Comparative Issues in the Governance of Research Biobanks: Property, Privacy, Intellectual Property, and the Role of Technology
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1 TRENTO FACULTYOFLAW 7/8MAY2010 ComparativeIssuesintheGovernance ofresearchbiobanks: Property,Privacy,IntellectualProperty, andtheroleoftechnology INTERNATIONALCONFERENCE
2 Research biobanks today are proliferating in big research centers and secondary hospitals serving peripheral areas. Alongside this development, huge population biobanks where biologicalmaterialsofentirecommunitiesaregathered,cataloguedandstudied arebeing establishedinagrowingnumberofcountriesallovertheworld. Privatecompaniesofferingbiobankingservicesareemergingasflourishingnewbusinesses. Just recently, the Report on a National Cancer Plan 2010/2012, issued by the Italian MinistryofHealthinJanuary2010,stressestherolethatanetworkofItalianbiobankswill playindevelopinganationalstrategyforcancerresearch. Thebiobankingboomofrecentyearshaspromptedalivelydebateonahostofinterrelated legal issues: 1) the Gordian knot of the ownership of biological materials; 2) the privacy concerns raised bythedifficultyofaccepting thatbiologicalsamplesmustbe completely anonymous without incurring the practical impossibility of exploiting their information potential,sincebiologicalandgeneticdataretainsuchpotentialonlyiftheycanbetracedto the evolving clinical history of the original donor; 3) the delicate role and the changing contentofthedonor s"informedconsent",asthemain legaltoolwhichmayserveto link the privacy and property interests of the donor with the research interests and the set of principles that should inform the functioning of the biobank; 4) the IP issues and the patentability of biological samples and the protection of databases storing genetic informationobtainedfromthesamples. Respondingtotheseproblemswillbecrucialforidentifyingthedistributionofthebenefits that can be obtained by exploiting the scientific research carried out on the biological samplesstoredinbiobanks. The conference Comparative Issues in the Governance of Research Biobanks: Property, Privacy, Intellectual Property and the Role of Technology is aimed at exploring, from a comparative viewpoint, theextenttowhichdigitaltechnologymayassistintacklingthe many regulatory issues raised by the practice of biobanking for research purposes, issues whichmaybeconsideredandanalyzedunderthetraditionalparadigmsofproperty,privacy, InformedConsentandIntellectualProperty(Patents). Thesedifferenttheoreticallegalfacetsofbiobankingactivityarestrictlyinterconnectedand mustbeanalyzedtakingsuchinterconnectionintoconsideration.aholisticconsiderationof theissuesinvolvedinresearchbiobankingappearstobetheonlywayinwhichanoptimal regulatory governance of biobanking activity can be successfully pursued. This perspective
3 highlights the importance of digital technology as the element capable of providing the infrastructure that may help to coordinate the different interests involved in biobanking activity,atthesametime(1)enablingtheinfrastructureinitselftoimplementtheregulatory standardsand(2)providinganenvironmentwheretheselfdeterminationofthedonorscan find its real expression without incurring transaction costs which may be impossible to sustain.
4 FINALPROGRAM Friday May7, Registration 8.50Welcomegreetings DavideBassi RectoroftheUniversityofTrento GianniSantucci DirectoroftheDepartmentofJuridicalSciences GiuseppeBernardi President Fondazioneprof.AlessioPezcoller Trento OpeningSession:IntroducingtheIssues Giovanni Pascuzzi,, "A Law & Technology Approach to the Law of Biobanking" UmbertoIzzo,UniversityofTrento, TheRoleofTechnologyinAnsweringtotheRegulatory NeedsofResearchBiobanking:GeneralRemarksandInterestsatStake MattiaBarbareschi,TrentinoBiobank APSSTrento, TheRealityofBiobankingRegulation fromabiobanker sperspective:scientificandmanagerialpremisesandunresolvedissues
5 FirstSession:Property,Privacy&InformedConsent Chairman:RobertoPardolesi,LuissUniversity,Rome Firstsubsession( ) GideonParchomovsky,UniversityofPennsylvania, PropertiesofBiobanks Stephen Munzer, UCLA School of Law, Privacy and Ownership: Research Biobanks Meet SyntheticBiology Roger Brownsword, King s College London, Regulating Biobanks: Another Triple Bottom Line CoffeeBreak Secondsubsession( ) JaneKaye,UniversityofOxford, ProtectingPrivacyintheWorldofGlobalBiobanking EricFeldman,UniversityofPennsylvania, TheGeneticInformationNondiscriminationAct:A SolutioninSearchofaProblem? FrancescoPizzetti,PresidentoftheItalianDataProtectionAuthority, PersonalHealthData andresearchbiobanking:theitaliandataprotectionauthorityview Lunch
