Conflicts of Interest
for the
Research Investigator
Camille A. McWhirter, J.D.
Director, Research Compliance
USF Health
Learning Objectives
Generally:
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Define a conflict of interest (COI)
Recognize different types of “self-interest” that
can create a conflict of interest
Understand what types of “self-interest” are
monitored in the research context and why
Learning Objectives (cont)
Regulatory Context:
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Understand the difference between the state’s
interest in regulating COI and the federal
government’s interest in regulating COI
Identify the three federal government agencies
who have rules regulating COI in research
Understand when each agency’s rules apply
Learning Objectives (cont)
Practical Application:
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Identify the types of financial interests that must be
reported prior to engaging in research
Know when to report financial interests and to whom
Understand how a COI Committee evaluates financial
interests
Be familiar with the types of management controls
available to manage conflicts of interest in research
“Working” Definitions
Conflict of Interest
A conflict of interest exists when an
individual’s professional or ethical obligations
might be compromised by self-interest.
Conflicts of Interest and Commitment
w/ University Employment
(Excessive time spent on external endeavors,
use of USF resources/name/students
in furtherance of private interests,
waiver of USF IP rights in private agreements)
Conflicts of Interest
in Research
(Personal financial interests
that may bias the design,
conduct or reporting
of USF Research)
General Conflicts of Interest
(Nepotism, Doing Business w/USF
in Private Capacity,
Board/Committee Membership,
Purchasing Decisions)
“Working” Definitions
Conflict of Interest in Research
A conflict of interest in research exists when an
investigator’s self-interests have the potential to
compromise an investigator's professional
judgment and objectivity in the design, conduct
or reporting of research.
Investigator
Any person responsible for the design, conduct
or reporting of research.
COI =
Individual +
Self-Interest +
An Ethical or
Professional Duty
COI in Research =
Investigator +
Self-Interest +
Objectivity in the
Design/Conduct/Reporting
of Research
HINT: The management
goal is to protect the
integrity of the research
Hypothetical: COI?
Dr. Needbucks of Public University invented a
drug to prevent Alzheimer’s disease.
DevicesRUs, wants to sponsor a study with Dr. N
as the PI to develop and test a device that will
deliver Dr. N’s drug directly to the brain.
Dr. N’s spouse is the president of Lab Solutions,
Inc. that manufactures lab supplies and
equipment.
Dr. N and her staff purchase all of their basic
supplies and equipment from Lab Solutions.
Ask:
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Investigator? Yes. The individual is an investigator on a
research study.
Self-Interest? Yes, financial interest of spouse in a company
that sells research products.
What is the professional/ethical obligation that is
compromised? The duty potentially compromised by this
self-interest is the duty of public stewardship--to refrain from
using one’s public position to enhance one’s private interests.
Conclusion: This is a conflict of interest in a research setting,
but not a “COI in Research” as we have defined it because
the investigator’s self-dealing, while perhaps a conflict with
her public position, does not compromise the integrity of the
research results.
What if during the course of the
study…
Dr. Needbucks purchases $30,000 worth of
stock in DevicesRUs?
Repeat the analysis:

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Investigator? Yes. The individual is an investigator on a
research study.
Self-Interest? Yes, Dr. N’s financial investment in the
sponsor/manufacturer of the device being tested.
What is the professional/ethical obligation that is
compromised? The duty potentially compromised by this
self-interest is the duty of objectivity in the design, conduct, or
reporting of the research study.
Conclusion: This is a “COI in Research” as we have defined
it. Note that there may be more than one type of conflict of
interest at work in the research context—multiple avenues of
self-interest and multiple professional or ethical duties.
Types of Self-Interest
Self-interest can manifest in the form of
 A financial benefit
 Enhanced reputation
 Personal relationships
 Professional relationships
 Other interests (political, religious,
intellectual)
What type of self-interest is
represented by these examples?
Dr. Warren is an investigator for a study testing a
new medical device. Dr. Snyder’s brother is one
of the owners of the company developing the
device.
(Personal Relationship)
Dr. Mercer sits on the IACUC and reviews a study
about cloning.
Dr. Mercer thinks cloning is
immoral and unethical.
(Personal Belief)
What type of self-interest is
represented by these examples?
Dr. O’Connor owns significant stock in a biotech company.
The company approaches him about conducting research
on the viability of a new genetics test.
(Financial Interest)
Dr. Tate is the co-founder of a new method of behavioral
therapy for which he has received worldwide recognition.
He is approached about conducting a study for another
form of therapy which, if effective, would render his form of
therapy obsolete.
(Reputation )
What type of self-interest is
represented by these examples?
Dr. Markham sits on the board of directors of Company X.
Company X is developing a new piece of equipment and
they ask Dr. Markham to conduct a study on the safety and
efficacy of the equipment.
