Biological Sample Collection, Processing, Storage and Information
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UNIT 2. BIOMARKERS: PRACTICAL ASPECTS CHAPTER 3. Biological sample collection, processing, storage and information management UNIT 2 CHAPTER 3 CHAPTER Jimmie B. Vaught and Marianne K. Henderson Summary The collection, processing and study that will involve the collection to assure that biological samples storage of biological samples occur of biological samples, many are of consistent quality and right in the larger context of organizations decisions need to be made that will for the intended analyses and study known as biological resource affect the quality of the samples goals. centres or biospecimen resources. and the outcome of the study. The Biological resource centres are (1,2) appropriate sample type(s) needs to Introduction service providers and repositories be chosen. The processing protocol of living cells, as well as genomes that will result in samples of suitable Although biological specimens have of organisms, archived cells and quality for the intended laboratory been collected for use in a variety tissues, and information relating to analyses must be selected from of molecular epidemiology, clinical these materials. The US National among various possible protocols. trial and basic research studies for Cancer Institute (3) defines a Consideration must be given to many years, it has only recently biospecimen resource as a “… the proper storage conditions been recognized that the protocols collection of human specimens and to maintain sample quality until and practices involved in collecting, associated data for research analyses are completed. All of these processing and storing specimens purposes, the physical entity activities must be monitored and actually comprise “biospecimen where the collection is stored, controlled by appropriate sample science.” As a result, many and all relevant processes and tracking and laboratory informatics organizations (Appendix 3.1) have policies.” The complexities involved systems. A comprehensive quality engaged in producing guidelines and in proper sample management management system, with standard best practices for these endeavours, policies and procedures are often operating procedures and other now known as biological resource underestimated. Prior to initiating a appropriate controls, is necessary centres or biospecimen resources. Unit 2 • Chapter 3. Biological sample collection, processing, storage, and information management 23 24 Appendix 3.1. Existing guidelines and best practices for biorepositories Title Authors/Origin Reference/Link Tissue Banking for Biomedical Research National Cancer Centre/Singapore http://www.bioethics-singapore.org/uploadfile/52533%20PMHT%20AppendixB-Dr%20Kon.pdf Australian Biospecimen Network, ABN/ Biorepository Protocols http://www.abrn.net/ Australia Biological Resource Centres: Underpinning the Future of Life Sciences OECD/International http://www.oecd.org/dataoecd/55/48/2487422.pdf and Biotechnology European Human Frozen Tumor Tissue TUBAFROST/The Netherlands http://www.tubafrost.org/ Bank – TUBAFROST Human Tissue and Biological Samples for use in Research: Operational and Ethical MRC/UK http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002420 Guidelines Best Practices for Repositories I: International Society for Biological & Collection, Storage, and Retrieval of Cell Preserv Technol 2008;6:3-58 Environmental Repositories/USA Human Biological Materials for Research First-Generation Guidelines for NCI- NCI/USA http://biospecimens.cancer.gov/bestpractices Supported Biospecimen Resources UN Recommendations on the Transport of UN Economic Commission for Europe, http://www.unece.org/trans/danger/publi/unrec/rev13/13files_e.html Dangerous Goods. Model Regulations UNECE/International Specimen Collection, Preparation, and LabCorp/International http://www.labcorp.com/datasets/labcorp/html/frontm_group/frontm/section/speccol.htm Handling Several organizations have published guidelines and best practices relevant to the discussion in this chapter (54). This table is adapted from the IARC publication International Network of Biological Resource Centres for Cancer Research: Recommendations on Common Minimal Technical Standards (2). These terms reflect the fact that performed under strictly controlled the intended analyses? Will it be specimen management takes place procedures. As the sensitivity and necessary to store smaller volumes in an environment that includes a specificity of analytic techniques in aliquots for future unplanned use wide range of policies concerning the have increased to an extraordinary to avoid thawing a larger aliquot? specimens and data, as well as the degree in recent years (see Chapter For example, it is important to physical structure, the biorepository. 4), it has become even more important consider that new technologies have Biological resource centres are to assure that biospecimens are of resulted in more sensitive analytical engaged in many activities beyond the highest quality. In addition, from techniques to apply to older samples storage, such as acquiring, the point in time that the specimens (see also Chapters 4 and 7), or older processing (e.g. aliquoting, DNA are collected until laboratory results samples may become sources of extraction) and distributing biological are analysed and reported, all of information to study the natural materials. The practices and the relevant information concerning history of a seemingly ‘new’ disease. policies that have been organized the specimen, as well as data • What quality standards do the into formal documents testify to the concerning the study participant specimens need to meet for valid UNIT 2 importance of following proper steps and laboratory analyses, must be laboratory analyses? Have such that will result in the highest quality properly stored in interoperable quality measures been validated? 3 CHAPTER specimens for research purposes. information management systems. • Have specimen collection, The use of proper procedures to This could mean multiple systems or processing and storage protocols produce biological specimens of multiple databases interconnected been standardized and validated in the appropriate quality, as well as in a single system. All of these pilot studies? the collection of relevant clinical, steps must be performed under • If the specimens will be stored epidemiologic and quality control a well-planned quality assurance for some period of time before data, gives the biospecimens their programme, and according to analysis, has the stability of the value in research. relevant legal and ethical standards intended biomarker, or other analyte, (discussed in Chapter 2). been determined for the planned Context and public health storage conditions? significance Examples/case studies • Will specimens need to be shipped to distant locations for Biological specimens (or Prior to initiating a study that involves analysis? If so, have packaging and biospecimens), such as blood, specimen collection, several key shipping protocols been validated to urine, saliva, and many other points must be considered. The assure the stability and safety of the types, are collected for a variety answers to these questions will be specimens and personnel who will of reasons, for normal patient important in determining whether the handle them? monitoring and care as well as for appropriate materials, equipment • Have all other logistical issues basic, clinical and epidemiologic and procedures are in place: been resolved, such as proper research studies. Many medical • What are the goals of the coding, labelling and identifying the advances, including studies of study? types of storage vessels? heart disease, AIDS and cancer, • What laboratory analyses will • What data will be collected have resulted from preliminary be needed to accomplish the study with the sample and the study, and developmental studies that have goals? is an appropriate informatics system relied on access to and proper use • What type of biospecimens available to collect and process this of the appropriate biospecimens. will be necessary for the intended information? The sources of biospecimens for laboratory analyses? • Have all appropriate informed these studies have been varied, as • How many specimens will consent, privacy and other ethical has their quality (1–4). be collected? If necessary, a and legal rules and regulations been For molecular epidemiology biostatistician should be consulted reviewed and adhered to in the studies, the ultimate success of a to assist in determining the number study planning? study depends on reliable laboratory required to achieve statistical • Are funding and other analyses of these specimens. In significance. resources for the proposed study’s order for laboratory analyses to be • What volume or size will specimen collection adequate? Will reliable, the collection, processing be required for each specimen it be necessary to consider lower and storage of specimens must be to assure that it is adequate for cost alternate methodologies? Unit 2 • Chapter 3. Biological sample collection, processing, storage, and information management 25 If there is a significant amount of to planning the most efficient to plan biospecimen collections uncertainty in answering the above specimen collection and processing with careful attention to the costs of questions, then additional thought to maintain the stability of the analyses and storage, especially if and planning will be needed before resulting sample aliquots, which are long-term storage will be necessary. beginning