Managing InstitutionInvestigator Relationships A Community Hospital Perspective

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Managing Institution-Investigator
RelationshipsA Community Hospital Perspective

• Sandra A. Davis, RN, MN
• Director, Risk and Compliance
• Huntington Hospital
• Pasadena, California

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Agenda

• Introduction to Huntington Hospital
• Signs and Symptoms To Watch For
• Risk and Compliance Issues
• Cures
• Controls
• Collaboration
• Communication
• Questions and Answers

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Huntington Hospital

• 525 Bed Acute Care Community Hospital
• 726 Active and Provisional Physicians
• Internal Medicine and General Surgery Residency
  Programs
• Affiliated with USC School of Medicine
• 30-40 New Research Protocols Reviewed Each Year
• SWOG

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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.

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Our Past
Leading us to our future...
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Henry E. Huntington
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Community Roots
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1907 Operating Room
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1908 - 1909
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Signs and Symptoms

• Studies approved by IRB before you know
• Un-depleted grant funds on closed studies
• Employees signing sponsor agreements
• Grant checks arriving unannounced
• Angry physicians waiting to start research
• IRB protocol approval prior to contract review
• RNs assisting physicians with research studies

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1926
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Risk and Compliance Issues

• Sponsor Contracts
• Clinical Competencies
• Resource Commitments
• Expense and Billing Management
• Insurance Coverage
• Sanctions

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Sponsor Contracts

• Indemnification agreements
• Designed for academic institutions
• Designed without regard to corporate practice of
  medicine
• Tax liabilities
• Grant management liabilities

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Clinical Competencies

• Protocol
• Investigational drugs
• Research budget
• Labor cost transfer
• Submittal of research expenses
• Reconciling expenses and timecards

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Resource Commitments

• Principal Investigator
• Reports to sponsor
• Reports to IRB
• Institution
• Legal fees
• IRB review
• Contract review
• Grant management/accounting
• Clinical staff
• Billing

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Expense Management

• Patient tracking
• Insurance coverage Vs. grant coverage
• Intercepting and backing out charges
• Reconciling expenses against budget
• Reconciling labor timecards against research
  records

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Insurance Coverage

• Exposure stats to broker or carrier
• Differentiating IRB risks Vs organizational risks
• Principal Investigator
• IRB members
• Indemnification
• Sponsor for research
• PI for Informed Consent and Protocol adherence,
  grant expense management
• Institution for IRB approval and monitoring,
  employee actions in support of research

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Sanctions

• Principal Investigator
• Office of Research Integrity
• Sponsor
• Medicare False Claims
• Institution
• Office of Human Research Protection
• Medicare False Claims
• Sponsor
• Private inurement

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Emergency Room 1960s
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Our Future
Preparing us for 100 more years...
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Cures

• Controls
• Collaboration
• Communication

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Improved Process
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Controls

• Pre-IRB
• Sponsor Contract
• Principal Investigator Agreement
• Research protocol budget
• Expense submittal process
• Post-IRB
• Periodic reports
• Monthly or quarterly budget and expense analysis

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Collaboration

• Working relationships
• Administration
• Legal analysis
• Research support
• Clinical support

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Communication

• Initial contact
• Monthly or quarterly reports
• Periodic updates

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Huntington Today
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Huntington Hospital
The Future
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Questions?