What to Disclose

Significant Financial Interests need to be disclosed if related to your Institutional Responsibilities.

      According to 42 CFR Part 50 (Subpart F, §50.603): A significant financial interest:

Consists of one or more of the following financial interests of the Discloser (and of the Discloser's spouse and dependent children) that reasonably appears to be related to the Discloser's institutional responsibilities:

1. 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;
2. 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 dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);
3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests (Note the exception found in the "Exceptions” section below).

Definitions

Conflict of Interest is a situation in which outside financial interests or other personal considerations may compromise or have the appearance of compromising an employee's actions or judgments in the administration, management, or performance of their professional activities. For researchers at UNMHSC, the definition is more specific as it refers to a situation in which outside financial interests may compromise, or have the appearance of compromising, a researcher's professional actions or judgments in the design, conduct, or reporting of their research results.

Financial Interest is anything of monetary value, including a fiduciary relationship with an outside entity. Financial interests are the most important component or components of a conflict of interest for researchers.

Institutional responsibilities mean an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on financial conflicts of interest, which may include for example: activities such as research, research consultation, teaching, professional and clinical practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Immediate Family Member is defined as limited to the individual, spouse or dependent children.

Clarifications

Speaking Engagement: There is an important distinction for compensation related to speaking for a pharmaceutical company in which the talk is educational or whether it is a marketing engagement (similar to speaker’s bureaus). In order to assure that the talk is for educational purposes, a professional service agreement (PSA) for the talk must be executed through HSC Preaward.

Participation in speaking or educational activities where content is controlled by pharmaceutical, biotechnology, medical device, or other for-profit entities is prohibited (i.e., outside entities may not require specific content or materials or have any approval rights over content or materials).

In order to protect the integrity of UNMHSC research and clinical practice, endorsement of products or commercial ventures is prohibited.

Income from seminars, lectures, or teaching engagements for educational purposes sponsored by a Federal, state, or local government agency, or an Institution of higher education, including academic teaching hospitals do not need to be disclosed.

Additionally, all speaking engagements must comply with the “Health Sciences Center Conflicts of Interest in Research Policy on Participation in Vendor-Sponsored Events.” 

Consulting and Advisory Engagements: The nature of the service that you may perform on behalf of an external entity as a consultant or adviser is the provision of advice and the exchange of ideas.

UNM-HSC encourages these relationships for their contributions to research, education, technological advancement, and professional development. UNM-HSC members must be cautious, however, to prevent unresolved conflicts of interest in these relationships that might undermine the credibility of their work or damage their reputation.

Involvement in consulting or advisory activities (including scientific advisory boards) related to your Institutional Responsibilities, whether compensated or non-compensated, is permitted. Consulting agreements between faculty and an outside entity must not confer any intellectual property rights or rights to research conducted at UNM.

Income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education, including an affiliated academic teaching hospital, medical center, or research institute does not need to be disclosed.

As guidance, here are a few examples of relationships that need to be disclosed:

• Consulting or advising sponsors of research, vendors, or other organizations that fund research and/or supply products used in research/clinical practice at UNM,
• Consulting or advising vendors that supply products used in research/clinical practice at UNM,

The following do NOT need to be disclosed:

• Consulting for a private company that is unrelated to your research or make products not used in your clinical practice or specialty,
• Consulting for federal, state, or local government agencies, or other non-profit institutions of higher education,

Executive Officer Roles: You must disclose any executive officer roles (e.g., Chief Executive Officer [CEO], Chief Operating Officer [COO], Chief Scientific Officer [CSO], or Chief Financial Officer [CFO]) in external for-profit companies that do business with UNM-HSC or are related to UNM-HSC’s mission while concurrently holding your UNM-HSC position and have it evaluated by the COI Office. Full-time faculty members and researchers must be mindful of their obligation to devote their primary professional efforts and allegiance to UNM-HSC.

Executive officer roles for which there is a professional services agreement through UNM do not need to be disclosed.

Board of Directors Positions: The UNM conflict of interest policy does not prohibit faculty from serving on a board of directors, but these positions must be declared. Where such outside activities are related to the faculty member's research, education, or clinical duties, being an officer or being paid in any way may represent an unmanageable conflict of interest, for instance, if that company is sponsoring your research or has licensed the technology.

Participation on a board of directors of university-affiliated companies that are part of job duties (for example, UNM research park companies) do not need to be disclosed, nor does participation on the board of directors of non-profit charitable organizations in which no financial remuneration is received.

Non-Paid Positions: Non-Paid positions that are related to your Institutional responsibilities are required to be reported, as potential conflicts of interest are not limited to financial interests. These will include but are not limited to positions such as being a board member or an advisory or review panel member. Any activity that is non-paid and has no relation to your institutional responsibilities does not need to be disclosed.

Sponsored Travel: Any reimbursed or sponsored travel related to your institutional responsibilities must be disclosed. Sponsored travel means 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. However, 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, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

Intellectual Property: Intellectual property rights and interests (e.g., patents, copyrights) must be disclosed upon receipt of income related to such rights and interests, as required by federal regulation. This requirement does not include intellectual property rights assigned to UNM or to UNM Rainforest (the University’s technology transfer unit) and agreements to share in royalties related to such rights (e.g., through licensing, royalty, or other intellectual property agreements).

Other situations may exist in which a person may have a potential or actual conflict of interest.

Exclusions

The following exclusions apply to payments or ownership to you or members of your immediate family. These excluded items need not be disclosed:

1. Outside interests that do not relate to your institutional responsibilities or the University’s educational, research, service, or other missions. For example, if you own/manage a rental property and it does not relate to your institutional responsibilities, this does not need to be disclosed.
2. Salary, royalties, or other remuneration paid by UNM to the investigator if the investigator is employed or appointed by UNM.
3. Payments by or ownership in the employer(s) of an immediate family member, unless that employer is a competitor of this institution or a vendor or supplier of goods or services to this institution. For example, if your spouse is employed by or owns a local dry-cleaning company, there is no need to disclose this (unless they have a contract with this institution that is related to your institutional responsibilities).
4. Payments by or ownership in a company that is unrelated to your institutional responsibilities. For example, payment from or equity in a company owning a chain of fast food restaurants would generally not need to be reported. In contrast, a company selling medical devices or video conferencing equipment would need to be reported if either appear related to your institutional responsibilities.
5. Any ownership in mutual funds, blind trusts, ETFs or retirement accounts in which you do not directly control the investment decisions. Other investments do not need to be reported, unless they related to a contract or regulatory approval you may have as faculty member.