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Part 11. Research
Section B. Research Ethics and Compliance
Policy Number 11.B.2
Date Issued: August 17, 2006
Approved By: Vice President for ResearchINSTITUTIONAL CONFLICT OF INTEREST IN HUMAN SUBJECTS RESEARCH
Section I. General Policy Guidelines
A. Policy Statement
It is the policy of The University of Texas at Austin to ensure that its human-subjects research is conducted with integrity and free from any actual or apparent institutional conflict of interest. This policy establishes the principles and procedures that enable the University to identify and avoid institutional conflicts of interest of a financial nature that present a significant risk to the perceived or actual objectivity of such research. The purpose of this policy is to provide a process by which the University can ensure that the decision-making processes for its financial and research activities related to human subjects research are separate; and that they are independently managed and monitored.
B. Scope of the Policy
This policy applies to any situation involving human-subjects research where there are actual or potential conflicts involving University equity holdings or royalty arrangements; or actual or potential conflicts involving University officials who have the authority to make decisions with institution-wide implications, and who hold positions with, or have financial interests in, entities that have an interest in University-sponsored human subjects research.
This policy is distinct from the University’s existing policy on Faculty Conflict of Interest (See the Original Handbook of Operating Procedures, Section 5.11, "Policy and Procedures for Promoting Objectivity in Research by Managing, Reducing, or Eliminating Conflicts of Interest"), which provides for the management of conflicts of interest that are personal to individual principal investigators.
C. Definitions
Business Entity means any entity recognized by law through which business for profit is conducted, including a sole proprietorship, partnership, firm, corporation, holding company, joint stock company receivership, or trust.
Human Subjects Research occurs when:
1. An investigator undertakes a systematic investigation including development, testing and evaluation designed to develop or contribute to generalizable knowledge that involves living individuals; and
2. The investigator obtains research data through intervention or interaction with individual human subjects, or from data bases that contain personally identifiable information about human subjects.
Institutional Conflict of Interest can occur whenever the external financial interests or business relationships of the University or of one of its officials are such that their actions could affect, or could reasonably appear to affect, the conduct, review or oversight of the University's human subjects research. The potential for institutional conflict of interest that could compromise the integrity of the University’s research mission generally arises in one of the two situations described below:
1. When the University, as an institution, has taken an equity interest in a business enterprise in which University employees conduct, or propose to conduct, research that could affect the value of the equity interest in that enterprise; or when the University holds a patent, license, or right to royalties on a process, technique, or production that it licenses to external companies, which in turn use University employees to conduct research on that process, technique or product; or
2. When a University official, with the authority to act on behalf of the University and to make decisions that have institution-wide implications, or whose decisions could reasonably be seen as affecting the conduct, review, or oversight of human subjects research, holds a significant financial interest in, consults for, serves on the board of, or is otherwise expected to act for the benefit of an entity that has a financial interest in University-sponsored human subjects research.
Significant Financial Interest in a Business Entity means (1) a controlling interest; (2) ownership of more than 10% of the voting interest; (3) ownership of more than 25% of the fair market value; (4) a direct or indirect participating interest by share, stock, or otherwise, regardless of whether voting rights are included, in more than 10% of the profits, proceeds or capital gains; (5) service as a member of the board of directors or other governing board; including a trustee or advisory director; (6) service as an officer; or (7) service as an employee.
University Official is defined as an individual who, because of his or her position with the University, has the capacity to affect, or can reasonably appear to affect, University processes for the conduct, review or oversight of human subjects research. Such officials can include the President, the Executive Vice President and Provost, Vice Presidents, Associate Vice Presidents and Vice Provosts, Deans, Department Chairs, and Directors of Organized Research Units.
Section II. Procedures for Disclosure, Review, and Responding to Information Reflecting Institutional Conflict of Interest
The Vice President for Research (VPR) has the responsibility for overseeing the process for reviewing, resolving and monitoring institutional conflict of interest that may arise from the business relationships of either the University or its officials with outside entities. Disclosures that may identify actual or potential institutional conflict of interest shall be handled as provided in Section D. below.
