Consent - English

Attachment 5 - Informed Consent (English)
Informed Consent
SURVEY TITLE:
Survey titled Congenital Heart Surveillance To Recognize Outcomes and WellbeinG (CH STRONG)

RESPONSIBLE ORGANIZATIONS:
Arkansas Center for Birth Defects Research and Prevention, University of Arizona College Of Medicine, Tucson,
National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention
(CDC), and March of Dimes.
PURPOSE:
People born with heart conditions are living longer because of better care. However, little is known about the
daily life of adults who were born with heart conditions. Thus, the Metropolitan Atlanta Congenital Defects
Program, the March of Dimes, and the CDC are asking adults born with a heart condition to complete a brief
survey. This survey asks questions about your access to care and quality of life. Your answers may help identify
unmet needs of adults born with a heart condition. This information may also help families who have children
with heart conditions plan for the future.
PROCEDURES:
Completing the survey is up to you. Nothing will happen if you decide not to complete the survey. If you decide
to take part in this survey, you can either complete the survey and mail it back in the postage paid envelope, or
you can complete the survey online by logging onto www.chstrong.org. We will take your return of the
completed survey as your consent to be part of this project. The survey will take about 20 minutes, but the
exact time depends on your answers. It would be helpful if you completed the entire survey. However, you can
refuse to answer any question and you can stop at any time.
RISKS:
There are no known risks to you for completing the survey. If you do not want to answer a question, you do not
have to. All personal information (name, date of birth, address, and contact person’s address) will be kept
private and never linked to your answers.
BENEFITS:
There is no benefit to you for completing the survey, but your answers are important to adults and families of
children born with heart conditions. The survey information may help identify unmet needs of adults who were
born with heart conditions. Additionally, this information may help families of children born with heart
conditions plan for the future. We will share what we learn at meetings and through papers and reports. We
will never share information that could identify you.
CONFIDENTIALITY:
We are contacting adults who were born with a heart condition. We are asking for your name and contact
information to confirm we have reached the correct person and to re-contact you in the future. You may decline
to be re-contacted now or at any time in the future.
All of the answers you provide will be kept private to the extent allowed under federal laws [Privacy Act of 1974
(5 U.S.C. § 552a)]. These laws do not prevent the project staff from reporting information needed for evaluating
or auditing the project.
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Attachment 5 - Informed Consent (English)
We will assign your survey a number. We will remove your name and address and that of your contact person
and keep that information separate from your answers to the survey questions. Only certain project staff will
have access to the information. None of your answers will be linked to your name or address. Your answers will
be combined with the answers from everyone else that took part in the survey.
All of the completed surveys will be kept at the CDC in locked cabinets in locked rooms with limited access by
the project staff. All the computer files will be kept on a secure, password-protected server.
COSTS/COMPENSATION:
We know your time is valuable. As a thank you, we included a $5.00 gift card for you in this survey packet.
Please keep the gift card, whether or not you complete the survey. If you choose to return your completed
survey via mail or complete it online, we will send you another gift card worth $10.00 to thank you for the
additional time and effort.
RIGHT TO REFUSE OR WITHDRAW:
Your participation in this survey is up to you. Nothing will happen if you decide not to take part. You can refuse
to answer any questions and you can stop at any time. If at any time you would like to have your survey
answers destroyed or removed from the project, please call (855) 484-0105.

If you have any questions, please contact:
The CH STRONG Project Manager
[email protected] or (855) 484-0105
If you have questions about your rights as a participant in this project, please call the CDC’s Office of the Deputy
Associate Director for Science at 1-800-584-8814. Leave a message including your name, phone number, and
refer to protocol 6768, and someone will call you back as soon as possible.

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