Navigating the Murky Waters of Conflict of Interest: Searching for the Middle Path.
On August 23, 2011, the U.S. Department of Health and Human Services issued the Final Rule on conflict of interest. The purpose of the rule was to provide a clear framework for federally funded studies to identify, reduce, avoid, and/or manage researchers' external commercial relationships that could appear to impact the design, conduct, or reporting of research. Since the issuance of the final rule, colleges and universities have been tasked with closely monitoring external commercial relations of faculty to ensure that potential biases in research are minimized. The monitoring has become an even greater challenge as federal dollars for research decline, along with colleges and universities' ability to internally fund research. External commercial relations, including faculty start-up companies, are often an easy go-to source for funding to continue research and development. In such cases, sources of funding vary from crowdfunding to commercial incubator or innovation project start-up funds. There have been many lessons learned since implementation. This article will site some common examples encountered at one university of commercial relationships that have the potential to affect human subject research. Every industry tie to academically based research must be closely reviewed to ensure appropriate interactions between researchers and sponsors. Equally imperative is to build a collaborative relationship with faculty and conflict of interest administrators. Transparency and partnership are key to developing workable management plans. Even when there is the presence of a significant financial interest, much can be done to protect human subjects as well as the integrity of the research. Independent oversight, prohibiting the principal investigator (PI) from recruiting patients, limiting access to data, replication of results, review of annual progress reports, informing patients of potential financial gain, and so forth, are just a few of the safeguards we can put into place to reduce potential bias and inform and protect human subjects. Just like we need to be creative in identifying new ways of approaching research problems, we need to be creative in how we approach and manage academic and industry relationships. This creativity has the potential to benefit researchers who are exploring new frontiers, patients who may enjoy increased health, and companies with successful products on the market. Caution should be taken when generalizing to other institutions as resources available to manage will vary across organizations.
The University of Chicago, IL, USA sczonia@uchicago.edu.
Susan C
SC
Zonia
D035843:Biomedical Research / Q000941:ethics*; D003132:Commerce; D016265:Conflict of Interest; D004345:Drug Industry; D032984:Ethics, Research; D006801:Humans; D007221:Industry; D012108:Research Personnel / Q000941:ethics*; D014481:United States; D014495:Universities
academic and industry ties; conflict of interest; corporate-funded research; federal regulation