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:

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

ACRONYMS AND ABBREVIATIONS

1 INTRODUCTION

2 DO SPONSORING ORGANIZATIONS INFLUENCE RESEARCH?

How Does Bias Happen?

Breaking the Cycle of Bias

Discussion

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

Discussion

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

Discussion

REFERENCES

APPENDIXES

A Workshop Agenda

B Biographical Sketches of the Moderators and Speakers

C Workshop Speaker Disclosures

Box, Figures, and Tables

BOX

1-1 Statement of Task

FIGURES

3-1 The influences and stakeholders in the health research ecosystem

3-2 Industry sponsors of ultraprocessed food research

4-1 NIH infographic illustrating the key features of the new requirements for grant applicants based on the enhancing reproducibility through rigor and transparency policy

5-1 The dominance of industry sponsors in biomedical clinical trials

5-2 Mapping medical product industry’s ties within the health care system

5-3 Risk-of-bias table for randomized controlled trials on pharmacologic interventions for infantile epilepsy

5-4 Strength-of-evidence table for trials on pharmacologic interventions for infantile epilepsy

TABLES

3-1 Industry Sponsors of Nutrition Science Organizations and Scientific Journals

5-1 Current AHRQ-Funded Evidence-Based Practice Centers

Acronyms and Abbreviations