Patient Outcomes Research Teams: Managing Conflict of Interest -- Copyright -- Acknowledgments -- Preface -- Contents -- Summary -- INSTITUTE OF MEDICINE STUDY -- DEFINING CONFLICT OF INTEREST -- MODELS FOR ADDRESSING CONFLICTS OF INTEREST -- POINTS TO CONSIDER -- 1 Introduction -- OUTCOMES RESEARCH -- THE INSTITUTE OF MEDICINE STUDY -- STRUCTURE OF THE REPORT -- 2 Patient Outcomes Research Teams -- THE MEDICAL TREATMENT EFFECTIVENESS PROGRAM -- PORT RESEARCH TOPICS -- PORT STRUCTURE -- PORT METHODS -- SPECIAL ASPECTS OF PORT RESEARCH -- SUMMARY -- 3 Conflict of Interest -- DEFINING CONFLICT OF INTEREST -- FINANCIAL RELATIONSHIPS THAT MAY GIVE RISE TO CONFLICTS OF INTEREST -- Equity and Other Financial Relationships -- Industry Support for University Research -- ACADEMIC AND PROFESSIONAL CONFLICTS OF INTEREST -- ADDRESSING CONFLICTS OF INTEREST -- Legislative Support for Technology Transfer -- EFFECTS OF UNIVERSITY-INDUSTRY COLLABORATION -- RELEVANT EFFORTS IN OTHER SECTORS -- Regulation or Federal Employees -- FDA Federal Advisory Committees -- The United States Pharmacopeial Convention -- Professional Associations -- National Research Council -- National Institutes of Health Grants Policy -- Academic Association and Institutional Guidelines -- AAMC Guidelines -- AAHC Guidelines -- Academic Institutional Guidelines -- Medical Publications -- Judicial and Legal Approaches -- SUMMARY -- 4 Sources of Concern About Conflicts of Interest in PORTs -- ELEVEN ISSUES OF SPECIAL CONCERN -- PORTs as Hybrid Entities: Research and Quasi-Regulatory Functions -- PORTs as a Public Trust for Development of Scientific Knowledge -- PORTs as a Quasi-Regulatory Process -- Protecting PORT Credibility -- Expectations of Cost Savings -- Concentration of Expertise -- Subjective Judgments and Multidimensional Outcome Assessments.

Biases Arising from Ties to Professional Colleagues and Associations -- Access to Data -- Adequacy of Existing Institutional Guidelines -- Multi-Institutional PORTs -- Nonuniversity Clinicians and Their Patients -- Private Funding for Technological Modifications and New Practices -- Additional Study Arms -- Secondary Protocols -- Consulting and Other Financial Arrangements -- Spin-Off Ventures and Intellectual Property Rights -- Equity Interests of PORT Investigators -- Freedom of Communication Within PORTs -- SUMMARY -- 5 Managing Conflicts of Interest: General Models and Approaches -- TWO MODELS OF CONFLICT OF INTEREST MANAGEMENT -- Prohibition Model -- Disclosure and Peer Review Model -- GENERAL APPROACHES TO DEALING WITH CONFLICTS OF INTEREST -- Disclosure -- Financial Distancing -- Self-Regulation -- Defining Categories of Acceptable Activities and Implementing Oversight -- Defining Categories of Unacceptable Activities and Implementing Prohibitions -- Sanctions -- SUMMARY -- 6 Points to Consider -- ASSUMPTION -- CONSIDERATIONS FOR PORTS AND THEIR INSTITUTIONS -- Attributes of Conflict of Interest Management -- Education for Researchers, Faculty, and Students -- Clearly Stated Expectations for Early and Complete Disclosure -- Well-Formulated and Well-Implemented Institutional Processes and Responses -- Emphasis on the Role of the Principal Investigator -- Professional Conflicts and Implications for PORT Research -- Freedom of Communication for PORT Researchers -- CONSIDERATIONS FOR AHCPR -- Industry-Sponsored Research -- Access to Data -- Intra- and Inter-PORT Differences -- Review of Grant Applications -- CONSIDERATIONS FOR THE HEALTH SERVICES RESEARCH COMMUNITY -- CONSIDERATIONS FOR INDUSTRY -- Publication and Communication of Findings among PORT Members and Industry -- CONSIDERATIONS FOR CONGRESS -- CONCLUDING REMARKS -- References.

Appendix A Institute of Medicine Workshop on Conflicts of Interest in Patient Outcomes Research Teams -- PROGRAM AND SUMMARY -- Appendix B Workshop Participants -- INVITED PARTICIPANTS -- PRESS REPRESENTATIVE -- INSTITUTE OF MEDICINE -- Appendix C Scenarios and Rapporteur Summaries -- APPENDIX C1. SCENARIO I -- Discussion of Scenario I -- APPENDIX C2. SCENARIO II -- CARDPAK: Start of Study -- Outside Activities of the PORT Members -- Preliminary Results of the PORT Analyses: Four Years into the Study -- Discussion of Scenario II -- APPENDIX C3. SCENARIO III -- Discussion of Scenario III -- Appendix D Background Papers -- APPENDIX D1. PORT RESEARCH COMPARED WITH CLINICAL RESEARCH: CONFLICTS OF INTEREST IN PATIENT OUTCOME RESEARCH -- Introduction -- Patient Outcomes Research Teams -- Conflicts of Interest in Patient Outcomes Research Teams -- Opportunity and Motive -- Traditional Conflicts of Interest: Funding, Consulting, and Equity -- Spinoff Ventures and Intellectual Property Rights -- Changing Stakeholders -- Conclusions: What's Different about Outcomes Research? -- References -- APPENDIX D2. PORTS: THEIR IMPACT ON HEALTH SERVICES RESEARCH, TECHNOLOGY INNOVATION, AND PAYMENT POLICY -- Introduction -- Health Services Research -- Structure -- Possible Threats to PORT Success -- Cost of the PORTS -- Concentration of Expertise -- Technology Innovation -- Payment Policy -- Kinds of Uses for Information -- Magnitude of Impact -- Discussion -- Conclusions -- References -- APPENDIX D3. THE EVOLUTION AND CURRENT STATUS OF CONFLICT OF INTEREST REGULATION IN BIOMEDICAL SCIENCE -- Introduction -- Historical Overview -- Recent Concerns Regarding Clinical Studies -- NIH Activity in the Area -- Recent Self-Regulation in Clinical Studies -- Recent Moves by Consortia and Individual Institutions -- Conclusions and Applications to the PORTs -- Notes.

APPENDIX D4. THE STRUCTURE AND METHODS OF PORTS: SOURCES OF BIAS -- PORT Mission -- Experiences of the Dartmouth Assessment Team -- Vulnerability of PORT Mission to Conflict of Interest and Corruption of Purpose -- Economic Conflict of Interest -- Ideological Corruption -- Existential Corruption -- Corruption of Discursive Practices.