DEPARTMENT OF RESEARCH
Administrative & Institutional Review Board
Conflict of Interest Guidelines for Clinical Research
The following policies and procedures apply to all human subjects research regardless of
funding source.
1. Annual Disclosure: All investigators involved in the conduct of clinical research must
report any significant financial interest associated with a research study in their initial
Administrative Review Board (ARB) and initial and continuing Institutional Review
Board (IRB) applications. A significant financial interest is defined as any interest that
could directly and significantly affect the design, conduct, or reporting of a research
project. If a significant financial interest does exist, a LifeBridge Health (LBH)
Financial Interest Disclosure Form must be submitted at the time of ARB and IRB
review. Only covered parties declaring a financial interest greater than $5,000 must
submit a Financial Interest Disclosure Form along with their ARB and IRB applications.
Individual investigators are also responsible for filing an updated form anytime there is
a relevant change in a significant financial interest.
2. Administrative Review Board (ARB) Review of Conflict of Interest: Based on the
information provided by investigators, the ARB will determine whether or not any of the
disclosed relationships constitute a real or potential conflict of interest. This initial
determination will be based on guidelines described below and in the LBH Department
of Research Policy on Conflict of Interest in Research (IRB Guide #5).
3. Disclosure and ARB Determinations Required Before Institutional Review Board
(IRB) Review: All investigators and key personnel having a significant financial
interest in a clinical research study must submit a Financial Interest Disclosure Form
annually. Furthermore, a conflict of interest determination by the ARB MUST be
rendered and on file for the principal investigator and all key personnel BEFORE the
IRB can complete an initial review of any human subjects protocol. To avoid possible
delays in protocol review, all investigators with either real or perceived conflicts of
interest should submit a Financial Interest Disclosure Form along with their ARB/IRB
applications, and update it whenever their reportable financial interests change.
4. Categories and Management Conditions: The ARB will initially assess whether real
or potential conflicts of interest exist, evaluate their magnitude and recommend to the
IRB what management conditions, if any, should be put in place in order to ensure that
any conflict of interest issues are appropriately managed. Written recommendations
will be forwarded to the appropriate LBH IRB for consideration and final resolution.
In addition to standard management conditions applicable to all investigators,
additional management conditions will apply to investigators conducting human
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subjects research based on whether their significant financial interests are judged to
be of either Moderate or Higher Risk as described below.
a. Conflict of Interest – Minimal Risk:
Individuals who report having no significant financial interests or financial interests
below the thresholds established for Moderate Risk situations (Table I) will be
classified in the Minimal Risk category. Minimal Risk situations do not require
specific management terms.
b. Conflict of Interest – Moderate Risk:
Significant Financial Interest (SFI) thresholds used to define Moderate Risk
conflicts are summarized in Table I. Individuals satisfying these thresholds will
automatically be assigned to the Moderate Risk category and will be subject to the
standard management conditions described in Table I. Depending on the nature of
the relationship between an investigator and any specific Outside Entity with which
they hold a significant financial interest additional management conditions may be
imposed by the IRB.
TABLE I: Thresholds and Standard Management Conditions for Conflict of Interest
Category
SFI Thresholds
1. Involved in
clinical
research
AND
Moderate
Risk
2. Receive more
than $5,000
from a
Financially
Interested
Company
Management Conditions
a. Can serve as Principal Investigator (PI) or
key personnel on clinical studies sponsored by
a Financially Interested Company with which
they have a SFI satisfying Moderate Risk
thresholds
b. Can recruit patients to such studies
c. Must disclose the relationship in publications,
seminars etc.
d. Must disclose the relationship to trainees,
fellows, etc. involved in the study
e. Cannot receive any personal (including
immediate family) incentives (recruitment
and/or performance incentives, research
support other than direct support for sponsored
clinical study, fellowships, lectureships, etc.)
related to such studies. Cannot serve as a
consultant for any study one is working on.
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c. Conflict of Interest – Higher Risk:
Certain financial interests and relationships between investigators and potential
sponsors of research represent a much greater risk with respect to conflicts of
interest. The thresholds summarized in Table II define these potentially higher risk
situations.
