Financial Conflicts of Interest (FCOI)
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.
The OU Board of Regents Policy on Conflict of Interest Health Sciences Center 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. Institutions receiving funding from any PHS entity must revise their institutional FCOI policy to be in full compliance with all of the regulations by August 24, 2012. Our FCOI policy, effective June 26, 2012, corresponds with the mandate of this new regulation.
The purpose of our FCOI website is to provide:
- An effective site for OUHSC researchers to get up-to-date and adequate information on the new requirements.
- A high-visibility location to display that OUHSC has an FCOI policy in compliance with regulatory requirements.
- Links to the mandatory training, full policy documentation and essential details on processes that investigators must follow to meet these new requirements.
The revised PHS FCOI rules will have an institutional-wide impact. OUHSC’s revised FCOI policy and its implementation plan will reflect the following federally required changes:
All OUHSC investigators:
Responsible for reading and complying with the OU Board of Regents Policy on Conflict of Interest Health Sciences Center.
Only for OUHSC Investigators engaged in Public Health Service (PHS)* funded research:
* PHS agencies include NIH, FDA, CDC, AHRQ, HRSA, IHS, SAMHSA, and ATSDR
Mandatory training requirements:
All PHS-funded “investigators” at the OUHSC must complete the online FCOI training which will be made available August 24, 2012. Successful completion of the training is required prior to the expenditure of funds on any newly-funded projects, including noncompeting continuation awards. This applies to all PHS-sponsored research projects as of August 24, 2012. Training must be completed at least every four years. Current PHS awards are not subject to these new requirements until the noncompeting continuation award.
“Investigator,” for the purposes of this policy, means the Principal Investigator and any person listed by the Principal Investigator as responsible for the design, conduct, or reporting of their sponsored program(s). These individuals are listed at the time of proposal submission.
Normally, all senior research personnel should be listed as “Investigators.” All of the following should be considered, to the extent they are responsible for the design, conduct, or reporting of the sponsored program: professorial faculty, research associates, emeritus faculty, research collaborators, visiting scientists, individuals with courtesy appointments. The term “Investigator” does not commonly apply to OUHSC departmental grant administrators or to the financial reporting staff of sponsored programs.
Under Federal Regulations. Principal Investigators and Key Personnel must disclose financial interests in non-governmental entities (e.g., for-profit entities) that are supporting research. Research support can be in the form of grants, contracts, subcontracts or subgrants, gifts, and donated equipment or supplies. Additionally, disclosures of financial interests related to research and research training are required when the research is supported by certain federal agencies, including NIH and NSF, or by sponsors who require review under federal guidelines, such as the American Cancer Society.
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 that occurs after August 24, 2012, 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).
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. The OUHSC will opt to provide a written response with the required reporting elements of an investigator’s FCOI management plan starting in August 2012.
2011 Public Health Service (PHS) Regulations
National Institute of Health Financial Conflict of Interest FAQ
OU Board of Regents’ Policy Regarding Conflict of Interest Health Sciences Center
We’re committed to helping you comply with these regulations. Please don’t hesitate to contact us with any questions.