Policy 5-703

  1. Background

    The Public Health Service (PHS) and the National Science Foundation (NSF) have regulations promoting objectivity in Research, as defined below, by requiring that a university applying for grants or cooperative agreements for Research insure that there is no reasonable expectation that the design, conduct, and reporting of the Research to be funded pursuant to the application will be biased by any significant financial purposes of complying with these regulations, and to maintain a Research environment that promotes faithful attention to high ethical standards. The University of Texas at Arlington (UT Arlington) has promulgated this policy relating to conflicts of interest applicable to all UT Arlington Investigators, as defined below, and applies to all Research sponsored by, or the Board of Regents intellectual property licensed to, an entity in which a UT Arlington employee owns an interest or serves as an employee, officer, or member of the Board of Directors regardless of the source of funding to be administered in conjunction with Texas laws setting forth standards of conduct (Texas Government Code, Chapter 572), the Code of Ethics of UT System, the Board of Regents' Rules and Regulations, Rule 30104, and UT Arlington Handbook of Operating Procedures (HOP), Administrative Policies, Chapter 5, General Policies, Subchapter 5-508, Conflicts of Interest, Conflicts of Commitment, and Outside Activities.

  2. Policy Statement Relating to Conflicts of Interest

    It is the policy of UT Arlington that no proposed, awarded or ongoing UT Arlington Research project shall be biased by Significant Financial Interest, as defined below, or commitment of UT Arlington Investigators responsible for the design, conduct, or reporting of that Research project.

    Furthermore, it is the policy of UT Arlington that all UT Arlington faculty (fully-,partially-, or non-salaried), administrators or staff who have ownership in a company will disclose that ownership to allow a review of potential conflicts of interest, conflicts of commitment, conflicts regarding employment and/or use of graduate students in the company.

    In addition, this policy applies to any faculty (fully-,partially-, or non-salaried), or staff, student, fellow, trainee, administrator, volunteer, or other individual who, under the aegis of UT Arlington or pursuant to the review and approval of UT Arlington's Institutional Review Board for the Protection of Human Subjects (IRB), conducts research involving human subjects.

    Prior to seeking UT Arlington approvals for submission of any Research grant applications, each Investigator must have submitted to his/her Department Chair a financial disclosure statement listing all Significant Financial Interests of the Investigator. Each such financial disclosure statement must be updated during the pendency of the award either on an annual basis, or as new reportable Significant Financial Interests are obtained. The Office of Research will maintain records, identifiable by Investigator, award and/or company, of all financial disclosures and all actions taken with respect to each Significant Financial Interest for at least three years beyond the termination or completion of the award, or until resolution of any action by a granting agency involving the records, whichever is longer. In the case of faculty or staff ownership of a company, all financial disclosures and all actions taken with respect to each Significant Financial Interest will be held for the life of the company plus the number of years as determined under UT Arlington HOP, Administrative Policies, Chapter 5. General Policies, Subchapter ADM 5-700 Records Management and Retention.

    This policy establishes guidelines of the appropriate structuring of relationships with industry and other outside ventures so as not to conflict with previously established responsibilities to UT Arlington. Investigators are expected to make reasonable inquiry as to whether their relationships and activities fall within the provisions of this policy. It is not the intent of this policy to eliminate or prohibit all situations involving potential conflicts of interest. This policy is intended to enable Investigators to recognize situations that may pose a conflict of interest, to report these situations to UT Arlington's Research Integrity Committee (RIC), as defined below, and to ensure that the RIC reviews these situations and, if necessary, supervises or monitors them. An integral part of this policy is a disclosure mechanism whereby Investigators regularly review their activities. This policy is intended to maintain the professional autonomy of researchers inherent in the self-regulation of Research and scholarship.

    UT Arlington's growing interaction with industry and for-profit enterprises has created new possibilities for the occurrence of conflicts of interest. These conflicts arise when there are opportunities for faculty or staff members to benefit financially either from the outcome of Research or from activities conducted in the course of responsibilities as a UT Arlington Research member.

    UT Arlington believes that with clear guidelines and principles, in conjunction with appropriate supervision and monitoring, it is possible for interaction between industry and UT Arlington to take place in a manner that is consistent with the highest traditions of scientific Research and in a way that energizes scientific creativity.

