The U.S. Public Health Service (42CFR Part 50) and the National Science Foundation (GPM310) have issued regulations and policies requiring institutions that apply for research funding to assume responsibility for ensuring that the financial interests of the employees of the institution do not compromise the objectivity with which such research is designed, conducted, or reported. In recent years, in order to achieve objectivity in research, the issue of conflict of interest has become increasingly important. University faculty and some staff members have taken on new and different functions in addition to the traditional roles of teaching, research and public service. Spin-off companies transferring technology developed in the laboratory, extensive consultative activities, and various types of public service involvement are encouraged by both federal and state agencies, and by the university as necessary for the public good. Governmental agencies, becoming more concerned about the extent and type of these activities as they relate to funded and proposed research and scholarly activities of faculty and some staff, have issued regulations which require universities to develop, publish, and enforce institutional policies which comply with certain federal mandates. Key in these policies is the requirement for regular, timely, and full disclosure of actual or potential conflicts of interests as they relate to significant financial interests which could reasonably be seen by an impartial observer as affecting the design, conduct or reporting of research or educational activities funded or proposed for funding by an external sponsor. To meet the requirement of federal regulations, The University of Texas at Dallas has adopted this policy on Research Investigator Financial Disclosure, which became effective on October 1, 1995, and shall continue in effect until rescinded or modified by appropriate University authority. This policy applies to all Investigators who submit proposals to and/or direct sponsored projects supported wholly or in part by U.S. Public Health Service, the National Science Foundation, and other U.S. Government agencies that adopt conflict of interest, financial disclosure, and objectivity in research requirements similar to those herein. This policy also applies to and is passed down to subgrantees, including commercial contractors, who contract with the university under a grant or contract that is supported wholly or in part by the U.S. Health Service, the National Science Foundation, and other U.S. Government agencies that adopt conflict of interest, financial disclosure, and objectivity in research requirements similar to those herein.
For the purposes of this policy, the following definitions shall apply:
- "INSTITUTION," "UNIVERSITY," and "UTD" mean The University of Texas at Dallas.
- "INVESTIGATOR" means the principal investigator, co-principal investigator, director, co-director, research scientist, or research associate and any other person at U.T. Dallas who is responsible for the design, conduct, or reporting of research or educational activities. This definition includes anyone who is paid by or whose work is supported by a grant or contract whether the support is internal or external (e.g., graduate students, postdoctoral fellows, but not technicians or clerical employees) and includes the spouse and dependent children of the Investigator.
- "RESEARCH" means a systematic investigation designed to develop or contribute to generalizable knowledge. As used in this policy, "RESEARCH" includes any such activity for which research funding is available from a federal agency through a grant, cooperative agreement, contract, or other assistance award.
- "CONFLICT OF INTEREST" or "SIGNIFICANT FINANCIAL INTEREST" means anything of monetary value, including but not limited to:
- salaries or other payments for services (e.g. consulting fees or honoraria);
- equity interests (e.g., stocks, stock options or other ownership interests); and,
- intellectual property rights (e.g., patents, copyrights and royalties from such rights).
- The term does not include:
- salaries, royalties, or other remuneration from UTD;
- income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
- income from service on advisory committees or review panels for public or nonprofit entities; or,
- financial interests in business enterprises or entities if the value of such interest does not exceed $10,000 per annum in salary, fees or other continuing payments or represent more than a five percent (5%) ownership interest for any one enterprise or entity when aggregated for the Investigator and the Investigator's spouse and dependent children.
- Each Investigator is required to disclose the following Significant Financial Interest(s):
- Any Significant Financial Interest of the Investigator that would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor; or
- Any Significant Financial Interest of the Investigator in an entity whose financial interest would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor.
- Regardless of the above minimum requirements, a faculty or staff member, in his or her own best interest, may choose to disclose any other financial or related interest that could present an actual conflict of interest or be perceived to present a conflict of interest. Disclosure is a key factor in protecting one's reputation and career from potentially embarrassing or harmful allegations of misconduct.
- Each Investigator who has Significant Financial Interest requiring disclosure shall complete an Annual Certification of Compliance Conflict of Commitment and Interest form and attach all required supporting documentation. A copy of the form is attached to this policy memorandum. The completed certification of compliance form must be submitted to the Director of the Office of Research Administration (ORA) annually or as changes occur.
