For Families

BIG Initiative: Information for Families

Read our latest issue of BIG news!

What do we do?

During your child’s care at Le Bonheur, he or she will most likely have blood drawn. Although we draw only the blood we need, sometimes there is a little left over. Usually, the leftover blood is thrown away, but with your permission and consent we could save it, so that it could be used to extract DNA. The extracted DNA would be stored in the Integrative Genomics Biorepository and made available to researchers striving to develop new treatments and cures for pediatric diseases.

The Integrative Genomics Biorepository is a locked containment facility on our campus. Access to the biorepository is very tightly controlled, and your child will never be identified in any presentation or publication arising from research involving his or her DNA.

Participation in the BIG Initiative

Donating your child’s DNA to the research repository provides opportunities for researchers to help discover new treatments, new relationships between genes and diseases and even cures for future patients. As a participant, your child could play an important role toward creating a brighter future for the field of pediatric health care.

Eligibility for Participation

Every child is eligible to participate in this initiative. While at Le Bonheur, we may visit you in person or give you a call to discuss the BIG Initiative, explain how it works and how one can choose to participate. Your child will be enrolled only after you or your child provides consent to enroll. It is completely voluntary to participate and has no cost. You may decide not to participate, and Le Bonheur will simply discard any unused portions from your child’s blood draws as we always have.

Withdrawal

Participation in the repository is always completely voluntary. If you’ve given consent but later change your mind, contact us at BIG-LBCH@uthsc.edu or 901-287-6473, and your child's DNA and personal health information will be removed from the repository. Please bear in mind that samples and information that have already been sent to researchers cannot be retrieved by the repository and may be used for research indefinitely. Send or leave a message, and we will get back to you as soon as possible.

Privacy and Security

Many steps will be taken to protect your child’s privacy. Any information that could directly identify your child from his or her sample will be removed and replaced with a code number. Your child’s name will never show up in the DNA sample database, and the master list linking the code number back to your child will be kept in a separate, secure location from the samples themselves. Every effort will be made to protect all samples and personal health information in the biorepository.

Communication

We will maintain communication about the initiative with you and your family by making newsletters available twice a year. The newsletter will be sent to the email address provided by you during enrollment. If you have changed your email, then please call us at 901-287-6473, or email us at BIG-LBCH@uthsc.edu, and we will update your information.

Additionally, researchers may contact you for enrollment in future studies which may or may not return results of genetic testing.

Learn More

Governance

To facilitate implementation, a governance model has been set up which oversees all operational aspects of the biorepository. Mentioned below are the boards and committees set up for effective BIG Initiative operations.

Advisory Board

The advisory board includes leaders from Le Bonheur and UTHSC in genetics, biomedical informatics, pediatrics and molecular diagnostics as well as the BIG team members. During the initial stages of the development of the initiative, the advisory board played a key role in approving plans and providing suggestions on changes that could make overall operations more effective. However, as the initiative progressed, the advisory board transformed into a reporting and advising channel that provides suggestions on improving current processes.

Research Oversight Committee

The Research Oversight Committee (ROC) is an interdisciplinary body comprising members from different arenas of health and clinical research at UTHSC and Le Bonheur. We have established this committee with five rotating trios of researchers, where the members of each trio have similar research interests. One member from each of the five trios will review specific applications and make decisions on how to best utilize the DNA samples and data for research.

Ethics Committee

Understanding the sensitive nature of interaction with patients and families as well as the DNA related research, we have established an ethics committee. This committee is composed of legal, ethics, regulatory and clinical representatives. The ethics committee meets quarterly and reviews all patient interaction materials and processes and receives reports on all research-related decisions made by the ROC.

Family Partners Council Sub-committee

The Family Partners Council (FPC) at Le Bonheur is composed of more than 40 families of children who have been treated at Le Bonheur. The FPC has been involved from the development phase of the initiative. BIG Initiative updates are provided to the FPC on a bi-annual basis. All new patient resources are shared will the FPC sub-committee for review prior to usage for enrollment of patients.

Frequently Asked Questions for Parents

Will my child’s personal health information be shared?

We remove personal health and identifying information from all samples before sharing with approved researchers. We will not release any information that could link the samples or health information to your child.

Does participating require drawing additional blood?

No, it does not require drawing any more blood from your child than what would already be drawn for his or her medical care.

Is there a cost to participate?

No, you will not have to pay anything to participate.

What happens to my child’s samples?

All BIG samples are frozen and stored in a locked containment facility. Access to these specimens is very tightly controlled and requires review and approval by the BIG Research Oversight Committee (ROC) and the Internal Review Board (IRB) at UTHSC. Researchers at Le Bonheur, UTHSC and the people they work with at other research institutions, including health-related commercial organizations, may use BIG samples in their studies. All samples are coded so that researchers will not know your child’s identity and your child will NEVER be publicly identified in any presentation or publication arising from research involving their DNA.

One of the ways BIG samples will be analyzed is through a collaborative partnership with a commercial company that performs health-related research and drug development. This company will perform genetic testing on all BIG samples, including a process called “whole exome sequencing,” which helps us to learn about the makeup of all the genes in your DNA. This genetic information will be made available for use by all the researchers in this collaborative partnership for future research studies.

How does my child’s participation help Le Bonheur?

Donating your child’s DNA to the research repository provides opportunities for researchers to help discover new treatments, new relationships between genes and diseases and even cures for future patients. As a participant, your child could play an important role toward creating a brighter future for the field of pediatric health care.

Do Le Bonheur or UTHSC ever use DNA for cloning?

No. Samples obtained for this project will never be used for cloning.

Will my child’s samples or data ever be sold?

No. Le Bonheur, UTHSC and our collaborators will not sell any of the DNA samples, the genetic information derived from them or your child’s personal health information.

What if I change my mind about participating?

Participation in the repository is always completely voluntary. If you’ve given consent but later change your mind, contact us at BIG-LBCH@uthsc.edu or 901-287-6473, and your child's DNA and personal health information will immediately be removed from the repository. Please bear in mind that samples and information sent to researchers before you opt-out cannot be retrieved and may be used in research indefinitely. Send or leave a message, and we will get back to you as soon as possible.

Contact Us:
Email: BIG-LBCH@uthsc.edu
Phone: 901-287-6473

BIG News

BIG News is a newsletter for participants in Le Bonheur's Biorepository and Integrative Genomics Initiative.