I. Conflict of Interest Policy

A. Preamble

The number and complexity of relationships between universities (members of their faculties and staff) and private industry, federal and state governments, and the non-profit sector have grown substantially in recent years. The University of Texas Medical Branch at Galveston (UTMB) encourages the dissemination of its scholarly research activity and worthwhile technology transfer while protecting UTMB’s integrity and fundamental goals of education and open inquiry.

Full-time faculty members and staff of UTMB recognize that their primary responsibility is to the accomplishment of their UTMB duties and responsibilities assigned to their respective positions of appointment. As such, external consulting, outside employment or outside activities that interfere with those duties or responsibilities may not be accepted.

Acceptance of a full-time appointment entails a commitment to give one's best efforts to this end and to assign first priority to the needs and goals of UTMB. At the same time, it is recognized that participation of faculty members and staff members in activities of government, professional associations, industry, and other private institutions may serve the academic interest of the Institution. The experience and enhanced national status that such participation brings to the faculty member or staff member is shared indirectly by UTMB, and these outside activities often contribute to the richness and diversity of the academic community. Moreover, as a result of such activities, society may benefit from the dissemination of knowledge and technology developed within the Institution.

This statement of UTMB policy has been prepared to outline UTMB’s approach to identifying and evaluating potential conflict of interest issues for all employees and the institution and to assist in carrying out the shared responsibility of addressing conflict of interest issues. To this end all UTMB covered individuals (see Definitions) are required by this Conflict of Interest Policy to avoid conflicts of interest in their relationships with outside organizations, unless these can be managed in accordance with this policy. The purpose of this policy on Conflicts of Interest is to 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.

The term conflict of interest refers to situations in which financial or other personal considerations may directly and significantly affect, or have the appearance of directly and significantly affecting a covered individual’s professional judgment in exercising any UTMB duty or responsibility or in the conducting or reporting of any type of research. The danger of a conflict of interest is that it represents an incentive for bias, a bias which influences decision making based on ones personal interest as opposed to the most objective decision. Such bias can adversely affect many UTMB activities including, but not limited to, decisions about UTMB employees; or the supervision or evaluation of students; human subject research; purchase of equipment and supplies; collection, analysis, and interpretation of data; sharing of results; choice of protocol; and the use of statistical methods.

A covered individual (see Definitions) may be considered to have a conflict of interest when he or she, or any of that person’s family, possesses a significant financial interest in an activity that involves his or her UTMB responsibilities. In addition, a covered individual may not, without approval of the Conflict of Interest 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.

UTMB regards all conflicts involving significant financial interest as potentially problematic and, therefore as requiring close scrutiny. This policy maintains that an individual who holds any significant financial interest in any activity, and especially research involving human subjects, may not conduct the activity. The intent of this policy is not to suggest that every financial interest jeopardizes the integrity of the activity, research, or the welfare of the human subject, but rather to ensure that UTMB systematically reviews any financial interest that might give rise to the perception of a conflict of interest. Indeed, following systematic review of a conflict the institution may choose to allow such activities to ensue in those circumstances that are reasonable or compelling and where risk can be mitigated.

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B. Policy Statement

It is the policy of UTMB that financially interested individuals may not engage in activities that have the potential to directly or indirectly:

1. affect UTMB’s interests;
2. compromise objectivity in carrying out UTMB’s responsibilities;
3. compromise the integrity of scientific research; or
4. otherwise compromise the performance of UTMB responsibilities,

unless the Institutional Conflict of Interest (COI) Committee provides prior approval of such activities and has established a plan to manage and/or monitor the activity. In addition, a covered individual may not, without prior approval, 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.

This policy applies to all significant financial interests (see Definitions) regardless of the source of the funding for the activity and the location the activity may be conducted.

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C. Rebuttable Presumption Against Conflicts of Interest

In order to assure that all potentially problematic circumstances are reviewed, UTMB will presume that a financially interested individual may not conduct the activity in question. This rule is not intended to be absolute; a financially interested individual may rebut the presumption by demonstrating facts that, in the opinion of the COI Committee, constitute compelling and/or reasonable circumstances. The individual would then be allowed to conduct the activity under conditions specified by the COI Committee and, if applicable, approved by the responsible IRB.

When reviewing circumstances which involve a potential institutional conflict of interest, the COI Committee will apply a rebuttable presumption against conducting the activity in question. This rule is not intended to be absolute; the presumption may be rebutted by demonstrating facts that, in the opinion of the COI Committee, constitute compelling and/or reasonable circumstances. The project at UTMB would then be allowed to be conducted under conditions specified by the COI Committee and, if applicable, approved by the responsible IRB.

