fCOI - Frequently Asked Questions (FAQ)
- Why does Cornell have a new policy on Financial Conflict of Interest (fCOI) Related to Research?
- How does this policy support the University's stated goal to encourage entrepreneurship, partnership with the industry and to promote economic growth in New York State?
- What is covered under the definition of "Research"? Is it only externally funded research? What about unfunded research or research through extension activities or outreach?
- What does the fCOI Policy require?
- Who is covered by the fCOI policy?
- What must be reported?
- What constitutes "Significant Financial Income" and "Significant Equity Interest"?
- How do you determine that the external entity engages in activities that are or could be related to a reporter's Cornell duties?
- What is a financial Conflict of Interest (fCOI) related to research?
- I have already discussed my external work with my department chair and received concurrence...why do I have to fill in this form now?
- Who will be able to see my information?
- Who makes up the fCOI Committee?
- How will the reported information be reviewed?
- Who will make determinations for management plans and how will they be communicated to the investigators?
- If the fCOIC determines that I have a conflict of interest related to research, what can I expect to see in a management plan?
- My current conflicts management plan was developed based on the 2010-2011 report information. Will I need a new management plan this year?
- If I am not receiving or planning on receiving any sponsored funds (including federal grants), why do I need to complete this form?
- I thought conflicts of interest were only required to be disclosed with human participants research?
- Why do I need to report on financial information for my spouse/same-sex partner, and dependent child(ren)…they are not Cornell employees?
- What happens if I don't complete the Financial Conflict of Interest and Conflict of Commitment Report form?
- Who can I contact with specific questions regarding my unique situation?
Why does Cornell have a new policy on Financial Conflict of Interest (fCOI) Related to Research?
Cornell University is committed to ensuring the integrity of the research process and maintaining the public trust and that of sponsors in the integrity and credibility of its faculty, its staff and its research programs. Thus the university must ensure that there is a reasonable expectation that research results are not biased by any external commitments and financial conflicts of interest.
The principles and procedures of this policy assure that university research personnel will report their external commitments and financial interests in a timely manner and that real and apparent financial conflicts of interest will be identified and responsibly managed. This policy builds upon the University Conflicts Policy and promotes compliance with all applicable federal and state laws, regulations, and policies regarding financial conflicts of interest. It also aligns with best practices in this area and with Cornell's strategic plan for the continued development and success of Cornell's research endeavors.
How does this policy support the University's stated goal to encourage entrepreneurship, partnership with the industry and to promote economic growth in New York State?
Engagement in external organizations and activities enable the transfer of knowledge and skills that enhance teaching, research, service, and the administration of university programs; as well as inspire solutions to benefit the world. Entrepreneurial endeavors and productive relationships with businesses can stimulate inquiry and provide opportunities to further academic research.
The university contributes to the economic development of New York State and the nation and brings important scientific and medical discoveries to the marketplace for the benefit of the public. Consistent with the Bayh-Dole Act of 1980, the university strongly encourages and supports the efforts of its research personnel to participate in the development and dissemination of intellectual property (IP) by entering into relationships with existing business entities or by starting their own. These relationships, however, also present situations where some degree of real or apparent financial conflict of interest is inevitable. This policy calls for the appropriate and timely reporting, management and / or disclosure of these relationships to ensure the integrity of the research process, the unbiased and effective development of university Intellectual Property, and the appropriate entrepreneurial participation and external engagement of its research personnel.
What is covered under the definition of "Research"? Is it only externally funded research? What about unfunded research or research through extension activities or outreach?
"Cornell research," for purposes of this report, is research conducted in the course of an appointment with the university and/or using university resources, and includes sponsored research and extension, non-sponsored research, and research-related agreements. It includes the following categories:
Sponsored research and extension: research and extension funded by federal and non-federal sources through contracts, grants, gifts, clinical trials, training grants, or other forms of funding.
Non-sponsored research: professional interests pursued through research that are supported by University funds including, but not limited to, internal allocations, gifts, endowment income, fellowships, licensing income, salary recovery, and cost sharing.
