COI 101: What is Conflict
of Interest and How Can it
Affect You?
Jennifer Morales
Research Compliance Specialist
Office of Research Integrity & Compliance
What is Conflict of Interest?
A situation in which financial or other
personal considerations may compromise or
have the appearance of compromising an
employee's professional judgment in
administration, management, teaching,
research or any other professional activities.
Examples of Possible COIs or those
Requiring Management Plans
(not inclusive)

Failure of the faculty member/researcher to fulfill university responsibilities (e.g.,
holding classes, advising students, conducting research…), due to involvement in
external activities.

Sponsored projects or technology licensing arrangements in which any of the
involved investigators (or members of their immediate families) have employment or
consulting arrangements and significant financial interests in the sponsor, or with
subcontractors, vendors, or collaborators.

Using university resources to conduct research that is sponsored by an entity in
which the faculty member/researcher or his/her family member has a significant
financial interest.

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 or provides gift funds for the researcher or his/her department.

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.
Examples of Possible COIs or those
Requiring Management Plans
(not inclusive)

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 family member has a financial interest.

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.

Conducting clinical trials on a drug or device developed by the faculty
member/researcher may be manageable if the research DOES NOT involve
human research subjects.

Equity (ownership) interest of the faculty member (or members of the
immediate family) in a sponsor.
 Diverting research opportunities from the university to a consulting entity or
business in which the faculty/researcher has a financial interest.
Possible Conflict of Interest
Situation – Funded Research
ABC Company
UTSA
Undisclosed Consultant Agreement
$75,000 fees & 25,000 shares
Faculty/Researcher
UTSA Resources/Lab Facilities
Student Research Projects
Research Data
Publications &
Possible Commercialization
Grades/Graduation
Possible Conflict of Interest
Situation – Non Funded Research
UTSA
Undisclosed Consultant Agreement
$75,000 fees & 25,000 shares
Faculty/Researcher
Student Research Projects
UTSA Resources/Lab Facilities
Research Data
Publications &
Possible Commercialization
License Intellectual Property/
Provisional Patent
Grades/Graduation
ABC Company
Guiding Principles

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The fact is that there will be conflicts.
The term Conflict of Interest “implies” wrongdoing.
Not all conflicts are necessarily impermissible and
MOST are manageable.
When human subjects are involved, there will be a
higher level of scrutiny
Complete and timely disclosure is essential
Case by case analysis and management is crucial
When conflicts of interest are
handled appropriately



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Helps prevent loss of public trust
Promotes objectivity in research
Increases public funding of research
Protects the reputation of the University as a
credible research institution
And…last but not least,
It’s the LAW!
COI Federal & State
Regulations


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42 CFR 50 Subpart F deals with grants
and cooperative agreements
45 CFR Part 94 deals with contracts
Texas Institutions should also see:
Texas Government Code Chapter 572
Section 572.005
How does UTSA Deal With
COI?
First, a distinction was made between the following:
1. Institutional Conflict of
Interest which is driven by
Texas Statute (Chapter
572, Government Code)

This Statute has
different thresholds for
reporting and does not
define areas pertinent to
research (i.e. human
subjects, intellectual
property, etc.)
2. Conflict of Interest in
Research & Intellectual
Property

Follows federal
regulations (CFR Title 42,
Vol1 Part 50 Subpart F &
CFR Title 45, Volume 1
Part 94 Section 94.4)
Institutional Responsibilities as
defined by Federal Regulations
1)
2)
3)
4)
Maintain a written, enforced policy
Inform Investigators of the policy, the
regulations and their responsibilities
Establish enforcement mechanisms and
define sanctions for non-compliance
Comply with the retention regulation – 3
years from date of submission of final
expenditures report
Institutional Responsibilities as
defined by Federal Regulations
Designate an Institutional Official to

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solicit and review disclosure statements
provide guidelines to identify COI
take action to ensure COI issues are
managed, reduced or eliminated
CCOI Structure

Voting Members and one alternate for each as follows:
 7 members, one from each College of the University
 One Community member not otherwise affiliated with the
University
 Small Business Development Center representative
 Institutional Review Board representative
 Office of Research Integrity and Compliance

