single irb updates...single irb updates vhrpp news you can use january 22, 2018 jenni beadles, med,...
TRANSCRIPT
SingleIRBUpdatesVHRPPNEWSYOUCANUSE
JANUARY22,2018
JenniBeadles,MEd,SingleIRBOperationsManager(VHRPP)BreeBurks,RN,MSN,CCRP,SeniorDirector(VCC)EmilySerdoz,MPA,ManagerofTranslationalResearch(VICTR)
OverviewReviewoftheNIHpolicyandterminologyVHRPPupdatesandrequirements◦ StudyteamresponsibilitieswhenVanderbiltistheReviewingIRB◦ StudyteamresponsibilitieswhenVanderbiltisaRelyingIRB
ResourcesavailabletostudyteamsatVanderbilt◦ VHRPP◦ VCCServices◦ RSSandSMARTIRBExchange
ReviewofNIHPolicy+KeyTerms
NIHPolicyonSingleIRBGrantApplicationswithreceiptdatesonorafterJanuary25,2018◦Ongoing,non-competingawardswillnotbeexpectedtocomplywiththispolicyuntilgranteesubmitsacompetingrenewalapplication
Non-exempt,NIH-fundedmulti-sitestudiesconductingthesameprotocolDomesticawardeesanddomesticsitesonly
TerminologySingleIRB(sIRB)• theIRBofrecord,selectedonastudy-by-studybasis,whichprovidestheethicalreviewforallsitesparticipatinginamulti-sitestudy.
CentralIRB(cIRB)• theIRBofrecordthatprovidestheethicalreviewforallsitesparticipatinginmorethanonemulti-sitestudy.Thesitesareusuallyinanetwork,consortiumorparticularprogram.
ReviewingIRB• theIRBofrecordtowhichauthorityforIRBreviewandoversightforastudyhasbeencededbyanotherinstitution
WhodetermineswhichIRBwillserveastheLeadIRB?Maybepre-determinedbystudysponsororgrant(primaryawardsite)
Previouslyestablishedbypriorarrangement(networkorcooperativegroup)
PrimaryPI’shomeinstitutionmayserveasIRB
Thedecisionisbasedontypeofprocedurestobeperformedorstudypopulation
TheVHRPPwilldetermineiftheVanderbiltIRBcanbethesingleIRBforastudyornetwork,aswellaswhenthe
VanderbiltIRBcancedereviewtoanotherIRB.
PurposeofthePolicyistogofromthis…
SITE1
InstitutionalReviewIRBReviewAncillaryReviews
SITE2
InstitutionalReviewIRBReviewAncillaryReviews
SITE3
InstitutionalReviewIRBReviewAncillaryReviews
SITE4
InstitutionalReviewIRBReviewAncillaryReviews
SITE5
InstitutionalReviewIRBReviewAncillaryReviews
…tothisCentralIRBReview
RelyingSite1
LocalReview
RelyingSite2
LocalReview
RelyingSite3
LocalReview
RelyingSite4
LocalReview
RelyingSite5
LocalReview
SingleIRBResourcesontheNIHWebsiteSingleIRBPolicyforMulti-siteResearch
https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm
FrequentlyAskedQuestions
https://grants.nih.gov/grants/policy/faq_single_IRB_policy_research.htm
WhatdoesthismeanforusatVanderbilt?
VHRPPExperienceSingleIRBreviewisnotnewtoVanderbilt’sIRB
AspartoftheTIN,workwithotherpremierIRBsacrossthecountrytodevelopharmonizedprocessesandsystems
ServeastheCentralIRBandRelyingIRBformultiplenationalnetworks
Membersandcontributorsofkeynationalrelianceplatforms
DesignatedSingleIRBteamconsistingof4peoplewithcollectively~25yearsofIRBexperience
WhatwilltheSingleIRBteamdo?
CoordinatereliancewiththeReviewingIRB(fullyexecutedagreementsmustexistbetweenIRBsinorderforreliancetobevalid)
CommunicatewiththeVanderbiltPIaboutstudystatus
CollaboratewithotherIRBstoensureprotectionsofhumansubjectsProvideadditionaleducationaswegrow
Provideguidance,andtoolsforgeneralassistance
WhenVanderbiltistheSingleIRB
HowdoIrequestVanderbiltbetheSingleIRB?
