Conflict of Interest

Frequently Asked Questions (FAQ's)

General

General FAQ's

To foster an environment of transparency in order to effectively determine conflicts of interest and conflicts of commitment and to engage in a collaborative process to mitigate these conflicts.
IHOP 6.5.1: Research Conflicts of Interest is an existing policy that is mandated by the U.S. Public Health Service (PHS) within the U.S. Department of Health and Human Services (HHS).

IHOP 6.5.2: Ethical Interactions with Industry, IHOP 6.5.4: Institutional Conflicts of Interest, and IHOP 6.5.5: Gifts, Honoraria, Fundraising, and Other Activities combine federal, state, and UT System regulations as well as ethical norms.

IHOP 6.5.3: Individual Conflicts of Interest, Conflicts of Commitment, and Outside Activities is a  policy promulgated by the University of Texas System in conjunction with the University of Texas Board of Regents.
If you are “responsible for the design, conduct, or reporting of research” and you have a question about prior approval or disclosure of outside activities or interests, you should consult IHOP 6.5.1: Research Conflicts of Interest.

If your institutional responsibilities do not involve research and your question is about prior approval or disclosure of outside activities or interests, you should consult IHOP 6.5.3: Individual Conflicts of Interest, Conflicts of Commitment, and Outside Activities.

If you have general questions regarding any interactions with Vendors or Industry (pharmaceutical companies, medical device manufacturers, etc.) either on or off UTMB campus, please consult IHOP 6.5.2: Ethical Interactions with Industry.

If you have questions about whether your action (purchasing decision, licensing activity, gift given to you or UTMB, etc.) could create a conflict for the institution as a whole, please consult IHOP 6.5.4: Institutional Conflicts of Interest.

If you have miscellaneous questions about the acceptability and appropriateness of gifts, fundraising activities, honorariums, raffles, etc. you should consult IHOP 6.5.5: Gifts, Honoraria, Fundraising, and Other Activities.
Yes. Federal regulations such as The Sunshine Act (part of the Affordable Care Act) and PHS' 2011 updates to its Objectivity in Research policy as well as widespread national attention on the issue have prompted many academic medical centers to strengthen their policies.
Individual Conflicts of Interest and Conflicts of Commitment

Individual Conflicts of Interest and Conflicts of Commitment FAQ's

A Conflict of Commitment (COC) is a situation in which the time or effort that a UTMB employee devotes to an outside activity directly or significantly interferes with the employee's fulfillment of his/her institutional responsibilities. It can also be a situation in which a UTMB employee uses State property without authority in connection with the employee's outside employment, board service, or other activity.

1.  Conducting business to further an outside activity while on UTMB time.
2.  Using UTMB resources (internet, email, tangible assets, etc.) to conduct business related to one's outside activity.
3.  Taking excessive personal or vacation leave to further one's outside activity.
4.  Spending UTMB time on outside activities that do not clearly contribute to the mission of UTMB or provide important elements of faculty or staff development.

A significant outside interest of a UTMB employee or one of the employee's immediate family members that could directly or significantly affect the employee's performance of his or her institutional responsibilities. The proper discharge of an employee's institutional responsibilities could be directly or significantly affected if the employment, service, activity, or interest: (1) might tend to influence the employee's conduct or decisions; (2) could reasonably be expected to impair the employee's judgment in performing his or her institutional responsibilities; or (3) might require or induce the employee to disclose confidential or proprietary information acquired through the performance of institutional responsibilities.
1.  Using your position at UTMB to recruit customers or patients for an outside activity.
2.  Providing preferential treatment to, or being in a position to provide preferential treatment to an outside entity for with whom you have a financial relationship.
3.  Employment activities with UTMB competitors in which your activities with the competitor are substantially similar to your institutional responsibilities at UTMB.
4.  Employment activities with, or substantial interest in, a UTMB vendor or sponsor when your institutional responsibilities involve selection of such vendor or sponsor's products and/or services.
5.  Accepting personal gifts from vendors or sponsors.
6.  Being involved in the decision to hire a company in which your spouse is an employee to provide services to UTMB.
7.  Involving students or post-doctoral students and trainees in work that could directly benefit a company in which the faculty member supervising the students has a personal financial interest.

