Patient outcomes research teams : managing conflict of interest

Patient outcomes research teams managing conflict of interest

Bibliographic Details
Main Author: Institute of Medicine (U.S.).
Corporate Author: Institute of Medicine (U.S.). Committee on Potential Conflicts of Interest in Patient Outcomes Research Teams (-)
Other Authors: Donaldson, Molla S. (-), Capron, Alexander Morgan
Format: eBook
Language:Inglés
Published: Washington, D.C. : National Academy Press 1991.
Edition:1st ed
Subjects:
Outcome assessment (Medical care) > United States.
See on Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820308106719
Table of Contents:
  • 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.

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