最新Informed Consent Considerations - Dana-FarberHarvard Cancer 知情同意的考虑-达纳farberharvard癌教学讲义PPT课件.ppt

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1、InformedConsentConsiderations-Dana-FarberHarvardCancer知情同意的考虑-达纳farberharvard癌OHRSMicheleRussell-Einhorn,JDSeniorDirector,OfficeforHumanResearchStudies2GeneralOverviewTheDF/HCCscientificreviewcommitteesandtheDFCIIRBsreviewalladultandpediatriccancer-relatedresearchonbehalfofBIDMC;BWH;CHB;DFCIa

2、ndMGH.3InstitutionalReviewBoardsDFCIIRBsoperateunderaFederalWideAssurancethatwehavewiththeU.S.DepartmentofHealthandHumanServices.DFCIIRBsoperateunderFederalregulationsthatspecificallydictatetheoperationsandsubstantivereviewoftheIRBs.DFCIIRBs,onbehalfoftheDF/HCC,currentlyhaveoversightofover175

3、0openresearchprotocolsinvolvinghumansubjects.7DFCIIRBsInformationRelatingtotheOperationofIRBs8DFCIIRBsIRBsAandB:meetonanalternatingbasiseveryTuesdayfrom12-2pm.expertisetoreviewanymatter,butfocusonnewprotocolsandamendments.9DFCIIRBsIRBsCandF:meetonanalternatingbasiseveryThursdaymorningfrom8-10

4、am.expertisetoreviewanymatterbutfocusoncontinuingreviews;amendments;adverseevents;andotherevents.10DFCIIRBsIRBD:meetstwicemonthlyonMondaysfrom10-12pmwasknownasthe“socialandbehavioralIRB”orthe“minimalriskIRB”,infact…reviewsanyresearchthatisnottechnicallyclinicalinterventionresearchaswellasrese

5、archthatisgreaterthanminimalrisk.additionalbonemarrowaspirates;additionalblooddraws;tissuerepositoryresearchetc.11DFCIIRBsIRBE:“rapidresponseIRB”smallnumberofmembersandcanrespondquicklytoanemergentsituation.12DFCIIRBsIRBG:PediatricPanelMeets1stand3rdMondayofeachmonthExpertisetoreviewanypediat

6、ricmatter13InstitutionsintheNews141516JHU-FDAWarningLettertoPIMarch31,2003“Ourrecordsindicatethatyouareawareofyoursponsorobligations…wenotethatonSeptember15,1997,yousubmittedanINDapplicationtotheFDA…(FDA)notifiedyouinwritingonOctober24,1997,thatyouwereprohibitedfrominitiatinganyofthesubmitte

7、dprotocolsduetosignificantsafetyconcernsandotherprotocoldeficiencies…includinginadequatechemistry,purity,andpre-clinicaldata;inadequateandconfusingstudyproceduresandprotocols,lackofinclusioncriteria,discontinuationcriteria,anddefinedsafetypar