Proposed system to reduce inefficiencies, inconsistencies in disclosure reporting across health, life science research fields
ALEXANDRIA, Va. - Published today by the Institute of Medicine (IOM), an expert Perspectives paper proposes an entirely new system for clinicians, researchers, students, trainees, and others to disclose financial relationships that may represent potential conflicts of interest. [The IOM publication corresponds to a “Viewpoint” column by the paper’s authors published in today’s Journal of the American Medical Association.]
Disclosure is a critical issue in the health, life sciences field, and is the primary way that most journals, institutions, professional societies and medical and scientific meetings manage conflicts of interest. The authors of the IOM discussion paper, Harmonizing Reporting on Potential Conflicts of Interest, including leaders from the health and life sciences fields, recommend the development of a single, national database in which full disclosure information would be entered by individual researchers, scientists and physicians and made available to third parties in a format that fits their specific reporting requirements.
Currently, medical schools, teaching hospitals, journals, professional societies, continuing education providers, and federal agencies request separate disclosure statements for varying activities resulting in duplication and burdensome effort as researchers must submit and update multiple forms to each discrete entity, potentially creating a situation in which researchers may inadvertently provide inconsistent information. Further, the Affordable Care Act “sunshine” provisions will require commercial health-related companies to report payments to physicians using another set of yet-to-be-defined disclosure reporting requirements.
“It would be difficult to imagine a more cumbersome and confusing system, one in which even the most diligent researcher runs the risk of producing an inaccurate report,” said Allen S. Lichter, MD, lead author of the discussion paper and chief executive officer of the American Society of Clinical Oncology (ASCO). “A coherent, uniform system will not only reduce the time spent by researchers on administrative tasks, but will very likely improve the accuracy and clarity of disclosure reporting.”
The discussion paper identifies and defines disclosure reporting elements that are common to different organizations and agencies involved in health care, including fees for services, intellectual property, grants, investment and ownership, and other items (such as travel, food, lodging, and gifts). Applying core data management principles, the discussion paper reviews options for data storage/maintenance, data entry/retrieval, and governance of a comprehensive system of information disclosure. The authors propose a centralized data repository operated under a not-for-profit status that ensures data security while increasing transparency in medical research and clinical practice.
“Without stifling necessary and productive collaborations between our nation’s health care researchers and commercial entities, this new system will provide much-needed standardization for disclosing financial relationships with industry,” said discussion paper co-author Ross McKinney, Jr., MD, Director of the Trent Center for Bioethics, Humanities & History of Medicine and Professor of Pediatric Infectious Diseases, Duke University School of Medicine. “This centralized approach will increase both transparency and public trust in our country’s scientific and medical research enterprise.”
Consistent with the recommendations in the IOM Discussion Paper, ASCO is already taking steps to reduce the burden of frequent, duplicative, and time-consuming disclosure requirements within the oncology community. The new ASCO disclosure management system, currently in its pilot phase, will provide a centralized database in which oncologists will be able to enter and update their general disclosure information in one central repository which will then be used to populate their disclosure for multiple purposes, including committee work, journal articles, and meeting abstracts. “The new ASCO system represents a giant leap forward in reducing the burden on oncologists to provide multiple disclosures for multiple purposes in any given year, while helping to ensure the greatest level of transparency and accuracy in disclosure reporting,” said Lichter.
The Harmonizing Reporting on Potential Conflicts of Interest Discussion Paper is part of a new category of IOM publications - Perspectives - which offer personal observations and opinions of leading experts on developments in health and health care. Perspectives are aimed at informing the discussion on pressing issues before the nation. As personal views, they reflect the opinions of the authors, not the Institute of Medicine. The Harmonizing Reporting on Potential Conflicts of Interest authors represented a broad range of leading experts from various stakeholder groups:
- Allen S. Lichter, MD (chair) – American Society of Clinical Oncology
- Ross McKinney, Jr., MD – Duke University School of Medicine
- Timothy Anderson – American Medical Student Association
- Erica Breese – Centers for Medicare & Medicaid Services
- Niall Brennan – Centers for Medicare & Medicaid Services
- David Butler – Consumers Union
- Eric G. Campbell, PhD – Mongan Institute for Health Policy, Massachusetts General Hospital
- Susan Chimonas, PhD – Columbia University
- Guy Chisolm, PhD – Cleveland Clinic
- Christopher Clark, JD – Partners HealthCare
- Milton Corn, MD – National Library of Medicine
- Allan Coukell, BScPharm – The Pew Charitable Trusts
- Diane Dean, PhD – National Institutes of Health
- Susan Ehringhaus, JD – Partners HealthCare
- Phil Fontanarosa – Northwestern University
- Mark Frankel – American Association for the Advancement of Science
- Raymond J. Hutchinson, MS, MD – University of Michigan Medical School
- Timothy Jost – Washington and Lee University
- Norman B. Kahn, Jr., MD – Council of Medical Specialty Societies
- Robin King, CAE – The Alliance for Continuing Medical Education
- Christine Laine – Annals of Internal Medicine
- Mary LaLonde, JD – Partners HealthCare
- Lorna Lynn, MD – American Board of Internal Medicine
- Patrick McCormick – Neurological Network, Inc.
- Pamela Miller – New England Journal of Medicine
- Heather Pierce – Association of American Medical Colleges
- Jill Hartzler Warner – Food and Drug Administration
- Paul Weber (formerly) – The Alliance for Continuing Medical Education
- Dorit Zuk, PhD – National Institutes of Health
The Harmonizing Reporting on Potential Conflicts of Interest Discussion Paper is available at www.iom.edu/COIperspective.
Information about ASCO policy priorities may be found at http://ascoaction.asco.org.
The American Society of Clinical Oncology (ASCO) is the world’s leading professional organization representing physicians who care for people with cancer. With more than 30,000 members, ASCO is committed to improving cancer care through scientific meetings, educational programs and peer-reviewed journals. ASCO is supported by its affiliate organization, the Conquer Cancer Foundation, which funds ground-breaking research and programs that make a tangible difference in the lives of people with cancer. Patient-oriented cancer information is available at www.cancer.net.
About The Institute of Medicine
The Institute of Medicine serves as adviser to the nation to improve health. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policy makers, health professionals, the private sector, and the public. The mission of the Institute of Medicine embraces the health of people everywhere.