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:

DianePowersDiane.powers@unchealth.unc.eduORSC@unchealth.unc.eduOfficephone:984-974-1427

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Questions

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