Brainscape's Knowledge GenomeTM


Top Flashcards (Certified)
All Flashcards

PIL > Animals (Scientific Procedures) Act 1986 > Flashcards

Animals (Scientific Procedures) Act 1986 Flashcards

(90 cards)

Start Studying
1
Q

UoS Ethical Policy Statement on the Use of Animals

A

no practical alternatives
minimize the harms
smallest numbers of animals used
highest standards of care and welfare

meet national legislative requirements

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

New ASPA

A

The Home Office Guidance on the Operation of the Animals (Scientific Procedures) Act 1986

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Scope of the New Animals (Scientific Procedures) Act 1986 [ASPA]

A

Implements Directive 2010/63/EU

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

What does the Act do………….?

A

Regulates any experimental or other scientific procedure to a “protected animal” that may have the effect of causing that animal pain, suffering, distress or lasting harm.

‘Regulated procedure’

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Regulated Procedure

A

‘Experiment’ - for a scientific purpose

REQUIRES BOTH A PROJECT AND A PERSONAL LICENSE

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Protected Animal

A

Any living vertebrate (other than man) and any cephalopod (Octopus, squid, cuttlefish and nautilus) from hatching

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What is a protected animal?

A

Any adult vertebrate or cephalopod (other than humans).

Any vertebrate in its foetal, larval or embryonic form is also protected:

  • For mammals, birds or reptiles, from two thirds way through gestation or incubation period .
  • Fish - from the time it becomes capable of independent feeding.
  • Cephalopods – from hatching

Working with these requires a personal and project licence

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

However - Not every animal is ‘protected’:

Working with non-protected animals requires no project or personal licence

A

Mammals, birds, reptiles: before 2/3 way through gestation

Fish etc. before independent feeding

Cephalopds before hatching

Other Invertebrates: flies, worms etc.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Animals are only ‘protected’ if they are ‘living’
You need no PIL or PPL to work with animals which are dead.

‘Living’ is defined as

A

Alive until there is permanent cessation of the circulation or the complete destruction of the brain.

Anaesthetised or decerbrate animals count as ‘living’

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Not all techniques are ‘regulated procedures’

You do not need a project or personal licence for the following:

A

Techniques used to identify animals

Breeding non GM animals

Euthanasia by approved/listed methods under Schedule 1 of ASPA

Recognised veterinary, agricultural or husbandry practices

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

The Act also regulates:

A

The breeding of genetically altered animals or animals with harmful mutations.

The breeding of animals for tissues for scientific purposes

The housing, care and supply of animals used in scientific procedures

Standards of housing and care are set out in specific Codes of Practice issued by the Home Office. New CoP based on Annex 3 of the Directive

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Schedule 1:

A

A list of approved methods for killing animals.

Allows trained people to kill animals without getting a personal licence.

Killing methods NOT on the Schedule 1 list need a project and a personal licence.
- This is a ‘regulated procedure’

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

SCHEDULE 2

A 
ANIMALS TO BE OBTAINED ONLY FROM DESIGNATED BREEDING OR SUPPLYING ESTABLISHMENTS
Dog
Cat
Primate
Mouse
Ferret
Rabbit
Rat
Guinea-pig
Hamster
Gerbils
Any bird of the species Coturnix coturnix (quail)
*Zebrafish*
*Frogs (including Xenopus)*
Pigs (if genetically modified)
Sheep (if genetically modified)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Code of Practice

A

Specifications for rooms, cage or pen sizes, stocking densities, and animal care standards are all prescribed in the “Code of Practice” (Annex 3)

Environmental conditions [temperature, humidity, air flow rates etc] are also defined by the “Code of Practice”

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Structure of ASPA

Before you start any experimental work (Regulated Procedures) you will need the following three authorisations:

A
  • Establishment Licence: Section 2C Licence [Licences the Place]
  • Project Licence: PPL [Licences the Programme of work]
  • Personal Licence: PIL [Licences the Individual]

Plus: Animal Welfare and Ethical Review Body [AWERB]

There is some work you can do without a PPL or PIL but you still need to be registered on the Establishment licence.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Establishment Licence

Licences the Place

A

Defines the type of establishment:
Scientific Procedures
Breeding (animals for procedures or tissues)
Supplying (animals or tissues)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Establishment Licence

Certain Officers must be nominated:
These are named on the Establishment Licence itself

A

Named Compliance Officer (NCO) (Previously the Certificate Holder)
responsible for ensuring compliance with the conditions of the establishment licence & who represents the governing authority of the institution.

