Research Conflict of Interest

Investigators must complete FCOI training prior to participating in sponsored projects and at least every four years thereafter. In addition, training on the university’s disclosure policy will be included in Research Security training and other relevant opportunities.

Investigators will be notified when their FCOI training requirement is due and must promptly complete it. Funds from new awards will be held until the training requirement has been met. See the university’s website for required research trainings for more information.

Investigators must complete FCOI training immediately (within 30 days or as outlined by the Director of the Research COI Program) in the following circumstances:

1. Upon hire, when an investigator is new to the university and is joining an ongoing sponsored project,
2. When the university finds that an investigator is out of compliance with the university’s FCOI policy or a sponsored project’s FCOI management plan, or
3. When the university revises its policy or procedures in a way that affects the requirements of investigators.

Investigators are responsible for promptly completing an electronic disclosure of additional activities and interests in the disclosure system as outlined in the university’s disclosure policy (No. 1045). The requirement to disclose must be met within 30 days of hire, annually as prescribed by the university, prior to engaging in any new activities, and within 30 days of discovering or acquiring a new SFI (see section 4, “Non-compliance”). Funds from new awards will be held until the disclosure requirement has been met by all investigators on the project.

These requirements focus on “significant financial interests”, which investigators will disclose on behalf of themselves and their immediate family members as a part of their disclosure to the university. SFIs include payments greater than or equal to $5,000 or any equity value held by the investigator or a member of their immediate family in the past 12 months from the disclosure date. See the SFI definition for more information. Note that investigators should resolve any doubt about disclosing in favor of disclosure.

An investigator may not serve as the principal investigator (PI) on both sides of a sponsored project if they hold a greater than 3% equity interest in the sponsoring entity. While an exception to this prohibition may be possible in certain limited instances, an exception is not possible when the PI proposes to serve on both sides of subaward/subcontract when they have a greater than 3% equity interest in the subrecipient. This arrangement must not be proposed in any sponsored projects. Otherwise, any exception to this prohibition must be approved by the department in advance of the proposal’s submission and by the Management Plan Advisory Committee once the sponsor approves and funding is received by the university. Due to these limitations, investigators contemplating similar arrangements are strongly encouraged to contact the Director of the Research Conflict of Interest Program during the proposal development stage.

The university must report to DOE when unmanageable conflicts of interest are proposed by the study team. Note that the university cannot manage a situation involving a PI on both sides of subaward/subcontract when the PI has a >3% equity interest in the sub. This arrangement cannot be proposed in this or any future sponsored projects.

Note that an investigator’s disclosures to the university do not alleviate their obligation to disclose to sponsors when proposing for or receiving funding. These disclosures allow sponsors to properly assess the capacity of the individual to carry out the proposed project and any potential overlap or duplication with other projects. Principal investigators and other senior/key personnel should review the guidance on OSP’s website, which outlines the current requirements for disclosing to federal sponsors.

Investigators on sponsored projects must disclose SFIs so that the university, through its designated university official, can identify and manage financial conflicts of interest to promote objectivity. The Director of the Research COI Program (or designee) is the designated university official responsible for making FCOI determinations for sponsored projects.

An FCOI assessment is a factual evaluation based on the existence of certain parameters that could lead to biased judgement. An FCOI is possible if the SFI held by the investigator or immediate family member is related to the sponsored project. An investigator's SFI is related to the sponsored project when the designated university official reasonably determines that the SFI could be affected by the project or is in an entity whose financial interest could be affected by the project. The designated university official may involve the investigator in their determination of whether an SFI is related to the sponsored project. An FCOI exists when the university, through its designated official, reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the sponsored project. If so, an FCOI exists and the designated university official must ensure that a plan to manage the SFI is developed and implemented to provide a reasonable expectation that the design, conduct, and reporting of the project will be free from bias resulting from an investigator’s financial conflict of interest.

All disclosed SFIs will be reviewed by the Director of the Research COI Program (or designee) who will ensure that a plan is put into place to promote objectivity, the FCOI is reported, and compliance is monitored as needed.

The MPAC is a standing committee of the university composed of faculty, administrative personnel, and ex-officio members convened as needed by the Director of the Research COI Program who serves as chair. The MPAC considers an investigator’s disclosure within the context of the project and provides recommendations to the program director for managing, reducing, or eliminating the FCOI. Committee members, appointed by the Senior Vice President for Research and Innovation for 3-year terms, must adhere to applicable rules of confidentiality pertaining to FCOI review as outlined to the member by the program director.

