Recruiting from UNC Health Care System Network …...Recruiting from UNC Health Care System Network...
Transcript of Recruiting from UNC Health Care System Network …...Recruiting from UNC Health Care System Network...
RecruitingfromUNCHealthCareSystem
NetworkEntities
UNCHCSOfficeofResearchSupport&Compliance(ORSC)
DianePowers,MPH,CHRC,CCRPSystemDirector,ResearchCompliance– NetworkEntities
DianeTowle,RN,CIPProgramManager,ORSC
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TheUNCHealthCareSystem• UNCHospitals– ReferstotheUNCHospitals(NCMemorial,NCNeurosciences,NCWomen’s,NCChildren’s,NCCancerHospitalandtheHillsboroughcampus)
• UNCHeathCareSystem– ReferstoUNCHospitalsanditsprovidernetwork,theclinicalprogramsoftheUNCSOM,and9affiliatehospitals
• NetworkEntities – 9affiliatehospitalsandhospitalsystemsacrosstheNorthCarolina– Alsoreferredtoas“NetworkEntities”(NE)– UNCPhysiciansNetworkfallsundertheNE“umbrella”;itisnot partofUNCHospitals
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OwnedNetworkEntities
CaldwellUNCHealthCare
NoResearchatthistime
ChathamUNC
Healthcare
Developing
OneObservational
Study
CentralIRB
HighPointRegionalUNCHealthCare
ActiveCardiologyOncologyHayworth
UNCIRB
UNCREXHealthcare
ActiveCardiology/NCHVR
Oncology
UNCIRB
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ManagedNetworkEntities
JohnstonUNCHealth
Care
Active
UNCIRB/Non-Oncology
DukeIRB/Oncology
LenoirUNCHealthCare
Someresearchinpractices
LocalIRBActive
NashUNCHealthCare
DevelopingOncology
ContractinProgress
UNCIRB
Pardee UNCHealthCare
ActiveOncology
LocalIRBActive
WayneUNCHealthCare
ActiveOncologyExternalPractice
ContractinProgress
LocalIRBActive
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RecruitingfromNEhospitals/clinics
Researchinvolvescontactwithsubjectsbut
islimitedtoUNCHCPatients
Researchlimitedtocollectionofexistingdata(collectedvia
Epic) Researchinvolvesinteractionwithsubjectsand
Subjectsrecruited/studiedatNEHospitalsand
UNCResearchteamincludesNECollaborator
Researchinvolvesinteractionwithsubjectsand
Subjectsrecruited/studiedatNEHospitalsbut
UNCResearchteamdoesnot includeNECollaborator
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RecruitingfromNEhospitals/clinics
• Youshouldrespond“yes”toscreeningquestion#6if yourresearchinvolvesinteraction/intervention(includingon-siterecruitmentorscreening)withsubjectsattheNE.
• TheUNCIRBprovidesIRBoversightforbothRex,HighPointandJohnstonnon-oncology);therefore,youshouldrespond“no”ifyourresearchinvolvesthesesites.
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RecruitingfromNEhospitals/clinics
• “CollaboratorsoutsideofUNC-CH”meanstheUNCIRBdoesnotserveastheIRBofrecordfortheexternalsite/organization.
• TheUNCIRBcurrentlyserves astheIRBforUNC-Rex,HighPointRegionalandJohnstonHealth(non-oncologyonly)
• Youshouldcheck“yes”ifyourresearchinvolvesinteractionwithsubjectsand you’veincludedaNECollaboratorothertheNEslistedabove.
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RecruitingfromNEhospitals/clinics
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RecruitingfromNEhospitals/clinics
YouhaveindicatedthatyouplantorecruitfromorconductresearchatoneormoreoftheUNCHCNetworkEntities(NE).Ifyouarenotemployed(i.e.,paidby)bytheNE,youmustcompletetheFacilityRequestForm(FRF)andsubmittoresearchreview@unchealth.unc.eduforapprovalpriortobeginningyourresearchproject.
