Conflict of Interest in Medical Research and Clinical Trials

Scientific Essay 2015 8 Pages

Medicine - Other


Table of Contents



Types of conflict of interest:
Financial conflict of interest:
Investigator based conflict of interest:
Institutional based conflict of interest:
Institutional Review Board (IRB) based conflict of interest:
Conflict of interest in publication
Management of conflicts of interest:




Conflict of interest in medical research or clinical trial refers to situations where a patient’s health is compromised by either financial or non-financial gains. It is defined as a dispute between a physician’s decision in patient’s best interest, and any potential personal gain (Columbia University, 2004). Concerns regarding the influence of biotechnology companies and pharmaceutical industries in research activities and funding of clinical trials have been increasing since the 1970’s (Resnik, 2010). Conflict of interest arising from wide range of financial ties with the private industry leads to undue pressure on professional judgments and put the objectivity of professional education and the patient’s care and confidence in medicine at risk. This bias may affect adverse events reporting, data analysis and interpretation. As such, there is a growing need to safeguard the interest of the human subjects and to protect their welfare while participating in research and clinical trials (Lo and Fields, 2009).


The concerns regarding conflict of interest have a long history. The Tuskegee Syphilis study (1932-1972) and the Willowbrook Hepatitis studies (1963-1966) are two infamous examples from the past showing clear conflict of interest in research. The 40 year long Tuskegee Syphilis study was conducted by the US Public Health Services (now Centers for Disease Control and Prevention). The aim was to observe the effect of the disease on untreated patients. The researchers involved in the study deliberately withheld prescribing medicines to the patients, despite of availability of effective medication for the treatment of Syphilis. This led to death of many patients until 1972 when the study was stopped. Another study, the WillowBrook Hepatitis enrolled mentally retarded children and infected them with hepatitis virus with the purpose to see its effects on the patient’s body and its response to vaccines (Columbia University, 2004; Emanuel, 2008).

Role of the pharmaceutical companies significantly increased in the research activities post 1980 when the Bayh-Dole Act was passed. The act permitted the transfer of technology of the federally funded projects to the private sector and required researchers to obtain product patents for commercial gains leading to expansion of industry sponsored research. However, the intervention of private companies in biomedical research started 10 years before the act was passed. In 1974, Monsanto entered into a 12 year development agreement with Harvard Medical School for $23 million to support research on anti-angiogenesis factors. Under the terms of this agreement Monsanto received exclusive worldwide licensing rights to all the inventions developed as part of this collaboration. Measures to control this conflict of interest arising from these collaborations have been seen since 1980, when professors of colleges and universities were required to reveal any financial terms with the private companies in California. Further reforms and new rules and regulations have been implemented in biomedical research in mid-1990s owing to the rising concerns regarding financial conflict of interest. This required the academic researchers, officers, and authors to disclose any potential conflict of interest (Emanuel, 2008).

Another infringement of the regulations related to conflicts arising from clinical research occurred in 1999 with the death of Jesse Gelsinger in a gene transfer experiment at University of Pennsylvania which raised questions regarding informed consent. This led the Association of American Medical Colleges develop stricter rules and issue a comprehensive analysis of conflict of interest (Emanuel, 2008).

Types of conflict of interest:

Financial conflict of interest:

The commercialization of research to attain any monetary benefits by compromising the quality or integrity of research leads to financial conflict of interest. It affects an investigator’s main responsibility to perform unbiased research making them pass skewed judgments. This eventually puts the research quality, patient’s health, and public trust in medical research at risk (Duke University, 2014; The Hastings Center, 2016). Rigorous initiatives have been taken at industry as well as individual states level recently with an aim to deal with these conflicts. The US Food and Drug Administration (FDA), the National Institutes of Health, and the Public Health Services have devised strict regulations and guidelines necessitating proper reporting to mitigate any conflict of interest in research studies funded by the Government (Chapman, 2011). Financial conflict of interest is the easiest to identify. It generally involves compensation for various research activities such as consulting, along with receiving equity holdings, licensing or royalty fees from the industry. According to Sismonda (2008), industry funded studies are more likely to report positive data. In a recent meta-analysis study conducted to evaluate whether a hydrolyzed formula of milk feeding infants causes allergic reactions, Boyle et al. (2016) found that there was conflict of interest in many research studies indicating that there was financial relationship with infant formula manufacturers.

