Guidelines for Conflict of Interest

These guidelines are established to provide guidance on the university's policy on conflict of interest and commitment, including outside employment. An implicit assumption underlying these policies is that the design, conduct, and reporting of research should not be biased by any significant financial interest and that outside professional activities of university faculty members and researchers must not detract from their full-time obligations to the university. Participation in research, or other professional activities with opportunities for personal gain, may not constitute an unacceptable situation. However, state and federal agencies have legitimate concerns that any research they sponsor is free of bias, due to financial interests of the investigator and institution; that funds provided be expended as intended; and that the commitment of time and effort be appropriate for the project supported. To qualify for federal funding, the university assumes the responsibility for ensuring that these concerns are addressed.

1. Definitions
2. Guiding Principles
3. Examples of Allowable Activities
4. Examples of Non-allowable Activities or those Requiring Management Plans (not inclusive)
5. Procedures for Declaring Potential Conflicts of Interest and Obtaining Approval for Management Plan
6. Initial Review of the COI Management Plan
7. Annual Review
8. Responsibilities
9. Management Plan for Potential Conflicts of Interest

Forms

• Financial Disclosure and Conflict of Interest [Word]
• Conflict of Interest Management Plan Annual Review [Word]

Related University Policies

• The Institutional Review Board (IRB) Procedures Manual for Faculty, Staff, and Student Researchers with Human Participants, Section 3.7 - Conflict of Interest
• University of Texas System
  • Conflict of Interest
• Handbook of Operating Procedures
• Regents' Ethics Policy
• Outside Employment Regulations

Visit the NIH COI Web site.

Definitions

As defined by the National Institutes of Health, a "conflict of interest" arises when an employee is involved in a particular matter as part of his/her official duties with an outside organization with which he/she also has a financial interest, or one which is imputed to him/her, i.e., the employee's spouse, minor children, an organization in which the employee serves as officer, director, trustee, partner, or employee, or a person or organization with which the employee is negotiating for prospective or has an arrangement for prospective employment. Conflicts of interest can arise out of the fact that a mission of the university includes faculty consulting and the commercialization of technologies derived from faculty research; however, an individual's actions or decisions cannot be determined by consideration of personal financial gain.

Conflict of Commitment:

Whenever an individual's outside activities exceed the permitted limits (normally one day per week), or whenever a full-time faculty member's/researcher's primary professional loyalty is not to The University of Texas at Austin, a conflict of commitment exists.

Persons Responsible for the Design, Conduct, or Reporting of Research:

The federal guidelines and the university's policy apply to "persons responsible for the design, conduct, or reporting of research." In some cases, graduate students and postdoctoral fellows may be responsible for the design, conduct, or reporting of research, such that they are considered to be an investigator under this policy and may be required to complete disclosure statements. In any situation, it is the responsibility of the principal investigator to ensure that students and postdoctoral fellows are not diverted from their primary educational mission.

Significant Financial Interests:

Financial interests in business enterprises or entities if the value of such interests: 1) exceeds $10,000 per annum of salary, fees, and other continuing payments; or 2) represents more than a five percent (5%) ownership interest in any one enterprise or entity when aggregated for the investigator and the investigator's spouse and dependent children.

Guiding Principles

Conflict of interest/commitment situations should be avoided.

• According to the university's conflict of interest/commitment policies, faculty should disclose any anticipated consulting or outside employment activities.
• Approval of any research study involving human subjects AND has a Conflict of Interest issue will be delayed until the Conflict of Interest issue is resolved.
• Written conflict of interest management plans must be approved by the university's Objectivity in Research Committee prior to beginning the research.
• Outside activities should not interfere with performance of the primary responsibilities expected of a full-time faculty member or researcher, and must not exceed 20 percent of the full-time obligation.
• Management or consulting roles in an outside private business generally are not acceptable, particularly in cases that require the faculty member/researcher to assume major responsibilities, such as day-to-day oversight of the company.
• Faculty/researchers involved in outside consulting or business activities that involve research must establish clear boundaries or "fire walls" to differentiate University responsibilities from their outside responsibilities.
• Faculty must disclose all potentially patentable inventions of IP created or discovered in the course of their university activities. Inventions are university property and the inventor will share royalties according to The University of Texas System policies.
• Faculty and researchers must make university obligations known to external entities with whom business is contracted and provide them with relevant University policies governing inventions and discoveries.

