COI Frequently Asked Questions
Federal regulations have been developed to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of federally funded research will be free from bias resulting from investigators' Financial Conflicts of Interest (FCOI).
Federal funding agencies require complete and accurate reporting of all sources of research support, financial interests and affiliations, both foreign and domestic. Regulations exist to protect the integrity of research that is federally funded, and institutions must have a policy and disclosure process in place that assures these federal agencies that institutions are examining financial interests held by investigators that meet certain thresholds and determines whether a conflict of interest may exist that must be addressed or mitigated.
If noncompliance with these disclosure and conflict management requirements is identified, potential actions that may be taken by the federal funding agencies may include withdrawing approval of the Program Director/Principal Investigator or other researchers contributing to the award, imposing specific award conditions, disallowing costs, witholding future awards including the possibility of suspending or terminating the award, see NIH Grants Policy Statement, Section 8.5. It is therefore always recommended to err on the side of disclosure.
What to disclose?
A conflict of interest (COI) is any circumstance where the personal, professional, financial, or other private interests of a person or institution compromise or have the potential to compromise the exercise of professional judgment or obligations or may be perceived as doing so.
A Financial conflict of interest is a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of research.
Significant Financial Interests (SFI) are defined as the following interests of the Investigator and the Investigator's spouse and dependent children:
1. With regards to publicly-traded entities, payments or value exceeding $5,000 when aggregated for an Investigator and the Investigator's spouse and dependent children from a single entity, including salary, consultant payments, honoraria, paid authorship, equity interest (stock, stock option, or other ownership interest) during the prior 12 months.
2. With regards to privately held entities, payments or value exceeding $5,000 when aggregated for an Investigator and the Investigator's spouse and dependent children from a single entity during the prior 12 months or when the Investigator and the Investigator's spouse and dependent children hold any equity interest (stock, stock option, or other ownership interest).
3. With regards to Intellectual Property, intellectual property rights and interests (patents, copyrights) upon receipt of income related to such rights and interests.
4. With regards to travel, any reimbursed or sponsored travel related to the Investigator's Institutional Responsibilities during the prior 12 months (with the exception of travel that is reimbursed or sponsored by a U.S. federal, state, or local government agency, a U.S. institution of higher education, a U.S. academic teaching hospital, a U.S. medical center, or a U.S. research institute that is affiliated with an institution of higher education.
Please refer to the SFI section of the Villanova Financial Conflict of Interest in Research Policy for more details.
- Salary, royalties, or other renumeration paid by Villanova to the investigator if the investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalties related to such rights;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as you do not directly control the investment decisions made in these vehicles;
- Income from seminars, lectures, and teaching engagements sponsored by U.S. Federal, state, or local government agencies; U.S. institutions of higher education or U.S. research institutes; U.S. academic teaching hospitals or U.S. medical centers that are affiliated with U.S. Institutions of higher education;
- Income from service on advisory committees or review panels for U.S. Federal, state, or local government agencies; U.S. institutions of higher education or U.S. research institutes; U.S. academic teaching hospitals or U.S. medical centers that are affiliated with U.S. institutions of higher education;
- Travel expenses paid by Villanova University or by a sponsored research award to the University;
- Travel reimbursed or sponsored by a U.S. federal, state, or local government agency, a U.S. institution of higher education, a U.S. academic teaching hospital, a U.S. medical center or research institute that is affiliated with a U.S. institution of higher education;
- Self-funded personal travel (vacations).
All travel sponsored or reimbursed by a foreign entity must be disclosed, regardless of the type of entity sponsoring the travel (University, government, non-profit, corporate, etc.) via the FCOI disclosure process.
Foreign travel and relationships with foreign entities raises other considerations for researchers as such relationships and support may need to be disclosed through other processes including FCOI disclosures, Current and Pending Support for NSF, or Other Support for NIH. Further, any trip outside the United States has the potential for the researcher to export both items and technical information that may be controlled. Investigators are strongly encouraged to consult with the University Compliance Office prior to traveling abroad for Villanova activities or with Villanova equipment (e.g. laptop computer, scientific equipment, other devices, etc.).
Who needs to disclose?
Investigators are all individuals responsible for the design, conduct, or reporting of the results of work performed or to be performed as part of a research project. "Investigator" includes, but is not limited to the Principal Investigator, Co-Investigators, and any other individuals (including personnel from other institutions) who are involved in accomplishing project objectives. It may include students, graduate and undergraduate, and other personnel who may be listed as authors on project results, even if they are not paid from the project.
In addition to Investigators, all University faculty, staff, students, and non-affiliated individuals who engage in the review or support of research as a member of a regulatory committee on behalf of Villanova University must also complete the disclosure. The regulatory committeees consist of the Institutional Review Board, the Institutional Biosafety Committee, and the Institutional Animal Care and Use Committee. For purposes of these Frequently Asked Questions, the term "Investigator" also refers to Regulatory Committee Member unless otherwise specifically noted.