    In the event that an Investigator participates in Research subject to this policy and the Research is being simultaneously supported by an organization that has a commercial interest in the outcome of the Research project, the Research support by such organization must be provided through UT Arlington. Any direct compensation or payment to the Investigator under that support shall be considered a Significant Financial Interest. This policy will provide assurance to the Investigators, UT Arlington, and, most importantly, the public, that relationships with industry have been examined and will be conducted in a manner consistent with UT Arlington and public values.

  3. Definitions

    1. Associated Entity. Associated Entity means any trust, organization, enterprise or any affiliate over which the Investigator, alone or together with his/her Family, possesses a material, decision-making position or Significant Financial Interest.

    2. Business. Business means any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company, receivership, real estate trust, or any other legal entity organized for profit or charitable purposes A Business also includes entities where UT Arlington may have participation on the Board of Directors of the Business or hold stock in the Business.

    3. Executive Position. Executive Position refers to any position that includes responsibilities for a material segment of the operation or management of a Business.

    4. Family. Family includes spouse, minor children, and other persons living in the same household, together with all individuals related within the second degree of affinity or third degree of consanguinity.

    5. Investigator. Investigator means UT Arlington faculty or staff members who are the principal Investigators or project directors, co-principal Investigators, as well as post-doctoral fellows, technicians, students or any other faculty or staff member at UT Arlington who is responsible for the design, conduct, or reporting of Research, educational, or service activities funded, or proposed for funding, by an external sponsor.

    6. Participation. Participation means to be a part of the described activity in any capacity, including, but not limited to, serving as the principal Investigator, co-Investigator, Research collaborator or provider of direct patient care. The term is not intended to apply to individuals who provide primarily technical support or who are purely advisory, with no direct access to the data (e.g., control over its collection or analysis) or, in the case of clinical Research, to the trial participants unless they are in a position to influence the study's results or have privileged information as to the outcome.

    7. Sponsored Research. Sponsored Research means Research, training and instructional projects involving funds, materials, or other compensation from external sources.

    8. Research. Research means a systematic investigation designed to develop or contribute to knowledge.

    9. Responsible University Official (RUO). The Responsible University Official will be the Vice President for Research. The Research Integrity Officer (RIO), as defined below, shall report to the RUO on all matters concerning this policy.

    10. Research Integrity Officer (RIO). The Research Integrity Officer will be the Assistant Vice President for Research/Director Office of Research. The RIO will chair the Research Integrity Committee, as defined below.

    11. Research Integrity Committee (RIC). The Research Integrity Committee shall review all Class B and Class C conflicts of interest and shall decide actions to be taken in reducing or eliminating existing or proposed conflicts of interest.

    12. Significant Financial Interest. Significant Financial Interest includes the following interests of the Investigator, his/her spouse and dependent children, or any foundation or entity controlled or directed by the Investigator or his/her spouse:

      1. Receipt of, or the right or expectation to receive monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees, honoraria, payments for directorships or executive roles);

      2. Equity interests (e.g. stocks, stock options, dividends or other ownership interests);

      3. Intellectual property rights (e.g., patents, copyrights and royalties from such rights); or,

      4. Any non-royalty payments or entitlements to payments in connection with the research that are not directly related to the reasonable costs of the research (as specified in the research agreement between the sponsor and the institution). This includes any bonus or milestone payments to the investigators in excess of reasonable costs incurred, whether such payments are received from a financially interested company or from the institution.

      5. Service as an officer, director, or in any other fiduciary role for a financially interested company, whether or not remuneration is received for such service.

      6. Receipt of, or the right or expectation to receive other value, such as in the form of a forbearance, forgiveness, interest in real or personal property, rent, capital gain, real or personal property, or any other form of compensation, such as gifts.

      Notwithstanding the foregoing, for the purposes of this policy, a Significant Financial Interest does not include:

      1. Interest(s) held directly through funds such as mutual funds, pension funds, or other institutional investment fund in which the Investigator or the Investigator's Family does not control the selection of investments.

      2. Further, the following financial interests do not rise to the level of a Significant Financial Interest:

        1. Salary or other remuneration received from UT Arlington;

        2. Standard royalties received for published scholarly work or other professional writings;

        3. Royalties or equities received under UT Arlington royalty-sharing policies (See UT Arlington Intellectual Property Policy);

        4. Consulting fees received from an entity in which neither the Investigator, the Investigator's Family, an Associated Entity of the Investigator, nor UT Arlington have any other relationship, provided that the consulting relationship has been approved in accordance with the UT Arlington Outside Employment Policy, and subject to all other policy requirements including appropriate devotion of time to UT Arlington;

        5. Income from seminars, lectures, or teaching engagements sponsored by public entities or non-profit; or,

        6. Income from services on advisory committees or review panels for governmental entities, public or non-profit entities.

