Scientific advances such as the sequencing of the human genome have created great promise for improving human health by providing a greater understanding of disease biology and enabling the development of new drugs, diagnostics, and preventive services. However, the translation of research advances into clinical applications has so far been slower than anticipated. This is due in part to the complexity of the underlying biology as well as the cost and time it takes to develop a product. Pharmaceutical companies are adapting their business models to this new reality for product development by placing increasing emphasis on leveraging alliances, joint development efforts, early-phase research partnerships, and public-private partnerships. These collaborative efforts make it possible to identify new drug targets, enhance the understanding of the underlying basis of disease, discover novel indications for the use of already approved products, and develop biomarkers for disease outcomes or directed drug use. While the potential benefits of collaboration are significant, the fact that the relationships among development partners are often financial means that it is vital to ensure trust by identifying, disclosing, and managing any potential sources of conflict that could create bias in the research being performed together.

Conflict of Interest and Medical Innovation is the summary of a workshop convened by the Institute of Medicine Roundtable on Translating Genomic-Based Research for Health in June 2013 to explore the appropriate balance between identifying and managing conflicts of interest and advancing medical innovation. A wide range of stakeholders, including government officials, pharmaceutical company representatives, academic administrators and researchers, health care providers, medical ethicists, patient advocates, and consumers, were invited to present their perspectives and participate in discussions during the workshop. This report focuses on current conflict of interest policies and their effect on medical innovation in an effort to identify best practices and potential solutions for facilitating innovation while still ensuring scientific integrity and public trust.

Contents

• THE NATIONAL ACADEMIES
• PLANNING COMMITTEE
• ROUNDTABLE ON TRANSLATING GENOMIC-BASED RESEARCH FOR HEALTH
• Reviewers
• Acknowledgments
• Abbreviations and Acronyms
• 1. Introduction and Overview
  • THEMES OF THE WORKSHOP
• 2. Conflict of Interest Policies: An Overview
  • THE CURRENT LANDSCAPE: DEFINITIONS AND GOALS
  • ENHANCING THE ACADEMIA–INDUSTRY RELATIONSHIP
  • NIH POLICY ON CONFLICTS OF INTEREST
• 3. Perspectives on Conflict of Interest Policies
  • POLICY TRANSPARENCY
  • COLLABORATION WITHIN CONFLICT OF INTEREST BOUNDARIES
  • SERVING ON ADVISORY COMMITTEES
  • NETWORK OF EXPERTS
• 4. Public Perceptions of Conflict of Interest
  • COMMUNICATING CONFLICT OF INTEREST
  • MEDIA PORTRAYALS OF CONFLICT OF INTEREST
  • PROVIDING CONTEXT FOR CONFLICT OF INTEREST
• 5. Managing Conflict and Facilitating Innovation
  • MANAGING CONFLICTS OF INTEREST AND BALANCING INNOVATION AT INSTITUTIONS
  • ALIGNING INCENTIVES IN THE RESEARCH ECOSYSTEM
  • PUTTING PATIENTS AT THE CENTER OF CARE
• References
• APPENDIXES
  • A Workshop Agenda
  • B Speaker Biographical Sketches
  • C Statement of Task
  • D Registered Attendees

Rapporteurs: Sarah H. Beachy, Adam C. Berger, and Steve Olson.

This project was supported by contracts between the National Academy of Sciences and the American Academy of Nursing (unnumbered contract); American College of Medical Genetics and Genomics (unnumbered contract); American Heart Association (unnumbered contract); American Medical Association (unnumbered contract); American Society of Human Genetics (unnumbered contract); Association for Molecular Pathology (unnumbered contract); Blue Cross and Blue Shield Association (unnumbered contract); College of American Pathologists (unnumbered contract); Department of the Air Force (Contract No. FA7014-0-P-0072); Department of Veterans Affairs (Contract No. VA248-P-1528); Eli Lilly and Company (unnumbered contract); Genetic Alliance (unnumbered contract); Health Resources and Services Administration (Contract No. HHSH250201100119P and Contract No. HHSH25034017T); International Society for Cardiovascular Translational Research (unnumbered contract); Johnson & Johnson (unnumbered contract); The Kaiser Permanente Program Offices Community Benefit II at the East Bay Community Foundation (Contract No. 20121257); Life Technologies (unnumbered contract); National Cancer Institute (Contract No. HHSN263201200074I, TO#5); National Coalition for Health Professional Education in Genetics (unnumbered contract); National Heart, Lung, and Blood Institute (Contract No. N01-OD-4-2139, TO#275); National Human Genome Research Institute (Contract No. N01-OD-4-2139, TO#264 and Contract No. HHSN263201200074I, TO#5); National Institute of Mental Health (Contract No. N01-OD-4-2139, TO#275 and Contract No. HHSN263201200074I, TO#5); National Institute of Nursing Research (Contract No. HHSN263201200074I, TO#5); National Institute on Aging (Contract No. N01-OD-4-2139, TO#275 and Contract No. HHSN263201200074I, TO#5); National Society of Genetic Counselors (unnumbered contract); Northrop Grumman Health IT (unnumbered contract); Office of Rare Diseases Research (Contract No. N01-OD-4-2139, TO#275); Pfizer Inc. (unnumbered contract); and PhRMA (unnumbered contract). The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the activity.

Suggested citation:

IOM (Institute of Medicine). 2014. Conflict of interest and medical innovation: Ensuring integrity while facilitating innovation in medical research: Workshop summary. Washington, DC: The National Academies Press.

NOTICE: The workshop that is the subject of this workshop summary 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.