Form 24 CIRB COI Update

OMB #0925-0753 Expiration Date: 06/30/2020

Attachment_B08_CoI_Scr_Wksht

OMB#0925-0753
Expiration
Date: 06/30/2020
The purpose of the information collection is to conduct reviews of clinical trial
studies. NCI guidelines
mandate
the
participation of institutions in the CIRB for Network group studies. You are being requested to complete this instrument so that
we
can
conduct
activities
involved
with the
of the of
NCI
CIRBtrial
Initiative.
yourmandate
participation
in Network of
group
The
purpose
of the
information
collection
is tooperations
conduct reviews
clinical
studies. Although
NCI guidelines
the participation
research
andincompletion
the forms
is voluntary,
if you
wish requested
to participate
in the CIRB,
you must so
complete
institutions
the CIRB forof
Network
group
studies. You
are being
to complete
this instrument
that we all
canquestions
conduct on
the
form. involved
The information
you provide
for allAlthough
participants
reportedinas
summaries.
It will beand
keptcompletion
private
activities
with the operations
ofwill
the be
NCIcombined
CIRB Initiative.
your and
participation
Network
group research
toofthe
by iflaw.
theextent
forms provided
is voluntary,
you wish to participate in the CIRB, you must complete all questions on the form. The information you
provide will be combined for all participants and reported as summaries. It will be kept private to the extent provided by law.
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for NOTIFICATION
this collection TO
of information
is OF
estimated
to average
RESPONDENT
ESTIMATED
BURDEN15 minutes per response, including the time
for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including the time for
reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden
collection
of information.
Anofagency
may not conduct
or sponsor,
and a person
is not required
to respond
to, a collection
of
estimate
or any
other aspect
this collection
of information,
including
suggestions
for reducing
this burden,
to: NIH, Project
information
unless
it displays
a currently
control
number.
comments ATTN:
regarding
this(0925-0753).
burden estimate
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20892-7974,
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of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705
completed
to this address.
Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0753). Do not return the completed form to this address.

NCI CIRB
MEMBER CONFLICT OF INTEREST SCREENING WORKSHEET
MEMBER NAME:
DATE COMPLETED:

The CIRBs follow standard operating procedures (SOPs) to ensure compliance with federal regulations
and guidance. These SOPs include a Conflict of Interest Policy for CIRB members.
Identification and management of CIRB Member conflicts of interest is essential to maintaining the
integrity of the NCI CIRB’s reviews. This form is meant to help members and the CIRB Operations
Office identify a member’s actual or perceived conflicts of interest per CIRB SOPs. Please complete this
worksheet and return it with your completed application and CV/Resume or Bio via email at
[email protected]

1. CIRB Standard Operations Procedures (SOPs) prohibit employees of the NCI from serving on the NCI
CIRB [SOP 4.2.4].
Are you an employee of the NCI?
No.
Yes.
2. The CIRB SOPs prohibit employees of the NCI from serving on the NCI CIRB, but in some cases,
individuals who are not employed by NCI but who have a working relationship with NCI in another

Website Version: May 26, 2017

capacity (e.g. a contractor or consultant, or serving on an NCI Disease-Specific Steering Committee) may
be perceived as having a conflict of interest.
Do you have any such relationship with NCI?
No.
Yes. If yes, describe the relationship in the space below.

3. Individuals who have a primary role (e.g. member of a network group disease committee or a study chair)
in the oversight, design or conduct of a study (or a particular subset of studies) under review by the CIRB
are considered to be conflicted for those studies and may be too frequently conflicted to serve on the CIRB.
A conflict also exists if an immediate family member (i.e. spouse, significant other, dependent child) or an
individual in a direct supervisory or reporting relationship to the member has such a role (e.g., a boss or
employee). [SOP 4.11.3.1]

Do you, an immediate family member, or an individual in a direct supervisory or reporting relationship to
you have a primary role in the oversight, design or conduct of a study (or a particular subset of studies)
under review by the CIRB?

CIRB Candidate (You)
No.
Yes. Indicate which
study/studies:

Immediate family member
(i.e. spouse, significant other,
dependent child)
No.
Yes. Indicate which
study/studies:

Individual in a direct supervisory or
reporting relationship to the CIRB
Candidate
(i.e. your boss or your employee)
No.
Yes. Indicate which
study/studies:

4. Individuals who have a role in the analysis or management of data for a study or for a particular subset of
studies under review by the CIRB are considered to be conflicted for those studies and may be too
frequently conflicted to serve on the CIRB.
A conflict also exists if an immediate family member (i.e. spouse, significant other, dependent child) or an
individual in a direct supervisory or reporting relationship to the member has such a role (i.e., a boss or
employee). [SOP 4.11.3.1]
Do you, an immediate family member, or an individual in a direct supervisory or reporting relationship to
you have a role in the analysis or management of data for a study or for a particular subset of studies
under review by the CIRB?