        7. Salary or other payments for services received from UT Arlington.

    13. Use of Human Subjects in Research. Human Subject means a living individual about whom an Investigator conducting Research obtains data through intervention or interaction with the individual or obtains data through identifiable private information. If a potential conflict of interest exists, and human subjects are involved in the Research, the Investigator will need to obtain the approval of UT Arlington's Institutional Review Board for the Protection of Human Subjects as well as the approval of the RIC.

  4. Conflicts of Interest

    A potential conflict of interest exists whenever an Investigator, his or her family, or an associated entity of the investigator possesses a material, decision-making or a significant financial interest in a commercial or professional activity or business that may impact a proposed, awarded, or ongoing UT Arlington Research project involving the Investigator. The impact may occur in, but is not limited to, the areas of time, effort, finances, or focus of effort as related to Research or adverse impact on a subordinate faculty or staff member. In general, a conflict of interest will be considered to exist whenever professional judgment concerning the performance of Research duties or activities as an Investigator for UT Arlington is unduly influenced by a secondary interest or a business.

  5. Guidelines Applicable to Potential Conflicts of Interest

    The following are representative categories of relationships and activities where conflicts of interest may arise that are subject to this policy. These classifications are representative only and are not intended to define absolute categories where conflicts of interest would or would not exist. If an Investigator is uncertain as to which category applies to a given relationship or activity, then he or she should disclose that relationship or activity to the Research Integrity Committee for review and a determination.

    1. CLASS A: Relationships or activities that are not allowed.

      Examples of CLASS A:

      1. Investigations involving a known conflict of interest and the use of Human Subjects who may be at risk from the procedures used; or

      2. Any Investigator making clinical or medical referrals to a Business in which the Investigator, a member of his or her Family, or an Associated Entity of the Investigator has a Significant Financial Interest.

    2. CLASS B: Relationships or activities that are only permitted after full disclosure to, review by, and written approval by the RIC. The RIC's approval may be contingent on certain requirements being implemented, including, but not limited to, on-going review and oversight by the RIC.

      Examples of CLASS B:

      1. Investigations involving a potential conflict of interest and the use of Human Subjects who may be at risk from the procedures used;

      2. Any Investigator conducting Research externally that would ordinarily be conducted within UT Arlington;

      3. Any Investigator assuming an Executive Position in a Business engaged in commercial or Research activities;

      4. Any Investigator receiving Sponsored Research through UT Arlington or gifts (whether in dollars or in kind) for Research from a Business in which the Investigator, a member of his or her Family, or an Associated Entity of the Investigator has a consulting agreement whereby a per hour or any other fee is received;

      5. A relationship or activity where an Investigator, his or her Family, or an Associated Entity of the Investigator possesses a material, decision-making or Significant Financial Interest in a commercial or professional activity or Business that has a potential impact on a proposed, awarded, or ongoing UT Arlington Research project involving the Investigator;

      6. Any Investigator taking administrative action within UT Arlington or any action that is beneficial to a Business in which Investigator, Investigator's Family, or an Associated Entity of Investigator has a Significant Financial Interest;

      7. Any Investigator participating in Research on a technology developed by a member of his or her Family, or an Associated Entity of the Investigator;

      8. Any Investigator serving on the Board of Directors or any advisory board of a Business from which the Investigator, or a member of his or her Family, or an Associated Entity of the Investigator receives Sponsored Research support or with which UT Arlington has a contractual relationship;

      9. Any Investigator who assigns students, post-doctoral fellows or other trainees to projects sponsored by a Business in which the Investigator, a member of his or her Family, or an Associated Entity of the Investigator has a Significant Financial Interest; or,

      10. Any Investigator who applies for federal funding, including, but not limited to, PHS and/or NSF funding for Research and the Investigator, or a member of his or her Family, or an Associated Entity of the Investigator have a Significant Financial Interest that could directly affect the design, conduct or reporting of the federally funded Research.

