RCR Casebook: Conflicts of Interest
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Researchers have various interests that encourage them to work long hours and make personal sacrifices. In some contexts, motivation for working hard may stem from the desire to develop a product that will both benefit patients and provide financial rewards, to advance professionally, or to receive social recognition.13 Although these interests are common and legitimate, they can create problems when researchers—knowingly or unknowingly—allow them to take precedence over their primary interests in advancing knowledge and meeting obligations regarding data integrity and the protection of subjects. The Institute of Medicine (IOM) has defined a conflict of interest as a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary influence.29
Nonfinancial conflicts of interest permeate the culture of academic research: Researchers may seek recognition, promotion, or justification of their intellectual biases.
In addition to these conflicting personal interests, researchers sometimes find themselves playing conflicting roles—for example, researcher and physician or researcher and course director—that can generate conflicting obligations to different parties.2
Financial conflicts of interest have received the most ethical and regulatory attention since industry support in research has grown significantly in the last twenty years and, unlike some non-financial interests, they are “identifiable, measurable, and susceptible to public disclosure”.30 Financial conflicts of interest may arise in the form of consulting payments, research funding, trips to professional meetings, or support of continuing education activities.31 Institutions, including academic research centers, may also have financial conflicts of interest. With the passage of the Bayh-Dole Act in 1980,32 it became easier for academic medical centers and industry collaborations to generate significant profits from products that were developed with government funding.
Financial and other incentives can motivate good research, and financial relationships of some kind are nearly always needed to support good research. So why have financial conflicts of interest attracted so much scrutiny and concern in recent years? First, there have been high profile cases involving human subject protection failures that involved researchers’ financial conflicts of interest.33,34Second, social science and behavior economic research on pharmaceutical industry practices have indicated that gifts of any size create feelings of obligation to reciprocate and that judgments are subject to an unconscious and unintentional self-serving bias even when individuals try to be objective. These studies help to explain how it is that individuals may have the best of intentions, yet nevertheless be influenced by financial relationships—the influence is often below the individual’s awareness.29,35Third, conflicts of interest may actually have biased the conduct and reporting of research. Review articles have found that industry funding of research is associated with higher rates of positive findings and findings supportive of sponsors interests, biased designs (e.g., the use of inappropriate comparators), and delayed publication of results.29,35
Researchers may also find that they have conflicts of commitment—many projects competing for their time. While they may increase the hours they work, federal laws stipulate that no one can work more than 100% effort; determining what percent effort is actually dedicated to a project, and protecting that effort, can be challenging in today’s busy research environments.2
To summarize, conflicts of interest are common, not intrinsically wrong, and may even motivate and enable good research. However, they present a risk that individuals will prioritize other interests over research integrity and the protection of human subjects, and therefore they require disclosure and management or elimination.1
The Cases and Role Play
1The Association of American Medical Colleges (AAMC) and Association of American Universities (AAU) have produced a thoughtful joint report presenting a framework for making conflicts of interest management decisions. The AAMC/AAU Report is available online for free.36. AAMC-AAU Advisory Committee on Financial Conflicts of Interest in Research. Protecting patients, preserving integrity, advancing health: Accelerating the implementation of COI policies in human subjects research. Washington DC: AAMC-AAU;2008.
The cases and role play in this chapter present a variety of situations commonly found in academic medical centers involving financial and non-financial conflicts of interest, conflicting roles, and conflicts of commitment. The scenarios provide the opportunity to identify effective management strategies and to engage those who fail to manage their conflicts adequately.
- Case One: A relationship between an academic researcher and a pharmaceutical company becomes complicated when a potentially patentable product emerges due to their joint collaboration. See Chapter 3 on Collaboration to explore other kinds of collaborative relationships.
- Case Two: A psychiatrist seeking to enroll a long-term patient of hers into a randomized placebo-controlled study feels conflicted when he responds eagerly with “whatever you think is best”.
- Case Three: A researcher decides to collaborate with an industry-sponsor half-way through a randomized controlled drug trial and does not notify the institution that he is receiving compensation for enrolling patients into the trial.
- Role Play: A successful MD-PhD professor who has taken on a superhuman number of roles and responsibilities approaches his department chair seeking his signature on a training grant that would require even more of his time and effort, something the department chair is reluctant to do, given the poor bi-annual effort reports he’s been turning in.