Research-related agreements: including but not limited to licensing agreements, material transfer agreements, non-disclosure agreements, and product testing agreements.
What does the fCOI Policy require?
The policy requires all university research personnel to report their external commitments and financial interests for themselves as well as for their spouse or same-sex partner and all dependent children (hereafter referred to as "family,") annually and on an event basis by the required deadlines (reporting on an event basis is not implemented yet). Details on what must be included in the annual and event reports are provided in FAQ #6.
The policy also requires that potential conflict of interest issues related to research are reviewed by the Financial Conflict of Interest Committee ("fCOIC"). The fCOIC will determine whether the reported financial interest constitutes a conflict of interest, and if so, how it should be managed to meet the principles of the policy. These determinations will be documented in the form of management plans when needed, and communicated to the investigator, who is required to agree to and comply with the terms of the management plan. The policy makes provisions for an Appeal to the Senior Vice Provost for Research (SVPR) in the event that the investigator disagrees with the fCOIC's determination. The SVPR may make recommendations to the fCOIC for changes to the management plan but the fCOIC's decision is final and may not be overturned by the SVPR.
Who is covered by the fCOI policy?
All research personnel are covered by this policy. Research personnel include: Any personnel on research projects, and members of the administrative staff who are involved in the design, conduct and reporting or direct administration of university research.
For sponsored research this includes: (1) Principal investigators, co-principal investigators, co-investigators, and any other individual named in a sponsored project budget, narrative, key personnel list, by CV attachment, or noted anywhere else by name in a proposal or award; and (2) Anyone who during the course of a sponsored project assumes a role synonymous with the roles above.
For non-sponsored research: Those whose role on the research project is analogous with the roles described above.
For IRB protocols: Principal investigators and co-investigators.
All research personnel are obligated to report not only their own external commitments and financial interests, but also those of their spouse or same-sex partner and all dependent children.
What must be reported?
Under the policy, University research personnel are required to report fully and accurately all external commitments and all research-related financial interests in accordance with the procedures for each campus, in order to provide sufficient information for the identification of real and apparent financial conflicts of interest. Research personnel must include the external commitments and financial interests of his/her spouse or same-sex partner and dependent child(ren).
Some examples of financial interests are:
- Honoraria or speaking fees, service on an advisory committee or review panel, lectureships or other paid appointments (excluding those from universities, federal, state or local government agencies. Do not include reimbursement for reasonable travel expenses.)
- Royalties (in which Cornell may or may not be a party) or payments for all publications other than those for traditional academic and scholarly publishing activities such as textbooks or educational materials.
- Gifts, vacations, airline tickets, and other non-monetary payments for personal use
- Housing or travel support beyond what is reasonably needed to discharge services rendered
- Financial bonus payments or other compensation and/or penalties related to the speed of human participant enrollment, number of enrollees, or other milestones
- Compensation from sale of goods or services
- Income from monetary loans to the entity or money borrowed from the entity
- Fees for services or other monetary payments not included above
The following are NOT considered Financial Interests:
- Salary or other remuneration from the Institution;
- income from seminars, lectures, or teaching engagements sponsored by universities or federal, state or local government agencies;
- income from service on advisory committees or review panels for universities or federal, state or local government agencies;
- reimbursements for reasonable travel expenses;
- gifts, grants or awards received by the Office of Sponsored Programs in support of your Cornell research
What constitutes "Significant Financial Income" and "Significant Equity Interest"?
A Significant Financial Interest (SFI) can broadly arise from two types of relationships: Significant Equity Interest and Significant Financial Income.
Equity includes the following:
- bonds, publicly traded stocks or stock options;
- privately held stocks or stock options;
- convertible securities;
- warrants (i.e., promise of funds upon a demonstration of need);
- interest in real or personal property;
- dividends, royalties, profit sharing, capital gains;
- legal partnerships or other ownership interests.
Equity, for the purposes of this report, does not include mutual fund interests or stocks held through any non-self-directed 403B, 401K, IRA, or other retirement accounts.