Step1:CompleteRelianceInterestFormontheSingleIRBHelppage
Step2:VHRPPwilldetermineiftheVanderbiltIRBcanbetheSingleIRB
Step3:Ifyes,SUBMITanewstudyviaDISCOVR-easusual
Note:ForallNIH-fundedresearchandwherepossibleforanyotherresearch,theSMARTIRBExchangeplatformwillbeusedasthebasisforreliance
RelianceInterestForm
Thingstothinkabout…BudgetingforIRBFeeswhenwritingyourgrant
Youarethecoordinatingcenter!(ifnoothercoordinatingcenterhasbeendesignatedforyourstudy)
Onboardingsites
AddingparticipatingsitesviaIRBsubmissions
Managingothersites’studydocuments/materials,includinggeneratingconsentformsforallsites
Communicationwithrelyingstudyteams
LinesofCommunication
ViaSMARTIRBAdaptedfromLinesofCommunication– Madison(Wisconsin)
ReviewingIRBLeadStudyTeamorCoordinating
Center
RelyingSiteStudyTeam
RelyingInstitutionIRB/HRPP
WhenVanderbiltistheRelyingIRB
Why+WhentosubmitReminder:theauthoritytodeterminewhetherVanderbilt’sIRBcedesreviewtoanotherIRBrestswiththeVanderbiltHumanResearchProtectionProgram◦ TheIRBhasmanyfactorstoconsider,likethesizeandscopeoftheIRB,fundingsource,accreditationstatus,etc
Assoonasyouarecontactedaboutbeingarelyingsite,submitarequestviaDISCOVR-eviatheabbreviatedapplicationpathway
Thesesubmissionswillbeassignedtoateamastheycurrentlyare
IRB Review
Reviewofinvestigatortrainingandexpertise
AncillaryReviews(Safety,Scientific,
COI)
Monitoringcompliancewithlocal,statelaws;HIPAA
InstitutionalResourcesReview
CongruencywithGrantsandContracts • Initial/newstudy
• Continuingreview• Amendmentstothe
study• Localchanges(changes
tofunding,keystudypersonnel,site-specificrequests)
• Potentialunanticipatedproblems
WhatisthedifferencebetweenLocalReview+LocalContext?
LOCALREVIEW
Alloftheelementsofreview,exceptIRBreview,requiredbyVanderbilttobeconductedbytheVHRPP(asshowninpreviouspiechart)
LOCALCONTEXT
AlloftheelementsspecifictoourlocationthatmayaffecttheconductofresearchatVanderbilt:◦ Stateandlocallaw◦ Institutionalpolicies
WhatneedstobesubmittedviaDISCOVR-e?IFWEARETHEREVIEWINGIRB:
FullIRBApplicationincludingallstudymaterials,documentsandrelatedinformation
sIRB Teamwillassistwithobtaininglocalcontextforrelyingsites
AllAmendments
ReportableEventsforallsites
ContinuingReviewincludingsiteenrollmentandstatusinformation
IFWEARETHERELYINGIRB:
AbbreviatedIRBApplicationforlocalcontext(KSP,Funding,Drugs/Devices/Biologics,Radiation,HIPAA,COI,ConsentForms– forlocalconsentlanguage)
AnyformsrequiredbytheReviewingIRB(COMPLETEDLocalContextWorksheets/Survey)
MajorAmendments
ContinuingReviewSubmissions
ToolstoFacilitatesIRBreviewDEVELOPED
sIRB Team+TeamLiaisons
RelianceInterestForm
TemplateLettersofSupport
Templatetextforgrantapplications
LetterofIndemnification(LOI)forSMARTIRBagreement
PIassurancedocument
Documentoutliningrequiredconsentlanguagewhenrelying
In-Persontrainingsessions
INPROGRESSDISCOVR-eenhancementstosupportsIRBsubmissions
Accessbyexternalusers
sIRB Feestructure
sIRB educationaltools
MonitoringStrategy
ToolstofacilitateCIRBreview[e.g.consenttool]
Everythinginonelocation
Forquestions,contacttheSingleIRBTeam
SingleIRBpageonVHRPPwebsite:https://wp0.vanderbilt.edu/irb/single-irb-help/
• [email protected]• 322-3597JenniBeadles
• [email protected]• 875-8989KariCampbell
• [email protected]• 875-8716TylerHubbard
• [email protected]• 875-8980JessicaJames
VanderbiltCoordinatingCenter
1.22.2018
CentralIRBSupportOptions
BreeBurks,RN,MSN,CCRPSeniorDirectorVanderbiltCoordinatingCenterVanderbiltInstituteforClinicalandTranslationalResearch
Agenda
• What’stheVCC?
