Laboratory Animal Science
Preclinicaltrials.eu ARRIVE guidelines nc3rs.org.uk
Legislation: Quality assurance in animal
experimentation: legal and practical demands
Relevant legislations:
Experiments on Animals Act
o Decree and regulations describe more detail on the act
o no experiments should be conducted on animals unless there are good
reasons for doing so, and no alternatives are available that would produce the
required result without using animals.
Directive EU
o Annex = appendix within directive
o Guidance document can be more easily adapted
Law of Nature Preservation
o Protection of species, field work,
Law on Animals
o Transport, weaning, mutilation, housing
Law on Environmental Pollution
o GMO
What is an animal experiment?
Animal: species, life stages
Goal of experiment: acquire or share knowledge
Pain, suffering: injecting a needle = threshold
Any use, invasive or non-invasive, of an animal for experimental or other scientific
purposes, with known or unknown outcome, or educational purposes, which may cause the
animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that
caused by the introduction of a needle in accordance with good veterinary practice.
Restriction: Not allowed to conduct experiments if the three R’s are not met
o (art 1d5)
Killing an animal for the purpose of organs is included in the Dutch law, but not in the
European law
Article 9 status: responsibility of designing the animal experiment and defining
human endpoints
Article 13f.2 status: carrying out the animal experiments, perform daily health checks
and euthanize the animals
,Involved parties, procedures, and control
Nationally
o Ministry of agriculture
o CA: ethical judgement & project license
o NVWA: institutional license, external supervision, yearly registration
o NCad: advice to minister, CCD, AWBs, disperse best practices
From idea to animal experiment:
1. Applicant: responsible researcher for set up of experiment/project
a. Requires MSC with 500 hours education in basic biology and LAS course
b. Species-specific knowledge
2. Application for project license
a. Non-technical summary
b. Project proposal: background, goal, importance, research strategy
c. Appendices animal experiments: type of procedures, number of animals,
discomfort
3. Approval & guidance by Animal Welfare Body (AWB)
a. Animal welfare, science quality, legal demands
b. Advice (3Rs), supervision
c. Meeting with submitting researcher, AWB member, biostatistician,
veterinarian if needed
d. Obligatory before experimental work can commence
e. Content and execution of the protocol are discussed
f. Main goals:
i. responsibilities are clear to all people involved
ii. information is sufficient to allow proper execution and inspection
iii. protocol is in accordance with project license
iv. data for legal registration are complete and correct
4. Advice by DEC: animal ethics committee
a. Ethical judgement on project applications
b. Advice to competent authority (CCD)
5. Approval by CCD
a. Ethical judgement & grant project license
b. Only the CCD can give license to a project upon advice of the DEC
Locally: Local execution of an animal experiment
6. Working protocol: fits exactly within project license
a. Details of experiments, agreements/responsibilities, amendments
b. Method of housing: social housing, cage size, bedding, enrichment, climate
c. Level of discomfort: non-recovering > mild > moderate (putting animals on
anesthesia) > severe (arthritis, PTSS) avoid suffering
d. Humane end points: A common misunderstanding is that animals should be
killed at a humane endpoint, you just stop doing the experimental procedures
i. The results have been achieved
ii. The animal suffers severely and unintentional
1. Specific clinical signs
, 2. General parameters of severe and unintentional suffering
iii. The animal is no longer suitable as a model and/or results can no
longer be achieved
iv. (see slides)
e. Method of killing (euthanasia): when reached human endpoint
i. Animal welfare, Legal demands, science quality (method should not
interfere)
7. Animal facility
a. Welfare log: in vicinity of animals that contains description of clinical signs.
i. Monitoring by qualified person (obligatory), daily and weekly
8. Quality and welfare monitoring
a. Internal oversight: technician/caretaker, AWB, designated veterinarian
i. AWB: execution according to project license and working protocol,
welfare log, competence personnel, communication, housing/care
b. External: NVWA
9. After the animal experiment
a. Welfare evaluation
b. Retrospective evaluation
c. Yearly registration
DEC: dieren experiment comississie
In order to maintain a unique line of mice with epilepsy present at birth, these mice are
bred. For this, one would need permission of the AEC.
A test with chicken embryo’s (3 days old) is not an animal experiment according to the
Experiment on Animals Act.
