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1、IRBStudyClosure,Suspension,orTerminationMarch7,2011VANJHCSInstitutionalReviewBoardStandardOperatingProceduresSTUDYCLOSURE,SUSPENSION,ORTERMINATION1PURPOSE/SCOPEThepurposeofthisStandardOperatingProcedure(SOP)istodelineatetheprocedureforstudyclosure,studysuspens
2、ion,orstudytermination.2POLICYProposedchangestotheresearch;includingastudyclosure,studysuspension,orstudyterminationmaynotbeinitiatedwithoutInstitutionalReviewBoard(IRB)approvalunlessthereisconcernregardingthesafety,rights,andwelfareofhumansubjectsorothers,the
3、unapprovedactionisnecessarytoeliminatethepotentialofapparentimmediateharmtothem,andtheIRBwillbenotifiedimmediatelybutnolaterthan5businessdaysofawarenessoftheevent.3DEFINITIONSInstitutionalReviewBoard(IRB):Thecommitteeformallydesignatedbytheorganizationtoreview
4、,requiremodificationsin,approve,disapprove,andconductcontinuingoversightofhumanresearch.SuspensionofIRBapprovalofresearch:referstotheIRBplacingatemporaryinterruptionorstopofsomeorallpreviouslyapprovedresearchactivitiesforconcernregardingthesafety,rights,orwelf
5、areofhumansubjects,investigators,orotherspendingoneormorecorrectiveactionsorevents.Followingcompletionofthecorrectiveaction,theconvenedIRBmayapprovesomeorallofthesuspendedresearchactivities.Note:ExpirationofIRBapprovaldoesnotinandofitselfconstituteSuspensionor
6、Termination.TerminationofIRBapprovalofresearch:AdirectiveoftheIRBtopermanentlywithdrawapprovalforsomeorallresearchactivities.4INVESTIGATOR-INITIATEDCLOSURE,SUSPENSION,ORTERMINATIONItistheresponsibilityoftheprincipalinvestigator(PI)topromptlynotifytheIRB,inwrit
7、ing,whenstudyactivitieshaveceased,areterminated,oraresuspendedbytheinvestigatorforanyreason,includingnormalandanticipatedstudyclosure.ThePIistosubmitacompletedIRBClosureRequestindicatingthereasonforclosingthestudywithanupdatedabstractandProjectDataSheet.Noteth
8、atifastudyisclosedtoaccrualandsubjectfollow-upordataanalysiswillcontinue,thestudymustremainactive,andIRBapprovalmustbemaintainedwithannualIRBcontinuingreview.Page4of4IRBStudyClosur
