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ABOUT THE PROJECT
OBJECTIVES AND SCOPE
Collaborations between academia and industry in biomedical research benefit society through the development of medical treatments and other products. However, their rise has been accompanied by increasing concerns about financial conflicts of interest that have the potential to bias research, compromise dissemination of research results, and decrease public trust. There is ongoing dialogue in the scientific community and the public about how best to manage these relationships to secure the benefits and minimize the risks. Current regulation and management involves partnerships between the government, sponsors of research, investigators, journals, and the public. It is essential that the various stakeholders work together to study the effectiveness of policies and practices, and strive to balance the need for more common standards with preserving case-by-case analysis and situational-driven decision-making, when warranted. While flexibility is needed, operating under more broadly agreed upon guidelines will benefit the public and ensure future public support for biomedical research.
Because policy recommendations addressing financial conflicts of interest have focused on the role of academic institutions in reviewing and overseeing investigator relationships with industry, FASEB issued guidelines for individual investigators in 2006.* Investigators as a group determine the effectiveness of policies and practices. This was a first step to articulate the perspective of investigators on financial conflicts of interest in research. The purpose of this current project is to continue the work of FASEB and other stakeholders, generate a broader discussion of issues, and implement voluntary policies and practices.
Two major objectives guided our activities. First, we seek to increase awareness and understanding of financial conflict of interest issues on the part of investigators in order to promote adherence to all relevant policies, encourage scientists to communicate with their institutions about these issues, and facilitate voluntary practices that encourage personal responsibility. Second, we also encourage more standard practices for financial conflict of interest disclosure and management in biomedical research.
Our approach is to provide guidance to address challenges that may occur due to financial relationships between academia and industry, not to judge whether a real or perceived conflict of interest exists. In fact, we urge those who develop statements and policies in this area to shift the terminology towards “financial relationships” and “financial interests” and away from “conflicts of interest” as much as possible and especially in communications to investigators. This is discussed further in the Toolkit. Overarching principles to guide individual behavior and policy development are presented and a list of recommended practices is provided to illustrate some ways in which the principles may be achieved.
* Brockway LM and Furcht LT. Conflicts of interest in biomedical research – the FASEB guidelines. FASEB Journal, 20:2435-2438, 2006.
FUNDING AND ADVISORS
This work was funded by a grant from Association of American Medical Colleges–Office of Research Integrity Responsible Conduct of Research Program for Academic Societies. A coalition of the following representatives served as an advisory committee to this project:
- Leo T. Furcht, M.D., Coalition Chair and FASEB Past President, Allen Pardee Professor and Head of Lab Medicine and Pathology, Univ. of Minnesota School of Medicine
- Carol Blum, Ph.D., Director, Research Compliance and Administration, Council on Government Relations
- Eric G. Campbell, Ph.D., Assistant Professor, Institute for Health Policy, Harvard Medical School
- Gail Cassell, Ph.D., Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company; Representing American Society for Microbiology
- Tony DeCrappeo, President, Council on Government Relations
- Susan Ehringhaus, J.D., Associate General Counsel for Regulatory Affairs, Association of American Medical Colleges
- Ezekiel Emanuel, M.D., Ph.D., Director, Dept. of Clinical Bioethics, National Institutes of Health
- Mark S. Frankel, Ph.D., Director, Scientific Freedom, Responsibility and Law Program, American Association for the Advancement of Science
- Joan Goldberg, Executive Director, American Society for Cell Biology
- Todd Margolis, M.D., Ph.D., Chair, Commercial Relationships Committee, Association for Research in Vision and Ophthalmology, Director, FI Proctor Foundation-Ophthalmology, Univ of California-San Francisco
- Barbara Perry, Senior Counselor of Congressional Affairs, NASULGC and Associate VP and Director of Federal Relations, Univ. of Washington
- Lawrence J. Rhoades, Director, Division of Education and Integrity, Office of Research Integrity, HHS
- Norka Ruiz Bravo, Ph.D., Director, Office of Extramural Research, National Institutes of Health
- Janet Shoemaker, Director, Public Affairs Office, American Society for Microbiology
- Nicholas Steneck, Ph.D., Director, Research on Research Integrity, Office of Research Integrity, Department of Health and Human Services
- James A. Severson, Ph.D., Vice Provost of Intellectual Property and Technology Transfer, University of Washington
FASEB Project Staff:
- Laura Brockway, Ph.D., Senior Science Policy Analyst, FASEB Office of Public Affairs
- Howard Garrison, Ph.D., FASEB Deputy Director for Policy and Director, FASEB Office of Public Affairs
- Guy Fogleman, Ph.D., FASEB Executive Director
- Kimberly McGuire, Policy Assistant, FASEB Office of Public Affairs
ACKNOWLEDGMENTS
FASEB greatly appreciates the participation of Gwynne Jenkins, Ph.D., AAAS Fellow at the NIH Office of Extramural Research, and Kevin Wilson, Director of Public Policy for the American Society for Cell Biology, during the coalition meeting phase.
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