Attachment 3H-M - Template Letters_110110

Attachment 3 H - M:
TEMPLATE LETTERS

Attachment 3H – Adult Query of Candidate Interest
Attachment 3I -

Pediatric Query of Candidate Interest

Attachment 3J - Confirming Candidate Qualifications and
Conflict of Interest (COI) Statement
Attachment 3K - Notification of Selection to Serve on
NCI CIRB
Attachment 3L - Notice of Rotation Off
Attachment 3M - Thank You to Retiring Members and
Acknowledgment of Resignation

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The EMMES Corporation. All rights reserved. The material contained herein is the confidential property of
The EMMES Corporation. No part of this material may be reproduced, photocopied, stored on a retrieval
system, or transmitted without the express written consent of The EMMES Corporation. Any unauthorized
use is prohibited.

Attachment 3H - Adult Query of Candidate Interest
Dear

,

You have been recommended by
as a potential Board member
for the NCI Central Institutional Review Board (CIRB). If you are not
familiar with the project, it is an NCI Initiative that was established to
eliminate redundant local IRB reviews of phase 3 Cooperative Group
trials while maintaining high standards of human subjects protections.
The Board meets twice a month via an internet enhanced conference
call. Each meeting lasts approximately 3-4 hours and occurs on the
first and third Thursday of the month at 9:00 am ET. There is also an
educational meeting every year that occurs in person. Board related
travel for the educational meeting is covered and a per diem is
provided. Board members serve two-year terms and receive an
honorarium for volunteering their time. You may refer to the NCI
CIRB website at www.ncicirb.org for more information.
The reason you are being considered is there is an opening for a
.
If you are interested in participating, please send me a current copy of
your CV. If you are not able to serve at this time but are interested in
this opportunity in the future, please provide a date when you believe
you will be available so that we may contact you again in the future.
I look forward to your reply. If you have any questions, please feel
free to contact me.
Thank you,
Jacquelyn L. Goldberg, J.D.
Head, Central IRB Initiative
National Cancer Institute, NIH
6130 Executive Boulevard Room 6102
Bethesda, MD 20892
goldberj@mail.nih.gov
ph 301-496-0510
fax 301-480-2642
www.ncicirb.org
cc:

NCI CIRB Project Officer
CIRB Administrator

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Attachment 3I – Pediatric Query of Candidate Interest
Dear

,

You have been recommended by
as a potential Board member
for the NCI Central Institutional Review Board (CIRB). .If you are not
familiar with the project, it is an NCI Initiative that was established to
eliminate redundant local IRB reviews of COG phase 2, 3 and pilot
trials while maintaining high standards of human subjects protections
The Board meets once a month via an internet enhanced conference
call. Each meeting will last approximately 3-4 hours and occurs on the
second Thursday of each month at 11:00 am ET. There is also an
educational meeting every year that occurs in person. Board related
travel for the educational meeting is covered and a per diem is
provided. Board members serve two-year terms and receive an
honorarium for volunteering their time. You may refer to the NCI
CIRB website at www.ncicirb.org for more information.
The reason you are being considered is there is an opening for a
.
If you are interested in participating, please send me a current copy of
your CV. If you are not able to serve at this time but are interested in
this opportunity in the future, please provide a date when you believe
you will be available so that we may contact you again in the future.
I look forward to your reply. If you have any questions, please feel
free to contact me.
Thank you,
Jacquelyn L. Goldberg, J.D.
Head, Central IRB Initiative
National Cancer Institute, NIH
6130 Executive Boulevard Room 6102
Bethesda, MD 20892
golderj@mail.nih.gov
ph 301-496-0510
fax 301-480-2642
www.ncicirb.org
cc:

NCI CIRB Project Officer
CIRB Administrator

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Attachment 3J – Confirming Candidate Qualif ications and COI
Dear

