HRPP Document No. 038
The Greenville Hospital System
Office of Research Compliance and Administration
HRPP Policies and Procedures
HRPP
Policy No. 801
Title: Conflicts of Interest in Research
Effective Date:
July 2012
1.0
PURPOSE
To promote objectivity in research by establishing standards that provide a reasonable
expectation that the design, conduct, and reporting of research is free from bias resulting
from researcher financial conflicts of interest. This policy applies to externally funded
research, regardless of the funding sources, as well as to research that does not have
external funding.
2.0
CONFLICTS OF INTEREST FOR STUDIES FUNDED BY THE US PUBLIC HEALTH
SERVICE (PHS)
3.1
Definitions
a. Investigator
A principal investigator, project director, co-investigator and any other person, regardless
of title or position, who is responsible for the design, conduct or reporting of sponsored
research (project) results, including collaborators and consultants.
b. GHS Conflict of Interest Committee (GHS COIC)
The Committee comprised of the Chairman of the three IRBs and the Director of
Corporate Integrity that will review disclosures and relevant features of the sponsored
project(s) and, on the basis of the review, to recommend to the Investigator any
modifications necessary to manage, reduce or eliminate any financial conflicts of
interests related to the project.
The convened IRB will review the proposed management plan. The IRB has final
authority to approve the management plan.
Examples of management plans include:
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Prohibiting the conduct of the research at GHS if the conflict cannot be managed.
Requiring another researcher conduct the research, or conduct parts of the research
such as recruitment and obtaining consent.
Require monitoring of the research, or parts of the research such as the consent
process.
Management may include a retrospective review and a mitigation report if necessary.
Other management activities as determined by the GHS COIC.
c. Financial Interest
An interest in a Business consisting of: (1) any stock, stock option or similar ownership
interest in such Business, but excluding any interest arising solely by reason of investment in
HRPP Document No. 038
such Business by a mutual, pension, or other institutional investment fund over which the
Faculty Member does not exercise control; or (2) receipt of, or the right or expectation to
receive, any income from such Business (or from an agent or other representative of such
Business), whether in the form of a fee (e.g., consulting), salary, allowance, forbearance,
forgiveness, interest in real or personal property, dividend, royalty derived from the licensing
of Technology, technology transfer, patents, gifts, rent, capital gain, real or personal property,
or any other form of compensation, or any combination thereof whose value exceeds $5,000.
d. Significant Financial Interest
A Financial Interest held by an Investigator, or the Investigator's spouse or dependent
children that reasonably appear to be related to the Investigator's Institutional
Responsibilities and that consists of one or more of the following:
1. Remuneration including, but not limited to salary, consulting fees, honoraria, and
paid authorship received from a publicly traded company during the twelvemonth period preceding the date on which an Investigator is making a disclosure,
and/or an equity interest (e.g. stock, stock options, or other ownership interest)
held in such publicly traded company, if the aggregate value of such
remuneration, plus the value of the equity interest as of the date of disclosure,
exceeds $5,000 for studies; or
2. Remuneration (including, but not limited to, salary, consulting fees, honoraria
and paid authorship) received from a non-publicly traded company during the
twelve-month period preceding the date on which an Investigator is making a
disclosure, if the remuneration exceeds the amount stated above, or there is
specific permission granted to use another triggering amount from the ORCA
Medical Director; or
3. Any equity interest in a non-publicly traded company or business, regardless of
value; or
4. Intellectual property rights and interests (e.g. patents and copyrights), upon
receipt of income related to such rights and interests.
5. Any reimbursed travel or travel expenses paid on an Investigator’s behalf related
to his/her institutional responsibilities, including circumstances when the exact
monetary value of the travel is not readily available. This requirement does not
apply to travel that is reimbursed by a Federal, state or local government, an
institution of higher education, an academic medical center or research institute
that is affiliated with an institution of higher education.