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D. Compelling Circumstances

In the event of compelling circumstances, an individual holding significant financial interest or UTMB having an institutional conflict of interest in human subjects research involving greater than minimal risk may be permitted to conduct the research. Whether the circumstances are deemed compelling will depend in each case upon the nature of the science, the nature of the interest, how closely the interest is related to the research, and the degree to which the interest may be affected by the research. When the financial interest is directly related to the research and may be substantially affected by it, (e.g., an equity interest in a startup company that manufactures the investigational product) the risk is greatest and the bar must be high; however even direct and potentially lucrative financial interests may be justified in some circumstances. For example, when the individual holding such interests is uniquely qualified by virtue of expertise and experience and the research could not otherwise be conducted as safely or effectively without that individual, he/she should be permitted the opportunity to rebut the presumption against financial interests by demonstrating these facts to the satisfaction of the COI Committee. The COI Committee might approve the involvement of such an individual in the research, subject to conditions that ensure effective management of the conflict and credible oversight of the research. [1]

In summary, the financially interested individual or the project when UTMB has an institutional conflict of interest must demonstrate the following to the COI Committee:

1. There is not a significant likelihood that subjects will be harmed by the involvement of the investigator or institution.
2. All financial incentives for bias have been appropriately mitigated.

Further, the financially interested individual or the project when UTMB has an institutional conflict of interest should demonstrate the following to the COI Committee:

1. The investigator and/or the institution is uniquely qualified to perform the research.
2. The research cannot be practically conducted without the researcher and/or the institution.
3. The significance of the research justifies the exception.

When the COI Committee makes an exception and the research is allowed, the following safeguards must be implemented:

1. Auditing of the human research protection practices in place during the research.
2. A disinterested observer must monitor the research.
3. A Data and Safety Monitoring Board must review the research and data.
4. Funds creating the conflict of interest must be placed into escrow until the research is completed. [2]

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E. Reasonable Circumstances

Conflicts of interest may occur in situations that do not involve human subject research or that involves human subject research of minimal risk. In these instances the rebuttable presumption continues to apply; however, the COI Committee need only apply a reasonable circumstances standard in determining whether the activity may ensue. The COI Committee may determine the specific reasonable circumstances. In general, the Committee should determine the extent of the conflict to the institution and the effect of the conflict upon the research or activity itself, the institution, and the sponsor or external party.

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F. Applicability of Policy

This policy covers any faculty (fully-, partially-, or non-salaried), temporary, or pay-by-letter or A&P employee. The policy also covers any covered individual who is on leave; excluding vacation, holiday, and personal holiday leave; if the leave is funded at least partially from UTMB sources. If the conflict involves research with human subjects this policy is also applicable to any faculty agent, staff, student, fellow, trainee, or administrator, who under the aegis of the institution or pursuant to the review and approval of the institution’s IRB, conducts research involving human subjects.

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G. Administrative Influence

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, and the like. While this policy is applicable to all faculty members and A&P employees, any staff with administrative responsibilities must take particular care to avoid relationships that have the potential to advantage the individual but adversely affect the institution’s interests or inject inappropriate considerations into administrative decisions.

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H. Definitions

1. Business means any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other legal entity organized for profit or charitable purposes. Business excludes UTMB-related entities, the meaning of which is inclusive of UTMB, the affiliated hospital(s), and any private medical practice or any other entity controlled by, controlling, or under common control with UTMB or any affiliated hospital with which UTMB has a contractual relationship for the purpose of providing patient care or education.

2. Compelling Circumstances are those facts that convince the institution’s Conflict of Interest Committee that a financially interested individual should be permitted to conduct human subject research involving greater than minimal risk. When considering a request by a financially-interested individual to conduct research, the circumstances that the COI Committee should evaluate include the nature of the research, the magnitude of the interest and the degree to which it is related to the research, the extent to which the interest could be directly and substantially affected by the research, and the degree of risk to the institution or to a human subject involved that is inherent in the research protocol. The Committee should also consider the extent to which the interest is amenable to effective oversight and management.

3. Compensation means income or monetary value given in return for services, including but not limited to wages, salaries, commissions paid salesmen, compensation for services on the basis of a percentage of profits, commissions on insurance premiums, tips, bonuses (including Christmas bonuses), termination or severance pay, rewards, jury fees, marriage fees and other contributions received by a clergyman for services, pay of persons in the military or naval forces of the United States, retired pay of employees, pensions, and retirement allowances are income to the recipients unless excluded by law.

4. Conducting Research means, with respect to a research protocol, designing research, directing research or serving as the principal investigator, enrolling research subjects (including obtaining subjects’ informed consent) or making decisions related to eligibility to participate in research, analyzing or reporting research data, or submitting manuscripts concerning the research for publication.

