It’s Been a Year — Time to Implement the New Regulations on Financial Conflict of Interest


As you may remember, last summer the Department of Health and Human Services issued a final rule in the Federal Register revising the regulations on financial conflicts of interest of extramural investigators. (For details on the major changes to the regulations, see the Financial Conflict of Interest (FCOI) website for a side-by-side comparison of the 1995 and 2011 regulations.) The regulations specified an implementation period of up to one year which ends today — August 24, 2012.

Over the past year I’ve spent a lot of time discussing the provisions of the new regulation pertaining to grants and cooperative agreements with many of you. Members of my staff have compiled extensive responses to the questions we received from you and your institutions. 

I’ve heard many questions about how we will monitor compliance with the revised regulations. We have developed a proactive compliance oversight program that will initially focus on the new FCOI policies that institutions are required to develop and post on the web. This will not only help us see how you’re doing  but will also help us identify best practices. Stay tuned as we will be reaching out to various institutions to assess compliance and help those that may need assistance with any other aspects of the new regulation. Thanks to all of you for the  hard work you’ve put in to implement all the new requirements and I appreciate your dedication as we partner to ensure objectivity in NIH-sponsored research.

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