PHS/NSF Financial Conflicts of Interest in Research

LSU’s Financial Conflicts of Interest (FCOI) Policy Statement 98 (PS-98) has been revised to comply with new Public Health Service (PHS) FCOI regulations, which went into effect on August 24, 2012.  The Office of Research & Economic Development (ORED) is using the revised policy as the guide for ensuring compliance with the new regulations.

The Policy continues to incorporate the guidelines of the National Science Foundation (NSF) which have not been updated at this time, and shall also now apply to other agencies requiring disclosure of Significant Financial Interests of Investigators.
It is important to know that the Investigator is defined in the federal regulations as any individual responsible for the design, conduct, or reporting of the sponsored research, including but not limited to PI, CoPI, postdoctoral associates, graduate students, collaborators or consultants. 

The main changes to PHS’s regulations include:

  • Lower financial disclosure thresholds ($10,000 to $5,000).
  • New Mandatory Conflict of Interest Training – All PHS-funded “investigators” must complete online FCOI training in the Collaborative Institutional Training Initiative (CITI) available from ORED’s website.
  • Increased transparency for travel reimbursement – PHS-funded investigators must disclose ALL travel reimbursements that are either sponsored by (i.e., paid by an outside entity) or reimbursed directly to the investigator from an outside entity for travel that occurs after August 24, 2012, with some exceptions.
  • New Public Accessibility requirements.

Disclosure:

  • For PHS and NSF funded research, at time of application, investigators shall indicate in the Sponsored Programs System (SPS) whether any Significant Financial Interests exists. Further, investigators will certify in SPS that the project conforms with PS-98.
  • For PHS funded research, prior to award acceptance, and on an annual basis investigators shall complete and submit to the Office of Sponsored Programs (OSP) a Significant Financial Interests Disclosure Form.
  • For PHS and NSF funded research, the investigator shall complete and submit to OSP a Significant Financial Interests Disclosure Form within 30 days of acquiring or discovering a new Significant Financial Interest.
  • For other agencies disclosure shall be as/when required by the agency.

Mandatory Training:

  • PHS funded researchers must complete FCOI training and provide proof of completion of training on this Policy prior to engaging in research funded by PHS, and at least every four years thereafter. They must also complete training within a reasonable period of time as determined by the Institutional Official in the event that this Policy is substantively amended in a manner that affects the requirements of Investigators, when an investigator is new to the institution, or if it is determined that the Investigator has not complied with this Policy or with a management plan related to their activities.
  • An online training module is available through the Collaborative Institutional Training Initiative (CITI) at https://www.citiprogram.org/. PHS investigators should enroll in the CITI training program under Louisiana State University, complete the Conflicts of Interest course, and print out a Completion Report in order to provide certification of training. A copy of this certification form should then be forwarded to OSP.