Despite of the clear evidences associated with the risks of industry funded research, some benefits of the collaboration has also been reported such as early launch of new drugs and devices to the market and driving economic growth and increasing research funding. Also, financial involvement may further increase researcher’s commitment towards the project, who would have otherwise been reluctant to pursue the invention without any compensation (The Hastings Center, 2008).

Financial conflict of interest can be further classified into the following types:

Investigator based conflict of interest:

Financial conflict of interest arising at the level of investigators is referred as investigator/physician led conflict of interest. A clinical trial investigator trial may develop financial links with the sponsors and may compromise the quality of research leading to biased and altered results. In a survey conducted involving 20,000 trials to ensure the integrity of research across industry as well as non-industry sponsored trials, Rochon et al. (2011) observed that adherence to the practice guidelines intending to promote objectivity of clinical trials was overall low particularly in industry sponsored studies. However, these physician-industry relationships are common in the medical practice as illustrated by Campbell et al. (2007) in another survey that enrolled 3,167 physicians across six specialities including cardiology, general surgery, anesthesiology, internal medicine, family practice and pediatrics. The survey results also indicated that physician and industry relationship may vary according to the physicians practice setting (Campbell et al. 2007).

Undisclosed interventions of the investigators and researchers fabricating the results were discovered by the US Senate investigation prompted research organizations to look at policies and guidelines associated with management of investigator based conflict of interest (Braf, 2010). As such, it becomes imperative to disclose such investigator led financial conflict of interest to the potential study participants. The role of disclosure was further proved by Solomon et al. (2015) in a survey conducted in multiple sclerosis patients to understand the patient’s perspective on industry-investigator financial relationship. According to the study disclosure of potential conflicts of interest should become a uniform part of informed consent and documentation practices in industry sponsored clinical trials.

Institutional based conflict of interest:

Institutional conflict of interest occurs when the financial interest of institutions or its officials may affect the processes such as conduct, oversight, and review of research involving human participants. These generally result into large donations from the industry to sponsor research projects. Many organizations require funding research projects; as such it becomes easier to seek industry funding compared to receiving funds from granting authorities. The collaboration between the industry and institution may also result in equity and royalty holdings. Institutional officers including board members, trustees, and senior officials may have several research based financial profits such as consulting fees, honorarium, membership in the board etc. (Emanuel, 2008).

The extent of the financial ties between the industry and institution was shown in a study conducted by Bekelmen et al. (2003). According to the study two third of institutions held equities in companies sponsoring the projects. Also, there was significant association between industry sponsorship and restriction on data sharing and publication as well as pro-sponsorship conclusions. Institutional conflict of interest could drastically impact institutional decision making and thereby risk the integrity and quality of research at risk. This necessitates the use of policies to safeguard research objectivity among academic research organizations as suggested in a study by Resnik et al. (2016). The study was conducted to analyze information about the conflict of interest arising at institutional level from top 100 academic institutions in the US. According to the study, most of the top academic institutions (72%) do not have a policy and standard form to review any institution based conflict of interest. The study also highlighted the absence of any Federal regulation to guide institutions on managing such conflicts of interest.

Institutional Review Board (IRB) based conflict of interest:

Institutional Review Board (IRB) is the primary body that protects the potential research participants and ensures that the patients are properly informed about the risks and benefits associated with the clinical research study in the US. However, there has been growing concern pertaining to the involvement of IRB in making monetary profits at the cost of patient’s health. In a recent study evaluating the relationship between industry and IRB members, few IRB members were found to be presenting biased protocols and voting for protocols holding a conflict (Campbell et al. 2015). Many IRB members charge fees to the sponsors to review the protocols, while others may have equity interests in company sponsored research study under review by the IRB. Existing guidelines form oversight agencies and federal funding must be re-evaluated and implemented by institutions to safeguard the interest of study participants without diluting the quality of research (Vogeli et al. 2013).



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Title: Conflict of Interest in Medical Research and Clinical Trials