The university's teaching and research environment fosters positive learning opportunities for students and preserves free discourse and dissemination of research results.

• Research conducted by a faculty member/researcher may not involve "works for hire" but must be judged as advancing scholarship and knowledge.
• Preferential access to research results, materials, or products generated from university teaching or research activities may not be provided to an outside entity for the personal financial gain of a faculty member/researcher, except in cases in which appropriate licensing arrangements have been developed and approved according to university policies.
• When appropriate, research should provide learning opportunities for undergraduate and/or graduate students.
• The university will not accept limits placed on the freedom to publish, except for short periods of delay that permit a sponsor to comment or to permit filing of patent applications in coordination with the university's patent policies.
• Selection of students for participation in a research project should not be inappropriately influenced by the interests of a sponsoring company, including a company in which the supervising professor may have a significant financial interest.
• Involvement of university students, including postdoctoral fellows, in outside professional activities of a faculty member/researcher can be beneficial, but their educational experience should not be diminished or diverted in any way.
• Student involvement in outside professional activities of a faculty member/researcher must be disclosed, reviewed, and approved in writing in advance to assure that exploitation or unreasonable interference with university duties and responsibilities, including coursework, does not occur.
• Students, associates, postdoctoral fellows, and research staff should have access to information about sources of funds that support their research.
• Students should not be involved in or employed by any company in which their thesis or dissertation supervisor has a substantial financial interest and, therefore, a potential conflict of interest.
• Additional federal requirements may be imposed on international students related to their immigration and naturalization status and involvement in the research of faculty members/researchers.

Examples of Allowable Activities

The following examples are not considered conflicts of interest and are exempt from reporting requirements, unless they are so extensive in time and effort that they constitute a conflict of commitment.

1. Receiving salary, royalties, honoraria, stipends, or other remuneration from The University of Texas at Austin.
2. Earning income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities.
3. Receiving income from service on advisory committees or review panels for public or nonprofit entities.
4. Holding financial interests in business enterprises or entities if the value of such interests does not exceed $10,000 per annum of salary, fees, and other continuing payments, or does not represent more than a five percent (5%) ownership interest in any one enterprise or entity when aggregated for the Investigator and the Investigator's spouse and dependent children.

Examples of Non-allowable Activities or those Requiring Management Plans (not inclusive)

1. Failure of the faculty member/researcher to fulfill university responsibilities (e.g., holding classes, advising students, conducting research, serving on departmental or university committees, supervising students in research lab), due to involvement in external activities.
2. Sponsored projects or technology licensing arrangements in which any of the involved investigators (or members of their immediate families) have employment or consulting arrangements and significant financial interests in the sponsor, or with subcontractors, vendors, or collaborators.
3. Using university resources to conduct research that is sponsored by an entity in which the faculty member/researcher or his/her family member has a significant financial interest.
4. Serving as a consultant or on the board of directors or major advisory committee of an external for-profit entity which sponsors the faculty member's/researcher's research or provides gift funds for the researcher or his/her department.
5. Hiring university students in consulting activities or a company in which the faculty member/researcher has financial interests. If the student's thesis/dissertation research is supervised by the faculty member, the conflict of interest situation may not be manageable.
6. Diverting research opportunities from the university to a consulting entity or business in which the faculty/researcher has a financial interest.
7. While acting in the context of his/her university duties, making professional referrals to or purchasing materials or services from a business in which an academic staff member or family member has a financial interest.
8. Serving as president or CEO, or holding any other position that requires involvement in the day-to-day operations of a for-profit sponsor. Such a situation creates an unacceptable conflict of interest and/or commitment, which must be reduced in order to be manageable.
9. Conducting clinical trials on a drug or device developed by the faculty member/researcher may be manageable if the research DOES NOT involve human research subjects.
10. Equity (ownership) interest of the faculty member (or members of the immediate family) in a sponsor.
11. Gifts to the university of cash or property which will be under the control, or will directly support the teaching or research activities of a faculty member from an entity in which that faculty member (or members of the immediate family) has an employment or consulting arrangement and/or significant financial interests.