• cIRB SupportOptions
• “Light-Touch”
• SupportforImplementation
• ComprehensiveImplementation
VCC-Background• Providescomprehensive,centralsupportforadiverseplatformofclinicalandtranslationalresearchprojects
• DedicateddivisionssupportVUMClocalenrollments,InvestigatorInitiatedTrials,ClinicalResearchNavigation,
andAuditing,ComplianceandEducation
• Currentlyoversee157activeprojects,16
ofwhichareinvestigatorinitiated
• Oversee204enrollingcenters
• Supportover28departments/divisionsat
VUMC
1% 1% 0% 3% 4% 3%
3% 3% 1% 0% 3%
9%
2%
14% 2% 1% 10%
1% 0% 0% 1% 3%
28%
4% 2% 1%
VCCSupportAreas DBMICardiacSurgeryHealthPolicyAllergy,Pulmonary,CriticalCare(7/8)Cardiology(6)
ClinPharm(9/10) DermatologyEndocrineInternMedicine/PublicHealthGeriatricHematology/Onc(9/10)InfectiousDisease(4)Rhematology/ImmunologyNeurology(2)NeurologicalSurgeryPlasticSurgerySurgery(3)ThoracicSurgeryUrologyOBGYNOrthoPathology(7/8)Pediatrics(1)Psych(5)RadiologyVU
LargeDepartments• Section15%• Medicine31%• Pediatrics28%
cIRB PathwayssIRB Apply?
CompletesIRB Request
“Light-Touch”
Education/Resources
VCCSupport
Education/Resources
sIRB SupportQuote
GrantText/LOS
VCCasCoordinatingCenter
Education/Resources
FullBudgetQuote
GrantText/LOS
Details• ReviewresourcesonDISCOVR-eWebpage
• NIH• Initialfundingafter1/25/18• Multicenter
cIRB PathwayssIRB Apply?
CompletesIRB Request
“Light-Touch”
Education/Resources
VCCcIRB Support
Education/Resources
sIRB SupportQuote
GrantText/LOS
VCCasCoordinatingCenter
Education/Resources
FullBudgetQuote
GrantText/LOS
Details
• Requestthroughcentralportalon
DICSCOVER-e
• Providestudyinformation
• #ofSites
• Contactinformation
• Coordinatingcenterselected
• PriorcIRB experience
• RFA
• Selectsupporttype
• TINProject?
cIRB PathwayssIRB Apply?
CompletesIRB Request
“Light-Touch”
Education/Resources
VCCcIRB Support
Education/Resources
sIRB SupportQuote
GrantText/LOS
VCCasCoordinatingCenter
Education/Resources
FullBudgetQuote
GrantText/LOS
Light-Touch
• Education/Resources/Checklistswillbeprovidedsupportinga“DIY”approach
• Investigatorwillprovideresources/personneltofacilitatecIRBprocess
• StudyProjectManager/CoordinatingCenterwill:
• ServeascontacttoPI’sandtheirCoordinatingTeamsatsites
• Facilitatecontinuedprogressofagreements,initialapproval,andongoingamendments
IRB
Pre-Award cIRB PathwayssIRB Apply?
CompletesIRB Request
“Light-Touch”
Education/Resources
VCCcIRB Support
Education/Resources
sIRB SupportQuote
GrantText/LOS
VCCasCoordinatingCenter
Education/Resources
FullBudgetQuote
GrantText/LOS
VCCcIRB Support• Education/Resources/Checklistswillbeprovided
supportingan“Ongoing,Facilitative”approach• Investigator/teamwillutilizeProjectCoordinator
fromVCCtoprovideongoingsupportasneeded• VCCcIRB ProjectCoordinatorwill:
• SupportCoordinatingCenterProjectManager/Team
• ProvideconsistentupdatesonoverallcIRBstatusacrosssites• Examples:weeklymeetings,consistentemail
communication,ongoingeducation/presentations;reportswithstatusupdates
• Providein-depthsupportifbarriers/questionsarise
• VCCcIRB ProjectCoordinatorwillnot:• CompleteIRBapplication/submissionson
behalfofsites• Serveasacontentexpertonthestudydesign
IRB+VCC
cIRB PathwayssIRB Apply?
