NCS Pilot-Westat IRB Approval Ltr

Appendix C

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Office of the Clinical Director
National Institute of Child Health
and Human Development
CRC; Room 5-2571
10 Center Drive MSC 1832
Bethesda, Maryland 20892-1832
FAX: 301 402-1073

MEMORANDUM
DATE: June 26, 2008
Peter Scheidt, M.D., MPH

TO:

FROM: Gilman Grave, MD
Through: Stephen G. Kaler, MD MPH
Clinical Director, NICHD
SUBJECT:

Disposition from 06/25/08 NICHD Institutional
Review Board Meeting

Below please find the disposition concerning the review of your protocol considered this
week by the IRB. Thank you very much for submitting this interesting study.
NEW PROTOCOL
National Children’s Study (The findings of the National Academy of Science
Review, and the response to those findings.)
Principal Investigator: Peter Scheidt
Protocol Title: The National Children’s Study – Pilot protocol.
Protocol number: New Application
Discussion and Disposition: The Board was favorably inclined in its
consideration of the National Children’s Study. However, it was understood that
the final protocol and consent procedures were not yet finalized. Therefore, the
Board agreed to table consideration of the protocol pending receipt of the updated
protocol, consent form and the script for the consent video. The vote was 6 in
favor, 1 opposed (the member preferred to defer consideration of the protocol
without a formal vote).
Recommendations:
1.
2.

Provide updated protocol, consent form and script of consent video.
Highlight changes
Provide list of DSMB members (including affiliations) for IRB review and

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3.
4.
5.
6.

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approval.
Provide a list of ongoing study working group members and affiliations
Provide an update to the IRB on at least a biannual basis.
Provide a plan for addressing health disparities noted in the IOM Report.
Provide a summary of the public comments received on the protocol.

THIS PROTOCOL EXPIRES JUNE 24, 2009

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Appendix C

C.12–3

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.

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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

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Appendix C

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TO:

Elaine Eaker and Paul Hurwitz

FROM:

Kerry Levin
Acting Chair, Institutional Review Board

February 11, 2008

SUBJECT:

ADDENDUM to approval letter dated 01-29-08 (CORRECTED)
National Children Study
Contract No. HHSN275200503395C
Project 8208
FWA5551
_____________________________________________________________________________________

On January 29, 2008, the Westat Institutional Review Board (IRB) assigned full approval of the
following: National Children’s Study (NCS), Contract No. HHSN275200503395C, Project 8208. The
approval covered 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.
Because this study presents no greater than minimal risk, requests for five waivers of informed
consent were granted by the board. The first three requests described below are waivers for
documentation of informed consent. The remaining two requests are waivers to allow signed informed
consent from only one parent or guardian since the IRB determined that permission of one parent was
sufficient. However, while discussed at the board meeting, explicit descriptions of each waiver were
inadvertently omitted from the approval letter. Therefore, each waiver is listed below:
1.

A waiver of the requirement for documentation of informed consent (obtaining a signed
consent form) for the enumeration stage. This step is designed to locate households
containing potentially eligible women for the Study. IRB regulations permit waiver of
documentation of informed consent when the research presents no more than minimal risk
[45 CFR pt. 46.116 (d) 46.117 (c) (2)].

2.

A waiver of the requirement for documentation of informed consent (obtaining a signed
consent form) for the screening stage. This step is only designed to determine the
eligibility of women for the study. The vast majority of women will not be eligible for the
study. IRB regulations permit waiver of documentation of informed consent when the
research presents no more than minimal risk [45 CFR pt. 46. 116 (d) 46.117 (c) (2)].

3.

A waiver of the requirement to obtain a signed consent form for each specific study visit
after enrollment. The project will obtain signed informed consent at enrollment, using

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either the video or the paper form, for eligible participants who choose to join the study.
IRB regulations permit waiver of documentation of informed consent when the research
presents no more than minimal risk and participants are provided with written information
regarding the research[45 CFR pt. 46. 116 (d) 46.117 (c)(2)].

4.

A waiver for both parents of the unborn child to sign the consent form for enrollment of
pregnant women and their unborn children into the study. 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.

5.

A waiver for both parents of pregnant minors to sign the consent form for enrollment of
pregnant minors into the study as long as it does not conflict with local jurisdiction
requirements. 45 CFR Part 46, Subpart D provides for "Additional Protections for Children
Involved as Subjects of Research." The requirement for parental permission may be inappropriate
in some cases. Examples include research involving older adolescents who, under applicable law,
may consent on their own behalf . The Coordinating Center will prepare procedures to be used

when the pregnant minor is legally allowed to provide consent, and when she is not. Each
Study Center will be responsible for adherence to their local jurisdictional requirements
regarding the consent and enrollment of the pregnant minor.

Note: All information included in the approval letter date January 29th, 2008 remains unchanged.

cc:

Institutional Review Board

Revised August 28, 2008