Att 7 - IRB Approval Amendment

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service
Centers for Disease Control
and Prevention (CDC)

Memorandum
Date:
d
From:

August 6, 2010

Subject

CDC Protocol 5923.0, “Proposal for the State and Metropolitan Area-Based ALS Surveillance.“
(Expedited)

To:

d

Constance M. Bonds, MPA, CIP
IRB “A” Administrator, Human Research Protection Office

Oleg Muravov, MD, PhD
NCEH/ATSDR/DHS
CDC's IRB "A" has reviewed and approved the request to amend protocol 5923.0, “ Proposal for the State and
Metropolitan Area-Based ALS Surveillance.” These changes included:
Modification 1. Clarifications to protocol based on ATSDR mandated external peer review and correction
of typographical errors.
The action was reviewed in accordance with 45 CFR 46.110(b)(2), minor changes to previously approved research
during the period (of one year or less) for which approval is authorized.
Reminder: IRB approval of protocol # 5923.0, will still expire on 5/17/2011.
Any problems of a serious nature must be brought to the immediate attention of the CDC IRB, and any
proposed changes to the protocol should be submitted as an amendment to the protocol for CDC IRB
approval before they are implemented.

If you have any questions, please contact your National Center Human Subjects Contact or the CDC
Human Research Protection Office at (404) 639-4967 or by e-mail at cbonds@cdc.gov. .

cc:
NCEH Human Subjects