,

Thank you for your interest in becoming a Board member for the NCI CIRB.
There are certain criteria that a person must meet in order to serve on the
CIRB as well as information we feel is helpful in assessing each candidate for
the Board.
Please provide your response to the following:
1. Do you currently have internet access and are you comfortable using a
computer for all communications and meetings?
2. Have you ever served on an IRB?
3. Are you currently sitting on an IRB that is a member of the CIRB
Initiative? If yes, does the panel you sit on review these CIRB studies
or does your IRB Chair do the facilitated review for them?
4. Do you have significant holdings in drug companies that would result
in frequent recusals from voting?
5. Do you have any co nflicts based on your review of the CIRB Conflict of
Interest Policy included at the end of this e-mail?
After we confirm that your answers will not impede you from serving on the
Board, a staff member will contact you regarding member orientation and
education.
Thanks again for your interest. If you have any questions, please contact
me.
Thank you,
Jacquelyn L. Goldberg, J.D.
Head, Central IRB Initiative
National Cancer Institute, NIH
6130 Executive Boulevard Room 6102
Bethesda, MD 20892
goldberj@mail.nih.gov
ph 301-496-0510
fax 301-480-2642
www.ncicirb.org
cc:

NCI CIRB Project Officer
CIRB Administrator

STATEMENT OF CONFIDENTIALITY
Collection of this information is authorized under 42 USC 285a. While your participation is completely
voluntary, to participate in the NCI CIRB, completion of this form is required. Data collected as part of the
NCI CIRB review is private and protected by law. Under the provisions of Section 301d of the Public Health
Service Act, no information that could permit identification of a participating individual may be released. All
such information will be kept private under the Privacy Act and will be presented only in statistical or
summary form.

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6.0
Members

Conflict of Interest of CIRB

The purpose of this policy is to ensure that all deliberations of the Adult and Pediatric
NCI’s CIRB affecting participants in research projects are conducted by members whose
overriding interest is the protection of those participants. At the same time, the policy is
not intended to unnecessarily deny the CIRB the benefit of the expertise of any of its
members in such deliberations.
When it is determined that any member has an existing conflict of interest in a study
before the CIRB, that member shall be absent throughout the deliberations concerning
that study and voting, except when the Chair or a majority of the members not conflicted
shall request that member’s presence for the purpose of responding to questions. If such a
member has been requested to remain in the meeting to respond to questions, they will be
absent for the final deliberation and vote. A member with a conflict of interest cannot be
assigned as a reviewer.
6.1 Definition of a Conflict of Interest
6.1.1

A member or her/his immediate family member (spouse, significant other
or dependent child) or a person in a direct supervisory or reporting
relationship with the member has 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 but is not limited to:
6.1.1.1 serving on a governing body or any significant supervisory
committee of the Cooperative Group that submitted the protocol
under consideration, such as a Disease Committee, the Board of
Directors, or a Data Monitoring Committee of the Cooperative
Group or
6.1.1.2 serving as a Study Chair of a currently active study or
6.1.1.3 working at the same institution as the Study Chair

6.1.2

6.1.3

6.1.4
6.1.5

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A member or immediate family member has a financial interest of $10,000
or more in any of the agents/devices/enterprises involved in the study
under consideration, or in any direct competitor of such an enterprise.
(Ownership interests arising solely from investment in a company by a
mutual, pension or other institutional investment fund over which the IRB
member does not have control shall not be included as a conflict of
interest or deemed such.).
A member or immediate family member within two years befo re the
deliberations receives any compensation from any enterprise involved in
the protocol under consideration, or from any direct competitor.
A member or immediate family member has a proprietary interest in the
research, such as a licensing agreement, copyright, patent or trademark.
A member is a Cooperative Group investigator and has either:

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6.1.5.1 identified a prospective subject for the study, or
6.1.5.2 enrolled a subject in the study or
6.1.5.3 performed or directed research interventions and interactions with
the subject. Item 6.1.5.3 does not apply to other physicians who
may be involved in the care of the patient, such as cross-over
attendings, surgeons or radiotherapists.
6.1.6

A member has potential to gain academic or career advancement based
upon participation in the study.
6.1.7 A member has an interest (financial or non- financial) that the CIRB or the
CIRB member believes conflicts with or biases his/her ability to
objectively review a study.
6.1.8 Each CIRB member is responsible for disclosing potential or actual
conflicts of interest to the appropriate NCI CIRB Coordinator as soon as
possible. This disclosure should occur prior to the scheduled CIRB
meeting, or at the beginning of the CIRB meeting, if not declared
previous ly. If a CIRB member has questions regarding a potential conflict,
the member must disclose the potential conflict to the appropriate NCI
CIRB Coordinator, who will forward the information to the appropriate
CIRB Conflict of Interest Subcommittee for evaluation. If the
Subcommittee does not have sufficient time to evaluate, the convened
CIRB will make the determination.
6.1.9 A copy of this policy shall be posted as a reference document on ePanel©
and the Chair shall call attention to the policy at the beginning of each
meeting. An entry in each meeting’s minutes will reflect adherence to this
policy.
6.2 Conflict of Interest Subcommittee
6.2.1

6.2.2

6.2.3

6.2.4

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The purpose of the Conflict of Interest (COI) Subcommittee is to review
potential conflicts of interest as disclosed by members when the member
is not certain as to whether the disclosed relationship constitutes a conflict
of interest requiring the member’s absence from the deliberations and
vote.
The COI Subcommittee is composed of a subset of CIRB members who
are appointed by the CIRB Chair. It is recommended that the three
members be an ethicist, a scientific reviewer, and a patient advocate.
Members with uncertainty regarding potential conflicts shall disclose the
pertinent facts of the potential conflict in writing to the NCI CIRB
Coordinator. The disclosure shall be submitted by the NCI CIRB
Coordinator to the CIRB Conflict of Interest Subcommittee for a
determination prior to the CIRB meeting.
The COI Subcommittee will review all such disclosures and render a
decision regarding whether or not the disclosure constitutes a conflict of
interest. Members with conflicts under consideration by the COI
Subcommittee will not be named as primary reviewers.

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6.2.5

6.2.6

6.2.7

6.2.8

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The COI Subcommittee will present a written report of its review no later
than the beginning of such meeting where research in which the potential
conflict exists will be reviewed.
The CIRB must accept the determinations of the COI Subcommittee
unless the determination was not unanimous or if the member alleged to
have the conflict appeals the Subcommittee’s determination.
If a conflict or potential conflict affecting an item on the agenda for a
convened meeting is disclosed too late for Subcommittee consideration,
the issue shall be dealt with directly by the CIRB as a committee of the
whole.
If a potential conflict is disclosed by a member of the COI Subcommittee
and sent to the Subcommittee for review, the CIRB Coordinator shall
designate a CIRB member not so conflicted to replace the disclosing COI
Subcommittee member for the conflict determination.

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Attachment 3K – Notification of Selection to Serve on NCI CIRB
Dear

,

We are pleased to notify you of your appointment to the NCI CIRB!
John Horigan, NCI CIRB Administrator, will be contacting you within
the next 10 days to begin the orientation process. He will serve as
your primary contact during this process and will work with you to
complete all of the necessary documents and orientation activities.
We look forward to working with you.
Sincerely,
Jacquelyn L. Goldberg, J.D.
Head, Central IRB Initiative
National Cancer Institute, NIH
6130 Executive Boulevard Room 6102
Bethesda, MD 20892
goldberj@mail.nih.gov
ph 301-496-0510
fax 301-480-2642
www.ncicirb.org
cc:

NCI CIRB Project Officer
CIRB Administrator

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Attachment 3L – Notice of Rotation Off

Dear
We have begun the process of retiring members who approaching
completion of their tenure or have served beyond their tenure so that
new members have the chance to serve.
We do not have a precise date yet for your rotation off the Board. The
Operations Office is working with the new appointees to determine
dates, but I will get back to you once a date is established.
OR
Your last meeting will be
Thank you for your time and your contributions to the CIRB.
John Horigan
NCI CIRB Administrator
NCI CIRB Adult/Pediatric Chair
cc: Head, Central IRB Initiative

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Attachment 3M – Thank You to Retiring Members and
Acknowledgment of Resignation

Dear

,

On behalf of the NCI CIRB Initiative, we want to thank you for your
service and dedication to upholding high standards of human subjects
protections. It is the diligence of our Board members that makes it
possible for this Initiative to continue to accomplish its goals. It has
been a pleasure working with you and we wish you success in the
future.
Regards,
Jacquelyn L. Goldberg, J.D.
Head, Central IRB Initiative
NCI CIRB Adult/Pediatric Chair
cc: CIRB Administrator

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