C.2 LOI2-BIO-24 Exemplar Consent Form

C.2 LOI2-BIO-24 Examplar Consent Form

OMB #: 0925-0647
Expiration Date: 01/31/2015

UNIVERSITY OF WISCONSIN-MADISON
Research Participant Information and Consent Form
Title of the Study: Contributions of the Maternal-Fetal and Microbiome Interactions and
Circulating Fetal DNA from Maternal Plasma and Cervical and Vaginal Fluid
Principal Investigator: Maureen Durkin, PhD, Dr PH (phone: 608-263-7507)
DESCRIPTION OF THE RESEARCH
You are invited to participate in a research sub-study to the National Children’s Study about the
genetic information such as DNA that is present in women during pregnancy and in babies
during the prenatal period and soon after birth.
You have been asked to participate because you are participating in the Vanguard Phase of the
National Children's Study.
The purposes of the research are to learn how early in pregnancy it is possible to find genetic
information about babies from a pregnant woman’s blood, and to better understand how to
measure genetic information about the many normal bacteria and other small organisms that
are present in the bodies of both women during pregnancy and their newborn babies over time.
This study will include approximately 100 pregnant women or women trying to conceive from
Waukesha County who are participating in the Vanguard Phase of the National Children's Study
and the babies resulting from these pregnancies.
In addition to the samples obtained at regularly scheduled National Children’s Study visits in
your home or at our clinic, we will schedule one visit for you with a nurse practitioner at
Waukesha Memorial Hospital, up to 2 visits in your home or the Wisconsin Study Center for
blood draws, and two visits in your home after your baby’s birth to collect saliva and stool
samples.
WHAT WILL MY PARTICIPATION INVOLVE?
If you decide to participate in this sub-study, you will be asked to contribute the following kinds
of samples that are in additional to the 2 blood samples from you and the cord blood sample
being collected for the larger National Children’s Study:
1. Blood samples from you at up to two additional time points [1 during pregnancy & 1 after
the birth). This can be performed in either your home or at the Wisconsin Study Center
office. We will draw up to 20 ml blood (4 teaspoons) at each draw.
Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing
the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden
estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project
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Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0647). Do not return the
University
of
Wisconsin
IRB
Protocol
Number
M-2011-0649,
11/21/2011
V3
completed form to this address.

NCS Fetal DNA/Microbiome Sub-study Consent

IRB Approval Date: 10/10/2011
Date IRB Approval Expires: 10/9/2012
FWA00005399 MR IRB
University of Wisconsin – Madison

2. Fluid and cells from inside your vagina. This will require you to visit Waukesha Memorial
Hospital during the third trimester of your pregnancy where a trained nurse-practitioner
will examine your vagina and cervix and collect the samples.
3. Saliva/buccal (cells from the inside of the cheek) swab collected from the mouth of your
child, with a cotton swab, after birth only if we are unable to collect cord blood at
delivery. As part of the NCS, you already gave us permission to collect umbilical cord
blood after your infant is born. We would like to analyze some of the cord blood
specifically for this sub-study. It would not require any additional procedures.
4. Placenta surface culture or swab after it has been delivered.
5. Stool samples from your child‘s diaper at three time points: soon after birth, 1 month and
6 months. Your participation in this sub-study will require a total of up to two hours and
twenty minutes of your time, in addition to travel time for one visit to Waukesha Memorial
Hospital. There will be a total of five data collection sessions, and each one will take
between 15 and 30 minutes.
ARE THERE ANY RISKS TO ME?
There is a small risk of bruising or discomfort from a blood draw.
Some subjects may experience embarrassment and/or physical discomfort at having the vaginal
exam.
There is a small risk that some information could be disclosed to someone outside of the project
or that, at some point, information stored in the controlled access databases could in some way
be linked back to a specific subject.
Since we are collecting genetic information, you should be aware that despite the recent
passage of a federal law that bars genetic discrimination in employment and some types of
insurance, the use by others of genetic information from the study of the samples we collect
could possibly impact you negatively in some way. For example, there is a very small risk that
genetic information obtained by this study could be used by law enforcement officials to try to
learn more about your or your family members for the purpose of a criminal investigation. To
minimize this risk, all samples will be labeled with Study codes and will be stored and
transported securely. All identifying information associated with the samples will be kept
separate and securely at the Study office.
The intent of this study is not to discover anything unrelated to the study purpose. However, we
want all participants who agree to home visits to know that if concerns about a problem that
could result in serious harm to you or another individual (e.g., abuse, neglect, domestic
violence) are identified at the visit we would report concern to the senior member of this
research study (Dr. Maureen Durkin) and the Institutional Review Board overseeing this study.
Additionally, certain field staff members are mandatory reporters of child abuse and neglect and
are required by law to report any suspected child abuse and neglect to the proper authorities.
This is the one instance where we may not be able to keep information about you that we
collected for the research study confidential.

