New Conflict of Interest Regulations – Get Ready!

All universities document potential conflict of interest that may exist with investigators and the sponsors of their research in order to establish mechanisms to protect research from bias. At Northwestern, there are forms for each investigator to complete, and we have a website that documents current relationships between investigators and sponsors.

The regulations related to investigator conflict of interest is going to be changing, and starting in 2013, more stringent requirements are going to be in place for universities that receive Federal funding. Most universities have already started to enact changes to get ahead of these requirements.

What’s coming down the pike?

The new rules will require investigators to report all significant financial interests in public and private ventures that they may benefit from at the time they receive a new award, whether the financial interest is directly related to the award itself. This includes significant financial interests related to the investigator’s roles at the institution (as a physician, investigator, instructor). The significant financial interest is now defined at $5,000 (was $10,000).

The institution is now required to evaluate this information and determine if there is bias, and will have additional reporting responsibilities to HHS, to develop plans to mitigate bias and correct problems when they exist.

What are we trying to avoid?

We’d like to avoid being featured in articles like this one. The Project on Government Oversight blog takes it’s role seriously – to monitor how government dollars are spent on research. And in this case they are questioning how effectively government dollars were spent. It might not be as simple as this news article has made it sound, or maybe it is, but by the time an issue has become public, an investigator, and the university has suffered unnecessarily.

The key is to understand the relationships that exist, complete the documentation in a timely manner, and ensure that all reporting and documentation is maintained appropriately to manage expenses.

Look for new guidelines in this area in the near future – we’re going to have some additional work to do to ensure that our investigators and their projects are protected.

 

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