A conflict of interest (COI) occurs when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in another.
Technology Incubators / Academic ties between physicians or medical researchers and pharmaceutical, medical device, and biotechnology companies can benefit society – most notably by promoting the discovery and development of new medications and medical devices that improve individual and public health. However some of these financial interests have raised concern about conflicts of interest which may present the risk of undue influence on professional judgments and thereby may jeopardize the integrity of scientific investigations, the objectivity of medical education, the quality of patient care, and the public’s trust in clinical trials and medicine.
The risk is that these conflicts could adversely affect the quality of research, possibly harming human subjects and anyone who relies on the research, including patients. It is difficult to prove that financial interests have caused researchers or their institutions to waiver in their commitment to producing quality studies, and there is considerable disagreement over which financial interests might inappropriately influence whom and under what circumstances. But studies of academic biomedical researchers have found troubling correlations between financial relationships with industry and problems with research, including a tendency to produce pro-sponsor results, increased secrecy, and poor study design.
Studies suggested that financial interests between academic researchers and industry are common, and are correlated with both results that favor sponsors and increased secrecy—scientists refusing to share data with colleagues, withholding negative data from publication, and delaying publication of research results.
- A 2007 survey found that nearly 60% of respondents had personal relationships with industry.
- A 2003 review article, found studies suggesting that between 23% and 28% of academic investigators received research funding from industry, over 40% received research-related gifts, and about 33% had personal financial ties with industry sponsors.
- A 1999 survey conducted by the Association of University Technology Managers, found that 68% of academic research institutions held equity in companies that in turn sponsored research there.
History of research ethics already witnessed two most outrageous studies where conflicts of interest in research caused suffering and loss of life: the Tuskegee Study of Syphilis in the Negro Male (1932-1972) and the Willowbrook Hepatitis Studies (1963-1966). Even though recent studies uncover “strong and consistent evidence” that industry-sponsored research tends to draw conclusions favoring industry, often uses an inactive control, and sometimes administers a higher dose of the sponsor’s drug than of the comparison drugs or uses comparison drugs that are poorly absorbed. Industry sponsorship of research, as well as involvement with start-up companies and other commercial relationships, were significantly associated with delaying publication or withholding data.
Academic researchers may also have a strong reluctance to give their time, expertise, or resources – including inventions – to industry without being compensated, even if compensation risks creating a conflict of interest. In 2005 one commentator proposed a principle of “no conflict, no interest” in NEJM, according to which a financial stake increases an individual’s commitment to a project and, therefore, its chances of success. This attitude may also reflect a belief that it is unfair to prevent individuals from profiting from their effort and that restrictions are intrusions on privacy and freedom of association.
Society traditionally has placed great trust in physicians and researchers and protecting the rights and well-being of the research subjects remains the most important duty. The Helsinki Declaration 1 (principle 6) and various other ethics guidelines clearly recognize this. The obligation does not necessarily clash with researchers’ commitment to conduct good research. Very often patients do better when enrolled in a clinical trial. Yet, research also involves risks. It exposes patients to unknown side effects and to the risk of receiving inferior therapies. When the interests of subjects and the interests of research collide, the obligation toward subjects must takes priority.
Campbell EG, Weissman JS, Ehringhaus S, Rao SR, Moy B, Feibelmann S, & Goold SD (2007). Institutional academic industry relationships. JAMA : the journal of the American Medical Association, 298 (15), 1779-86 PMID: 17940234
Campbell EG, Rao SR, DesRoches CM, Iezzoni LI, Vogeli C, Bolcic-Jankovic D, & Miralles PD (2010). Physician professionalism and changes in physician-industry relationships from 2004 to 2009. Archives of internal medicine, 170 (20), 1820-6 PMID: 21059976
Brockway LM, Furcht LT, & FASEB (2006). Conflicts of interest in biomedical research–the FASEB guidelines. FASEB journal : official publication of the Federation of American Societies for Experimental Biology, 20 (14), 2435-8 PMID: 17142792
For More Information: www.iom.edu/conflictofinterest