Significant Financial Interest does not include:
1. An Employee's salary or royalties received from the Greenville Hospital System;
or
2. Income from seminars, lectures or teaching engagements sponsored by a federal,
state or local government agency or an institution of higher education; or
3. Income from service on panels for a federal, state or local government agency or
institution of higher education.
e. Institutional Responsibilities
The institution has the responsibility to educate investigators and research staff about
disclosures and responsibilities related to financial conflict of interest.
 Education is required of each individual initially and at least every four years.
 Education is required immediately when:
o Financial conflict of interest policies are revised in a manner that
changes investigator requirements.
HRPP Document No. 038
o
o
An investigator is new to the organization.
An investigator is non-compliant with financial conflict of interest
policies and procedures.
f. Related to the research
A researcher’s financial interest is considered to be related to the research when the
researcher is engaged in the research (interacting or intervening with participants,
obtaining consent, conducting analysis of data). A person’s financial interests are not
related to research when they are not engaged in research. For example, providing advice
about the design of studies, conducting analysis of de-identified information, or providing
information about research (where a clinician does not recruit or obtain consent) are
examples where a person is not engaged in research. When a person has a financial
interest but is not engaged in PHS-funded research, that interest is not considered related
to PHS-funded research for purposes of compliance with PHS funded research conflict of
interest requirements.
2.2
CONFLICTS OF INTEREST WHICH MUST BE DISCLOSED BY
INVESTIGATORS
A Significant Financial Interest is an interest held by the Investigator in which the value of
the interest could directly or significantly affect the design, conduct or reporting of the
research; a proprietary interest in the tested product, including, but not limited to, a patent,
trademark, copyright or licensing agreement; any equity interest in the sponsor of a covered
study, i.e., any ownership interest, stock options, or other financial interest who value cannot
be readily determined through reference to public prices; any arrangement where the value of
the ownership interests would be affected by the outcome of the research or ownership
interests that exceeds $5,000 in any one single entity when aggregated for the immediate
family. This requirement applies to all covered studies, whether ongoing or completed; any
equity interest in a publicly held entity or non-publicly held entity that exceeds $5,000 in
value. The requirement applies to interests held during the time the clinical investigator is
carrying out the study and for 1 year following completion of the study; and significant
payments of other sorts, which are payments that have a cumulative monetary value of
$5,000 or more made by the sponsor of a covered study to the investigator or the
investigator’s institution to support activities of the investigator exclusive of the costs of
conducting the clinical study or other clinical studies, (e.g., a grant to fund ongoing research,
compensation in the form of equipment or retainers for ongoing consultation or honoraria)
during the time the clinical investigator is carrying out the study and for 1 year following
completion of the study.
The GHS Financial Conflict of Interest form must be updated on an annual basis by
either completing the Investigator and IRB Member Conflict of Interest form located on
the GHS website http://www.ghs.org/eirb or during Continuing Review via the eIRB
Continuing Review module.
Any change in financial information regarding a study sponsored by the US Public
Health Service must be immediately reported to the Office of Corporate Integrity within
30 days or acquisition or discovery.
HRPP Document No. 038
3.0
CONFLICTS OF INTEREST FOR STUDIES NOT FUNDED BY THE US PUBLIC
HEALTH SERVICE (PHS)
3.1
Definitions
a. Investigator
A principal investigator, project director, co-investigator and any other person, regardless
of title or position, who is responsible for the design, conduct or reporting of sponsored
research (project) results, including collaborators and consultants.
b. GHS Conflict of Interest Committee (GHS COIC)
The Committee comprised of the Chairman of the three IRBs that will review disclosures
and relevant features of the sponsored project(s) and, on the basis of the review, to
recommend to the Investigator any modifications necessary to manage, reduce or
eliminate any financial conflicts of interests related to the project.