5. Conflict of Commitment – The term of conflict of commitment refers to situations in which outside relationships or activities (such as consulting or outside employment) directly and significantly affect, or have the appearance of directly and significantly affecting, an employee’s ability or perception of ability to exercise any UTMB duty or responsibility or in the conducting or reporting of research.

6. Conflict of Interest -- The term conflict of interest refers to situations in which financial or other personal considerations may directly and significantly affect, or have the appearance of directly and significantly affecting, an employee’s professional judgment in exercising any UTMB duty or responsibility or in the conducting or reporting of research.

7. Covered Individual, for activities involving human subjects research, includes any faculty (fully-, partially-, or non-salaried) or faculty agent, staff, student, fellow, trainee, or administrator who, under the aegis of the institution or pursuant to the review and approval of the institution’s IRB, conducts research involving human subjects. For all other activities covered individual means all faculty, A&P employees and IRB members.

8. Disclosure means a release of relevant information about significant financial interests to parties outside the institution’s COI review and management processes (e.g., to research subjects or journal editors).

9. Executive Position refers to any position that includes responsibilities for a material segment of the operation or management of a business, including Board membership.

10. External Business means all businesses except the University of Texas Medical Branch at Galveston, UTMB Hospitals, the Campus-Based or Community-Based Outpatient Clinics, UTMB HealthCare Systems the Area Health Education Center (AHEC) affiliates, any private professional practice, or any other entity controlled by or under common control with UTMB or with which UTMB has a contractual relationship for the purpose of providing professional services or education.

11. The Family of a faculty member or A&P employee includes his or her spouse, dependent children, stepchildren, parents, brothers, sisters, grandparents, and grandchildren. For the purposes of this policy, family also includes those involved in amorous relationships with the faculty member or A&P employee in question.

12. Financially Interested Company means a commercial entity with financial interests that would reasonably appear to be affected by the conduct or outcome of the research. This term includes companies that compete with the sponsor of the research or the manufacturer of the investigational product, if the covered individual actually knows that the financial interests of such a company would reasonably appear to be affected by the research. This term also includes any entity acting as the agent of a financially interested company (e.g., a contract research organization).

13. Financially Interested Individual means a covered individual who holds a significant financial interest that would reasonable appear to be affected by the individual’s research or other activity.

14. Human Subjects Research includes all research meeting the definition of “research” performed with “human subjects” as these terms are defined in the federal Common Rule (45 C.F.R. Part 46 and 21 C.F.R. Part 56), regardless of the source of research funding or whether the research is otherwise subject to federal regulation. In the event that the Common Rule definitions of “human subjects” or “research” are modified through rulemaking, any such revisions shall apply for the purposes of this guidance.

15. Institutional Conflict of Interest means whenever the financial interests of the institution, or of an institutional official acting within his or her authority on behalf of the institution, might affect – or reasonably appear to affect – institutional processes for the conduct, review, or oversight of research or for exercising any UTMB duty or responsibility.

16. Institutional Official means a President, Executive Vice President, Vice President, Dean, or Chief Operating Officer, or other institutional official who is responsible for the oversight of programs within the institution.

17. Participate means to be part of the described activity in any capacity, including but not limited to, serving as the principal investigator, co-investigator, research collaborator, expert witness, 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 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.

18. Reporting means the provision of information about significant financial interests by a covered individual to responsible institutional officials and to the institutional COI Committee, or the transmission of such information within institutional channels (e.g., from the COI Committee to the IRB).

19. Reasonable Circumstances means the circumstances that a reasonable prudent layperson would expect a covered individual to maintain given the need to accomplish a specific task related to UTMB activities but having a significant financial interest. Reasonable circumstances might include the extent of the conflict to the institution and the potential effect of the conflict upon the research or activity itself, the institution, and the sponsor or external party.

20. Responsible Institutional Review Board (IRB) is the institutional review board (or boards) with jurisdiction over the research as specified in the multiple projects assurance (MPA) (or the federal-wide assurance (FWA) that the institution has provided to the U.S. Department of Health and Human Services, or as otherwise established under DHHS or FDA regulation or policy.

