IRB approval

DD

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Centers for Disease Control

and Prevention (CDC) ______________________________________________________________________

Memorandum

DATE: December 8, 2009

FROM: IRB G Administrator

Human Research Protection Office

Office of Scientific Regulatory Services

Office of the Chief Science Officer, OD/CDC

SUBJECT: IRB Approval of Continuation of Protocol #4443, "Cigarette Yield and Body Burden of Smoke Toxins (Human Smoking Behavior Study)”, (Expedited)

TO: Patricia Richter

NCCDPHP/OSH

CDC's IRB G has reviewed and approved the request to continue protocol #4443, "Cigarette Yield and Body Burden of Smoke Toxins (Human Smoking Behavior Study)”, for the maximum allowable period of one year. CDC IRB approval will expire on 12/8/2010. The continuation action was reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b)(1), category (3).

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 12/8/2010.

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 your National Center Human Subjects Contact or the CDC Human Research Protection Office at (404) 639-4721 or e-mail: [email protected].

Felecia Peterson

cc:

Joan Redmond-Leonard

Jacquie Bertrand

Jon Baio