StATS: What constitutes a conflict of interest? (May 4, 2006)

I am a member of a committee that helps researchers set up Data Safety and Monitoring Boards (DSMBs) for research projects at Kansas University Medical Center (KUMC). The typical study that we would help set up DSMBs for would be small scale single center trials. We recommended that the typical DSMB have two specialists in the medical area of the research and a statistician. We ask the principal investigator to nominate the two specialists.

Some debate ensued about whether the specialists nominated by the principal investigator would have a conflict of interest because they presumably would know and would have worked with the principal investigator.

Conflict of interest is a tricky thing, and sometimes I think people apply the term without thinking carefully about it. I believe that anyone with a financial stake in the outcome of a clinical trial should not sit on the DSMB and make decisions about possible early termination of the trial. Also individuals with a close professional affiliation need to be excluded. For example, a researcher who has co-authored research papers with the principal investigator should be excluded. But you can't start excluding people because they know each other or because one regularly refers patients to the other or because they attended the same medical school. Once you start down that road, you may find it impossible to find anyone who does not have a conflict.

There is no easy answer, though, for where you would draw the line. A general rule is  that the more transparent and replicable the research process is, the less you have to worry about a conflict of interest. So, for example, you might accept a meta-analysis from a group that has a financial stake in the outcome, but not an invited editorial.

This page was written by Steve Simon while working at Children's Mercy Hospital. Although I do not hold the copyright for this material, I am reproducing it here as a service, as it is no longer available on the Children's Mercy Hospital website. Need more information? I have a page with general help resources. You can also browse for pages similar to this one at Category: Conflict of interest.