What
is a conflict of interest? |
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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.
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What
is UTMB’s Conflict of Interest Policy? |
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It is the policy of UTMB that financially
interested individuals may not engage in activities that have
the potential to directly or indirectly
- affect UTMB’s interests;
- compromise objectivity in carrying out UTMB’s responsibilities;
- compromise the integrity of scientific research; or
- 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.
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Who
has to complete the annual evaluation form? |
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For activities involving human subjects
research, 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 must complete and sign the annual evaluation
form. For all other activities all faculty and A&P employees
must complete and sign the annual evaluation form.
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What
is considered “human subjects research”? |
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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.
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What
is considered as “conducts research”? |
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Conducts 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.
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Who
is considered “family”? |
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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.
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What
is considered a “significant financial interest”? |
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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 minimis amount established in PHS regulation (presently $10,000),
or are expected to exceed that amount in the next twelve months.
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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. |
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. |
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). |
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What
is not considered a “significant financial interest”? |
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a)
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Salary, royalties, or other remuneration
from UTMB; |
b) |
Income from seminars, lectures, or
teaching engagements sponsored by public or nonprofit entities;
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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. |
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What
is considered “in the aggregate” for the de minimus
amounts? |
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The total of all relationships with
a single financially interested company exceeds $10,000 or 5%
equity ownership. For example, 2 consulting agreements with Company
XYZ for $5,500 and $5,000 for the same annual period would “aggregate”
to $10,500 and be considered a significant financial interest.
However, 1 consulting agreement with Company ABC for $5,500 and
1 consulting agreement with Company XYZ for $5,000 for the same
annual period would NOT be “aggregated” and NOT considered
a significant financial interest.
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What
is considered a “business”? |
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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.
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What
is considered “sponsored research”? |
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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.
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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. |
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What
is considered a “technology”? |
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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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When
are annual evaluation forms due for FY04? |
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The due date has not been finalized.
The COI official will notify all covered individuals once it has
been set.
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What
if I begin employment after the annual due date? |
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The annual evaluation form is due
within 30 days of the start of your employment to the COI Official.
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Do
I have to report changes in my activities and/or interests before
the next annual form due date? |
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Yes. Any changes, additions or elimination
of activities and/or interests must be reported by submitting
an updated evaluation form within 30 days of the change, addition
or elimination to the COI Official.
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Do
I have to complete the form if I have no activities to disclose
or if my interests are less than amounts as defined in “significant
financial interest”? |
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Yes. Covered individuals (see above)
must complete and sign the annual evaluation form. If you have
no activities or your interests are less than the amounts as defined
in “significant financial interest”, you should respond
accordingly to the questions.
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Who
can I contact with questions? |
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Questions concerning the interpretation
or applicability of this policy should be directed to the UTMB
COI Committee’s administrative support at ext. 747-1723.
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What
are the penalties if I fail to complete, sign and submit my annual
evaluation form? |
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Instances of deliberate breach of
policy including, but not limited to, failure to file or knowingly
filing an incomplete, erroneous, or misleading disclosure form,
violations of the guidelines or failure to comply with prescribed
monitoring procedures, will be adjudicated in accordance with
applicable disciplinary policies and procedures for each covered
individual. Possible sanctions may include some or all of the
following actions: |
1) |
termination of the activity that
is a conflict of interest; |
2) |
divestiture of significant financial
interests; |
3) |
disciplinary action against the employee
up to and including termination. Disciplinary action will be administered
according to the UTMB Institutional Handbook of Operating Procedures
(IHOP) Section 3.10, Discipline and Discharge and the Regent’s
Rules Part I, Chapter 3, Personnel, Section 6, Tenure, Promotion,
and Termination of Employment. |
4) |
In the case of a violation of criminal
or civil law, violators may be subject to civil or criminal penalties. |
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How
do I appeal a decision by the COI Committee? |
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To appeal a negative decision of
the COI committee, you may present your appeal to your appropriate
Dean or Vice President. If the Dean or Vice President approves
the appeal, then the appeal must be made directly to the UTMB
President. The UTMB President will decide whether to permit the
activity or to uphold the decision of the COI committee.
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Will
my evaluation form be treated confidentially? |
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The forms will be considered confidential;
and the information disclosed in the forms will be available only
to individuals duly charged with the responsibility for review.
However, the information may be released in accordance with and
as required by Texas law or lawful court order.
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