symposium for research administrators
TRANSCRIPT
Symposium for Research Administrators
University of Wisconsin-MadisonOctober 8th, 2019
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University of Wisconsin - Madison
NavigatingtheRoadfromResearchIdeatoHumanSubjectsStudyActivation
LisaWerningLynnHaynes
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University of Wisconsin - Madison
KeystepsinActivationPathway
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StudyInception
• Novelidea• Feasibility• DiscoverFundingOpportunities
StudyDesign
• Protocol• HIPAA• ConsentForm• PatientMaterials
• IRBApplication
Approvals
• IRB• Ancillarycommittees
• Otherrequirements
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StudyInception-Isthisprojectfeasible?
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PatientPopulation
Credentials
SpaceInnovativeandNovel
FiscalComponentsto
Success
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DepartmentalFeasibilityAttestation
BestCaseScenario
UsualScenario
YourDepartment’sScenario
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University of Wisconsin - Madison
Training:HIPAA&HumanSubjectsProtection
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HIPAAtrainingUWBiomedical,SocialandBehavioral,andVA
training
Studyteammembertrainingstatus (orin
ARROW,clickon“ViewStudyTeamTraining”)
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TrainingSnapshot
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University of Wisconsin - Madison
TrainingSnapshot
8Linkdirectlytotherequiredtraining
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IRBApplication- RegulationsandPolicies(whosayswehavetodothat?)
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CommonRule–mostfederallyfundedresearch
Food&DrugAdministration
(FDA)
HealthInsurancePortability&
PrivacyAct(HIPAA)PrivacyRule
StateLawsUW-Madison
HRPPpolicesIRBguidance
VeteransAdministration
(VA)
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IRBApplication
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KeystoSuccess- HelpyourinvestigatordecideiftheirstudyneedsIRBreviewand/orOversight
Research+HumanSubjects=OversightSee:ActivitiesRequiringoversightonHRPP webpage
• Manystudiesare“nothumansubjects”orare“exempt”(perfederaldefinitions),butSTILLNEEDIRBreviewtomakedetermination.
• Usetheguidanceandprogramevaluationself-certificationtools(HSIRBs orED/SBS)tohelpdecideifsubmissiontoIRBisrequired.
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HumanSubjectsProtocol
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KeystoSuccess- Ifyouneedaprotocol-WRITEANEXCELLENTPROTOCOL• ManyapplicationstoHSIRBsneedaformalwrittenprotocol
WHY?• Becauseaprotocolprovidesacomprehensiveroadmapofthestudyfor
allstakeholders.Areadershouldbeabletoconductastudyfromstarttofinishbasedontheprotocol.
• Itisanaccountofstudyconductandexecution,includingobjectives,design,procedures,measures,studymanagement,dataacquisitionandanalysisandethicalconsiderations.
University of Wisconsin - Madison
HumanSubjectsProtocol
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Keystosuccess- KnowthedifferencebetweenaGrant,ProtocolandIRBapplication
ü Grantdescribesthescienceü Protocolisaroadmapoftheimplementationofthehumanssubjects
researchcomponentsofthegrantü IRBapplicationisacollectionandorganizationofkeyfeaturesofthe
protocolprimarilyaddressingtheprotectionofhumansubjects.
• Usetemplates– ICTRhasaprotocoldevelopment serviceandhasstartedtoposttemplates.USEthemtocaptureallappropriateinformationforyourstudy.
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Step1:OutlineandExplainStudyProcedures
Focusapplicationonactivitiessubjectswillundertake
Describeactivities– donotassumeactivitiesareuniversal
Leaveinformationonanalysisintheprotocol
Usewhitespaceandheadings
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Step2:IdentifyRisksoftheStudy
ConsidertherisksposedtosubjectsbyproceduresANDanalyses
Describephysicalrisksanddiscomforts
• Includecommonandrarebutseriousrisks
Describepsychosocialrisks
• Breachofconfidentialityataminimum!
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Step3:DescribeProcedurestoMinimizeRisks
ShowtheIRBhowyouareminimizingallrisks
Addressbothimmediaterisksanddelayedrisks
ResearchRequirements≠ClinicalRequirements
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Step4:ProvideJustification
DonotassumetheIRBknowswhatyouaredoingorwhy
Whenaskedforjustificationsorexplanations,providethem
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RecentChangestoReduceAdministrativeBurden
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FundingandIRBCongruence
• CertificationisconfirmationbyPItoRSP(andRSPtoNIH)thattheyhave(orwillhaveforactivitieslateintheproject)IRBapprovalforworkproposedinthegrant
• RSPusesPLuS toconfirmthattheIRBapplicationintheWISPRrecordisapproved.
Congruencenolonger
required,butcertification ofIRBapprovalis
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HowtoFacilitateCertificationandReleaseofFunding
AddyourIACUC/IRBprotocolstoWISPERrecordsfirst.
Usethenew“chooser”toselectallfundingsupportingtheresearch.
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Newfundingpage
University of Wisconsin - Madison
Newfundingpage
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University of Wisconsin - Madison
Studyteamactivities
InARROW,thenewchooserfiltersthefundingforthatPI,withthemostrecentproposalsatthetop.• Ifyoudonotseetheexpectedfunding,youcansearchbyPI,MSN,grantnumberortitle.
• NOTE:forsomestudies(pilotawardsfromthecancercenterorICTR),studyteamscanselecttheprimarygrant(ietheCancerCentergrantortheCTSAawardforICTR)ifthatgrantisultimatelysupportingtheproject.
University of Wisconsin - Madison
WhathappensatIRB?
Administrativereviewwillconfirmthatassociatedfundingappearstobeappropriateforthestudy(PI,granttitleseemsappropriatefortheIRBapplication).
Adminreviewmayrequestinformationaboutpeerreviewfromstudyteamfornovelfoundations.
IRBdoesNOTneedgrantapplicationorconfirmationofapproval/JITmaterials
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AncillaryCommitteesandOtherRequirementstoConsider
Cybersecurity/ClinicalResearchDataService
(CRDS)
ScientificReviewCommittee
ProtocolReviewMonitoringCommittee
ResearchandSponsored
Programs(RSP)
RadioactiveDrugResearch
Committee(RDRC)
OnCore/AncillaryService
Review/MedicareCoverage
VAR&DCommittee
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University of Wisconsin - Madison
Resources
• FAQforscientificreview:https://kb.wisc.edu/hsirbs/94085• ChangestoCongruencereview:https://kb.wisc.edu/hsirbs/93382• GeneralResearchquestions:https://research.wisc.edu/• HIPAAtraining:https://compliance.wisc.edu/hipaa/training/• UWBiomedical,SocialandBehavioral,andVAtraining:https://research.wisc.edu/compliance-policy/human-research-protection-program/hrpp-training/citi-human-subjects-protections-hsp-training-instructions/
• HS-IRBKB:https://kb.wisc.edu/hsirbs/• QuestionsaboutChooser:AndrewDrinkwater ([email protected])• Questionsaboutinvoicing(industrysponsoredstudies):VielskaBRAUTIGAM([email protected])
• Questionsaboutcertification/congruencerequests:LynnHaynes([email protected])
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WhatQuestionsDoYouHave?
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