AMITA Health
Disclosure of Financial Interest Form for Non-PHS Funded Research
This form applies to non-Public Health Service (PHS) funded research only. If your research is PHS funded, see the ABHS policy,
“Financial Conflict of Interest for PHS Funded Research,” and complete the ABHS Significant Financial Interest Disclosure Form.
This Financial Disclosure Form is to be completed in connection with the IRB “Financial Conflicts-of-Interest for Non-PHS Funded
Research” policy. Please refer to the policy or to the definitions below for the terms used herein. Please note, answering “yes” to any
of the following questions does not mean the financial interest is inappropriate or improper, it means only that disclosure and
evaluation, and in some cases, approval and oversight, are required. The purpose of this Financial Disclosure Statement in
conjunction with the IRB policy is to help members of the research team determine if the combination of their professional activities
pose any threat to the objective pursuit of their research or may have an effect on the protection of human subjects.
Definitions
1.
Conflict of Interest: A “Conflict of Interest” exists where a “Significant Financial Interest” of a “Covered Individual” would
reasonably appear to be affected by the clinical research, or is held in entities that would reasonably appear to be affected by
the clinical research, or where some circumstance would cause an independent observer to reasonably question whether an
individual’s professional actions or decisions are determined by consideration of personal gain, financial or otherwise.
2.
Covered Individual: Includes any investigator, member of the investigator’s research staff, student, fellow, trainee, or
administrator who conducts or supports research involving human subjects at AMITA Health and who is in a position to
influence the design, conduct or reporting of the research. For purposes of this policy, “covered individual” includes the
individual’s spouse and dependent children except as noted otherwise.
3.
Financially Interested Company: Means a commercial entity with financial interests that would reasonably appear to be
affected by the conduct or outcome of the research. The term includes companies that compete with the sponsor of the
research or the manufacturer of the investigational product, if the covered individual actually knows that the financial
interests of such a company would reasonably appear to be affected by the research. This term also includes any entity acting
as the agent of a financially interested company, such as a contract review organization.
4.
Financially Interested Individual: Means a covered individual who holds a “Significant Financial Interest” that would
reasonably appear to be affected by the individual’s research involving human subjects.
5.
Significant Financial Interest: Includes the following interests of the covered individual (and his or her spouse and dependent
children), or of any foundation or entity controlled or directed by the individual or his or her spouse:
a)
Salary, consulting fees, honoraria (including honoraria from a third party; if the original source is a financially
interested company), gifts, or “in-kind” compensation from a financially interested company (or entitlement to
same), whether for consulting, lecturing, travel, service on an advisory board, or for any other purpose not directly
related to the reasonable costs of conducting the research (as specified in the research agreement with the sponsor),
that when aggregated exceeds $5,000 during the prior twelve-month period or is expected to exceed $5,000 over the
next twelve-month period.
b)
Other business income, such as dividends, rents, capital gains, interest etc., from a financially interested company
(or entitlement to the same) that when aggregated exceeds $5,000 during the prior twelve-month period or is
expected to exceed $5,000 over the next twelve-month period.
c)
An equity interest, in the form of stock, stock options, real estate, or any other interest (e.g., recourse loans to a
financially interested company) that when aggregated is greater than or equal to a 5% ownership interest or that
exceeds $5,000 in value in a publicly-traded financially interested company.
d)
Equity interests as defined above (or entitlement to same) of any amount in a non-publicly-traded financially
interested company.
e)
Royalty income or the right to receive future royalties under a patent, patent application or copyright, where the
research is directly or indirectly related to the licensed technology or work.
f)
Any non-royalty payments (or entitlements to same) in connection with the research that are not directly related to
the reasonable costs of the research (as specified in the agreement with the sponsor). This includes any bonus,
incentives or milestone payments to the covered individual in excess of reasonable costs incurred as well as other
types of financial support (e.g., funding research staff salaries).
g)
Service by a covered individual or his / her spouse as a Board Member, Officer, Director, Partner, Trustee, etc., for a
financially interested company, whether or not remuneration is received for such service.
h)
An appointment to serve on the scientific advisory board of a financially interested company unless the covered
individual has no current significant financial interest in the financially interested company or the investigational
product and agrees not to hold such an interest for a period of at least three years following completion of any
related research conducted at or under the auspices of AMITA Health.
Financial Disclosure Form
Version: 5-1-08, rev 2-10, 8-12, 9-15
1
AMITA Health
Disclosure of Financial Interest Form for Non-PHS Funded Research
This form must be completed by the PI on behalf of himself/herself as well as all members of the research team who are
responsible for the design, conduct or reporting of the proposed research (“covered individuals”). This form must be submitted with
each initial and continuing review application and as new significant financial interests are obtained.
Principal Investigator:
AMITA Health Facility / Dept:
Telephone Number:
Address:
Sponsor:
IRB #:
Project Title:
1.