21. Significant Financial Interest means anything of monetary value, including, but not limited to

    a)	Consulting fees, honoraria (including honoraria from a third party, if the original source is a financially interested company), gifts or other emoluments, or “in kind” compensation from a financially interested company (or entitlement to the same), whether for consulting, lecturing, travel, service on an advisory board, or for any other purpose not directly related to the reasonable costs of conducting the research or activity (as specified in the agreement), that in the aggregate have in the prior calendar year exceeded the de minimus amount established in PHS regulation (presently $10,000), or are expected to exceed that amount in the next twelve months.
    b)	Equity interests, including stock options, of any amount in a non-publicly-traded financially interested company (or entitlement to the same).
    c)	Equity interests (or entitlement to the same) in a publicly-traded financially interested company of either $10,000 or 5% equity ownership. [3]
    d)	Royalty income or the right to receive future royalties under a patent license or copyright, where the research is directly related to the licensed technology or work of any amount.
    e)	Compensation from a financially interested company (or entitlement to interests (e.g. stocks, stock options, or other ownership interests); and intellectual property rights (e.g. patents, copyrights, and royalties from such rights) that in the aggregate have in the prior calendar year exceeded the de minimus amount established in PHS regulation (presently $10,000), or are expected to exceed that amount in the next twelve months.

    
    
22. This term does not include:

    a)	Salary, royalties, or other remuneration from UTMB;
    b)	Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
    c)	Income from service on advisory Committees or review panels for public or nonprofit entities;
    d)	An equity interest that, when aggregated for the employee and his or her family, meets both of the following tests: (1) does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value and (2) does not represent more than a five percent ownership interest in any single entity;
    e)	Non-UTMB salary, royalties, or other payments, including consulting fees and expert witness testimony, that, when aggregated for the employee and his or her family over the next twelve months, are not expected to exceed $10,000 in the aggregate; or
    f)	Interest in mutual funds where the individual has no control over the selection of holdings.

    
    
23. Sponsored Research means research, training, and instructional projects involving funds, materials, or other compensation from outside sources under agreements that contain any of the following:

    a)	The agreement binds UTMB to a line of scholarly or scientific inquiry specified to a substantial level of detail. Such specificity may be indicated by a plan, by the stipulation of requirements for orderly testing or validation of particular approaches, or by the designation of performance targets.
    b)	A line-item budget or modular budget is involved. A line-item budget details expenses by activity, function, or project period. The designation of overhead (or indirect costs) qualifies a budget as “line item.”
    c)	Financial and/or programmatic reports are required.
    d)	The award is subject to external audit.
    e)	The agreement provides for the disposition of either tangible (for example, equipment, records, technical reports, theses, or dissertations) or intangible (for example, rights in data, copyrights, or inventions) properties which may result from the activity.

    
    
24. Technology means any process, method, product, compound, drug, device, or any diagnostic, medical, or surgical procedure developed using UTMB, facilities, equipment, or funds, whether intended for commercial use or not.

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II. Conflict of Interest Protections

A. Receiving Payment for Research Subject Recruitment to Clinical Drug Trials or other Clinical Studies

UTMB employees may not receive a personal payment or benefit of any type for recruiting a research subject to a UTMB sponsored clinical drug trial or study. See Regent’s Rules. Often a payment may be made to UTMB via physicians, principal investigators, or study coordinators for recruiting, enrolling, and maintaining records for patients on certain clinical drug trials and/or clinical studies. The research subject must be informed that the UTMB is receiving or may receive a payment prior to the research subject’s agreement to be enrolled in the clinical drug trial or clinical study. It should be noted initially that the UTMB Institutional Review Boards discourage the payment of recruitment fees (monetary or in kind) in any form due to the potential that such a practice could be perceived as coercive and bordering on unethical research subject recruitment. In addition, several professional medical associations and groups have stated that this practice is unethical. However, if it is deemed absolutely necessary to provide recruitment fees for recruitment of research subjects, the UTMB IRB policy is categorized as follows:

1. UTMB Employees: The payment of recruitment fees to UTMB employees (including those who may be research subjects themselves) who identify and/or recruit research subjects for an approved research protocol is not permitted. Funds may be used to pay the regular salaries of UTMB employees who recruit research subjects, but grant funds cannot be used to make additional payments for recruitment of human subjects into research protocols.
2. UTMB Students: Payment of recruitment fees to UTMB students is permitted, providing that the student(s) are not receiving a salary, part of a salary, or stipend from the University or any grant.
3. Research Subjects: Payment of recruitment fees to research subjects is permissible, providing that the subjects do not fit either category as described above.

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B. Payment for Results

UTMB prohibits payments from UTMB or any source to any covered individual, if such payments are conditioned upon a particular research result or are tied to successful research outcomes.

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C. Other Conflicts of Interest

A financially interested individual may not be involved in any activity when he or she owns or controls a significant financial interest in a financially interested entity that is a sponsor or vendor or receives significant income from the activity. In the event of reasonable circumstances, the COI Committee may determine that the activity may ensue if the risk is minimal to the institution and does not pose any “kickback” or improper payments or influences.