(Professional Relationship)
State Regulations (Code of Conduct of
Public Officers and Employees)
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The state regulations only address general COI of public
officers and employees and are designed to prohibit
and/or manage conflicts between a public employee’s
duties to the state employer and the employee’s
personal interests
Example: A public employee acting in a private
capacity, may not sell goods to his or her own agency.
Example: A public employee may not have an ongoing
or regularly recurring conflict with his or her public
employment (catch-all provision).
What interests are the state COI regulations designed to
protect?
Federal Regulations (NSF/PHS and
Food & Drug Administration)
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The federal regulations only address self-interest (i.e.,
secondary interests) in the research context.
Example: Universities receiving federal funds to conduct
research must have policies to manage bias in the
design, conduct or reporting of research funded with
federal dollars (PHS/NSF).
Example: A sponsor of a new drug/device must certify
that COI of investigators in studies supporting the FDA
approval of the drug/device either does not exist or is
adequately managed.
What interests are the federal regulations designed to
protect?
Federal Regulations
The federal regulations only address one
type of “self-interest”:
FINANCIAL INTERESTS
(Why?)
Federal Regulations

Food and Drug Administration
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Applies in research involving a drug, device
or biologic.
Requirements are directed at the sponsor
Requires disclosure at the time of application
for approval of a drug device or biologic.
Evaluates the impact of the researcher’s
financial interests on the reliability of the
study.
Federal Regulations

Public Health Service (PHS) & National Science
Foundation (NSF)
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Requirements are directed at the institutions receiving grants
from these agencies
Requires institutions to develop a COI policy and program
that meets certain minimum requirements
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One requirement is that the institution must require
investigators to disclose significant financial interests in the
research
Deliberately vague to permit flexibility in the administration of
policy
PHS and NSF regulations were developed cooperatively to
make the regulations consistent.
PHS/NSF COI Regulations
Investigator Responsibilities:
Must report any significant financial
interests (including those of spouse and
dependent children) to a designated
institutional official.
Reportable Financial Interests
USF policy requires investigators to report not only
“significant financial interests”, but:
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Anything of monetary value, or a potential value that cannot
readily be determined, including
 salary
 consulting fees
 honoraria
A proprietary interest in the research project, including
 a patent
 trademark
 copyright
 licensing agreement
Reportable Financial Interests (con’t)
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A position as director, officer, partner, trustee, or member of
board of directors of any entity related to the research;
A consulting, advisory, employment, ownership/equity or any
other interest or relationship in any entity related to the
research (including interests in a non-publicly traded
corporation of indeterminate value);
Any other financial interest or external commitment that the
Investigator believes may interfere with his or her ability to
protect human research participants
There is no minimum amount below which an interest
is exempt from reporting!
EXCEPTIONS:
The following financial interests and commitments are generally
recognized as NOT relating to or not being impacted by the
outcome of the research and therefore do NOT need to be
disclosed:
 Salary, royalties or other remuneration received from USF or
the USFPG.
 Receipt of royalties for any published scholarly works and
other writings.
 Income from seminars, lectures, or teaching engagements
sponsored by public or nonprofit entities. NOTE: All
honoraria received from commercial entities must be
disclosed.
EXCEPTIONS (con’t):
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Income from service on advisory committees or review
panels for public or nonprofit entities.
Interests in commercial enterprises on the part of an
Investigator which commercial enterprises are in no way
related to the Investigator’s professional role and/or
obligations.
Any “arms length” financial interest (i.e., those that occur
through participation in a mutual fund or employer retirement
plans), where the participant has no control over the
investment decision
Income from speaking engagements sponsored by
government or non-profit
Income from advisory boards of government or non-profit
Conflict of Interest Committee
USF has a Conflict of Interest Committee
(COIC) to evaluate, manage COI in
research, and to ensure that the
institution’s COI policies and procedures
and applicable COI regulations are met.
General Principles
in Dealing with COI in Research
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COI is virtually unavoidable.
COI does not preclude participation of an
investigator in a project.
Must have a culture of honest and full disclosure
so that steps can be taken to manage conflicts
effectively
Not all COI can be managed.
Disclosure Process for Financial
Interests in Research at USF
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Opportunities to Identify Financial Interests
in Research
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DSR Internal Form Question on COI
IRB Application Question on COI
DSR Annual Reminder Form
Education & Word of Mouth for non-sponsored,
non-human subjects studies
All Roads lead to the
Financial Relationships Disclosure Form
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When should financial interests be
reported on the FRDF?
Upon Initial Submission of Research Proposal
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to DSR (for sponsored research)
or to the Investigator’s Department Chair or Committee (for nonsponsored research)
prior to engaging in the research.
Upon Joining a Research Project.
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must submit the FRDF within 60 days of beginning work on the
research.
When should financial interests be
reported on the FRDF? (con’t)
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Upon Acquisition of Any New Reportable Interests.
 Investigators who have previously submitted an FRDF
 but who acquire new Reportable Financial Interests or
otherwise have a change in the status of such interests
 must submit a new FRDF within 60 days of the
acquisition or change in interest.

