Att 6 - IRB Approval

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Memorandum
DATE:

5/18/2010

FROM:

IRB Administrator
Human Research Protection Office
Office of Scientific Integrity
Office of the Associate Director for Science

SUBJECT:

CDC Approval of New Protocol 5923.0, “Proposal for the State and Metropolitan AreaBased ALS Surveillance.“ (Expedited)

TO:

Oleg Muravov, MD, PhD
NCEH/ATSDR/DHS/SRB

CDC's IRB 'A” has reviewed the request for approval of new protocol #5923.0,“ Proposal for the State and
Metropolitan Area-Based ALS Surveillance,“ and has approved the protocol for the maximum allowable
period of one year. CDC IRB approval will expire on 5/17/2011. The protocol was reviewed in accordance
with the expedited review process outlined in 45 CFR 46.110(b)(1), category(5).
If other institutions involved in this protocol are being awarded CDC funds through the CDC Procurement
and Grants Office (PGO), you are required to send a copy of this IRB approval to the CDC PGO award
specialist handling the award. You are also required to verify with the award specialist that the awardee
has provided PGO with the required documentation and has approval to begin or continue research
involving human subjects as described in this protocol.
As a reminder, the IRB must review and approve all human subjects research protocols at intervals
appropriate to the degree of risk, but not less than once per year. There is no grace period beyond one
year from the last IRB approval date. It is ultimately your responsibility to submit your research protocol
for continuation review and approval by the IRB. Please keep this approval in your protocol file as proof of
IRB approval and as a reminder of the expiration date. To avoid lapses in approval of your research and
the possible suspension of subject enrollment and/or termination of the protocol, please submit your
continuation request at least six weeks before the protocol's expiration date of 5/17/2011.
Any problems of a serious nature should be brought to the immediate attention of the IRB, and any
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 your National Center Human Subjects Contact or the CDC
Human Research Protection Office at (404) 639-4967or by e-mail at [email protected]).

Constance M. Bonds, MPA, CIP
IRB Administrator
Centers for Disease Control and Prevention
cc:
NCEH Human Studies Review