FCOI Part 2: So What’s Different about the New Regulation?

More about the new Financial Conflict of Interest regulation from the presentation I attended – which will make all of our lives a lot more interesting, I’m sure.

First, the definition of a significant financial interest has changed quite a bit – if an investigator buys a stock or has any interest in a private company that their university thinks may have some impact on their research, it needs to be declared. Any travel related to their research needs to be documented and declared, and all this needs to be declared within 30 days of an event. (Did I just hear your heart drop?) Every institution I talked to was discussing a declaration form of some kind that an investigator would have to review every 30 days.

Think about everything you do that may involve a private company or a non-profit. If an investigator makes a donation to a political candidate that may impact his or her ability to garner research dollars as a private citizen, will that act need to be declared? Probably…it depends. We’ll have to see what happens. And if an investigator has a subcontract with an entity that has no FCOI policies and the prime assumes this monitoring capacity, won’t this be a tremendous burden.

Further, every time an investigator joins a project, their FCOI has to be assessed – and an investigator from the point of view of financial conflict of interest won’t be the same working definition as the typical “key personnel” definition. This will be a broader interpretation – to include anyone that can impact the scientific outcome of the project.

I’ve saved the best part for last.

Now you’re asking, what happens when an investigator doesn’t declare a conflict for some reason (all of us have investigators that could win the Nobel Prize and we’d find out by turning on the TV first)…?

Essentially, this regulation is the equivalent to a pit bull on steroids. Failing to detect an actual financial conflict of interest that is found, after an investigation, to impact the scientific outcome of a project, is akin to being found guilty of scientific misconduct. Failing to disclose, in and of itself, triggers an investigation, freezing of funds and all sorts of hell and tarnation that we all want our investigators to avoid, even if the result is that the potential FCOI is found not to adversely affect the scientific integrity of the process.

Bottom line – as research administrators, we need to take the documentation of financial conflicts at the time of the proposal with incredible seriousness (no automatic checking of the boxes anymore) and when we meet with our PI’s, we need to make sure that personnel on the projects are who we think they are, and if someone new is added, we’re going to be the ones that know. We need to ensure they are reviewed on a timely basis (to get them through a 60 day window).

Tracking and reporting financial conflicts of interest is not a bad thing. It will be horribly burdensome for the 98% of the good investigators out there in order to prevent and manage those few bad actors. Unfortunately, we have the headlines already to know why this is needed.

Get ready – more hoops to jump through are on the way.

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