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:
huma@cdc.gov.
Felecia Peterson
cc:
Natalie Gilles
Robin
Ikeda
Laurie Reid
Jon Baio
| File Type | text/html |
| File Modified | 0000-00-00 |
| File Created | 0000-00-00 |