Att 8_IRB

From:
Sent:
To:
Cc:
Subject:

McCleary, Jennifer (CDC/OD/OCSO)
Monday, September 28, 2009 1:36 PM
Thomas, Cheryll C. (CDC/CCHP/NCCDPHP)
Redmond Leonard, Joan (CDC/CCHP/NCCDPHP); Sandul, Amy
(CDC/CCID/NCHHSTP)
2594: IRB Approval of Continuation of Protocol (Expedited)

Importance:

High

DATE:

9/28/2009

FROM:

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

SUBJECT:
IRB Approval of Continuation of Protocol #2594, "National
Program of Cancer Registries - Cancer Surveillance System (NPCR-CSS)"
(Expedited)
TO:

CHERYLL Thomas
NCCDPHP/DCPC

CDC's IRB "C" has reviewed and approved your request to continue
protocol #2594 for the maximum allowable period of one year and it will
expire on 10/20/2010. The protocol was reviewed in accordance with the
expedited review process outlined in 45 CFR 46.110(b)(1), Category 5.
It is noted that the study does not involve contact with subjects.
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 10/20/2010.
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 the Human Research Protection
Office at (404) 639-4721 or e-mail: huma@cdc.gov.

Jennifer McCleary, BA, CIP
cc:
Joan Redmond-Leonard
Amy Sandul