From: Zhang, Ping (CDC/CCHP/NCCDPHP)
Sent: Wednesday, March 28, 2007 12:11 PM
To: Sims, Thelma (CDC/CCHP/NCCDPHP)
Subject: FW: 4825: IRB Approval of Continuation of Protocol , (Expedited)
______________________________________________
From: Peterson, Felecia (CDC/OD/OCSO)
Sent: Wednesday, March 21, 2007 2:26 PM
To: Zhang, Ping (CDC/CCHP/NCCDPHP)
Cc: Redmond-Leonard, Joan A. (CDC/CCHP/NCCDPHP); Thomas, Darlene (CDC/CCHP/NCCDPHP); Woollery, Trevor (CDC/OD/OCSO); Lawton, Kay E. (CDC/CCID/NCZVED)
Subject: 4825: IRB Approval of Continuation of Protocol , (Expedited)
DATE: 3/21/2007
FROM: IRB Administrator
Human Research Protection Office
Office of the Chief Science Officer, OD/CDC
SUBJECT: IRB Approval of Continuation of Protocol #4825, "Assessing Diabetes Detection Initiative for Policy Decisions" (Expedited)
TO: Ping zhang [PAZ2]
NCCDPHP/DDT
CDC's IRB "G" has reviewed and approved your request to continue protocol #4825 for the maximum allowable period of one year and it will expire on 3/8/2008. The protocol was reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b)(1), Category (7).
Please Note: A request for waiver of documentation of informed consent for the Local Implementation Team (LIT) and Clinical Leadership surveys was reviewed in accordance with 45 CFR 46.117 ©. This request is hereby approved in accordance with 46.117 ©(1), considering the IRB find the request reasonable since no sensitive or personal identying information will be associated with the surveys--each survey will be assigned a unique study identification number and the local implementation team and clinic leadership survey participants will encounter very little risk as a result of being in the study. The survey asks for no personal information of the respondent and only collects general information about costs and staff hours associated with the implementation of the DDI in their region or clinic.
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 3/8/2008.
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.
Felecia Peterson
cc:
Joan Redmond-Leonard
Darlene Thomas
Trevor Woollery
Kay Lawton
| File Type | application/msword |
| File Title | From: |
| Author | Battelle |
| Last Modified By | Battelle |
| File Modified | 2007-12-20 |
| File Created | 2007-12-20 |