    3. CLASS C: Relationships or activities, which are normally allowable because they involve minimal financial interests, are generally accepted practices and/or are unrelated to institutional activities. These situations do not require disclosure to the RIC, unless a known conflict of interest exists.

      An example of CLASS C:

      1. Any Investigator participating in the review, assessment, or consideration by a committee of a governmental agency, such as a study session or proposal review panel.

  6. Procedures

    1. On an annual basis, all Investigators must certify to their Department Chair or Unit Head and Dean their knowledge of and compliance with UT Arlington's policy for promoting objectivity in Research by managing, reducing, or eliminating conflicts of interest as outlined herein (a sample certification form is at the end of this subchapter). The certification form also requires similar information about members of the Investigator's immediate family. At minimum, disclosures must include the information found on the sample certification form at the end of this subchapter.

      In addition, Investigators must disclose to their Department Chair or Unit Head and Dean on an ad hoc basis new situations in which Significant Financial Interests are obtained and which may raise questions of conflicts of interest as soon as such situations develop.

    2. The Department Chair or the Unit Head and the Dean will review the certification statement, sign it, and forward it to the Office of Research. In those cases where activity is reported, certifications will be forwarded to the RIC.

    3. The RIC will review the financial disclosure, determine whether an actual or potential conflict of interest exists, and determine what conditions or restrictions, if any, should be imposed by UT Arlington to manage, reduce, or eliminate such conflict of interest. An actual or potential conflict of interest exists when a reviewer reasonably determines that a Significant Financial Interest could affect the design, conduct, or reporting of the Research or educational activities in question.

    4. Examples of conditions or restrictions that might be imposed to manage, reduce, or eliminate actual or potential conflicts of interest include:

      1. Public disclosure of Significant Financial Interests;

      2. Monitoring of the Research by independent reviewers;

      3. Modification of the Research plan;

      4. Disqualification from Participation in all or a portion of the Research project in question;

      5. Divestiture of Significant Financial Interests; and,

      6. Severance of relationships that create actual or potential conflicts.

    5. The Chair of the Research Integrity Committee will forward the signed certification form along with the RIC's recommendation to the Responsible University Official. The RIO shall confer with the Responsible University Official about the recommendation of the RIC.

    6. If a conflict exists, or if there is a potential of a conflict, and it is the recommendation of the RIC to develop a conflict of interest management plan, the RIO shall work with the Investigator to develop the plan. The plan will then be submitted to the RIC for initial approval. Upon obtaining initial approval from the RIC, the RIO will seek the approval of the RUO. Once approval of the RUO is obtained, the RIC will undertake the implementation, management, and oversight of the plan.

    7. If the recommendation of the RIC involves divestiture of financial interests or severance of relationships that create actual or potential conflicts, the RIC will notify the RUO. The RUO will confer with the Provost. The Provost will make the final decision. If the Provost approves the divestiture or severance of relationships, the RIC will provide oversight.

  7. Responsibilities and Appeals

    1. Responsibilities of Department Chairs, Unit Heads, and Academic Deans. Each Department Chair, Unit Head, and Dean is responsible for the timely review of annual certifications, as well as ad hoc disclosure reports. The Office of Research shall work with each college or school, as needed, in the distribution, receipt, processing, and review of disclosure forms. Disclosure forms shall be submitted to the Office of Research.

      Deans and Unit Heads will file their own disclosures and certifications of compliance with the Vice President for Research.

    2. Responsibilities of Research Integrity Officer. The Assistant Vice President for Research/Director Office of Research is UT Arlington's RIO. He/she is responsible for interpreting and overseeing implementation of and compliance with this policy. He/she serves as Chair of the RIC and reports to the RUO.

      The RIO is responsible for keeping the appropriate external funding agency informed if UT Arlington finds it is unable to satisfactorily manage an actual or potential conflict of interest for any activity in which that agency requires that it be notified in such an instance.

    3. Appeals of Decisions Made by the University Research Integrity Committee. Should an Investigator wish to appeal a decision made by the RIC, he/she may present the appeal to the RUO. The RUO will confer with the Provost and the Provost will render a decision.

