IRB determination

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Memorandum
Date
d
From

January 14, 2022

Subject

IRB Approval of Continuation of CDC Protocol #2087, "The National Birth Defects Prevention
Study" (Expedited)

To

ELIZABETH AILES, PhD, MPH
NCCBDDD/DBDDD

Jerrell Little
IRB Administrator
Human Research Protection Office

CDC's IRB-Committee 2 has reviewed and approved your request to continue protocol 2087 for
the maximum allowable period of one year and it will expire on 1/29/2023. The protocol was
reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b) (1),
categories 3, 5, and 7. Contact with participants has begun and continues.
If other institutions involved in this protocol are being awarded CDC funds through the CDC
Office Financial Resources (OFR), you are required to send a copy of this IRB approval to the
CDC OFR award specialist handling the award. You are also required to verify with the award
specialist that the awardee has provided OFR 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 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 1/29/2023.
Any problems of a serious nature must be brought to the immediate attention of the CDC
IRB, and any proposed changes to the protocol should 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 (404) 639-7570 or e-mail: huma@cdc.gov.
cc:
Scott Campbell MS