- Each UTD Investigator must:
- Read and understand the policies and procedures contained in this policy memorandum and its regulatory basis pertaining to conflict of interest and objectivity in research and significant financial interests.
- Accept his or her responsibility to disclose significant financial interests to the Director of ORA and the University Research Integrity Committee by completing, signing, and submitting the certification of compliance form on or before a date which allows adequate time for preliminary review prior to the proposal deadline date.
- Update the certification of compliance form as changes occur, or at a minimum annually, so that the statement of significant financial interests on file is current and accurate while an award is pending or while an award is in force.
- Make the following certification to UTD and to the federal agency prior to proposal submission:
- "I have read and understand The University of Texas at Dallas Policy Memorandum 95-III.21-69, Research Investigator Financial Disclosure, and I have disclosed all significant financial interests as required by it. I will comply with the provisions of the policy to report changes in my significant financial interests and will comply with conditions or restrictions imposed by UTD to manage, reduce or eliminate actual or potential conflicts of interest and commitment."
- Should any Investigator disagree with the findings and/or decisions of the University Research Integrity Committee, that Investigator may appeal those findings/decisions to the UTD Executive Vice President and Provost (Provost). In such cases, the Provost shall review all of the materials relating to the action in question, shall discuss the findings/decisions with the Investigator and Director of ORA and shall make a final decision as to the action.
- Certification of Compliance
- The Certification of Compliance Conflict Commitment and Interest form will be reviewed for potential conflict of interest and/or commitment. If a potential conflict appears to exist the Director of ORA will forward a copy of the form with supporting documentation to a subcommittee of the University's Research Integrity Committee. This subcommittee, through the Director of ORA, shall discuss the conflict with the Investigator(s) and then recommend to the full Research Integrity Committee appropriate action that should be taken by the full Committee to manage, reduce or eliminate that conflict. The full committee shall decide appropriate action to be taken and advise the Director of ORA. The Director of ORA shall then:
- Notify the Investigator(s) of the requirements of the Committee.
- Assist the Investigator(s) in taking appropriate action to manage, reduce or eliminate the actual or potential conflict of interest.
- Certify to the awarding component of the federal agency regarding the existence of significant financial interests and management thereof prior to expenditure of any federal funds.
- Notify the awarding component of the federal agency, within 60 days of a conflict report to the Director of ORA, of the identification and management, reduction, or elimination of any significant financial interest that originates or becomes known to UTD after an award has been made and funds are being expended.
- Maintain confidentiality, to the extent permitted by law, on all disclosures and records of actions taken to manage significant financial interests for at least three years beyond the termination or completion of the award or until resolution of any action by a federal agency involving the records, whichever is longer, and make these records available for audit by authorized agencies.
- Examples of conditions or restrictions that might be imposed to manage actual or potential conflicts of interest include:
- Public disclosure of significant financial interests;
- monitoring of research by independent reviewers;
- modification of the research plan;
- disqualification from participation in all or a portion of the research funded by the federal agency;
- divesture of significant financial interests; and/or
- severance of relationships that create actual or potential conflicts.
- Enforcement and Penalties for Failure to Comply Enforcement of the requirements of this policy is the responsibility of Academic Deans and Directors, the University Research Integrity Committee and the Provost. Assessing the nature of a violation and administering a penalty to a UTD faculty or staff member who violates this policy are the responsibilities of the Provost or the Vice President to whom that employee is accountable. Penalties for violation of this policy range from a reprimand and immediate corrective action to dismissal from the university for falsely certifying that no action or potential significant financial interests exist. The procedures followed in cases involving a faculty member are found in the University's Policy Memorandum 94-III.21-61, University Policy on Faculty Conduct. In cases involving a staff member, the procedures followed are found in the University's Administrative Policies and Procedures Manual, (http://www.utdallas.edu/utdgeneral/business/admin_manual/) Section D, Subsection D8, Policy and Procedures For Discipline and Dismissal and Grievances of Employees.
Policy Form: PM 95-III.27-69 The University of Texas at Dallas Annual Certification of Compliance Conflict of Comment and Interest