Procedures for Declaring Potential Conflicts of Interest and Obtaining Approval for Management Plan

1. Determine if you have a potential conflict of interest by reviewing these guidelines and the relevant sections of The University of Texas Handbook of Operating Procedures or the Office of Sponsored Projects Handbook. If you have questions regarding the policy, please contact your associate dean for research and/or the associate vice president for research (512-471-2877).

   You may also want to review The University of Texas System Ethics Policy, Attachment One to HOP Sec. 5.11, Regents' Rules, Part One, Chapter III, Section 4, as well as The University of Texas at Austin Institutional Review Board (IRB) policies and procedures regarding conflicts of interest, Section 3.7.

2. Declare a potential conflict of interest by completing the form, Financial Disclosure and Conflict of Interest Report [Word]. Paper copies can be obtained from the Office of Sponsored Projects (OSP) or the Office of Technology Licensing (OTL). Submit the form to OSP at the time of submitting the research proposal (if applicable) or to the OTL if a license agreement is involved. The materials will be forwarded to the Office of the Vice President for Research, along with a copy of the proposal, research agreement, and/or license agreement, if applicable.
3. Develop a Potential Conflict of Interest Management Plan in cooperation with the associate vice president for research responsible for the university's conflict of interest policy. Refer to the Management Plan section of this site. Also, refer to Procedure for Obtaining Approval of Plan to Manage Conflicts of Interest.
4. Forward the Management Plan to the Office of the Vice President for Research. If the research is externally funded, a meeting of The University's Objectivity in Research (OIR) Committee will review the proposed management plan.
5. Once the Management Plan has been approved by the OIR Committee, you will be asked to write a letter of certification to the Vice President for Research indicating that you accept the management plan and agree to abide by it. See D2, Procedure for Obtaining Approval of Plan to Manage Conflicts of Interest.
6. The chairperson of the OIR Committee will prepare the institutional certification letter that will accompany the employee certification letter and management plan to the Executive Vice Chancellor for Academic Affairs. For an example of the institutional letter that will be prepared, see Submitting a Plan to Manage Conflict of Interest to UT System for Approval.
7. Once the Executive Vice Chancellor for Academic Affairs has approved the plan, the documents—management plan, employee certification letter, institutional certification letter—will be prepared by the Office of the Vice President for Research for placing on the Institutional Docket of the next Board of Regents' meeting. (Meetings are held on May 10, August 10, November 10, and February 10. UT Austin internal deadline is 6 weeks prior to the Board meeting.)
8. Each such financial disclosure statement must be updated during the period of the research grant or contract on an annual basis, or more often if any new reportable Significant Financial Interests are obtained.
9. In addition, even if the researcher has no reportable Significant Financial Interests at the time a proposal is written/submitted and/or a grant or contract is awarded, he or she has the obligation to complete a financial disclosure statement if any reportable Significant Financial Interests are subsequently obtained.

Guidelines for Conflict of Interest: Initial Review of the COI Management Plan

The investigator must provide to the OIR Committee the following information for review:

• All relevant financial interests that exceed the threshold of significance as defined in the Conflict of Interest policy.
• All external commitments and documentation that involvement does not exceed permissible levels as defined in the Conflict of Interest policy.
• Description of the facts and circumstances regarding the investigator's financial involvement with the sponsoring organization and measures that will be taken to ensure that the financial involvement will not affect or impair the conduct of the research in accordance with the applicable University policies and the highest professional standards.
• Documentation of how the interests of the University will be maintained in consideration of the investigator's interest in the sponsor.
• Evidence that the research project will lead to the advancement of knowledge rather than to merely benefiting the sponsor.
• Evidence that the research project will contribute to the University's mission of teaching, research, and public service.
• When applicable, evidence that the best interests of the University and the public will be served by granting an exclusive license to the sponsor.
• Descriptions of any patent applications that have been filed, or any intent to file patent applications, related to or arising from this research program. If any patent applications have been filed, what was the filing date and applicant name?
• All relevant information concerning the faculty member's activities have been acquired (i.e., there been full disclosure).