Significant Equity Interest is defined as follows:
For a publicly held business, an equity interest that when aggregated for you and your family, exceeds the Public Health Service (PHS) threshold, currently: (i)$5,000 in value as determined through reference to public prices or other reasonable measures of fair market value; or (ii)representing 5% ownership in such business.
For a privately held business, any equity interest in such business, regardless of the amount.
Significant Financial Income is defined as follows:
Payments of anything of monetary value (including the value of an equity interest) from a single entity that when aggregated for you and your family (as defined in the procedures for each campus) for the past 12 months or expected over the next 12 months, exceeds the Public Health Service (PHS) threshold, currently $5,000.
Thus an SFI exists when the investigator has a Significant Equity Interest or derives or expects to derive Significant Financial Income from an external entity.
How do you determine that the external entity engages in activities that are or could be related to a reporter's Cornell duties?
While the determination of whether activities are related to a reporter's Cornell duties can be complicated and must be done on a case by case basis, the following general considerations can help to understand the areas where the Cornell duties of an individual may intersect with the activities or interests of the external entity:
- Entity is a sponsor, subcontractor, or supplier or lessor of goods, materials, proprietary information, services, or facilities for your Cornell duties.
- Entity makes use of your Cornell research or scholarly work either directly or indirectly. Making use of your Cornell research indirectly, for example, may be when you are paid to provide expert testimony, to act as a witness or provide an opinion, which is derived from your Cornell duties
- Entity is a member of an industry, trade, or advocacy group that directly funds your research or funds a sponsor of your Cornell research.
- Entity manufactures, commercializes, or is developing a product that is being used, evaluated, or further developed by your Cornell research.
- Entity will receive materials, data, or other information from your Cornell research and/or other Cornell duties.
- Entity is a competitor of a sponsor of your Cornell research.
- Entity refers human participants for your Cornell research.
- Entity has some other relationship not described above that could be related to or could be affected by your Cornell duties.
What is a financial Conflict of Interest (fCOI) related to research?
A financial conflict of interest occurs when research personnel have a financial self-interest that might interfere or appear to interfere with his or her professional duties to Cornell or the conduct of the research.
While such situations do not imply that the activities are inappropriate or unethical, if they could bias or create a reasonable perception by a neutral observer of bias in the research with the intersecting financial interests, they must be reported. Although this policy applies specifically to fCOI related to research, the annual fCOI report form is designed to collect information about all financial interests related to an individual's professional obligations to Cornell. All non-research related financial intersects will be reviewed by Units, in accordance with the policies specific to the Unit and pursuant to other applicable Cornell University policies.
I have already discussed my external work with my department chair and received concurrence... why do I have to fill in this form now?
In order to assure a consistent and comprehensive approach for all of our research personnel, we are implementing the new financial conflicts of interest related to research policy and process. The newly created Financial Conflicts of Interest Committee is now responsible for reviewing reports, collecting additional required information, identifying financial conflicts of interest, and determining required management plans. The committee is also charged with ensuring that any management plan oversight or reporting is documented and completed in accordance with the plan. Under the current process, reporting of real or apparent financial conflicts has been reviewed at the unit level. This may have resulted in inconsistent determinations regarding whether a conflict exists, as well as differences in the development and scope of conflict management plans. Consistency in the process and the actions will support the interests of the entire research community.
Who will be able to see my information?
The university is committed to maintaining the confidentiality of reported information as far as is practicable and consistent with legal obligations. All information and written materials provided to the fCOIC will be shared only with committee members and staff who are involved in the processing and review of the information, and with those who create and implement management plans. Other individuals, including unit heads and IRB members and staff, will receive the information on a need-to-know basis. Individuals with access to confidential personal information are required to sign a confidentiality agreement.
Reporting and all communications will be made electronically through the Cornell University Financial Conflict of Interest and Conflict of Commitment Reporting electronic tool, a secure, restricted research administration database.
Who makes up the fCOI Committee?
