SIS_CGIRB_CR_Approval_20120927_Att9

SISOMB2012 ATTACHMENT 9: CGIRB CR
Signature Page
Title

SSS1-06-402_Sandler_Dale_P._Approvals_2012-09-27

Summary Sandler Dale P.
Signed By:

Reason:

Date/Time:

Melody Sawyer

Authorized Signature

September 28, 2012 9:43:00 AM EDT

September 28, 2012

Dale P. Sandler PhD
National Institute of Environmental Health Sciences (NIEHS)
111 T W Alexander Drive MSC A3-05
Research Triangle Park, NC 27709
Re:

Protocol #: 02-E-N271
IRB Tracking #: SSS1-06-402

Dear Dr. Sandler,
Enclosed please find an Approval Notice dated September 27, 2012 for the above- mentioned protocol.
This is to inform you that the Copernicus Group IRB has approved the above-referenced study for
another year. Please continue to use the latest IRB approved Site-Specific Subject Information and
Consent Form(s). Note that any changes in the study must be communicated to the Copernicus Group
IRB.
If you have any questions regarding the contents of this letter or your working relationship with
Copernicus Group IRB, please do not hesitate to call us at 1-888-303-2224 or email us at
[email protected]. To avoid delay in locating your records we ask that you refer to the IRB Tracking
number located in the header of this letter. Send faxes for this project to 1-919-654-7197.
Copernicus Group IRB
cc: Elizabeth Long O'Connell, Social And Scientific Systems (Email)
Polly Armsby, Social And Scientific Systems (Email)

Copernicus Group IRB
One Triangle Drive Suite 100
Durham, NC 27713
M ailing Address:
P.O. Box 110605
Research Triangle Park, NC 27709

Experience and Innovation in Ethical Review ™

Telephone:
Toll-Free:
Fax:
E-M ail:
Web:

919-465-4310
888-303-2224
919-465-4311
[email protected]
www.cgirb.com

Confidentiality Notice: This document is for the sole use of the intended recipient(s) and may contain confidential and privileged information.
Any unauthorized review, use, disclosure or distribution is prohibited.
If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.

IRB APPROVAL DATED:
September 27, 2012
STUDY EXPIRATION DATE: September 26, 2013
Protocol #: 02-E-N271
Investigator: Dale P. Sandler PhD
Approval Includes:
Re-Approval of Study

Investigator Address: Dale P. Sandler PhD
National Institute of Environmental Health Sciences (NIEHS)
111 T W Alexander Drive MSC A3-05
Research Triangle Park, NC 27709
Sponsor:

NIEHS

CRO:

Social and Scientific Systems

Protocol Title:

The Sister Study: Environmental and Genetic Risk factors for Breast Cancer

Approval is granted subject to the following considerations:
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Responsibilities of the Principal Investigator as found in the Investigator Guidebook
In the event that non-English speaking subjects are recruited, a cert ified translation
of the informed consent must be approved by the IRB befo re recruit ment.
If subjects who cannot read are recru ited, there should be an imp artial witness to attest to the
adequacy of the consent process and to the subject's voluntary agreement to be in the study. This
witness should also verify the subject's signature or mark on the consent form.
Please note that if revisions are required for any approved item (part icularly advertisements), they
must be approved prior to use.
If pediatric subjects are to be enrolled then they should be re-consented when they become of legal age.
Please note that CGIRB requires the reporting of any unanticipat ed problems involving risks to subjects
or others as soon as possible, but in all cases within 10 business days in accordance with the applicable
regulatory standards and CGIRB requirements.

IF YOU HAVE ANY QUESTIONS, CALL COPERNICUS GROUP IRB AT 1-888-303-2224
This signature certifies that the information contained in this IRB Approval Notice is true and correct as verified by the
minutes and records of The Copernicus Group, Inc. It also certifies that The Copernicus Group, Inc. is in full co mpliance
with FDA Code of Federal Regulat ions (21 CFR Parts 50, 56, 312, and 812 and 45 CFR) and ICH Gu idelines.
Signature

See appended electronic signature page
Authorized Signature

Copernicus Group IRB
One Triangle Drive Suite 100
Durham, NC 27713
M ailing Address:
P.O. Box 110605
Research Triangle Park, NC 27709

IRB TRACKING # SSS1-06-402

Experience and Innovation in Ethical Review ™

Telephone:
Toll-Free:
Fax:
E-M ail:
Web:

919-465-4310
888-303-2224
919-465-4311
[email protected]
www.cgirb.com

Confidentiality Notice: This document is for the sole use of the intended recipient(s) and may contain confidential and privileged information.
Any unauthorized review, use, disclosure or distribution is prohibited.
If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.