Practical Handbook on the 3Rs in the Context of the Directive 2010/63/EU

1st Edition - November 18, 2021
Imprint: Academic Press
Editors: Gianni Dal Negro, Silvia Sabbioni
Language: English
Paperback ISBN:
9 7 8 - 0 - 1 2 - 8 2 1 1 8 0 - 9
eBook ISBN:
9 7 8 - 0 - 1 2 - 8 2 1 2 5 2 - 3

Practical Handbook on the 3Rs in the Context of the Directive 2010/63/EU provides updated information on the EU Directive 2010/63/EU, which is the European Union legislation that p… Read more

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Practical Handbook on the 3Rs in the Context of the Directive 2010/63/EU provides updated information on the EU Directive 2010/63/EU, which is the European Union legislation that protects animals being used in research. EU Directive 2010/63/EU is the European Union (EU) legislation 'on the protection of animals used for scientific purposes' and is one of the most stringent ethical and welfare standards worldwide.

Cover image
Title page
Table of Contents
Copyright
Dedication
Quotes
Contributors
Editors' preface
Acknowledgment
Chapter 1. Ethics and law on human–animal relationship
Ethical aspects (Marta Piscitelli)
Legal aspects (Enrico Maestri)
Chapter 2. Communication and transparency in research involving animals
Introduction (Lluis Montoliu)
The ARRIVE guidelines (Lluis Montoliu)
Public perception of animal research (Lluis Montoliu)
Practicing communication and transparency in animal research
School and research hand in hand (Annarita Wirz)
Chapter 3. Anatomy, physiological features, genetics and genetic alterations, breeding and strain differences relevant to the choice of the model—Impact of 3Rs
Introduction and general concepts: basic anatomical features relevant to the choice of models (Paolo de Girolamo and Livia D'Angelo)
Evolution of the anatomy and physiology of pain pathways and its relevance in relation to the severity of procedures (Adalberto Merighi and Laura Lossi)
Breeding, genetics, genetic alterations, and strain differences relevant to the choice of the model (Marcello Raspa and Ferdinando Scavizzi)
Genetic modification of zebrafish (Livia D'Angelo)
Impact of 3Rs in the genetically altered model creation, management, and phenotyping (Marcello Raspa and Ferdinando Scavizzi)
Chapter 4. Animal welfare
Animal welfare and behavior (Viola Galligioni and Paola Zarattini)
Design of in vivo research infrastructures and laboratory animal facilities (Helmut Fuchs and Martin Hrabe de Angelis)
Management in vivo research infrastructures and laboratory animal facilities (Olga Boruc)
Chapter 5. Methods of handling and procedures
Introduction
Rodent and rabbit handling methods (Luisa Corsi, Chiara Attanasio)
Marking methods of rodents and rabbits (Luisa Corsi, Chiara Attanasio)
Basic procedures, substance administration and sampling in rodents and rabbits (Luisa Corsi, Chiara Attanasio)
Methods of zebrafish handling (Livia D'Angelo, Chiara Attanasio)
Methods of identification and marking of zebrafish (Livia D'Angelo, Chiara Attanasio)
Basic procedures performed on zebrafish (Livia D'Angelo, Chiara Attanasio)
Chapter 6. Animal health management and hygiene
Introduction (Ferdinando Scavizzi and Marcello Raspa)
Classification of animals and basic structures to their microbiological characteristics (Ferdinando Scavizzi and Marcello Raspa)
Cleaning, sanitizing, and sterilization procedures (Ferdinando Scavizzi and Marcello Raspa)
Risks (Viola Galligioni and Ferdinando Scavizzi)
Health and environmental monitoring in animal unit (Ferdinando Scavizzi and Viola Galligioni)
Health monitoring program (Ferdinando Scavizzi and Marcello Raspa)
Diagnostic tests (Ferdinando Scavizzi and Viola Galligioni)
Exhaust air dust filters (Viola Galligioni and Ferdinando Scavizzi)
Environmental monitoring (Ferdinando Scavizzi and Marcello Raspa)
Interventions in case of pathogen contamination (facility outbreak) (Marcello Raspa and Viola Galligioni)
Health status and well-being (Marcello Raspa and Ferdinando Scavizzi)
Links to website
Traceability (Viola Galligioni)
Local arrangements for use of animals (Viola Galligioni)
Animal transport (Viola Galligioni)
Biosafety and biocontainment (Valentina Vasina)
Allergy (Valentina Vasina)
Zoonosis (Valentina Vasina)
Risk prevention and hazard mitigation (Valentina Vasina)
Chapter 7. Recognition of pain, distress, and suffering
Introduction (Cholawat Pacharinsak, Patrick Sharp, and Sara Fuochi)
Background (Cholawat Pacharinsak, Patrick Sharp, and Sara Fuochi)
Pain, distress, and suffering (Cholawat Pacharinsak, Patrick Sharp, and Sara Fuochi)
Recognition of species-specific signs of distress, pain, and suffering of most common laboratory animals (Cholawat Pacharinsak, Patrick Sharp, and Sara Fuochi)
Welfare assessment of genetically induced phenotypes (Anne Zintzsch)
Chapter 8. Harm to research animals, severity categories, and humane endpoints
Harm and suffering in research animals
Severity classification
Humane endpoints
Chapter 9. Anaesthesia, analgesia, and killing
Introduction
Anaesthesia and analgesia
Criteria for selection of anaesthesia protocols and drugs
Nonpharmacological control of pain and distress
Notes on the anaesthetic inhalers
Killing methods
Chapter 10. Replacement
Preface
Introduction
What does a replacement method mean?
Replacement methods and testing strategies
What is a scientifically satisfactory replacement method?
International acceptance of replacement alternatives to animal experimentation
Conclusions
Chapter 11. Design of procedures and projects
Introduction (Derek Fry)
Basic design considerations (Derek Fry)
How to plan experiments from day one (Adrian Smith)
Animal models (Joanne Storey)
Experimental design and statistical analysis (Simon Bate)
Preclinical systematic reviews (Merel Ritskes-Hoitinga)
Harm-benefit assessment (Joanne Storey)
Further reading
Index

