At Le Bonheur Children’s Hospital, in addition to treating illnesses and injuries, we are also home to a Research Institute that works to discover new and better cures to treat pediatric disease. Our Research Institute has established the Biorepository and Integrative Genomics (BIG) Initiative – a collection of DNA samples to help our doctors study the influence of genes, or blueprints in each of the body’s cells, on what diseases we get and how well we respond to treatment. Your child's participation could help create a brighter future for kids tomorrow.
The Biorepository for Integrative Genomics (BIG) Initiative will facilitate highly effective genomics based research at Le Bonheur Children's Hospital and UTHSC to support future personalized healthcare delivery platforms.
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:
Everyone is eligible to participate in this initiative. Your child will be enrolled only after you or your child provides consent to enroll. It is completely voluntary and has no cost. This repository is completely voluntary. 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.
Participation in the repository is always completely voluntary. If you’ve given consent but later change your mind, contact us at BIG@lebonheur.org or 901-287-7485 and your child's DNA and personal health information will be removed from the repository. 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.
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 or mailed to your address. If you have changed your email or mail address then please call us at 901-287-4876 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.
Genomic research has played a crucial role in understanding cancer related genomic biology and predicting health outcomes based on genetic interactions. The Biorepository for Integrative Genomics (BIG) Initiative has been established to facilitate highly effective genomics based research at Le Bonheur Children’s Hospital and UTHSC.
Through the Integrated Genomics Biorepository we will generate genomic data on all consenting patients at Le Bonheur Children’s Hospital. Future research studies will explore drug metabolism, guide therapies based on pharmacogenomics, and eventually will support large scale prospective studies to identify prognostic indicators of disease progression, health outcomes and support future personalized healthcare delivery platforms.
Receiving DNA samples from the biorepository
DNA samples can be obtained only after submitting a BIG Materials Distribution Request. Pooled applications will be reviewed monthly by a Research Oversight Committee (ROC). Because DNA is a valuable resource which is limited in quantity, the ROC will make decisions on whom to grant the DNA samples. Decisions will be based on the following criteria: validity of the research proposal, widest utility and consideration of ethics in DNA-based research.
After the committee has made a decision, the selected researcher will be informed and the information relayed to the Integrated Genomics Biorepository (IGB). Researcher granted approval to access DNA samples will then apply for Institutional Regulatory Board approval. Once approved, the researcher is expected to provide both ROC and IRB approval. Once approved, the researcher is expected to provide both the ROC and IRB approval notices to the IGB. Applicants will then sign the Research Material Use Agreement (RMUA), after which the IGB lab will provide samples to the researcher.
Requirements for Application
- Name, department/affiliation, campus/institution location, and contact info for PI
- Names and affiliations of project collaborators
- Project Summary (1 short paragraph)
- Scientific Significance of Project (1 short paragraph) - should include significance/importance of BIG samples/data to project
- Impact Statement on Healthcare (1 short paragraph)
- Description of any significant ethical concerns or issues that could be raised by the project
- Project Narrative suitable for the general public (1-3 sentences)
- Sample number and power estimate based on sample size; or justification for low powered sample set/not providing estimate (indicate method/tool used to generate estimate)
- Description and justification of sample and/or data generation and analysis methodologies (e.g., whole exome sequencing, GWAS, etc.)
- Name/description of data-generating Analysis Service Provider (if using one)
- Source of funding for analysis
Online acceptance of the agreement listing policies, procedures and bylaws governing the application review, dissemination and utilization of samples, ownership of data generated from genomic analysis and publication acknowledgements is mandatory.
To apply for samples, first identify a research cohort in TriNetX (rEDW). Once a preliminary list of available samples in the cohort has been verified by and received from the IGB, then fill out a BIG Materials Distribution Request.
For more information, please read our BIG sample request FAQ.
To facilitate implementation a governance model has been set up which oversees all operational aspects of the biorepository. Below mentioned are the boards and committees set up for effective BIG Initiative operations.
The advisory board includes leaders 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 and the advisory board transformed into a reporting and advising channel that provides suggestions on improving current processes.
Research Oversight Committee
The ROC is an interdisciplinary body comprising of members from different arenas of health and clinical research. We have established this committee with five pair of members who will review applications and make decisions on how to best utilize the DNA samples for research.
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 comprised of legal, ethics, regulatory and clinical representatives. The Ethics committee meets quarterly and reviews all patient interaction materials and processes, as well receives report on all research related decisions made by the ROC.
Family Partners Council Sub-committee
The Family Partners Council at LBCH comprises of over 40 families of children who have been treated at LBCH. 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 samples for the repository are frozen and stored in a locked containment facility on our campus. Access to these specimens is very tightly controlled, and your child will NEVER be publicly identified in any
presentation or publication arising from research involving his or her DNA.
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.
Does Le Bonheur ever use DNA for cloning?
No. Samples obtained for this project will never be used for cloning.
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@lebonheur.org or 901-287-4876 and your child's DNA and personal health information will immediately be removed from the repository. Send or leave a message, and we will get back to you as soon as possible.
BIG News is a newsletter for participants in Le Bonheur's Biorepository and Integrative Genomics Initiative.