From: Macaluso, Renita (CDC/CCHP/NCCDPHP) (CTR)
Sent: Tuesday, February 17, 2009 12:39 PM
To: Sims, Thelma (CDC/OD/OCSO)
Cc: OMB Clearance (CDC); NCCD/COCHP/OMB Clearances (CDC); Benard, Vicki (CDC/CCHP/NCCDPHP)
Subject: FW: 5439: Site-Restriction - IRB Approval of New Protocol , (Expedited)

Follow Up Flag: Follow up
Flag Status: Completed
Enclosed is the documentation relating to finalization of IRB approval.  The site restrictions have been lifted.
Thank you and please let me know if you need anything else related to the IRB approval.

___________________________________
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.


From: Peterson, Felecia (CDC/OD/OCSO)
Sent: Friday, February 06, 2009 5:13 PM
To: Benard, Vicki (CDC/CCHP/NCCDPHP)
Cc: Macaluso, Renita (CDC/CCHP/NCCDPHP) (CTR); Peterson, Felecia (CDC/OD/OCSO)
Subject: RE: 5439: Site-Restriction - IRB Approval of New Protocol , (Expedited)

Hi Vicki,
 
Thanks for sending me the local IRB approval/authorization agreements; I have updated our database system to reflect this information.  The site-restriction has been lifted and the participating collaborators can proceed with the study activities now. 
 
Felecia D. Peterson
IRB Administrator/Program Specialist
Centers for Disease Control and Prevention
Office of the Chief Science Officer
Human Research Protection Office
1600 Clifton Road, N.E. - Mailstop D73
Atlanta, Georgia 30333
Phone: (404) 639-4961
Fax: (404) 639-4901
E-mail: [email protected]
 


From: Benard, Vicki (CDC/CCHP/NCCDPHP)
Sent: Friday, February 06, 2009 3:50 PM
To: Peterson, Felecia (CDC/OD/OCSO)
Cc: Benard, Vicki (CDC/CCHP/NCCDPHP); Macaluso, Renita (CDC/CCHP/NCCDPHP) (CTR)
Subject: RE: 5439: Site-Restriction - IRB Approval of New Protocol , (Expedited)

Felecia -
Here are the attachments requested below:
5 sites are deferring to Battelle
Battelle and Mercy Hospital have their own IRB letters attached.
1. Need current Local IRB Approval documentation for Battelle Memorial Institute, Seattle, WA -
Titled: Battelle IRB.pdf
2. "                                                                                          " Mercy Hospital, Chicago, IL
Titled: MercyFax.pdf
3."
                                                                                            "St. Mary's Hospital, Centralia, IL - it is our understanding that St. Mary's Hospital will be relying on Battelle
Titled: St. Mary.pdf
4. "                                                                                           "Rea Clinic, Christopher, IL - relying on Battelle
Titled: Rea and Logan.pdf
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.
Yes, under HRSA and deferring to Battelle
Titled: VNA.pdf
6.
 Need current Local IRB Approval documentation for Lake County Hlth Dept, Waukegan, IL
- Lake is also deferring to Battelle
Titled: Lake.pdf
7.
Need current Local IRB Approval documentation/information for Logan County Community Hlth Improvement Ctr,  Decatur, IL will be relying on Battelle Memorial Institution.
Titled: Logan.pdf (this is same as Rea and Logan, they are both on one attachment)
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
All letters have been signed deferring to Battelle IRB as indicated.
 
I will be working until 7 pm tonight, please let me know if you need anything in addition to this.
Thanks,
Vicki
 


From: Peterson, Felecia (CDC/OD/OCSO)
Sent: Friday, September 05, 2008 9:30 AM
To: Benard, Vicki (CDC/CCHP/NCCDPHP)
Cc: Redmond-Leonard, Joan A. (CDC/CCHP/NCCDPHP); Bloom, Sharon (CDC/CCID/NCHHSTP); Baio, Jon (CDC/CCHP/NCBDDD)
Subject: 5439: Site-Restriction - IRB Approval of New Protocol , (Expedited)

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