Global harmonization of standards for the care, use and ethical oversight of animals in science
About the Initiative
ICLAS is leading a new initiative to develop a document outlining globally harmonized, high-level performance (outcome-based) standards for the care, use, and ethical oversight of animals in science. The initiative aims to support high-quality scientific research while promoting animal welfare.
The target date for completing this work is early 2028.
Why Is This Initiative Needed?
Legislation, guidelines, and codes for research animal care, use, and oversight exist in all regions, including several international documents. However, across the globe, there is great variation in the aspects covered, when they were produced, and how well they are followed. Some of the main texts widely used as references are becoming outdated.
Differences in how experiments using animals are planned and conducted, how animals are housed and cared for, as well as personnel competence and research governance and oversight, are among the well-documented factors known to impact animal welfare, research reproducibility, and robustness. Good standards that are effectively implemented are also important for meeting public expectations.
A single set of high-level performance standards, with truly international reach and acceptance, is a needed step toward improving animal welfare and science. Having a transparent set of expected standards that are endorsed and promoted by key organisations could:
Improve research quality and reproducibility.
Improve standards of animal welfare.
Allow a better understanding of standards in other regions.
Give increased confidence to the scientific community about studies in the scientific literature.
Improve the confidence of funding bodies and journal publishers in the scientific and ethical quality of work being carried out and submitted for publication.
Help inform and support the work of organisations that operate across regions and multiple countries (e.g., pharmaceutical companies and animal breeders).
Assist accreditation organisations that use standards in this sector.
Improve the confidence of wider society in how animals are used and cared for in research.
Importantly, these standards should be viewed as guidance and not substitutes for following relevant local and national legislative and regulatory requirements.
Who Will Have Input into the Creation of These Standards?
ICLAS approached relevant representative global and regional bodies, including science councils and federations of laboratory animal science associations, to invite them to play a key role in guiding the development of these Standards.
To date, the following organisations are participating in this initiative:
AAALAC International (Global)
AALAS (USA)
AFLAS (Asia)
ANZCCART (Australasia)
CCAC (Canada)
CIOMS (Global)
FELASA (Europe)
FESSACAL (South America)
FESAHANCCAL (Hispanic Societies and Associations of North America, Central America and the Caribbean)
IACLAM (Global)
PAN-LASE (Africa)
In addition, the following organisation has stated that it will endorse the document produced:
- International Science Council (Global)
We are pleased to see such wide-ranging support, covering every continent of the globe except Antarctica.
Drafting Committee and Working Group members represent and bring diverse perspectives from 34 nations. In selecting Working Group members, a balance needed to be struck between expertise and geographical representation, while for some Working Groups, expertise was the priority.
Geographical representation refers to a country within a region rather than membership of a specific organisation, as some contributing organisations are global while others are regional. Given the need to balance expertise and geographical representation for most Working Groups, and expertise alone for others, not every continent is represented in every Working Group.
How Will This Initiative Be Coordinated?
To facilitate the efficient management of the project, including time, cost, communication, and the production of the draft Standards, representative organisations with a global or regional (e.g., continent-level) role were more heavily involved in the initial activities.
The ICLAS Special Working Group on Global Harmonization (SWGGH) established a Drafting Committee comprising representatives from the partner organisations that had expressed their wish to participate in this initiative.
The Drafting Committee membership reflects geographical and disciplinary representation. This committee recommended specialists and experts from their organisations and networks, who now form the Working Groups, each consisting of five to seven members.
The composition of the Working Groups received final approval from the ICLAS SWGGH.
Working Groups are responsible for producing the content for each section of the Standards. This content will then be reviewed and agreed upon by the Drafting Committee and finally approved by the ICLAS SWGGH.
A Project Coordinator with expertise in international projects has been appointed by ICLAS to help manage the delivery of this initiative.
Consultation with the Wider Community
There will be two rounds of consultation on the draft texts with the wider community.
To ensure that a broad range of perspectives and expertise is incorporated into the development of the Standards, drafts will be shared widely with other relevant organisations for feedback. These may include national authorities and associations, other interest groups, representatives of scientific journal publishers, and representatives from the pharmaceutical sector, such as EFPIA.
As part of this feedback process, input will also be sought, as appropriate, from specialist groups within laboratory animal science, including those working with specific animal groups (e.g., wildlife and non-human primates) and those working across different fields of research (e.g., pharmacology, physiology, neuroscience, and toxicology).