c. Financial Interest
An interest in a Business consisting of: (1) any stock, stock option or similar ownership
interest in such Business, but excluding any interest arising solely by reason of investment in
such Business by a mutual, pension, or other institutional investment fund over which the
Faculty Member does not exercise control; or (2) receipt of, or the right or expectation to
receive, any income from such Business (or from an agent or other representative of such
Business), whether in the form of a fee (e.g., consulting), salary, allowance, forbearance,
forgiveness, interest in real or personal property, dividend, royalty derived from the licensing
of Technology, technology transfer, patents, gifts, rent, capital gain, real or personal property,
or any other form of compensation, or any combination thereof whose value exceeds $5,000.
d. Significant Financial Interest
A Financial Interest held by an Investigator, or the Investigator's spouse or dependent
children that reasonably appear to be related to the Investigator's Institutional
Responsibilities and that consists of one or more of the following:
1.Remuneration including, but not limited to salary, consulting fees, honoraria, and
paid authorship received from a publicly traded company during the twelve-month
period preceding the date on which an Investigator is making a disclosure, and/or an
equity interest (e.g. stock, stock options, or other ownership interest) held in such
publicly traded company, if the aggregate value of such remuneration, plus the value
of the equity interest as of the date of disclosure, exceeds $5,000 for studies; or
2. Remuneration (including, but not limited to, salary, consulting fees, honoraria and
paid authorship) received from a non-publicly traded company during the twelvemonth period preceding the date on which an Investigator is making a disclosure, if
the remuneration exceeds the amount stated above, or there is specific permission
granted to use another triggering amount from the ORCA Medical Director; or
3. Any equity interest in a non-publicly traded company or business, regardless of
value; or
4. Intellectual property rights and interests (e.g. patents and copyrights), upon
receipt of income related to such rights and interests.
5. Any reimbursed travel or travel expenses paid on an Investigator’s behalf related
to his/her institutional responsibilities, including circumstances when the exact
monetary value of the travel is not readily available. This requirement does not
apply to travel that is reimbursed by a Federal, state or local government, an
institution of higher education, an academic medical center or research institute that
is affiliated with an institution of higher education.
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Significant Financial Interest does not include:
1. An Employee's salary or royalties received from the Greenville Hospital System;
or
2. Income from seminars, lectures or teaching engagements sponsored by a federal,
state or local government agency or an institution of higher education; or
3. Income from service on panels for a federal, state or local government agency or
institution of higher education.
e. Institutional Responsibilities
The institution has the responsibility to educate investigators and research staff about
disclosures and responsibilities related to financial conflict of interest.
 Education is required of each individual initially and at least every four years.
 Education is required immediately when:
o Financial conflict of interest policies are revised in a manner that
changes investigator requirements.
o An investigator is new to the organization.
o An investigator is non-compliant with financial conflict of interest
policies and procedures.
3.2
CONFLICTS OF INTEREST WHICH MUST BE DISCLOSED BY
INVESTIGATORS
A significant financial interest is an interest held by the investigator in which the value of the
interest could directly or significantly affect the design, conduct or reporting of the research;
a proprietary interest in the tested product, including, but not limited to, a patent, trademark,
copyright or licensing agreement; any equity interest in the sponsor of a covered study, i.e.,
any ownership interest, stock options, or other financial interest who value cannot be readily
determined through reference to public prices; any arrangement where the value of the
ownership interests would be affected by the outcome of the research or ownership interests
that exceeds $5,000 interest in any one single entity when aggregated for the immediate
family. This requirement applies to all covered studies, whether ongoing or completed; any
equity interest in a publicly held entity or non-publicly held entity that exceeds $5,000 in
value. The requirement applies to interests held during the time the clinical investigator is
carrying out the study and for 1 year following completion of the study; and significantly
payments of other sorts, which are payments that have a cumulative monetary value of
$5,000 or more made by the sponsor of a covered study to the investigator or the
investigator’s institution to support activities of the investigator exclusive of the costs of
conducting the clinical study or other clinical studies, (e.g., a grant to fund ongoing research,
compensation in the form of equipment or retainers for ongoing consultation or honoraria)
during the time the clinical investigator is carrying out the study and for 1 year following
completion of the study.