    4. Responsibilities of Investigators. UT Arlington Investigators involved in Research shall be responsible for:

      1. Reading, understanding and following this policy;

      2. Disclosing financial and commitment interests to the Office of Research by completing, signing, and submitting the Statement of Interest Form ('Statement') on or before a specified date or before submission of the grant/contract application;

      3. Ensuring that funded Research carried out through subgrantees, contractors or collaborators provide that these entities' investigators comply with UT Arlington's Conflict of Interest Policy or that these entities provide assurance of compliance with all federal regulations and state law;

      4. Updating the Statement with the Office of Research as changes occur, so that the Statement on file is current and accurate at all times when an award is pending or in force;

      5. Disclosing financial and commitment interests to the Office of Research by completing, signing, and submitting the Statement on or before a specified date or before submission of the grant/contract application; and,

      6. Obtaining, prior to submission of the Statement, review and signature of the Department Chair or Unit Head, Dean, and, if appropriate, the Chair of the RIC in compliance with this policy and with its regulatory basis.

    5. Appeals. In the event of a disagreement with the findings and/or decisions of the RUO, the Investigator may appeal those findings/decisions to the 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 the RUO, and shall make a final decision as to the action. All decisions of the Provost of an appeal under this policy are final.

  8. Self-Disclosure of Situations Involving Potential Conflicts of Interest

    1. In order to help in the identification of potential conflicts of interest, all Investigators involved in Research shall be required to submit a 'Statement of Interest' to accompany any Research proposal of the Investigator, regardless of support. This Statement shall be submitted to the Department Chair or Unit Head who must review it, sign it, and submit it to the Dean. The Dean then reviews the Statement, signs it, and submits it to the Office of Research. Failure to submit the Statement or submission of an incomplete Statement may result in delay of the submission of grant applications.

    2. Initial review of the Statement will be conducted by the Office of Research. Individual Investigators will be notified of any additional information that is necessary for review of the Statements. Information necessary to complete the process shall be submitted within thirty days from the date of notice of an incomplete Statement. Regardless of review by the Office of Research, it remains the responsibility of the individual Investigator to fully disclose all information on the Statement.

    3. Fully completed Statements will be divided into two categories:

      1. Statements that do not involve a Class A or Class B situation, a Significant Financial Interest, and/or other potential conflicts of interest will require no further review. Records identifiable to any grant awarded to the Investigator will be maintained to show that review has taken place and no further action is needed by the Investigator, unless a factual change occurs. If required by a granting agency, notice of no need for further review will be forwarded to the agency in accordance with the agency's policy.

      2. Statements that involve a Class A or Class B situation, a Significant Financial Interest, and/or other potential conflicts of interest will require further review. Statements including Class A situations will not be approved. Statements including Class B situations will only be approved after full disclosure to, review by, and written approval by the RIC.

  9. Enforcement

    1. UT Arlington anticipates that its Investigators will comply fully, promptly, and in a timely manner with this policy. Instances of deliberate breach, including: (i) failure to submit required Statements or updates thereof; (ii) failure to provide additional information requested by the Investigator's Department Chair or Unit Head, Dean, the RIC, or the Office of Research; (iii) knowingly filing an incomplete, erroneous, or misleading Statement; (iv) knowingly violating applicable laws, UT Arlington Policies or Procedures or the rules and regulations of this policy; (v) or failure to comply with prescribed conditions or restrictions that have been imposed pursuant to this policy, will subject the Investigator to disciplinary action under UT Arlington Policies or Procedures and the Regents' Rules and Regulations. Such action could result in a formal reprimand, non-renewal of appointment, termination of appointment for good cause, or any other enforcement action mandated by a granting agency.

    2. If the failure of an Investigator to comply with this policy has biased the design, conduct, or reporting of the Research, UT Arlington, through the RUO, will promptly notify the granting agency of the incident and the corrective action taken.

  10. The Research Integrity Committee

    1. The Provost shall annually appoint a standing RIC that shall consist of not less than five tenured UT Arlington faculty members and the Assistant Vice President for Research/Director Office of Research. Faculty members shall serve staggered three-year terms. The Assistant Vice President for Research/Director Office of Research shall serve as the Chair of the RIC. The Vice President for Research shall resolve any unbreakable ties in voting. Should any member fail to complete his/her term, the Provost shall appoint a replacement for the remainder of that member's term. The Provost may remove an RIC member at any time for failure to perform his/her RIC duties adequately or as required to serve the best interests of UT Arlington. A member shall recuse him or herself in areas where the member has a personal or professional interest. The Chancellor shall resolve any conflict of interest issues involving the President of UT Arlington.

