FCOI Requirements-Office of Research Integrity and Compliance - Carnegie Mellon University

FCOI Requirements for the CMU Research Community

Two regulatory standards guide CMU's FCOI policy.  Most Investigators seeking or receiving federal funds are required to disclose Financial Conflicts of Interests as set forth by the National Science Foundation (NSF).  Investigators seeking or receiving funds from a Public Health Service agency are required to disclose Significant Financial Interests related to their Institutional Responsibilities.  These terms have very specific definitions and are discussed at length in CMU's FCOI Guidelines [PDF] document and in the disclosure forms.  In the event it is determined that an actual financial conflict of interest exists, the conflict must be eliminated, reduced or managed prior to spending on the award.

CMU has two different primary disclosure forms:

Investigators with PHS funding are also required to complete the PHS Sponsored and Reimbursed Travel Disclosure form [DOC].  Investigators are responsible to update their disclosure annually and as necessary when their financial interests change.

The disclosure forms are in WORD format, designed to be completed electronically, saved and e-mailed to ORIC at coi-compliance@andrew.cmu.edu.  Additional forms are available as supplements to the FCOI and SFI Disclosure forms.

PHS funded Investigators must also complete training on the FCOI regulations prior to spending on an award and every four years thereafter. See the information on the COI training section.

For a high level overview of CMU's FCOI policy and process, please refer to the FCOI Quick Reference [PDF] document.  Questions about the disclosure process can be sent to coi-compliance@andrew.cmu.edu.  Questions can also be directed to Ann Mathias at 412-268-4727.

"Investigators" Must be Identified

Federal regulations require that PHS Investigators and some other federally funded Investigators file a disclosure prior to submitting a proposal for funding.  The term Investigator is defined in the regulation.

"Investigator" means the Project Director, Principal Investigator or any other person, regardless of title or position, who is responsible for design, conduct or reporting of research funded or proposed for funding.   This includes key personnel identified in the grant application, progress report or other report submitted to the funding agency by the Institution.

To be considered an Investigator for the purpose of FCOI, an individual has a level of responsibility such that they can have a meaningful impact on the results of the research. This could include recording study data without quality control mechanisms, independently analyzing data, and serving as an author on publications.  If an individual's role in the research is significant enough that they are specifically listed in a proposal for funding, they are considered to be an Investigator and should complete a disclosure.

For assistance in determing if a specific individual should disclose and what form they should use, see the FCOI Decision Tree [PDF].