CONFLICT OF INTEREST IN
RESEARCH
Jane Mostoller
Associate General Counsel
Office Of Research
OBJECTIVE
 Access to information regarding conflict of
interest
 Knowledge of basic concepts of conflict of
interest in research
BASIC FOUNDATIONAL
DEFINITION:
 Section 4: Human Resources Department of the FSU Faculty
Handbook
Applies to all university employees (derived from Board of Regents
policy)
 No employee of the State University System shall have any interest,
financial or otherwise, direct or indirect; engage in any business
transaction or professional activity; or incur any obligation of any
nature which is in substantial conflict with the full and competent
performance of his duties in the public interest.
 All employees of the State University System are governed by the
provisions of Section 112.313, Florida Statutes, setting standards of
conduct for public officers and employees of agencies, and Section
112.3145, Florida Statutes, mandating the disclosure of certain
financial interests.
CONFLICT OF INTEREST
HEADLINES AND EVENTS:
 Conflicts of Interest bedevil psychiatric drug research
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– USA Today 6/2/2009
UM Professor Reprimanded for Apparent Conflict of
Interest – The Baltimore Sun 1/23/2010
Baylor College of Medicine Faces NIH Sanctions over
Financial Conflicts – The Chronicle of Higher
Education 1/20/2010
Board Disciplines 3 Doctors for failure to disclose
financial interests in medical device – The New York
Times 5/3/2011
Top Psychiatrist Failed to Report Drug Income – The
New York Times 10/4/2008
CONFLICT OF INTEREST MAY BE
REGULATED BY:
 Federal Regulations
 State Statute
 University Policy
FEDERAL REQUIREMENTS
NIH and NSF Conflict of Interest regulations
implemented in 1995
 The result of public concern – Series of press
reports of incidents where outside activity
appeared to influence research results
 Compromised confidence in research
Department of Heath and Human Sciences issued an
updated Final Rule on COI revising the 1995
regulations in August 2011. Institutions have one
year to implement the new regulations.
FEDERAL REQUIREMENTS
The revised regulations:
 Require investigators to disclose to their institution all Significant
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Financial Interests
Lower the monetary threshold of SFI from $10,000 to $5,000
Require institutions to report additional information on identified
financial COI and how they are being managed
Require institutions to make certain info accessible to the public
concerning identified SFIs held by senior/key personnel
Require investigators to complete training related to the regs
and their institution’s financial conflict of interest policy
FEDERAL REQUIREMENTS
 Department of Health and Human Services
(DHHS) through Public Health Services
(PHS) which is the federal agency over NIH,
implemented particular regulation changes
effective August 24, 2012, and FSU revised
its NIH conflict of Interest policy as a new
PHS Conflict of Interest Policy.
 Information related to the new PHS policy
can be found at
http://www.research.fsu.edu/researchcomplia
nce/phs.html
FEDERAL REQUIREMENTS
 Note that this website contains the PHS /FSU
Policy on Conflict of Interest, the online
Training Module for Investigators, and the
Disclosure Reporting form – accessed
through the Electronic Disclosure
Management System (EDMS).
KEY DEFINITIONS:

Disclosure of Significant Financial Interests means an Investigator’s disclosure of
significant financial interests to an Institution.

Entity means any domestic or foreign, public or private, organization (excluding a federal
agency) from which an Investigator (and spouse and dependent children) receives
remuneration or in which any person has an ownership or equity interest.

Financial conflict of Interest (FCOI) means a significant financial interest that could
directly and significantly affect the design, conduct, or reporting of PHS-funded research.

FCOI report means an Institution’s report of a financial conflict of interest to a PHS
Awarding Component.

Financial Interest means anything of monetary value, whether or not the value is readily
ascertainable.
KEY DEFINITIONS:

Institutional responsibilities means an Investigator’s professional responsibilities on
behalf of the Institution such as research, research consultation, teaching, professional
practice, institutional committee memberships, and service on panels such as Institutional
Review Board or Data and Safety Monitoring Boards.

