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Financial Conflict of Interest in Research

WHAT TO DISCLOSE

What do you disclose?

  • All research or research activities in which the investigator is engaged;
  • Any financial interest related to research or research activities held by the investigator or a covered family member of the investigator;
  • The total amount of salary or other payments received from the performance of research or research activities in the preceding 12 months, in rounded, whole dollar amounts;
  • A description and the value of any equity interest (e.g., stock, stock options, or other ownership interest or entitlement to such an interest) related to research or research activities rounded, whole dollar amounts by reference to public prices or other reasonable measures of fair market value;
  • A description and the value of any intellectual property or royalty interests related to research or research activities in rounded, whole dollar amounts;
  • The source of any SFI, including the source’s name and principal address; and
  • For each occurrence of reimbursed or sponsored travel, the purpose of the trip, the identity of the sponsor/organizer, the destination and the duration of the trip. Texas A&M-San Antonio, at its discretion, may require an investigator to disclose additional information in order to determine whether the travel at issue constitutes a FCOI.

What is considered an SFI?

A financial interest, including but not limited to one or more of the following interests of the investigator (and those of the investigator’s covered family members) that reasonably appears to be related to the investigator’s institutional responsibilities:

  1. With regard to any publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the 12 months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated for the investigator and members of his/her immediate family, 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, an SFI exists if the value of any remuneration received from the entity in the 12 months preceding the disclosure (when aggregated for the investigator and members of his/her immediate family) exceeds $5,000, or when the investigator (or the investigator’s immediate family) holds any equity interest (e.g., stock, stock option, or other ownership interest);
  3. Intellectual property and royalty interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests;
  4. The occurrence of any reimbursed or sponsored travel related to their institutional responsibilities (including that which is paid on behalf of the investigator but not reimbursed to the investigator so that the exact monetary value may not be readily available); provided, however, that this does not include travel that is reimbursed or sponsored
  5. Gifts, when the value of a single gift received by the investigator or a covered family member in the preceding 12 months exceeds $250, or when the aggregated value of multiple gifts received from a single entity within the preceding 12 months exceeds $250, excluding gifts received from a covered family member; or
  6. Any fiduciary position held by an investigator or a covered family member in a for-profit or nonprofit entity in the preceding 12 months, including a position as a member of the board of directors, an officer, or other executive or management position, for which the investigator or covered family member received any form of remuneration or reimbursement for expenses.

What is NOT considered an SFI?

SFI does NOT include:

  1. Salary, royalties, or other remuneration paid by Texas A&M-San Antonio to the investigator if the investigator is currently employed or otherwise appointed by the university;
  2. Intellectual property rights assigned to the TAMU system or its members and agreements to share in royalties related to such rights;
  3. 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;
  4. Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency or an institution of higher education as defined by 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;
  5. Income from service on advisory committees or review panels for a federal, state, or local government agency, or an institution of higher education as defined by 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;
  6. Travel reimbursed or sponsored by a federal, state, or local government agency, or an institution of higher education as defined by 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.

How do you know if your SFI is related to your Institutional Responsibilities?

Investigators must disclose those SFIs that “reasonably appear to be related” to the Investigator's institutional responsibilities.

Each Investigator can make a reasonable, good-faith determination about whether any given SFI is related to their institutional responsibilities, rather than simply disclosing everything. They need to ask whether, to the best of their knowledge, the research or other institutional responsibilities that they have could affect the value of the financial interest or could have a financial impact on the entity in which they hold the financial interest (even if only in the future). In general, income received from consulting or speaking on behalf of an entity is always related because the investigator has been retained as a consultant based on their overall expertise in the field. In addition, if an entity in which a SFI is held is involved in the same research project (e.g., via a subcontract), then it is always related to the investigator's institutional responsibilities.

What are some examples of projects related to SFI?