TABLE II: Thresholds and Standard Management Conditions for Conflict of Interest
Category
SFI Thresholds
Management Conditions
1. Involved in clinical research
1. The investigator must disclose the
relationship in publications,
And
abstracts and oral presentations
2. Depending on the circumstances,
the investigator may not::
2. Receive more than $5,000
annually from a sponsoring
a) serve as PI (protocol chair, study
Financially Interested
director) of any clinical study
Company
sponsored by the Financially
Interested Company
And
b) serve as “key personnel” on any
clinical study sponsored by the
3. Significant ownership of
Financially Interested Company
Higher Risk
stock or intellectual property
c) recruit patients to the particular
or any other ownership
study in question
interest in the sponsoring
3. If a conflict develops or is
Business Entity
discovered after initiation of a study,
the investigator must notify the
Or
ARB/IRB and disclose the
relationship to trainees, fellows, and
4. Leadership role or service as
staff involved with the study .
an officer or director for the 4. Cannot receive any personal
sponsoring Financially
(including immediate family)
Interested Company
incentives (capitated payments,
(directorship, scientific
research support, fellowships, etc.)
board, Board of Directors)
directly related to such studies
In all cases in which these threshold conditions are met or exceeded the full ARB
will review the particulars of the involved relationship(s) and will classify the
relationship(s) as Moderate or Higher Risk. In addition to standard management
conditions applicable to all investigators, additional management conditions
summarized in Table II may apply in situations designated by the IRB as Higher
Risk.
The major difference between management of Moderate and Higher Risk conflicts
is that individuals found to have Higher Risk conflicts may not serve as PI for that
clinical research, may not participate in any other key personnel capacity, and may
not recruit patients to studies sponsored by the Outside Entity with which they have
significant financial interests.
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5. Possible Management Strategies:
a. The conflicted investigator may be excluded from contract negotiations with the
outside entity.
b. The conflicted investigator should disclose his/her financial relationship with the
company in all publications, abstracts and oral presentations that report on research
related to the commercial interests of the company and/or its competitors. Such
conflict must also be reported in grant applications pertaining to research of interest
to the company.
c. The conflicted Investigator should request and submit a declaration of COI from the
sponsor summarizing the existing financial conflict the sponsor currently has with
the investigator and the sponsor’s plans for management of the perceived/potential
conflict at that site.
d. The conflicted investigator may be prohibited from serving as Principal Investigator
(PI) on the research study. Where possible, the alternative PI selected should not be
one who reports administratively to the conflicted investigator. In those cases where
this situation cannot be avoided, a different individual should be responsible for
conducting the alternative PI’s annual performance evaluations. The conflicted
Investigator may be permitted to serve as a co-investigator on the research study.
e. In some cases, although not a requirement, the conflicted Investigator may be
prohibited from serving as a researcher on the study and may be required to remove
himself from all aspects of the project.
f. An Oversight Committee comprised of qualified faculty (not all from the same
department) may be constituted to assure the LBH community that an individual’s
financial relationship with a company will not compromise the integrity of LBH
research. The Oversight Committee should meet with the conflicted investigator on
a periodic basis (at least annually) and record its conclusions in a written report. The
report should be provided to those who requested the creation of such Committee.
g. The conflicted investigator could be excluded from, or not be the sole individual
responsible for, designing the study and recording, analyzing, and reporting
research data. All research results shall be published, regardless of whether the
results are favorable or unfavorable to the interests of any sponsor or to the outside
interests of the conflicted investigator.
h. Request a declaration of COI from the sponsor summarizing the existing financial
conflict the sponsor currently has with the principal investigator and their plans for
management at the site level of this perceived/potential conflict.
i. A researcher with outside financial interests could be required to complete the NIH
Tutorial on Financial Conflict of Interest (FCOI) Requirements for NIH-Supported
Institutions (http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm).
j. LBH may decline to enter into a research agreement if a conflict of interest cannot be
managed effectively
6. Exceptions to Higher Risk management conditions 1, 2 and 3 under Compelling
Circumstances: In the event of compelling circumstances, an individual holding
significant financial interests in a Financially Interested Company sponsoring a specific
clinical study may be permitted to serve in the role of PI or other key personnel for the
study and may be permitted to recruit patients to the study.
