Single IRB Updates...Single IRB Updates VHRPP NEWS YOU CAN USE JANUARY 22, 2018 Jenni Beadles, MEd,...
Transcript of Single IRB Updates...Single IRB Updates VHRPP NEWS YOU CAN USE JANUARY 22, 2018 Jenni Beadles, MEd,...
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?