Some examples include:

  1. You are a paid consultant to COI, Inc., which also subcontracts a portion of a research project to your lab at the University.
  2. You are a paid consultant to COI, Inc., and you subcontract a portion of your research project back to COI, Inc.
  3. You are a paid speaker for COI, Inc. and also the PI of a research project funded by COI, Inc.
  4. COI, Inc. has paid for your travel. You also conduct research at the University that is likely to develop intellectual property that you know would be of interest to COI, Inc.
  5. You own stock in COI, Inc. and COI, Inc. provides cost-sharing on an award in your lab at Texas A&M- San Antonio.

You received an honorarium or other payments from another University. Does that need to be disclosed?

No. Income from a federal, state, or local government agency, or an institution of higher education as defined by 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, is not included in SFI and does not need to be disclosed. However, honoraria or payments from foreign institutions MUST be disclosed.

You own equity interest in a company. Should you disclose that?

Yes. You must determine and disclose the percentage of equity ownership held in the company. If the percentage is unknown, determine and disclose the number of stock/stock warrants/options held.

Does income from a federal agency need to be disclosed?

No. Income from a federal, state, or local government agency, or an institution of higher education as defined by 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, is not included in SFI and does not need to be disclosed. However, payments from foreign institutions MUST be disclosed.

Does income from professional societies need to be disclosed?

Yes. Professional societies are non-profit organizations, and travel and income paid from them must be disclosed.

If you sit on an editorial board, does your income from the journal need to be disclosed?

This depends on whether the journal is a private organization or if it is published by a U.S. government agency or a U.S. institution of higher education. Follow the same guidelines as for other income.

You receive royalties and licensing income from a patent owned by Texas A&M University. Does it need to be disclosed?

No. Royalties or other remuneration received from the Texas A&M System are excluded from the definition of SFI and does not need to be disclosed.

Should you disclose mutual funds and other investments?

Investments such as mutual funds, in which an investigator does not have control over the individual securities held, are excluded from SFI and do not need to be disclosed. If you own other investments (i.e. stock in an individual corporation), even if held in a retirement account, and those investments can be bought or sold at your discretion, you will need to evaluate each such investment in order to determine whether it is reasonably related to your institutional responsibilities.

If someone from a business comes to campus and takes you to lunch to discuss your research. Do you need to disclose that?

The lunch would be considered a gift and could be disclosed if, in aggregate with other compensation or any equity in the company, you exceed the $5,000 income threshold for the past 12 months. However, if the lunch (gift) is the only financial interest you have in the company, then it would not need to be disclosed. Please note that this is not a travel expense as the lunch occurred locally. Also, if you receive meals while travelling, you would not be required to disclose them specifically, but they could be included in the total expense of the trip if you know the expense.

Does income as an expert witness need to be disclosed?

Income from service as an expert witness should be disclosed if it relates to your institutional responsibilities. If the work you perform as an expert witness is based on your general expertise but does not relate directly to specific work that you perform at the University, the compensation does not need to be disclosed. However, if the work you perform as an expert witness does directly relate to a specific research project(s) or to other activities you are involved in, such as purchasing decisions, then you should disclose your expert witness compensation.

Do you need to disclose the amounts you received for travel?

Yes. The revised federal regulation does not provide a minimum threshold for the disclosure of reimbursed or sponsored travel. The occurrence of any reimbursed or sponsored travel related to the investigator’s institutional responsibilities must be disclosed, UNLESS the reimbursed or sponsored travel is by a federal, state, or local government agency, or an institution of higher education as defined by 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 travel does not need to be disclosed?

You do not need to disclose travel that is sponsored or reimbursed by a federal, state, or local government agency, or an institution of higher education as defined by 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 details should you disclose for travel?

You should disclose the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.

In addition, all International travel must require Export Control clearance.

What if you do not know the cost of the trip?

The actual cost of a trip is not required information in your disclosure of sponsored or reimbursed travel. The only required information is the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Cost is an optional entry if you have the information available. Many investigators receive travel that is paid directly on their behalf (sponsored) and are never aware of the actual cost.

Do you need to disclose the costs of meals received during travel?

If you receive meals while traveling, it is not required to be disclosed specifically, but can be included in the total expense of the trip if you know the expense.