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D. Supervision of Students/Trainees

The impact on students and other trainees of activities that could potentially create conflicts of interest is of particular concern. It is essential that all UTMB employees constantly demonstrate their commitment to the highest intellectual and ethical standards in all aspects of teaching, research, and service, particularly where opportunities for conflict may exist. As a corollary, the training experiences of students are expected to incorporate the value of objectivity and the importance of public trust. Special care must be taken when faculty members and A&P employees involve students in outside professional activities in which the faculty member and/or A&P employee has a financial interest. At the same time consideration must also be accorded to those students who are not involved in the activities. The responsibility for protecting the interests of students falls particularly on the Department Chair and Dean who are charged with monitoring the potential conflicts of faculty members. Monitoring necessarily includes making the conflicts of interest policy and the monitoring process known to affected students and establishing appropriate mechanisms for receiving their feedback. It is essential that Deans and Department Chairs be committed to ensuring that conflict situations do not interfere with the duties of the faculty member with regard to training of students. The COI Committee will provide the management plan and/or monitoring procedures to department chairs and deans with the expectation that they will enforce the requirements of the COI Committee.

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E. Conflicts of Interest Related to the Institution

As a fundamental principle, UTMB should ensure that in practice, the functions and administrative responsibilities related to research are separate from those related to investment management and technology licensing.

The COI Committee will review any conflicts or potential for conflicts that involve investments or companies owned by the institution or any institutional officials. When the COI Committee determines that an institutional official should be permitted to hold a significant financial interest in a financially interested research sponsor even though the official will not be formally recused from research-related responsibilities involving human subjects, its conclusions, along with any management conditions to be imposed, should be communicated to the IRB of record. All relevant institutional conflicts should be disclosed to the research subjects in a form to be approved by the IRB of record.

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F. Personal Contracts with External Companies

UTMB employees may not enter into contracts with any company that requires the employee to promote or introduce a product or process to the institution. Moreover, employees may not use their affiliation with UTMB to in any way enhance or diminish any product or company. See UTMB Policy 2.6.5 Acceptance and/or Solicitation of Gifts or Benefits from Vendors.

If a covered individual receives compensation in excess of 25% of his or her base salary in any 12-month period from all financially interested company(ies), the covered individual may not conduct research or business on behalf of UTMB with the financially interested company(ies) without the prior approval of the COI Committee.

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G. Gifts to the Institution from Vendors to Specified Faculty or to Departments to Fund Research or Education

Gifts from vendors to support research or education may be accepted only if the donation is accompanied with a letter or other instrument from the vendor indicating that the specific purpose of the donation is to support UTMB research or education and is not intended to influence purchasing decisions or research outcomes. The donation must be approved by the appropriate Dean of the faculty member and must be accepted by the Office of University Advancement. This policy does not prohibit grants and/or contracts from vendors for research or clinical trials where a formal agreement exists.
Gifts or benefits given to faculty members or employees as a grant for studies of products when the studies require little or no actual scientific pursuit should not be accepted. An example is a payment given as a “research grant” to a faculty member for minimal record keeping tasks. [4]

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H. 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: Standards of Conduct and Conflict of Interest, Texas Government Code Section 572, Offenses Against Public Administration, Texas Penal Code Title 8, Texas Penal Code Section 39.02 (a) Texas Education Code Section 51.912 (a). 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 Part Two, Chapter XII, Section 7.3, University of Texas System Business Procedure Memoranda, and the UTMB Institutional Handbook of Operating Procedures (IHOP). Information on these laws, regulations, and policies is available from the UTMB Legal Affairs Department. This policy shall be interpreted in a manner consistent with applicable federal and Texas laws and regulations on conflicts of interest and commitment.

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III. Conflict of Commitment Protections

A. Aggregate Time for All Outside Commitments

The maximum amount of aggregate time spent on outside commitments which is compatible with fulfilling the primary responsibility to UTMB should not exceed 26 work days per fiscal year (beyond annual leave) and must by approved by the responsible, direct supervisor (i.e., Department Chair, Dean, Vice President, or Institutional Official) after discussion with the faculty member or staff member. The 26-day level is considered to be a threshold and not necessarily a limit on outside activities. Intermittent activities such as visiting lectureships are desirable and bring honor and credit to the faculty member and to the University, but excessive time devoted to these activities can compromise the faculty member's ability to meet his or her obligations to UTMB. In addition, faculty members at ranks below full professor must consider the impact of secondary commitments on their ability to fulfill the criteria for promotion.

Individual lectureships, conferences and scientific or professional meetings, or UTMB business meetings need not be included in the 26-day threshold unless those activities otherwise constitute or include activities described elsewhere in this policy. On the other hand, activities that must be reported include ongoing or repetitive arrangements with an outside organization for activities such as consultation, research, laboratory testing, teaching, writing or membership on advisory groups and councils. All activities must also adhere to UTMB and departmental leave policies.

