Financial Conflict of Interest (FCOI)
Conflicts of interest in research occur when university members are in a position to influence research and their extramural activities are such that they or their family may receive a financial benefit or improper advantage from the research. Conflicts of interest have the potential to inappropriately influence many aspects of research - from how a study is designed, how data is collected, analyzed and reported, to what individuals/suppliers are involved in the work. In a university setting, especially one that promotes technology transfer and entrepreneurial activity, conflicts of interest are inevitable.
Dr. Karl is a founder of a company that utilizes technology developed in her lab at CMU. She has an equity interest in the company and receives remuneration from the company. This is related to Dr. Karl's institutional responsibility. These financial interests should be disclosed if Dr. Karl is funded by PHS. They may or may not constitute a conflict of interest.
Dr. Smart is an economist at CMU. Dr. Smart consults for a bank, assisting with economic forecasting. Dr. Smart received $8,000 in payment for his consulting services last year. This is related to Dr. Smart's institutional responsibilities. These financial interests should be disclosed if Dr. Smart is funded by PHS. If the bank is sponsoring Dr. Smart's work at CMU this may be a conflict of interest.
Dr. Jones patented technology he developed at Great Eastern University. Dr. Jones is currently on faculty at CMU doing similar work. Dr. Jones receives royalties from Great Eastern University. This is related to his institutional responsibilities and must be disclosed if he is funded by PHS. This may or may not result in a conflict of interest.
Dr. Bing is a founder of a company that utilizes technology developed in her lab at CMU. Equity interests and remuneration from this company are related to Dr. Bing's institutional responsibility. Dr. Bing receives federal funding for further development of the technology. Dr. Bing would like to subcontract with her company for a portion of the work to be done. This is a conflict of interest.
In some instances it is necessary to manage, reduce or eliminate conflicts of interest. CMU works very hard to find structures that allow researchers to continue their work when there is a conflict. Examples of mechanisms that are used to manage conflicts include:
- Public disclosure of SFIs,
- Monitoring of research by independent reviewers,
- Modification of the research plan, or
- Change of personnel.
If an Investigator has a conflict of interest, s/he is asked to inform other members of the research team.
Once agreed to, ORIC monitors compliance with the management plan. Management plans are sometimes updated to reflect changes in research personnel, financial interests or other factors.
Review of Disclosures and Reporting to Federal Agencies and the Public
Once received by ORIC, disclosure forms will be reviewed to determine if a financial conflict of interest exists. If no FCOI is identified, the disclosure will be filed and stored as required by law. If it appears that an FCOI may exist, further review is required. This review may be conducted by ORIC staff, CMU's Conflict of Interest committee, and CMU's Vice President for Research. The determination as to the existence of a financial conflict of interest will be made in consultation with the individual researcher making the disclosure. In some instances, the individual's department head will be consulted.
Disclosure forms and the information contained therein are used for the purpose of reviewing and managing financial conflicts of interest and as required by law. The information is treated as private and confidential. In certain circumstance, some information must be shared with funding agencies and the public.
CMU is required to notify NSF's Office of General Counsel in the event a financial conflict of interest related to an NSF award is identified and CMU finds that is it unable to appropriately manage the conflict.
In the event an Investigator has a financial conflict of interest related to PHS funding, CMU is required to report certain situations to the PHS funding agency. These reports are made by staff in ORIC. Investigators do not need to report directly to PHS.
In the event it is determined that a researcher has a financial conflict of interest as it relates to PHS funded research, the regulation requires that certain information be made available to the public. The information that CMU is required to release includes:
- Investigator's name;
- Investigator's title, and role with respect to the research;
- Name of the entity in which the SFI is held;
- Nature of the SFI (stock, income, etc.);
- Approximate dollar value of the SFI in dollar ranges ($0 - $4,999, $5,000 - $9,999, $10,000 - $19,999, amounts between $20,000 - $100,00 by increments of $20,000, amounts above $100,000 by increments of $50,000), or if the interest is one whose value cannot be readily determined through reference to public information, a statement to that effect.
The law provides the university with a choice between posting information about FCOIs on the internet and making the information available within five (5) days of a written request. CMU has chosen to make information available upon written request to the Office of Research Integrity and Compliance. Requests can be made by submitting the PHS FCOI Request form [DOC].
Information Specific to Investigators Seeking or Receiving Public Health Service Agency Funding
The Public Health Service includes the following agencies:
- National Institutes of Health,
- Centers for Disease Control and Prevention,
- Food and Drug Administration,
- Agency for Healthcare Research and Quality,
- Agency for Toxic Substances and Disease Registry,
- Health Resources and Services Administration,
- Indian Health Services, and
- Substance Abuse and Mental Health Services Administration.
PHS Significant Financial Interest Disclosure
"Investigators" seeking or receiving funds from a PHS agency are required to disclose "Significant Financial Interests" (SFI) that are related to their "Institutional Responsibilities". This includes certain remuneration received or ownership interests held by the Investigator, spouse/domestic partner (as defined by CMU for purposes of benefits) or dependent children. Investigators are responsible for filing an accurate disclosure prior to submitting a proposal for funding and updating their disclosure annually or within thirty (30) days of discovering or acquiring a new Significant Financial Interest.
Details on what constitutes a Significant Financial Interest, related to Institutional Responsibilities are outlined in the FCOI Guidelines [PDF].