Investigator means the project director or principal investigator and any other person,
regardless of title or position, who is responsible for the design, conduct, or reporting of
research, including collaborators or consultants.

Institutional Official means the individual within FSU that is responsible for the solicitation
and review of disclosures of significant financial interests of Investigators and those of the
Investigator’s spouse and dependent children related to the Investigator’s institutional
responsibilities. For the purposes of this policy, the Institutional Official shall be designated
by the Vice President for Research.

Manage means taking action to address a financial conflict of interest, which includes
reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that
the design, conduct, and reporting of research will be free from bias.
KEY DEFINITIONS:

PD/PI means a project director or Principal Investigator of a PHS-funded research
project; the PD/PI is included in the definition of Investigator.

PHS means the Public Health Service of the U.S. Department of Health and
Human Services (HHS), and any components of the PHS to which the authority
involved may be delegated. The components of the PHS include, but are not
limited to, the Administration for Children and Families, Administration on Aging,
Agency for Healthcare Research and Quality, Agency for Toxic Substances and
Disease Registry, Centers for Disease Control and Prevention, Federal
Occupational Health, Food and Drug Administration, Health Resources and
Services Administration, Indian Health Service, National Institutes of Health, and
Substance Abuse and Mental Health Services Administration.

PHS Awarding Component means the organizational unit of the PHS that funds
the research that is subject to the subpart.

Research means a systematic investigation, study or experiment designed to
develop or contribute to generalizable knowledge.
Significant Financial Interest(SFI)
Significant Financial Interest (SFI) means a financial interest consisting of one or more of the
following interests of the Investigator (and those of the Investigator’s spouse and dependent
children) that reasonably appears to be related to the Investigator’s institutional responsibilities:

With regard to a publicly traded entity, a SFI exists if the value of any remuneration
received from the entity in the twelve months preceding the disclosure and the value of
any equity interest in the entity as of the date of disclosure, when aggregated for a single
entity, exceeds $5,000. Remuneration in this section includes salary and any payment for
services not otherwise identified as salary (such as consulting fees, honoraria, paid
authorship); equity interest includes any stock, stock option, or other ownership interest,
as determined through reference to public prices or other reasonable measure of fair
market value;

