Conflict of Interest
The university is a public institution committed to the mission of teaching, research, and creative/scholarly activity, and professional and university service and public outreach. To these ends, the university balances an assortment of principles: maintaining an atmosphere that promotes free and open scholarly inquiry; facilitating the transfer of information and technology for the benefit of the public; and serving as a prudent steward of public and private resources entrusted to it. Faculty and staff have a primary commitment to their basic university duties of teaching, research, and creative/scholarly activity, and professional and university service and public outreach. These basic duties often limit outside activities. As a result, professional and personal activities may present financial conflict of interest situations which should be evaluated under the auspices of this and other applicable university policies. (Section 5.10.2, Norman Campus Faculty Handbook)
Public Health Service Financial Conflict of Interest (FCOI)
Conflicts of interest in research may occur when outside financial interests or commitments/relationships compromise, or have the appearance of compromising, the professional judgment of a researcher when designing, conducting, or reporting research. If an investigator believes a financial or commitment conflict of interest exists with a proposed project for themselves or a member of their team then they are required to disclose the conflict and follow the guidance below. Even if there is no identified PHS FCOI, the Investigator should ensure compliance with the University Conflict of Interest Policy (https://apps.hr.ou.edu/FacultyHandbook/#5.10).
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. The University’s PHS FCOI policy and the implementation plan corresponds with the mandate of this new regulation. Note that these requirements affect not only National Institute of Health (NIH) proposals/awards but other agencies (listed below) who have adopted this guidance.
Disclosure of PHS FCOI (and FCOI) is done by the Primary Investigator (PI) (see definition below) at submission of the information sheet prior to proposal submission. According to the federal reporting requirements, the project director or investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research must submit a FCOI disclosure form at the time of application, within 30 days of acquiring or discovering a new Significant Financial Interest (SFI), and annually after the Notice of Award. If there is insufficient space to include all your SFIs in one report, submit a second report with those relationships that did not fit in the first submission.
Overview of PHS FCOI Process
According to the federal requirements, all PHS-funded 'Investigators' at the University must complete the online FCOI training available here: https://www.citiprogram.org/. 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 is awarded.
New users to the CITI program must create an account. The same CITI account can be used for both the FCOI requirement and the University's IRB training requirement.
In addition, education is required immediately when:
- Financial conflict of interest policies are revised in a manner that changes researcher requirements,
- A researcher is new to the University, or
- A researcher is non-compliant with financial conflict of interest policies and procedures
Definitions and PHS Agencies/Delegations
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, postdocs, GRAs, or students.
Significant Financial Interest (SFI)
SFI means a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse/domestic partner or dependent children) that reasonably appear to be related to the Investigator's University responsibilities:
- With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of the disclosure, when aggregated, exceeds $5,000.
- With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests that is not paid through the University
A FCOI means an SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
 The requirements regarding Investigator financial conflicts of interest in research funded under PHS grants or cooperative agreements can be found at http://grants.nih.gov/grants/FCOI_Final_Rule_inspection_Desk.pdf, pp 53283-53288.
Public Health Service (PHS) means the Public Health Service of the U.S. Department of Health and Human Services and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to:
- Agency for Healthcare Research and Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control and Prevention (CDC)
- Food and Drug Administration (FDA)
- Health Resources and Services Administration (HRSA)
- Indian Health Service (IHS)
- National Institutes of Health (NIH)
- Office of Global Affairs (OG)
- Office of the Assistant Secretary for Health (OASH)
- Office of the Assistant Secretary for Planning and Evaluation
- Office of the Assistant Secretary for Preparedness and Response (ASPR)
- Office of Public Health and Science
- Substance Abuse and Mental Health Services Administration (SAMHSA)
Other agencies following PHS regulations include (but aren’t limited to):
Alliance for Lupus Research, Alpha-1 Foundation, American Asthma Foundations, American Cancer Society, American Heart Association, American Lung Association, Arthritis Foundation, CurePSP, JDRF - Juvenile Diabetes Research Foundation, Lupus Foundation of America, Patient-Centered Outcomes Research Institute (PCORI), and Susan G. Komen Foundation
Institutional Responsibility to Review Disclosures
Upon receipt of the Information Sheet (where SFI/FCOI is identified) and/or when the official disclosure process detailed above is initiated and prior to award, the internal process for PHS FCOI/COI begins (see above). Upon receipt of award from the Public Health Service and prior to expenditure of any funds, as well as within 60 days for any interest that the University identifies as conflicting subsequent to the University’s initial report under the award, or at the time of an NIH award extension, the University must determine:
- If the SFI is related to the Investigator’s research responsibilities and to the specific research award in question
- If the SFI creates an FCOI
- If an FCOI is determined to exist, then a Management Plan detailing how the conflict will be managed, reduced, or eliminated must be developed and implemented
As part of the University’s responsibilities, the Office of Research Services coordinates with designated officials to ensure the certification documents, management plan, and any required training is completed prior to finalizing award processing and within regulation time requirements for FCOI disclosed after initial award set up.
