Consent for Bloodspot Release

Form Approved
OMB No. 0920-0010
Exp. 01/31/2017
Informed Consent for Release of Leftover Newborn Bloodspots

TITLE OF STUDY: Birth Defects Study To Evaluate Pregnancy exposureS or BD-STEPS

RESEARCHERS:
National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control
and Prevention, and the Centers for Birth Defects Research and Prevention in Arkansas,
California, Iowa, Massachusetts, New York and North Carolina.
PURPOSE OF STUDIES USING NEWBORN BLOODSPOTS:
Major birth defects occur in about three out of every 100 babies. The cause of the birth defect is
unknown for most of these babies. Birth defects can be prevented only if these causes are
understood. Researchers are working with the Centers for Disease Control and Prevention
(CDC) to study babies who do and do not have birth defects to try to understand their causes. To
help us to understand environmental and other causes of birth defects, you have already provided
us with information through a telephone interview. To help us understand more about how genes
and other biologic factors may play a role in birth defects, we also plan to do studies that use
leftover newborn bloodspots.
PROCEDURES FOR RELEASE OF LEFTOVER NEWBORN BLOODSPOTS:
If you decide to participate in this part of the study, we would like to have your permission to
request some of the leftover heel stick blood (also called a newborn bloodspot) that was already
collected from your baby shortly after birth by the . The collects a few drops of blood onto a card
from the heel of every baby born in to check for certain rare inherited
conditions. They usually have leftover newborn bloodspots on these cards. The has agreed to let us have some of the leftover newborn bloodspots from
your baby if we have your permission. These samples will be used to study genes and other
biologic factors, which may play a role in why some babies have birth defects. They will only be
used to study birth defects and for no other purpose. We have no plans to ever destroy these
samples.
SHARING YOUR CHILD’S NEWBORN BLOODSPOT DATA FOR FUTURE
RESEARCH:
Public reporting burden of this collection of information is estimated to average 15 minutes, 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 CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta,
Georgia 30333; ATTN: PRA (0920-0010).

To do more powerful research, it is helpful for researchers to share information they get from
studying newborn bloodspots. Your child’s newborn bloodspot data and some limited other
information (such as your child’s race, ethnic group, and birth defect type) might be placed into
one or more centralized scientific databases (such as National Institutes of Health databases).
Sharing this information will allow it to be combined with information from other studies so that
researchers can learn even more about birth defects. Your child’s name will not be included in
the databases. The other information included, such as your child’s race and ethnic group, helps
researchers learn whether the factors that lead to birth defects are the same in different groups of
people. It is possible that such findings could one day help prevent birth defects. However,
results reported by group, such as race or ethnicity, could cause distress to group members.
The data will be stored in an electronic format with a code number that does not contain any
information that could identify your child. A researcher who wants to study your child’s data
must apply for access to the data. Only researchers who have a birth defects study that is
approved by a human subjects review committee and a certified agreement to use the data for
birth defects research will be allowed to see and use your child’s information. Researchers who
are given access to the data will be agreeing to use appropriate security measures.
RISKS OF SHARING LEFTOVER NEWBORN BLOODSPOTS:
There is no physical risk because the bloodspots have already been collected from your child
shortly after birth. To protect your child’s confidentiality, no names or other personal
information will be attached to the newborn bloodspot samples. The sample data will be stored in
electronic format with a code number that does not contain any information that could identify
your child. Because genetic information is unique to each person, there is a small chance that
someone could trace it back to your child if they have another source of your child’s genetic
information. Although genetic information is unique to each person, each person shares some
genetic information with their blood relatives. As a result, it may be possible that genetic
information from blood relatives could be used to help identify your child. Similarly, it may be
possible that genetic information from your child could be used to help identify blood relatives.
There is also a chance your child’s information could be improperly released. The risk of this
happening is very small and we have many safeguards in place to keep your child’s information
confidential. Additionally, there are state and federal laws that protect against genetic
discrimination.
BENEFITS OF SHARING LEFTOVER NEWBORN BLOODSPOTS:
There is no personal benefit to you or your child for taking part in this study. The major benefit
is that this study may result in a better understanding of the causes of birth defects. We will
share what we learn with other health professionals through medical publications. None of these
publications will include information that could identify you or your child in any way.
CONFIDENTIALITY:
All information that we gather in this study will be kept confidential. This is assured by a
Certificate of Confidentiality that protects your legal rights under the Public Health Service Act
(under section 301[d] of the Public Service Act 42 U.S.C. 241[d]). The Certificate of
Confidentiality prevents study staff from being forced under a court order or other legal action to
identify your child or anyone else in this study. This protection lasts forever (even after death)