The fCOI Committee is appointed by the Senior Vice Provost for Research (SVPR) and includes as voting members no fewer than seven members of the Ithaca faculty chosen from both the endowed and contact colleges. The committee also includes, in a non-voting status, University administrators, including representatives from the Office of Research Integrity and Assurance (ORIA), Office of Sponsored Programs (OSP), Cornell Center for Technology, Enterprise and Commercialization (CCTEC), and the Office of University Counsel. The SVPR appoints one of the voting members to serve as chair of the FCOIC.
How will the reported information be reviewed?
The Financial Conflicts of Interest Committee (fCOIC) and its administrators in the Office of Research Integrity and Assurance (ORIA) are responsible for reviewing reports, collecting additional required information, identifying financial conflicts of interest and determining required management plans.
The standard review process is summarized below:
- The reporter completes, certifies and submits an annual report to the fCOIC using the electronic fCOI reporting system.
- If the status of the report is "No Review Required", the reporter is not required to do anything further until or unless there is an event that triggers an action - see FAQ #10. The reported information will not be subject to further review by the fCOIC, although the information will be retained for auditing purposes.
- If it is determined that further review of the information is required, the fCOI Administrators will conduct an administrative and compliance review of the information, to ensure that all the information is complete and that all supporting documentation/information is made available for the fCOIC to make a decision. This process may include conversations with the reporter, the OSP, CCTEC, Counsel's office, the IRB and IACUC.
- The fCOI administrators will make an initial determination of the level of review required, which will lead to one of two options: an expedited review by a sub-committee within the fCOIC, or a full committee review. This determination will be based on the complexity and relatedness of the issue(s) giving rise to the conflict. Review by either the sub-committee or the full board will include a review of the reported information, the reporter's area of research and expertise, and the totality of the relationships, from all interested perspectives including that of the reporter, the University, peer faculty and an objective party. Confidentiality will be maintained at all times, and information will only be shared with those with a need to know based on a role in the analysis of the conflict.
Who will make determinations for management plans and how will they be communicated to the investigators?
The fCOIC, either as a full committee, or through a sub-committee, will determine whether a management plan is necessary. When a management plan is required, the fCOI staff will draft a management plan for review by the fCOIC or designated subcommittee. The process of developing a management plan may involve the reporter and other individuals/offices as required. For an expedited review (see FAQ 14), the sub-committee will make the final decision on the disposition of the conflict and the management plan. For a full committee review, the full committee will vote on the disposition of the conflict and the management plan. Disposition is documented and communicated to the reporter through the fCOI system. If a management plan is to be implemented, the reporter will be required to acknowledge in writing acceptance of the terms of the management plan. In the event a reporter disagrees with the disposition of the conflict and the related management plan, the reporter may submit an appeal in writing to the committee.
If the fCOIC determines that I have a conflict of interest related to research, what can I expect to see in a management plan?
Each situation involving a financial conflict of interest will have its own unique considerations, such as the scope and type of the financial interest, risk to human participants, the expertise of the researcher, the possibility of a concern with data integrity, involvement of students or employees, etc. One management plan cannot fit all types of conflicts. However, in determining the scope of a management plan, the following issues will usually be considered:
- Disclosure – To editors and conference organizers and/or in publications and presentations, in publicity, to human participants in the consenting process, students directly supervised by the reporter, and collaborators on the research.
- Conduct of research - Oversight / data monitoring by an unaffiliated third party or a non-conflicted collaborator may be required
- A conflicted individual cannot be PI for human participant research
- Use of Cornell facilities, purchases and services - ensuring institutional resources are not used for personal gain
- Progress and protection of students and supervised employees - no restrictions on right to publish, or progress towards a degree and no coercion to further faculty financial interests
- Intellectual property, technology transfer - licensing and negotiation
- Updates required if circumstances change
- Sample management plans and a guidance matrix to help determine the general circumstances that call for the different levels of the management plan, are available here http://www.oria.cornell.edu/COI/managementplan/. Note that these are generalizations that may or may not apply to any individual's unique situation. Please consult the COI staff for more guidance or if you have specific questions about the documents or the matrix.