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B. Reporting All Outside Commitments

When a covered individual anticipates that he or she will meet or exceed the 26-day annual threshold, the covered individual must disclose the number of aggregate time (in days) spent on outside commitments, prior to any agreement to undertake the outside commitment, using the annual disclosure form. However, disclosure is a continuing obligation, as it also must be made if a possible conflict becomes evident when a covered individual’s ongoing relationship with an outside party changes or prior to exceeding the 26-day annual threshold.

The commitment disclosure form for a covered individuals meeting or exceeding the 26-day threshold must be reviewed and approved by the responsible, direct supervisor (i.e., Department Chair, Dean, Vice President, or Institutional Official). Following approval by the responsible, direct supervisor (i.e., Department Chair, Dean, Vice President, or Institutional Official), the commitment disclosure form then shall be reviewed by the COI Committee. The purpose of the COI Committee’s review is to ensure that the proposed time for outside commitments complies with policies of UTMB and necessary approval has been granted. After these reviews are completed by the COI Official, and the proposed time for outside commitments is found to comply with all relevant policies, a written statement of approval will be sent to the covered individual with a copy to the responsible, direct supervisor (i.e., Department Chair, Dean, Vice President, or Institutional Official).

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IV. Prohibited Activities

A. External Activities

1. Making referrals of UTMB work to an external business or professional office in which such individual or a family member has a significant financial interest. “External business” excludes the University of Texas Medical Branch at Galveston, UTMB Hospitals, the Campus-Based or Community-Based Outpatient Clinics, UTMB HealthCare Systems, the Area Health Education Center (AHEC) affiliates, any private professional practice, or any other entity controlled by or under common control with UTMB or with which UTMB has a contractual relationship for the purpose of providing professional services or education.
   
2. Associating one’s name or one’s work with an external activity in such a way as to profit monetarily by trading on the reputation or good will of, or implying sponsorship or endorsement by UTMB. An example of a context in which this might occur is an external professional activity for pay. Mere identification of UTMB as one’s employer and of one’s position at UTMB is permitted, provided that such identification is not used in a manner that implies sponsorship or endorsement by UTMB.
   
3. Acceptance by a UTMB employee or a family member of other than nominal gratuities or special favors from one whom the individual knows is doing business with or proposing to do business with UTMB not to exceed $50 per person per day. Nominal may include, but are not limited to, meals, or gifts of texts. See the UTMB IHOP Policy 2.5.6, Acceptance and/or Solicitation of Gifts or Benefits from Vendors.

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B. Public Disclosure

1. Publishing or formally presenting results of research under UTMB auspices, or providing expert commentary on a subject, without simultaneously disclosing any significant financial interest relating to such results or such subject.
   
2. Unauthorized use of privileged information acquired in connection with one’s UTMB responsibilities. This section is not intended to apply to standard publication activity.
   
3. Recommendations for Investigators Disclosing a Financial Interest on Publications is provided in Appendix A .

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C. Administrative Responsibilities

1. Taking administrative action in the course and scope of UTMB responsibilities that is beneficial to a business in which the individual or a family member has a significant financial interest.
   
2. Influencing the negotiation of contracts between UTMB and an outside organization with which the individual or a family member has a significant financial interest.

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D. Committee Participation

Serving on a Committee of a governmental agency or private entity and simultaneously participating in the consideration by such a Committee of the regulation or application of a technology that is owned by or contractually obligated (by license or exercise of option to license) to a business in which that covered individual or a family member has a significant interest.

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V. Process for Evaluating Conflicts of Interest

B. Conflict of Interest Committee

1. Composition and Meetings

The COI Committee shall be appointed by the UTMB President and meet at least monthly or as necessary. The COI Committee shall consist of nine (9) official, voting members and (2) ex-officio, non-voting members. The nine (9) official, voting Committee members shall represent the following UTMB interests:

a)	COI Official
b)	Purchasing
c)	Legal Affairs
d)	Academic, clinical or basic science department, institute, or center administrator
e)	Director, Office of Research Subject Protections (recused from voting on institutional conflicts of interest involving human subjects research)
f)	Clinical faculty member who is a principal investigator of a federal grant or contract or of a clinical drug trial or other clinical study involving human subjects in the study.
g)	Basic Science faculty member who is a principal investigator of a federal grant or contract involving human subjects in the study.
h)	Faculty member at large from any UTMB school
i)	A member of the local Galveston County community

The ex-officio members of the Committee shall be a representative from the Office of the Vice President for Research and a representative from the Office of Institutional Compliance. The faculty members and administrator appointees shall be appointed for two year staggered terms in order to maintain continuity for the Committee. The community member of the Committee shall be appointed for two years and may serve additional terms if the person and the President so desire. The representatives from Purchasing, Legal Affairs, and the Director of Research Subject Protection shall be permanent representatives on the Committee but may be removed from the Committee at the request of their supervisor who will offer a different representative from their respective office. The ex-officio members of the Committee shall be permanent members of the COI Committee.

