Transcript VCOM Conflicts of Interest Policy

VCOM Conflict of Interest Policy
Overview of Financial Conflict of
Interest Related to Research
December 4, 2013
Purpose of Regulation & Policy
• The VCOM policy follows the federal regulation,
Responsibility of Applicants for Promoting Objectivity in
Research, 42.CFR.50, Subpart F and 45.CFR.94.
• This regulation establishes standards that provide a
reasonable expectation that the design, conduct and
reporting of research funded under PHS-agencies will
be free from bias resulting from investigator financial
conflict of interest.
• VOM policy dictates that all externally sponsored
research shall follow this regulation, not just those
projects funded by PHS agencies.
December 4, 2013
Applicability
• This policy is applicable to investigators who
plan to participate or who are participating in
any extramurally funded research at VCOM.
• Additional regulations as described in
42.CFR.50 and 45.CFR.94 are applicable to any
PHS-funded research at VCOM.
Investigator includes the principal investigator/project
director and any other person, regardless of title or position,
who is responsible for the design, conduct or reporting of
research. This includes the principal investigator, coinvestigators, lab technicians, collaborators or consultants.
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Definitions
A conflict of interest arises in a situation in which an
actual, potential or perceived conflict exists that cause
undue influence over judgment associated with
VCOM responsibilities such as performing research,
reporting research results or mentoring students.
Conflicts of interest in research may occur when
outside financial interests compromise, or have the
appearance of compromising, the professional
judgment of an investigator when designing,
conducting or reporting research.
December 4, 2013
Definitions
A significant financial interest consists of one or more of the
following interests of the investigator (and those of the
investigator’s spouse and dependent children) that reasonably
appear to be related to the investigator’s institutional
responsibilities:
• Any financial interest in a publicly traded entity where the
value of any remuneration received from the entity in the
twelve months preceding the disclosure and the value of any
equity interest as of the date of disclosure, when aggregated,
exceeds $5,000. Remuneration includes salary and any
payment for services not otherwise identified as salary. Equity
interest includes any stock, stock option or other ownership
interest as determined through reference to public prices or
other reasonable measures of fair market value.
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Definitions
• Any financial interest in a non-publically traded entity where the value of
any remuneration received from the entity in the twelve months
preceding the disclosure, when aggregated, exceeds $5,000 or when the
Investigator holds any equity interest.
• Intellectual property rights and interests (e.g., patents, copyrights) upon
receipt of income related to such rights and interests.
• Travel related to an Investigator’s institutional responsibilities that is either
paid on behalf of the Investigator or not directly reimbursed to the
Investigator. This does not apply to travel reimbursed or sponsored by a
government agency, institution of higher education, academic teaching
hospital, medical center or a research institute affiliated with an
institution of higher education. Disclosure is required only by the
Investigator and not the Investigator’s spouse or dependent children.
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Disclosure
All individuals listed on the grant or protocol,
regardless of title or position, who may be
responsible for the design, conduct or reporting
of the research must complete a Research
Financial Conflict of Interest Disclosure Form in
order to disclose all financial interests that
would reasonably appear to be related to their
institutional responsibilities.
December 4, 2013
Disclosure
It is important to disclosure and manage
financial conflicts of interest in order to:
• Protect the integrity of all research conducted
at VCOM,
• Comply with federal regulations,
• Support and not impede research and
• Ensure the safety of community and human
subjects research volunteers.
December 4, 2013
Disclosure
Investigators need to disclose:
• Consulting income, honoraria or salary (excluding that
from VCOM) from a commercial entity,
• Equity (such as stock or stock options) held directly in
publicly traded or privately held companies,
• Royalties received from technology licensed for a
commercial entity,
• Fiduciary role (such as officer, director or trustee) for a
commercial entity and
• Externally reimbursed or sponsored travel from
professional associations, societies, foundations,
commercial entities or foreign governments.
December 4, 2013
Disclosure
• Investigators must complete the Research
Financial Conflict of Interest Disclosure Form each
time they are involved with an extramurallyfunded research project.
• This form must be submitted at the time of the
proposal submission to the ORA.
• Disclosure forms must be updated within 30 days
of any new activity or change in the status of the
existing disclosure.
• Disclosure must pertain to all institutional
responsibilities.
December 4, 2013
Determining FCOI
The Institutional Integrity Officer will review all
disclosure forms for actual, potential or
perceived significant financial interest:
• Is financial disclosure related to the research?
• Is financial disclosure significant?
• Could the financial disclosure be perceived to
directly and significantly affect the research,
technology or commercial entity?
December 4, 2013
Determining FCOI
• The Conflict of Interest Committee will review
any significant financial interests so identified
by the Institutional Integrity Officer.
• The Committee will determine if the
significant financial interest is related to the
research.
• If related, the Committee will determine
whether the significant financial interest is a
financial conflict of interest.
December 4, 2013
Management
Management strategies include:
• Public disclosure such as when presenting or
publishing research results or directly to
participants in the informed consent form.
• Modifications and changes to the research plan
including a change of responsibilities or
disqualification from participation in some or all
portions of the research.
• Reduction or elimination of interests, such as
selling all equity interests or severance of
relationships that create interests.
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Monitoring
When a management plan is implemented, VCOM
shall monitor investigator compliance with the
management plan:
• This shall occur on an ongoing basis until the
completion of the research project,
• Shall be done by an independent monitor or
committee,
• Oversight includes audits of the research and
consent/enrollment process,
• May require interests be escrowed.
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Reporting to Public
For any financial conflicts of interest in PHS-funded
research, the following must be reported within five
days in response to a written request:
• Investigator name, title and role on the project
• Project title and number
• Name of entity in which a significant financial
interest has been disclosed
• Nature of the interest
• Approximate dollar amount
December 4, 2013
Subrecipient Requirements
For all subrecipient entities involved in applications to
PHS agencies or who have a written agreement with
VCOM that falls under PHS-funded research:
• Subrecipient entities must certify whether they will
follow their own COI policy consistent with the federal
regulations or whether they will follow VCOM’s policy.
• If subrecipient entity will follow VCOM’s COI policy,
VCOM must collect disclosure forms from subrecipient
investigators, ensure they receive training and manage
and monitor any financial conflicts of interest. These
activities must occur prior to funds being expended.
December 4, 2013
Questions
For any questions related to the Financial Conflicts
of Interest in Research Policy, please contact:
• Email: [email protected]
• Research Division: 540-231-1465/540-231-8239
• Office of Research Administration home page:
http://www.vcom.vt.edu/ora/index.html
December 4, 2013