NOTE: Although these activities may create a conflict of interest, the conflict can often be mitigated by implementing a management plan to ensure that the conflicting interest/activity does not affect an employee's institutional responsibilities in any way.
Yes, the following activities are impermissible and will not receive prior approval:
1.  Industry-sponsored “speakers bureaus” (i.e., contractual relationships to give talks in which the topic(s) and/or content are provided by the company). Faculty members must retain full control and authority over professional material the faculty member presents. Such communications or presentations may not be subject to approval by any commercial interest other than approval for the use of proprietary information.
2.  Participating in marketing and training programs designed solely or predominantly for sales, marketing, or promotional purposes.

Additionally, due to the amount of payment offered, some outside activities create the perception of impermissible conflicts of interest that cannot be managed. The following are dollar limits above which a conflict of interest reasonably appears to exist:
1.  Per Event: Full-time faculty and full-time administrative and professional employees may not accept more than $5,000 in income in the form of compensation for services lasting one (1) day, $10,000 for services lasting two (2) days, or $15,000 for services lasting three (3) or more days, per event, per entity, provided that at no time the fees accepted exceed the fair market value of the services provided.
2.  Per Year: Full-time faculty and full-time administrative and professional employees may not accept income for services in the form of compensation amounting to more than 50% of their total base salary in any 12-month period from all outside companies; or more than 25% of their total base salary in any 12-month period from a single outside entity.

NOTE: these dollar limits apply only to entities and activities that reasonably appear to relate to your institutional activities. For example, the dollar limits would apply to a faculty member's outside compensation (consulting, speaking, etc) from a pharmaceutical or medical device manufacturer, but would not apply to a faculty member's outside compensation from an online selling/ebay type business because that business would not relate to what the faculty member does at UTMB.
For Faculty - This time is defined by the number of hours per week necessary for the performance of job duties, which includes teaching, research, service, and patient care.

For Staff - This time is defined by a work day with set hours and for other staff this time is defined as a work day with set hours plus on call service as needed.
A significant outside interest of a UTMB employee or one of the employee's immediate family members that could directly or significantly affect the employee's performance of his/her institutional responsibilities. The proper discharge of an employee's institutional responsibilities could be directly or significantly affected if the employment, service, activity, or interest: (1) might tend to influence the employee's conduct, decisions, or judgment in the design, conduct, or reporting of research; (2) could reasonably be expected to impair the employee's judgment in performing his/her non-research related institutional responsibilities; or (3) might require or induce the employee to disclose confidential or proprietary information acquired through the performance of institutional responsibilities.
1.  Sponsored programs or technology licensing arrangements in which any of the involved investigators (or their spouse/domestic partner, dependent children and any other persons within their household) have employment or consulting arrangements and significant financial interests in the sponsor, or with subcontractors, vendors, or collaborators.
2.  Using university resources to conduct research or programs that are sponsored by an entity in which the faculty member/researcher or his/her spouse/domestic partner, dependent children and any other persons within their household has a significant financial interest.
3.  Serving as a consultant or on the board of directors or major advisory committee of an external for-profit entity which sponsors the faculty member's/researcher's research/program or provides gift funds for the researcher or his/her department.
4.  Hiring university students in consulting activities or a company in which the faculty member/researcher has financial interests. If the student's thesis/dissertation research is supervised by the faculty member, the conflict of interest situation may not be manageable.
5.  Diverting research opportunities from the university to a consulting entity or business in which the faculty/researcher has a financial interest.
6.  While acting in the context of his/her university duties, making professional referrals to or purchasing materials or services from a business in which an academic staff member or their spouse/domestic partner, dependent children and any other persons within their household has a financial interest.
7.  Serving as president or CEO, or holding any other position that requires involvement in the day-to-day operations of a for-profit sponsor. Such a situation creates an unacceptable conflict of interest and/or commitment, which must be reduced in order to be manageable.
8.  Equity (ownership) interest of the faculty member (or their spouse/domestic partner, dependent children and any other persons within their household) in a sponsor.
Prior Approval

Prior Approval FAQ's

1.  Full-time faculty
2.  Full-time exempt staff
3.  Full-time nurses (except LVNs and nurse assistants)
4.  Full-time nonexempt staff - but only if they are: authorized to execute contracts on behalf of UTMB have authority to exercise financial discretion.
5.  Part-time faculty - only if, in the employee's opinion, the activity reasonably appears to create a COI.
6.  Part-time exempt staff - only if, in the employee's opinion, the activity reasonably appears to create a COI.
7.  Part-time nurses - only if, in the employee's opinion, the activity reasonably appears to create a COI.
Log on to the UT System Electronic Database (using your UTMB ID and password), fill out the screening questions and follow the instructions to fill out a prior approval request form.

