Conflict of Interest

Significant financial interests

(i) Publicly Traded-Entities - With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value. (ii) Privately Held Entities - With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or domestic partner and dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest). (iii) Intellectual Property - Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests. (iv) Travel Reimbursements - Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Institutional Responsibilities in the twelve months preceding the disclosure; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. With respect to human subjects research, the term "Significant Financial Interest" shall include cases involving any amount of remuneration and any equity ownership.

COI

A conflict of interest is a set of circumstances that creates the risk that one's professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest.

Frequency of Outside Activity Reporting for Faculty and Staff

An annual disclosure is required from all UMass Lowell personnel regarding outside activities as defined in Trustee Policy T96-047. There are separate forms for faculty and staff:

Examples of outside activity resulting in FCOI

Consulting, Textbook/Software sales (file Textbook Disclosure Form), Teaching for other Institutions, Advisory Boards/Review Panels, Professional Certification/Licensure, and Others (Income from patent, working for a company part time).

FCOI

Financial conflict of interest policy- "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors" issued at 42 CFR Part 50, Subpart F (the "FCOI Regulations").

Examples of conditions and restrictions for managing FCOI (associated with projects)

For all management plans, examples of conditions or restrictions that might be imposed to manage conflicts of interest include, but are not limited to: (1) public disclosure of significant financial interests; (2) appointment of independent monitor(s) capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest; (3) modification of the research plan; (4) change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research; (5) reduction or elimination of the financial interest (e.g., sale of an equity interest); or (6) severance of relationships that create financial conflicts. Additional conditions and restrictions (including a lower threshold for review) shall apply to cases involving human subjects as provided for under the Human Subjects Guidelines.

FCOI Disclosure Forms for Sponsored Research

Initial - Faculty investigators are required to submit a Summary FCOI Disclosure Form for for each proposal submission for sponsored research. The disclosure form is initiated by and sent to the researcher(s) from ORA. Additional forms may be necessary, depending on the nature of the research and collaborations. Online training is also required for PHS and affiliated agencies. Training is available on the CITI Program website. Annual - Disclosures must be updated annually for awarded activities. For researchers who have a FCOI disclosure to file, a detailed disclosure must be completed for review. Other forms for sponsored research include: Summary Financial Conflict of Interest Disclosure Form for All Sponsored Research Investigator's Detailed Financial Interest Disclosure Subrecipient Commitment Form Non-UML PHS Individual Investigator Disclosure of Financial Interests

Conflict management process at Umass Lowell

Management of Potential Conflicts • If it is determined that you may be conflicted, the Director of Institutional Compliance will work with you to gather the facts in order to present the case to the UMass Lowell Conflicts Committee for review and a suggested management plan. • The VCRI (Vice Chancellor for research and innovation) oversees the UMass Lowell Conflicts Committee and represents the campus, with an appointed faculty member, on the system-wide committee. • The Campus Conflicts Committee reviews and recommends a proposed management plan that is submitted to the System-wide Conflicts Committee for a final management plan. • The System-wide Conflicts Committee sends a letter to the faculty/employee for their signature and agreement to the plan. • If applicable, the Director of OIC and/or a campus oversight committee is assigned to assist in oversight of the management plan.

Significant FCOI threshold values:

PHS (including NIH) Agency (Significant Financial Interest threshold is $5,000) Other Federal Agency (Significant Financial Interest threshold is $1,000 for Clinical research and $10,000 for Non-Clinical research) External Funding, Non-Federal(Significant Financial Interest threshold is $10,000)

Detailed FCOI review process

The Office of Institutional Compliance will review the Investigator's Detailed Disclosure Form to ensure completeness and consistency with prior disclosures. The form, along with any supporting documentation, shall be forwarded to the UMass Lowell Conflict of Interest Committee for review as necessary. The Committee will consider whether any of the disclosed Significant Financial Interests of the Investigator is related to the project and whether the financial interest could directly and significantly affect the design, conduct or reporting of the project. If the campus committee determines that there is a financial conflict of interest, it will draft a proposed management plan for the Vice Chancellor of Research and Innovation to present at the Systemwide Conflicts Committee. Following are examples of when an Investigator have a financial conflict of interest (FCOI): (i) if the Investigator (together with his/her spouse or domestic partner and dependent children) has a significant financial interest in an entity that could be affected by the research results from a proposed PHS-funded contract based on an analysis of the scope and subject matter of the proposed project described in the application, or (ii) if the Investigator (together with his/her spouse or domestic partner and dependent children) has a significant financial interest in an entity that licenses technology from the University which has resulted in license income and that technology is the subject of a proposed PHS-funded award. The designated institutional official(s) may consult with all appropriate institutional and governmental officials to evaluate the potential COI.

NOT Significant Financial Interest

The term "Significant Financial Interest" does not include: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights;income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

What are "Institutional Responsibilities" of a PI?

This refers to a PI's professional responsibilities on behalf of the Institution, including activities such as research, teaching, clinical or other professional practice, academic activities, scholarly events, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards