Investigator Significant Financial Interests in Research and Disclosure Requirements
Research Conflict of Interest Management Plans
In pursuit of our mission to educate health science professionals, discover and translate advances in the biomedical and social sciences, and model the best practices in clinical care and public health, employees of the University of Texas at Houston Health Science Center (UTHealth) often enter into collaborations with outside entities in the private sector such as pharmaceutical, medical device, and biotechnology companies. Per UTHealth Policy, “Conflict of Interest, Conflict of Commitment and Outside Activities” (HOOP 20), review of such outside activities must occur by the employee’s supervisor. While such activities can benefit the university through medical and scientific breakthroughs or information about recent trends, in some circumstances these relationships may give rise to the appearance of potential financial conflicts of interest, especially in the realm of research activities.
The university's concern with financial conflicts of interest reflects the ever-increasing complexity of our work, the heightened national and governmental sensitivity to such matters, and our commitment to the public interest. UTHealth’s established Policy (HOOP 20) requires that all UTHealth faculty members disclose their related outside activities and financial interests on an annual basis and as their disclosure situation changes throughout the year. In addition, a separate Policy, “Research Conflicts of Interest” (HOOP 94), requires individuals responsible for the design, conduct, or reporting of research to disclose their related significant financial interests at the time of each proposed research project (at the time of a protocol submission, sponsored research application, or other research that may be funded internally through department funds or gifts). Activities and interests that are defined per policy as significant* and related to proposed research are then reviewed by institutional officials and the UTHealth Research Conflicts of Interest Committee.
For activities and interests that are determined to represent a financial conflict of interest in research (i.e., the interest could directly and significantly affect the design, conduct, or reporting of research), a Research Conflict of Interest Management Plan may be implemented that includes strategies to manage, reduce, or eliminate the identified conflict. Each Plan may require actions such as: 1) disclosing the financial interest in publications and presentations; 2) informing research collaborators and students about the related financial interest; 3) requiring future disclosures as the financial interest changes; 4) additional standards if human subjects are involved in the research; and 5) regular reviews that occur at least annually. The final determination of whether a financial conflict of interest in research exists and whether the implementation of a Management Plan is appropriate is made by the university’s Conflict of Interest Official, the Executive Vice President for Academic and Research Affairs (George M. Stancel, Ph.D.) Each issued Plan is then reviewed prior to the award of subsequent related research projects to determine if the Plan continues to be sufficient to manage the identified conflict.
In compliance with the UT System Administration Policy entitled “Disclosure of Significant Financial Interests and Management and Reporting of Financial Conflicts of Interest in Research-Health Institutions” (UTS175), UTHealth posts information available to the public about each employee with a significant financial conflict of interest in research for whom a Research Conflict of Interest Management Plan has been approved (see LIST). UTHealth makes this information available to the public in the interest of transparency and increasing the public trust and confidence in the research community. Research Conflict of Interest Management Plans represent complex relationships that have gone through several levels of review by UTHealth and are unique to each individual faculty member. Learn more about how UTHealth identifies, evaluates, and manages potential research conflicts of interest at our website.
"Significant" Financial Interests include the aggregate interests of the Covered Individual and his/her family members. Such interests are defined by the Research Conflicts of Interest Policy and include, but are not limited to:
- From a publicly traded entity: Compensation in the preceding 12 months (includes payment for services such as consulting, advising, lectures, honoraria, paid authorship; reimbursed or sponsored travel; and royalties, fees, and rights to such interests) and the value of stock, stock options, or ownership interests held on the date of disclosure, that when aggregated exceeds $5,000. (Does not include interests in mutual funds/retirement accounts where the individual does not control the holdings, or royalties and other fees paid to the employee by UTHealth.)
- From a private entity: Compensation (see above) in the preceding 12 months that when aggregated exceeds $5,000.
- From a private entity: Any amount of stock, stock options, ownership interests, or rights to such interests.
- Service as an officer, director, or other fiduciary position for an outside entity from which the individual received remuneration or payment for expenses in the preceding 12 months.
- Gifts received from an outside entity in the preceding 12 months that exceed $250 in value, or multiple gifts from a single entity that in the aggregate exceed $250 in value.
The term “Family Member” is defined as your spouse, dependent children/step-children, any person financially dependent upon you, and any person with whom you have joint financial interests where your professional responsibilities at UTHealth could affect or be affected by those interests.
Researchers must also disclose other financial interests not specifically required by the Policy if they have concerns that the activity or interest would appear to affect or be affected by the proposed research.
The term “Entity” refers to any organization, company, foundation, trust, or other enterprise.