of animals for drug testing. There is evidence that some companies believe testing on animals is legally required as part of the drug approval process.

That’s why we’ve filed a petition with the FDA today, requesting that the agency take a series of steps to make it plain and clear that animal testing isn’t legally required for drug approval and that the agency encourage companies to use non-animal methods when available. The FDA is legally required to consider and respond to our petition.

The petition asks the FDA to make the following changes to its regulations and guidance documents, which are documents that provide additional information on how to comply with its regulations:

• Amend its regulations to make it clear that the FDA does not require animal testing for drugs. 
• Publish a new guidance document describing the non-animal test methods that can be used in place of animal tests. The document should be updated regularly as new non-animal methods become available.  
• Commit to adding text to all existing and future guidance documents regarding the regulation of drugs. The new text should encourage companies to use non-animal methods whenever possible and refer them to the new guidance document on accepted non-animal methods.  

Without these changes, the lack of clarity in FDA regulations will continue to perpetuate the status quo. That means tens of thousands of animals per year continue to suffer in archaic tests such as those we documented in an undercover investigation at a laboratory in 2022. The ambiguity surrounding whether animal testing is needed for drugs to gain approval is harmful in several ways. It creates confusion and discourages innovation. It may also negatively impact human health. 

We all agree that the FDA has a responsibility to make sure that drugs intended for people are safe and effective. This is all the more reason why the agency should promote the use of data from non-animal test methods based in human biology; animal testing is not a reliable predictor of safety or efficacy in humans. Animal testing has acknowledged scientific limitations, but innovative non-animal technologies will only continue to improve. Emerging technologies such as organ-on-a-chip models offer promising approaches that are based on human biology and yield more reliable results.  

We are not alone in our demand for the adoption of more humane testing methods. University centers devoted to non-animal methods are making the same case, and a pioneering 2007 National Research Council report spurred the creation of numerous governmental initiatives focused on the ultimate replacement of animals in toxicity testing. As a result of our longstanding political advocacy, Congress has also publicly supported and secured increased funding for alternatives to animal use. The time for change is now. You can help prevent countless animals from suffering by urging the FDA to update its drug testing regulations and embrace non-animal alternatives . 

By supporting our petition to modernize the FDA’s drug testing regulations and guidance documents, you can help us create a future where compassion and scientific advancement go hand in hand.

Sara Amundson is president of the Humane Society Legislative Fund. 

Taking Suffering Out of Science

About the author

Kitty Block is President and CEO of the Humane Society of the United States and CEO of Humane Society International, the international affiliate of the HSUS

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Our fight against expanded use of monkeys in research heats up

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Good news! Washington becomes 12th state to ban sale of animal-tested cosmetics

Animal Testing: Should Animal Testing Be Allowed? — Argumentative Essay

Animal testing: introduction, animal testing: debatable questions, animal testing: conclusion.

Animal testing denotes the use of animals in medical experiments to unveil the potency, safety, toxicity, and viability of developed drugs. Concurrently, the phenomenon also applies to other biological experiments, which utilize animals as specimens. The method incorporates the administration of pharmaceutical compounds into biological systems (test animals).

This usually occurs for scientific purposes and medical developments. The process is debatable and has been disputed by animal activists, religious groups, and ethical communities who believe that the trend is immoral and inappropriate since animals cannot be compared with human beings (Panza & Potthast, 2010).

Animal testing usually involve vertebrates like rodents, cats, dogs, birds, and Guinea pigs among others. Since this is a disputable phenomenon, where one can argue for or against the act, this paper supports the aspects of animal testing with bountiful reasons based on its viability in investigating pharmacological compounds. Without animal testing, numerous drugs, which currently help the humankind, could have missed.

Since human beings cannot commence crude pharmaceutical investigations as test specimens, using test animals is significant in this context. It is advisable to execute scientific investigations elsewhere before introducing them into human beings. It is crucial to agree that animal testing might be unethical phenomenon as argued by some groups; nonetheless, it should continue following its merits and contributions to the humankind in the realms of drug investigations and scientific discoveries.

With regard to animal testing, debatable questions emerge. In this paper, “Should animal testing be abandoned due to ethical claims surrounding it?” forms the debated question. This question tries to unveil whether it is viable for biologists and medical scientists to cease from using animals for experimental investigations.

