Non-Compliance with COI Policy

What happens if you don't meet COI-related deadlines or comply with other requests from the FCOI Committee or the Vice Provost for Research?

Compliance with university policies is expected of all Cornell personnelfaculty, staff and students. Principle 11 of University Financial Conflict of Interest Related to Research Policy 1.7 details that persons subject to the policy must report on time and comply with any plans developed to manage their real or apparent financial conflicts of interest. Sanctions are imposed when people do not report as required or fail to comply with management plans.

The FCOI committee and the Vice Provost for Research are responsible for taking actions to address violations of University Policy 1.7. In addition, sponsors and government agencies may take actions they deem appropriate with respect to research they sponsor or regulate.

Types of Non-compliance

Failure to disclose outside interests to Cornell accurately, completely, or on time

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Academic personnel and others who must complete a COI report are required to disclose their outside interests once a year, during the annual disclosure cycle that typically runs from mid-April to mid-May, and throughout the year when their outside financial interests change. More information on the disclosure process is available at: COI Reporting: When and What.

  • Failure to report during the annual cycle
    There is a strict deadline for reporting, which is communicated throughout the annual cycle via email. Failure to meet this deadline could result in a number of sanctions (see below).
  • Failure to disclose changes to outside relationships throughout the year
    Throughout the course of the year, if external commitments and financial interests materially change, academic personnel must update their COI report in a timely fashion.
  • Examples of other disclosure-related non-compliance
    • Providing incorrect, incomplete or misleading disclosures of outside interests
    • Engaging in outside activities that are not allowed by the University (see Cornell Policy 4.14)

Failure to comply with a conflict management plan

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When the Cornell FCOI Committee implements a plan for managing a conflict, the investigator must fulfill all terms of the plan.  Some examples of violating the terms of the plan include:

  • Not making required disclosures to individuals, sponsors, or in publications/presentations;
  • Using Cornell space, funds, name, personnel or other resources to support outside interests;
  • Involving their Cornell students or staff in their work with the external entity;
  • Accepting restrictions on the design, conduct or reporting of Cornell research to benefit an outside financial interest;
  • Failing to submit an annual compliance checklist to the COI office.

Consequences for Non-compliance

Violations of the COI policy threaten the integrity of Cornell research, inhibit academic freedom and open dissemination of research results, and adversely affect Cornell’s ability to seek and maintain research funding. Given these severe repercussions, noncompliance with COI policy must be handled swiftly and firmly.

Examples of general corrective actions

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  • Requiring that retrospective disclosures be made;
  • Withholding research funds and freezing expenditures;
  • Preventing the investigator from participating in research until the non-compliance is addressed;
  • More intense monitoring of compliance with the conflict management plan, such as: financial reviews; appointing a Co-PI; requiring a data monitoring plan; reviewing publications to ensure that proper disclosures are made; meeting with students and staff; reports to the COI committee;
  • Requiring training in COI;
  • In serious or repeated cases of non-compliance, the committee may require that the conflict of interest be eliminated. In this case, either the investigator must withdraw from their relationship with the outside entity, or they must no longer engage in related Cornell research.

Potential sanctions for failure to report during the annual cycle

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  • Non-compliant individuals cannot be named as a PI, Co-PI or Key Personnel on any new proposal submitted or new award received, or on any research protocols (IRB, IACUC, IBC). Colleges and Grant & Contract Officers (OSP, CVM, CALS) will not submit any proposals, and OSP will not accept any awards until the non-compliant individual produces evidence of their compliant status or is removed from the proposal or award.
  • In cases where a non-compliant individual is the Principal Investigator (PI) on an active award, the individual’s department and college will identify an alternate PI and request approval from the funding agency for the proposed change. If approval is not granted, the award will be terminated and any resulting costs will be covered by the original PI’s discretionary funds, and then department or college funds, if needed.
  • Any salary or stipend of the non-compliant individual that is being charged to a sponsored award may be stopped for the entire period that the individual is non-compliant, and for the period of time that it takes the COI Committee to review and act on any possible management plan actions. Only non-sponsored funds may be used to cover the salary or stipend during that time, and retroactive salary charges to a sponsored award will not be allowed.
  • If the individual is key personnel on a PHS-funded award, the non-compliance will be reported to the funding agency.
  • Non-compliant individuals will not be eligible to enter into technology transfer agreements.
  • Future annual salary increases will not be paid for the pay periods during which the individual remains non-compliant. Unpaid amounts will not be reimbursed.
  • If the individual has a temporary assignment at Cornell, such as a Visitor, Adjunct or Courtesy appointment, that appointment will be terminated.

Note: Any suspension of research activities and associated salary will be undertaken in accordance with the applicable university policies and codes.

Examples of PHS (NIH)-related Sanctions

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For projects funded by the NIH or another PHS agency, violation of COI policy comes with other severe consequences. Some of these actions include:

  • Cornell must report non-compliance to NIH within 30 days of when the University becomes aware of an issue. The report must include specific information, including the name of the individual, the nature of the conflict and the non-compliance, and the steps Cornell has taken and will take to address the problem. NIH may respond with additional requirements.
  • Reports may be made available to the public.

Appeals

Investigators may appeal actions taken by the COI committee concerning non-compliance. When the COI committee has voted to implement a corrective action, the committee’s decision is final. Although the Vice Provost for Research (VPR) may request that the committee reconsider its decision, s/he may not override the decision. Note that units within the University or central administration may take additional steps to address violations of COI policy.

Any investigator who has failed to comply with COI policies should seek guidance from the COI office.