Named Veterinary Surgeon (NVS)
advising on the welfare and treatment of the animals

Named Animal Care and Welfare Officer (NACWO)
overseeing the welfare and care of the animals

Named Training and Competency Officer (NTCO)
ensuring that those dealing with animals are adequately educated, trained and supervised until they are competent and that appropriate further training continues

Named Information Officer (NIO)
ensuring that those dealing with animals have access to any information they need

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Named Compliance Officer (NCO) (Previously the Certificate Holder)

A

responsible for ensuring compliance with the conditions of the establishment licence & who represents the governing authority of the institution

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Named Veterinary Surgeon (NVS)

A

advising on the welfare and treatment of the animals

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

Named Animal Care and Welfare Officer (NACWO)

A

overseeing the welfare and care of the animals

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

Named Training and Competency Officer (NTCO)

A

ensuring that those dealing with animals are adequately educated, trained and supervised until they are competent and that appropriate further training continues

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Named Information Officer (NIO)

A

ensuring that those dealing with animals have access to any information they need

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

Establishment Licence Holder

A

All establishments must also keep a register of all individuals involved in animal work to ensure adequate training in the following functions:

(a) Persons carrying out experimental procedures on animals (PIL’s)
(b) Persons designing procedures and projects (PPL’s)
(c) Persons taking care of animals
(d) Persons killing animals. (Sched. 1 users)

Can be listed in more than one category – or all four.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

Establishment License

List all rooms registered on the 2C license

A

Defines what the rooms can be used for:

The species
Holding rooms (short/long term)
Non sterile procedures/sterile procedures