Gianni Dal Negro

Dr. Gianni Dal Negro is an European Registered Toxicologist with over 30 years of experience in Research and Development applied to both the regulatory and non-regulatory areas in the pharmaceutical sector. In his career, he has represented the European Federation of Pharmaceutical Industries and Associations (EFPIA) in the ECVAM Scientific Advisory Committee (ESAC); he has been member of international committees and he has contributed to international initiatives relevant to the 3Rs (science, legislation, regulatory requirements). Before retiring, Dr. Dal Negro has been World-wide Director of 3Rs at GlaxoSmithKline Ltd, UK, Industry Chair of the European Partnership for Alternative Approaches to Animal Testing (EPAA), and member of the Royal College of Veterinary Surgeons in UK. He is past President of the Italian Association of Laboratory Animal Science (AISAL). Dr. Dal Negro has authored and co-authored several papers in peer-reviewed journals. He is also a member of the Editorial Board of the Journal Toxicology in Vitro (Elsevier).

Affiliations and expertise

Former World-wide Director of 3Rs, GlaxoSmithKline Ltd., London, UK

Silvia Sabbioni

Dr. Silvia Sabbioni Pharm. D, PhD, is Professor in Laboratory Medicine at the University of Ferrara, Italy, where she teaches Microbiology. She is part of the Microarray Facility of the Emilia Romagna Region Life Sciences Technopole (LTTA) at the University of Ferrara, where she coordinates the microbiome studies in the NGS-based genome analysis service. Amongst her research activities, she is involved in the study of microRNAs in oncogenesis and, more recently, also in novel health surveillance approaches through microbiome analysis. She has authored and co-authored over 70 papers in peer-reviewed journals. Professor Sabbioni is also member of the Editorial Board of the Scientific Journal Cancers (MDPI, Basel, Switzerland). She is former member of the Emilia Romagna Region Ethical Committee and Chair of the Animal Welfare Body (AWB) of the University of Ferrara; currently, she is a AWB member at the same Institution and member of the Board of the Italian Association of Laboratory Animal Science (AISAL).

Affiliations and expertise

Professor at the Department of Life Sciences and Biotechnology, University of Ferrara, Italy

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health