Form 25 COI Screening

COI Screening for [Month Day, YYYY] [CIRB TYPE] CIRB Meeting
Attachment B09_Col_Scr_Mtgs

OMB# 0925-0753, Expiration Date: 07/31/2021

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
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and a person is not required to respond to, a collection of information
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NOTIFICATION
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including
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An agency may not conduct or sponsor, and a person is not required to respond
to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0753). Do not return the
completed form to this address.

1. Initial Reviews
[Study ID], [Study Title] (Protocol Version Date
MM/DD/YYYY)

You

Have a primary role in the oversight, design or conduct of the
project or has a role in the analysis or management of the data.
This includes:
serving on a governing body or other supervisory
committee with group-wide oversight of the coordinating
group that submitted the study,
serving on a Disease Committee, Working Group, or Data
Monitoring Committee of the coordinating group that
submitted the study for CIRB review,
serving as a Study Chair of a study under review with the
CIRB
employed by the same institution as the Study Chair

1

“Immediate Family” is defined by the CIRB SOPs as a spouse, significant other or dependent ch

July 2018

v. 10/18/2017

Supervisor/
Employee

Check the box next to the statement if the statement is true of you, an immediate family 1 member
or a person in a direct supervisory or reporting relationship with you. A checked box indicates
you are conflicted for review of the study. Report the conflict to the CIRB Operations Office in
advance of the CIRB Meeting.

Study Chair: [Name]; [Institution]
Agent / Drug / Enterprise
[Agent] – [Manufacturer] ([Supplier])

Family
Member

1. Initial Reviews

You
Have a financial interest of $5000 or more in any
agent/device/enterprise involved in the study, or any direct
competitor (does not apply if the investment is not under your
direct control, i.e. investment via a mutual fund)
Have received any compensation within two years before the
deliberations from any enterprise involved in the study under
consideration, or any direct competitor
Have a proprietary interest in the research such as a licensing
agreement, copyright, patent, or trademark

Have the potential to derive benefit (financial benefit, career
advancement or otherwise) based upon the outcome of the study

Have an interest (financial or non-financial) that the CIRB or the
CIRB member believes conflicts with or biases his/her ability to
objectively review the study

July 2018

v. 10/18/2017

Family
Member

Supervisor/
Employee

COI Screening for [Month Day, YYYY] [CIRB TYPE] CIRB Meeting

2. Other Reviews
[Study ID], [Study Title] (Protocol Version Date
MM/DD/YYYY)

You

Are a Signatory Institution Principal Investigator for this study
AND have done any of the following:
identified a prospective participant for the study (i.e.
actively evaluating a patient for potential participation in
the study)
enrolled a participant in the study,
performed or directed research interventions and
interactions with the study participant (does not apply to
other physicians who may be involved in the care of the
patient, such as cross-over attendings, surgeons, or
radiotherapists.)

Have a primary role in the oversight, design or conduct of the
project or has a role in the analysis or management of the data.
This includes:
serving on a governing body or other supervisory
committee with group-wide oversight of the coordinating
group that submitted the study,
serving on a Disease Committee, Working Group, or Data
Monitoring Committee of the coordinating group that
submitted the study for CIRB review,
serving as a Study Chair of a study under review with the
CIRB
employed by the same institution as the Study Chair

2

“Immediate Family” is defined by the CIRB SOPs as a spouse, significant other or dependent child.

July 2018

v. 10/18/2017

Supervisor/
Employee

Check the box next to the statement if the statement is true of you, an immediate family 2 member
or a person in a direct supervisory or reporting relationship with you. A checked box indicates
you are conflicted for review of the study. Report the conflict to the CIRB Operations Office in
advance of the CIRB Meeting.

Study Chair: [Name]; [Institution]
Agent / Drug / Enterprise
[Agent] – [Manufacturer] ([Supplier])

Family
Member

2. Other Reviews

You
Have a financial interest of $5000 or more in any
agent/device/enterprise involved in the study, or any direct
competitor (does not apply if the investment is not under your
direct control, i.e. investment via a mutual fund)
Have received any compensation within two years before the
deliberations from any enterprise involved in the study under
consideration, or any direct competitor
Have a proprietary interest in the research such as a licensing
agreement, copyright, patent, or trademark

Have the potential to derive benefit (financial benefit, career
advancement or otherwise) based upon the outcome of the study

Have an interest (financial or non-financial) that the CIRB or the
CIRB member believes conflicts with or biases his/her ability to
objectively review the study

July 2018

v. 10/18/2017

Family
Member

Supervisor/
Employee