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
``` Establishment license Things involved (overview) ```
Defines the type of establishment Named officers (NCO, NVS, NACWO, NTCO, NIO)
26
Project Licences [PPL]
Defines a programme of work Subject to specified conditions Defines the place of work
27
Project Licences [PPL] | Defines a programme of work
Part C - Purpose (Previously sec 17) Part D - Plan (of work) (Previously sec 18) Part E - Protocols [Previously Q19b]
28
Project Licences [PPL] | Subject to specified conditions
Standard (New for 2013) 25 conditions – end of all PPL’s Additional/Special - in covering letter – only certain PPL’s
29
Project Licences [PPL] | Defines the place of work
Primary/Secondary availability/podes
30
Project Licences [PPL] | Arranged and managed by a Project Licence Holder (PPL Holder)
Personally responsible for compliance Responsible for supervision of Personal Licensees
31
Project Licences [PPL] | Record keeping requirements
Detailed records on the use of all animals Submission of an official Annual Return (Now a digital spreadsheet)
32
Project Licences [PPL] | Duration
Up to 5 years
33
Project Licences - General
Regulated programmes of work and procedures will only be authorised if there are no scientifically suitable alternatives that could replace animal use, could reduce the number of animals used or could refine the procedures used to cause less suffering. [These are the principles of the “3Rs”]. The likely benefits (to humans, other animals or the environment) must be weighed against the likely welfare costs to the animals involved. [Cost/Benefit analysis].
34
Project Licences - General Important things to remember: Project licenses are split into sections
Sec C: Scientific Background (including benefits) Sec D: Programme of Work (including purpose of work) Sec E: Protocols (how you are going to do the work)
35
Project Licences [PPL] | Sec C
Scientific Background (including benefits)
36
Project Licences [PPL] | Sec D
Programme of Work (including purpose of work)
37
Project Licences [PPL] | Sec E
Protocols (how you are going to do the work)
38
Project Licences [PPL] | Protocols – Section E (19b)
List the techniques that can be used on the animals May not have to complete every step Important to read the document carefully before starting work
39
Project Licences [PPL] Protocols Each separate protocol has a severity limit
Defines the maximum severity allowed under a particular protocol sheet Steps used to minimise p/s/d/lh must be described and adhered to
40
Severity Limits - Guidelines
Mild Slight or minimal or transitory effects (e.g. blood sampling) Moderate Potential to cause greater suffering (e.g. toxicity tests, minor surgery) Severe Welfare likely to be seriously compromised (e.g. major surgery, acute toxicity tests with significant morbidity) Non-Recovery Entire protocol performed under deep non-recovery anaesthesia
41
Severity Limits | Mild
Slight or minimal or transitory effects (e.g. blood sampling)
42
Severity Limits | Moderate
Potential to cause greater suffering (e.g. toxicity tests, minor surgery)
43
Severity Limits | Severe
Welfare likely to be seriously compromised (e.g. major surgery, acute toxicity tests with significant morbidity)
44
Severity Limits | Non-Recovery
Entire protocol performed under deep non-recovery anaesthesia
45
Project Licences [PPL] | Protocols (Additional parts)
Adverse effects: What harm may come to the animals and how will you deal with them. Humane end points: At what defined point will a procedure be terminated on humane grounds. These are legally binding conditions of the PPL
46
Adverse effects
What harm may come to the animals and how will you deal with them
47
Humane end points
At what defined point will a procedure be terminated on humane grounds
48
Legally binding conditions of the PPL
Adverse effects | Humane end points
49
PPL | Individual Study Plans (ISP’S)
Required for every separate study performed under a PPL. For every new batch of animals. More specific than the general PPL but must represent what the PPL specifies. May be different for each study. PPL holder, all PIL’s unit manager and NACWO must sign before work starts.
50
PPL New for 2013 | Actual Severity
Severity classification based on the whole lifetime experience of individual animals Death = severe unless it is not related to the study or animal can be shown to have not suffered Autopsy is likely to be required to establish cause of death
51
PPL New for 2013 Actual Severity Whole lifetime experience
Records the ‘Actual Severity’ to each animal – not just the severity limit on the protocol The worst event the animal experiences defines the severity, not just the condition of the animal at the end of the procedure
52
PPL New for 2013 Actual Severity You may need advice or information from a number of sources to get an accurate result:
NACWO’s Technicians Veterinary staff/Named Vet
53
Re-Use of Animals in Scientific Procedures
Requires specific permission under a PPL Occurs where, following the use of the animal in a series of regulated procedures making up [the first] protocol, the animal is used in a subsequent [the second] protocol but where a naïve animal could otherwise have been used There is NO automatic requirement to kill a healthy animal at the conclusion of a protocol - Options include, continuing to look after the animal at the establishment, releasing the animal as a pet
54
Project Licences [PPL] | Personal license holders