My current conflict management plan was developed based on the 2010-2011 information. Will I need a new management plan this year?
The management plans implemented in 2012 will remain in place unless the committee determines that the information provided in the 2011-12 disclosure is such that the terms of the management plan need to be modified. In that case, the COI office will contact you and advise you that of the new terms and work with you to implement them.
If I am not receiving or planning on receiving any sponsored funds (including federal grants), why do I need to complete this form?
Cornell's interest in protecting the integrity of research is not limited to any one area of research such as that performed under federal grants. For all research conducted under the auspices of Cornell, effective reporting and proper management of financial conflicts of interest related to research ensure research integrity, maintains the public's and sponsors' trust in Cornell's research, and protects faculty against imputation or accusations of inappropriate action due to personal financial interest and external commitments.
The policy was developed on the recommendation of President Skorton's Task Force on Conflicts of Interest (November 2009) and with the advice and approval of the University Conflicts Committee. It meets the recommended standards of being fully in compliance with federal regulations and closely aligned with best practices as recommended by the AAMC/AAU, and is similar to those at our peer institutions who have recently updated their FCOI policies. This approach will ensure that we are at the forefront of proven compliance practices, supporting the highest standards in research integrity.
I thought conflicts of interest were only required to be disclosed with human participants research?
Regardless of the location or type of research being conducted, three principles are accounted for in the process of university review of reports of external commitments and financials interests; (1) respecting the confidentiality of reported information; (2) managing rigorously both real and apparent financial conflicts of interest; and (3) achieving consistency across the university in the way that financial conflicts of interest are identified and managed.
The policy covers the conducting or reporting of research, including the collection, analysis, and interpretation of data, the hiring of staff, procurement of materials, sharing of results, choice of protocol, involvement of human participants, and the use of statistical methods.
Special attention is paid when research personnel have academic oversight responsibilities for undergraduates, graduate students, or postdoctoral associates who are working on projects that are funded by, or conducted in collaboration with, an external entity in which the research personnel have a financial interest.
Why do I need to report on financial information for my spouse/same-sex partner, and dependent child(ren)…they are not Cornell employees?
Real or apparent conflicts of interest address the potential for real or perceived influence on research that could affect the results. Because of the closeness of the family relationships, the reporter is deemed to know about their financial interests, and therein lies the perception or actuality that a reporter may be subject to influence based on those extended interests. This inclusion aligns with federal regulations, and is an accepted fact within the scope of financial conflicts of interest disclosure and management.
To ensure that we are only collecting and reviewing the information relevant to your Cornell duties, for your family you are only required to report the significant financial interests with an entity that engages in activities that might intersect with your Cornell duties in any way. Thus income or equity interests for your family that are unrelated to your Cornell duties do not need to be reported.
What happens if I don't complete the Financial Conflict of Interest and Conflict of Commitment Report form?
The awareness of real or apparent financial conflicts of interest is the responsibility of every member of the Cornell community and the reporting of external financial interests is an affirmative requirement of every individual engaged in research under the auspices of Cornell.
Failure to complete the annual financial Conflicts of Interest and External Commitment form may restrict the submittal of proposals for new funding to which you may be a party. Additionally, the Institutional Review Board will withhold final approval of human participant research protocols until completion of the annual fCOI form and the resolution of any potential issues. Further sanctions may include but are not limited to:
- Inability to maintain principal investigator status on sponsored projects;
- Ineligibility to enter into technology transfer agreements;
- A letter in an individual's personnel file indicating that his/her good standing as a member of the university has been called into question;
- Withdrawal of an annual salary increment pending submission of the completed report form;
- Suspension of research activities and associated salary in compliance with applicable university policies and codes.
Who can I contact with specific questions regarding my unique situation?
For questions about the fCOI policy, procedures or the review process, please contact
Director, Office of Research Integrity and Assurance
For assistance with using the fCOI Report Management System, please contact
Conflict of Interest Administrator
For additional information about the fCOI policy and procedures, case studies and FAQs you may also visit the Cornell fCOI website.