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Whether the circumstances are deemed compelling will depend in each case upon the
nature of the clinical research, the nature of the significant financial interest(s), how
closely the interest(s) is related to the clinical research, and the degree to which the
interest may be affected by the outcome of the clinical research. When the significant
financial interest is directly related to the clinical research and may be substantially
affected by it (e.g., an equity interest in a start-up company that manufactures the
investigational product) the risk is greatest and the bar must be high. However, even
direct and potentially lucrative financial interests may be justified in some
circumstances. For example, when the individual holding such interests is uniquely
qualified by virtue of expertise or experience and the clinical research could not
otherwise be conducted as safely or effectively without that individual, he or she
should be permitted the opportunity to rebut prohibition against participation (e.g.
serving as PI; key personnel; recruiting patients) by demonstrating these facts in
writing to the satisfaction of the IRB. The IRB may then approve the involvement of
such an individual in the clinical research, subject to conditions that ensure effective
management of the conflict and credible oversight of the clinical research.
If the IRB grants exceptions for any particular protocol, the following information MUST
be provided in the corresponding human subjects research consent form:
a.
b.
c.
d.
e.
Source of funding for the study
The nature of the PI’s relationship with the study sponsor
Any payments the PI receives from the sponsor
Provisions for ensuring subject’s protection
Contact information for the IRB
When the IRB agrees to grant an exception under compelling circumstances, the
committee will prepare a report summarizing the IRB’s recommendation and transmit it
to the ARB.
7. Prohibition on Payments for Results: Payments from LBH or the research sponsor
to an investigator are prohibited if such payments are conditioned upon a particular
research result or are linked to successful research outcomes. Payments for subject
enrollment or for the referral of patients to clinical studies are only permitted when
such payments:
a. Are reasonably related to costs incurred, as specified in research agreements
between the sponsor and LBH;
b. Reflect the fair market value of services performed; and
c. Are commensurate with the efforts of the individual(s) performing the research.
8. Publication Policy: Under no circumstances may a sponsor of clinical research limit
the rights of the principal investigator to receive, analyze or interpret any data
generated as part of the sponsored research project, nor restrict publication of the
results, regardless of the outcome of the research. A sponsor may request that
publication be delayed as much as 90 days for the purpose of pre-publication review,
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or for a period of time that is agreed to by both parties. The only exception to this
policy is a federally sponsored multi-center study in which the clinical trial agreement
prohibits the investigator from publishing his or her own results before completion and
publication of the multi-center study.
9. Protection of students/residents/trainees: Significant financial interests may give
rise to conflicts with an investigator’s responsibility to foster the academic development
of students, residents and/or trainees. An investigator’s financial relationship with an
Outside Entity may not place restrictions on the activities of
students/residents/trainees. Investigators judged to have Moderate or Higher Risk
conflicts must disclose the details of the relevant relationship(s) to all
students/residents/trainees prior to their involvement in the clinical research.
10. Disclosure to IRBs: Each time a clinical protocol is submitted to the IRB for review,
each investigator will be asked to:
a. Declare if they have significant financial interests with any sponsor of the study,
and if so
b. Attest that they have a current financial disclosure form on file with the ARB and
submit a copy of that form along with the IRB application,
c. Disclose the risk level assigned to the relationship by the ARB, and
d. Acknowledge that they have read and agree to comply with LBH ARB/IRB
policies.
The ARB will share information about individual ARB determinations with the LBH
IRBs. IRBs have the ultimate responsibility and authority to evaluate how any
particular conflict of interest determinations impact specific research protocols
involving human subjects. Thus, IRBs may impose additional terms, conditions,
limitations or other management elements they believe are necessary to ensure the
protection of human subjects when approving any research protocol.
11. Sanctions for Non-compliance: The LBH IRB will not review a protocol unless a) all
key personnel listed on the protocol have declared their status of financial interest as
indicated in the ARB/IRB application forms, b) all required annual financial disclosure
forms are submitted, and c) the ARB has rendered a decision concerning the potential
for conflicts for each key personnel. Deliberate misrepresentation of information
provided to the ARB/IRB or failure to comply with the terms of this policy may result in
sanctions up to and including loss of investigator status.
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