If the designated university official determines that an FCOI exists, they will develop a plan for managing the FCOI that must be adopted prior to the start of the project. Funding for the associated project will not be released until the management plan has been implemented and agreed to by the investigator and other relevant individuals as well as all necessary approvals for the Act being obtained (see section 3.8, “State Conflict of Interest Act - Exception Process for Sponsored Project Contracts”). If funding has already been released, it might be frozen until a management plan is agreed to by the investigator and other relevant individuals.

The designated university official will develop the management plan based on state and federal requirements and input from the MPAC, the investigator with an FCOI, and other relevant stakeholders, as needed. The management plan aims to mitigate the risk of bias, promote objectivity, and provide academic and professional protection for graduate students and postdoctoral scholars, respectively.

Mitigations will be based on a risk assessment of the FCOI scenario. Possible management plan components include, but are not limited to:

1. Disclosure of the SFI in publications and presentations of results from the project,
2. Disclosure of the SFI to project colleagues, postdoctoral scholars, and graduate students,
3. Recommendation to disclose the SFI to prospective research participants (subject to Institutional Review Board (IRB) consideration),
4. Appointment of an independent monitor to take appropriate measures, to the extent possible, to promote research objectivity, protect the academic progression of graduate students, protect the professional progression of postdoctoral scholars, and review project expenditures,
5. Modification of the project plan or personnel roles to promote objectivity, and
6. Reduction or elimination of the SFI.

As described in the plan, investigators are responsible for contacting the Research COI Program within 30 days when changes to the management plan are needed (for example, when graduate students are being added to the project when there was no graduate student involvement anticipated when the plan was initially put into place).

Investigators are responsible for accuracy, honesty, and transparency regarding their external activities and financial interests in all matters, regardless of the additional disclosure strategies instituted by the university in management plans. This includes but is not limited to disclosing completely and accurately in accordance with the disclosure requirements of journals, conferences, professional associations, and government agencies.

Once the management plan has been implemented and agreed to by the investigator as well as all necessary approvals for the Act being obtained (see section 3.8, “State Conflict of Interest Act - Exception Process for Sponsored Project Contracts”), the designated university official will report the FCOI determination and the agreed upon management plan to the following, as appropriate:

1. OSP/the sponsor,
2. The Human Research Protection Program (HRPP) or Animal Care and Use Program (ACUP) for review by the IRB or Institutional Animal Care and Use Committee (IACUC), respectively,
3. The external IRB serving as the IRB of record for the research, and
4. The FCOI point of contact at Carilion Clinic or Children’s National Hospital if the investigator is primarily appointed there.

The Research COI Program will notify OSP that the contract may be executed and funding may be distributed, and the project may begin. PHS exempts Phase I SBIR/STTR Programs from the FCOI reporting requirement. Otherwise, the policy of the Public Health Service (PHS) requires FCOI reporting through eRA Commons. The Department of Energy (DOE) requires reporting of any FCOI that cannot be eliminated or appropriately managed, and any FCOI with foreign governments or their instrumentalities. DOE may also tailor reporting requirements on a per-contract basis. The policies of the National Science Foundation (NSF) and the National Aeronautics and Space Administration (NASA) require FCOI reporting only if the university finds that it is unable to satisfactorily manage an FCOI or if the university determines that an NSF- or NASA-funded project will proceed without an FCOI management plan.

The university must apply relevant FCOI requirements of the originating sponsor to subrecipients. For FCOI reports for subrecipients on federally sponsored projects, see section 3.10.1, “Subrecipients.”

The university monitors compliance with FCOI management plans on an ongoing basis. The investigator and individuals engaged in oversight must periodically provide an update on the fulfillment of the management plan’s terms upon request of the Research COI Program. While the investigator with an FCOI is primarily responsible for complying with the management plan, the investigator’s department head and others asked to participate in oversight must follow the plan and monitor compliance as described in the plan.

If the university finds the investigator is not in compliance with their management plan, the investigator is responsible for complying with all corrective actions, enforcement mechanisms, and sanctions imposed by the university (see section 4, “Non-compliance”).

As an agency of the Commonwealth of Virginia, all university employees are subject to the Code of Virginia’s “State and Local Government Conflict of Interests Act” (or “the Act”). The Act prohibits employees from having a personal interest in a university contract, other than their own employment contract. This prohibition applies if the employee receives more than $5,000 in payments from or holds more than 3% equity interest in the entity, even if the person is not a signatory of the contract.

