A catalogue of criteria to objectify the harm-benefit analysis according to Austrian legislation
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1 LINZ th Eurpean Cngress n Alternatives t Animal Testing EUSAAT th Annual Cngress f EUSAAT September 2013, University f Linz, Austria A catalgue f criteria t bjectify the harm-benefit analysis accrding t Austrian legislatin Prject: Develping a methdlgy t evaluate animal experiments funded by the Austrian Federal Ministry fr Science and Research Dr. Nrbert Alzmann, Dr. Vera Marashi, Univ.-Prf. Dr. Herwig Grimm Messerli Research Institute (Vienna, Austria), Unit f Ethics and Human-Animal Studies (University f Veterinary Medicine, Vienna, Medical University f Vienna, University f Vienna)
2 1. Prpsal by the researcher Applicant Prpsal Cmpetent authrity Prject evaluatin Prject acceptable? 2
3 2. Prject evaluatin by the authrity Directive 2010/63/EU*) Austrian Animal Experimentatin Act (TVG 2012) Prject evaluatin shall verify that the prject meets the fllwing criteria**): the prject is justified frm a scientific r educatinal pint f view r required by law the purpses f the prject justify the use f animals prcedures t be carried ut as painlessly***) and in the mst envirnmentally sensitive manner pssible. *) Eurpean Parliament (2010): Directive 2010/63/EU f the Eurpean Parliament and f the Cuncil f 22 September 2010 n the prtectin f animals used fr scientific purpses. In: Official Jurnal f the Eurpean Unin Octber 20, 2010 L 276/ Article 38 (Prject evaluatin) **) Tierversuchsgesetz TVG (Austrian) Animal Experimentatin Act 2012, Federal Law n Experiments n Live Animals (BGBl. I N. 114/2012 f 28 Dec. 2012); 29 (1) ( Prjektbeurteilung ) ***) Directive: in the mst humane [ ] manner pssible 3
4 2. Prject evaluatin by the authrity Prject evaluatin shall cnsist in particular f the fllwing*): evaluatin f the bjectives f the prject, the predicted scientific benefits r educatinal value; assessment f the cmpliance with the requirements f the 3Rs assessment and assignment f the classificatin f the severity harm-benefit analysis *) 29 (2) TVG 2012 ( Prjektbeurteilung ) 4
5 3. Harm-benefit analysis a harm-benefit analysis f the prject, t assess whether the harm t the animals in terms f suffering, pain and fear*) is justified by the expected utcme taking int accunt ethical cnsideratins, and may ultimately benefit human beings, animals r the envirnment, in which the cmpleted catalgue f criteria [ ] has t be cnsidered, **) The Minister fr Science and Research publishes***) until 31 Dezember 2015 a catalgue based n scientific criteria in rder t bjectify the harm-benefit analysis *) Directive: distress **) 29 (2) N. 4 TVG 2012 ***) 31 (4) TVG
6 4. Requirements fr an apprpriate catalgue structuring the discussin bjective and transparent decisin making fair evaluatin intersubjective cmparing f results (cf. review Varga et al.*); aspect f justice; cherent standard f prtectin integrate ethical criteria int the evaluatin prcedure which will be typically carried ut by nn-ethicists *) Varga, O., Sande, P. and Olssn, I.A.S. (2012): Assessing the animal ethics review prcess. In: Ptthast, T. and Meisch, S. (Eds.): Climate change and sustainable develpment. Ethical perspectives n land use and fd prductin. Wageningen Acad. Publishers,
7 4. Requirements fr an apprpriate catalgue a. assistance fr the researcher t prvide the relevant infrmatin b. assistance fr the authrity wh cnducts the prject evaluatin but nt intended t replace a well infrmed respnsible decisin shuld include all relevant criteria 7
8 5. Relevant criteria Annex VI f the Directive 2012/63/EU: Aspects that a prpsal has t cmprise fr apprval 21 Austrian Animal Experiment Regulatin (TVV 2012*) *) Tierversuchs-Verrdnung 2012 TVV 2012 (BGBl. II N. 522/2012 f 28 Dec. 2012) Directive 2012/63/EU 8
9 6. Categries A1) General prject data A2) Assignement t ne f the legal purpses Infrmatin abut special aspects: Duplicatin f experiments Experiments using special species Reuse f animals B) Alternatives? / Indispensability C) Imprtance f the prject (incl. benefit) D) Quality f the experiment Scientific quality and efficiency Quality f the persnnel E) Burdens f the animals F) Breeding, husbandry and care G) Harm-benefit analysis H) Retrspective assessment 9
10 7. Structure f the questins Sympsium at the Messerli Research Institute, March 2013: Taking Ethical Cnsideratins int Accunt? Methds t Carry Out the Harm-Benefit Analysis Accrding t the EU Directive 2010/63/EU. Phts: 10
11 7. Structure f the questins 1) Checklist structure 2) Scring methdlgy 3) Cmparative apprach 11
12 7. Structure f the questins 1) Checklist structure (checking facts) Yes / N respectively crrect / nt applicable e.g.: Des the leader f a prject including surgery has an academic qualificatin crrespnding t 27(1) N.1 TVG 2012*)? x Yes N If nt, des she/he has a crrespnding educatin, which ne: Des the leader has sufficient specialized knwledge? Which ne: _ FELASA-Curse categry _ C Yes N x x Yes N *) 27 (1) ( Prjektleiterinnen der Prjektleiter ) N. 1 TVG 2012 in cnjunctin with 19 (2) N. 2 TVG
13 7. Structure f the questins 2) Scring methdlgy (evaluatin by weighting f issues) Questins will be answered accrding t each categry The applicant is asked t describe an issue Additinally he has t answer specific questins by grading (e.g. 1 5) r awarding pints (ready answers are ffered) Fr the prject evaluatin, the authrity/cmmittee makes its wn assessment and checks if the applicant s estimatin is plausible 13
14 7. Structure f the questins 2) Scring methdlgy (evaluatin by weighting f issues) After describing the issue the researcher has t answer additinal questins, e.g.: Realistic ptential f the experiment t achieve the bjective x Estimatin Researcher 1. Excellent 2. Very gd 3. Gd 4. Average 5. Inadequate x Estimatin Authrity 1. Excellent 2. Very gd 3. Gd 4. Average 5. Inadequate The prpsed evaluatin by grades is based n the prject evaluatin fr funding as used by the FWF*) in Austria *) Fnds zur Förderung der wissenschaftlichen Frschung (Austrian Science Fund) FWF (2012): Bewertungshandbuch für das Translatinal-Research-Prgramm, Appendix I: Fragen an FachgutachterInnen eines TRP-Prjekts, Sectin 1. Nte: The criteria aim als t prjects in the field f basic research, see Sectin 1 N
15 7. Structure f the questins 3) Cmparative apprach Extremes fr the adjustment f the catalgue Which appraisals are a n g, cf. Zurich Negative List *) *) Liste nicht mehr zulässiger Tierversuche an den Zürcher Hchschulen (List f animal tests which are n lnger allwed at institutes f higher learning in Zurich). In: ALTEX 14, 2/97,
16 8. Overall judgement Harm-benefit analysis Presumably, the results f each categry will be determined the results f each categry g int the verall judgement (harm-benefit analysis) 16
17 9. The prject Outline 2013 June 2014: develpment f the Austrian Catalgue f Criteria June 2014 June 2015: evaluatin f the catalgue Dec. 2015: final reprt 17
18 Thank yu fr yur attentin! 18
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