Patients and the public benefit when physicians and researchers collaborate with pharmaceutical, medical device, and biotechnology companies to develop products that benefit individual and public health. At the same time, concerns are growing that wide-ranging financial ties to industry may unduly influence professional judgments involving the primary interests and goals of medicine. Such conflicts of interest threaten the integrity of scientific investigations, the objectivity of professional education, the quality of patient care, and the public’s trust in medicine.

This Institute of Medicine report examines conflicts of interest in medical research, education, and practice and in the development of clinical practice guidelines. It reviews the available evidence on the extent of industry relationships with physicians and researchers and their consequences, and it describes current policies intended to identify, limit, or manage conflicts of interest. Although this report builds on the analyses and recommendations of other groups, it differs from other reports in its focus on conflicts of interest across the spectrum of medicine and its identification of overarching principles for assessing both conflicts of interest and conflict of interest policies. The report, which offers 16 specific recommendations, has several broad messages.

Contents

• The National Academies
• Committee on Conflict of Interest in Medical Research, Education, and Practice
• Acknowledgments
• Reviewers
• Preface
• Summary
  • ABSTRACT
  • PRINCIPLES FOR IDENTIFYING AND ASSESSING CONFLICTS OF INTERESTS
  • POLICIES ON CONFLICTS OF INTEREST: OVERVIEW AND EVIDENCE
  • CONFLICTS OF INTEREST IN BIOMEDICAL RESEARCH
  • CONFLICTS OF INTEREST IN UNDERGRADUATE, GRADUATE, AND CONTINUING MEDICAL EDUCATION
  • CONFLICTS OF INTEREST AND MEDICAL PRACTICE
  • CONFLICTS OF INTEREST AND DEVELOPMENT OF CLINICAL PRACTICE GUIDELINES
  • INSTITUTIONAL CONFLICTS OF INTEREST
  • THE ROLE OF SUPPORTING ORGANIZATIONS
  • OVERVIEW AND LIST OF RECOMMENDATIONS
• 1. Introduction
  • OVERVIEW AND THEMES OF REPORT
  • HISTORICAL AND POLICY CONTEXT
  • ORGANIZATION OF REPORT
• 2. Principles for Identifying and Assessing Conflicts of Interest
  • WHAT IS A CONFLICT OF INTEREST?
  • WHAT ARE THE PURPOSES OF CONFLICT OF INTEREST POLICIES?
  • WHY NOT EXAMINE THE MOTIVES OF THE DECISION MAKER OR THE VALIDITY OF THE DECISION?
  • SHOULD POLICIES ALSO REQUIRE THAT PROFESSIONALS AVOID THE “APPEARANCE OF CONFLICT OF INTEREST”?
  • HOW CAN CONFLICTS OF INTEREST BE ASSESSED?
  • HOW CAN CONFLICT OF INTEREST POLICIES BE EVALUATED?
  • CONCLUSION
• 3. Policies on Conflict of Interest: Overview and Evidence
  • OVERVIEW OF CONFLICT OF INTEREST POLICIES
  • DISCLOSURE: AN ESSENTIAL BUT INSUFFICIENT ELEMENT OF POLICY
  • PROHIBITING OR ELIMINATING CONFLICTS OF INTEREST
  • EVALUATING AND MANAGING CONFLICTS OF INTEREST
  • RECOMMENDATIONS
• 4. Conflicts of Interest in Biomedical Research
  • COLLABORATION AND DISCOVERY IN BIOMEDICINE
  • INDUSTRY FUNDING AND RELATIONSHIPS IN BIOMEDICAL RESEARCH
  • CONCERNS ABOUT RELATIONSHIPS WITH INDUSTRY
  • RESPONSES TO CONCERNS ABOUT CONFLICTS OF INTEREST IN RESEARCH
  • RECOMMENDATIONS
• 5. Conflicts of Interest in Medical Education
  • BACKGROUND AND CONTEXT
  • LEARNING ENVIRONMENTS IN MEDICAL SCHOOLS AND RESIDENCY PROGRAMS
  • THE LEARNING ENVIRONMENT IN ACCREDITED CONTINUING MEDICAL EDUCATION
  • GHOSTWRITING, SPEAKERS BUREAUS, AND INDEPENDENCE OF PUBLICATIONS AND PRESENTATIONS
  • RECOMMENDATIONS
• 6. Conflicts of Interest and Medical Practice
  • THE BROADER CONTEXT: PHYSICIAN PAYMENT, SELF-REFERRAL, AND CONFLICTS OF INTEREST IN MEDICAL PRACTICE
  • INDUSTRY PROMOTIONAL ACTIVITIES AND PRACTICING PHYSICIANS
  • RESPONSES TO CONCERNS ABOUT INDUSTRY RELATIONSHIPS AND CONFLICTS OF INTEREST IN COMMUNITY PRACTICE
  • RECOMMENDATIONS
• 7. Conflicts of Interest and Development of Clinical Practice Guidelines
  • BACKGROUND AND CONTEXT
  • GROUPS THAT DEVELOP CLINICAL PRACTICE GUIDELINES
  • FINANCIAL RELATIONSHIPS IN GUIDELINE DEVELOPMENT
  • POLICIES ON CONFLICTS OF INTEREST IN CLINICAL PRACTICE GUIDELINE DEVELOPMENT
  • RECOMMENDATIONS
• 8. Institutional Conflicts of Interest
  • WHAT ARE INSTITUTIONAL CONFLICTS OF INTEREST?
  • EXTENT OF INSTITUTIONAL RELATIONSHIPS WITH INDUSTRY
  • RESPONSES TO INSTITUTIONAL CONFLICTS OF INTEREST
  • SPECIAL CHALLENGES IN MANAGING INSTITUTIONAL CONFLICTS OF INTEREST
  • RECOMMENDATIONS
• 9. Role of Supporting Organizations
  • HOW SUPPORTING ORGANIZATIONS CAN INFLUENCE MEDICAL INSTITUTIONS
  • RECOMMENDATIONS
• References
• Appendixes
  • A Study Activities
  • B U.S. Public Health Service Regulations: Objectivity in Research (42 CFR 50)
  • C Conflict of Interest in Four Professions: A Comparative Analysis
  • D How Psychological Research Can Inform Policies for Dealing with Conflicts of Interest in Medicine
  • E The Pathway from Idea to Regulatory Approval: Examples for Drug Development
  • F Model for Broader Disclosure
  • G Committee Biographies

This study was supported by Contract No. N01-OD-4-2139, TO #201 of the National Institutes of Health, Contract No. 63229 of the Robert Wood Johnson Foundation, The Greenwall Foundation, the ABIM Foundation, Contract No. S07-2 of the Josiah Macy Jr. Foundation, Contract No. 1007182 of the Burroughs Wellcome Fund, and also the endowment fund of the Institute of Medicine, all contracts between the National Academies.

Suggested citation:

IOM (Institute of Medicine). 2009. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: The National Academies Press.

Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for the project.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.