Institutional Conflict of Interest in Human Subject Research
Handbook of Operating Procedures 7-1220
Institutional Conflict of Interest in Human Subject Research
I. Policy Statement
It is the policy of The University of Texas at Austin (“University”) to ensure its human subject 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.
This policy is distinct from the University’s other existing policies on conflicts of interest in research, including HOP 7-1210, "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 the individual.
II. Reason for Policy
To provide a process by which the University can ensure the decision-making processes for its financial and research activities related to human subject research are separate and independently managed and monitored.
III. Scope & Audience
This policy applies to all University employees engaged in human subject research and those individuals who provide oversight, management and/or review of such activity.
IV. Definitions (specific to this policy)
- Business Entity:
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 Subject Research:
- An investigator undertakes a systematic investigation including development, testing and evaluation designed to develop or contribute to generalizable knowledge that involves living individuals; and
- 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 subject 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 three situations described below:
- 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;
- 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
- 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 subject 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 subject 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, the value of which exceeds $1,000,000; (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:
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 subject 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.
V. Website (for policy)
|Office of the Associate Vice President for Research/ Conflict of Interest Official (for research)||Phone:512-471-8871||Website:|
VII. Responsibilities & Procedures
Sec. I 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.
- 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.
- Disclosure of Officials' Financial or Business Relationships
University officials must furnish written conflict of interest disclosures as may be required by state or federal authorities or by The University of Texas System Administration or institutional policies. This disclosure will be made at least annually and within thirty (30) days of a change in the individual's financial or business relationship that would require disclosure under such laws or policies.
- Review of Disclosure Information
The Office of Research Support (“ORS”) assists, supports and reviews all proposed human subject research and administers the Objectivity in Research program. The VPR shall provide the director of ORS with copies of Financial Disclosures that are related to human subject research and meet the definition of “Significant Financial Interest in a Business Entity”, and with the quarterly reports received from the OTC.
The ORS director shall review all proposed human subject 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 ORS director must 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 ORS for review by the University's Institutional Review Board.
- Responding to Information Reflecting Potential Institutional Conflict of Interest
- 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:
- totally divest him or herself of the financial interest; and/ or
- resign from the board or other position with the external entity that has a financial interest in University-sponsored human subject research. Proposed research cannot be approved or continued until such action is taken by the affected official.
- All Other Institutional Conflicts of Interest
The VPR shall appoint an Institutional Conflict of Interest Committee, which must consult with the VPR where other actual or apparent institutional conflicts of interest are identified to determine whether to:
- In cases involving a business entity, require the OTC to divest the University's current equity holdings and/or its right to royalties in that business entity, as well as its right to acquire equity holdings in the future;
- Propose modifications to the proposed human subject 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;
- Prohibit the proposed human subject research when in the best interests of the public or the University, upon recommendation from the Director of the Office of Research Support;
- 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
- If feasible, develop an institutional conflict of interest management plan.
- Monitoring the Conflict of Interest Process
The Institutional Conflict of Interest Committee (“ICOIC”) shall monitor the institutional conflict of interest process. It shall meet as required but not less than annually to:
- Ensure that University officials are in compliance with the disclosure obligations of this policy;
- Review and propose to the VPR modifications to the plans for managing institutional conflict of interest.
Any member of the ICOIC 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.
Sec. II Delegation of Authority for Compliance with Policy
The president delegates the vice president for research as the University official responsible for interpreting and overseeing implementation of and compliance with this policy.
VIII. Form & Tools
Last review date: May 28, 2013
Nest scheduled review: May 2015
Policy issued: August 17, 2006
Previously HOP 11.B.2