Attachment J-2
IRB Approval of
Continuation of Protocol
From: McCleary, Jennifer (CDC/OD/OCSO)
Sent: Thursday, August 06, 2009 7:35 AM
To: Ulin, Brigette F. (CDC/CCEHIP/NCIPC)
Cc: NCIPC Human Subjects (CDC); Redmond Leonard, Joan (CDC/CCHP/NCCDPHP); Youngblood, Laura (CDC/CCID/OD)
Subject: 5383: Site Restricted - IRB Approval of Continuation of Protocol (Expedited)
Importance: High
DATE: August 6, 2009
FROM: IRB-C Administrator
Human Research Protection Office
Office of Scientific Regulatory Services
Office of the Chief Science Officer, OD/CDC
SUBJECT: Site Restricted - IRB Approval of Continuation of Protocol 5383, "Choose Respect Initiative Concept and Message Testing" (Expedited)
TO: Brigette Ulin
NCIPC/DVP
CDC's IRB "C" has reviewed and approved your request to continue protocol #5383 for the maximum allowable period of one year and it will expire on 7/22/2010. The protocol was reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b)(1), Categories 6 and 7.
SITE RESTRICTION: Study activities may not begin/continue with the following collaborator/site until documentation indicating current IRB approval has been received by CDC’s Human Research Protection Office (HRPO) and the PI has been notified by HRPO that this restriction has been lifted and study activities may begin:
Ogilvy Public Relations Worldwide
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 7/22/2010.
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].
Jennifer McCleary
Cc:
Joan Redmond-Leonard
Laura Youngblood
| File Type | application/msword |
| Author | Nancy Accetta |
| Last Modified By | its7 |
| File Modified | 2010-05-21 |
| File Created | 2010-04-28 |