At a minimum, the University's OIR Committee will determine whether a Significant Financial Interest could affect the design, conduct, or reporting of the research activities funded or proposed for such funding and determine what conditions or restrictions, if any, should be imposed to manage such interests. Any conditions or restrictions to resolve or manage conflicts of interest must be determined and implemented before the expenditure of any funds awarded under a grant or contract. Examples of conditions or restrictions that may be imposed to manage actual or potential conflicts of interest include:

• Public disclosures of Significant Financial Interests;
• Monitoring of the research by independent reviewers;
• Modification of the research plan;
• Disqualification from participation in all or a portion of the research project in question;
• Divestiture of Significant Financial Interests;
• Severance of relationships that create actual or potential conflicts;
• Appointing an impartial person to monitor the use of students;
• Removing purchasing decision authority;
• A leave of absence for the faculty member with or without pay; or
• The conflict cannot be managed and, therefore, the agreement cannot be approved.

Guidelines for Conflict of Interest: Annual Review

The investigator must provide to the OIR Committee a copy of the annual report to the sponsor and the following information for review:

• Description of additional funding obtained by the investigator for this research program. Identify funding source(s).
• Describe any changes in personnel appointed to work on this research program during the past year or since the most recent report.
• Describe articles or other publications that have been generated from this research program and where they have appeared. Provide evidence that research results have been faithfully and accurately reported.
• Describe any changes in terms of the agreement between the company and the investigator's research lab. during the past year or since the most recent report.
• Describe any research information or intellectual property that has been disclosed to the company. Attach copies of any written communications between the PI and the company that reflect any disclosure of research information or intellectual property.
• Describe any changes in the investigator's financial position with the company.
• Describe any changes in the researcher's family members' position with the company.

Responsibilities

1. Responsibility of the Investigator/Researcher

It is the responsibility of the investigator/researcher to disclose all Significant Financial Interests and business relationships on the Financial Disclosure Statement (FDS) and to continue to complete necessary paperwork regarding potential conflicts of interest or commitment during the period of a grant, contract, or licensing arrangement. The investigator/researcher is responsible for working with the Office of the Vice President for Research, its officers, and the OIR Committee in managing, reducing, or eliminating any conflict of interest or commitment. This includes the completion of a COI Management Plan, the preparation of an Annual Review Report, and any update of a COI Management Plan.

The investigator/researcher is responsible for updating any information relevant to a conflict of interest or commitment during the period covered by the management plan and for notifying the chair of the OIR Committee of any additional potential conflicts of interest or commitment that may arise.

The investigator/researcher must disclose to the relevant dean, associate dean for research, or department chair all current or prospective situations that may raise questions of conflict of interest or commitment as soon as such situations become known to the investigator/researcher.

2. Responsibility of College Deans/Department Chairs

College deans and department chairs are responsible for advising the investigator/researcher of the appropriate resources for guidance in managing a potential conflict of interest or commitment when any potential or perceived conflicts are brought to the chair's or dean's attention.

3. Responsibility of the Chair of the Objectivity in Research Committee

The Vice President for Research has charged the chair of the OIR Committee with the responsibility for the implementation of, and compliance with, this policy. The chair of the OIR Committee is responsible for reviewing all Financial Disclosure Statements. The OIR Committee chair will maintain all records received and created pursuant to this policy as well as all records of actions taken with respect to each conflict of interest or commitment at least five years beyond the termination or completion 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.

4. Responsibility of the Office of Sponsored Projects (OSP)

OSP shall forward any Financial Disclosure Statements received during the grant proposal process to the chair of the Objectivity in Research Committee.

In the event that federally funded research at the University is carried out through a subcontractor or collaborator, the University will require the subcontractor or collaborator to certify that its investigator/researcher is in compliance with a policy on objectivity in research that meets requirements of the federal sponsor's regulations. OSP will also monitor subrecipients for compliance.

5. Responsibility of the Office of Technology Commercialization (OTC)

OTC shall remind the investigator/researcher to submit an FDS to the chair of the OIR Committee when necessary. OTC will provide the chair of the OIR Committee with information requested, including a copy of the license, sale, or release agreement, if applicable. OTC will inform the chair of the OIR Committee prior to the execution of a license, sale, or release agreement.

Management Plan for Potential Conflict of Interest

If you believe that you need a Conflict of Interest Management Plan, please call Dr. Robert A. Peterson's assistant at 512-471-2877. Dr. Peterson is the chair of the Objectivity in Research Committee, and his office will be glad to help you determine whether or not you need a management plan. If a management plan is necessary, Dr. Peterson's office will be happy to assist you with drafting the management plan.