Website Version: May 26, 2017

CIRB Candidate (You)
No.
Yes. Indicate which
study/studies:

Immediate family member
(i.e. spouse, significant other,
dependent child)
No.
Yes. Indicate which
study/studies:

Individual in a direct supervisory or
reporting relationship to the CIRB
Candidate
(i.e. your boss or your employee)
No.
Yes. Indicate which
study/studies:

5. Individuals who serve on a governing body or any significant supervisory committee of the coordinating
group that submits studies for CIRB review, such as a Disease Committee, the Board of Directors, or a Data
Monitoring Committee of the coordinating group are considered to be conflicted for those considered to be
conflicted for those studies and may be too frequently conflicted to serve on the CIRB.

A conflict also exists if an immediate family member (i.e. spouse, significant other, dependent child) or an
individual in a direct supervisory or reporting relationship to the member has such a role (i.e. a boss or
employee). [SOP 4.11.3.1.1]
Do you, an immediate family member, or an individual in a direct supervisory or reporting relationship to
you, serve on a governing body or any significant supervisory committee of the coordinating group
that submits studies for review by the CIRB?

CIRB Candidate (You)
No.
Yes. Indicate which coordinating
group(s):

Immediate family member
(i.e. spouse, significant other,
dependent child)
No.
Yes. Indicate which coordinating
group(s):

Individual in a direct supervisory or
reporting relationship to the CIRB
Candidate
(i.e. your boss or your employee)
No.
Yes. Indicate which coordinating
group(s):

6. Individuals who serve as Study Chairs of currently active studies (open to accrual) or who are employed by
the same institution as Study Chairs may be considered to be conflicted for those studies and may be too
frequently conflicted to serve on the CIRB.

Website Version: May 26, 2017

A conflict also exists if an immediate family member (i.e. spouse, significant other, dependent child) or an
individual in a direct supervisory or reporting relationship to the member has such a role (i.e. a boss or
employee). [SOP 4.11.3.1.2 and SOP 4.11.3.2]
a.

Do you, an immediate family member, or an individual in a direct supervisory or reporting
relationship to you, serve as a Study Chair of a currently active study?

CIRB Candidate (You)
No.
Yes. Indicate which
study/studies:

Website Version: May 26, 2017

Immediate family member
(i.e. spouse, significant other,
dependent child)
No.
Yes. Indicate which
study/studies:

Individual in a direct supervisory or
reporting relationship to the CIRB
Candidate
(i.e. your boss or your employee)
No.
Yes. Indicate which
study/studies:

b.

To the best of your knowledge, are you, an immediate family member, or an individual in a direct
supervisory or reporting relationship to you, employed by the same institution as the Study Chair
of a currently active study?

CIRB Candidate (You)
No.
Yes. Indicate which
study/studies:

Immediate family member
(i.e. spouse, significant other,
dependent child)
No.
Yes. Indicate which
study/studies:

Individual in a direct supervisory or
reporting relationship to the CIRB
Candidate
(i.e. your boss or your employee)
No.
Yes. Indicate which
study/studies:

7. Please list institutions with which you, an immediate family member, or an individual in a direct
supervisory or reporting relationship to you, have an affiliation (as a consultant, contractor, or employee).
[SOP 4.11.3.2]

CIRB Candidate (You)

Immediate family member
(i.e. spouse, significant other,
dependent child)

Individual in a direct supervisory or
reporting relationship to the CIRB
Candidate
(i.e. your boss or your employee)

If applicable.

If different from your own.

1.

1.

1.

2.

2.

2.

3.

3.

3.

Website Version: May 26, 2017

8. Individuals who have a significant financial interest in any oncology-related agents/devices/enterprises may
be considered to be conflicted for studies involving those agents/devices/enterprises (or
agents/devices/enterprises developed by direct competitors) and may be too frequently conflicted to serve
on the CIRB.
A conflict also exists if an immediate family member (i.e. spouse, significant other, dependent child) or an
individual in a direct supervisory or reporting relationship to the member has such a role (i.e. a boss or
employee). [SOP 4.11.3.3, 4.11.3.3.1, 4.11.3.3.2, 4.11.3.3.3]
a.

Do you, an immediate family member, or an individual in a direct supervisory or reporting
relationship to you, have a financial interest of $5,000 or more in any oncology-related
agents/devices/enterprises?

CIRB Candidate (You)
No.
Yes. Indicate which
agents/devices/enterprises:

Immediate family member
(i.e. spouse, significant other,
dependent child)
No.
Yes. Indicate which
agents/devices/enterprises:

Individual in a direct supervisory or
reporting relationship to the CIRB
Candidate
(i.e. your boss or your employee)
No.
Yes. Indicate which
agents/devices/enterprises:

b. Have you, or an immediate family member received any compensation from any oncology-related
enterprise within the last two years?
CIRB Candidate (You)
No.
Yes. Indicate which agents/devices/enterprises:

Website Version: May 26, 2017

Immediate family member
(i.e. spouse, significant other, dependent child)
No.
Yes. Indicate which agents/devices/enterprises: