Conflict of Interest (COI) Overview
Financial conflicts of interest in sponsored research occur when the financial interests of Investigators (or those of the Investigator’s spouse/domestic partner and dependent children) could directly and significantly affect the design, conduct or reporting of CMU research, or present the appearance of doing so. 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 naturally arise and they must be addressed appropriately.
Federal regulations and guidance regarding financial conflicts of interest in research (e.g., PHS regulations entitled “Promoting Objectivity in Research,” 42 CFR Part 50 and 45 CFR Part 94) also promote objectivity in research and require that the design, conduct, and reporting of research funded under federal grants, cooperative agreements, or contracts will be free from bias resulting from conflicts. Many nongovernmental funding organizations also have conflict of interest requirements.
Conflicts may also arise in other University activities unrelated to sponsored research (e.g., unfunded research or educational or service activities) when a University member’s personal/external interests may influence how they conduct their University activities.
To complete a disclosure in the SPARCS system, it is critical to understand the terms used in the regulations and CMU requirements.
“Investigator” means the Project Director (PD), Principal Investigator (PI), Co-Investigator or any other person, regardless of title or position, who is responsible for design, conduct or reporting of sponsored research, including research that is funded or proposed for funding. This includes all faculty, staff, and students specifically named in sponsored research funding applications, proposals, or budgets, including in any proposal or budget submitted in SPARCS, and all key personnel who are identified in a progress report or other report submitted by CMU to a funder. If an individual’s role in the research is significant enough that they are specifically named in a proposal for funding or on a budget, CMU considers the individual to be an Investigator as defined above and the individual should complete a disclosure.
A “Significant Financial Interest” (SFI) is a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse/domestic partner and dependent children) that reasonably appear to be related to the Investigator’s Institutional Responsibilities (defined further below):
- With regard to any publicly traded entity, a SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure plus the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
- With regard to any non-publicly traded entity, a SFI 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/domestic partner or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest). An Investigator does not need to know the specific dollar value of an ownership interest because any equity interest in a non-publicly traded entity is a SFI even if the value is unknown.
- With regard to intellectual property rights and interests (e.g., patents, copyrights), a SFI exists upon receipt of income of greater than $5,000 related to such rights and interests.
Exceptions and examples are available in the FCOI Guidelines.
How and When to Disclose
Disclosures are filed via the SPARCS COI system at the following times:
- Initial Disclosure: Each Investigator who is planning to participate in CMU sponsored research must disclose an up-to-date listing of the Investigator’s significant financial interests (SFI) (as defined below) no later than the time of application for research funding. Before CMU submits a new funding proposal, Investigators listed on the proposal will receive an email reminding them of their current disclosures listed in SPARCS. It is the Investigator’s responsibility to review this email and, if they find their information is out of date, to log in to SPARCS and submit an update prior to the proposal’s submission. Each new Investigator who, subsequent to the submission of an application for funding, or during the course of a sponsored research project, plans to participate in the project, must similarly disclose SFIs through SPARCS prior to participating in the sponsored research project. On a case-by-case basis, ORIC may request disclosures through SPARCS for unfunded, gift funded, or internally-funded research.
- Annual updates: Each Investigator who is participating in CMU research must submit an updated disclosure of SFIs at least annually (even if only to acknowledge no change to previous disclosures) during the period of the research activity.
- Updates within 30 days: Each Investigator who is participating in CMU research must submit an updated disclosure of SFIs within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI, or upon request by ORIC.
Initial disclosures and Annual updates will be initiated automatically by the SPARCS system; the Investigator will receive an email telling them when it is time to complete this disclosure. Researchers may initiate an update at any time from within SPARCS, or may contact ORIC to request that an update be assigned to them.
Review of COI Disclosures
CMU uses an electronic system (SPARCS) to collect and store certifications.
ORIC will review certifications to determine if a conflict exists, and ORIC may contact the Investigator for additional information. The objective of ORIC’s review is to determine whether an Investigator’s disclosed SFI is related to the Investigator’s research activity, and if so, whether the SFI is a Financial Conflict of Interest (FCOI).
A FCOI exists when ORIC reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the Investigator’s research activity. ORIC will consider several factors in determining whether a conflict exists, including:
- The nature and extent of the research and an Investigator’s role on a project;
- The nature of the Investigator’s research activity, including whether it relates to basic or fundamental research directed at understanding basic scientific processes;
- Whether the research involves intellectual property linked to the SFI;
- Whether the research could affect the value of an Investigator's SFI;
- The amount of a SFI; and
- Where the Investigator holds a financial interest in another company, whether the Investigator’s interest could result in the Investigator influencing company decisions, or whether the research could have a significant impact on the company’s business or financial outlook.
In conducting its review, ORIC may call upon subject-matter experts as needed with respect to any particular project, such as division management and others with relevant expertise. If it appears that a conflict may exist, further review is required. This review may be conducted by ORIC staff, the relevant department head, dean, OVPR, the Office of General Counsel, and/or their designees.
In some instances it is necessary to manage, mitigate, reduce or eliminate conflicts of interest. CMU works with Investigators to explore whether there are structures that would allow research to continue when there is an appropriately-avoided or managed FCOI. Examples of mechanisms that are used to avoid or manage conflicts include:
- Public disclosure of financial interests (e.g., when presenting or publishing research);
- Monitoring of research by independent reviewers;
- Modification of the research plan;
- Change of personnel or personnel responsibilities;
- Divestment of the financial interest;
- Severance of relationships that create the conflict (e.g., consulting);
- For research projects involving human subjects research, disclosure of conflicts directly to human participants; or
- Written disclosure of the conflict to all individuals working on the research project.
ORIC will communicate its determination regarding a management plan to the Investigator in writing. The Investigator may not commence or participate in the research until the Investigator agrees to and complies with a management plan imposed to manage a FCOI. Once agreed to, ORIC works with departments to monitor compliance with the management plan. Management plans are sometimes updated to reflect changes in research personnel, financial interests or other factors.
Reporting to Federal Agencies and the Public
CMU is required to notify certain research sponsors about FCOIs and management plans to address the FCOI. Investigators will cooperate with CMU to fulfill all reporting requirements to research sponsors, including those relating to organizational conflicts of interest and other conflicts.
In the event it is determined that a researcher has a financial conflict of interest as it relates to PHS or DOE funded research, the regulation requires that certain information be made available to the public about the Investigator's significant financial interest (SFI). 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.
In these cases, the PHS and DOE regulations provide the university with a choice between posting information about financial conflicts of interest 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 FCOI Request form [DOC].
Information Specific to Investigators Seeking or Receiving Public Health Service Agency Funding
The Public Health Service includes the following agencies:
- Administration for Children and Families (ACF)
- Agency for Health Care Research & 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 Preparedness and Response (ASPR)
- Office of Public Health and Science (OPHS)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
A number of other sponsors have adopted the PHS COI standards.