Idibell - Aaalac

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Idibell - Aaalac

Ethical Review Processin a non profit organizationIDIBELL, SpainMarga NadalIDIBELLAAALAC International Conference in Europe May 2009IDIBELL M NADAL AAALAC International Conference Rome May 2009 1


TABLECONTENTS1. IDIBELL and AF presentation2. Spanish and Regional legislation3. IACUC responsibilities and ethicalreview process4. AAALAC site visits (2006 and 2008)5. ConclusionsIDIBELL M NADAL AAALAC International Conference Rome May 2009 3


IDIBELL and AF presentationThe Bellvitge Institute for Biomedical Research (IDIBELL) is anon profit research foundation set up on June 16, 2004 as its ownlegal entity resulting from the change of name of the previousAugust Pi i Sunyer Foundation (FAPS), set up in 1998.Barcelona, Spain1missionTo promote, develop, administrate and disseminate the biomedicalresearch and research education in the field of health sciences,essentially in the Bellvitge campus and to administrate theresources devoted to research and to research education“visionIDIBELL has to become an excellent center to initiate a researchcareer in cellular medicine, where high standard basic research isat the service of relevant clinical questions and of economicdevelopmentIDIBELL M NADAL AAALAC International Conference Rome May 2009 4


IDIBELL and Animal Facility Introduction1• The IDIBELL has scientificcooperation agreements with:• Barcelona University (UB)• Catalan Institute of Oncology(ICO)• University Hospital of Bellvitge(HUB)Barcelona University Animal Facility:1.546m², mostly housing largespecies (pig, dog, rabbit)Facility Unit in Duran and ReynalsHospital:• 800m2 SPF mice (OGM andimmucompromised)• AAALAC Unit 1155 since 2006• 1999 (500m2) 2009 (800m2)IDIBELL M NADAL AAALAC International Conference Rome May 2009 5


TABLECONTENTS1. IDIBELL and AF presentation2. Spanish and Regional legislation3. IACUC responsibilities and ethicalreview process4. AAALAC site visits (2006 and 2008)5. ConclusionsIDIBELL M NADAL AAALAC International Conference Rome May 2009 6


TABLECONTENTS1. IDIBELL and AF presentation2. Spanish and Regional legislation3. IACUC responsibilities and ethicalreview process4. AAALAC site visits (2006 and 2008)5. ConclusionsIDIBELL M NADAL AAALAC International Conference Rome May 2009 8


IDIBELL Ethical review processPRINCIPAL INVESTIGATOR –AF PERSONNEL MEETINGIACUC - IDIBELLMEETINGASSESSMENTFAVOURABLE PRIORMODIFICATIONFAVOURABLEUNFAVOURABLE3IF PI ACCEPTSANIMAL CARE & USECOMISSIONS REGIONALGOVERNMENTFAVOURABLE PRIORMODIFICATIONFAVOURABLEUNFAVOURABLEIF PIANSWERS IN10 DAYSIDIBELL M NADAL AAALAC International Conference Rome May 2009 10


TABLECONTENTS1. IDIBELL and AF presentation2. Spanish and Regional legislation3. IACUC responsibilities and ethicalreview process4. AAALAC site visits (2006 and 2008)5. ConclusionsIDIBELL M NADAL AAALAC International Conference Rome May 2009 11


AAALAC site visit (2006 and 2008)AAALAC Preparation site visit (new IACUC responsibilities)IACUC: Animal Care and Use Program Revision / Semmianual Inspection2006: FirstAAALAC site visitfull accreditation number 1155Two Suggestions for Improvement were related to operation of theIACUC4SFI 1 The visitors commented possible interference in the goodoperation of the IACUC because the president of the committee andthe animal facility director were the same person.SFI 2 The annual revision of the procedures and the generaloperation of the animal facility is carried out by only one member ofthe IACUC2008: Second AAALAC site visitno SFI related to IACUC.IDIBELL M NADAL AAALAC International Conference Rome May 2009 12


AAALAC site visit (2006) SPFSFI 1 The visitors commented possible interference in the goodoperation of the IACUC because the president of the committeeand the animal facility director are the same person.4Correction SFI 1:At the special meeting of the IACUC members agreed to reviewthe composition of the committee and incorporating a new memberand replacing the presidentThe new composition also was ratified by the IDIBELL GeneralDirector and the local competent organism (Animal ExperimentalCommission of the regional administration).IDIBELL M NADAL AAALAC International Conference Rome May 2009 13


IACUC composition 2009Members In charge of Profession Represented toMarga Nadal Member 2001President 2006Scientist(without animalexperience)ScientistBelenLLoveresMember 1999 Medical Doctor Non affiliatedAnna Bigas Member 1999 Member 1999(animal user)Scientist4Joana VisaExternal Member2000VeterinarianAnimal FacilityDirectorPresident 2003-2006Member 2006Alvaro GimenoExternal Member2007VeterinarianAnimal FacilityUni. BarcelonaAlbertAltafajExternal Member2005VeterinarianAnimal FacilityBarcelonaScience ParkCristina Costa Member April 2009 Scientist(animal user)ScientistIDIBELL M NADAL AAALAC International Conference Rome May 2009 14


SFI 2 The annual revision of the procedures and the generaloperation of the animal facility is carried out by only one member ofthe IACUCCorrection SFI 2:AAALAC site visit (2006 and 2008)4The IACUC approved some operation changes:Semi-annual inspection of the animal care and use program following OLAWrecommendation (Office of laboratory Animal Welfare, USDA, semi-annualOLAW program and facility review checklist ).One of the semi-annual inspections will coincide with the annual AAALACreport .These semi-annual inspections will be carried out by all the members of theIACUC.An annual Post-Approval Monitoring of Animal Uses Protocol (PAM) will becarried out by all the members of the IACUC.researchersIDIBELL M NADAL AAALAC International Conference Rome May 2009 15


Customers (Researchers) Satisfaction SurveyYearCustomerattentivenessFacilitiesSpecialServicesPersonnel IACUC AAALAC AverageOverall2005 3,76 3,65 3,81 4,31 4,13 3,93 3,902006 3,86 3,53 3,13 4,02 4,06 3,79 3,732007 3,94 4,10 4,07 4,43 3,97(PAM)4,71 4,182008 4,20 3,94 3,94 4,25 3,53(PAM)4,45 4,31Scale 1-51:strongly disagree2: somewhat disagree3: neutral4. Somewhat agree5:strongly agreeIDIBELL M NADAL AAALAC International Conference Rome May 2009 16


TABLECONTENTS1. IDIBELL and AF presentation2. Spanish and Regional legislation3. IACUC responsibilities and ethicalreview process4. AAALAC site visits (2006 and 2008)5. ConclusionsIDIBELL M NADAL AAALAC International Conference Rome May 2009 17


ConclusionsIn relation to ethical review and due to the presence of legalframework since 1997 the process of AAALAC accreditation forIDIBELL has meant :1 .- improve the composition of the IACUC decreasing the possibilityof conflict of interest52 .- improve the semiannual animal facility inspection by the IACUCmembers3 .- To strengthen the postaproval monitoringquality improvement in the use of laboratory animalsIDIBELL M NADAL AAALAC International Conference Rome May 2009 18

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