The Perfect Storm:
Challenges on the Horizon for Funding and
Regulatory Controls in Research
Andrew Nelson
Executive Director
HealthPartners Research Foundation
Compression Forces
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External Factors
Internal Reactions
Storm Forecasting
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HealthPartners
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Clinic system consisting of 30 clinics and 600 physicians
Largest hospitals in the Twin Cities, Regions Hospital.
9,200 employees, the vast majority of which are care providers
Health plan with 675,000 members.
 MN networks with over 11,000 physicians
 Open access and care system network models
 National network capability
 Insured and self-insured products
HealthPartners Research Foundation, Institute for Medical
Education, and are founding members of the Institute for Clinical
Systems
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HealthPartners Research Foundation
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Over 200 active studies
13 Million Dollar Budget in 2005
Research staff of 100, 27 research investigators
One of the founding member of the HMO Research Network
92% externally funded
Strategic focus: Integration of Research and Practice
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External Factors - Dramatic Changes
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Use of data, data bases and health information
technologies
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Financing of health care
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Quality and tolerance
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Trust in research
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Research discoveries – genomics and other wonders
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External Factors - Dramatic Changes cont.
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IOM Responsible Research, 2003
Privacy concerns and regulatory responses
Research funding flat/declining
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Legislating & political influencing science
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Public access to research and health plan data
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Translating research into practice
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Privacy Concerns and Regulatory Responses
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HIPAA privacy and security
 Gramm-Leach-Blieley
 Common Rule
 FDA
 State Law
 Institutional compliance and risk management
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HPRF Response
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Upswing in proposal development
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Staff restructuring and organizational consolidated
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Investigator roles and expectations evolving
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Finance and compliance controls continuously
expanding
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HPRF Response Cont.
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“Integrating research and practice” strategic
direction evolving into “Optimizing Practice
Through Research”
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Increasing collaborations and research networks
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Synergy within and value to HealthPartners
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Creating research technology transfer
opportunities
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Expanded health information technology research
agenda
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Storm Forecast
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Storm will become norm
Value proposition for research increasingly challenged
Nature of research will focus on utility and effectiveness
Open data bases
Risk adversity increasing
Compliance burden increasing
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