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?