Despite the conventional use of these animals in numerous scientific experiments, it is still debatable on their viability and potency. Arguably, the animal testing phenomenon should continue with regard to scientific investigations.

The need for efficacy, safety, novelty, and certainty in the realms of drug-use require thorough investigative experiments, which can only materialize when test animals are incorporated. Firstly, some animal have systems that resemble those of human beings; thus, the ability to use such animals give a broader chance of executing an elaborate experimental investigation.

Using animals as representative of humans is a critical phenomenon when scrutinized critically. There are numerous individuals who have disputed this claim as stated in the research question. The desire to continue with the animal testing phenomenon has infuriated numerous activists who are against it (Panza & Potthast, 2010).

Nonetheless, it is evident and appropriate that this phenomenon should continue for further discoveries to be realized. It is questionable how further medical research will occur and how this will materialize without the use of test animals. This is an impossible phenomenon, which demands those who are arguing against animal testing to reconsider their stands.

Another issue is that human beings cannot be used as experimental animals. The drugs administered into humans must be of some quality, minimized toxicity, viable to use, potent, safe, and effective. This means that they have been investigated and approved by the concerned bodies after scientific investigations. If animal testing will be abandoned, no effective experimentation will occur on biological vessels.

Evidently, invitro (using experimental tubes) experimentations are slow and incomprehensive. This means that scientific investigations will delay and sometimes results might not occur. It is vital to consider that animal testing has helped significantly since its inception several decades ago. It has remained a viable, trusted, and considerable experimental design for pharmaceutical products and other scientific investigations.

Harrison & Hester (2006), which identifies alternative of animal testing, agrees that attaining an alternative of this trend is daunting and minimally achievable. Scientific considerations support this trend since there are limited alternatives to replace the method comprehensively (Harrison & Hester, 2006).

Those who are against animal testing claim that animals are not human beings and equating the two is inconsiderable. Evidently, animal are not exact copies of humans. There are numerous differences noticeable amidst the two factions. Additionally, they argue that what works best in a guinea pig (an experimental animal), might not exactly perform in humans.

The two factions (humans and test animals) are different hence the assumption that they can emulate each other is misled. Notably, this argument is understandable; however, as the situation stands, it is still appropriate to conduct animal testing to help in research investigations. Humans can hardly be used for crude or undeveloped researches as the ones done with test animals. This means that animal testing is still the best option.

According to Schmidt (2001), which discusses the aspects of animal testing, recognizes that it is important to infer that what is inconsumable for test animals is similarly consumable for humans. It is possible to note the adverse effects of drugs with animals, make appropriate changes in the composition of the tested drug, and later emerge with effective, safe, and potent compound worth human utilization.

Watson (2009), which describes the ethical issues related to animal testing, argues that some ethical claims behind the animal testing are baseless when compared to human lives saved daily due to animal testing executed to investigate proper and effective drugs. A mere claim that it is immoral to inject or administer unworthy compounds into an innocent animal while doing research is superfluous. This simply means that those who are against animal testing hardly want researches to be done using animals.

This is good and considerable; however, these very people hardly provide viable alternatives that can work better compared to the conventional animal testing provisions. Besides, they are also among those who gain from the findings and results achieved from such investigations. Evidently, almost all drugs currently used in the world at one point passed through animal testing to unveil their viability, safety, efficacy, toxicity levels, and other viable provisions demanded in this context.

Concurrently, it is inappropriate to abandon animal testing as claimed by the activists. The current discoveries on genetics, reproduction, developmental biology, and study of behaviors among others could have not materialized minus animal testing.

Additionally, there are other viable provisions that characterize the phenomenon besides the known pharmaceutical investigations which usually occur using test animals as stipulated before. In these mentioned fields, there are still considerable knowledge gaps that will necessitate further application of animal testing in order to unveil additional information.

This phenomenon can hardly occur minus animal testing since there will be no specimens for further research. The ethical claims fronted by the mentioned activists should cease from hindering further investigations (Watson, 2009). It is evident that discoveries made from animal testing are numerous and helpful to the human race as indicated earlier. The need for more investigations and application of animal testing will continue to exist following its viability, applicability, and reliability in the aspects of research.