A staff member from the office of the COI official will be responsible for facilitating the meetings and recording the activities of the Committee.

Recusal should be required whenever any member has an actual or apparent conflict of interest with regard to any matter under review.

UTMB’s Intellectual Property Management Office should report to the COI Committee (or an appropriate institutional official charged with identifying circumstances for institutional conflict of interest review) when, as a result of a licensing agreement, UTMB 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 research conducted at or under the auspices of UTMB.

2. Responsibilities

a)	Review of Annual Evaluation Forms for Possible Conflict of Interest The Conflict of Interest Committee will be responsible for collecting and reviewing all of the Annual Evaluation Forms for Possible Conflict of Interest and any request by a financially interested individual to rebut the presumption that he or she may not conduct human subject research or any other activity that involves a significant financial interest. The COI Committee must provide individuals the opportunity to appear before the Committee and/or submit written comments regarding the issues. The response of the individual will become an official part of the conflict review record. The COI Committee will make a final determination as to whether the activity may proceed including a management plan and monitoring procedures, if necessary, or whether the covered individual must divest his or her financial interest in the sponsor of the project.
b)	Documentation of the COI Committee’s Findings The COI Committee must document its findings and the bases for any recommendations to permit or to recommend against permitting a financially interested individual to conduct any conflicted activity. The COI Committee should prepare a summary report describing the nature and amount of the financial interest and the Committee’s recommendations. This summary report should be made available to the IRB. When the COI Committee has recommended that a financially interested individual be permitted to conduct human subjects research and the IRB has approved the research and the individual’s participation, the summary report should be available to the research subjects or the public upon proper request. The COI Committee must notify the IRB when a disclosure statement must be included in the informed consent document for the human subject research. The IRB must include this statement in the informed consent document.
c)	Management Plan and Monitoring Mechanisms When a financially interested individual is permitted to conduct human subjects research, as a first principle, the COI Committee should require the financially interested individual to minimize the potential for conflict of interest by reducing or eliminating the interest or the individual’s direct involvement in the research. If there are reasonable and/or compelling circumstances that would allow the activity to continue, the COI Committee is responsible for designing and implementing a management plan for the conflict as well as appropriate monitoring procedures and or other conditions to be imposed when a financially interested individual is involved in a conflicted activity. In accordance with Texas law, UTMB shall establish a procedure to mitigate or minimize potential conflicts of interest. At a minimum, the plan should include the following: Disclose all potential conflicts of interest and commitment, both financial interests and participation in the sponsor or licensee company as an employee, officer or director. Identify factors such as the following that may mitigate the likelihood of actual conflicts of interest. a. Whether a sponsor or licensee is publicly or privately held may affect the covered individual’s status as a board member, officer, or “key” employee. b. A significant difference between the research emphasis of the sponsor or licensee and that of the individual may reduce the likelihood of actual conflicts of interest. Implement effective management strategies, such as the following, to minimize development of actual conflicts of interest and commitment. a. Assign independent personnel to monitor the covered individual’s research activities. b. Require administrative review and approval of the covered individual’s research project(s) that is/are subject to potential conflicts of interest. c. Require modification of research plans or transfer portions of research to independent researchers, if necessary, to avoid actual conflicts of interest. Carefully review sponsorship and license terms. Be aware of any indications that the arrangement may not be an “arm’s length” transaction. Specifically investigate: a. Grants of an equity interest to an individual that provide disproportionate compensation   i. relative to the standard share of royalties a faculty member might receive for technology licensed to an unrelated company, or   ii. relative to the services provided Compensation should be fair market value for the services provided; rarely would the value of the services provided be greater than $175 per hour. b. Licensing of inventions covering basic research that may cause the licensee to compete with the institution for grant funding. c. The present or near-term capacity to perform the essential functions outlined in the company’s business plan. d. Contracts-back to the institution of development work, which suggests that the technology could not have been licensed to a company in an arm’s length transaction (exception: unique facilities).
d)	Special Instructions for Monitoring Students With respect to any monitored activity in which a student is involved, the following requirements shall be observed: All monitors must meet regularly (at least annually) with students of the faculty member who has an activity that is being monitored. Decisions as to which students should be included in these meetings should be left to the discretion of the monitor(s) and/or the Deans and Department Chairs. Monitors are urged to recognize that students who are not directly involved in a conflicted activity may still be affected by a faculty member’s conflicted activity commitments. In addition, the COI Committee should consider requesting monitors to participate as observers in the research advisory Committees/thesis or dissertation Committee of any student directly involved in a conflict of interest situation. All students beginning studies with a faculty member who has an approved management plan for a conflict of interest situation must be informed: (a) that the conflicted activity exists, and (b) that the student’s concerns, if any, can be discussed with the Department Chair, Dean, or, if applicable, the COI Committee, and/or the monitor or monitoring panel, as appropriate.
e)	Communication to the IRB The COI Committee will alert the responsible IRB and responsible institutional officials whenever a financially interested individual proposes to conduct human subjects research. Prior to the IRB’s final approval (whether initial or continuing approval) of human subjects research, the COI Committee will have informed the responsible institutional officials of any significant financial interests held by financially interested individuals who will conduct the research, as well as the COI Committee’s findings and recommendations concerning the same. When the COI Committee determines that an institutional official should be permitted to hold a significant financial interest in a financially interested research sponsor even though the official will not be formally recused from research-related responsibilities involving human subjects, its conclusions, along with any management conditions to be imposed, should be communicated to the IRB of record. All relevant institutional conflicts should be disclosed to the research subjects in a form to be approved by the IRB of record. Return to Top | Return to Conflict of Interest Main Page