6 Thirdsubsession( ) Mariachiara Tallacchini, Cattolica University of Piacenza, Human Tissues in the Public Space :BeyondtheProperty/PrivacyDichotomy AmedeoSantosuosso,UniversityofPavia, ShouldPrivacyBeAbolishedinBiobanking? AndreaRossato,UniversityofTrento, DigitalArchitecturesandtheRegulationofResearch Biobanks PaoloGuarda,UniversityofTrento,"BiobanksasElectronicGatekeepersofPersonalHealth Data:OpenIssues" Matteo Macilotti,, "Reshaping Informed Consent in the Biobank Context Questiontimeforallthesubsessionsandpreliminaryconclusions Teabreak SecondSession:MedicalandTechnologicalPerspectives Firstsubsession( ) Chairman:GiorgioStanta,UniversityofTrieste Giuliano D Agnolo, Vice President National Committee for Biosafety Rome / with the collaborationofelenabravo,istitutosuperioredisanità, TheItalianPrototypeNetworksof ResearchBiobanks GeorgesDagher,Director forclinical research infrastructuresatthefrenchnationalhealth
7 and medical research institute (INSERM Paris), The Biobanking and Biomolecular ResourcesResearchInfrastructure(BBMRI):CoordinationofEuropeanTissuesBanks ManfredDietel,Charité UniversitätsmedizinBerlin, SurgicalPathologyArchives:Invaluable HistoricalCollectionsforCancerResearch Giorgio Inghirami, University of Turin, Biospecimen Collection, Storage and Quality Assurance.DoWeNeedanEuropeanStandard? Dinner20.00 SaturdayMay8,2010 Secondsubsession( ) Special Seminar organized with the scientific collaboration of SIAPEC (Italian Society of AnatomicalPathologyandDiagnosticCytopathology)&IstitutoSuperiorediOncologia Chairman:GianluigiTaddei(UniversityofFirenze),PaolodellaPalma(APSS Trento) Oscar Nappi, Cardarelli Hospital Napoli, Biobanks and the Italian Society of Surgical Pathology MattiaBarbareschi,TrentinoBiobank APSSTrento, SurgicalPathology:APowerfulSource ofwellannotatedhumantissuesforcancerresearch GiorgioStanta,UniversityofTrieste, AnItalianNetworkofArchivalTissuesBiobanks MauroTruini,NationalInstituteforCancerResearch Genova, GovernanceofBiobanksfor CancerResearch:ProposalforaMaterialTransferAgreement
8 Discussants: EnzoGalligioni,APSS Trento GuidoGrandi,Novartis Milano MarcoPierotti,CancerInstitute Milano AlessandroQuattrone,UniversityofTrento CoffeeBreak ThirdSession:Biobanks,IntellectualProperty,andDigitalTechnology Chairman:GideonParchomovsky,GiovanniPascuzzi Roberto Caso,, "Control over Biobanks Information: A Law and TechnologyApproach" Donna Gitter, Baruch College New York City, The Challenges of Achieving Open Source SharingofBiobankData Richard Gold, McGill University Montreal, Beyond Open Source: Patents, Biobanks and Sharing Thomas Margoni, University of Western Ontario / Matteo Macilotti,, TheRoleofMaterialTransferAgreementsinBiobanking MarkPerry,UniversityofWesternOntario, AccessingBiobanksandBenefit Sharing
9 12.15Plenarydiscussion 12.40Conclusions 12.50Endoftheconference
10 Informationabouttheconference Workinglanguages: English and Italian Simultaneous translation from and to the working languages of the conferencewillbeprovided SpeakersarerequestedtopresentatitleandanabstractoftheirpresentationinEnglish,but arewelcometopresenttheirpapersinitalian. Deadlinesforthespeakers: forsubmittingtheabstract(maxonepage):april15,2010 for submitting the text of the presentations for the proceedings of the conference (Blue Bookstandards):October31,2010 Deadlinefortheregistrationonlineofparticipants:April24,2010 Venue:ROOMB FacultyofLawoftheUniversityofTrento ViaVerdi53,Trento ITALY AftertheconferenceavideooftheconferencewillbemadeavailableonlinefromtheTrento UniversityWebSite Organization,Sponsorships,Credits TheconferenceisjointlyorganizedbytheDepartmentofLegalSciencesoftheUniversityof TrentoandtheAssociation ORSA ObiettivoRicercaeStudioeAggiornamento oftrento. The initiative is promoted by the Trento Research Unit of the the FIRB National Research Project Genetic Tests and Biobanks: Bioethical Issues in Law and Society ( ), a multicentric research project jointly carried out by the Universities of Trento, Bologna, MilanoBicocca,andPisa,whichisfundedbytheItalianMinistryofEducation,Universityand Research.
11 ScientificandOrganizingCommittee: MattiaBarbareschi,RobertoCaso,UmbertoIzzo,MatteoMacilotti,GiovanniPascuzzi FinancialSupportfortheconferenceisgratefullyacknowledgedfromthefollowingsponsors: FondazionePezcollerTrento FondazioneCassadiRisparmiodiTrentoeRovereto Specialpatronagehasbeengrantedbythefollowinginstitutions: AziendaProvincialeperIServiziSanitariTrento; MedicalAssociationTrento; ISS(IstitutoSuperiorediSanità)Rome; LegaItalianaperlaLottaaiTumori FondazioneTrentinaperlaRicercasuiTumori Attendanceoftheconferencewillbeacknowledgedasgivingtitletoprofessionalcreditsby thefollowingprofessionalorganization(warning:acknowledgementprocedurepending): BarAssociation NotaryAssociation BiologistsAssociation
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