CDC Protocol#5923_ Amendment approval

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control

and Prevention (CDC)

M emorandum

Date

d

November 1, 2011

From

Jason Abel

IRB-A Administrator, Human Research Protection Office

Subject

IRB Approval of Amendment to CDC Protocol #5923.0, "Proposal for the State and Metropolitan Area-Based ALS Surveillance" (Expedited)

To

Oleg Muravov, MD, PhD

NCEH/ATSDR

CDC's IRB A has reviewed and approved your request to amend protocol #5923.0, “Proposal for the State and Metropolitan Area-Based ALS Surveillance.” This amendment adds Chicago, San Francisco, and Los Angeles to the state and metropolitan areas with active surveillance for ALS cases.

The action was reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b)(2), minor changes to previously approved research during the period of one year for which approval is authorized.

Reminder: IRB approval of protocol #5923.0 will still expire on 05/17/2012.

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 (404) 639-4721 or e-mail: [email protected].

cc:

NCEH/ATSDR Human Subjects (CDC)

-----