The viewpoint that animals equally have moral rights is evident; however, it is disputable in this context since it acts as a hindrance to lucrative investigations and discoveries that are helpful to the humankind. Hayhurst (2000), which debates on animal rights, denotes that individuals who perceive animal as having rights are equally accurate in their opinions; nonetheless, they should also consider the merits of animal testing to their lives and beyond.

This relates to the ethical arguments posted with regard to this topic. It forms the center of argument from various people. It is crucial to denote that animal testing has numerous provisions worth noting in varying contexts. This relates to its viability and potency in unveiling the less investigated claims with regard to life. According to various sources, some arguments regarding the aspects of animal testing are invalid and misleading (Hayhurst, 2000). They simply emerge from undue compassion for animals.

This contributes to why this paper agrees with the continuity of animal testing. Precisely, its merits surpass its baseless flaws numerous times. It is recommendable to scrutinize these arguments before they derail the realities that encompass a given matter. It is crucial to consider such provisions following their viability in this context.

Additionally, those who argue against animal testing claim that such animals lack the capacity to express themselves hence can hardly show their pain, dissatisfaction, and suffering.

This is a critical claim; however, it is not enough to support the ban against animal testing. Conversely, scientists, medics, and biologists who use such animals apply moral aspects to their undertakings; hence, will barely intend to harm such experimental animals. Since such ethical observations are carried out within the mentioned experimental testing, it is considerable to continue with the animal testing phenomenon. Adjusting the conditions of these tests might equally help in upholding the ethical demands.

Another argument is that animal testing simplifies and speeds the experimental designs meant to make discoveries. This could have not been achievable minus such experimental trends. Testing developed research products on animals elicit the desired results with promptness. It is daunting and time consuming to develop therapeutic and diagnostic compounds from human beings. This relates to the aspects of delay claimed earlier.

Scientists will not be able to attain their demands in time. This might discourage them from continuing with investigations. Since the use of animal testing provides instant results, its application is widespread, applicable, and viable in numerous contexts. The aspects of safety indicated earlier in these claims equally contribute to the applicability of animal testing. It is improper to execute unsafe experiments or unverified drugs on humans.

The repercussions might be devastating than when it was applied on test animals (Schmidt, 2001). For example, developments and investigations on HIV drugs cannot occur on humans at their initial stages. It is advisable to develop them through animal testing before rendering them usable by humans. It is possible to adjust the composition of the given compound to unveil its viable concentrations. Emerging with instant results supports the application of animal testing and contributes massively in this context.

Animal testing is a helpful phenomenon in biological, medical, and other scientific investigations demanding its incorporation. The phenomenon is helpful, viable, and should be embraced despite the opposing opinions. Animal testing helps in developing effective, safe, viable, qualitative, and less toxic drugs. Following the merits of animal testing, its application and advancements should continue while observing ethical concerns.

Harrison, R. & Hester, R. (2006). Alternatives to Animal Testing . Ohio, OH: Cengage Learning.

Hayhurst, C. (2000). Animal testing: The animal rights debate . New York, NY: Rosen Pub. Group.

Panza, C. & Potthast, A. (2010). Ethics For Dummies . Hoboken: John Wiley & Sons.

Schmidt, A. (2001). Animal testing in infectiology . Basel: Karger.

Watson, S. (2009). Animal testing: Issues and ethics . New York, NY: Rosen Pub.

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IvyPanda. (2018, November 6). Animal Testing: Should Animal Testing Be Allowed? — Argumentative Essay. https://ivypanda.com/essays/animal-testing-argumentative-essay/

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Home — Essay Samples — Social Issues — Animal Testing

Argumentative Essays on Animal Testing

Hook examples for animal testing essays, the ethical dilemma hook.

Begin your essay by presenting the ethical dilemma surrounding animal testing. Explore the moral questions it raises and the conflicting viewpoints of proponents and opponents.

The Historical Perspective Hook

Take your readers on a journey through the history of animal testing. Discuss its origins, evolution, and its role in scientific and medical advancements over time.

The Scientific Advancements Hook

Highlight the scientific breakthroughs and discoveries that have resulted from animal testing. Discuss how it has contributed to medical treatments, vaccines, and the understanding of diseases.

