Disciplinary Differences in Conflict of Interest Policy Communication, Attitudes, and Knowledge

By Canary, Heather E.; Hansen, Kody D. et al. | Journal of Research Administration, Fall 2015 | Go to article overview

Disciplinary Differences in Conflict of Interest Policy Communication, Attitudes, and Knowledge


Canary, Heather E., Hansen, Kody D., Rinehart, Marc D., May, Kristal, Barlow, Jahn, Journal of Research Administration


Introduction

Financial conflicts of interest (COI) in research exist when an investigator potentially benefits financially from the research in which that individual is involved. One common conflict occurs when an investigator establishes a financial relationship with an industry partner through receipt of industry-sponsored research, gifts, or remuneration from consultation, speaking engagements, etc. Several studies suggest that industry partnerships can cause conscious or subconscious bias on study design, data collection and analysis, and reporting of results, no matter the nature of the relationship (Bekelman, Li, & Gross, 2003; Berger, 2015; BesRastrollo, Schulze, Ruiz-Canela, 8>c Martinez-Gonzalez, 2013; Lexchin, Bero, Djulbegovic, & Clark, 2003; Sah & Fugh-Berman, 2013). Another common conflict of interest occurs when an investigator generates intellectual property through research. Generating intellectual property alone does not cause a financial conflict of interest, but a conflict does arise if an existing industry' partner or a university-funded start-up company' commercializes the intellectual property'. Although remarkably little research exists on conflicts of interest involving startup companies, financial and commitment conflicts are an obvious concern, especially if the researcher also holds an equity' interest in the company' (Smith, 2011).

The volume of industry-physician relationships and number of start-up companies appears to be increasing. According to Ornstein, Weber, and Nguyen (2013), pharmaceutical and medical device companies made payments to physicians of $4 billion from 2009-2013. That figure was nearly matched ($3.53 billion) between August 2013 and December 2014 (Groeger, Ornstein, Tigas, & Jones, 2015).1 Similarly, the number of university start-up companies created per year increased from 330 in 2003 to 647 in 2012 (Valdivia, 2013).2 These data together demonstrate that as industry'-physician relationships and university' investments in start-ups and licensing of intellectual property increase, so do the number of potential conflicts of interest related to research.

The increasing likelihood of conflicts of interest and lack of transparency' of physician's industry' relationships have received the attention of government regulators, leading to policy changes. In 2008, Senator Chuck Grassley (R-IA) called for policy' revisions concerning industry' payments to individual physicians. This led to the Physicians Payments Sunshine Act (2010) and the Department of Health and Human Services adopting new regulations to Public Health Services funding, which included changes to the National Institute for Health (NIH) conflict of interest policy' in 2011. Some of the new NIH regulations set standards on investigators' industry' relationships and intellectual property. Because the NIH is the largest research funding agency' outside of the Department of Defense (White House Office of Science and Technology' Policy, 2014), changes to its COI policy have had a major impact on COI policies and procedures of the nation's universities and colleges that seek NIH grant funding. The new NIH COI policy holds universities accountable for ensuring that researchers comply'with federal regulations. As a result, many' research universities made significant changes to their COI policies and procedures in 2012 based on NIH standards.

Implementation of a newuniversity COI policy' (COIP) is challenging. Tire policy must be robust enough to account for an array' of possible conflicts of interest, including the aforementioned examples, as well as accommodating a diverse population of researchers. Universities with closely associated medical schools face an extraordinär}' challenge if the university desires a unified and comprehensive COIP. Clinical researchers at medical schools may have more industry-related conflicts based on the large amounts of money pharmaceutical and medical device companies give to physicians. …

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