CDC IRB Approval Letter

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Memorandum
Date

December 11, 2017

From

Clarietha T. Washington
IRB Administrator, Human Research Protection Office

Subject

CDC IRB Approval of Continuation of Protocol #6949.0, “Monitoring and Evaluation Protocol
for the Zika Contraception Access Network (Z-CAN)” (Expedited)

To

Maura Whiteman, PhD, BS
CCHP/NCCDPHP/DRH
CDC's IRB "C” has reviewed and approved the request to continue protocol “6949.0,
“Monitoring and Evaluation Protocol for the Zika Contraception Access Network (Z-CAN)”, for
the maximum allowable period of one year. CDC IRB approval will expire on 12/22/2018. The
continuation action was reviewed in accordance with the expedited review process outlined in 45
CFR 46.110(b)(1), categories 7.
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 along with
available IRB approvals from all collaborators. 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 along with all completed supporting
documentation at least six weeks before the protocol's expiration date of Error! Reference
source not found.8.
Any problems of a serious nature must be brought to the immediate attention of the CDC
IRB, and any proposed changes to the protocol are required to be submitted as an
amendment to the protocol for CDC 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) 639-7570 or e-mail: huma@cdc.gov.
cc: Joan Redmond Leonard
Nicole (Nicky) Cohen