November 15, 2008 (Vol. 28, No. 20)
Approach to Data Provides Safe and Secure Transfer of Demographic Information
A biobank is a repository for collections of biological materials such as blood, serum, tissue, and DNA as well as medical history and lifestyle information from representative portions of the human population. The Swedish Act on Biobanks defines biobank as “biological material from one or several human beings collected and stored indefinitely or for a specified time and whose origin can be traced to the human or humans from whom it originates.”
Biobanks are found in a variety of organizations. They can exist inside academic medical institutions as well as pharmaceutical and biotechnology companies, or they can operate as independent organizations delivering biological materials to researchers.
The safe and secure transfer of this demographic information is paramount, so biobanks must have a comprehensive policy in place to ensure that they meet the needs of biomedical researchers without violating donors’ rights.
The role of biobanks in research today is partially a product of the Human Genome project. Once we characterized the genome, we entered the genomic age and researchers focused their efforts on understanding how triggering a specific gene impacted the human body. This mapping of the Human Genome gave scientists the ability to identify genes and their functions, and also understand the role genetics plays in the origin and progression of diseases.
Biobanks provide the biological samples that make this research possible. Using the information stored in biobanks, researchers can investigate why some people develop particular diseases while others do not. They can consider how each person’s lifestyle, environment, and genes impact the progression of particular illnesses. With the knowledge of how disease is triggered, scientists are better able to identify potential diagnosis and treatment strategies.
The volume of biological samples and the associated medical records kept in biobanks require a powerful laboratory information management system (LIMS) to gather, store, sort, and retrieve data in a usable format. Samples and the associated patient information can be collected once or over time depending on the sample type and the goals of the biobank.
This clinical information must be linked to the biological samples in a secure way. When researchers make a sample request, they need to be able to query patient information to select the correct samples without violating the patient’s privacy. Therefore the data-management system needs to support complex sample requests based on patient demographic and sample type.
For example, a research study may need 5,000 plasma samples from male caucasian patients age 30–40 with a particular type of melanoma. The biobank needs to be able to search through their plasma samples as well as their whole blood samples to determine if that order can be fulfilled.
In addition to samples, the LIMS must manage the associated patient consent and the chain of custody. The biobank is responsible for honoring the patient’s consent no matter where the sample is in the biobank.
For instance, a patient might donate her ovarian tumor to further cancer research. She might approve the use of the sample for ovarian cancer only and not for use as secondary cells for other research. It is important that the donor’s consent is honored. If for any reason the consent is retracted, it is the legal responsibility of the biobank to destroy the patient’s samples. The biobank must notify all research facilities to destroy any remaining samples in their possession. For biobanks, tracking the chain of custody and the patient consent associated with a sample is as important as tracking the sample itself.
Another key requirement of LIMS is that it enables integration to automation systems. Biobanks experience high sample volumes so they need to be using the latest robotics solutions to manage their samples and their customers’ requests.
The Nord-Trøndelag Health Study (HUNT) Biobank in Norway is one of the largest population-based health studies ever performed. Initiated to support epidemiological, clinical, and preventive medical research, HUNT Biobank provides insight into disease status and progression, particularly in relation to quality-of-life measures such as environment, education, and occupation.
Receiving an enormous volume of 5,000 samples per week, HUNT Biobank needed a data-management solution capable of delivering speed, efficiency, and simplicity in a single system. It was important that the system could interface with the laboratory’s existing robotics, import files from the hospital laboratory, return results, and generate a feedback document for every participant.
The system was also required to provide clinical follow-up, data handling, and quality control following data collection, and then distribute coded data files to various research groups (Figure 1).
Another major medical research initiative, the UK Biobank in Manchester, England, stores answers to 200 lifestyle and medical questions and a total of up to 15 million individual blood and urine sample aliquots from 500,000 people. Additional follow-up questions will be asked over the next 20–30 years, providing researchers with the information they need to study the progression of illnesses such as cancer, heart disease, diabetes, and Alzheimer’s disease.
UK Biobank needed a data-management system to track samples and their associated data. For each aliquot, the system had to store its parent, grandparent, rack bar code ID, rack position, store rack location, and aliquot contents (Figure 2).
In total, UK Biobank needed to obtain several hundred million data points within the underlying database. To appropriately archive the vast amount of data generated by UK Biobank, the solution needed to be part of an automated system that received samples, fractioned them into appropriate vessels for testing, analysis, and storage, and then tracked and stored all data relative to the sample. The system also needed to provide daily updates and management reports.
The implementation of Thermo Scientific Nautilus LIMS in biobanking applications, such as at HUNT and the UK Biobank, automates data collection, management, and processing, eliminating human-related errors resulting from manual data transcription. Results are stored in a central database and are available to download in real-time. The LIMS is able to track sample status and allow access to both raw and derived data while providing precise linkage between participants and samples/aliquots.
It is also possible to maintain a record of the volume of samples used and the volume remaining, helping with replacement decisions from the back-up archive as well as resource access decisions for depleted samples. By improving efficiency and data reliability, the system enables more informed decisions faster than ever.
Featuring instrument integration capabilities, Nautilus LIMS allows data to be easily imported from a variety of analytical platforms, easing data management. The solution incorporates security functionality, enabling users to keep regulated data separate from unregulated processes, thereby ensuring maximum data authenticity, integrity, and traceability.
In addition, the implementation of Nautilus LIMS in biobanking applications is associated with a reduced total cost of ownership investment. Overall laboratory productivity is improved.
Nautilus LIMS is a flexible and robust system with automated plate-handling capabilities and easily configured extensions. The solution includes patented workflows technology with a flexible and intuitive interface to graphically map laboratory workflows of the sample life cycle.
Over the last few years, researchers have realized the importance of global biobank networking. Standardizing on an LIMS solution across different biobank laboratories is a means of achieving easy data sharing and public access to findings on a global basis. Such implementations will ensure that knowledge acquired through biobank research initiatives will be appropriately applied to promote health.
Modern LIMS address the need of biobanks for accurate data capture, secure storing, effective location and handling management, real-time reporting of data, and maximum operational efficiency.
With the help of LIMS, biobank scientists gain insight into the genetic and environmental causal factors associated with a wide range of debilitating diseases, obtaining vital information needed to work on future preventive and curative measures.
LIMS deployment enables dependable transmission of information between different biobanks and between biobanks and various health registries. Productivity, throughput, and accuracy increase, all while improving data administration, sample traceability, and regulatory compliance.
Doug Holbrook (firstname.lastname@example.org)is product manager informatics, Thermo Fisher Scientific. Web: www.thermo.com/informatics.