Will Crawford on Conflicts of Interest in Clinical Research [Podcast]

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By Adam Turteltaub

The topic of conflicts of interest (COIs), especially in healthcare, is a very broad one. It can encompass professional activities, board membership, purchasing, procurement and more. But it is the financial conflicts, especially for those that conduct research, that can be most problematic.

To help unpack the topic we are joined in this podcast by Will Crawford (LinkedIn), an associate in the DC office of Hogan Lovells. He explains that, in the case of research, a COI occurs whenever the interest of the investigator, their spouse or children can affect the design, conduct, or reporting of institutional research. And, of course, there is a potential conflict when activities like consulting and speaking can affect primary employment areas.

Federal regulations have expanded greatly in this area, with the Public Health Service now being joined by the US Department of Energy and even NASA with regulations of their own. Compliance teams need to monitor the changing direction from all three.

What else should compliance teams be doing? First, ensure the training is adequate and reflects the changing regulations. That includes helping others understand that the changing regulations are a necessary reflection of evolving risk. Second, ensure that the compliance team, itself, understands the current rules; there is much confusion out there.

Other things to consider or embrace:

  • Centralizing the process for managing COIs
  • Requiring more disclosures and independent review boards
  • Planning for greater transparency
  • Developing policing and monitoring systems

Finally, be mindful of joint ventures. They can create great opportunity, but they also carry substantial risk.