VI. Implementation

A. Authority

Federal, state law and the Rules and Regulations of the University of Texas System Board of Regents (hereinafter referred to as Regent’s Rules) require UTMB to have a conflict of interest policy and this policy includes the required elements of a conflict of interest policy. This policy will be published and maintained on the UTMB Conflict of Interest web site. The policy will be mailed to all faculty members and A&P employees initially and changes or amendments to the policy will be mailed to faculty members and A&P employees within 60 days of the adoption of the change or amendment. The President of UTMB and the COI official are responsible for implementing and maintaining the policy.

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B. Requirement to Report any Significant Financial Interest to UTMB COI Official

All UTMB covered individuals are required to report annually to the institutional COI official all significant financial interests that would reasonable appear to be affected by the individual’s current or anticipated institutional activities, especially research involving human subjects. In making such reports, each covered individual must explicitly declare whether he or she does or does not have such financial interests. Failure to report is unacceptable and will result in disciplinary action up to and including termination.

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C. Annual Evaluation Form for Possible Conflict of Interest

Because of the necessity to avoid conflicts of interest and commitment and the appearance thereof, all covered individuals are required to submit annually for evaluation, on the form provided as Appendix A certain financial and other information. Individual circumstances may require additional or more frequent submissions, particularly if there is any significant change in personal financial, fiduciary status, activities, or relationships that would result in a conflict of interest as defined by this policy. The information provided must be accurate and may have a direct bearing on the individual’s employment status with the institution. This form includes a written acknowledgement that the covered individual has read and understands this conflict of interest policy and agrees to comply with UTMB’s conflict of interest policy. Moreover, the covered individual agrees to disclose any conflict of interest to a patient or any other individual or institution that might possibly be harmed by the conflict.

The form shall be submitted to the COI official by September 30 of each fiscal year. The COI Committee will evaluate the forms and determine whether there is a conflict and whether reasonable and/or compelling circumstances exist that would allow the activity to continue or recommend divestiture of the significant financial interest. If the activity involves research with human subjects involving greater than minimal risk, then there must be compelling circumstances that would allow the research to ensue. [6]

Sanctions for furnishing false, misleading, or incomplete information include, but are not limited to, administrative intervention to termination of employment, all in accordance with applicable institutional policies.

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D. Expedited Review Process

Individuals involved in activities resulting in monitoring plans in the previous year or individuals who have no changes to their disclosures from the previous year may, under certain circumstances, utilize the expedited review process. If monitoring mechanisms for an activity have previously been implemented following appropriate review and approval as described by the Policy, the covered individual may use the Expedited Review Process described in this paragraph unless:

1. a complaint has been issued against that individual in connection with the activity;
2. there is new information regarding the activity that may affect the decision or action of the COI Committee; or
3. the standards by which the activity was judged have changed.

Should any one of the three above-mentioned circumstances take place, the forms must be fully reviewed utilizing the process outlined in the Policy. In the absence of any of the above-mentioned circumstances, the COI official may simply attach to the Annual Evaluation Forms when submitted to the President, Dean, Vice President, a statement affirming

1. that the activity is unchanged from the last time it was reviewed;
2. the monitoring mechanisms are still in place and are functioning effectively; and
3. that the activity continues to have his/her a