UTMB HANDBOOK OF OPERATING PROCEDURES

Section 6 Compliance Subject 6.1 General Compliance Policy 6.1.12 Conflict of Interest and Commitment Policy

06/15/04 -Originated 11/14/06 -Reviewed w/ changes -Reviewed w/o changes Office of Research Subject Protection -Author

Conflict of Interest and Commitment Policy for Research and Education

Policy

This Policy is intended to provide a basic overview of Conflict of Interest and Commitment guidelines at UTMB. Detailed guidance regarding the Policy and applicable procedures may be accessed via the UTMB Conflict of Interest Manual. The purpose of this Policy is to: 1. Provide guidelines for those relationships with outside organizations that will help to assure the primacy of academic integrity and delineate the bounds of acceptable conduct for those who conduct any type of research and particularly research involving human subjects 2. Provide UTMB’s approach to identifying and evaluating potential conflict of interest and conflict of commitment issues for faculty and staff members and UTMB 3. Assist in carrying out the responsibility of addressing conflict of interest and conflict of commitment issues To this end, all Covered Individuals are required to avoid perceived and actual conflicts of interest and conflicts of commitment in their relationships with outside organizations, unless a conflict has been disclosed and can be managed in accordance with an institutionally approved conflict management plan as required by this Policy. A Covered Individual shall be considered to have a conflict of interest when he or she, or a member of that person’s Family, possesses a Significant Financial Interest in an activity that involves his or her UTMB responsibilities. These responsibilities might involve business operations, such as conflicts associated with the purchasing of goods or services, or human subjects research. Regarding research activities, a Covered Individual with a conflict of interest shall not, without prior approval by the Conflict of Interest and Commitment Committee, conduct research in the field of his or her UTMB responsibilities externally and in competition with UTMB and its legitimate interests when that research is within the course and scope of his or her UTMB employment.

Policy, continued	A Covered Individual shall be considered to have a conflict of commitment when he or she devotes excessive time (as defined by the Conflict of Interest and Commitment Committee, approved by the UTMB President, and described in the UTMB Conflict of Interest Manual) to outside activities which have the potential to compromise the employee’s ability to meet his or her obligations to UTMB. A Covered Individual shall not receive excessive compensation (as defined by the Conflict of Interest and Commitment Committee, approved by the UTMB President, and described in the UTMB Conflict of Interest Manual) in relation to his or her UTMB base salary from any or all Financially Interested Entities while he or she conducts research or business, on behalf of UTMB, the Financially Interested Facility (ies).
Institutional Conflicts	The rigorous application of this Policy will be particularly important in the case of persons exercising significant institutional authority. Individuals in administrative positions have substantial influence over others by virtue of their role in professional appointments, promotions, tenure decisions, allocations of space, determinations of salary, etc. Faculty and staff with administrative responsibilities shall avoid relationships that have the potential to adversely affect the institution’s interests or inject inappropriate considerations into administrative decisions.
Disclosure Requirements/ Compliance Responsibility	UTMB expects Covered Individuals to comply fully and promptly with this Policy, including the requirements of disclosure. All Covered Individuals are required to complete a Conflict of Interest Disclosure Form at the time of employment and at the time of the annual disclosure period thereafter. In addition, whenever a change has occurred in their current disclosure situation (e.g., a new relationship, a change to an existing relationship, or the termination of a relationship), Covered Individuals are required to re-submit a Conflict of Interest Disclosure Form within 30 days. It will be the responsibility of the appropriate department chair, vice president, or dean to ensure that all Covered Individuals complete Conflict of Interest Disclosure Forms as required.

Conflict of Interest Official and Committee, continued	The UTMB President shall appoint a Conflict of Interest Official, who shall report to the UTMB President regarding all conflict of interest and commitment activities. Upon recommendation of the Conflict of Interest Official, the UTMB President shall appoint a Conflict of Interest and Commitment Committee, consisting of: faculty members and administrators from academic, clinical and/or basic science departments; representatives from various university areas such as Research Services, Office of Research Subject Protections, Purchasing and Legal Affairs; and representatives from the local Galveston County community. The Conflict of Interest and Commitment Committee shall meet as necessary to review disclosures and other related issues brought to the attention of the Committee. The Conflict of Interest and Commitment Committee shall make recommendations as needed and shall design and implement management plans to manage, reduce or eliminate identified conflicts of interest. Some management plans may require prior approval from the University of Texas System.
Relationship to Federal and Texas Laws and Regulations, University of Texas System Policies and UTMB Policies	There are applicable federal and Texas laws and regulations on conflicts of interest and commitment, including but not limited to: the Code of Federal Regulations, Texas Government Code, Texas Penal Code, and Texas Education Code. This policy supplements federal and state laws and regulations as well as other institutional policies, including but not limited to the Rules and Regulations of the University of Texas System Board of Regents, University of Texas system Business Procedure Memoranda, and the UTMB Institutional Handbook of Operating Procedures (IHOP).
Violations	Instances of deliberate breach of Policy including, but not limited to, failure to file or knowingly filing an incomplete, erroneous, or misleading Conflict of Interest Disclosure Form, violations of the guidelines, or failure to comply with prescribed monitoring procedures, will be adjudicated in accordance with applicable disciplinary policies and procedures for each covered individual. Possible sanctions may include some or all of the following actions: 1. Termination of the activity that is a conflict of interest 2. Divestiture of significant financial interests

Violations, continued	3. Disciplinary action against the employee up to and including termination. Disciplinary action shall be administered according to the UTMB Institutional Handbook of Operating Procedures and the Regent’s Rules and Regulations. In the case of a violation of criminal or civil law, violators may be subject to civil or criminal penalties.
Appeals	Covered Individuals who wish to appeal a decision of the Conflict of Interest and Commitment Committee may present an appeal to his or her appropriate Dean or Vice President. If the Dean or Vice President approves the appeal, ten the appeal is forwarded to the UTMB President for final review. The UTMB President shall decide whether to permit the activity or to uphold the decision of the Conflict of Interest and Commitment Committee.
Maintenance of Records	The Conflict of Interest Official shall maintain all Conflict of Interest Disclosure Forms and related records. All records are official records and shall be maintained according to an appropriate retention schedule. The forms shall be considered confidential and the information disclosed in the forms will be available only to individuals duly charged with the responsibility for review. However, the information may be released in accordance with and as required by Texas law or lawful court order.
References	42 Code of Federal Regulations 50, Subpart F, Sections 50.601 to 50.607 Texas State Statutes Regents’ Rules and Regulations For additional information, refer to the UTMB Conflict of Interest Manual located on the Conflict of Interest and Commitment web page