The Alternatives and Innovations Hook

Explore alternative methods and innovations in research that aim to replace or reduce the use of animals in testing. Discuss advancements like in vitro testing and computer modeling.

The Animal Welfare Hook

Focus on the welfare and ethical treatment of animals used in testing. Discuss regulations, guidelines, and efforts to minimize harm and suffering in research.

The Legal and Regulatory Landscape Hook

Examine the legal and regulatory framework surrounding animal testing in different countries. Discuss laws, restrictions, and their enforcement.

The Public Opinion and Activism Hook

Discuss public perceptions of animal testing and the role of animal rights activists in advocating for change. Highlight notable campaigns and their impact.

The Unintended Consequences Hook

Explore unintended consequences or risks associated with animal testing, such as potential harm to humans due to species differences or the limitations of animal models.

The Future of Research Hook

Discuss the future of scientific research and the possibilities for reducing or eliminating animal testing. Explore emerging technologies and trends in biomedical research.

The Personal Story Hook

Share a personal or anecdotal story related to animal testing, such as the experiences of a researcher, activist, or someone affected by medical advancements achieved through animal testing.

The Ethics of Animal Testing: Scientific Progress and Animal Welfare

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Ethical Statement for Animal Testing

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Discussion Whether Animals Testing is Necessary

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The Ethics of Animal Testing: an Argument Against Its Practice

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Animal testing, referred to as animal experimentation, animal research, or in vivo testing, involves the utilization of animals other than humans in scientific experiments aimed at manipulating the factors influencing the behavior or biological processes being investigated.

Throughout history, the practice of animal testing has deep roots dating back centuries. The earliest recorded instances can be traced back to ancient civilizations, where animals were used for various scientific and medical purposes. The Greek physician Galen, during the second century AD, conducted experiments on animals to understand human anatomy and physiology. However, the formal establishment of animal testing as a systematic approach began to take shape during the 19th century with the emergence of modern medical research. In the late 1800s, advances in scientific knowledge and technology led to an increased demand for animal testing in various fields, including medicine, toxicology, and physiology. The development of anesthesia further facilitated the experimentation on animals by reducing pain and discomfort. Throughout the 20th century, animal testing became more widespread and institutionalized, particularly in the pharmaceutical industry.

Public opinion on animal testing is a complex and diverse topic, with viewpoints spanning a wide spectrum. While there are those who support the use of animals in scientific research for the advancement of human knowledge and medical breakthroughs, others express strong opposition due to ethical concerns and the perceived mistreatment of animals. Some people argue that animal testing is necessary for the development of life-saving treatments and the improvement of human health. They believe that animals provide valuable insights into human biology and the effectiveness of potential therapies. On the other hand, opponents of animal testing argue that it is cruel and unnecessary, advocating for alternative methods such as in vitro testing, computer modeling, and human cell-based assays. Public opinion on animal testing often hinges on the balance between scientific progress and animal welfare. The growing awareness of animal rights and ethical considerations has fueled debates and discussions surrounding the topic. As society becomes more conscious of animal welfare, there is an increasing demand for alternative testing methods and greater transparency in the treatment of animals involved in research. Ultimately, public opinion plays a crucial role in shaping policies and regulations surrounding animal testing.

1. Scientific advancement. 2. Human health and safety. 3. Understanding diseases. 4. Regulatory requirements. 5. Animal welfare improvements.

1. Ethical concerns. 2. Inadequate human relevance. 3. Availability of alternatives. 4. Animal welfare. 5. Speciesism and moral status.

One example of media representation is the documentary "Earthlings" directed by Shaun Monson. This influential film explores different aspects of animal exploitation, including animal testing, and highlights the ethical concerns surrounding the practice. It has garnered widespread attention and prompted discussions about the treatment of animals in scientific research. Social media platforms have also become powerful tools for activists and organizations to share information and advocate for alternatives to animal testing. Hashtags like #StopAnimalTesting and #CrueltyFree have gained traction, raising awareness and encouraging conversations on the topic.

