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