1. Director, Risk and Compliance
Managing Institution-Investigator Relationships A 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. Leading us to our future...
Our Past
Leading us to our future...

6. Henry E. Huntington

7. Community Roots

8. 1907 Operating Room

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
RN’s 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 Institution
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 Principal Investigator Institution
Office of Research Integrity
Sponsor
Medicare False Claims
Institution
Office of Human Research Protection
Private inurement
Close down IRB for not protecting rights
of human subjects

19. Emergency Room 1960’s

20. Preparing us for 100 more years...
Our Future
Preparing us for 100 more years...

21. Cures
Controls
Collaboration
Communication

22. Improved
Process

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

24. Collaboration Working relationships Administration Legal analysis
Research support
Clinical support

25. Monthly or quarterly reports
Communication
Initial contact
Monthly or quarterly reports
Periodic updates

26. Huntington Today

27. Huntington Hospital
The Future

28. Questions?