CompletesIRB Request
“Light-Touch”
Education/Resources
VCCcIRB Support
Education/Resources
sIRB SupportQuote
GrantText/LOS
VCCasCoordinatingCenter
Education/Resources
FullBudgetQuote
GrantText/LOS
VCCasCoordinatingCenter• “Comprehensive”approach• InvestigatorwillutilizeVCCProjectManagerto
performallcIRB dutiesandsupportallcIRB needs• VCCcIRB ProjectManagerwill:
• ServeasthestudydesigncontentexpertandleadcIRB contactforresearchteams/PI’satparticipatingsites
• InpartnershipwiththeVUMCHRPP,provideeducationandtrainingtosites(initialandongoing)
• CompleteallcIRB applicationsandamendments
• ProvideconsistentupdatesonoverallcIRBstatusacrosssitesandensurecIRB processesareontrack
IRB+VCC
cIRB PathwayssIRB Apply?
CompletesIRB Request
“Light-Touch”
Education/Resources
VCCcIRB Support
Education/Resources
sIRB SupportQuote
GrantText/LOS
VCCasCoordinatingCenter
Education/Resources
FullBudgetQuote
GrantText/LOS
EducationandResources
• DISCOVRe:Centralareawhereeducationandresourcesarelocated
• Providedwithresourcesandtoolsthatfityourindividualneeds• Not“onesizefitsall”
cIRB PathwayssIRB Apply?
CompletesIRB Request
“Light-Touch”
Education/Resources
VCCcIRB Support
Education/Resources
sIRB SupportQuote
GrantText/LOS
VCCasCoordinatingCenter
Education/Resources
FullBudgetQuote
GrantText/LOS
sIRB SupportQuote• SupportprovidedtoCoordinatingCenterProject
Manager• VCCwillnotgivefeedbackonstudy
design/science• FederalCharge-backCore
• Ratesareactualcosts• Rateschangeasactualcostschange
• Hourlyrateschargedforsupport(~$70/hour)
FullBudgetQuote• Comprehensivecoordinatingcentersupport
provided,includingsIRB submissionsandprocesses• FederalCharge-backCore
• Ratesareactualcosts• Rateschangeasacual costschange
• Hourlyrateschargedforsupport(~100/hour)
cIRB PathwayssIRB Apply?
CompletesIRB Request
“Light-Touch”
Education/Resources
VCCcIRB Support
Education/Resources
sIRB SupportQuote
GrantText/LOS
VCCasCoordinatingCenter
Education/Resources
FullBudgetQuote
GrantText/LOS
GrantText/LettersofSupport• VCCwillprovidespecificlanguagetohighlight
resourcesandexpertiseprovidedforcIRBassistance• SupportfortheCoordinatingCenterTeam• Fullprojectmanagementofstudy
• IncludingcIRB implementation
v CentralportalonDISCOVRe willprovidereadygranttextfor“Light-Touch”pathway
v TINsubmissionswillhavetailored,customizedlanguageprovided
v SMARTIRBEXCHANGEgranttextisalsoavailabletosupportsubmissions
VCC-GetinTouch
• Requestsupportforanewproject
• Viewourteams
• Getinformationonourservices
• Identifyactivestudiesinyourarea
• Getgranttext
vcc.vumc.org
VanderbiltInstituteforClinicalandTranslationalResearch:ResearchSupportServices
EmilySerdoz,MPAManagerofTranslationalResearch
VanderbiltInstituteforClinicalandTranslationalResearch
VICTR-RSSsIRBConsultationServicesandSupport
GrantPreparationToolkit
SMARTIRBExchange
GrantPreparationToolkitWhataretheNIHgrantrequirements?