The University will monitor investigator compliance and report identified FCOI to the NIH via eRA Commons FCOI Module per the regulation. Any investigator who has knowledge or suspicion of an FCOI that has not been reported should contact the chair of the Conflict of Interest committee or email VPRFCOI@ou.edu
The Provost has established a Conflict of Interest committee. The Conflict of Interest committee will handle review of the Investigators’ FCOI Disclosure forms as required by this policy and pursuant to the faculty handbook and/or as required by the Board of Regents policy.
If sub-awardees/subrecipients, contractors, or collaborators carry out agency funded research, the University will take reasonable steps, via written agreement, to ensure that the collaborating entity has its own policies in place that meet the requirements of the PHS policy or that investigators working for such entities follow the policies of the University.
Situations of Noncompliance
In the event the University identifies a significant financial interest that was not disclosed in a timely fashion by the Investigator or was not previously reviewed by the University during an on-going PHS funded research project, the University will, within 60 days, determine whether a financial conflict of interest exists and will implement a management plan.
In addition, whenever a financial conflict of interest is not identified or managed in a timely manner, the University will, within 120 days of its determination of non-compliance, complete a retrospective review of the investigator’s activities and the PHS funded research project. The purpose of the review is to determine whether any PHS research conducted during the period of non-compliance was biased in its design, conduct, or reporting.
The documentation of the retrospective review will include all the elements of a regular review (Proposal/Project number, Title, PD/PI name [or contact if multiple PI/PD model used], name of investigator with conflict; name of entity with which the Investigator has an FCOI), and the reasons for the retrospective review. The methodology of the review and findings/conclusions of the review will also be documented.
Based on the retrospective review, if appropriate, the University will update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI and monitor Investigator compliance with the plan. If bias is found, the University will notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report will include the key elements documented in the retrospective review, the impact of the bias on the research project and University’s plan of action or actions to eliminate or mitigate the effect of the bias.
In any case in which Health and Human Services (HHS) determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness or a drug, medical device, or treatment has been designed, conducted or reported by an Investigator with a financial conflict of interest that was not managed or reported as required by PHS regulations, the University will require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.
Prior to the expenditure of funds, the University will make certain that information concerning FCOI held by Senior/Key personnel is publicly accessible by a written response to any requester within five business days of a request or as required by law. This response will provide current information (subject to annual updates and within 60 days of identification of a new FCOI) and will include: the Investigator’s name, title, and role with respect to the research project; the name of the entity in which significant financial interest is held; the nature of the significant financial interest; and the approximate dollar value of the significant financial interest (in pre-specified dollar ranges), or a statement that a value cannot be readily determined.
If the University responds to written requests for the purposes of this subsection, the University will note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an annual basis and within 60 days of the University's identification of a new financial conflict of interest, which should be requested subsequently by the requestor.
Maintenance of Records
The University will maintain records relating to all Investigator disclosures of financial interests and the University’s review of and actions taken related to such disclosures for at least three years from the date the final expenditures report is submitted to the sponsor, or where applicable, from other dates specified in PHS regulations. Primary repository of records is the Cayuse system.
Inquiries about the NIH FCOI regulation for grants and cooperative agreements may be directed to: VPRFCOI@ou.edu.