Appendix_I CDC IRB Approval

DATE:

3/16/2009

FROM:

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

SUBJECT:
Extension of IRB Approval for Continuation of Protocol
#4169, "Study to Explore Early Development (SEED) (formerly CADDRE)"
(Expedited)
TO:

Diana Schendel, PhD
NCBDDD/DBDDD

[DCS6]

CDC's IRB "C" has completed the review of the continuation and has
approved your request to continue protocol #4169. Approval of #4169
has been extended to the maximum allowable period of one year and it
will now expire on 2/18/2010. The protocol was reviewed in accordance
with the expedited review process outlined in 45 CFR 46.110(b)(1),
Categories 3, 5 and 7.
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 along with available IRB approvals from all collaborators.
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 along with all completed supporting documentation
at least six weeks before the protocol's expiration date of 2/18/2010.
Any problems of a serious nature must 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
cc:
NCBDDD Human Subjects Review
Marques Harvey