Key FCOI ideas
- By Federal mandate, this policy was effective August 24, 2012.
- All externally-funded Investigators have new, lower dollar thresholds for disclosing their conflicts of interest.
- All PHS-funded Investigators must complete FCOI training and are responsible to disclose sponsored travel reimbursements.
Conflicts of interest in research may occur when outside financial interests compromise, or have the appearance of compromising, the professional judgment of a researcher when designing, conducting, or reporting research.
UNE's Significant Financial Interest Disclosure policy seeks to maintain the appropriate balance among all competing interests that have the potential to produce bias in the design, conduct, or reporting of the research or distort technology transfer transactions.
In 2011, the Public Health Service (PHS) released revised financial conflict of interest (FCOI) regulations (42 CFR 50) that apply to any institution receiving funds from a PHS entity. UNE's revised FCOI policy went into effect in August 24, 2012, in compliance with the federal regulation.
The purpose of this FCOI webpage is to provide:
- Up-to-date and adequate information on the new requirements.
- A location to display that UNE has an FCOI policy in compliance with regulatory requirements.
- Links to the mandatory training, full policy, and essential details on processes that investigators must follow to meet these new requirements.
UNE’s revised FCOI policy reflects the following changes:
All UNE Investigators
- Lower Monetary Threshold: The minimum monetary threshold for reporting an SFI is lowered from $10,000 to $5,000, with a $0 threshold for disclosure of equity in a non-publicly traded company.
- A new disclosure form has been developed to reflect the new policy.
- A new Pink Sheet (UNE Proposal Transmittal form) has been developed to reflect the new policy and should be used for all new submissions.
PHS Agencies include
- National Institutes of Health (NIH)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Office of Public Health Science (OPHS)
- Health Resources and Services Administration (HRSA)
- Food and Drug Administration (FDA)
- Agency for Healthcare Research and Quality (AHRQ)
- Centers for Disease Control and Prevention (CDC)
Only for Investigators engaged in Public Health Service (PHS) Funded research
- Mandatory Training Requirements
All PHS-funded "Investigators" must complete online FCOI training (provided by UNE through Citi Training) prior to the expenditure of funds on any newly-funded projects, including noncompeting continuation awards. Training must be completed at least every four years. Current PHS awards (pre-8/2012) are not subject to these new requirements until the noncompeting continuation award. However, we encourage investigators to take the FCOI training to fulfill this mandatory requirement. The definition of an "investigator" includes the Principal Investigator (PI) and any other person (regardless of title or position) that the PI identifies as independently responsible for the design, conduct, or reporting of the research. While this online training is required for PHS-funded investigators, it is encouraged for all non-PHS-funded investigators as well.
- Disclosure of all externally-funded travel reimbursements
PHS-funded investigators must disclose all travel reimbursements that are either sponsored by (that is paid by an outside entity directly to the investigator) or reimbursed directly to the investigator from an outside entity for travel, with some exceptions. Exceptions include: travel reimbursements from an institution of higher education, a federal/state/local government, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education. This disclosure requirement does not apply to funding provided to the investigator via the institution (for example as part of sponsored research projects, paid from departmental discretionary or gift funds). Travel disclosures are to be made via the UNE FCOI Disclosure Form, Section F, within 30 days of travel completion.
- New requirements for FCOI information made accessible to the public
The new regulations require public transparency of investigators’ FCOI management plans either by a publicly-accessible website or by a written response within five business days to a request for an institution’s financial conflict of interest policy. This includes providing certain information regarding any key personnel whose significant financial interests are related to PHS-funded research. UNE will provide written response to any request submitted to the Director of Research Administration within five days.
All PHS-funded investigators must complete mandatory online training prior to engaging in PHS-funded research. Training completions will be recorded automatically. Completion records will be made available to the Office for Sponsored Programs (OSP) for verification of Investigator compliance with the mandatory training requirement.