Wehavegainedvaluableknowledgeandlessonsfromourpastexperiencewith contactingpatientstoparticipateinresearchstudiesandproposetoaddressthemin theiAGREEstudy.Theselessonsincludethefollowing:Patientsareunawarethattheir ?de-identified?datacanbesharedforresearchpurposeswithoutconsent,andmost patientsdonotknowtheirdataarebeingsharedforresearchandwhomayhave accessedtheirdataforwhattypeofresearch.Evenwhenidentifiabledatathatinvolve anapprovalprocessareinvolved,e.g.,genomes,thegrantingofconsentwaiversis highlyvariableamonginstitutions.Patientsaresatisfiedwhengiventheopportunityto choosewhenandwithwhomtosharewhichportionsoftheirdata,andtheir participationlevelsinresearchdidnothaveanadverseeffectwiththisopportunity. ThroughiAGREE,wewillmeetwithstakeholderstodefinetheirneeds,developdata sharingpolicies,andgathertheirassessmentofthefitofthedevelopedplatformtotheir expressedneeds.Thedevelopedplatformwillbeanelectronicconsentingplatformthat authenticatespatientsandrecordstheirconsent,allqueriesthatusetheirconsented data,andmeta-dataonqueryresultsthathavebeensharedwithdatarequestors.We willdis-intermediatetheprocessofcheckingwhichdatacanbemadeavailableto researchersbybindingresearcherrequeststodatathatuseacommondatamodeland redactusingthepatientconsents.Ourplatformwillincreasetransparencyintheuseof patients?data.Forexample,anyinstitutionalrepresentativecancheckthatpatients? consentswerefollowedinadatarequest,andpatientscanviewwhichstudiesused theirdata.Furthermore,patientswouldonlyneedtomakechoicesonceforall institutionswheretheirdataarestored,orchoicesmaybeinstitution-specific.Patients willalsoreceiveanotificationbeforetheirdataareusedtorespondtoadatarequest, andtheywillhavetheopportunitytochangetheirdatasharingpreferencesbasedon thestudyinformationorleavepermissionsasis. Wewilldeploythisplatformattheseveninstitutionsparticipatinginthisproject.These collaboratingsitesconsistofbothprivateandstate-ownedinstitutions,sothisproject willuncoverpoliciesthatmeetlocalaswellasstateregulations.
Honoringpatientpreferencesforsharingtheirelectronichealthrecordsinawaythat meetsinstitutionalrequirementsforadoptionisachallenge.Throughourstudy,we proposetofindasolutionforboth,whichwillresultinasystemthatauthenticates patients,allowsthemtomakesharingchoices,andchangesharingchoicesbasedon eachstudy?sparameters.Inaddition,wewillincorporatetheneedsandinputof stakeholders(e.g.,patients,institutionalleaders,IRBexperts)duringeachstageofthe project.
