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Ethical evaluation

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

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Ethical evaluation

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  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 No restrictions Abolition Scientists Animal welfare Patient groups

  4. 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

  5. Harmonization excellence Law, science & ethics

  6. 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 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 • .. 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

  8. Reporton 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

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

  10. Cost Benefit Cost-benefit Cost Benefit

  11. 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

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

  13. Practical Ethics • Ethics Committees • Do we have to know ? • basic research • applied research • 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 • Identification of problem areas • Item(s) to be improved • Thought assistance

  15. 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’s scoring

  16. 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 / Research

  17. 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

  18. 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? Porter / Animals II

  19. 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

  20. 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

  21. 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 Example:Xylitol and dogs

  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. 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= excellent Scoring xylitol study 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.

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

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

  28. Retro perspective ethics evaluation?

  29. 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

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