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Ethical evaluation Timo Nevalainen University of Eastern Finland.

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Presentation on theme: "Ethical evaluation Timo Nevalainen University of Eastern Finland."— Presentation transcript:

1 Ethical evaluation Timo Nevalainen University of Eastern Finland

2 Ethics? to do good not to do bad Is it worth it? Does it hurt?

3 Interests groups Abolition No restrictions Scientists Animal welfare Patient groups

4 Tools for assessment? Science community well meaning ethical purpose well meaning ethical purpose how to balance purpose with cost how to balance purpose with costPhilosophies animal rights, utilitarism animal rights, utilitarism at project level of little help at project level of little helpLaw

5 Law, science & ethics excellence Harmonization

6 Council of Europe (CoE) Convention Revision of Appendix A CoE working groups CoE working groups species specific documents species specific documents general, rodents, rabbit, dogs, cats, primates, fish and farm animals enrichment and group housing enrichment and group housing mandatory unless there is a veterinary or scientific reason not to

7 European Science Foundation Use of Animals in Research (2001)..animal use should be subjected to independent expert review..animal use should be subjected to independent expert review.. both scientific and animal welfare considerations.. both scientific and animal welfare considerations.. weighing of the likely benefit and likely animal suffering …an essential part of the review process.. weighing of the likely benefit and likely animal suffering …an essential part of the review process

8 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 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 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 should include a cost/benefit analysis

9 Revision of the Directive Experts meet in Brussels Four groups Scope, the 3Rs, Central Database Scope, the 3Rs, Central Database Authorisation Authorisation Ethical review Ethical review Cost-benefit analysis and severity classification Cost-benefit analysis and severity classification

10 Cost-benefit Benefit Cost Benefit Cost

11 Can a proper cost-benefit analysis be made? A cost-benefit analysis = An ethical judgement A cost-benefit analysis = An ethical judgement Basis: weight suffering of the experimental animals against fulfilling human needs

12 Why is Cost-Benefit difficult? 1.Different scientific viewpoints 2.Conflicting daily experiences 3.Different (moral) viewpoints 4.Considerable political charge

13 Practical Ethics Ethics Committees Do we have to know ? Do we have to know ? basic research applied research Project review Project review cost-benefit analysis probability to get valid, reliable results

14 Breakdown of costs and benefits Both should be assessed Relative weight of elements? How to use? Scoring systems Scoring systems Identification of problem areas Identification of problem areas Item(s) to be improved Item(s) to be improved Thought assistance Thought assistance

15 Porters 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: , 1992

16 Porter / Research A. Aim of the experiment 1 = alleviation of substantial human ior animal pain 1 = alleviation of substantial human ior animal pain 3 = clear benefit to human or non-human health or welfare 3 = clear benefit to human or non-human health or welfare 5 = advancement of knowledge 5 = advancement of knowledge B. Realistic potential to achieve goals 1 = excellent 1 = excellent 5 = very limited or cannot be assessed 5 = very limited or cannot be assessed

17 Porter / Animals I C. Species 5 = NHP, 4 = other mammals…. 5 = NHP, 4 = other mammals…. D. Likely pain 5 = Severe..1 = None 5 = Severe..1 = None E. Duration of pain 5 = very long..1 = none or very short 5 = very long..1 = none or very short

18 Porter / Animals II F. Duration of experiment in relation to life span (LS) in relation to life span (LS) 5 = > 0.2 x LS 5 = > 0.2 x LS (mouse – 110 days) 4 = 0.02 x LS 4 = 0.02 x LS 3 = x LS 3 = x LS 2 = x LS 2 = x LS 1 = x LS 1 = x LS (mouse – 10 min) G. Number of animals 5 =>100 4 = = = = 1-5 or lowest score for appropriate no of animals?

19 An example of possible cost Quality of animal care (New App A) Excellent Excellent space above minimum / group housing / enrichment / bedding space above minimum / group housing / enrichment / bedding Very good Very good one of the criteria above missing one of the criteria above missing Good Good two of the criteria above missing two of the criteria above missing Satisfactory Satisfactory three of the criteria above missing three of the criteria above missing Poor Poor minimum space, alone and no enrichment minimum space, alone and no enrichment

20 Concluding Remarks Unfair for fundamental research ? 57 Nobel prizes in medicine 57 Nobel prizes in medicine Problems with GM-animals ? life time studies, high number of animals life time studies, high number of animals Expects major advances with minor cost yet, ideal worth thriving for yet, ideal worth thriving for Limits set too low? Breakdown clarifies thinking

21 Example: Xylitol and dogs Man commonly used sweetener commonly used sweetener positive effects on caries and on ear infections positive effects on caries and on ear infections excessive use may induce laxative effects 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

22 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 ?

23 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=moderateE2=short F1=very short G2= 5-10 H1= excellent C-H= 13, A-H=19

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

25 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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28 Cost – Means - Benefit principle Benefit Cost Means Facilities, transport Training and competence Veterinary care Experimental design - species, number - species, number - end points - end points - alternatives - alternatives Animal source Negative results Pain, distress, discomfort, suffering Duration, frequency, severity of those Death Human health Animal health Safety (toxicity studies) Increasing knowledge Ecology Economy (macro)

29 Nordic Forum 2003: Cost - Benefit - Means COST BENEFIT LowHigh Low Means Quality of care Pain Quality Likelihood Purpose no and species

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31 Retro perspective ethics evaluation?

32 Cost benefit primer Four short study protocols Read through and discuss in groups identify both benefits and costs identify both benefits and costs weigh them against each other weigh them against each other consider means to consider means to increase the benefits decrease the costs


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