Effective August 24, 2012, the Public Health Service (PHS) require grantees to manage any actual or potential conflict of interest that may be presented by compensated outside activities and other financial interests of Investigators involved in sponsored research projects funded by the Public Health Service (PHS). In addition, several non-federal sponsors that have adopted this policy as their own, for example, American Heart Association (AHA). The primary purpose of the federal regulations is to prevent bias in the design, conduct, or reporting of research projects. Investigators working on projects funded by these various granting agencies must abide by these requirements.
The FCOI is to be disclosed to the Division of Sponsored Programs (DSP) with each grant application being submitted where the source of funding will be from a US Public Health Service Services Organization (PHS, HHS, NIH, HRSA, FDA, SAMSA, AHRQ, CDC, CMS), as a recipient or as a subrecipient, with the exception of STTR/SBIR Phase I projects, which have been exempted by federal rule. The FCOI disclosure is also required with grant applications submitted to non-federal sponsors that have adopted this PHS FCOI policy as their own, for example, American Heart Association (AHA).