Financial Compensation from Financially Interested Companies
YES
NO
Is any covered individual of the research team (including spouses and/or dependent children) currently receiving income (e.g.,
salary, consulting / training and education fees, honoraria, gifts, rents, dividends, capital gains, interest etc.) from a financially
interested company for any purpose not directly related to the reasonable costs of conducting the research (as specified in the
research agreement) that when aggregated exceeded $5,000 over the past twelve months or is expected to exceed $5,000 over the
next twelve months?
2.
Equity Interests in Financially Interested Companies
YES
NO
Is any covered individual (including spouses and/or dependent children) currently holding financial interests (e.g., stock; stock
options and warrants; real estate; loans with recourse; etc.) in a publicly-traded financially interested company that when
aggregated is greater than or equal to a 5% ownership or that exceeds $5,000 in value OR is any covered individual (including
spouses and/or dependent children) currently holding financial interests in any amount in a financially interested company that is
not publicly traded?
3.
Intellectual Property
YES
NO
Is any covered individual (including spouses and/or dependent children) currently receiving or entitled to receive compensation
from a financially interested company due to intellectual property (e.g., royalties under a patent, patent application or copyright)
where the proposed research is directly or indirectly related to the licensed technology or work?
4.
Other Relevant Financial Interests
YES
NO
Is any covered individual (including spouses and/or dependent children) currently receiving or entitled to receive any non-royalty
or other payments in connection with the research that are not directly related to the reasonable costs of the research (as specified
in the research agreement with the sponsor) including, but not limited to, any bonus, incentives or milestone payments in excess
of reasonable costs incurred?
5.
Miscellaneous
YES
NO
Does any covered individual or their spouse serve as a Board Member, Director, Officer, or in any other fiduciary capacity OR
have an appointment to serve on the scientific advisory board of any financially interested company?
If you answered YES to any of the above questions, please identify the conflicted member of the research team and attach a
complete description of the situation, including dollar values and attach any supporting documentation.
We have read and understand AMITA Health IRB’s Financial Conflicts-of-Interest for Non-PHS Funded Research policy; have made
all financial disclosures required by it, if any; and will comply with any conditions or restrictions imposed by the AMITA Health IRB
or AMITA Health to manage, reduce or eliminate actual or potential conflicts of interest.
PI Signature
Financial Disclosure Form
Version: 5-1-08, rev 2-10, 8-12, 9-15
Date
2
AMITA Health
Disclosure of Financial Interest Form for Non-PHS Funded Research
This disclosure form pertains to the following members of the research team, including the PI, who are considered “covered
individuals” under AMITA Health IRB policy (print additional pages as needed).
NAME:
STUDY DESIGN?
HUMAN SUBJECTS CONTACT?
HANDLES SCIENTIFIC DATA?
COMPLETES CASE REPORT FORMS?
NAME:
STUDY DESIGN?
HUMAN SUBJECTS CONTACT?
HANDLES SCIENTIFIC DATA?
COMPLETES CASE REPORT FORMS?
NAME:
STUDY DESIGN?
HUMAN SUBJECTS CONTACT?
HANDLES SCIENTIFIC DATA?
COMPLETES CASE REPORT FORMS?
NAME:
STUDY DESIGN?
HUMAN SUBJECTS CONTACT?
HANDLES SCIENTIFIC DATA?
COMPLETES CASE REPORT FORMS?
NAME:
STUDY DESIGN?
HUMAN SUBJECTS CONTACT?
HANDLES SCIENTIFIC DATA?
COMPLETES CASE REPORT FORMS?
FUNCTION:
(e.g., PI, sub-investigator, coordinator, data manager or analysis, etc.)
□ YES
□ YES
□ YES
□ YES
□ NO
□ NO
□ NO
□ NO
FUNCTION:
(e.g., PI, sub-investigator, coordinator, data manager or analysis, etc.)
□ YES
□ YES
□ YES
□ YES
□ NO
□ NO
□ NO
□ NO
FUNCTION:
(e.g., PI, sub-investigator, coordinator, data manager or analysis, etc.)
□ YES
□ YES
□ YES
□ YES
□ NO
□ NO
□ NO
□ NO
FUNCTION:
(e.g., PI, sub-investigator, coordinator, data manager or analysis, etc.)
□ YES
□ YES
□ YES
□ YES
□ NO
□ NO
□ NO
□ NO
FUNCTION:
(e.g., PI, sub-investigator, coordinator, data manager or analysis, etc.)
□ YES
□ YES
□ YES
□ YES
□ NO
□ NO
□ NO
□ NO
This form and supporting documentation may be returned to the IRB Administrative Coordinator in a sealed envelope (if desired) with
initial /continuing review applications or at any time a disclosure is being made.
Financial Disclosure Form
Version: 5-1-08, rev 2-10, 8-12, 9-15
3