UK LEGISLATION COURSE 6 - pt 1

Question 1

what is the PPL

Answer 1

project licence

Question 2

who grants the project licence

Answer 2

the Sec of State

Question 3

what is covered under the PPL

Answer 3

specifies programme of work - regulated procedures to animals at specieied places (PEL/POLE)

Question 4

what is the apaplication progression before it can be approved

Answer 4

• PPL - writted by potential holder - locally assessed by the AWERB before sign off by the applicant and the PELh
• the signed applciation - progresses tohome office inspectorate for harm vs benefot assessment, consideration
• granting, referral or refusal

Question 5

what is the longest a project licence can last for

Answer 5

up to 5 years

Question 6

what are the responsibilites of the PPL h

Answer 6

• scientific directions, management and control of programme of work
• compliance with T&C of licence
• supervision, training conduct an dperformance of PIL - working on PPL
• provide annual stat return to home office

Question 7

what reason can a PPL be granted

Answer 7

• basic research
• trasnlational/ applied research with following aims
• development/ testing of saftey for drugs. foods, feed
• protection of natural environment
• preserve animal species
• higher education or trainng for acquisition of skills
• forensic enquiries

Question 8

what is section A of the the project licence

Answer 8

personal details of the project licence application - mini cv

Question 9

what is section B of the project licence

Answer 9

• details of place where work will take place - PEL/POLE

Question 10

What is Section C of the PPL

Answer 10

scientific knowledge/backgroun - releavnt to scientific /progreamme

Question 11

what is section D of the project licence

Answer 11

covers the programme of work - objective of teh project - how this will be accomplished - and subsections addressing 3Rs

Question 12

what is covered under Section E of the project licence

Answer 12

covers the experimental protocols

Question 13

what is section F of PPL

Answer 13

declaration sections - includes signatures of PPL applicant and PELh

Question 14

what is section G - of the PPL

Answer 14

non-technical summary section

Question 15

under what section of the PPL is the severity catagories cclassed under

Answer 15

section E - assigned prospective catagory

Question 16

in what appendix of ASPA does it contain guidance of severity

Answer 16

• appendix G

Question 17

what is classed as non-recovery severity classification

Answer 17

• prcedure performed under general anaesthetic - anaimsl = not recover consciousness

Question 18

what is classed as a mild severity classification

Answer 18

• experience short term - mild pain , suffering, dostress - as well as some procedures - with no significant impact on wellbeing or gerneral conditions of the animals

Question 19

what are some examples are there of MILD procedures

Answer 19

• small infrequent blood samples
• skin irritation tests- mild
• tissue biopsy/cannulation
• procedures - terminated before animal shows more than minor changes to normal behaviour
• breeding of GM aniamls with mild phenotypic effects
• mofles - expose aniamls - to nocious stimuli - breifly assocaited with mild pain/suffering

Question 20

what is classed as a moderate procedure -

Answer 20

• likely to experience short term - moderate pain, suffering/ distress as well as procedures liekly to cause moderate impairment of wellbeing or general condition of aniamls

Question 21

what are examples of a moderate procedure

Answer 21

• toxicity testing avoiding lethal endpoints
• surgery when used with analesia and post op care
• frequent applicaion fo test substanced produing moderate clinical effects
• withdrawal of blood samples - >10% circulating volume - in conscious aniamls without volume replacemnt
• induction of a tumour causing moderate pain or distress
• withdrawal of food for 48 hours - in adult rats

Question 22

what is a severe procedure

Answer 22

• likely to experience severe pain, suffering , distress, long lasting moderate pain, suffering distress - as well as procedure - liekly to cause asevere imparment of th ewell being or general condiition of the animals

Question 23

what os examples of severe procedures

Answer 23

• acute toxicity procedures - morbitity - and death
• efficacy test of anti-microbial agents and vaccines
• some models of disease - welfare = comprimised
  surgery - under general anaesthesia - expected o result in severe or perisistant moderate post-op pai
  even if one aniamsl = suffer substantial effects - procedure merits a severe limit

Question 24

what must be done after the procedure

Answer 24

classify the actual severity - by PPLh or qualified person

Question 25

if the actual severity recorded was below the expected what must it be recorded as

Answer 25

sub-threshold

Question 26

are there standard conditions for the PPL

Answer 26

yes