Jimmie B. Vaught

Blood Collection, Shipment, Processing, and Storage

As part of the AACR Annual Meeting Methods Workshop “Sample Collection, Processing, and Storage for Large-Scale Studies: Biorepositories to Support Cancer Research,” blood specimen collection, processing, storage, and dissemination issues were discussed. Whole blood and blood fractions comprise a major portion of biospecimen collections for population-based studies. Although procedures for collecting, processing, storing, and shipping blood components are generally standardized and well documented, several important factors need to be considered before a new study involving blood collection is initiated. Blood is collected from study participants for a variety of purposes, including as a source of DNA, and for a variety of laboratory analyses that may be done on whole blood or blood fractions, including serum, plasma, and lymphocytes. Blood or blood fractions may be shipped to laboratories and biorepositories either at ambient temperature, cooled or frozen, depending on the intended analyses. Blood processing may include fractionation, cryopreservation to preserve the viability of lymphocytes, or purification of nucleic acids. The proper storage conditions depend on a variety of factors, including the intended analyses and whether the specimens will be used within a short period or need to be stored for longer periods. As for all laboratory and biorepository procedures, blood collection, shipment, processing, and storage should be conducted under a strict quality assurance program, including standard operating procedures and regular quality control reviews. (Cancer Epidemiol Biomarkers Prev 2006;15(9):1582–4)

2009 Biospecimen Research Network Symposium: Advancing Cancer Research through Biospecimen Science

This report details the proceedings of the 2009 Biospecimen Research Network (BRN) Symposium that took place on March 16 to 18, 2009, the second in a series of annual symposia sponsored by the National Cancer Institute Office of Biorepositories and Biospecimen Research. The BRN Symposium is a public forum addressing the relevance of biospecimen quality to progress in cancer research and the systematic investigation needed to understand how different methods of collection, processing, and storage of human biospecimens affect subsequent molecular research results. More than 300 participants from industry, academia, and government attended the symposium, which featured both formal presentations and a day of workshops aimed at addressing several key issues in biospecimen science. An additional 100 individuals participated via a live webcast (archived at http://brnsymposium.com). The BRN Symposium is part of a larger program designed as a networked, multidisciplinary research approach to increase the knowledge base for biospecimen science. Biospecimens are generally understood to represent an accurate representation of a patients disease biology, but can instead reflect a combination of disease biology and the biospecimens response to a wide range of biological stresses. The molecular signatures of disease can thus be confounded by the signatures of biospecimen biological stress, with the potential to affect clinical and research outcomes through incorrect diagnosis of disease, improper use of a given therapy, and irreproducible research results that can lead to misinterpretation of artifacts as biomarkers. Biospecimen research represents the kind of bricks-and-mortar research that provides a solid scientific foundation for future advances that will directly help patients.

International Approaches to Advancing Biospecimen Science

Biospecimen quality is affected by a number of preanalytical factors that may or may not be obvious to the investigator. These factors are introduced through multiple biospecimen collection, processing, and storage procedures, which can differ dramatically within and between medical institutions and biorepositories. Biospecimen Science is the emerging field of study that is attempting to quantify and control such variability. A variety of efforts are under way around the world to establish research programs, evidence-based biospecimen protocols, and standards to improve the overall quality of biospecimens for research. Cancer Epidemiol Biomarkers Prev; 20(5); 729–32. ©2011 AACR.

International Efforts to Develop Biospecimen Best Practices

Variables introduced during the processes involved in biospecimen collection, processing, storage, and analysis are among the potential sources of bias in biomarker research. International efforts are under way to develop best practices to standardize biospecimen handling protocols. In general, documents on best practices address three major recurring themes: technical best practices on infrastructure and specimen handling, recommendations on informatics and data management, and recommendations on ethical, legal, and social issues. There are many areas of agreement among various international efforts, but no single set of practices has emerged as a unifying document. The ethical, legal, and social issues are particularly difficult to harmonize due to the many country-specific issues that are governed by a variety of local and federal rules and regulations. Given the increasingly international nature of research involving biomarkers and biospecimens, it will be necessary to continue to cooperate in the development of harmonized evidence-based best practices. Several international organizations including the International Cancer Genome Consortium are engaged in such efforts. Cancer Epidemiol Biomarkers Prev; 19(4); 912–5. ©2010 AACR.

