___________________________________
Renita
Macaluso
Paperwork Reduction Act clearance liaison
CDC/NCCDPHP/OD/OPEL
Email:
[email protected]
Telephone:
770.488.6458
Please
cc: internal NCCDPHP correspondence supporting the OMB clearance process
to
NCCD/COCHP/OMB Clearances (CDC),
and include the OMB control no.
0920-XXXX in the Subject line of the message.
DATE:
9/5/2008
FROM: IRB
Administrator
Human Research Protection
Office
Office of the Chief Science Officer, OD/CDC
SUBJECT:
Site-Restriction - IRB Approval of New Protocol #5439, "CDC's Cervical Cancer
Study (Cx3): An Intervention Pilot Study of HPV in Illinois NBCCEDP"
(Expedited)
TO: Vicki
Benard
[VDB9]
NCCDPHP/DCPC
New
protocol #5439 has been approved by CDC IRB "G" for the maximum allowable period
of one year and it will expire on 9/3/2009. The protocol was reviewed in
accordance with the expedited review process outlined in 45 CFR 46.110(b)(1),
categories (5) & (7).
Please Note: Study activities may not
begin with the following collaborator/sites until the following
documentation/information has been received and is on file with this
office:
1. Need current Local IRB Approval documentation for
Battelle Memorial Institute, Seattle, WA
2.
"
" Mercy Hospital, Chicago,
IL
3."
"St. Mary's Hospital, Centralia, IL - it is our understanding that St. Mary's
Hospital will be relying on Battelle
4.
"
"Rea Clinic, Christopher, IL - relying on Battelle
5.
" "VNA
of Fox, Aurora, IL - please ensure that VNA of Fox is added to HRSA assurance as
being authorized to rely on this IRB, if they are not under HRSA FWA number then
they need to apply for their own FWA number.
6. Need current Local
IRB Approval documentation for Lake County Hlth Dept, Waukegan, IL
7. Need
current Local IRB Approval documentation/information for Logan County Community
Hlth Improvement Ctr, Decatur, IL will be relying on Battelle Memorial
Institution. Please also ensure that the following institutions that's
relying on Battelle is added to their assurance as being authorized to rely on
their
IRB.
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 9/3/2009.
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:
[email protected].
Felecia Peterson
cc:
Joan
Redmond-Leonard
Sharon Bloom
Jon
Baio
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