Taking Financial Relationships into Account When Assessing Research

Abstract

Many scientific journals, government agencies, and universities require disclosure of sources of funding and financial interests related to research, such as stock ownership, consulting arrangements with companies, and patents. Although disclosure has become one of the central approaches for responding to financial conflicts of interest (COIs) in research, critics contend that information about financial COIs does not serve as a reliable indicator of research credibility, and therefore, studies should be evaluated solely based on their scientific merits. We argue that, while it is indeed important to evaluate studies on their scientific merits, it is often difficult to detect significant influences of financial relationships that affect research credibility. Moreover, at least five factors can be examined to determine whether financial relationships are likely to enhance, undermine, or have no impact on the credibility of research. These include as follows: whether sponsors, institutions, or researchers have a significant financial stake in the outcome of a study; whether the financial interests of the sponsors, institutions, or researchers coincide with the goal of conducting research that is objective and reliable; whether the sponsor, institution, or researchers have a history of biasing research in order to promote their financial goals; how easy it is to manipulate the research in order to achieve financial goals; and whether oversight mechanisms are in place which are designed to minimize bias. Since these factors vary from case to case, evaluating the impact of financial relationships depends on the circumstances. In some situations, one may decide that the financial relationships significantly undermine the study's credibility; in others, one may decide that they have no impact on credibility or even enhance it.

Keywords:

• bias
• conflict of interest
• disclosure policies
• financial relationships
• objectivity
• scientific research

ACKNOWLEDGMENTS

This article is the work product of an employee or group of employees of the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). However, the statements, opinions or conclusions contained therein do not necessarily represent the statements, opinions or conclusions of NIEHS, NIH, or the United States government. We are grateful to Bruce Androphy and Bill Schrader for helpful comments.

Notes

1. We define ‘bias’ as “use of a method, data collection, data analysis, or interpretation of results that, in the consensus view of scientists of a discipline, tends to yield results that distort the truth of a hypothesis under consideration, diminishing or negating the reliability of the knowledge claim” (Krimsky, 2012, p. 3). Bias may be deliberate, e.g., data fabrication or data suppression, or subconscious.

2. Some organizations define a COI as situations that are likely to compromise or may appear to compromise judgment or decision-making (Association of American Universities, 2001). We do not use this definition of a COI, because appearance (or perception) is a subjective concept: something that appears to compromise judgment to one person might not to another. Under our definition, a COI is likely to compromise judgment or decision-making. Likelihood (or probability) is based on evidence, not on subjective perceptions. When the situation only appears to compromise judgment or decision-making, we would define this as an appearance of a COI rather than a COI. See Resnik (2007) for further discussion.

3. Although we have presented evidence concerning the impact of financial relationships on clinical research, it is important to note that this effect is not limited to research sponsored by pharmaceutical and biotechnology companies (Bekelman et al., 2003). The impact of financial relationships have become a concern in research sponsored by the chemical (Goozner, 2004b; Elliott, 2011; Volz and Elliott, 2012), energy (Michaels, 2008), food and beverage (Lesser et al., 2007; Barbor, 2009; Rowe et al., 2009), pesticide (Sass and Needleman, 2004; Shrader-Frechette, 2007), and tobacco (Bero, 2005; Michaels, 2008) industries.

4. By ‘objective’ we mean independent of financial, personal, political, cultural, or other factors. Although no study is completely objective, objectivity can still function as a goal to which researchers should aspire. By following well-accepted methods, scientists can minimize the impact of bias or control for its effects (Resnik, 2007). By ‘reliable’ we mean that the results can be reproduced by independent researchers.