With regard to any non-publicly traded entity, a SFI exists if the value of any
remuneration received from the entity in the twelve months preceding the disclosure,
when aggregated for a single entity, exceeds $5,000, or when the Investigator (or the
Investigator’s spouse or dependent children) holds any equity interest (e.g. stock, stock
option, or other ownership interest); or
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Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income
related to such rights and interests, which exceeds $5,000 from a single entity.
Travel (TR)
Investigators also must disclose the occurrence of any reimbursed or
sponsored travel (i.e. that which is paid on behalf of the Investigator and not
reimbursed to the Investigator so that the exact monetary value may not be
readily available), related to their institutional responsibilities; provided,
however, that this disclosure requirement does not apply to travel that is
reimbursed or sponsored by a Federal, state, or local government agency,
an Institution of higher education as defined at 20 U.S.C. 1001(a), an
academic teaching hospital, a medical center, or a research institute that is
affiliated with an Institution of higher education. The de minimus threshold
does not apply for the reporting of travel.
The disclosure of reimbursed or sponsored travel must include the purpose
of the trip, the identity of the sponsor/organizer, the destination, the
duration, and monetary value, in order to determine whether a FCOI may
exist with the research endeavor.
The term “significant financial disclosure” does not include the following types of
financial interests:
 salary, royalties, or other remuneration paid by the Institution to the
Investigator if the Investigator is currently employed or otherwise appointed
by the Institution, including intellectual property rights assigned to the
Institution and agreements to share in royalties related to such rights,
income from investment vehicles such as mutual funds and retirement
accounts, as long as the Investigator does not directly control the
investment decisions made in these vehicles
 income from seminars, lecture, or teaching engagements sponsored by a
Federal, state, or local government agency, an Institution of higher
education as defined at 20 U.S.C. 1001(a), an academic teaching hospital,
a medical center, or a research institute that is affiliated with an Institution of
higher education, or income from service on advisory committees or review
panels for a Federal, state, or local government agency, an Institution of
higher education as defined at 20 U.S.C. 1001(a), an academic teaching
hospital, a medical center, or a research institute that is affiliated with an
Institution of higher education.
FEDERAL REQUIREMENTS for NSF
A principal investigator and all others with
substantial research responsibilities must file
a financial disclosure form with the University
by the time a grant application is submitted
which identifies any significant financial
interests of the PI, his or her spouse and
dependent children that would reasonably
appear to be affected by the proposed
research, or is an outside interest that would
reasonably appear to be affected by the
research.
FEDERAL REQUIREMENTS for NSF
Significant financial interests are:
 Any sort of compensation, in cash or other
form, for services to an individual and his or
her immediate family, the value of which
exceeds $10,000 in a one-year period; or
 An equity interest which exceeds $10,000 or
which exceeds a five percent ownership
interest.
 Example: An investigator owns stock in a
company providing the research funding or
an investigator has an ownership interest in a
company that may profit from a university
invention
Conflicting interests are not necessarily unacceptable,
and many can be managed through disclosure and
oversight. NSF requires that institutions report only
those conflicts that have not been resolved.
FSU Significant Financial Interest Disclosure Form
for NSF Available through Sponsored Research
Services website
www.research.fsu.edu/contractsgrants/forms.html
FEDERAL REQUIREMENTS for NSF
Institution is required to:
 Review all financial disclosures
 Determine whether a conflict exists
 Determine what action should be taken to
manage, reduce or eliminate such conflicts
FEDERAL REQUIREMENTS
Citations:
 http://grants.nih.gov/grants/policy/coi/
 National Science Foundation
 s. 510 Grant Policy Manual
OTHER CONFLICTS OF INTEREST IN
FEDERALLY FUNDED RESEARCH
 DHHS - Human Subjects Research (committee
member conflict of interest). No IRB may have
a member participate in review of any project in
which the member has a conflicting interest.

FDA - Clinical Investigation/Trials (committee
member conflict of interest) and financial
disclosure by clinical investigators and
sponsor(s).

