The University of Texas Health Science Center at Houston (“the university”) is committed to ensuring that financial interests of investigators and the institution do not affect, or appear to affect, the design, conduct or reporting of research or compromise the protection of human subjects. Therefore, members of the university community conducting or supervising research or educational activities using public or private funding from any source must disclose potential conflicts of interest and, when appropriate, work cooperatively with the Executive Vice President for Research (EVPR) to develop and implement plans to manage, reduce or eliminate conflicts of interest. The approval of the University of Texas (UT) System Office of General Counsel and Executive Vice Chancellor for Health Affairs is also required for employees who are pursuing sponsored research agreements or licensing agreements for intellectual property with entities where they have equity or serve as a board member, officer or key employee.
This policy deals exclusively with financial interests related to research. Conflicts of interest related to an employee’s status as an employee of the State of Texas are discussed in HOOP Policy 2.19 Conflicts of Interest and Outside Activities.
This policy does not necessarily preclude the conduct of research where a conflict of interest, or potential conflict of interest, is present. Within the process, there may be situations where the research is allowed to proceed if it is of sufficient importance and there are compelling circumstances (refer to the Definitions section below).
For questions regarding this policy, contact the Office of the Executive Vice President for Research.
Members of the University Community: Members of the university community to whom this policy applies include but are not limited to full and part time faculty, visiting scientists, staff, trainees, volunteers and observers.
Institutional Officials Covered: Individuals whose research related financial interests are considered “institutional” interests include institutional officials who have research oversight authority, act on behalf of the institution, or have immediate oversight of human subjects research. These include but are not limited to the President, executive vice presidents, vice presidents, deans and department chairs.
Significant Investigator Financial Interests in Research: The aggregate interests of the investigator and his/her immediate family (spouse and dependent children).
This term refers to anything of monetary value that would reasonably appear to be affected by the outcome of the proposed research, regardless of whether that entity is sponsoring the research. Such interests include, but are not limited to:
In addition to the exceptions noted above, the term significant investigator financial interest in research does not include:
Investigators should also disclose other significant financial interests not specifically required by this policy if they have concerns the interests would reasonably appear to be affected by the proposed research (e.g. significant financial interests of family members other than a spouse or dependent children).
Significant Institutional Financial Interests in Research: Include interests held by the institution and/or interests of institutional officials.
A. UTHSC-H: Significant financial interest in research refers to anything of monetary value that would reasonably appear to be affected by the outcome of the proposed research. Such interests include, but are not limited to:
B. Institutional Officials: Significant financial interests in research for institutional officials utilize the threshold defined for investigators.
Research: A systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. The term encompasses basic and applied research and product development.
PHS Awarding Component: The organizational unit of the PHS that funds the research.
All grants and research contracts submitted through the Office of Sponsored Projects (OSP) and research requiring review by Research Support Committees (Committee for the Protection of Human Subjects (CPHS)) must include a completed Research Conflicts of Interest Certification for all key personnel responsible for the design, conduct or reporting of the proposed research or other educational activities. The principal investigator (PI), defined as the individual who has primary responsibility for design, management and reporting of applicable research, is responsible for identifying key personnel who must complete the certification and ensuring completion of same.
If a research project involves subgrantees, contractors or non-university collaborators, the subgrantee, subcontractor or collaborating institution must provide assurances that a financial conflict of interest policy is in effect at that institution.
Investigators and/or related colleagues or staff who indicate potential conflicts in the Certification for federal grants or proposals to non-profit entities must complete a Research Conflicts of Interest Disclosure for Federal Grants or Proposals to other Non-Profit Entities. This disclosure must be submitted with the Certification to the OSP and forwarded to the EVPR for review.
Investigators and/or related colleagues or staff who indicate potential conflicts in the Certification for grants/contracts with for-profit entities must complete a Research Conflicts of Interest Disclosure for Grants with For-Profit Entities and Research Contracts that is submitted with the Certification to OSP and forwarded to the EVPR for review.