If you are engaged in the design, conduct, or reporting of research, you will need to fill out a disclosure form detailing your 2013 calendar year outside activities and interests (required by the Public Health Service) before filling out a prior approval/updating your disclosure for 2014 activities that you are either currently engaged in or planning to engage in.
1. All outside employment or other compensated activity;

     Ex: activities for which you receive salary, retainer, honoraria, IP          rights/royalties, deferred comp., etc.
     Ex: activities for which you receive sponsored travel or reimbursement from private entities (sponsored or reimbursed travel by a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education is exempted from the prior approval requirement)

2. Service on outside boards, regardless of whether compensated or not; (Subject to some exceptions)

3. Any uncompensated activity that reasonably appears to create a COI or COC. Employee determination of whether they need to disclose this. If the activity reasonably appears to be related to any research you engage in, you should seek prior approval before engaging in the activity.
Personal board service
Ex: religious, neighborhood, school, youth sports, political organization
Must be done on employee's own time

Uncompensated board service integral to the mission of UTMB
Ex: professional or scholarly society
Can be done on UTMB time, but only if you receive prior approval to attend during UTMB time.

Activities that clearly contribute to the mission of UTMB or are important to faculty/staff development
Ex: academic or scholarly in nature; higher education; professional society; state, local, federal gov't or institution of higher education
Ex: editor of scientific or scholarly journal or similar communications Can be done on UTMB time, but only if you receive prior approval to attend during UTMB time.
It is recommended that you submit your prior approval form at least thirty (30) days prior to beginning an outside activity to ensure ample time to receive approval from the approval authority. However, in situations where this is not possible, please submit your prior approval form as soon as reasonably possible.
Approval for outside activities lasts for a maximum of one (1) year. When a prior approval expires, the employee will be responsible for seeking renewed approval for the subsequent year if the outside activity is continued.
After logging onto and filling out a prior approval form on the UT System electronic database, your prior approval form will electronically route to the UTMB Conflicts of Interest Office for initial determination of whether the activity is permissible under IHOP 6.5.3 - Individual Conflicts of Interest, Conflicts of Commitment, and Outside Activities, or other relevant IHOP or UT System policies and whether the activity reasonably appears to create a conflict that requires a management plan.

If the activity is deemed impermissible the employee will receive notice in writing that his or her request for approval has been denied. This denial decision is appealable.

If the activity is deemed permissible or permissible with a management plan, the prior approval form will be electronically routed to the employee's supervisor for ultimate approval or denial. The supervisor's final decision is also appealable by the employee.
Disclosure

Disclosure FAQ's

In its aggregate form, the disclosure creates a comprehensive picture of activities that have been approved through the prior approval process above and other activities and interests that do not require prior approval, but must be disclosed.
Disclosure is retrospective in nature while prior approval is prospective. Furthermore, certain outside activities require prior approval (see above) and are automatically disclosed once approval is attained, meanwhile financial interests such as gifts over $250, family member activities/interests, and substantial interests in business entities do not require prior approval, but still must be disclosed within 30 days of acquiring a new interest if, in the opinion of the employee, they create a reasonable appearance of a conflict of interest.

Those employees who are responsible for the design, conduct, and reporting of research, must fill out an annual disclosure form every year. This disclosure form certifies activities that were disclosed/received prior approval in the preceding calendar year (for the 2014 calendar year, all 2013 activities must be re-disclosed since we will be using a new electronic system and process).

Those employees who are not responsible for the design, conduct, and reporting of research are not required to complete a disclosure form annually, however, they are required to seek prior approval and complete disclosures on an ongoing basis as outlined by IHOP 6.5.3: Individual Conflicts of Interest, Conflicts of Commitment, and Outside Activities. They may be prompted to update these disclosures if their outside activities or interests are ongoing.
Certain disclosed information will be available on a publicly accessible and searchable website for the purpose of fostering a transparent environment with regards to conflicts of interest and conflicts of commitment. Only the following disclosed information will be available on such a website:

1.  The nature and extent of an activity, and the range of compensation if over $5,000, for all managed conflicts of interest or conflicts of commitment. Conflicts are considered managed if the institution requires that a management plan be put in place to mitigate the conflict;
2.  All information disclosed by UTMB's President; and
3.  Instructions for gaining access to a copy of any conflict management plan

NOTE: Information regarding family members will not be posted publicly.