• NameofthesIRBofrecord• IndicateALLofthefollowing• Allsites,includinganyaddedafteraward,agreetorelyonsIRB• Siteswillsignrelianceagreementthatwillincludeacommunicationplan• Indicatewhowillmaintainrecordsofthisagreement
• Exceptions,ifapplicable,(sitesthatwillnotbeusingthesingleIRB)
GrantPreparationToolkitComponents• Granttexttemplate• Helpdeterminingsite’ssign-ontothereliance-relatedagreements• Budgetpreparation• Templatelettersofsupportforparticipatingsites,ifneeded• Helpgettinginstitutionsignedontothereliance-relatedagreements
HowtorequestVUMCserveasthesingleIRBofrecord?• CentralportalonVUMCHRPPSingleIRBwebsite:https://www.vanderbilt.edu/irb/single-irb-help/ ComingSoon!
SampleCommunicationPlansGeneralLinesofCommunication CIRBWorkflowUsingSMARTIRBExchange
ReviewingIRB
LeadStudyTeamorCCC
RelyingSiteStudyTeam
RelyingInstitutionIRB/HRPP
ViaSMARTIRBAdaptedfromLinesofCommunication– Madison(Wisconsin)
VICTR-RSSsIRBConsultationServicesandSupport
GrantPreparationToolkit
SMARTIRBExchange
Anationalpolicyandrelianceagreementarenecessary,butnotsufficient,tosupportsIRBreview
TheRelianceAgreementisa1ststep.
ITsolutionsareneededtosupportsingleIRBdocumentationandcommunication
acrossinstitutions.
ImplementingaNationalSingleIRBPolicy
SMARTIRBExchange:AnEvolvingITPlatform
WhatisSMARTIRBExchange?
SMARTIRBExchangeisatoolfor…• IRBs todocumentandtrackIRBreliancerelationships• Coordinatingcenters/LeadStudyTeamstomonitorstudystartupandmanageapprovals• IRBsandstudyteamstocentralizedthecaptureoflocalconsiderations• IRBsandCoordinatingcenters/LeadStudyTeamstomanageallIRBapprovaldocumentsforParticipatingSites
• IRBs to streamlineandautomatestudy-relatednotificationstoParticipatingSites
SMARTIRBExchangeisNOT…• Notarelianceagreement• NotaReviewingIRB
Aweb-basedportalthathelpsfacilitatetheimplementationofasingleIRBfrominitiatingtherelianceprocessthrustudyclose.
InitialInteractionswithSMARTIRBExchange
sIRB createsstudyinExchange
[optional]Participating
Sites(HRPP+PI)submitlocalcontextinExchange,ifapplicable
CCC/LeadStudyTeamexports
localcontextandsubmitsittosIRB,ifusedtocapturelocalcontext
sIRB uploadssiteapprovaltoExchange
Exchange emailsapproval
notificationtoparticipatingsitestudyteam+HRPPapproval
ParticipatingSiteStudyTeam logsintoaccessapprovaldocuments
IRBde
cide
stoserveassIRB
forstudy
LeadStudyTeams/CCCsuseExchangetotrackthestepstoreliance
Aretheagreementscomplete?
HastheHRPP/IRBagreedtorely?
Hasthesiteenteredlocalcontext?
ExporttheinformationtosubmittoDISCOVR-E(asitiscompleted)
RelyingSiteStudyTeams:(1)enterlocalcontextintoExchange
Confirmcontactinformationandanydifferencesinconsent,recruiting,DSMBatthelocalsite.
ZosterEyeDiseaseStudy
Harvard
ZosterEyeDiseaseStudy
HarvardUniversityMedicalCenter
Harvard
SarahSamuelson
Sarah.samuelson@hu
RelyingSiteStudyTeams(2)useExchangetoreceivenotificationsofapproval
Vanderbilt University Medical Center has shared IRB approval for your institution, Harvard University Medical Center, for the following study:
andlogintoaccessapprovaldocuments
• [email protected]• AboutSMARTIRBExchange• Resources:ComingtotheVUMCHRPPSingleIRBwebsite
AdomaManfulSystem&Materials
Development
EmilySerdoz,MPAProjectManager
BridgetSwindell,RN,CCRPStudySupport
LindaTanOnboarding&UserSupport
SMARTIRBExchangeTeam
Questions?