Selected Issues > Conflicts of Interest in Research
Conflicts of Interest in Research

coi imageIdeally, all medical research would be objective. But what if researchers testing a new drug are paid by the drug’s manufacturer? What if they are stockholders or even partners in that company? Financial conflicts of interest have become more common in recent years, as industry has become more involved in research and medical education.

Drug and biotechnology companies now finance the majority of clinical trials, up from just 32% in 1980. Financial arrangements take many other forms, including company stock for individual scientists, licensing revenues, donation of funds and equipment to medical schools and hospitals, and positions of influence on advisory boards.

From the Hastings Center

Hastings Center Report

Eight Years after Jesse’s Death, Are Human Research Subjects Any Safer?

By Paul Gelsinger and Adil E. Shamoo 
It has been more than eight years since Jesse Gelsinger died in a gene therapy clinical trial. But despite press exposure and public outcry, no progress has been made in fixing the broken system of protections for subjects of human research.

Hastings Center Report

Human Research Protections: Time for Regulatory Reform?

By Karen Maschke 
Many commentators are calling for regulatory reform, and the federal oversight agencies are considering whether changes are needed and where. The challenge is to start from a solid foundation of ethical principles and to identify both the regulatory gaps that should be filled and regulatory overburden so that it does not meaningfully protect research participants.

Bioethics Forum

Smoke and Mirrors

Adriane Fugh-Berman and Douglas Melnick

IRB: Ethics & Human Research

Developing Model Language for Disclosing Financial Interests to Potential Clinical Research Participants

By Kevin P. Weinfurt, Jennifer S. Allsbrook, Joëlle Y. Friedman, Michaela A. Dinan, Mark A. Hall, Kevin A. Schulman, and Jeremy Sugarman
As part of a larger research study, we present model language for disclosing financial interests in clinical research to potential research participants, and we describe the empirical basis and theoretical assumptions used in developing the language.  The empirical process for creating appropriate disclosure language resulted in a generic disclosure statement for cases in which no risk to participants’ welfare or the scientific integrity of the research is expected, and nine more specific disclosure statements for cases in which some risk is expected.  The disclosure statements are not meant to be canonical, but were instead designed to reflect the typical situations in which disclosure of financial interest might be considered by an institutional review board or conflict of interest committee.  Individual institutions could modify key phrases to suit their purposes, and others could use the language in future empirical work on informed consent to better refine the options for disclosing financial interests in clinical research.

IRB: Ethics & Human Research

Conflicts of Interest in Research: How IRBs Address Their Own Conflicts

By Leslie E. Wolf and Jolanta Zandecki
We conducted this study to determine whether medical schools address conflicts of interest among their IRB members and staff, and, if so, in what ways.  We analyzed the conflict of interest policies for 121 U.S. medical schools whose research is funded by the National Institutes of Health.  About three-quarters of the schools we studied have written policies that address IRB conflicts of interest, and almost 80% of them defined the term, although their definitions varied substantially.  The majority of IRBs explicitly prohibit a conflicted member from participating in discussion and voting, but few explicitly prohibit serving as a reviewer or extend their policies to cover IRB staff.  This illustrates important gaps in these policies.  A few policies even conflict with federal requirements.  More specific policies might improve consistency and increase confidence in the integrity of IRB oversight.

IRB: Ethics & Human Research

How Independent Are IRBs?

By Ruth Macklin
What does it mean to say that ethics committees that provide prospective review of research involving human beings should be “independent”?  In the United States, IRBs—which are typically located within and review research protocols at the institution for which most of their members work—cannot really be considered independent.  Yet separating the IRB from the research institution may in turn mean less independence from a trial’s sponsors, as this kind of IRB is commercially motivated and paid directly by the sponsor.  One possible answer is to create independent IRBs that are not for profit, but how this model would attract financial and administrative support is unclear.

Bioethics Forum

Industry Payola at the FDA

Carl Elliott

Bioethics Forum

The Dog Ate My Disclosure

Adriane Fugh-Berman

Bioethics Forum

Fewer Bitter Pills?

Susan Gilbert

Resources

Thomas H. Murray & Josephine Johnston (2010). Trust and Integrity in Biomedical Research: The Case of Financial Conflicts of Interest. Johns Hopkins University Press.

Carl Elliott (2010). White Coat, Black Hat: Adventures on the Dark Side of Medicine. Beacon Press.

 Institute of Medicine (2009). Conflict of Interest in Medical Research, Education, and Practice.

 Federation of American Societies for Experimental Biology, Shared Responsibility, Individual Integrity: Scientists Addressing Conflicts of Interest in Biomedical Research

Department of Health and Human Services, Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection

AAMC Task Force on Financial Conflicts of Interest in Clinical Research, Protecting Subjects, Preserving Trust, Promoting Progress - Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research

AAMC Task Force on Financial Conflicts of Interest in Clinical Research, Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution's Financial Interests in Human Subject Research

Additional Readings

E.G. Campbell et al., “A National Survey of Physician-Industry Relationships,” New England Journal of Medicine 356 (2007): 1742-50.

E.G. Campbell et al., “Institutional Academic-Industry Relationships,” Journal of the American Medical Association 298 (2007): 1779-86.

J.E. Bekelman, Y. Li, and C.P. Gross, “Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review,” Journal of the American Medical Association 289 (2003): 454-65.

S. Krimsky, Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research?(Rowman & Littlefield Publishers Inc., 2003).