Those employees responsible for the design, conduct, or reporting of research may have additional information posted on a publicly accessible and searchable website pursuant to federal regulations. This additional information includes, but is not limited to; information regarding the individual's research; the approximate dollar value (by range) of the financial interest/activity even if under $5,000; family member information if a family member's activity creates a conflict of interest with regard to the individual's research, etc.
Interactions with Industry

Interactions with Industry FAQ's

Industry includes any for-profit entity or the representative of such entity that develops, produces, markets, sells, or distributes drugs, biomaterials, herbal/nutritional products, devices (including durable medical devices), services (including home health care services), hospice care, or equipment intended for use in the practice of clinical specialties.
No. Tickets to a sporting event are personal gifts that serve no academic purpose. In order for a gift from Industry to be considered acceptable, five (5) conditions must be met:
1.  The gift must be reasonable in value;
2.  must be related to a bona fide academic or educational purpose;
3.  cannot violate the general or criminal standard for gift acceptance by government employees outlined in Texas state law (cannot be given with the intent to influence institutional decision making);
4.  cannot be in the form of cash, checks, or other negotiable instruments; and
5.  in circumstances in which food, lodging, transportation, or entertainment is provided, the donor must be present.
No. If you are merely attending a conference or meeting, funding/reimbursement for travel, lodging, meals, etc. may not be accepted from Industry.

However, if you are presenting, participating in a panel discussion, moderating a panel, or performing in other substantive educational roles at the conference or meeting then acceptance of funding or reimbursement for travel/lodging is acceptable. Remember however, that an Industry representative must be present for the acceptance of meals or entertainment to be permissible.
No. Meals funded by industry should not be provided on the UTMB campus, nor at UTMB-sponsored events held in off-campus locations that are not provided as part of appropriately sanctioned educational activities (e.g. scientific or educational meetings)
Yes, while this practice is discouraged, this is the rare instance where gifts from Industry are acceptable. However, if the item is branded with the company logo or name, the item should not be used on campus.
Yes, but several conditions must be met:

1.  The activity must be designed to promote evidence-based clinical care and/or advance scientific research and cannot be promotional in nature;
2.  The meeting or lecture content, including slides and written materials must be determined independently by the UTMB employee without prior approval or final approval requirements by the Industry sponsor;
3.  Lecturer must make it clear to the audience that the content of the lecture reflects the views of the lecturer and not UTMB;
4.  Financial support by Industry must be fully disclosed at the meeting by the sponsor;
5.  Lecturer must explicitly describe all of his or her relevant financial interests (past, existing, or planned) to the audience;
6.  Attendees must not be compensated or otherwise materially rewarded (gifts) for attendance;
7.  The UTMB employee must receive compensation and expense reimbursement only for the services provided and the compensation must be reasonable with regard to fair market value;
8.  Lecturer must receive prior approval before engaging in a compensated presentation sponsored by Industry.

For a full list of conditions, please see IHOP 6.5.2 - Ethical Interactions with Industry.
In order for a speaker bureau agreement to be compliant with UTMB policy, it must afford the speaker full control and authority over professional material the speaker presents (Industry sponsor may not have prior or final approval rights and Industry sponsor may not “ghostwrite” presentation material). Such material may not be contractually subjected to approval by any commercial interest (i.e., industry sponsor) other than approval for the use of proprietary information. Furthermore, the presentation may not be associated with or have the intent of being designed for the sole or predominant purpose of selling or marketing a branded product, device, or other good.
Gifts

Gifts FAQ's

Yes, unsolicited gifts from patients and/or patients' family members may be accepted so long as they are of reasonable value and are not given to influence or secure preferential treatment.

Gifts of cash or cash equivalents from patients and/or patients' families provided in the context of patient-care activities must be fully assigned to the Institutional Trust Fund as required by UTMB's MSRDP Faculty Practice Plan Bylaws.