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for any persons who were subjects in the research during any time the Certificate was in effect.
However, you should understand that the researchers are not prevented from reporting
information obtained from you to authorities in order to prevent serious harm to yourself or
others. Records may be reviewed by officials checking on the quality of the research.
Information obtained from you may be shared with researchers when and if it has been approved
by human research subject review committees. Researchers will never use any names in reports
or publications. Genetic data will be used only for the study of birth defects. You may request a
copy of the Certificate of Confidentiality for this study at any time.
COSTS/COMPENSATION:
We have included a $10 gift card as a token of appreciation for your time and interest.
RIGHT TO REFUSE OR WITHDRAW:
Participation in all parts of this study is voluntary. You are free to not take part in the study and
you are free to withdraw from any or all parts of this study at any time without penalty or loss of
benefits to you. You may request to have your child’s newborn bloodspot samples, the sample
data, and the interview data removed from the study at any time. In addition, when your child
reaches the age of 18, he or she can also contact the study and request to withdraw. After
receiving this request, we will remove your child’s newborn bloodspot samples and sample data
from all future studies. However, we cannot remove newborn bloodspot samples and sample data
from studies that started before the request was received.
LABORATORY RESULTS:
The BD-STEPS studies that will be done on the leftover newborn bloodspots are not meant to
test the medical status of your child. The research labs we use in BD-STEPS do not have the
same quality control standards as clinical labs, which can make the tests less reliable than those
from a clinical lab. Since all BD-STEPS studies will be done in research labs, we will not return
your child’s individual results. We will publish summarized results in the study newsletter. This
newsletter is available to all participants when it is published online each year at
www.bdsteps.org. If you have questions about whether any genetic tests would be useful to you
or your child, we recommend that you consult your health care provider.
CONTROL AND OWNERSHIP OF NEWBORN BLOODSPOT SAMPLES:
The leftover newborn bloodspot samples that are shared with BD-STEPS will be studied by birth
defects researchers when and if a proposed study has been approved by a human subjects review
committee. The samples will be studied shortly after they are received or will be stored for
studies in the future. OR will have
control over the stored samples unless you request that your child’s sample be removed from
storage. OPTIONAL (FOR CENTERS WHERE SAMPLE OWNERSHIP AND
STORAGE LOCATIONS DIFFER): The samples will remain under the ownership of the

COMMERCIAL VALUE OF NEWBORN BLOODSPOT SAMPLES:
Your child’s newborn bloodspot samples or newborn bloodspot data will not be used for
commercial purposes.

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If you have any questions, please contact:
1-888-743-7324 or [email protected]
If you have questions about your child’s rights as a subject in this research study, please
call <> OR << insert local IRB contact if not
deferring.>>

PARTICIPANT CONSENT:

Print child's name: _______________________________________________
I give permission for my child’s leftover newborn bloodspots to be requested from the
. Please sign below (either parent may sign).
These samples have already been collected and no additional collection is needed.
Parent: I have read this consent form or had its contents explained to me.
All of my questions have been satisfactorily answered.
Parent’s signature: _____________________________ Date: ____________
Print parent’s name:_____________________________________________________

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