managing institution-investigator relationships · pasadena, california. agenda introduction to...
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ManagingInstitution-Investigator
RelationshipsA Community Hospital Perspective
Sandra A. Davis, RN, MNDirector, Risk and Compliance
Huntington HospitalPasadena, California
Agenda
Introduction to Huntington HospitalSigns and Symptoms To Watch ForRisk and Compliance IssuesCures
ControlsCollaborationCommunication
Questions and Answers
Huntington Hospital
525 Bed Acute Care Community Hospital726 Active and Provisional PhysiciansInternal Medicine and General Surgery Residency ProgramsAffiliated with USC School of Medicine30-40 New Research Protocols Reviewed Each YearSWOG
Mission
Huntington Hospital is committed to providing superior health care close to home. Our mission is to improve the health of the communities we serve by:
Addressing community needs in partnership with other organizations.Providing health care services to the region within our financial capacity.Pursuing excellence and innovation in patient care, education and research.
Our PastLeading us to our Leading us to our
future...future...
Henry E. Huntington
Community Roots
1907 Operating Room
1908 - 1909
Signs and Symptoms
Studies approved by IRB before you knowUn-depleted grant funds on closed studiesEmployees signing sponsor agreementsGrant checks arriving unannouncedAngry physicians waiting to start researchIRB protocol approval prior to contract reviewRN’s assisting physicians with research studies
1926
Risk and Compliance Issues
Sponsor ContractsClinical CompetenciesResource CommitmentsExpense and Billing ManagementInsurance CoverageSanctions
Sponsor Contracts
Indemnification agreementsDesigned for academic institutionsDesigned without regard to corporate practice of medicineTax liabilitiesGrant management liabilities
Clinical Competencies
ProtocolInvestigational drugsResearch budgetLabor cost transferSubmittal of research expensesReconciling expenses and timecards
Resource Commitments
Principal InvestigatorReports to sponsorReports to IRB
InstitutionLegal fees
IRB reviewContract review
Grant management/accountingClinical staffBilling
Expense Management
Patient trackingInsurance coverage Vs. grant coverageIntercepting and backing out chargesReconciling expenses against budgetReconciling labor timecards against research records
Insurance Coverage
Exposure stats to broker or carrierDifferentiating IRB risks Vs organizational risks
Principal InvestigatorIRB membersIndemnification
Sponsor for researchPI for Informed Consent and Protocol adherence, grant expense managementInstitution for IRB approval and monitoring, employee actions in support of research
Sanctions
Principal InvestigatorOffice of Research IntegritySponsorMedicare False Claims
InstitutionOffice of Human Research ProtectionMedicare False ClaimsSponsorPrivate inurement
Emergency Room 1960’s
Our FuturePreparing us for 100 Preparing us for 100
more years...more years...
Cures
ControlsCollaborationCommunication
Principal Investigator wants to do research
Office of ClincialResearch notified
grantassistanceneeded?
Meetsadministrative
review criteira?Stop
Reviewagreement
between HH andPI
stop
Agreement signedbetween HH andgrant sponsor
Researchstarts
Establishan
expenseallocationprocesswith PI
Yes
GrantAssistance
NoNo
Yes
Yes
Grant Accounting Ongoing research andgrant management by
Office of Clinical ResearchClinical Research
Support
IRB CommitteeApproval?
No
Improved
Process
ControlsPre-IRB
Sponsor ContractPrincipal Investigator AgreementResearch protocol budgetExpense submittal process
Post-IRBPeriodic reportsMonthly or quarterly budget and expense analysis
Collaboration
Working relationshipsAdministrationLegal analysisResearch supportClinical support
Communication
Initial contactMonthly or quarterly reportsPeriodic updates
Huntington Today
Huntington Hospital
The Future
Questions?