Updated Disclosures must be submitted to the EVPR during the award/contract period if new reportable interests are obtained, and the updated Disclosure should be submitted within 30 days of obtaining the financial interests. Investigators who initially have no reportable interests must also complete a Disclosure and submit it to the EVPR if new reportable interests are subsequently obtained during the award/contract period, and the Disclosure should be submitted within 30 days of obtaining the financial interests.
Clinical investigators conducting clinical studies for U.S. Food and Drug Administration (FDA) applications for a human drug, biological product or device must also comply with the FDA's financial disclosure requirement that financial disclosures be updated both during the course of the study and for one year following the completion of the study.
Investigators initiating research reviewed by the CPHS or the Animal Welfare Committee (AWC), and not requiring the review and approval of OSP, should disclose any potential research conflicts of interest directly to the EVPR using the applicable Disclosure instrument.
Significant university financial interests developed when the institution receives equity in entities that license its intellectual property are reported by the Office of Technology Management (OTM) to the EVPR. Financial interests of institutional officials must be annually disclosed to the Executive Vice President, Chief Operating and Financial Officer in the Financial Disclosure and Conflict of Interest Report, with the exception of the President who discloses his financial interests through the Texas Ethics Commission. If these individuals have a significant financial interest in a company sponsoring university research, the interests are reported to the EVPR.
Investigators also identify institutional financial interests related to their proposed research, if known, on the applicable Research Conflicts of Interest Disclosure form.
Disclosures and significant research related institutional financial interests are reviewed by the EVPR or his/her designee and the Research Conflicts of Interest Committee (RCOIC). The Committee assesses if investigators, the university or institutional officials’ financial interests may affect, or have the appearance of affecting, the design, conduct or reporting of research, or the safety of human participants, and recommends to the EVPR if and how conflicts should be managed, reduced or eliminated. The Committee should report perceived or potential conflicts, and, if conflicts exist, it should recommend if conflicts should be managed, reduced, and/or eliminated, conflict management strategies, and individuals to serve on an oversight committee. The Committee may recommend that the research not go forward.
The EVPR makes the final determination regarding what actions are required to manage, reduce or eliminate conflicts of interest. Any conditions or restrictions to resolve or manage conflicts must be determined and implemented before the expenditure of any funds awarded for a grant or contract. If the research involves human research subjects, appropriate information will also be made available to CPHS to consider in its review of the CPHS application. In the event a project receives RCOIC and CPHS approval, a summary report of conflicts of interest, if not detailed in the consent form, should be provided to research participants or the public, on request.
If the approval of the UT-System Office of General Counsel and Executive Vice Chancellor for Health Affairs is required, a conflict of interest management plan must be developed.
The EVPR will maintain documentation of actions taken on research conflicts of interest for at least three years from the date of submission of the final expenditures report or beyond the termination of the research grant or contract; or, until resolution of any action by the granting or contracting agency/entity involving the records, whichever is longer. The EVPR will also make the information about conflicting interests on PHS-funded research and the strategies used to manage, reduce or eliminate the conflicts and protect the research from bias available, upon request, to the Department of Health and Human Services (HHS).
Upon the conclusion of the review process, the EVPR will communicate information about the outcome to the dean, department chair, and other individuals, as appropriate.
For PHS-sponsored projects, the EVPR must notify the Awarding Component prior to expending any funds that a conflict of interest exists and provide assurance the conflict is being managed, reduced or eliminated. Reporting is not required for applications for Phase I support under the Small Business Innovation Research and Small Business Technology Transfer programs.
If conflicts develop and are identified after the initial award is made, the EVPR must notify the PHS within 60 days of identifying the conflict.
The EVPR must also promptly notify the PHS Awarding Component of corrective actions taken if an investigator has biased the PHS funded research.
An investigator may appeal to the EVPR if he/she does not concur with the proposed plan for managing/eliminating research conflicts of interest, or if the research is not permitted to be conducted. A written appeal should be submitted within 30 days of notice of the proposed management plan or denial and include evidence detailing the investigator's concerns and/or compelling circumstances which support his/her claim that the management plan should be revised and/or the research should go forward. The EVPR will review the appeal, and also request the review/advice of the RCOIC. It is, however, the responsibility of the EVPR to approve, modify or reject any proposed revisions to the conflict of interest management plan. The EVPR may also appoint an external ad hoc group to provide an additional level of review in the appeal process and report its findings and recommendations to the EVPR. The decision of the EVPR is final.
