Trinity University expects all
employees to exercise good judgement, professional commitment, and the
highest ethical standards in their extramural activities if those activities
can in any way affect the university. Every employee has an obligation
to avoid any activity, agreement, business investment or interest, or other
situation that could be construed to be in conflict with the university's
interest or to interfere with the employee's duty to serve the university.
Where existing outside interests contravene the policy, the employee will
be permitted a reasonable period, not to exceed three months, to make adjustments.
Research proposals are not to be submitted to grantor agencies until the
university official responsible for sponsored research
has been satisfied that the outside interest has been reduced/eliminated.
1. Policy It is the policy of Trinity University that:
1.1 No employee shall have a direct or indirect interest in any business enterprise that is a competitor of the university or has dealings with the university as a supplier. An employee in a position to influence a university business decision for which he/she may receive material benefit should disclose the nature of the conflict to his/her immediate supervisor, and, where possible remove himself/herself from involvement in the decision. If the individual(s) continue to participate in the decision process, discussion with supervisors and documentation of the potential conflict should be presented to the Conflict of Interest Committee.
1.2 No employee shall seek or receive, for personal
or any other person's gain, any payment, whether for services or otherwise,
loan (except from a bank), gift or discount of more than nominal value,
or entertainment that goes beyond common courtesies usually associated
with accepted business practice from any business enterprise that is a
competitor of the university or has current or known prospective dealings
with the university as a supplier or could benefit from your submission
of research data.
1.3 No employee shall, for personal or any other
person's gain, deprive the university of any opportunity for benefit that
could be construed as related to any existing or reasonably anticipated
future activity of the university.
1.4 No employee shall, for personal or any other person's gain, make use of or disclose confidential information learned as a result of employment by the university. Any information that has been acquired in connection with sponsored research by university members cannot be withheld from the sponsoring organization(s) for personal benefit.
1.5 No employee shall have any outside interest that materially interferes with the required time or attention that the employee must devote to the university. Employees should not undertake or orient activities to serve the needs of an outside organization at the expense of fulfilling the mission of the university.
1.6 Before considering outside employment or consulting activities, an employee should discuss with his/her appropriate supervisor potential conflicts of commitment or interest. Employees regularly involved in consulting activities from which they profit financially, are not in conflict as long as:
i) University resources (laboratories, studios, equipment, computational facilities, and/or human resources) are not used more than incidentally without reimbursing the university.
ii) Such activities do not unduly interfere with the time and energy committed by the individuals to their primary responsibilities to the university. The allowable amount of time dedicated to consulting will be governed by the Consulting Policy.
iii) Such involvement does not inhibit the publication of research findings developed in the course of the individual's regular university activities.
1.7 The university actively encourages involvement
in professional organizations, panels, advisory commissions, government,
charitable and community organizations. However, such involvement
should not become so dominant that university members no longer effectively
satisfy their responsibilities to the university.
1.8 Faculty members must exercise prudence in directing
students and supervised employees toward activities from which the
faculty might financially benefit. If a potential conflict
exists, faculty are encouraged to consult their department
chair or dean for an independent evaluation of the activities' educational
merits.
1.9 No employee shall act or be involved in any situation that potentially conflicts with the principle that this policy is intended to implement.
2. Exceptions
2.1 Specific exceptions may be made by the Conflict of Interest Committee upon application in writing by the employee. Such exceptions shall be wholly discretionary and shall be adopted at such times and under such conditions as will serve the interests of the university.
2.2 The Conflict of Interest Committee is composed of four Vice Presidents or his/her designee. Each must be in attendance to consider the exception. Absentees will be considered negative votes. The President of the University will make the decision in case of a tie vote.
2.3 The Conflict of Interest Committee will determine whether an actual or potential conflict of interest exists, and determine what conditions or restrictions, if any, should be imposed by Trinity to manage, reduce or eliminate such conflict of interest.
3. Standard for Compliance
3.1 Prohibitions of this policy should be construed broadly
rather than narrowly. A conflict of interest may be deemed to exist
even though it may not result in financial loss to the university,
regardless of the motive of the employee involved.