Employees will disclose personal interests as a part of their disclosure to the university, consistent with the university’s disclosure policy (No. 1045). Once an employee discloses their personal interest in a sponsored project contract, the Director of the Research COI Program will determine whether an exception under the Act is available and assist the employee in applying for the approvals needed to qualify for an available exception.

The usual exception process for sponsored project contracts is found in the Act at Section § 2.2-3106 C. 8. An exception for a prohibited conflict of interest in a sponsored project contract is often possible if the following criteria are met:

1. The contract involves research and development and/or commercialization of intellectual property (which includes SBIR/STTR subawards),
2. The employee’s personal interest has been disclosed in the university’s disclosure system, and the required approvals have been received prior to the university entering into a contract with the entity,
3. A management plan is agreed to by the employee, which includes the conditions of the state law exception that must be addressed by the conflicted employee, and
4. The employee promptly files a disclosure statement (called the Statement of Economic Interests) initially and annually thereafter as instructed by the Commonwealth of Virginia until all relevant sponsored project contracts close.

Following the President’s approval, the Research Conflict of Interest Program will notify Human Resources, who will contact the conflicted employee regarding the initial disclosure statement required by the Act. The conflicted employee is responsible for following all requirements of the state law exception process as outlined in their management plan and § 2.2-3106 C. 8. See section 5, “Definitions”, for more information about a “personal interest in a contract.”

Investigators must comply with the university’s disclosure policy (No. 1045) and all related policies, as applicable, like the university’s policies for gifts. Note that gifts or donations of any kind, including equipment, must go through the proper channels and never to the employee directly, consistent with the university’s policies (No. 12110, 12115).

Investigators may only use the university’s facilities and resources for university business (Statement of Business Conduct Standards). Use of the university’s facilities or resources on behalf of an external entity is not permitted unless the university is performing the scope of work authorized through an award or subaward that is fully executed before work begins. Only the documented scope of work is authorized to be performed using the university’s facilities and resources.

The requirements in this section are for the designated university official. This section applies to federally sponsored projects (as indicated) and sponsoring entities that are adherent to the federal FCOI regulations.

The designated university official is required to submit FCOI reports of investigators, consistent with section 3.6, “FCOI Reporting.” The official must submit FCOI reports to the direct sponsor if the university is a subrecipient on a federally sponsored project. The designated university official must also submit FCOI reports of collaborating investigators from subrecipient institutions to the sponsor, consistent with the sponsor’s requirements and section 3.10.1, “Subrecipients.”

The designated university official must maintain records related to SFI disclosure and FCOI management for a minimum of 3 years after final expenditures reporting. As per PHS regulations, under certain criteria, the designated university official will make available to a requestor within 5 business days of a request required information about an FCOI held by an investigator on a PHS-funded project.

During an ongoing PHS-funded project, when an investigator who is new to participating in the project or an existing investigator discloses a new SFI to the university, the SFI will be reviewed within 60 days by the designated university official to determine whether an FCOI exists and, if so, a management plan will be implemented on at least an interim basis. The designated university official will submit an FCOI report to OSP/the sponsor within 60 days of identifying an FCOI for an added investigator or a new FCOI for an existing investigator.

In cases of PHS non-compliance, when the designated university official identifies an SFI that was not disclosed, identified, reviewed, or managed in a timely manner, the official will review and determine whether the SFI is a financial conflict of interest and, if so, the FCOI must be reported to PHS within 60 days. The official will implement, on at least an interim basis, a management plan specifying the actions that have been, and will be, taken to manage the FCOI going forward. Within 120 days of the non-compliance determination, the university will complete and document a retrospective review to determine whether any PHS-funded project conducted during the time period of the non-compliance was biased in the design, conduct, or reporting of such project. The designated university official will enlist an independent individual to assist in making this assessment. If bias is found, the PHS awarding component will be notified promptly and a mitigation report will be submitted by the designated university official. Based on the results of the retrospective review, if appropriate, the official will update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. Phase I SBIR/STTR Programs are exempt from this process.

For DOE-funded projects requiring FCOI reporting, the designated university official must disclose clearly and explicitly in the application to DOE when applying for funding; report to DOE prior to a new investigator participating in the project after the time of application; and provide DOE with an annual FCOI report for the duration of the project period.

In cases of DOE non-compliance, the university must promptly notify DOE in writing when it becomes aware that an investigator failed to comply with the university’s disclosure policy or management plan and include the corrective action taken or to be taken.