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fCOI Main > Roles and Responsibilities of the financial Conflict of Interest Committee

Roles and Responsibilities of the financial Conflict of Interest Committee

Letter of Introduction from the fCOI Committee Chair and Vice Provost for Research

Roles Included:

  • financial Conflict of Interest Committee (fCOIC) also Committee
  • fCOIC Chair (Chair)
  • fCOI Administrators

Committee Membership: The fCOIC 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 contract colleges. The Committee also includes, in a non-voting status, university administrators, including representatives from the Office of Research Integrity and Assurance, Office of Sponsored Programs, Cornell Center for Technology, Enterprise and Commercialization, and the Office of University Counsel. The SVPR appoints one of the voting members to serve as chair of the fCOIC. Member terms are usually 3 years, although the terms can vary based on the individual circumstances of each member and as agreed upon between the member and the SVPR.

Committee Responsibilities: The fCOIC is responsible for ensuring that all real or apparent financial conflicts of interest are identified and managed. Supported by the fCOI Administrators, the fCOIC reviews reported information, requests additional material as needed, identifies real or apparent financial conflicts of interest, devises an appropriate plan to manage the conflict, communicates the plan to the research personnel and monitors compliance with the plan. The fCOIC may consult with Unit heads and others as appropriate. In cases where the reporter appeals the fCOIC decision and management plan to the SVPR, the committee reviews the appeals and any appeal recommendations from the SVPR and issues binding and final decisions on the appeals. Where needed, the committee participates in the investigation of cases of potential non-compliance and reports findings in accordance with policies and regulations.

Members of the fCOIC will participate in the review and approval of the draft policies, procedures and management plans proposed by the fCOI Administrators.

Information and written materials provided to the fCOIC and its administrators are shared to the most limited degree possible with those committee members and staff who are involved in the processing and review of reported information and the creation and implementation of management plans and others on a need-to-know basis.

Chair Responsibilities: The primary responsibilities of the fCOIC Chair are to ensure that the committee decisions are in line with the University policies and guidelines for management of external commitments and financial interests of Cornell researchers, and to establish an environment of communication, open dialogue and effective resolution of issues under discussion by the committee. As a member of the fCOIC, the Chair will review some fCOI disclosures and contribute to the development of management plans to effectively address the real or apparent conflict. Although the compliance related subject matter expertise on COI will be provided by the fCOI Administrators, the Chair is expected to be broadly familiar with the policy requirements, so that s/he can effectively advise and guide the committee regarding the fCOI management process. In cases where the nature of the external relationship or the conflict is unclear, or the terms of the management plan are contested by the reporter, the Chair may be required to dialogue with the reporter and his/her leadership to attempt to arrive at a mutually acceptable resolution. The Chair may be consulted by the SVPR when identifying new members to the fCOIC, or changes to the membership as deemed appropriate. While training activities and materials will be developed and coordinated by the fCOI Administrators, the Chair will participate in the training and orientation of newly appointed committee members.

fCOI Administrator Responsibilities: fCOI Administrators provide administrative and tactical support to the fCOI function and the fCOIC in the following ways.

Compliance Support:

  • Serve as Subject Matter Experts and advise reporters, members of the fCOIC on fCOI related policies, regulations, guidelines and best practices;
  • Train and provide continuing education to the fCOIC members and general research population in the identification and management of financial conflicts of interest, including related university policies and procedures and federal regulations, either directly or through external consultants;
  • Draft for the consideration, review and approval by the fCOIC operating principles, procedures and sample management plans for common Conflict of Interest situations at Cornell;
  • As required, or when requested by the fCOIC, research and provide input on alternative approaches to Conflict Management, and engage outside expertise as needed to help resolve concerns;
  • Stay current with developments in the regulatory environment, assess their applicability to the Cornell Ithaca campus, and advise the fCOIC of impacts;
  • In accordance with required regulations and best practices, work closely with the fCOIC and the SVPR, to implement any required or recommended changes to the reporting and management of disclosures.

Committee Support:

  • Coordinate the reporting, collection, review, resolution and communication regarding annual and event-based reports of external commitments and financial interests;
  • Assist and advise reporters regarding Cornell policy considerations and regulatory requirements;
  • Conduct preliminary reviews of reports to ensure completeness and obtain additional information or clarifications from the reporter or other individuals as needed;
  • Conduct an initial screening of reports to determine whether they are exempt from review, eligible for expedited review, or require full committee review;
  • Exempt from fCOIC review reports that do not present a significant financial conflict of interest related to research;
  • Facilitate an expedited review of reports that pose real or apparent financial conflicts of interest that can be easily addressed by standard management plan measures;
  • Determine the applicable Cornell policy and regulatory requirements in relation to the report, make an initial recommendation and draft initial management plans for further review by the fCOIC;
  • In cases of appeal, coordinate the process of submission, review and resolution of appeals.

Administrative Support:

  • Maintain documentation of all committee deliberations and decisions;
  • Conduct any follow up required by the fCOIC in regard to a report or management plan;
  • Serve as the primary liaison between the committee and reporters, and facilitate discussions between the reporter, the fCOIC and others as deemed necessary by the fCOIC;
  • Report to external agencies those conflicts that require such reporting;
  • Maintain and update the e-COI report management system to ensure that it meets the policy and regulatory functional and committee needs; and
  • Manage the tracking and disposition of Unit COC and NRR COI reviews.

fCOI Main > Roles and Responsibilities of the financial Conflict of Interest Committee