,
Preclinicaltrials.eu ARRIVE guidelines nc3rs.org.uk
Legislation: Quality assurance in animal
experimentation: legal and practical demands
Relevant legislations:
Experiments on Animals Act
o Decree and regulations describe more detail on the act
o no experiments should be conducted on animals unless there are good
reasons for doing so, and no alternatives are available that would produce the
required result without using animals.
Directive EU
o Annex = appendix within directive
o Guidance document can be more easily adapted
Law of Nature Preservation
o Protection of species, field work,
Law on Animals
o Transport, weaning, mutilation, housing
Law on Environmental Pollution
o GMO
What is an animal experiment?
Animal: species, life stages
Goal of experiment: acquire or share knowledge
Pain, suffering: injecting a needle = threshold
Any use, invasive or non-invasive, of an animal for experimental or other scientific
purposes, with known or unknown outcome, or educational purposes, which may cause the
animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that
caused by the introduction of a needle in accordance with good veterinary practice.
Restriction: Not allowed to conduct experiments if the three R’s are not met
o (art 1d5)
Killing an animal for the purpose of organs is included in the Dutch law, but not in the
European law
Article 9 status: responsibility of designing the animal experiment and defining
human endpoints
Article 13f.2 status: carrying out the animal experiments, perform daily health checks
and euthanize the animals
,Involved parties, procedures, and control
Nationally
o Ministry of agriculture
o CA: ethical judgement & project license
o NVWA: institutional license, external supervision, yearly registration
o NCad: advice to minister, CCD, AWBs, disperse best practices
From idea to animal experiment:
1. Applicant: responsible researcher for set up of experiment/project
a. Requires MSC with 500 hours education in basic biology and LAS course
b. Species-specific knowledge
2. Application for project license
a. Non-technical summary
b. Project proposal: background, goal, importance, research strategy
c. Appendices animal experiments: type of procedures, number of animals,
discomfort
3. Approval & guidance by Animal Welfare Body (AWB)
a. Animal welfare, science quality, legal demands
b. Advice (3Rs), supervision
c. Meeting with submitting researcher, AWB member, biostatistician,
veterinarian if needed
d. Obligatory before experimental work can commence
e. Content and execution of the protocol are discussed
f. Main goals:
i. responsibilities are clear to all people involved
ii. information is sufficient to allow proper execution and inspection
iii. protocol is in accordance with project license
iv. data for legal registration are complete and correct
4. Advice by DEC: animal ethics committee
a. Ethical judgement on project applications
b. Advice to competent authority (CCD)
5. Approval by CCD
a. Ethical judgement & grant project license
b. Only the CCD can give license to a project upon advice of the DEC
Locally: Local execution of an animal experiment
6. Working protocol: fits exactly within project license
a. Details of experiments, agreements/responsibilities, amendments
b. Method of housing: social housing, cage size, bedding, enrichment, climate
c. Level of discomfort: non-recovering > mild > moderate (putting animals on
anesthesia) > severe (arthritis, PTSS) avoid suffering
d. Humane end points: A common misunderstanding is that animals should be
killed at a humane endpoint, you just stop doing the experimental procedures
i. The results have been achieved
ii. The animal suffers severely and unintentional
1. Specific clinical signs
, 2. General parameters of severe and unintentional suffering
iii. The animal is no longer suitable as a model and/or results can no
longer be achieved
iv. (see slides)
e. Method of killing (euthanasia): when reached human endpoint
i. Animal welfare, Legal demands, science quality (method should not
interfere)
7. Animal facility
a. Welfare log: in vicinity of animals that contains description of clinical signs.
i. Monitoring by qualified person (obligatory), daily and weekly
8. Quality and welfare monitoring
a. Internal oversight: technician/caretaker, AWB, designated veterinarian
i. AWB: execution according to project license and working protocol,
welfare log, competence personnel, communication, housing/care
b. External: NVWA
9. After the animal experiment
a. Welfare evaluation
b. Retrospective evaluation
c. Yearly registration
DEC: dieren experiment comississie
In order to maintain a unique line of mice with epilepsy present at birth, these mice are
bred. For this, one would need permission of the AEC.
A test with chicken embryo’s (3 days old) is not an animal experiment according to the
Experiment on Animals Act.
,
