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Abstract
Russell and Burch’s 1959 original definitions of the 3Rs (replacement, reduction and
refinement) are widely used today as standards for the ethical use of non-human animals
in research, although they have a number of limitations. Authors and institutions
around the world have addressed some of these, coming up in certain cases with more
accurate, functional, and up-to-date definitions. However, not only do there still
remain limitations needing to be addressed, but some that have been addressed resulted
in discrepancies, contradictions, and general confusion as to how best apply the 3Rs
in practice. In order to clarify the meaning of the 3Rs and enable more optimal implementation
of these principles in animal experimentation, this article provides a theoretical
discussion for revised definitions of the original 3Rs via examination of some of
their main limitations and inconsistencies. First, we offer up the original definitions
as presented in the context of Russell and Burch’s book
The Principles of Humane Experimental Technique. Then, we examine the main limitations and present clear specifications and requirements
for such revised definitions. After presenting our revised definitions, we conclude
with various implications for animal welfare within the context of experimentation.
Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, we propose 7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value-enhancements of health or knowledge must be derived from the research; (2) scientific validity-the research must be methodologically rigorous; (3) fair subject selection-scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks; (5) independent review-unaffiliated individuals must review the research and approve, amend, or terminate it; (6) informed consent-individuals should be informed about the research and provide their voluntary consent; and (7) respect for enrolled subjects-subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. Fulfilling all 7 requirements is necessary and sufficient to make clinical research ethical. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted. JAMA. 2000;283:2701-2711.
There is widespread concern about the quality, reproducibility and translatability of studies involving research animals. Although there are a number of reporting guidelines available, there is very little overarching guidance on how to plan animal experiments, despite the fact that this is the logical place to start ensuring quality. In this paper we present the PREPARE guidelines: Planning Research and Experimental Procedures on Animals: Recommendations for Excellence. PREPARE covers the three broad areas which determine the quality of the preparation for animal studies: formulation, dialogue between scientists and the animal facility, and quality control of the various components in the study. Some topics overlap and the PREPARE checklist should be adapted to suit specific needs, for example in field research. Advice on use of the checklist is available on the Norecopa website, with links to guidelines for animal research and testing, at https://norecopa.no/PREPARE.
Simple Summary This review outlines the latest in a succession of updates of the Five Domains Model, which, at each stage, incorporated contemporary verified scientific thinking of relevance to animal welfare assessment. The current update includes, within the structure of the Model, specific guidance on how to evaluate the negative and/or positive impacts of human behaviour on animal welfare. Persons whose actions may be evaluated include, but are not limited to, livestock handlers, owners of draught animals, veterinary care staff, pound/shelter staff, zoo-keepers, wildlife managers, hunters, researchers, companion animal owners, owners of sport/recreational animals, animal trainers and service animal handlers. Situations where human–animal interactions may have negative welfare impacts include: when animals have had little or no prior human contact, when human presence adds to already threatening circumstances, when human actions are directly unpleasant, threatening and/or noxious, when humans’ prior actions are remembered as being aversive or noxious and when the actions of bonded humans cause unintended harms. In contrast, situations where human–animal interactions may have positive welfare impacts include: when the companionable presence of humans provides company and feelings of safety, when humans provide preferred foods, tactile contacts and/or training reinforcements, when humans participate in enjoyable routine activities or in engaging variable activities, when the presence of familiar humans is calming in threatening circumstances and when humans act to end periods of deprivation, inhibition or harm. The explicit delineation within the Model of the potential impacts of human interactions on the welfare of animals enhances the Model’s utility. Additional updates in this latest version are also explained. Abstract Throughout its 25-year history, the Five Domains Model for animal welfare assessment has been regularly updated to include at each stage the latest authenticated developments in animal welfare science thinking. The domains of the most up-to-date Model described here are: 1 Nutrition, 2 Physical Environment, 3 Health, 4 Behavioural Interactions and 5 Mental State. The first four domains focus attention on factors that give rise to specific negative or positive subjective experiences (affects), which contribute to the animal’s mental state, as evaluated in Domain 5. More specifically, the first three domains focus mainly on factors that disturb or disrupt particular features of the body’s internal stability. Each disturbed or disrupted feature generates sensory inputs which are processed by the brain to form specific negative affects, and these affects are associated with behaviours that act to restore the body’s internal stability. As each such behaviour is essential for the survival of the animal, the affects associated with them are collectively referred to as “survival-critical affects”. In contrast, Domain 4, now named Behavioural Interactions, focusses on evidence of animals consciously seeking specific goals when interacting behaviourally with (1) the environment, (2) other non-human animals and (3) as a new feature of the Model outlined here, humans. The associated affects, evaluated via Domain 5, are mainly generated by brain processing of sensory inputs elicited by external stimuli. The success of the animals’ behavioural attempts to achieve their chosen goals is reflected in whether the associated affects are negative or positive. Collectively referred to as “situation-related affects”, these outcomes are understood to contribute to animals’ perceptions of their external circumstances. These observations reveal a key distinction between the way survival-critical and situation-related affects influence animals’ aligned behaviours. The former mainly reflect compelling motivations to engage in genetically embedded behavioural responses, whereas the latter mainly involve conscious behavioural choices which are the hallmarks of agency. Finally, numerous examples of human–animal interactions and their attendant affects are described, and the qualitative grading of interactions that generate negative or positive affect is also illustrated.
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History
Date
received
: 26
January
2024
Date
revision received
: 06
June
2024
Date
accepted
: 19
July
2024
Page count
Tables: 1,
References: 70,
Pages: 11
Funding
Funded by:
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, doi http://dx.doi.org/10.13039/501100001711;
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