DATE:       1/17/2008

FROM:       IRB Administrator
                   Human Research Protection Office
                   Office of the Chief Science Officer, OD/CDC

SUBJECT:    IRB Approval of New Protocol #5322, "The Effectiveness of Teen Safe Driving Messages and Creative Elements on Parents and Teens" (Expedited)

TO:         MICHELE HUITRIC    [AOI1]
                NCIPC/

New protocol #5322 has been approved by CDC IRB "G" for the maximum allowable period of one year and it will expire on 1/16/2009.  The protocol was reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b)(1), category (7).

Please Note: The IRB recommend approval of the protocol pending one clarification: for the focus group participants, it is recommended to include a link to a hotline or have a mental health counselor on sight. The primary reviewer was unable to locate any such plan in the protocol.  The suggestion is based on the following focus group questions which may evoke a charged emotional response:

    1.  Parent focus group: "Have any of your children been involved in any type of car collision? Did they ever hit anything?" "Please describe the circumstances."
    2.  Teen focus group: "Have you ever been involved in any type of car collision (did you ever hit anything?)" "Please describe the circumstances."  

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 1/16/2009.

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:
Natalie Gilles
Robin Ikeda
Laurie Reid
Jon Baio