Sponsor Influences on the
Quality and Independence of
Health Research
______
Dara Rosenberg, Elizabeth Boyle,
Alexandra McKay, and Joe Alper,
Rapporteurs
Board on Population Health and Public
Health Practice
Board on Health Sciences Policy
Health and Medicine Division
Proceedings of a Workshop
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
This activity was supported by contracts between the National Academy of Sciences and the Gordon and Betty Moore Foundation and Rita Allen Foundation. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
International Standard Book Number-13: 978-0-309-70352-9
International Standard Book Number-10: 0-309-70352-2
Digital Object Identifier: https://doi.org/10.17226/27056
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2023. Sponsor influences on the quality and independence of health research: A workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/27056.
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PLANNING COMMITTEE FOR A WORKSHOP ON SPONSOR INFLUENCES ON THE QUALITY AND INDEPENDENCE OF HEALTH RESEARCH1
LONNIE KING (Chair), Academy Professor and Dean Emeritus, the Ohio State University College of Veterinary Medicine
C. K. GUNSALUS, Director, National Center for Principled Leadership and Research Ethics, University of Illinois Urbana-Champaign
AARON KESSELHEIM, Professor of Medicine, Harvard Medical School
ROSS MCKINNEY, Chief Scientific Officer, Association of American Medical Colleges
FAITH MITCHELL, Institute Fellow, Urban Institute
LANA SKIRBOLL, Sanofi (retired)
CATHERINE WOTEKI, Visiting Distinguished Institute Professor, University of Virginia Biocomplexity Institute, and Professor of Food Science and Human Nutrition, Iowa State University
Staff
ELIZABETH BARKSDALE BOYLE, Project Director (from October 2022) Senior Program Officer
ROSE MARIE MARTINEZ, Senior Board Director
ALEXANDRA MCKAY, Research Associate
Y. CRYSTI PARK, Program Coordinator
DARA ROSENBERG, Associate Program Officer
KATHLEEN STRATTON, Project Director (until October 2022) and Scholar
CLARE STROUD, Senior Board Director
Consultants
JOE ALPER, Science Writer
___________________
1 The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.
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Reviewers
This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine (the National Academies) in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.
We thank the following individuals for their review of this proceedings:
ARAMANDLA RAMESH, Meharry Medical College
GARY RUSKIN, U.S. Right to Know
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by Lawrence J. Appel, Johns Hopkins University. He was responsible for making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.
We also thank staff member Jennifer Heimberg for reading and providing helpful comments on this manuscript.
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Contents
2 DO SPONSORING ORGANIZATIONS INFLUENCE RESEARCH?
3 EXAMPLE OF FUNDER INFLUENCE ON HEALTH RESEARCH
Protecting Public Health in the Face of Corporate Disinformation
The Intended and Unintended Consequences of Health Technology and Observational Real-World Evidence
Industry Funding Bias in Nutrition Science on Ultraprocessed Foods
What You Do Not See Is What Counts: A Peek Behind the Smokescreen
Can Data and AI Make It Easier to Manage the Impacts of COIs?
Sponsor Influence in Diabetes Research: An Industry Case Study
4 PROTECTION OF RESEARCH INTEGRITY
Research Integrity in Extramural Research at NIH
Gaining Sponsor Support While Maintaining Scientific Independence
Application of Corporate Ethical Policies and Governance Processes, with a Focus on Bioethics
Panel Discussion: Where Are the Points of Influence on Scientific Research?
5 CONSIDERING MODELS, PROCESSES, AND PRINCIPLES TO PROTECT RESEARCH INDEPENDENCE AND QUALITY
A Deep Dive into Professionalism: Potential Policy Approaches to COIs
Role of the Sponsor or Funder in Research Studies
Alternatives to Industry: Seeking Independence in Biopharmaceutical Research
Protecting the Scientific Integrity of the IARC Monographs
Minimizing Bias in AHRQ Evidence-Based Practice Center Program Systematic Reviews
Panel Discussion: Protecting the Independence of Research
Box, Figures, and Tables
BOX
FIGURES
3-1 The influences and stakeholders in the health research ecosystem
3-2 Industry sponsors of ultraprocessed food research
5-1 The dominance of industry sponsors in biomedical clinical trials
5-2 Mapping medical product industry’s ties within the health care system
5-4 Strength-of-evidence table for trials on pharmacologic interventions for infantile epilepsy
Acronyms and Abbreviations
ABA | American Beverage Association |
AHRQ | Agency for Healthcare Research and Quality |
AI | artificial intelligence |
COI | conflict of interest |
CSR | NIH Center for Scientific Review |
EPA | Environmental Protection Agency |
EPC | AHRQ Evidence-Based Practice Center |
FDA | Food and Drug Administration |
GRADE | Grading of Recommendations Assessment, Development and Evaluation |
HEI | Health Effects Institute |
HHS | Department of Health and Human Services |
IARC | International Agency for Cancer Research |
ILSI | International Life Sciences Institute |
NIH | National Institutes of Health |
NTP | National Toxicology Program |
OER | NIH Office of Extramural Research |
OSHA | Occupational Safety and Health Administration |
PCORI | Patient-Centered Outcomes Research Institute |
PFAS | per and polyfluoroalkyl substances |
PFOA | perfluorooctanoic acid |
UCSF | University of California, San Francisco |
USDA | United States Department of Agriculture |