FARS Subpart 9.5 Organizational and
Consultant Conflicts of Interest
AAMC Report 2002 – Conflict of Interest
in Human Subject Research
“ With the welfare of research subjects always
of foremost concern, an institution should
regard all significant financial interests in
human subjects research as potentially
problematic and therefore, as requiring close
scrutiny. Institutional policies should establish
the rebuttable presumption that an individual
who holds a significant financial interest in
research involving human subjects may not
conduct such research.”
DHHS Report 2004 – Conflict of Interest
in Human Subjects Research
Final guidance touches on individual conflicts of
interest as well as institutional conflicts of
interest.
“Ipso facto” circumstances
Definition- “By that very fact”
New direction – federal concern expands from
disclosure of individual conflicts of interest (NIH
and NSF) to include institutional conflicts of interest
(AAMC, AAU, DHHS reports) Death of Jesse
Gelsinger was pivotal in expanding need for
disclosure.
Institutional Conflict of Interest
AAU report (2001) indicates that an
institutional financial conflict of interest may
occur when the institution or an affiliated
foundation or organization, has an external
relationship or financial interest in a company
that itself has a financial interest in a faculty
research project.
Current Reality: Institutions must manage
two types of conflicts of interest:
 Individual
 Institutional
GAO Report 2003 –
Shift from Individual conflicts of interest to
institutional conflicts of interest.
University Research is a vital part of the nation’s
research and development efforts. The federal
government has been the primary source of
funding for this research. Historically the primary
return on the federal government’s investment in
university research was the advancement of
scientific knowledge. Science progresses through
open communication among scientists and the
sharing of research results.
The federal investment in university research not
only has advanced scientific knowledge but also has
yielded thousands of inventions each year. For some
universities, it has also yielded new streams of
income that helped to support their research and
education missions. University ownership of
inventions and the right to license to businesses has
created partnerships between universities and
businesses, giving rise to concerns that financial
conflicts of interest might restrict the dissemination
of research results or bias the conduct or results of
federally funded research.
(Potential for institutional conflicts of interest).
State Regulation of Conflicts of
Interest:
Part III, Chapter 112, Florida Statutes – Code of
Ethics for Public Officers and Employees
Section 112.311, F.S.
 “It
is essential to the proper conduct and operation of
government that public officials be independent and
impartial and that public office not be used for private
gain other than the remuneration provided by law”.
 At the same time the legislature recognized that
public officials and state employees should not be
“denied the opportunity to acquire and retain private
economic interests except when conflicts with the
responsibility of such officials to the public cannot be
avoided”. Thus the Code is designed to “protect
against any conflict of interest and establish
standards for the conduct of elected officials and
government employees in situations where conflicts
may exist”.
Conflict of Interest Definition
Means a situation in which regard for a
private interest tends to lead to a disregard of
a public duty or interest. Section 112.312(8),
F.S.
Key prohibitions from the statute are:
 Misuse of position
 Use of information
 Gifts and honoraria
 Doing business with the university
 Conflicting employment and contractual
relationships
Exemptions from the prohibited
activities:
 Competitive bid with disclosure to the Florida
Department of State
 Sole source purchases
 Certain goods and services, emergency
purchases
 Transactions of less than $500.00 per
calendar year
 Research and license agreements ( in effect
at FSU for a faculty researcher)
(Disclosure of Financial Interests and Post
Employment Restrictions and Penalties)
Sources for more information
 Florida Commission of Ethics- opinions
http://www.ethics.state.fl.us
 Florida Attorney General’s Office –
interpretation and applicability
http://myfloridalegal.com/opinions
FSU Policies – Faculty Handbook Sections 4:
Human Resources DepartmentConflict of Interest
(http://www.facultyhandbook.fsu.edu/section4.html)
No faculty member should engage in any regular
or intermittent activity which interferes with the
full discharge of the academic responsibilities of
teaching, research, and service.
No faculty member or staff member shall engage in
any outside activity which interferes with the full
performance of his or her assigned duties. Such
activities shall not create a conflict of interest, which
is defined in Chapter 112.312 to mean a situation in
which regard for a private interest tends to lead to
disregard of a public duty or interest.
Before engaging in any outside activity that may
create a conflict of interest, the faculty or staff
member shall submit to the department chairman or
appropriate supervisor a written statement of the
FSU Outside Employment Statement Form.
(http://hr.fsu.edu) Forms Index
“Outside Activity”
Any private practice, private consulting,
additional teaching or research, or other
activity, compensated or uncompensated,
which is above and beyond a faculty or staff
member’s assigned duties, and for which the
University has provided no compensation.
Prohibitions in FSU Conflict of Interest Policy
flow directly from Section 112.313, F.S.
(Exception: Use of textbook – See FSU
Handbook)
Exemptions in the FSU Conflict of Interest Policy
flow directly from Section 112.313(12), F.S.
The determination of whether or not and to what
extent a given outside activity of a faculty or staff
member interferes with the performance of
assigned duties is the responsibility of the person’s
chairman or appropriate supervisor who is
expected to apply sound professional judgment
based upon standard practice in the particular field
or discipline.
Contact
Jane Mostoller, Associate General Counsel,
Office Of Research
E-mail
jmostoller@fsu.edu
Phone
644-0284
Fax
644 4392
Location:
2010 Levy Avenue Building B Suite276
Innovation Park
Tallahassee, FL 32306-2742
CAMPUS MAIL CODE: 2742