The topic of animal testing is important due to its ethical, scientific, and societal implications. From an ethical standpoint, it raises profound questions about the treatment of sentient beings and the moral responsibility we have towards animals. It prompts us to consider the balance between scientific progress and animal welfare, urging us to explore alternative methods that minimize harm. Scientifically, animal testing has been instrumental in advancing medical knowledge and developing treatments for various diseases. However, it is essential to continually evaluate its effectiveness, limitations, and potential alternatives to ensure both human and animal well-being. Furthermore, the issue of animal testing has societal implications as it reflects our values and priorities as a society. It prompts discussions about our relationship with animals, the extent of their rights, and the importance of promoting more humane practices.

The topic of animal testing is worth writing an essay about due to its complex nature and the multitude of perspectives it encompasses. It is a subject that elicits strong emotions and raises critical ethical, scientific, and social questions. Writing an essay on animal testing allows for an in-depth exploration of these issues and encourages critical thinking and analysis. By delving into the topic, one can examine the ethical considerations surrounding the use of animals in experiments, weighing the potential benefits against the moral implications. Additionally, it provides an opportunity to evaluate the scientific validity and reliability of animal testing as a method for understanding human biology and developing medical treatments. Furthermore, an essay on animal testing opens avenues for discussing alternative approaches and advancements in technology that can reduce or replace animal experimentation. It allows for an exploration of the societal impact of animal testing, including public opinion, legislation, and the influence of media.

1. Each year, millions of animals are used in scientific experiments worldwide. According to estimates, over 100 million animals, including rabbits, mice, rats, dogs, and primates, are subjected to testing for various purposes, such as biomedical research, drug development, and toxicity testing. 2. Animal testing is not always reliable in predicting human outcomes. Studies have shown that there can be significant differences between animals and humans in terms of anatomy, physiology, and drug metabolism. This raises concerns about the validity and relevance of using animal models for understanding human diseases and developing treatments. 3. Alternatives to animal testing are emerging and gaining traction. Scientists and researchers are actively exploring innovative methods, such as in vitro cell cultures, computer modeling, and organ-on-a-chip technology, to simulate human biology and predict human responses more accurately. These alternative approaches aim to reduce or eliminate the need for animal testing while still ensuring the safety and efficacy of new products and treatments.

1. Abbott, A. (2005). Animal testing: more than a cosmetic change. Nature, 438(7065), 144-147. (https://go.gale.com/ps/i.do?id=GALE%7CA185466349&sid=googleScholar&v=2.1&it=r&linkaccess=abs&issn=00280836&p=AONE&sw=w&userGroupName=anon%7E513ffe31) 2. Doke, S. K., & Dhawale, S. C. (2015). Alternatives to animal testing: A review. https://www.sciencedirect.com/science/article/pii/S1319016413001096 Saudi Pharmaceutical Journal, 23(3), 223-229. 3. Hajar, R. (2011). Animal testing and medicine. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3123518/ Heart views: the official journal of the Gulf Heart Association, 12(1), 42. 4. Bottini, A. A., & Hartung, T. (2009). Food for thought… on the economics of animal testing. ALTEX-Alternatives to animal experimentation, 26(1), 3-16. (https://www.altex.org/index.php/altex/article/view/633) 5. Valappil, S. P., Misra, S. K., Boccaccini, A. R., & Roy, I. (2006). Biomedical applications of polyhydroxyalkanoates, an overview of animal testing and in vivo responses. Expert Review of Medical Devices, 3(6), 853-868. (https://www.tandfonline.com/doi/abs/10.1586/17434440.3.6.853) 6. File, S. E., Lippa, A. S., Beer, B., & Lippa, M. T. (2004). Animal tests of anxiety. Current protocols in neuroscience, 26(1), 8-3. (https://currentprotocols.onlinelibrary.wiley.com/doi/abs/10.1002/0471142301.ns0803s26) 7. Madden, J. C., Enoch, S. J., Paini, A., & Cronin, M. T. (2020). A review of in silico tools as alternatives to animal testing: principles, resources and applications. Alternatives to Laboratory Animals, 48(4), 146-172. (https://journals.sagepub.com/doi/pdf/10.1177/0261192920965977) 8. Donnellan, L. (2006). Animal testing in cosmetics: recent developments in the European Union and the United States. Animal L., 13, 251. (https://heinonline.org/HOL/LandingPage?handle=hein.journals/anim13&div=18&id=&page=)

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