Annually
 upon receiving a request from DSR to certify the status of
the Investigator’s Reportable Financial Interests
 Instructions for completion of such annual disclosure
forms/certifications will be included with the request from
DSR.
Disclosure Process at USF (con’t)
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Completed FRDF Submitted to
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DSR (all sponsored studies); or
USF Health COI Committee (non-sponsored
studies)
DSR routes FRDF to USF Health COI Committee
for studies involving USF Health employees or
human subjects
CONFLICT OF INTEREST IN RESEARCH: DISCLOSURE PROCESS
Research means a systematic investigation,
including research development, testing,
and evaluation, designed to develop or
contribute to generalizable knowledge.
STOP. This process
does not apply to you.
NO
START
Do you have a
financial interest or external commitment
that relates to or could be impacted by
the outcome of current or proposed
research?
YES
Financial Relationships
Disclosure Form
Complete a Financial
Relationships Disclosure Form
(FRDF)
GO TO
PAGE 2
Financial Interest or External
Commitment means
 Anything of monetary value, or a
potential value that cannot readily be
determined,
 a proprietary interest in the
Research Project, including a patent,
trademark, copyright, licensing
agreement or other intellectual
property interest in the test article or
method;
 a position as director, officer,
partner, trustee, or member of board
of directors of any entity Related to
the Research;
 a consulting, advisory,
employment, ownership/equity or any
other interest or relationship in any
entity Related to the Research
(including interests in a non-publicly
traded corporation the value of which
interests cannot be readily determined
through reference to public prices);
 or any other financial interest or
external commitment that the
Investigator believes may interfere
with his or her ability to protect
human research participants.
Human subject means a living individual
about whom an investigator conducting
research obtains (1) data through
intervention or interaction with the
individual or (2) identifiable private
information.
Does the research involve
human subjects?
NO
FROM
PAGE 1
Is this research sponsored?
YES
Submit form to Division of
Sponsored Research
(Liz O’Connell ADM 200)
NO
YES
Are you affiliated with
USF Health?
YES
Submit form to USF Health
Conflict of Interest (COI)
Administrator
(Camille McWhirter MDC 2)
YES
NO
Submit form to USF
Conflict of Interest in
Research (CoIRC)
Committee
(Vinita Witanachchi MDC 35)
STOP
STOP
NO
Does the research involve
human subjects?
Review Process for Financial Interests
in Research at USF (con’t)
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COI Administrator develops management plan in
consultation with interested person
COI Administrator may approve without Committee
review if certain conditions are met (BUT not for human
subjects research)
COI Committee Reviews FRDF and Management Plan
Notification to
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Interested Person
DSR
IRB (if USF IRB is IRB of record)
CONFLICT OF INTEREST IN RESEARCH: REVIEW PROCESS
NON-SPONSORED, NO HUMAN
SUBJECTS, NOT A USF HEALTH
EMPLOYEE
Submit form to USF Conflict of
Interest in Research (CoIRC)
Committee
(Vinita Witanachchi MDC 35)
ALL SPONSORED RESEARCH
Submit form to Division of
Sponsored Research
(Liz O’Connell ADM 200)
NONSPONSORED USF
HEALTH OR HUMAN
SUBJECTS
Submit form to USF Health COI
Committee
(Camille McWhirter MDC 02)
USF CoIRC or Administrative Review
USF Health COI Committee or
Administrative Review
Notify investigator of COI determination
and forward approval memo and
management plan (if any) to DSR, if
applicable
Notify investigator of COI
determination and forward approval
memo and management plan (if any)
to IRB and DSR, if applicable
STOP
STOP
COI Committee Review
MOTIVATION
How much incentive does the INV have to
bias the design, conduct or reporting of the
research?
OPPORTUNITY
Is the INV in a position to bias the design,
conduct or reporting of the research?
Possible Steps to Manage COI
Elimination of the conflicting interest (e.g.,
divestiture of financial interest or removal from
project)
Substitution of non-interested personnel on the
project
Public disclosure of the financial interests (journals,
research subjects, collaborators, etc.)
Monitoring of research by independent reviewers
Look for inherent management controls (e.g., the
research has objective endpoints that are not
subject to manipulation by the investigator)
What happens next?
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Once an approved management plan or
disclosure is in place, the investigator’s
responsibility is to
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adhere to the terms of the management plan;
and
submit a new disclosure upon any change in the
financial interests upon which the approved
management plan or disclosure is based within
60 days of the change in interest.
Why Should an Investigator Report
Financial Interests?
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Allows the interest to be evaluated and
managed by knowledgeable individuals
Promotes public trust and reduction of liability
for investigator and institution
Triggers institutional processes that safeguard
human research participants
Reporting and management of financial
interests in research is required by USF policy
and federal regulations--compliance is
necessary to continue receiving federal funding