IMPORTANT:IfyourIRBapplicationdoesnotincludeanypersonnelfromtheUNCHCNE(e.g.,Rex,HighPoint)atwhichyouplantorecruitfromorconductresearchat,inadditiontoobtainingIRBapproval,youmustalsoreceiveapprovalfromtheNE.YouMAYNOTproceedwithyourresearchuntilyouhaveobtainedapprovalfromboththeIRBandtheNE.ToobtainapprovaltoconductresearchatoneormoreoftheUNCHCSNEhospitals,youmustsubmitthecompletedFRFtotheemailaddressprovidedbelow.
Note:Approvalisnotrequiredforstudieswheretherewillbenophysicalpresenceforrecruitment,clinicalinterventions,tests,proceduresordedicatedlocaldatacollectionperformedattheNE. 9
RecruitingfromNEhospitals/clinics
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1. …butIalreadyhaveapprovalfromtheUNCIRBtoconductmyresearchataNetworkEntity.
Response:TheIRBreviewsandapprovestheconductofthestudy.SeeinformationinthemulticentersectionoftheIRBISapplication:“Researchersareremindedthatadditionalapprovalmaybeneededfromrelevantgatekeepers toaccesssubjects.”TheOfficeofResearchSupportandComplianceservesastheGatekeeper.
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2. WhentheCDW-Hprovidesmewithalistofpotentiallyeligiblesubjectsformystudy,doIneedtoobtainapprovaltocontactsubjectswhoreceivehealthcareataNetworkEntityifmyresearchstudyisconductedatUNC?
Response:Youdonotneedpermissiontocontactpatientstoelicittheirinterestinyourresearchstudyaslongasyoudonotplantorecruiton-site.Dependingonthetypeofstudy,theIRBmayrequireapprovalofthepatient’streatingphysician.
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3. WhentheCDW-Hprovidesmewithalistofpotentiallyeligiblesubjectsformystudy,doIneedtoobtainapprovaltocontactsubjectswhoreceivehealthcareataNetworkEntityifmystudyisconductedataNetworkEntity?
Response:Anytimeyouplantorecruiton-siteorconductresearchataNetworkEntity(i.e.,usetheirspace,servicesand/orequipment)youmusteithercollaboratewitharesearcherattheNetworkEntityorobtainapprovalbycompletingandsubmittingtheFacilitiesReviewForm totheOfficeofResearchSupportandCompliance(ORSC). 13
4. WhenyousayIneedtoworkwithacollaboratorattheNE,doesthecollaboratorneedtobeaphysician?
Response:ItdependsonthetypeofstudyandroleofthecollaboratorattheNE.Generally,thecollaboratordoesnotneedtobeaphysician.
SomeinvestigatorsatUNChavea“businessassociation”withsomeoneattheidentifiedNetworkEntitywhowillsupporttheirresearchiftheyhaveprivilegesattheNE andplantodoalloftheworkthemselves. 14
5. InadditiontocompletingtheFacilitiesReviewForm(FRF),whatelsedoIneedtodo,ifIamcollaboratingwithaNEphysician?
Response:TherewillusuallybeasubcontractofsomekindbetweenUNCandtheNEsite.ORSCreviewingtheFRFwillinitiatethecollaborationbetweentheUNCInvestigator,thebusinesscontactattheNetworkEntityandthelegalcounselattheNetworkEntityfortheagreement.
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6. IftheNetworkEntityispartoftheUNCHealthCareSystem,whydoIneedpermissiontoconductmyresearchthere?
Response:MostNEhospitals(includingRexandHighPoint)areseparatelegalentities. AnythingbeyondthecollectionofdatarequirespermissiontoenterNEhospitalsand/orclinics.NEsmaydeclineresearchiftheimpacttoregularbusinessand/orpersonnelisnotfeasible.Itisimportanttoreachouttoinvestigateopportunitiespriortodevelopingyourproject,thencarefullydescribeuseof1)personnel,2)testsand3)servicesneededtofacilitateyourresearchattheNEsites. 16
5. WhodoIcontacttoidentifyacollaboratoratonetheNEhospitals?
Response:ExistingcontactsintheresearchspecialtyattheEntity,orcontact:
[email protected]@unchealth.unc.eduOfficephone:984-974-1427
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Questions
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