While the thresholds for disclosure are the same for all types of research, additional diligence in evaluation and management is required for research with potential risks to human subjects or with potential implications for medical care and the practice of medicine. The RCOIC applies the rebuttable presumption standard when reviewing significant financial interests in human subjects research i.e., individuals with significant financial interests may not conduct the research unless there are compelling circumstances. Compelling circumstances include factors such as unique investigator expertise; unique institutional resources; unique access to particular patient populations; nature of science; level of risk for human subjects; and degree to which financial interests and research are linked. While this policy is consistent with simultaneous review of a given research proposal by both RCOIC and CPHS, the RCOIC review process will be completed and the report forwarded to the CPHS before the protocol receives final review and approval. CPHS may request revision of the recommended management plan if it feels the conflict cannot be managed or the proposed plan is insufficient. These two committees will not work in isolation from each other and the RCOIC process should provide sufficient information to ensure that, as applicable, conflicts are managed and research participants are informed.
The EVPR is responsible for overseeing the development and implementation of conflict of interest management plans. In most cases, he/she will delegate these oversight responsibilities to the RCOIC, but management plans developed by the Committee must be approved by the EVPR prior to implementation.
In cases where sponsored research agreements or licensing agreements for intellectual property are made with an entity where an employee owns an interest or serves as an employee, officer or member of the Board of Directors, the President, the UT-System Office of General Counsel and the Executive Vice Chancellor for Health Affairs must also approve the plan.
Elements required in the management plans are summarized in UT-System's Guidelines for Plans to Manage Research Conflicts of Interest.
Research continuation may be allowed in the face of a conflict depending upon (1) the nature of the science, (2) the specific financial interest, (3) the magnitude of the interest and the degree to which it is related to the research, and (4) the extent to which the interest is amenable to effective oversight and management.
While evaluation and management of the potential conflict is the goal, it is recognized that some conflicts may not be manageable. Nonetheless, when the investigator has a unique capability and must be involved with a critical research project to ensure its proper performance, it may be appropriate for the research to go forward with a well defined and carefully monitored management plan.
The UT-System Vice Chancellor and General Counsel must be informed by October 1 of each year of university employees who own an interest or are employees, officers or members of the boards of directors in business entities with UT-System agreements involving the research, development, licensing or exploitation of the employees' intellectual property.
The university anticipates that investigators will comply fully and promptly with this policy. Examples of non-compliance include, but are not limited to:
Failure on the part of an investigator to comply with this policy may result in disciplinary action and/or sanctions; examples of possible sanctions include formal reprimand; non-renewal of appointment; termination of appointment for good cause; and/or any other enforcement action mandated by the applicable government granting agency.
The EVPR is responsible for investigating instances of non-compliance and determining whether to impose sanctions and what sanctions will be applied. In making these determinations, he/she may consult with the applicable department chair, the dean, the RCOIC or other appropriate individuals.
If the failure to comply has resulted in a bias of the design, conduct or reporting of research, the EVPR will take appropriate corrective actions and promptly notify the PHS Awarding Component of corrective actions to be taken.
An investigator who is the subject of a disciplinary action may appeal such action in accordance with established university faculty grievance and/or disciplinary procedures.
If HHS determines that a PHS-funded project to evaluate a drug, medical device or treatment was conducted by an investigator with a conflict that was not disclosed or managed, the investigator must disclose the conflict in each public presentation of the results of the research.
Although investigators are responsible for certifying whether or not significant financial interests exist, and, as applicable, disclosing such potential conflicts of interest with their research, third parties may also report potential conflicts of interest (e.g. faculty, department chairs and other administrative persons, representatives of pharmaceutical companies). Such identifications may be made directly to the Office of the EVPR (officeofresearch@uth.tmc.edu) or to the UTHSC-H - Compliance Hotline via email (compliance@uth.tmc.edu) or anonymously via phone (1-888-472-9868).
Created 2/03; Updated 06/05; 08/07; 02/08