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Ethical evaluation Timo Nevalainen University of Eastern Finland

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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. No restrictions. Abolition. Scientists. Animal welfare. Patient groups. Tools for assessment?. Science community - PowerPoint PPT Presentation

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Page 1: Ethical evaluation

Ethical evaluation

Timo NevalainenUniversity of Eastern Finland

Page 2: Ethical evaluation

Ethics?

to do goodnot to do bad

Is it worth it?Does it hurt?

Page 3: Ethical evaluation

Interests groups

Abolition No restrictions

Scientists

Animal welfare Patient groups

Page 4: Ethical evaluation

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

Page 5: Ethical evaluation

Law, science & ethics

excellence

Harmonization

Page 6: Ethical evaluation

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

Page 7: Ethical evaluation

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 processwww.esf.org

Page 8: Ethical evaluation

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

Page 9: Ethical evaluation

Revision of the Directive

Experts meet in Brussels Four groups

Scope, the 3Rs, Central Database Authorisation Ethical review Cost-benefit analysis and severity

classification

Page 10: Ethical evaluation

Cost-benefit

Benefit

CostBenefit

Cost

Page 11: Ethical evaluation

Can a proper cost-benefit analysis be made?

A cost-benefit analysis = An ethical judgementBasis: weight suffering of the experimental animals against fulfilling human needs

Page 12: Ethical evaluation

Why is Cost-Benefit difficult?

1. Different scientific viewpoints2. Conflicting daily experiences3. Different (moral) viewpoints4. Considerable political charge

Page 13: Ethical evaluation

Practical Ethics

Ethics Committees Do we have to know ?

basic researchapplied research

Project reviewcost-benefit analysisprobability to get valid, reliable results

Page 14: Ethical evaluation

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

Page 15: Ethical evaluation

Porter’s scoring

A. Purpose of studyB. Probability for reaching the purposeC. SpeciesD. Anticipated painE. Duration of painF. Duration of expG. Number of animalsH. Animal care

Scoring 1-5Points C-H max 30 limit 15

Points A-H max 40 limit 22

Ref: Nature 356: 101-102, 1992

Page 16: Ethical evaluation

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

Page 17: Ethical evaluation

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

Page 18: Ethical evaluation

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?

Page 19: Ethical evaluation

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

Page 20: Ethical evaluation

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

Page 21: Ethical evaluation

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

Page 22: Ethical evaluation

Formulating hypothesis

Kuzuya et al. 1966: Xylitol in dogs produces much stronger insulin release than glucoseHypothesis: Ingested xylitol causes insulin secretion, which results in hypoglycemiaBUT: Was this tested in the 2-year toxicity study ?Hypoglycemia only in fasted dogs ?What about home-made first aid ?

Page 23: Ethical evaluation

Scoring xylitol studyA. Purpose of studyB. Probability for reaching the purposeC. SpeciesD. Anticipated painE. Duration of painF. Duration of expG. Number of animalsH. Animal care

A3=clear health benefit B3=moderateC4=sentient, consciousD3=moderateE2=shortF1=very shortG2= 5-10 H1= excellent

C-H= 13, A-H=19

Page 24: Ethical evaluation

Insuliini ja glukoosi vasteet ksylitolille (1.5 g/kg po)

020406080

100120140160180200

0 100 200 300 400

Time (min)

Insu

lin (m

U/L

)

0

1

2

3

4

5

Glu

cose

(mm

ol/L

)

InsulinGlucose

Page 25: Ethical evaluation

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.

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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)

Page 29: Ethical evaluation

Nordic Forum 2003:Cost - Benefit - Means

COST

BENEFIT

Low High

High

Low

Means

Quality of care

Pain

Quality

Likelihood

Purpose no and species

Page 30: Ethical evaluation
Page 31: Ethical evaluation

Retro perspective ethics evaluation?

Page 32: Ethical evaluation

Cost benefit primer

Four short study protocolsRead through and discuss in groups identify both benefits and costs weigh them against each other consider means to

increase the benefitsdecrease the costs