A. Disclosure of University Financial or Business Relationships
The University's Office of Technology Commercialization (OTC), which serves as a bridge between University-sponsored research and commercialization partners, shall provide the Office of the Vice President for Research with quarterly reports that disclose the entities in which the University holds equity positions or from which it has the right to receive royalty payments.
B. Disclosure of Officials' Financial or Business Relationships
University officials, as defined by this policy, shall disclose as a part of their "Financial Disclosure and Conflict of Interest Statements" filed annually with the Office of the Vice President for Institutional Relations and Legal Affairs (VPIRLA), information concerning any significant financial interest in, or position held with a business entity. The VPIRLA shall provide the VPR, or his or her delegate, copies of the disclosure statements. The VPR or delegate shall review the statements and identify any situations where an actual or potential institutional conflict of interest exists and respond as provided in Section D below.
The VPIRLA shall review the VPR's own "Financial Disclosure and Conflict of Interest Statement" for any institutional conflict of interest; and, pursuant to Section D. below, will notify the VPR of the need to either:
1. Totally divest him or herself of the financial interest; and/or
2. Resign from the board or other position with the external entity that has a financial interest in University human subjects research.
C. Review of Disclosure Information
The Office of Research Support and Compliance (ORSC) assists, supports and reviews all proposed human subjects research. The VPR shall provide the director of ORSC with copies of the "Financial Disclosure and Conflict of Interest Statements" received annually from the VPIRLA, and with the quarterly reports received from the Office of Technology Commercialization.
The ORSC director shall review all proposed human-subjects research proposals it receives with the disclosure information provided by the VPR to identify any actual or potential institutional conflict of interest present in the proposals. The ORSC director shall refer any research proposals for which an actual or potential institutional conflict of interest has been identified to the VPR for a response pursuant to Section D below. Once the institutional conflict of interest is resolved, the affected proposal shall be returned to ORSC for review by the University's Institutional Review Board.
D. Responding to Information Reflecting Potential Institutional Conflict of Interest
1. Actual or Apparent Conflict of Interest of the President, Executive Vice President and Provost, or the Vice President for Research
If the President, Executive Vice President and Provost, or the Vice President for Research is found to have an actual or apparent institutional conflict of interest, he or she shall either
a. Totally divest him or herself of the financial interest; and/ or
b. Resign from the board or other position with the external entity that has a financial interest in University-sponsored human subjects research. Proposed research cannot be approved or continued until such action is taken by the affected official.
2. All other Institutional Conflicts of Interest
The VPR shall appoint an Institutional Conflict of Interest Committee, which shall consult with the VPR where other actual or apparent institutional conflicts of interest are identified to determine whether to:
a. Require the OTC to divest the University's current equity holdings or right to royalties; and its right to acquire equity holdings in the future;
b. Propose modifications to the proposed human subjects research that would remove the possibility that the University, or any of its units or officials, would benefit financially from the results of the proposed research;
c. Prohibit the proposed human subjects research when in the best interests of the public or the University, upon recommendation from the Director of the Office of Research Support and Compliance;
d. Direct that the University official who holds a significant financial interest divest him- or herself of that interest, or remove him- or herself from the decision process involving such research;
OR
e. If feasible, develop an institutional conflict of interest (ICOI) management plan.
E. Monitoring the Conflict of Interest Process
The Institutional Conflict of Interest Committee shall monitor the Institutional Conflict of Interest Process. It shall meet as required but not less than annually to:
1. Ensure that University Officials are in compliance with the disclosure obligations of this policy;
2. Review and propose to the Vice President for Research modifications to the plans for managing institutional conflict of interest.
Any member of the ICOI committee who has a financial interest in or serves as a paid consultant for an entity that is involved in a research proposal shall not participate in the review under this policy.
Section III. Delegation of Authority for Compliance with Policy
The Vice President for Research is the University Official responsible for interpreting and overseeing implementation of and compliance with this Policy. This authority has been delegated to him by the President.
For Assistance. Questions regarding this policy should be directed to the Office of the Vice President for Research (471-2877).
Source: New UT Austin Policy (developed in accord with AAHRP recommendation and AAU Task Force on Research Accountability)