Ex-officio Members, non-voting member and alternate from the
following:
 Institutional Compliance and Risk Assessment
 Technology Transfer Office
 Office of Sponsored Programs
 Office of Vice President for Business Affairs
Policy
UTSA policy applies (and at times
exceeds) the federal regulations
and includes both funded and
non-funded research.
Components of Conflict of
Interest Management

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Disclosure
Review
Management
Monitoring
Reporting
Investigator Responsibilities

Submit financial disclosure statements listing
all Significant Financial Interests:


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That would reasonably appear to be affected by
the research
In entities whose financial interests would
reasonably appear to be affected by the research
Comply with all institutional requirements
Who should disclose?
The Principal Investigator AND any
other person responsible for the
design, conduct, or reporting of
research or proposed research AND
includes their Spouse/Domestic
Partner, Dependent Children and
Others in the Household
Who does that include?
RAs &
Graduate RAs
Sub-Contractors
Sub-Recipients
Lab Personnel
Research
Doctoral &
Post Doctoral
Students
PIs
Co-PIs
Other
Collaborators
Includes their Spouse/Domestic Partner, Dependent Children and Others in the household
Significant Financial Interest
Anything of monetary value, including but not
limited to, salary or other payments for
services (e.g., consulting fees or honoraria);
equity interests (e.g., stocks, stock options or
other ownership interests); and intellectual
property rights (e.g., patents, copyrights and
royalties from such rights).
The term does
NOT include:

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Salary, royalties, or other remuneration from
the applicant institution;
Any ownership interests in the institution, if the
institution is an applicant under the SBIR Program
(including STTR); (UTSA Policy Differs)
Income from seminars, lectures, or teaching
engagements sponsored by public or nonprofit
entities; (UTSA Policy Differs)
Income from service on advisory committees or
review panels for public or nonprofit entities; (UTSA
Policy Differs)
The term does
NOT include:

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An equity interest that when aggregated for the
Investigator and their spouse and dependent
children, 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 % ownership interest in
any single entity; or (UTSA Policy Differs)
Salary, royalties or other payments that when
aggregated for the Investigator and their spouse and
dependent children over the next twelve months, are
not expected to exceed $10,000. (UTSA Policy Differs)
What is a Financial Conflict of
Interest?
UTSA adopted the NIH definition:
A significant financial interest that
could directly and significantly affect
the design, conduct, or reporting of
research.
Significant Financial Interest vs.
Financial Conflict Of Interest:


A Significant Financial Interest (SFI) is not
always a Financial Conflict of Interest (FCOI)
An FCOI exists when a designated Institutional
Official reasonably determines that an SFI could
directly and significantly affect the design,
conduct, or reporting of the research (usually
with the recommendations of a COI Committee)
Procedure

Created and implemented a procedure for collecting
Disclosure Forms
st
 Annually on February 1 for all researchers, and
others specified by Chair/Dean, whether research
is funded or not funded
 Updated PRIOR to submitting a funding proposal
or entering into a technology licensing
arrangement, or any other contract that binds the
University.
 Within 30 days of hire/appointment for all new
faculty researchers or new staff on research
projects.
Electronic System
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An electronic system was purchased from
ClickCommerce and was implemented on
February 1, 2010
It is tied into the mandatory acknowledgements
which ALL employees are currently required to
complete on an annual basis
It will combine the process for reporting ICOI and
COIs in Research/IP
Electronic System

Network login information
is used to log into
ClickCommerce website

Select the “New
COI” button to
access the
electronic
disclosure form
Website: https://oric.utsa.edu
Other Interests

In addition to financial interests that must be
managed, reduced, or eliminated, an Institution
may require the management of other conflicting
interests as the Institution deems appropriate.

This includes managing Conflicts of Commitment to
ensure that all employees carry out their duties to the
University first, before commitments to any outside
entity.
Contact Information
Bernard Arulanandam, Ph.D., MBA
Chair, Committee on COI in Research & IP
(210) 458-5492 bernard.arulanandam@utsa.edu
Martha R. Treviño, M.A.
Director, Ethical Conduct of Research
Office of Research Integrity & Compliance
(210) 458-4531 martha.trevino@utsa.edu
Jennifer Morales
Research Compliance Specialist
Office of Research Integrity & Compliance
(210) 458-4233 jennifer.morales@utsa.edu
Website: http://vpr.utsa.edu/oric/coi