NCS Pilot - Westat IRB Approval Ltr - 2008-01-29

TO:

Elaine Eaker and Paul Hurwitz

FROM:

Kerry Levin
Acting Chair, Institutional Review Board

January 29, 2008

SUBJECT:

IRB Review and Approval
National Children Study
Contract No. HHSN275200503395C
Project 8208
FWA5551
_____________________________________________________________________________________

On January 8, 2008, the Westat Institutional Review Board (IRB) conducted its review of the
following: National Children’s Study (NCS), Contract No. HHSN275200503395C, Project 8208. This
review covers all procedures before and during the mother’s pregnancy through the birth visit and the one
month visit. Data collection activities with the mother, father and child after the one month visit will be
presented and addressed at a subsequent IRB meeting. Westat’s IRB reviews all studies involving human
research before activities may begin under 45 CFR pt 46.
Due to the complexity of the study, project staff organized several informational steps to help
familiarize the Board with the goals and objectives of the study prior to a voting decision. First, an
informational session during the December 11th IRB meeting was held. During this meeting, project staff
provided the Board with an overview of the project and presented a sample of the video consent process.
Following this session, the IRB Board Chair circulated a series of questions from Board members to
project staff. The final review of study materials and procedures took place during the January Board
meeting which was also included a discussion of the answers provided to all of the questions and requests
for further clarification regarding answers to some questions.
Following the January Board meeting, additional information was submitted by the NCS project
staff to supplement answers to questions which had been submitted previously. These answers now
appear in the final record and are included as an attachment to the study protocol. Some of the answers
will require modification to the study protocol at a future time. It is anticipated that a copy of the revised
protocol reflecting the answers to questions will be sent to this IRB for the record.
Lastly, even if the protocol does not change, if Westat’s role with regard to data collection should
change, those aspects of the study must be reviewed by the Westat IRB.
The Board determined that NCS presents no greater than minimal risk to the pregnant woman and
their unborn children. It was also determined that the number of ultrasounds being conducted does not
place the women or child at increased risk, based on documentation provided to the Board.

Because this study presents no greater than minimal risk, the Board waives the requirement for the
father’s consent for the child or unborn fetus [45 CFR 46.116 of Subpart A and 46.408 (b)]. The father
however, will be required to provide written consent for his own participation in the study. In addition, a
waiver for permission from both parents has been granted for emancipated pregnant minors as long as it
does not conflict with local jurisdiction requirements. Each Study Center will be responsible for
adherence to their local jurisdictional requirements regarding the consent and enrollment of pregnant
minors. The Coordinating Center will prepare procedures to be used when the pregnant minor is legally
allowed to provide consent, and when she is not, and the Study Centers will be required to adhere to their
local laws.
Based upon this approval, the project must submit a Certificate of Confidentiality to the IRB as
soon as it is received; no reference to the Certificate may be made to the women whose consent for
enrollment is sought until the Certificate is obtained.
It is understood that no data collection will begin until approval of the study by the NICHD IRB.
In addition, no data collection will begin at any study center site until the approval of the study, including
all activities of the study center and their subcontractor or organizations, by that Center’s IRB. It is
anticipated that the NICHD agency IRB will serve as the central NCS IRB to review any protocol
changes from the package approved here by the Westat IRB. Any such approvals of changes made by the
NICHD IRB will be transmitted to the Westat IRB for our records and use in oversight of Westat’s
Coordinating Center activities.
In accordance with 45 CFR 46, the Board unanimously approved this study for the phases
submitted, which includes procedures before and during the pregnancy of the mother, up to the birth of
the child.
You are obligated to submit the study for an annual review on or before January 29, 2009. In the
interim, you are responsible for notifying the Office of Research Administration as soon as possible if
there are any injuries to the subjects, problems with the study, or changes to the study design that relate to
human subjects.

cc:

Institutional Review Board