Appendix L CDC IRB Approval for Focus Groups 11-5-06

Appendix
From: Honein, Margaret
Sent: Sunday, November
To: Ruuska, Sarah
Subject: Fw: 2087: IRB

L CDC IRB Approval Leeter for Focus Groups.txt
(Peggy)
06, 2005 10:05 AM
Approval of Amendment

-------------------------Sent from my BlackBerry Wireless Handheld
-----Original Message----From: Galusha, Pamela
To: Honein, Margaret (Peggy)
CC: NCBDDD Human Subjects Review ; Merritt, Robert
Sent: Sat Nov 05 13:29:43 2005
Subject: 2087: IRB Approval of Amendment
DATE:

11/5/2005

FROM:

IRB Administrator
Human Research Protection Office
Office of Scientific Regulatory Services
Office of the Chief Science Officer, OD/CDC

SUBJECT:
IRB Approval of Amendment to Protocol #2087, "The National Birth Defects
Prevention Study" (Expedited)
TO:

Margaret Honein, PhD, MPH
NCBDDD

[MRH7]

CDC's IRB B has reviewed and approved your request to amend protocol #2087 by adding
a genetic testing fact sheet, adding a partial ID to the informed consent documents
in the cheek cell collection kits, to add candidate genes to the study, to delete
Emory University as a collaborator, and to add Biologics Focus Groups. The action
was reviewed using the expedited review process outlined in 45 CFR 46.110(b)(2),
"Minor changes in previously reviewed research during the period (of one year or
less) for which approval is authorized."
Reminder: IRB approval of protocol #2087 will still expire on 2/17/2006. Any
problems of a serious nature should be brought to the immediate attention of the
IRB, and any other proposed changes to the protocol should be submitted as an
amendment to the protocol for IRB approval before they are implemented.
If you have any questions, please contact the Human Research Protection Office at
(404) 639-4721 or e-mail: huma@cdc.gov.

Pam Galusha
cc:
NCBDDD HSR
Rob Merritt

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