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/

• jenni.beadles@vanderbilt.edu• 322-3597JenniBeadles

• kari.campbell@vanderbilt.edu• 875-8989KariCampbell

• tyler.hubbard@vanderbilt.edu• 875-8716TylerHubbard

• jessica.james@vanderbilt.edu• 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

• admin@SMARTIRBExchange.org• AboutSMARTIRBExchange• Resources:ComingtotheVUMCHRPPSingleIRBwebsite

AdomaManfulSystem&Materials

Development

EmilySerdoz,MPAProjectManager

BridgetSwindell,RN,CCRPStudySupport

LindaTanOnboarding&UserSupport

SMARTIRBExchangeTeam

Questions?