Biospecimens and biorepositories: from afterthought to science.

Biospecimens are recognized as critical components of biomedical research, from basic studies to clinical trials and epidemiologic investigations. Biorepositories have existed in various forms for more than 150 years, from early small collections in pathology laboratories to modern automated facilities managing millions of samples. As collaborative science has developed, it has been recognized that biospecimens must be of consistent quality. Recent years have seen a proliferation of best practices and the recognition of the field of “biospecimen science.” The future of this field will depend on the development of more evidence-based practices in both the research and clinical settings. As the field matures, educating a new generation of biospecimen/biobanking scientists will be an important need. Cancer Epidemiol Biomarkers Prev; 21(2); 253–5. ©2012 AACR.

Biobankonomics: A taxonomy for evaluating the economic benefits of standardized centralized human biobanking for translational research

Investments in medical research and development enable the scientific progress that influences our societys body of knowledge about disease, the quality of health care, and our quality of life. Critical components of these investments include the technological and human capital factors rooted in human specimen biobanking, which can be considered foundational to driving post genomic scientific and medical research. Their importance to cancer research, information-based medicine, and quality of health care are becoming increasingly recognized by pharmaceutical companies, non profit foundations, academic researchers, and government research agencies. However, the failure to standardize tissue collection, handling, processing, and preservation so that data can be directly compared between specimen sets, as well as insufficient leveraging of the highest quality tissue samples and associated data across an array of research needs, have strained economies of scale for the biobanking field. Although existing biobanks for private research contribute economic benefits to stakeholders that can be easily substantiated, little has been published to demonstrate the positive outcomes generated from the use, application, and dissemination of their resources more broadly. Through the use of analogous examples, this article presents a rationale for how standardization and consolidation of biobanking resources would contribute to the realization of budget savings, cost avoidances, process efficiencies, and other financial impacts to both the research community and the public. A number of areas are examined, including laboratory analysis efficiencies, data modeling accuracy, infrastructure cost savings, reduced clinical trials evaluation costs, improvements in patient diagnosis, and the potential impact on industry professionalization and job creation. Areas for further study are also outlined.

Best Practices for Establishing a Biobank

A biobank may be defined as the long-term storage of biological samples for research or clinical purposes. In addition to storage facilities, a biobank may comprise a complete organization with biological samples, data, personnel, policies, and procedures for handling specimens and performing other services, such as the management of the database and the planning of scientific studies. This combination of facilities, policies, and processes may also be called a biological resource center (BRC) ( www.iarc.fr ). Research using specimens from biobanks is regulated by European Union (EU) recommendations (Recommendations on Research on Human Biological Materials. The draft recommendation on research on human biological materials was approved by CDBI at its plenary meeting on 20 October 2005) and by voluntary best practices from the U.S. National Cancer Institute (NCI) ( http://biospecimens.cancer.gov ) and other organizations. Best practices for the management of research biobanks vary according to the institution and differing international regulations and standards. However, there are many areas of agreement that have resulted in best practices that should be followed in order to establish a biobank for the custodianship of high-quality specimens and data.

Biorepository and Biospecimen Science: A New Focus for CEBP

In January 2006, Cancer Epidemiology, Biomarkers & Prevention ( CEBP ) introduced the new subject area of Biorepository and Biospecimen Science. In creating this new category, the journal is recognizing what many investigators, including molecular epidemiologists, have known for years: that the

Ethical, Legal, and Policy Issues : Dominating the Biospecimen Discussion

With over 300 million human specimens currently stored in the United States, biospecimens are invaluable to the scientific research community. In addition to technical considerations related to the physical quality of a biospecimen, multiple ethical, legal, and policy issues also affect the ability

Key Elements of Access Policies for Biorepositories Associated with Population Science Research

The National Cancer Institute Best Practices for Biospecimen Resources recommend that each biorepository establish clear guidelines for access to biospecimens and their associated data ([1][1]). The National Cancer Institutes Division of Cancer Control and Population Sciences currently supports 18