Ethical Issues in the Management of Financial Conflicts of Interest in Biomedical Research
December 2001 - December 2004
This Center project examines concerns that arise in managing financial conflicts of interest in biomedical research, focusing particularly on the ethical implications of the role of private, for-profit corporations in financing and carrying out research with human subjects. The project consists of three primary activities: clarifying the ethical issues in managing conflicts of interest in the research setting; analyzing and offering a critique of current academic, professional and government guidelines for conflict management; and developing recommendations to inform public and private policies regarding conflicts.
To carry out these activities, the Hastings Center has brought together an interdisciplinary research group with expertise in bioethics, medical research, medicine, law, business, economics, and the financing and administration of research in public and private settings. The group has met four times over the past two years to hear and respond to presentations by group members and outside experts, to deliberate together about the issues, and to arrive at recommendations.
Project results will be disseminated through printed and web-based educational materials, presentations at professional meetings and other public forums, formal and informal contacts with key individuals involved in public or private conflict of interest management policy, and contacts with members of the press.
Center project staff: Thomas H. Murray, Daniel Callahan, Mary Ann Baily, Angela Wasunna, Josephine Johnston.
Funded by: The Donaghue Foundation
PROJECT INFORMATION
In addition to the Center's project staff, the following individuals are members of the project's working group:
Raymond Andrews
The Donaghue Foundation
Wendy Baldwin
University of Kentucky
David Blumenthal
Institute for Health Policy
Harvard Medical School
Gary Cohen
Millennium Pharmaceuticals, Inc.
Robert Cook-Deegan
Center for Genome Ethics, Law and Policy, Duke University
Rebecca Dresser
Washington University School of Law
Henry Etzkowitz
Science Policy Institute
SUNY Purchase
Joseph J. Fins
New York Presbyterian Hospital - Cornell Campus
Gerald D. Fischbach
Department of Pharmacology
Columbia University
Lynne Garner
The Donaghue Foundation
David Korn
Association of American Medical Colleges
Greg Koski
Massachusetts General Hosptial
Harvard University
Barbara F. Mishkin
Hogan & Hartson, LLP
David Perlman
PricewaterhouseCoopers LLP
Rosemary B. Quigley
Center for Medical Ethics and Health Policy, Baylor College of Medicine
Harriet S. Rabb
Rockefeller University
Erica Rose
GlaxoSmithKline
Michele Russell-Einhorn
PricewaterhouseCoopers LLP
William M. Sage
Columbia Law School
Harold Shapiro
The Woodrow Wilson School of Public and International Affairs
Princeton University
Savio L.C. Woo
The Carl C. Icahn Institute for Gene Therapy and Molecular Medicine
SELECTED RESOURCES
The references and websites listed below are examples of the public and academic debate surrounding the question of conflicts of interest in biomedical research. They do not necessarily reflect the findings of the project working group, or the views of its members.
- 42 CFR 50 Subpart F - Responsibility of Applicants for Promoting Objectivity
in Research for Which PHS Funding is Sought.
http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm - Department of Health and Human Services. Draft "Financial Relationships
and Interests in Research Involving Human Subjects: Guidance for Human Subject
Protection".
http://ohrp.osophs.dhhs.gov/humansubjects/finreltn/finalguid.pdf - General Accounting Office. HHS Direction Needed to Address Financial Conflicts
of Interest.
http://www.gao.gov/ - Association of American Medical Colleges. Protecting Subjects, Preserving
Trust, Promoting Progress - Policy and Guidelines for the Oversight of Individual
Interest in Human Subjects Research.
http://www.aamc.org/research/coi/start.htm - Association of American Medical Colleges. Protecting Subjects, Preserving
Trust, Promoting Progress II: Principles and Recommendations for Oversight
of an Institution's Financial Interests in Human Subjects Research.
http://www.aamc.org/research/coi/start.htm - Association of American Universities. Report on Individual and Institutional
Financial Conflict of Interest.
http://www.aau.edu/research/COI.01.pdf - American Society of Clinical Oncology: Revised Conflict of Interest Policy.
Journal of Clinical Oncology 2003;21(12):1-3.
http://www.asco.org/asco/downloads/CoI_Policy_FINAL.pdf - EA Boyd, MK Cho, LA Bero. Financial Conflict-of-Interest Policies in Clinical Research: Issues for Clinical Investigators. Academic Medicine 2003; 78(9):769-74.
- Blumenthal D, Causino N, Campbell E, Louis KS. Relationships between academic
institutions and industry in the life sciences--an industry survey. New
England Journal of Medicine 1996; 334(6):368-373.
http://content.nejm.org/cgi/content/short/334/6/368 - Center for Science in the Public Interest's Integrity in Science Project.
Includes a link to CPSI's searchable database of scientists and non-profits
ties to industry.
http://www.cspinet.org/integrity/index.html
PUBLIC CONFERENCE
The Hastings Center and the Donaghue Foundation hosted a one-day conference Integrity in Biomedical Research: The Case of Financial Conflicts of Interest on May 12th at Water's Edge Resort in West Hartford, Connecticut.
This conference provided both a platform to present the Center's research project outcomes and an opportunity for a diverse panel of experts to present and debate the most important questions raised in the management of financial conflicts of interest in health research, medicine, and the biomedical sciences today. Speakers included Drummond Rennie, Rosemary Quigley, Josephine Johnston, Thomas Murray, Greg Koski, and Sheldon Krimsky.
Download pamphlet "Integrity in Biomedical Research: The Case of Financial Conflicts of Interest" (Adobe Acrobat, 345 kb).
Download the Center’s interim project findings: "Financial Conflicts of Interest in Biomedical Research: Project Findings” (Microsoft PowerPoint presentation, 64Kb).
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Last Updated: 22 March 2007