By Francesca Tentori, Sharon Steig and Bruce Robinson
Increasing attention is being paid to the issue of conflict of interest (COI) and strategies to address it, with specific emphasis placed on financial COI (FCOI). In August 2011, the U.S. Department of Health and Human Services (HHS) released revised FCOI regulations that build on the previous regulations by expanding the requirements to a broader group of individuals, lowering the reporting threshold for significant financial interests, and requiring more frequent training and disclosure. The National Institutes of Health (NIH) is an excellent resource for those who wish to read and understand the new FCOI regulation in more detail.
So what is COI and why is monitoring it so important? COIs arise when an individual has multiple personal or professional commitments that may prevent an individual from making unbiased opinions or conclusions, such as a researcher who has dual effort at a clinical practice and a research institution. Organizations may also have a COI due to competing funding sources or project objectives.
COIs are not inherently bad or wrong, but they do require a concerted effort from investigators, organizational leader ship, and grants administrators to recognize, understand, and communicate the implications of each situation and discuss appropriate ways to manage any issue that arises. If not properly managed, they may affect all aspects of a study, from the design to data analysis to reporting the study findings.
In a research setting they often arise from an organization having multiple funding sources, as well as an individual researcher’s commitments to advisory boards, professional societies or speaking engagements.
As publicly funded grants and contracts remain in short supply due to budget constraints and increased competition, private entities may continue to show interest in funding external research activities.
Organizations can and should seek funding from both sources, because each presents unique opportunities to engage in productive research.
However, these organizations must be aware of public perceptions and take the appropriate steps to minimize the influence of funding sources on research output, including implementing internal policies and increasing awareness, monitoring and transparency.
Arbor Research Collaborative for Health is a nonprofit research organization specializing in research that affects clinical practice, policy development and medical payment systems.