3.2 Each investigator who is/will be responsible
for the design, conduct or reporting of research or educational activities
funded by federal monies will submit an annual disclosure statement to
the official university sponsored project representative. Annual Disclosure
Statements should be submitted between the first business day of January
and the last business day of January. If a possible conflict of interest
arises, the employee is encouraged to discuss the matter with the appropriate
Vice President designated by the Conflict of Interest Committee to determine
whether such a conflict in fact exists and, if so, how it may be resolved.
3.3 Significant financial interests of an investigator's spouse and dependent children are required to be disclosed on the annual disclosure statement.
3.4 The Vice President or Dean of each division of the university shall be responsible for appropriate dissemination of this policy.
3.5 The official university sponsored project representative will be responsible for maintaining all documented actions taken by Trinity with respect to each confidential significant financial interest. Documentation retention is for 3 years after the completion of the grant.
3.6 The official university sponsored project representative must notify the appropriate funding authority within 60 days of becoming aware of a significant financial interest of a principal investigator that was not disclosed when the grant was approved. An investigator with a significant financial interest that was not disclosed or managed in accordance with the Department of Health and Human Services guidelines must disclose that financial interest in each public presentation of the results of the research concerning the evaluation of the safety or effectivenesss of a drug, medical device or treatment.
3.7 All financial disclosures must be updated during the pendency of a research award, either on an annual basis, or as new reportable significant financial interests are obtained.
3.8 The official university sponsored project representative must notify the funding source if Trinity's Conflict of Interest Committee determines that it is unable to manage an actual or potential conflict of interest within 60 days after it is known.
3.9 If the failure of an employee to
comply with this policy has biased the design, conduct, or reporting of
federally funded research data
the official university sponsored project representative must promptly
notify the grantor of the corrective action taken.
4. Reports and Investigation
4.1 The Conflict of Interest Committee shall have authority to direct the internal auditing department to investigate any suspected violation of this policy by any university member.
4.2 Violation of this policy may be grounds for disciplinary action. The university will make the final determination for disciplinary action. Many actions are available and may be taken in a fashion consistent and commensurate with the nature of the proven acts of misconduct. Examples include:
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TRINITY UNIVERSITY
Conflict of Interest Disclosure Statement (PART A)
1. Have you read the university's policy on conflict of interest
within
the past 12 months, and do you understand
that policy? Circle one YES
NO
2. Do you agree to comply with any conditions or restrictions
imposed
by the Trinity University Conflict of Interest Committee to
manage
, reduce or eliminate actual or potential conflicts of interest?
Circle one YES
NO
3. Are you an investigator involved in a research project or do
you
plan to submit a research proposal concerning
design, conduct, and
reporting of research data? If your answer is yes, please complete
parts B & C(if required) also.
Circle one YES
NO
4. Please list below and/or on an attached page(s) the following
information concerning any management
responsibilities that you
had or anticipate having in any for-profit
business.
FIRST Business
Name of Business:______________________________
Nature of Business:_____________________________
Responsibility:
1. CEO
2. Other (Please specify)_____________________
Number of days: Past year__________ Anticipated______
Description of duties:_________________________________
__________________________________________________
__________________________________________________
NAME (Print) __________________________
Title __________________________
Division or Department__________________________
Signature______________________
Date________________
TOTAL NUMBER OF DISCLOSURE STATEMENT PAGES _________
**************************************************************************
TRINITY UNIVERSITY
Conflict of Interest Disclosure Statement (Part B)
Please answer "YES" if the activity or interest described has taken place in the last 12 months, or if you anticipate (based on your current best guess) that it will take place within the next 12 months. Italicized words are defined on the reverse side of Part A & B.
1. EQUITY INTERESTS IN RELATED BUSINESSES YES NO
Could the value of equity interest held in any related
business by you or anyone in
your family have been (be) influenced
by the exercise of your professional duties at
Trinity. ?
2. FINANCIAL CONNECTIONS WITH RELATED BUSINESS YES NO
Have you (will you) or anyone in your family been (be)
in a policy position or had
(will have) receipts of more than $500 from any
for-profit business (excluding
consulting income) whose activities
relate to your professional area at Trinity ?