All Personal Licence holders must be able to have access to the Project Licence under which they are working All Personal Licence holders should understand what the Project Licence covers All Personal Licence holders must have the permission of the Project Licence holder to work under their Project Licence
55
Compliance with ASPA
Legal Requirement
56
ASPA summary
A ‘regulated procedure’ (experiment) needs both an establishment, project and personal licence if: - The procedure is for a scientific purpose which may cause P/D/S/LH - The animal is ‘protected’ (a vertebrate (or cephalopod) over the prescribed age) - The animal is ‘alive’ (including terminal anaesthesia or dead by a non-schedule 1 method) All regulated procedures require an: - Establishment licence - Project licence - Personal licence * *NO regulated procedure can take place without all three**
57
ASPA summary | When do you NOT require the PIL and PPL licenses?
Culling using schedule 1 methods Animals below the age of protection Husbandry techniques/breeding non GM animals Veterinary procedures (subject to Vet Surgeons act)
58
Personal Licences [PIL]
Defines the place to which the license is issued Can be used in connection with ANY PPL Species groupings may be licensed (rather than individual species) Defines authorized regulated techniques (categories of techniques will be licensed) Subject to certain conditions (standard, additional/special inc supervision conditions) Requires detailed record keeping Duration Fees
59
Personal Licences [PIL] | Defines the
place to which the license is issued
60
Personal Licences [PIL] | Can be used in connection with ANY PPL
Subject to permission from the Project Licence holder Subject to the technique being required by that authorised programme of work
61
Personal Licences [PIL] | Species
Species groupings may be licence (rather than individual species): NB: Many still using individual species as previously
62
Personal Licences [PIL] | Species groupings
Rodents (inc. mice, rats, guinea pigs, hamsters and gerbils) and rabbits Small carnivores (inc. dogs, cats and ferrets) Non-human primates (old world, e.g. macaques, and new world, e.g. marmosets) Farm animals (inc. pigs, goats, sheep and cattle) Horses Birds Reptiles Amphibians Fish Cephalopods
63
Personal Licences [PIL] | Defines authorised regulated techniques
Categories of techniques will be licenced (rather than a list specifying separate techniques): A. Procedures not requiring any anaesthesia B. Procedures requiring simple anaesthesia for restraint or non-recovery C. Procedures requiring more complex anaesthesia plus surgery D. Procedures requiring anaesthesia plus administration of Neuromuscular Blocking Agents
64
Personal Licences [PIL] Defines authorised regulated techniques A
Procedures not requiring any anaesthesia
65
Personal Licences [PIL] Defines authorised regulated techniques B
Procedures requiring simple anaesthesia for restraint or non-recovery
66
Personal Licences [PIL] Defines authorised regulated techniques C
Procedures requiring more complex anaesthesia plus surgery
67
Personal Licences [PIL] Defines authorised regulated techniques D
Procedures requiring anaesthesia plus administration of Neuromuscular Blocking Agents
68
Personal Licences [PIL] | Subject to certain conditions:
``` Standard conditions (New for 2013) - 3R’s, Welfare, prevention of pain etc. ``` Additional/special conditions, including supervision conditions
69
Personal Licences [PIL] | Requires detailed record keeping
Details of all procedures performed Details of supervision [Training Records – now mandatory] Cage labels + ISP’s
70
Personal Licences [PIL] | Duration
Open ended but can be revoked at any time
71
Personal Licences [PIL] | Fees
Annual fee payable – currently £242 Billed via the Establishment Licence Holder via BSU
72
Personal Licence Application
Applicants must be at least 18 years old Must have minimum educational qualifications Must complete a Modular Training Programme Must complete an Application Form - NB Modular Training Certificate is NOT a licence to work
73
Personal Licensee Responsibilities
Appreciate that competence in performing techniques is gained through practical experience not theory Must have good understanding of: Biology of the relevant species Handling and husbandry of the relevant species How to perform techniques correctly Recognize illness/pain/suffering/distress and what action to take MUST be supervised by PPLH or experienced licensee until “signed off as competent” using mandatory Training Records
74
Personal Licensee Responsibilities Must have good understanding of:
Biology of the relevant species Handling and husbandry of the relevant species How to perform techniques correctly Recognize illness/pain/suffering/distress and what action to take
75
Personal Licensee Responsibilities Before starting any procedure check:
The place/room where you are about to perform your technique is licenced The Project Licence [PPL] authorises the technique, the purpose for which it is being done and you have the agreement of the Project Licence holder. Your Personal Licence [PIL] authorises the categories of technique and the species. Your Personal Training and Competency Record form is available and is up to date.
76
Personal Licensee Responsibilities Important: The training records now replace the detailed personal licences of the past.
All work must be initially supervised and signed. No unsupervised work can be carried out until training records are signed off No work can be taught to others until considerable experience has been gained and this section is signed on your training record