    2. Responsibilities of the Research Integrity Committee. The RIC shall be responsible for:

      1. Soliciting, reviewing, and maintaining records of the potential conflict of interest information required by this policy;

      2. Obtaining additional information from Investigators and other sources as necessary to make informed judgments and decisions;

      3. Taking appropriate action to identify, investigate, manage, reduce, resolve and/or eliminate actual and potential conflicts of interest in accordance with this policy. Such resolution may include, but is not limited to: (i) the public disclosure of a Significant Financial Interest; (ii) monitoring of Research by independent reviewers; (iii) modification of Research plans; (iv) disqualification from Participation in Research including, but not limited to, PHS and/or NSF funded Research; (v) divestiture of the Significant Financial Interest; and/or (vi) requiring the severance of relationships and/or activities that have created the potential conflict of interest;

      4. After full review of a matter, issuing a written determination to the Investigator;

      5. Notifying the RUO of significant potential conflicts of interest that have been reviewed by the RIC;

      6. Reporting the results of all determinations and all actions taken to the RUO for communication to the appropriate agencies; and

      7. Maintaining confidentiality, to the extent permitted by law, on all disclosures and records of actions taken to manage potential conflicts of 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. The records will be available for audit by authorized agencies.

  11. Consulting Agreements Involving Employees

    1. Faculty and staff members involved in Research who are contemplating outside professional activities for which they will be paid, such as consulting, must submit a written request for approval to their Department Chair or Unit Head in accordance with UT Arlington Personnel Policies. Faculty and staff members must exercise caution in entering into consulting agreements. Many such agreements provide that new inventions and ideas will be assigned to the company employing the faculty or staff member as a consultant. Care should be exercised to see that no UT Arlington facilities are used in any way in the performance of the consulting agreement and that the subject matter of inventions to be assigned to the company pursuant to the consulting agreement is not within the scope of the responsibilities of the faculty or staff member to UT Arlington.

    2. Rights in inventions within the scope of the faculty and staff member responsibilities to UT Arlington developed using the UT Arlington's facilities or funding will be owned by UT Arlington pursuant to the UT Arlington and UT System's Intellectual Property Policy irrespective of the terms of the consulting agreement. Each consulting agreement must include the following paragraph recognizing UT Arlington's overriding rights:

      "The Company recognizes that the consultant is a faculty or staff member of UT Arlington (and as such, a faculty or staff member of the State of Texas), and has existing and overriding contractual obligations to UT Arlington. Nothing in this agreement shall be construed as requiring the consultant to violate those obligations. The Company specifically recognizes that the consultant has a contractual obligation to assign to UT Arlington all Intellectual Property pursuant to the UT Arlington Intellectual Property Policy that is related to the consultant's employment responsibilities."

  12. Use of Human Subjects

    1. Any faculty (fully-, partially-, or non-salaried), or staff, student, fellow, trainee, administrator, volunteer, or other individual who, under the aegis of UT Arlington or pursuant to the review and approval of UT Arlington's Institutional Review Board for the Protection of Human Subjects (IRB), conducts research involving human subjects must complete and submit a Statement for review by the RIC. The statement must be updated as circumstances of the Investigator or his/her spouse or dependent children change.

    2. Reporting of UT Arlington Financial Interests Obtained Through Licensing Agreements. UT Arlington's technology transfer unit should report to the RIC when, as the result of a licensing agreement, UT Arlington takes (or intends to take) an equity interest, stock options, or any entitlement to an ownership interest in, or royalty payments from, a potential sponsor of human subjects research conducted at or under the auspices of UT Arlington.

    3. Reporting of Personal Financial Interests of Institutional Officials. Institutional officers, board members, and administrators who oversee human subjects research -- including the president, vice president for research, deans, chairs, institute heads, and the chairs of the IRB and RIC -- are be required to make an annual report of any personal financial interests that might appear to be affected by human subjects research conducted at or under the auspices of UT Arlington.

    4. Reporting of Financial Interests by IRB Members. UT Arlington requires that IRB members report annually any personal and significant financial interests that might reasonably appear to be affected by the scope of their responsibilities. This includes when the IRB member is aware that the company in question is or may become a sponsor of human subjects research at UT Arlington.

    5. The RIC shall undertake the following processes prior to final IRB approval of the research:

      1. Begin its evaluation with the rebuttable presumption that financially interested individuals may not conduct human subjects research.

