Form 25 COI Screening

COI Screening For Month, Day, Year Meeting
OMB #0925-xxxx

Expiry Date: xx/xx/xxxx

Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of your participation in the NCI CIRB is protected by The Privacy Act of 1974.
Participation is voluntary, and there are no penalties for not participating or withdrawing from the NCI CIRB at any time. Refusal to participate will not affect your benefits in any way. The information
collected will be kept private to the extent provided by law. Names and other identifiers will not appear in any report of the NCI CIRB. Information provided will be combined for all participants an
reported as summaries. You are being requested to complete this instrument so that we can conduct activities involved with the operations of NCI CIRB Initiative.
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. 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 (0925-0625*). Do not return the completed form to this address.

1. Initial Reviews
Study ID, Study Title (Protocol Version Date
MM/DD/YY)
Study Chair: Name; Institution
Agent / Drug / Enterprise

Agent – Manufacturer (Supplier)

Check the box next to the statement if the statement is true of you, an immediate family1
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.
Have a role in the oversight, design or conduct of the project
You Family
Supervisor/
or has a role in the analysis or management of the data (this
Member
Employee
includes:
sitting on a governing body or significant supervisory
committee of the Coordinating Group,
serving as a Study Chair for any study of the
Coordinating Group, or
working at the same institution as the Study Chair
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 the last two years
from any enterprise involved in the study, or any direct
competitor

1

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

1

Pre-Meeting Conflict of Interest Worksheet
For Month, Day, Year
Have a proprietary interest in the research such as a
licensing agreement, copyright, patent, or trademark

Have the potential to gain academic or career advancement
based upon participation in 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

2. OtherReviews
Study ID, Study Title (Protocol Version Date
MM/DD/YY)
Study Chair: Name; Institution
Agent / Drug / Enterprise

Agent – Manufacturer (Supplier)

Check the box next to the statement if the statement is true of you, an immediate family
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.
Are a Coordinating Group investigator for this study AND
You Family
Supervisor/
have done any of the following:
Member
Employee
enrolled a participant,
identified a prospective participant (i.e. actively
evaluating a patient for potential participation in the
study)
performed any directed research-related interventions
and interactions with a participant on this study (this
does not apply to cross-over attending)
Have a role in the oversight, design or conduct of the project
or has a role in the analysis or management of the data (this
includes:
sitting on a governing body or significant supervisory
committee of the Coordinating Group,
serving as a Study Chair for any study of the
Coordinating Group, or
working at the same institution as the Study Chair
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)

2

Pre-Meeting Conflict of Interest Worksheet
For Month, Day, Year
Have received any compensation within the last two years
from any enterprise involved in the study, or any direct
competitor
Have a proprietary interest in the research such as a licensing
agreement, copyright, patent, or trademark
Have the potential to gain academic or career advancement
based upon participation in 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

3