77
Personal Licensee Responsibilities Take primary responsibility for your animals
Animals need to be checked daily unless alternative arrangements have been made. Take veterinary and welfare advice if in any doubt your animals. If severity limits (defined in protocol sheets) or anticipated adverse effects are exceeded, notify the PPLH immediately Act in accordance with principle of the 3R’s
78
Personal Licensee Responsibilities Take primary responsibility for your animals: Anaesthetics
Always use anaesthetics when performing techniques, unless the anaesthetic itself is more traumatic than the actual technique NEVER use neuromuscular blocking agents without additional specific PPL and PIL authority - These are NOT anaesthetics, must be used in conjunction with an anaesthetic and the HO inspector normally requires at least 48 hours notice of their use
79
Personal Licensee Record Keeping Responsibilities All animals (individually or cages) MUST be labelled with information including
Animal identity (strain, sex, source etc) Personal Licence Holder, Name, number or code Project Licence number Procedure/Protocol Sheet Number Principal techniques applied and dates Principal adverse effects expected
80
Personal Licensee Record Keeping Responsibilities Personal Records (e.g. Lab Book) must be kept of all procedures performed including:
Animal identification details Techniques performed by date Whether techniques supervised and by whom Any morbidity or mortality encountered and action taken Fate of animal at end of procedure Personal Training and Competency records must be kept updated.
81
Personal Licensee Responsibilities - General
Delegation of Personal Licence is NOT generally allowed - Only permitted if additionally authorised on the Personal Licence - Only applies to certain simple techniques such as withholding of food or water, feeding special diets, placement of animals in restraining devices, pairing of genetically altered animals Performance in public is NOT permitted Animals may NOT be moved from one designated establishment to another without additional permissions Animals may NOT be released from the controls of ASPA (e.g. into the wild or as pets) without additional permissions
82
Animal Welfare and Ethical Review Body [AWERB] (Replaces ERP)
Provides ethical and operational advice to the institution, particularly with respect to project licence applications and standards of animal care and welfare. Promotes the use of ethical analysis to increase awareness of animal welfare issues and develop initiatives leading to the widest possible application of the 3Rs.
83
Named Animal Care & Welfare Officer | Duties of the NACWO include:
Providing advice on animal care and welfare to researchers Ensuring day to day care of animals Participating in the AWERB Process Responsibility for defined areas on the Establishment Licence Currently 6 in BSU
84
Named Veterinary Surgeon | Duties of the NVS include:
Providing veterinary advice to researchers Providing 24/7 veterinary cover Prescribing, supplying and controlling the use of POM medicines (Veterinary Medicines Act – no longer legal to use human drugs on animals) Maintaining animal health records Participating in the AWERB Process
85
Schedule 1
List of approved methods of humane killing of protected animals - Species specific - Stage of development specific Does not require PIL or PPL authority (as the technique is unregulated) NB: Everyone using Schedule 1 techniques MUST be registered on the Establishment Licence (including current PIL holders) Appropriate training needed (Currently PIL AB of HO Course) List of trained personnel held by the Institution Someone competent to kill must be available at all times From Jan 13 allowed to use anaesthesia/sedation prior to culling technique
86
Schedule 1 | Schedule 1 methods MUST be confirmed by one of the following:
Confirmation of permanent cessation of the circulation Destruction of the brain Dislocation of the neck Exsanguination Confirming the onset of rigor mortis Instant destruction of the body in a macerator
87
Schedule 1 | 3 R's
Principles of the 3R’s must be applied even when using schedule 1 methods only. If you are in any doubt about Schedule 1 issues (or any other procedure) please contact a NACWO or NVS
88
Home Office Inspectors
Medical or veterinary qualifications Advise the Secretary of State on applications for Licences and Certificates Make visits of inspection to determine compliance with Certificates, Licences and their conditions - Majority of visits are unannounced Report infringements
89
Animals in Science Committee | [formally APC]
Independent body that separately advises the Secretary of State + animal welfare and ethical review bodies on matters relating to acquisition, breeding, accommodating, care and use of protected animals Advise on certain severe protocols, primate work etc. - Membership includes animal welfare activists, scientists, licence holders, lawyers and lay people Details still to be confirmed
90
Some Other Animal Related Legislation
Animal Welfare Act 2006 The Veterinary Surgeons Act 1966 Agriculture (miscellaneous Provision) Act 1968 Endangered Species (Import & Export) Act 1968 Wildlife & Countryside Act 1981 Transit of Animals (amendment) Order 1988 International Air Transport Association (IATA) Live Animals Regulations The Welfare of Animals during Transport Order 1994

PIL (5 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions