BIG Research

In addition to treating illnesses and injuries, our hospital is home to the Regional One Health Research Institute, LLC, through which we are expanding our clinical research activities geared towards the discovery of new and improved treatment options for both adult and pediatric diseases and medical conditions. The University of Tennessee Health Science Center established the Biorepository for Integrative Genomics (BIG) Initiative to provide a collection of DNA samples in order to help researchers study how genes, or the blueprints in each of the body’s cells, influence which diseases we get and how well we respond to treatment.

The University of Tennessee Health Science Center expects that the BIG Initiative will facilitate highly effective genomics-based research to support future personalized healthcare delivery platforms. By participating, patients at Regional One Health can play a direct role in the discovery of new treatments and/or cures for diseases, and thus contribute to a better quality of life for patients everywhere.

Patient participation is always 100% voluntary, and there are numerous safeguards in place to protect each patient’s privacy and security.

What do we do?

During your care at Regional One Health, you 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 it could be used to extract DNA. The extracted DNA would be stored in the Integrative Genomics Biorepository (IGB) and be made available to researchers striving to develop new treatments and cures for diseases.

We will create a link between each patient’s de-identified medical record and the DNA sample to allow researchers to better understand how genes directly affect one’s health. For instance, if we wanted to study the DNA of children with asthma, we would need the ability to pull only those samples belonging to patients with asthma. Having a link to the medical record makes the samples even more useful. The information from each patient’s medical record will be coded so that the patient cannot be re-identified.

The IGB is a locked containment facility. Access to the biorepository and related information systems is very tightly controlled, and you will never be identified in any presentation or publication arising from research involving your DNA.

Participation in the BIG Initiative

Donating your DNA to this research biorepository provides opportunities for researchers to help discover new treatments, new relationships between genes and diseases, and even cures for future patients. As a participant, you could play an important role toward creating a brighter future for health care.

Eligibility for Participation

Every patient is eligible to participate in this initiative. While at Regional One Health, 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. You will be enrolled only after you provide consent to enroll. If the patient is a minor, parental consent is required to enroll. Participation in this biorepository is completely voluntary and has no cost. You may decide not to participate, and Regional One Health will simply discard any unused portions from your blood draws as we always have.

Withdrawal

Participation in the biorepository is always completely voluntary. If you’ve given consent but later change your mind, contact us at [email protected] or 901-545-8699 and your DNA and personal health information will be removed from the biorepository. Please bear in mind that samples and information that have already been sent to researchers cannot be retrieved by the biorepository and may be used for research indefinitely. Send or leave us a message, and we will get back to you as soon as possible.

Privacy and Security

Many steps will be taken to protect your privacy. Any information that could directly identify a patient from their sample will be removed and replaced with a code number. Patients’ names will never show up in the DNA sample database, and the master list linking the code number back to the patient 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.

The biorepository is covered by a Certificate of Confidentiality from the National Institutes of Health. Even a court order cannot force us to reveal any information from this project. If anyone should gain access to the genetic information that is produced from your sample, there is a law that protects against using this information to make it harder to get or keep health insurance, jobs, or other opportunities.

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 and will also be placed on this website. If you have changed your email please call us at 901-545-8699 and we will update your information.

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

BIG Initiative

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.

Through the Integrated Genomics Biorepository (IGB), we will generate genomic data on consenting patients at Regional One Health. This 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 (WES) 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-ROH 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 IGB. Researchers granted approval to access DNA samples will then apply for Institutional Regulatory Board (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., WES, 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 and/or data, first identify a research cohort in the UTHSC Enterprise Data 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-ROH Materials Distribution Request.

For more information, please read our BIG-ROH Sample Request FAQ below.

Governance

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

Advisory Board

The BIG-ROH Advisory Board includes leaders from multiple departments at Regional One Health, UTHSC researchers in genetics, biomedical informatics, and molecular diagnostics, as well as the BIG-ROH team members. The Advisory Board plays a key role in approving plans and providing suggestions on changes that could make overall operations more effective.

Research Oversight Committee

The ROC is an interdisciplinary body comprised of members from different arenas of health and clinical research. Committee members will review applications and make decisions on how to best utilize the DNA samples for research.

Ethics Committee

Understanding the sensitive nature of interaction with patients and families as well as DNA-related research, we have established an independent Ethics Committee that is comprised of legal, ethics, regulatory, and clinical representatives. This committee meets periodically to review all patient interaction materials and processes, and also receives reports and advises on all research-related decisions made by the ROC.

Community Engagement

In addition to our website and social media platforms, another means that BIG-ROH will use for advice and feedback is the Community Advisory Board organized through the UTHSC Office of Student Affairs and Community Engagement. As the BIG-ROH Initiative progresses, we will expand community outreach activities as opportunities arise.