      2. Prohibit payments from UT Arlington or external sponsor to a human subject, if such payments are conditioned upon a particular research result.

      3. UT System Component Institution policies shall not permit payments for subject enrollment, other than reimbursements to patients for reasonable expenses.

      4. Payments for patient referral to research studies will be permitted only to the extent that such payments:

        1. Are reasonably related to costs incurred;

        2. Reflect the fair market value of services performed; and

        3. Are commensurate with the efforts of the individual(s) performing the research.

      5. Under this policy UT Arlington prohibits individuals from entering into research agreements that:

        1. Permit a sponsor or other financially interested company to require more than a reasonable period of pre-publication review, or

        2. Interfere with an investigator's access to the data or ability to analyze the data independently.

      6. UT Arlington will not allow agreements with sponsors or financially interested companies that restrict the activities of students or trainees or bind students or trainees to non-disclosure provisions. When deemed unavoidable, the policy should subject such agreements to close scrutiny and fully disclose them to all students and trainees.

    TO BE COMPLETED BY EACH INVESTIGATOR.

    THE UNIVERSITY OF TEXAS AT ARLINGTON

    STATEMENT OF INTEREST

    Annual Certification of Compliance with the Policy for Promoting Objectivity in Research by Managing, Reducing or Eliminating Conflict of Interest

    Name: ____________________________________________________________

    Title: _____________________________________________________________

    Department(s)/Unit: __________________________________________________

    Campus Telephone Number: _______________ E-Mail Address: ______________

    The following questions apply to your current situation. If there are any changes during the current fiscal year (i.e., September 1 through the following August 31) you must resubmit this form with the new information. If you answer yes to any of the questions below, provide an attached detailed and thorough written description and explanation.

    1. Do you currently conduct internally or externally sponsored research or are you supported by a grant or contract the outcome of which could affect the interests of an enterprise or entity in which you (or members of your immediate family, i.e., spouse, or dependent children as defined by the Internal Revenue Service) have employment or consulting arrangements and/or financial interests?

    Yes_____(If yes, attach a detailed description and explanation) No____

    2. Do you currently have internally or externally sponsored research or are you supported by a grant or contract where you (or members of your immediate family) have employment or consulting arrangements and/or significant financial interest with the sponsor of the research, a subcontractor to the grant, a vendor, or a research collaborator?

    Yes____( If yes, attach a detailed description and explanation) No____

    3. Do you currently have gifts, cash, or property which are under your control, or which directly support your teaching or research activities from an enterprise or entity in which you (or members of your immediate family) have an employment or consulting arrangement and/or financial interests?

    Yes____ (If yes, attach a detailed description and explanation) No____

    4. Does the University currently have a technology licensing arrangement with an enterprise or entity for which you (or your immediate family members) have employment or consulting arrangements and/or financial interests?

    Yes____ (If yes, attach a detailed description and explanation) No____

    5. Describe in an attachment the involvement, if any, of any UT Arlington students or post-docs in your research.

    6. Describe in an attachment the involvement, if any, of human subjects in your research.

    Certification

    In submitting this Statement, I certify that the above information is true to the best of my knowledge and I have read and understand the University of Texas at Arlington's Conflict of Interest Policy, Ethics Policy, and Faculty or Staff Outside Employment Policy. I certify that I have disclosed all potential financial and commitment interests as required by all UT Arlington policies, including these policies. I agree to comply with provisions of UT Arlington policies to immediately report changes in my Financial Interests. Furthermore, I agree to comply with conditions or restrictions imposed by UT Arlington to manage, reduce or eliminate actual or potential conflicts of interest. All statements made in this Statement of Interest Certification of Compliance With the Policy for Promoting Objectivity in Research by Managing, Reducing or Eliminating Conflict of Interest are made with the knowledge that willful false statements and the like are punishable by fine or imprisonment, or both under 18 U.S.C. ยง 1001.

    Signature: _____________________________ Date: ___________

    Investigator

    Completed Certification must be submitted to your Chair or Unit Head and Dean for administrative review and approval. If you have a dual appointment in more than one department, college or school, all Chairs and Deans must sign.

    Signature: ____________________________ Date: ______________

    Department Chair/Unit Head

    Signature: ____________________________ Date: ______________

    Dean

    Upon completion, please submit to the Office of Research, P.O. Box 19145

    Please address any questions concerning this Statement to the Research Compliance Officer, Office of Research, 817-272-2105.