Ethical evaluation Timo Nevalainen University of Eastern Finland.
-
Upload
preston-newbold -
Category
Documents
-
view
215 -
download
1
Transcript of Ethical evaluation Timo Nevalainen University of Eastern Finland.
Ethical evaluation
Timo Nevalainen
University of Eastern Finland
Ethics?
to do good
not to do bad
Is it worth it?
Does it hurt?
Interests groups
Abolition No restrictions
Scientists
Animal welfare Patient groups
Tools for assessment?
Science community well meaning ethical purpose how to balance purpose with cost
Philosophies animal rights, utilitarism at project level of little help
Law
Law, science & ethics
excellence
Harmonization
Council of Europe (CoE) Convention
Revision of Appendix A CoE working groups species specific documents
general, rodents, rabbit, dogs, cats, primates, fish and farm animals
enrichment and group housingmandatory unless there is a veterinary or scientific reason not to
European Science Foundation
Use of Animals in Research (2001) ..animal use should be subjected to independent
expert review .. both scientific and animal welfare considerations .. weighing of the likely benefit and likely animal
suffering …an essential part of the review process
www.esf.org
Report on Directive 86/609 … s (2001/2259(INI))
by Committee on the Environment, Public Health and Consumer Policy
must be able clearly to substantiate and justify the purpose … the experiments will be of benefit to animals or humans
an ethical and animal-welfare assessment must be carried setting limits to the level of stress to which the animals may be subjected
should include a cost/benefit analysis
Revision of the Directive
Experts meet in Brussels
Four groups Scope, the 3Rs, Central Database Authorisation Ethical review Cost-benefit analysis and severity
classification
Cost-benefit
Benefit
CostBenefit
Cost
Can a proper cost-benefit analysis be made?
A cost-benefit analysis = An ethical judgement
Basis: weight suffering of the experimental animals against fulfilling human needs
Why is Cost-Benefit difficult?
1. Different scientific viewpoints2. Conflicting daily experiences3. Different (moral) viewpoints4. Considerable political charge
Practical Ethics
Ethics Committees Do we have to know ?
basic research
applied research Project review
cost-benefit analysis
probability to get valid, reliable results
Breakdown of costs and benefits
Both should be assessedRelative weight of elements?How to use?
Scoring systems
Identification of problem areas Item(s) to be improved Thought assistance
Porter’s scoring
A. Purpose of study
B. Probability for reaching the purpose
C. Species
D. Anticipated pain
E. Duration of pain
F. Duration of exp
G. Number of animals
H. Animal care
Scoring 1-5
Points C-H max 30 limit 15
Points A-H max 40 limit 22
Ref: Nature 356: 101-102, 1992
Porter / Research
A. Aim of the experiment 1 = alleviation of substantial human ior
animal pain 3 = clear benefit to human or non-human
health or welfare 5 = advancement of knowledge
B. Realistic potential to achieve goals 1 = excellent 5 = very limited or cannot be assessed
Porter / Animals I
C. Species 5 = NHP, 4 = other mammals….
D. Likely pain 5 = Severe..1 = None
E. Duration of pain 5 = very long..1 = none or very short
Porter / Animals II
F. Duration of experiment in relation to life span
(LS) 5 = > 0.2 x LS
(mouse – 110 days) 4 = 0.02 x LS 3 = 0.002 x LS 2 = 0.0002 x LS 1 = 0.00001 x LS
(mouse – 10 min)
G. Number of animals 5 =>100 4 = 20-100 3 = 10-20 2 = 5-10 1 = 1-5 or lowest score for
appropriate no of animals?
An example of possible cost
Quality of animal care (New App A) Excellent
space above minimum / group housing / enrichment / bedding Very good
one of the criteria above missing Good
two of the criteria above missing Satisfactory
three of the criteria above missing Poor
minimum space, alone and no enrichment
Concluding Remarks
Unfair for fundamental research ? 57 Nobel prizes in medicine
Problems with GM-animals ? life time studies, high number of animals
Expects major advances with minor cost yet, ideal worth thriving for
Limits set too low?
Breakdown clarifies thinking
Example:Xylitol and dogs
Man commonly used
sweetener positive effects on
caries and on ear infections
excessive use may induce laxative effects
Dogs 2-year toxicity study
at 2 g/kg daily in diet resulted in minor liver changes
accidental consumption of xylitol: mortality with seizures clinically
Formulating hypothesis
Kuzuya et al. 1966: Xylitol in dogs produces much stronger insulin release than glucose
Hypothesis: Ingested xylitol causes insulin secretion, which results in hypoglycemia
BUT: Was this tested in the 2-year toxicity study ?
Hypoglycemia only in fasted dogs ?
What about home-made first aid ?
Scoring xylitol study
A. Purpose of study
B. Probability for reaching the purpose
C. Species
D. Anticipated pain
E. Duration of pain
F. Duration of exp
G. Number of animals
H. Animal care
A3=clear health benefit
B3=moderate
C4=sentient, conscious
D3=moderate
E2=short
F1=very short
G2= 5-10
H1= excellentC-H= 13, A-H=19
Insuliini ja glukoosi vasteet ksylitolille (1.5 g/kg po)
020406080
100120140160180200
0 100 200 300 400
Time (min)
Insu
lin
(mU
/L)
0
1
2
3
4
5
Glu
cose
(m
mol
/L)
InsulinGlucose
A Dutch system to support decision-making
In 1999 Frans Stafleu, Ronno Tramper, Jan Vorstenbosch and Jaap Joles have developed a system to support decision-making.
In order to compare the apples with the oranges they quantified the different aspects.
Cost – Means - Benefit principleBenefitCost
Means
Facilities, transportTraining and competenceVeterinary careExperimental design - species, number - end points - alternativesAnimal sourceNegative results
Pain, distress, discomfort, sufferingDuration, frequency, severity of thoseDeath
Human healthAnimal healthSafety (toxicity studies)Increasing knowledgeEcologyEconomy (macro)
Nordic Forum 2003:Cost - Benefit - Means
COST
BENEFIT
Low High
High
Low
Means
Quality of care
Pain
Quality
Likelihood
Purpose no and species
Retro perspective ethics evaluation?
Cost benefit primer
Four short study protocols
Read through and discuss in groups identify both benefits and costs weigh them against each other consider means to
increase the benefits
decrease the costs