Att 8 - IRB Approval

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Memorandum

Date
d
From

September 9, 2010

LaShonda Roberson, MPH
LT, USPHS
IRB-B Administrator
Human Research Protection Office

Subject

CDC Approval of New Protocol 5994.0, "Behavioral Assessment Component of the
Behavioral Assessment and Rapid Testing Project" (Expedited)

To

Peter Thomas, PhD, MPH
NCHHSTP/DHAP-SE
CDC's IRBB has reviewed the request for approval of new protocol 5994.0, "Behavioral Assessment
Component of the Behavioral Assessment and Rapid Testing Project," and has approved the
protocol for the maximum allowable period of one year. CDC IRB approval will expire on 9/7/2011. The
protocol was reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b)(1),
categories 4 and 7.
The IRB determined that the study poses minimal risk to subjects. Pregnant women and fetuses are
allowed. Waiver of documentation of informed consent for adults is approved.
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 9/7/2011.
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 email at huma@cdc.gov).

CC:
NCHHSTP Human Subjects