3. OUTSIDE EMPLOYMENT OF STUDENTS OR STAFF YES NO
In your activities outside of Trinity, did you (will you)
utilize, in either a paid or
unpaid capacity, the services of Trinity students
or staff over whom you exercise
supervisory or academic responsibility in
your role at the University?
4. USE OF TRINITY RESOURCES TO SUPPORT EXTERNAL ACTIVITIES
YES
NO
Did you (will you) make use of Trinity facilities
, equipment, intellectual property ,
or staff services to support consulting
at a for-profit business or some other
commercial activity?
5. OTHER FINANCIAL INTERESTS YES NO
Have you (will you), or anyone in your family had (have)
a financial interest in any
contract , sale, or other transaction to which Trinity
was a party?
6. OTHER SITUATIONS YES NO
Are there (will there be) any other situations, not listed above,
that may create an
actual or perceived conflict of interest between your
role at Trinity and an outside
interest?
NAME (Print) __________________________
Title
__________________________
Division or Department__________________________
Signature_____________________
Date___________________
NOTE: If you answered "YES" to any question, please fill out
Part C
***************************************************************************
Conflict of Interest Disclosure Statement - Definitions
Activities: includes both direct activities and financial interest in the activities of other businesses.
Business: Any corporation, partnership, proprietorship, firm, franchise, association, holding company, joint stock company, receivership, trust, or any other legal entity organized for profit. It does not include mutual funds over which you have no control, or any governmental committee, community, political, academic, charitable, religious, social, or professional non-profit organization.
Contracts: Excludes the terms of your own or any family member's employment contract with the university.
Trinity: Includes all units operated by the university.
Equity interests: Ownership or control of stock, stock options, or other investment instruments.
Facilities: Excludes your office, office equipment and incidental supplies (e.g. copying, FAX, long distance telephone service) for which you reimburse Trinity University.
Family: Spouse, affectional partner, children, siblings, parents, dependents, or members of your household.
Intellectual property: Includes organized information, ideas, fabrication methods, devices, or substances that are patented or copyrighted or have that potential, and that are partially or fully owned by Trinity. Exclude any intellectual property for which you hold a license from Trinity or which is in the public domain.
Investigator: The principal investigator, co-principal investigators, and any other person at the institution who is responsible for the design, conduct, or reporting of research or educational activities funded by a federal grant.
Policy position: A director, officer, partner, manager, or agent in any managerial position.
Receipts: Includes loans, gifts, royalties and earned income other than consulting fees. Exclude grants, contracts, or any other sums that you or your family member receive from Trinity, no matter what the original source.
Significant financial interests: Any business, equity interests
or intellectual property of the investigator or his immediate family
that would reasonably appear to be directly and significantly affected
by his/her federally funded research or proposed federally funded research.
Other business, equity interests or intellectual property that
exceeds $5000 or 5% combined family ownership. Anything of monetary
value, including but not limited to, salary or other payment for services
(e.g., consulting fees or honoraria); equity interests, and intellectual
property rights.
The term does not include:
TRINITY UNIVERSITY
Conflict of Interest Disclosure Statement (Part C)
* Italized words are defined on
the back of Part B.
1. Equity Interests in Related Business
Please provide the following information for any equity interest held in any related business by you or anyone in your family which could have been influenced by the exercise of your professional duties at Trinity. Also, provide the following information if you anticipate this happening. Complete a Part C for each unique interest.
1a. Business name:___________________________________
1b. Publicly traded:
YES
NO
1c. Value of equity interest:
(1)Less than $5000 (2)Between
$5,000-$50,000 (3)Over $50,000
1d. Percentage owned or controlled:
(1)Less than 1% (2)Between 1-4.9% (3)Between
5-50% (4)Over 50%
1e. Relationship of owner to you: (1)self (2)family member (3)other
1f. Past period or anticipated: (1)Past period (2)Anticipated (3)Both
1g. Relationship of business to my research activities: (Circle all
that
apply)
a. Business sponsors Trinity Research for which I am a
PI.
b. Business sponsors Trinity Research in which I participate
but I am not the PI.