For more details, see the "definitions" section of the Villanova Financial Conflict of Interest in Research policy.
Immediate family refers to an Investigator's spouse and dependent children. You do not need to disclose familial employment or information related to retirement or investment accounts not managed by the individual unless related to your research project.
When do I need to disclose?
There are three points in time when a new or updated disclosure is required:
1. When submitting a research proposal to the Office of Grants and Contracts or a human subjects research proposal to the Office of Research Protections;
2. Annually as part of the Fall disclosure campaign;
3. Within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest.
Once you complete the disclosure form via the COI Risk Manager system or submit the paper/PDF form to the Office of Research Protections, it becomes available for review by the members of the Financial Conflict of Interest in Research Committee (FCOI Committee). The Committee meets periodically to review those disclosures wherein Investigators have indicated that they have one or more Significant Financial Interests (SFIs).
Per the Villanova Financial Conflicts of Interest in Research Policy, the Associate Vice Provost for Research appoints the members of the FCOI in Research Committee. Core members of the FCOI Committee consist of the Director of the Office of Research Protections (who has also been appointed for pre-review and referral of disclosures to the FCOI Committee), the Director of the Office of Grants and Contracts, and the University Compliance Officer. An attorney from the Office of the Vice President and General Counsel is an ex officio member.
Whenever a disclosure requires additional information or analysis, the FCOI Committee also includes an appointee from the Dean from the College/School where the Investigator or Regulatory Committee Member derives his or her primary Institutional Responsibilities. For staff disclosures that require further analysis the FCOI Committee includes a representative from the Department of Human Resources.
In reviewing submitted disclosures, the FCOI Committee initially determines if the Significant Financial Interest is related to the research which means that it could potentially compromise or bias the Investigator's professional judgment or objectivity. If the determination is positive, then the FCOI Committee must determine whether the disclosed interest constitutes a Financial Conflict of Interest in that it could directly and significantly affect the design, conduct, or reporting of the research.
In order to assist in their review, the FCOI Committee is guided by an extensive set of practices that are outlined in the Financial Conflict of Interest in Research policy. The FCOI Committee will often reach out to the Investigator directly gain a better understanding of the interest that has been disclosed and any potential impact on the research project(s).
The cooperation of the Investigator in providing information throughout this process is key to a successful resolution of any conflict review analysis. In the end, the FCOI Committee may decide that the project may start, as designed, or may request that modifications to either the research project, the financial interest, or both take place in the form of a Conflict of Interest Management plan that is developed in consultation with the Dean's appointee to the FCOI Committee and the investigator. The Management plan is presented and agreed to by the Investigator, the Dean's appointee, and the University.
The information submitted by the Investigator in the FCOI disclosure report is treated with the utmost confidentiality to the extent permitted by applicable law and regulation. Access to such records at Villanova is limited to the Investigator, FCOI Committee members, and other University representatives who have a legal right or business need to review this information.
If the Investigator has Significant Financial Interests that are deemed to constitute a Financial Conflict of Interest and a COI management plan is developed, the plans are often required to be submitted to the federal sponsoring agencies. In particular, the National Institutes of Health (NIH) requires that such management plans be submitted in conjunction with the funded research project. The provisions of the management plan may require investigator disclosure of the conflict to collaborators, research staff, and in related published findings. Further, if the research project is funded by NIH or other PHS Awarding Agency, Villanova may have public reporting obligations as set forth by the sponsor's terms and conditions.
Similarly, where there is an instance of non-compliance that must be investigated due to failure to disclose one or more Significant Financial Interests or other violation of the applicable regulations, the results of such investigation may also need to be submitted to the federal sponsoring agency. In such instances, the FCOI Committee will let the Investigator know the information that is being submitted and the rationale for such disclosure, to the extent permitted by the regulations.
Lastly, this information may be requested pursuant to a valid and enforceable legal process. These requests are typically handled by the Office of the Vice President and General Counsel in accordance with established processes.
In addition to the Financial Conflicts of Interest in Research Policy, the University has various other policies and procedures addressing conflict of interest in different contexts. These include, but are not limited to, the following:
- Conflict of Interest and Business Ethics Policy- Applicable to all employees of the University, this policy addresses ethical conduct in the performance of University affairs and sets forth disclosure requirements for situations that may involve a conflict between employee personal interests and the interest of the University;
- Amended and Restated Policy Concerning Potential Conflicts of Interest - Trustees, officers, and other key employees of the University are required to report conflicts of interest on an ongoing basis and file an annual report with the University documenting such conflicts;
- Faculty Handbook policies address potential conflicts of interest that faculty members may encounter in their duties to the University and mechanism for avoiding and managing same;
- The University has implemented Procurement Standards aimed in part at preventing conflicts of interest that may arise in vendor relationships.
