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ORCI Update

By Shannon Wapole

Overview of the new Public Health Service (PHS) Financial Conflict of Interest regulations

In August 2012 new regulations regarding Financial Conflicts of Interest (FCOI) were enacted for all Public Health Service (PHS) funded research. These changes are designed to promote the objectivity in research and to maintain public trust for funded institutions.  All investigators on PHS/NIH funded research must complete training and annually disclose their significant financial interests to the Office of Research Compliance and Integrity.

Certain definitions changed under the new FCOI regulations, the first being the definition of Investigator. An Investigator is any person whose contributions affect the outcome of the PHS/NIH funded research. This is not limited to the Primary Investigator. A project may have any number of investigators who must disclose their significant financial interests. The regulations also state that investigator includes the individual, their spouse, and any dependent children.  

The definition of significant financial interest (SFI) also changed. There are three major types of SFIs. The first is if an investigator has an interest amounting to more than $5,000 in a publicly traded entity. This includes equity ownership. The second is if an investigator has any interest in a private entity. For private entities there is no monetary threshold. The third is travel sponsorship or reimbursement which also has no monetary threshold. All of these SFIs must be disclosed annually to the Office of Research Compliance and Integrity.

Another major change is the training requirement. All investigators must receive training regarding the new regulations. Currently, NIU offers in-person training to fulfill this requirement. All investigators must complete the training before funds are dispensed and thereafter every four years. A training session is scheduled for Monday, June 3rd 2013. Please contact the Office of Research Compliance and Integrity for more information.

Public accessibility is also a new requirement. If any individual makes a request for FCOI information, NIU must respond with information regarding the investigator and any FCOI they may have.

This is only a brief outline of the changes. The updated FCOI policy and disclosure form can be found online at the Office of Research Compliance and Integrity website. This policy is limited to PHS/NIH funded research, however it is expected similar regulations will extend to all funded research at NIU in the upcoming months.

Additional information can be found at http://grants.nih.gov/grants/policy/coi/coi_faqs.htm#3156 or by contacting Shannon Wapole, NIU Research Integrity Coordinator at SWapole@niu.edu.