DEPARTMENT OF RESEARCH
Administrative & Institutional Review Board
Conflict of Interest Guidelines for Clinical Research
The following policies and procedures apply to all clinical 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
ARB and initial and continuing IRB applications. If a significant financial interest does
exist, an 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
$10,000 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
subjects research based on whether their significant financial interests are judged to
be of either Moderate or High Risk as described below.
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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
Management Conditions
a. Can serve as 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
2. Receive more
than $10,000
but less than
e. Cannot receive any personal (including
$25,000
immediate family) incentives (recruitment
annually from a
and/or performance incentives, research
Financially
support other than direct support for sponsored
Interested
clinical study, fellowships, lectureships, etc.)
Company
related to such studies.
c. Conflict of Interest – High 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.
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TABLE II: Thresholds and Standard Management Conditions for Conflict of Interest
Category
High Risk
SFI Thresholds
Management Conditions
1. Cannot serve as PI (protocol chair,
study director) of any clinical study
1. Involved in clinical research
sponsored by the Financially
Interested Company
And
2. Cannot serve as “key personnel”
on any clinical study sponsored by
2. Receive more than $25,000
the Financially Interested Company
annually from a sponsoring
3. Cannot recruit patients to the
Financially Interested
particular study in question
Company
4. May refer patients to an
independent third party for study
Or
information and possible enrollment
5. If an exception is made by the IRB,
3. Any ownership interest in
the investigator must disclose the
sponsoring Business Entity
relationship in publications,
seminars etc.
Or
6. If a conflict develops or is
discovered after initiation of a
4. Leadership role or service as
study, the investigator must
an officer or director for the
disclose the relationship to
sponsoring Financially
trainees, fellows, etc. involved with
Interested Company
the study
(directorship, scientific
7. Cannot receive any personal
board, Board of Directors)
(including immediate family)
incentives (capitated payments,
research support, fellowships, etc.)
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 High Risk. In addition to standard management
conditions applicable to all investigators, additional management conditions
summarized in Table II will apply in situations designated by the IRB as High Risk.
The major difference between management of Moderate and High Risk conflicts is
that individuals found to have High 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.
5. Exceptions to High 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.
6. 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.
7. 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,
or for a period of time that is agreed to by both parties. The only exception to this
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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.
8. 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 High Risk
conflicts must disclose the details of the relevant relationship(s) to all
students/residents/trainees prior to their involvement in the clinical research.
9. 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.
10. 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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