Managing InstitutionInvestigator Relationships A Community Hospital Perspective

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Managing InstitutionInvestigator Relationships A Community Hospital Perspective

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Huntington Hospital. 525 Bed Acute Care Community Hospital. 726 Active and ... Huntington Hospital is committed to providing superior health care close to home. ... – PowerPoint PPT presentation

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Title: Managing InstitutionInvestigator Relationships A Community Hospital Perspective

1
Managing Institution-Investigator
RelationshipsA Community Hospital Perspective

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

2
Agenda

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

3
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

4
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.

5
Our Past
Leading us to our future...
6
Henry E. Huntington
7
Community Roots
8
1907 Operating Room
9
1908 - 1909
10
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

11
1926
12
Risk and Compliance Issues

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

13
Sponsor Contracts

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

14
Clinical Competencies

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

15
Resource Commitments

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

16
Expense Management

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

17
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

18
Sanctions