Research COI
Overview
An individual financial conflict of interest in Research may exist when an individual's activities or personal financial interests may directly and significantly affect, or have the appearance of directly and significantly affecting, the individual's professional judgment in the design, conduct, or reporting of Research results or in exercising an institutional duty or responsibility related to Research.
UTMB Covered Individuals engaged in any type of research on campus are required to complete education and training and submit a disclosure of individual Significant Financial Interests within 30 days of the date of initial employment, annually and must request and receive approval prior to engaging in certain outside activities.
If your UTMB responsibilities include the design, conduct, or reporting of research activities, such as a Principal Investigator, research staff, research nurse, obtaining informed consent, etc., you are REQUIRED to take the updated training course. If you are unsure whether you are required to take the training, please email coi.in@utmb.edu and we will assist you.
Policy
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IHOP 6.5.1 Research Conflicts of Interest
Definitions
Research: Any systematic investigation designed to develop or contribute to generalizable knowledge, including biomedical, behavioral and social-sciences research or other scholarly activity.
Covered Individual: an Individual who is required to complete a financial disclosure conflicts of interest form. UTMB requires the following to submit a financial conflicts of interest disclosure form: (1) all faculty engaged in organized research activities; (2) members of institutional research review-related committees; (3) staff members who negotiate or execute research agreements on behalf of UTMB; and (4) any Individual who, regardless of title or position, is responsible for the design, conduct or reporting of research, including a principal investigator, co-investigator, faculty agent, research tech, research nurse, staff, fellow or administrator who participates in research.
Covered Family Member: for purposes of disclosure, a Covered Family Member includes (1) a spouse; (2) a dependent child or stepchild; (3) any other person financially dependent on the Covered Individual; and (4) any other person with whom the Covered Individual has joint financial interests such that an objective third party could reasonably conclude that the Covered Individual's decisions or other exercise of professional responsibilities at the institution could be influenced by the effect of that action on the person's financial interest. Any Individual may be identified as a Covered Family Member without regard to whether a legal or biological family relationship exists with the Covered Individual. If the Covered Individual is in doubt, the Covered Individual should resolve the doubt in favor of disclosure. In disclosing financial interests, the interest of any legal entity, including a foundation or a trust that is controlled or directed by the Individual or by the Individual and Covered Family Members is considered to be the interest of the Covered Individual or Covered Family Member as if the separate legal entity did not exist.
Research Conflict of Interest: a significant outside interest of a UTMB Covered Individual or a Covered Family Member that may directly and significantly affect, or have the reasonable appearance of directly and significantly affecting a Covered Individual's professional judgment in the design, conduct, or reporting of research results or in exercising an institutional responsibility related to research.
Disclosure Rules
Significant Financial Interest: A covered individual’s disclosure statement must include the following information about the covered individual and covered family members, but only in regard to interests that reasonably appear to be related to the individual’s institutional responsibilities:
1. From a Publicly-Traded Entity: the total amount and source of payments received in the preceding twelve (12) months from a publicly-traded entity and the value of any equity interest held in the entity on the date of disclosure, including: (a) salary or other payments for services such as consulting fees, honoraria, or paid authorship; and (b) equity interests held, including stock, stock options, or other ownership interest or entitlement to such an interest, valued by reference to public prices or other reasonable measures of fair market value.
2. From a Non-Publicly Traded Entity: the total amount and source of payments received in the preceding twelve (12) months from a non-publicly traded entity and a description of any equity interest held in the entity on the date of disclosure, including: (a) salary or other payments for services such as consulting fees, honoraria, or paid authorship; and (b) equity interests held in any amount, including stock, stock options, or other ownership interest or entitlement to such an interest.
3. Travel: any reimbursed or sponsored travel provided in the preceding twelve (12) months. The disclosure of travel must include the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, the value, and whether a Covered Family Member accompanied the Covered Individual on the trip. The Conflict of Interest Official may request further information about a Covered Individual’s travel, including the monetary value of the travel, in order to determine whether the travel constitutes a RCOI.
(NOTE - There is a $5,000 threshold in 1-3 above that is only relevant for determination of whether the interest is a Significant Financial Interest. For purposes of disclosure, there is a $0 threshold. Therefore, covered individuals shall disclose any payments that reasonably appear to be related to the individual's institutional responsibilities, regardless of dollar amount.)
4. Intellectual Property and Royalties: a description of intellectual property rights held and any agreements to share in royalties related to those rights; and the amount and source of royalty income that the Covered Individual or Covered Family Member received or had the right to receive in the preceding twelve (12) months.
5. Gifts: the value and source of a single gift that the Covered Individual received in the preceding twelve (12) months that exceeds $250 in value, or multiple gifts from a single entity that in the aggregate exceed $250 in value, other than gifts from a Covered Family Member, or close personal friend with whom the Covered Individual has an independent relationship unrelated to his/her status or work at UTMB.
6. Fiduciary Positions: service as an officer, director, or fiduciary for a for-profit or nonprofit entity in the preceding twelve (12) months for which the Covered Individual received any sort of compensation, salary, or payment for expenses, and the name and principal address of the entity.
NOTE - Some of the interests described above require Covered Individuals to seek and acquire prior approval before engaging in the activity. Others allow covered individuals to update their disclosure statements within 30 days of acquiring the interest. Please consult IHOP 6.5.3 - Individual Conflicts of Interest, Conflicts of Commitment, and Outside Activities to determine if your activity requires prior approval.
The following interests are not considered to be “significant financial interests” and do not need to be disclosed by a Covered Individual on a disclosure statement:
- Salary, royalties, or other remuneration paid by UTMB to the Covered Individual, if the Covered Individual is currently employed or otherwise appointed by UTMB;
- Income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government, 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 affiliated with an institution of higher education;
- Income from service on an advisory committee or review panel for a Federal, state, or local government, 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 affiliated with an institution of higher education;
- Income from investment vehicles, such as mutual funds or retirement accounts, as long as the Covered Individual does not directly control the investment decisions made in those vehicles; or
- Travel reimbursed or sponsored by a Federal, state, or local government agency, 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.
External Resources
NIH Final Rule: Responsibility of Applicants for Promoting Objectivity in Research
NIH Final Rule FAQs