BIG Initiative: Information for Researchers
Genomic research has played a crucial role in understanding cancer-related genomic biology and predicting health outcomes based on genetic interactions. The Biorepository and Integrative Genomics (BIG) Initiative has been established to facilitate highly effective genomics-based research at Le Bonheur Children’s Hospital and the University of Tennessee Health Science Center (UTHSC).
Through the Integrated Genomics Biorepository (IGB), we collect DNA samples to be used for the generation of genomic data on all consenting patients at Le Bonheur Children’s Hospital. Genomic data will be generated and archived from multiple sources, including genomic analyses performed by investigators who receive BIG samples for approved research studies, the genomics analysis facility in the IGB and through collaborations between UTHSC and commercial companies that perform health-related research.
Beginning in 2020, a collaborative agreement between UTHSC and a commercial company that performs health-related genomics research and pharmaceutical development will start to provide whole exome sequencing and genome-wide SNP genotyping data from BIG samples using Illumina platforms. As genomic data accrues in the IGB data archive, it will be made available for all approved research studies. Future research studies will explore drug metabolism, guide therapies based on pharmacogenomics and eventually support large scale prospective studies to identify prognostic indicators of disease progression, health outcomes and support future personalized health care 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 notified of the decision and the information relayed to the Integrated Genomics Biorepository (IGB). A researcher granted approval to access DNA samples then applies for Institutional Review Board (IRB) approval, incorporating the BIG notification letter in their IRB application. Once approved by the IRB, the researcher is expected to provide both the ROC and IRB approval notices to the IGB. Applicants will then sign a 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 principal investigator
- Names and affiliations of project collaborators
- Project summary (one short paragraph)
- Scientific significance of project (one short paragraph) which should include significance and importance of BIG samples and data to project
- Impact statement on health care (one short paragraph)
- Description of any significant ethical concerns or issues that could be raised by the project
- Project narrative suitable for the general public (one to three 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 and 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.
How Researchers Can Apply to BIG
To apply for samples and/or data, first identify a research cohort in the UTHSC research enterprise warehouse (rEDW) using TriNetX. 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.