The GHS Financial Conflict of Interest form must be updated on an annual basis by
either completing the Investigator and IRB Member Conflict of Interest form located on
the GHS website http://www.ghs.org/eirb or during Continuing Review via the eIRB
Continuing Review module.
HRPP Document No. 038
3.3
WEB POSTING OF FINANCIAL CONFLICT OF INTEREST INFORMATION
This policy and each update of this policy will be accessible through the Internet.
a) For each financial conflict of interest that is found to exist by the GHS Conflict
of Interest Committee, the Institution will make the following information
available in regard to each covered individual who contributes to the scientific
development or execution of the research project in a substantive, measureable
way, including a covered individual who is the project director or principal
investigator;
1. The covered individuals name;
2. The covered individuals title and role with respect to the research;
3. The name of the entity in which the significant financial interest is
held;
4. The nature of the significant financial interest that constitutes a
financial conflict of interest; and
5. The approximate value of the significant financial interest by range
or, if the dollar value cannot be determined by reference to public
prices or other reasonable measures of fair market value, a statement
to that effect.
b) The approximate dollar value of the significant financial interest shall be
provided within the following ranges if it can be determined by public access or
other reasonable measures of fair market value:
1. $0 - $4,999
2. $5,000 - $9,999
3. $10,000 - $19,999
4. Amounts between $20,000 - $100,000 by increments of $20,000; or
5. Amounts above $100,000 by increments of $50,000.
c) The institution will update the information required by this section annually. In
addition, for any financial conflict of interest of a covered individual whose
information must be available under this section and for which the information
was not previously available, the institution will make the information required
by this section available not later than the 60th day after the financial conflict of
interest is identified.
d) The information must note that it is current as of the date listed and is subject to
updates.
e) The information required by this section must remain available for five years
after its most recent update.
f) For PHS-funded research, in regard to project directors, principal investigators,
and other senior or key personnel, this information must be available BEFORE
expending PHS funds.
4.0
ORGANIZATIONAL CONFLICT OF INTEREST
An organizational conflict of interest may exist when GHS has a financial interest(s) in research
that could cause a conflict with clinical care. Organizational conflicts of interest may include
GHS's interests in the following:
 Licensing, technology transfer, and patents, when GHS owns the intellectual property
 Investments of GHS, in excess of $500,000
 Gifts, when the donor has an interest in the research in excess of $500,000
 Financial interests of senior administrators in excess of $250,000
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
Other financial interests that are determined to be a conflict of interest
When organizational conflicts of interest are identified, they are managed by the office of
corporate integrity, which may develop a management plan when appropriate.
5.0
FINAL DETERMINATION REGARDING CONFLICTS OF INTEREST (REVIEW OF
DISCLOSURES)
Any disclosure of an interest of $5,000 or greater will be reviewed by the GHS Research Conflict of
Interest Committee.
For any Public Health Services (PHS) funded study (Public Health Service means the Public Health
Service of the US Department of Health and Human Services, and any components of the PHS to
which the authority involved may be delegated, including the National Institutes of Health (NIH))
where financial interest exceeds $5,000 a report must be made to the GHS Research Conflict of
Interest Committee. The GHS Research Conflict of Interest Committee has the responsibility and
authority regarding the acceptability of a management plan for conflicts of interest. The GHS
Research Conflict of Interest Committee will notify the Principal Investigator in writing of its
decision.
6.0
SANCTIONS
Failure to comply with this Policy will be grounds for disciplinary action pursuant to the relevant
GHS policies.
In addition, federal regulations may require reports to the federal sponsor of any information which
may show a violation of GHS policy. GHS may require mandatory education, monitoring of
research, suspension of research privileges, suspend or terminate research or enact other sanctions as
appropriate. In addition, sponsors may suspend or terminate the award and/or debar an Investigator
from receiving future awards in the event of failure to comply with applicable federal regulations on
disclosure, review, and management of significant financial interests related to federally sponsored
projects.
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Medical Director, Office of Research Compliance & Administration
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Greenville Hospital System Institutional Official
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