A Project Coordinator with expertise in international projects has been appointed by ICLAS to help manage the delivery of this initiative.
ICLAS, primarily through the Special Working Group on Global Harmonization, will retain ultimate control over the project and provide final approval for the version of the Standards to be published.
What Will Be Covered in This Document?
Several useful reference texts already exist.
The CIOMS/ICLAS Guiding Principles for Biomedical Research Involving Animals (2012, four pages) provides high-level principles. Ten fundamental principles are also set out in the Basel Declaration. More extensively, Chapter 7.8 of the WOAH Terrestrial Animal Health Code, which includes a section on the use of animals in research and education and has been included since 2010 (11 pages), provides additional guidance on relevant concepts.
Widely used texts, such as the USA's Guide for the Care and Use of Laboratory Animals (8th edition, 2011, 246 pages) and the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes (ETS 123, 1986, 48 pages) and its associated Appendix A (2006, 109 pages), are more comprehensive. They also include performance standards and some detailed engineering standards concerning species-specific housing and care, such as cage or enclosure dimensions.
ICLAS is clear that any new guidance produced through this initiative must add value to the resources already available.
It is not the intention of ICLAS for the guidance produced through this initiative to prescribe specific details covering every possible aspect of research animal care and use, nor are engineering standards desired.
Engineering standards do exist for a number of parameters, usually related to housing and care, and can be helpful. However, these standards can differ greatly across regions, their underlying evidence is not always clear, and they can quickly become outdated as our understanding of animal behaviour, welfare, and needs evolves.
Rather, the focus of this initiative will be to establish shared understandings and expectations regarding outcome-based standards for key factors that affect animal health and well-being and scientific integrity.
Twelve Areas of Focus
The Drafting Committee and SWGGH agreed on the following twelve areas of focus, each with an assigned Working Group:
- Animal Welfare
- Behavioral Needs of Animals
- Veterinary Care
- Ethical Oversight
- Humane Endpoints
- Experimental Design
- Ethical Principles
- Training and Competency
- Culture of Care
- Sourcing of Animals
- End of Research Options
- Physical Infrastructure and Maintenance
There are, of course, also challenges associated with standards based on performance outcomes. These outcomes can be subjective; for example, people's opinions on whether the needs of animals are being met, or whether an ethical review process is robust and effective, may differ.
However, on balance, it is considered that the guidance produced through this initiative should focus on defining performance outcomes that support high-quality science while ensuring that animals have a good life, in line with the Five Domains approach to evaluating animal welfare.
What Will the Final Standards Look Like?
As an approximate guide, the Standards document produced through this work is expected to be around 40–50 pages long, allowing approximately four to five pages per topic.
The Standards will not seek to provide an exhaustive account of everything that could be said about each topic. Instead, they will aim to communicate clearly and concisely a shared understanding of the most important aspects: why they matter and what they should achieve in practice.
The vision is for the final published Standards to be valuable to the global scientific community and wider society, including regulators and other stakeholders involved in the use of animals in research and testing.
The aim is to establish expectations and a shared understanding of the key factors and actions that support high-quality, ethical science and good animal welfare.
These Standards should be viewed as guidance and not as substitutes for compliance with relevant local and national legislative and regulatory requirements.
It is also recognised that institutions and countries will vary in their current ability to meet some or all of the elements set out in the Standards.
Although the high-level performance (outcome-based) standards will be designed to be operational and realistically achievable, they will also encourage continuous improvement. Examples of leading practices to aspire to will be included.
Contact Information
For questions about this initiative, please contact the ICLAS Strategic Working Group:
Email: globalharmonisation@iclas.org
Five Domains
https://www.mdpi.com/2076-2615/10/10/1870
ILAR Guide
https://www.mdpi.com/2076-2615/10/10/1870
ETS123 and Appendix A
https://norecopa.no/media/2iydns5h/ets-123-original.pdf
https://felasa.eu/Portals/0/Library/Cons123(2006)_AppendixA_en.pdf?ver=RoWmQzq5GoZpVwU3K9jw_g%3D%3D
WOAH terrestrial animal code
https://www.woah.org/en/what-we-do/standards/codes-and-manuals/
Basel Declaration