c. Business sponsors research outside of Trinity in which
I participate
d. Business does not sponsor my research, but my research
could have
financial implications for the business.
e. Other (please specify) _______________________________________
_______________________________________________________________
1h. Relationship of business to my extension activities:(Circle
all
that apply)
a. Business sponsors extension activities outside of Trinity
in which I participate.
b. Business does not sponsor my extension activities, but
these activities could
have financial implications for the business.
c. Other (Please specify)_______________________________________
_______________________________________________________________
1i. Relationship of business to my supervisory/administrative
activities at Trinity: (Circle
all that apply)
a. I am involved in decisions regarding services (other
than sponsored research)
which the business provides to/receives from Trinity.
b. I assign or supervise students, residents, fellows,
or other faculty whose work
could have financial implications for the business.
c. Other (Please specify) _______________________________________
Conflict of Interest Disclosure Statement (Part C)- Continued
2. Financial Connections with Related Businesses
Please provide the following information for any for-profit business whose activities relate to your professional area at Trinity in which you or anyone in your family has been in a policy position or from which you or anyone in your family received loans, gifts, royalties or earned income of total value greater than $500 (excluding consulting income). Also, please provide the following information if you anticipate this happening. Exclude any income that is reported in your answer to question 1.
2a. Business name: _______________________________________
2b. Publicly traded:
YES
NO
2c. Total value received:
(1)Less than $5,000 (2)Between $5,000-50,000
(3)Over $50,000
2d. Financial connection with the business: (Circle
all that apply)
a. Consulting/employment
b. Loan
c. Gifts
d. Honoraria for papers
or lectures
e. Director, Officer,
Partner, Agent, or managerial position
f. Royalties
g. Other (Please specify)________________________________________
2e. Your relationship to individual who has financial connection
with
the related business:
(1) Self (2) Family member
(3) Other
2f. Past period or anticipated: (1)Past period (2)Anticipated
(3)Both
2g. Relationship of business to my research activities:
(Circle all that apply)
a. My research
has no financial implications for the business.
b. Business
sponsors Trinity Research for which I am a PI.
c. Business
sponsors Trinity Research in which I participate but I am not the PI.
d. Business
sponsors research outside of Trinity in which I participate
e. Business
does not sponsor my research, but my research could have
financial implications for the business.
f. Other (please
specify) __________________________________
2h. Relationship of business to my extension activities:(Circle
all
that apply)
a.
My extension activities have no financial implications for the business.
b.
Business sponsors extension activities outside of Trinity in which I participate.
c.
Business does not sponsor my extension activities, but these activities
could
have financial implications for the business.
d.
Other (Please specify)____________________________________
2i. Relationship of business to my supervisory/administrative
activities at Trinity: (Circle all that
apply)
a.
My Trinity supervisory/administrative activities have no financial
implications for the
business.
b.
I am involved in decisions regarding services (other than sponsored research)
which the business provides to/receives from Trinity.
c.
I assign or supervise students, residents, fellows, or other faculty whose
work
could have financial implications for the business.
3. Outside Employment of Students or Staff
In the space below, please describe
your utilization or anticipated utilization of the services,
In either paid or unpaid capacities,
of any Trinity students or staff for activities external to
Trinity over whom you exercise
supervisory or academic responsibility in your role at the
University.
3a. Employment or utilization of services of staff:
PAST PERIOD
ANTICIPATED
Number of staff involved: _____________________________
__________________
Total Number of days: ________________________________
__________________
Related to my Trinity Duties
YES
NO
YES
NO
Unrelated to my Trinity Duties
YES
NO
YES
NO
3b. Employment or utilization of services of graduate students:
PAST PERIOD
ANTICIPATED
Number of staff involved: _____________________________
___________________
Total Number of days: ________________________________
___________________
Related to my Trinity Duties
YES
NO
YES
NO
Unrelated to my Trinity Duties
YES
NO
YES
NO
3c. Employment or utilization of services of undergraduate students:
PAST PERIOD
ANTICIPATED
Number of staff involved: _____________________________
____________________ Total Number of days: ________________________________
____________________
Related to my Trinity Duties
YES
NO
YES
NO
Unrelated to my Trinity Duties
YES
NO
YES
NO
4. Use of Trinity Resources to support External Activities:
In the space below, please describe any use that you made or anticipate making of Trinity facilities , equipment, intellectual property , or staff services to support consulting at a for-profit business or some other commercial activity.