Separate and apart from financial conflict of interest in research disclosure requirements, all faculty members must also disclose (and in some cases receive prior approval for) outside professional activities in accordance with applicable policies, as these activities may interfere with their professional obligations to the university. Unlike FCOI in research, conflicts of commitment may not necessarily be financial in nature and examples may include:
- Teaching, research, or administration of a grant at (or a related affiliation with) an educational institution, organization, government agency, foundation, or other entity outside of the University;
- Employment outside of the University;
- Asusming a founding or co-founding role of a company;
- Assuming an executive or managerial position outside of the University.
As part of the U.S. Government's efforts to protect U.S. intellectual property and the integrity of federally funded research endeavors, major federal sponsors have issued clarification and new guidance regarding requirements for disclosing other support. This information is necessary to appropriately assess budget and scientific overlap with other sources of support and ensure investigators have time available to commit to federally funded awards.
Generally, at the time of proposal/Just in Time, the following information needs to be disclosed to the sponsoring agency:
- All Outside Appointments, including paid and unpaid, as well as honorary
- External (foreign and domestic) sources of support
- Externally (foreign and domestic) provided in-kind resources
Villanova University is committed to the pursuit of scientific progress to address a myriad of societal challenges that are by their nature borderless such as climate, access to natural resources, progress in the delivery of health and education outcomes, and countless others. To this end, Villanova University welcomes research faculty and students from around the world to engage in the creation, communication, and exchange of knowledge, and collaborative international research.
Over the past two years, numerous instances have arisen wherein foreign influence has resulted in grave risks to U.S. institutions of higher education through threats to the integrity of scientific research, violations of confidentiality requirements in the peer review process, theft of intellectual property, and espionage directed toward our national security. Because of these instances, federal sponsoring agencies have developed new guidance and directives on how best to address and mitigate these risks.
Villanova University is committed to compliance with the ethical and legal principles that underpin the integrity of scientific research. As we learn more about how risks of undue foreign influence can materialize in our institutions, we have set out to raise awareness of these issues so that we can continue to promote international collaborative research, with a full understanding of the risks, and the benefits, associated with these activities.
As it relates to both conflicts of interest in research and conflicts of commitment, and disclosures of other support to federal agencies, investigators and other key personnel can play a significant role in ensuring that Villanova University does not become yet another U.S. institution of higher education adversely impacted by undue foreign influence. Examples of how to proactively address undue foreign influence include:
- Ensure that the disclosure of Significant Financial Interests as required by the disclosure form, such as an ownership of interest in any corporate entity, includes all interests whether they are foreign or domestic.
- Ensure that travel related to the investigator's institutional responsibilities which is reimbursed by a foreign government or entity is always disclosed.
- Ensure that junior faculty members who are new to Villanova and to research are advised of the disclosure obligations that pertain to these foreign interests.
- Ensure that investigators and other key personnel follow the University's and their college's/school's specific disclosure requirements for conflicts of commitment.
- Ensure that the conflict of commitment disclosures conform with both the expectations and requirements of federal sponsoring agencies and U.S. laws governing international collaborative research. These disclosures should include commitments in time, whether paid or unpaid, such as:
- research efforts under an appointment or affiliation with a foreign institution or entity.
- support provided by a foreign entity or government in the form of non-monetary resources or in-kind support such as lab space, equipment, or supplies.
- an honorary, visiting, or adjunct appointment at a foreign university.
- selection to participate in a foreign talent program or similar type program.
Villanova University will continue to raise awareness and provide additional infromation that investigators may find helpful throughout the year. Please note that the Office of Grants & Contracts, Office of the Vice President and General Counsel, and University Compliance Office are available to assist investigators who may have questions regarding undue foreign influence.
Villanova investigators have access to a peer-reviewed training course covering Conflicts of Interest. This training may be found at www.citiprogram.org and is required of any individual completing a FCOI disclosure.
To add the training to your learner profile, login with your CITI username and password at the link above (or register as a new learner if needed). Navigate to the Main Menu at the bottom of the page and choose “Add a course” in order to add the Conflicts of Interest training course and complete the certification. The course should take about 30 minutes to complete.
In some cases, researchers may feel most comfortable having a way to report concerns anonymously, for example, in situations where violations of policies or standards may have occurred. Villanova provides an ethics and compliance hotline, EthicsPoint, through a company called Navex Global for these situations. With EthicsPoint, you can file a confidential, anonymous report via either the telephone or the Internet, and concerns will be shared with appropriate University personnel.
EthicsPoint is available via toll free number 1-855-236-1443 or at villanova.ethicspoint.com.
Questions regarding the ethics and compliance hotline can be referred to the University Compliance Office.