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University of Wisconsin IRB Protocol Number M-2011-0649, 11/21/2011 V3
NCS Fetal DNA/Microbiome Sub-study Consent
IRB Approval Date: 10/10/2011
Date IRB Approval Expires: 10/9/2012
FWA00005399 MR IRB
University of Wisconsin – Madison

In the event that you are physically injured as a result of participating in this research,
emergency care will be available. You will, however, be responsible for the charges for the
emergency care. There is no commitment to provide any compensation for research-related
injury. You should realize, however, that you have not released this institution from liability for
negligence. Please contact the investigator, Maureen Durkin at 608-263-7507 if you are injured
or for further information.
ARE THERE ANY BENEFITS TO ME?
We don't expect any direct benefits to you or your child from participation in this study. The
information you provide will help scientists to develop methods that can be used to discover
things affecting children’s health beginning in the prenatal period and continuing after birth.
WILL I BE COMPENSATED FOR MY PARTICIPATION?
You will receive $50 for your participation in the vaginal sampling and $25 for any blood
collected independent of the Vanguard Phase of the NCS. We will also reimburse you mileage
for travel to and from the Study Center and/or Waukesha Memorial Hospital at $0.485/mile and
childcare expenses will be reimbursed at $7.00 for each hour if needed.
HOW WILL MY CONFIDENTIALITY BE PROTECTED?
Identifiable information about you and your child will not be shared outside the study. The
information gathered about you and your child will be protected with safeguards that protect all
of your information within the NCS. This includes use of participant number codes to separate
your identity from the data collected and written statements from all study personnel promising
to keep your information confidential. Only coded data will be shared with research partners at
the Medical College of Wisconsin, the University of Pittsburg, Yale University, University of
California-Irvine, and Baylor College of Medicine. If information about this study is published,
your name will not be used. Only group characteristics will be published.

WHOM SHOULD I CONTACT IF I HAVE QUESTIONS?
You may ask any questions about the research at any time. If you have questions about the
research after you leave today you should contact the Principal Investigator Maureen Durkin,
PhD, Dr PH at 608-263-7507.
If you are not satisfied with response of research team, have more questions, or want to talk
with someone about your rights as a research participant, contact the UWHC Patient Relations
Representative at 608-263-8009 or University of Wisconsin Medical Foundation Patient
Relations Representative at 800-552-4255 or 608-821-4819.
Your participation is completely voluntary. If you decide not to participate or to withdraw from the
study it will have no effect on any services or treatment you are currently receiving.

Page 3 of 4
University of Wisconsin IRB Protocol Number M-2011-0649, 11/21/2011 V3
NCS Fetal DNA/Microbiome Sub-study Consent
IRB Approval Date: 10/10/2011
Date IRB Approval Expires: 10/9/2012
FWA00005399 MR IRB
University of Wisconsin – Madison

Your signature indicates that you have read this consent form, had an opportunity to ask any
questions about your participation in this research and voluntarily consent to participate. It also
indicates that you as the parent of the child agree to allow your child to participate after birth.
You will receive a copy of this form for your records.

Name of Participant (please print):________________________________________________

Signature: ________________________________________________ Date: _____________

Name of Person Obtaining Consent (please print):___________________________________

Signature: _________________________________________________ Date: ____________

Page 4 of 4
University of Wisconsin IRB Protocol Number M-2011-0649, 11/21/2011 V3
NCS Fetal DNA/Microbiome Sub-study Consent
IRB Approval Date: 10/10/2011
Date IRB Approval Expires: 10/9/2012
FWA00005399 MR IRB
University of Wisconsin – Madison