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
5. Other Financial Interests
In the space below, please describe the financial interests that you, or anyone in your immediate family had or anticipate having in any contract , sale, or other transaction to which Trinity was or will be a party.
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
6. Other Situations
In the space below, please describe any other situations, not listed above, that may create an actual or perceived conflict of interest between your role at Trinity and an outside interest. Also, please describe any situations that anticipate arising.
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
**********************************************************************
The following information relates to the Trinity Administration responsibilities
concerning
the implimentation of a university Conflict of Interest Policy concerning
faculty involved in research funded by federal contracts or grants:
¤50.603 Definitions
Investigator ... includes the investigator's
spouse and
dependent children .......................Definitions
back Part B & 3.3 (new)
¤50.604 Institutional responsibility regarding
SIGNIFICANT
FINANCIAL INTERESTS of Investigators
(a) Each Institution must: TU Conflict Policy
1) Inform each investigator...........................................................3.4
2) Designate an institutional official(s) to
solicit & review financial disclosure
stmts. from each investigator who is
planning to participate in funded research........................3.2
(new)
3) Investigators provide a listing of
significant financial interests prior
to the
time an application is submitted
...................................Intro & 3.7 (new)
4) ... take such actions as necessary to ensure
that any such financial interest will
be
managed, reduced, or eliminated..........................................2.3
(new)
5) Maintain records, identifiable to each award
of all financial disclosures & all
actions
taken by the Institution with respect
to each
SIGNIFICANT FINANCIAL INTEREST.........................3.5
(new)
6) Establish procedures for resolving any
alleged violation of the financial conflict
of
interest policy & establish appropriate
enforcement action for failure to comply...............................4.2
7) Certify, in each application for funding to
which this subpart applies
i) There is in effect a written
& enforced
administrative
process to eliminate
Significant
Financial Interests of the
type described
at ¤ 50.605 (a).......................................3.2 (new)
ii) Certify that actions will
be taken prior
to the award of funding to manage,
reduce or eliminate Significant Financial
Interests of the type described at ¤ 50.605 .................Intro
(new)
iii) The Institution agrees
to make info.
available, upon request, to HHS regarding
all Significant Financial Interest identified
by the Institution of the type described at
¤50.605 and how those interests have been
managed, reduced or eliminated....................................3.5 (new)
iv) The Institution
will otherwise comply
with this subpart.
8) i) Notify the awarding component of the
identification and management,
reduction or
elimination of any Significant
Financial
Interests of the type described
at ¤ 50.605 that
originates or becomes known to
the institution
after the grant or cooperative
agreement has
been awarded, within 60 days of
its becoming
aware of that interest..............................................3.6
(new) & 3.8(new)
ii) The HHS may at any time request
submission
of, or review on site, all
records pertinent to
these certifications.
To the extent permitted
by law, all records of financial
interests will
be maintained confidentially.....................................................
3.5 (new)
iii) An investigator may participate
in a
funded research project
simultaneously supported
by an organization that
has a commercial interest
in the finding of the research
project....Any
direct compensation or payment
to the
Investigator under that
support is considered a
financial interest under
this subpart.............................................2.1
¤50.606 Management of Significant Financial Interests
(a) If the failure of an employee to comply with
the policy of the institution
has biased the design
conduct, or reporting of
the ... research, the
institution must promptly
notify the ... awarding
component................................................................................3.9
(new)
(c) In any case in which HHS determines that a ...
funded project of clinical research
whose purpose
is to evaluate the safety or effectiveness
of a drug,
medical device, or treatment has
been designed,
designed, conducted, or reported
by an investigator
with a Significant Financial Interest
that was not
disclosed or managed as required
by this subpart,
The institution must require disclosure
of the
financial interest in each public
presentation................................3.6 (new)