Abstract
The International Society for Biological and Environmental Repositories (ISBER) is very proud to announce the publication of the 5th Edition of the ISBER Best Practices: Recommendations for Biorepositories. The ISBER Best Practices are a set of guidelines describing effective practices for the management of human and environmental repositories. The guidelines are an ideal starting point for new biobanks but also serve as an important reference tool for established repositories, especially those looking to introduce new areas of practice.
The concept of working to “best practice” has been around throughout history although it has been suggested that the phrase was first coined in the 1960s 1 in the business and financial management fields. Since then, the term has evolved and been adopted in many different sectors. In general, they are practices that are evidence and value-based practices that are known to produce good outcomes if followed. A review of literature suggests that the term surfaced most prominently in Chicago during the 1990s when Zemelman, Daniels, and Hyde collected what was then the “current, national consensus recommendations about ‘best educational practice,’” and gathered “all the traditional knowledge” to determine the “best” methods. 2
In biobanking, as within other sectors, there is a defined hierarchy of compliance requirements where legal instruments exist. Some countries, for example, Finland and Sweden, have direct biobanking laws. Countries/regions may also have relevant regulations, which are not laws themselves, but rather legal directives that explain implementation of statutes or laws. At the next level down, voluntary consensus standards such as ISO 20387 General Requirements for Biobanking and Best Practices 3 are available—their use could be motivated by the needs of users or a biobank's desire to provide more assurance of products.
For an individual biobank, the set of applicable laws, regulations, or standards may not be straightforward to identify, but is important to understand. Best Practices, however, are techniques, procedures, or methods that are used to maintain quality and fitness for purpose and are intended to complement standards as well as many laws and regulations; they should be both consensus and evidence based. The ISBER Best Practices, therefore, do not constitute a standard or legal instrument; rather, they are recommendations that can support the creation of standard operating procedures in the context of a repository's quality management system.
They are not detailed procedures but guidelines to help develop and improve a biobank's policies and procedures. The term “Best Practice” is used throughout the ISBER document to describe a level of operation that is above the basic recommended practice. It is important to note that adoption of best practices will vary based on the goals and circumstances of a given repository. It is recognized that it may not be possible, or even desirable, for the designated “Best Practice” to be implemented in all instances.
An important feature of the “ISBER Best Practices 5th Edition” is their broad and complementary applicability—a biobank may use them as a place to begin, or as an aid in achieving other goals, such as accreditation to a biobanking standard. This document was developed by experts who also have an understanding of complementary tools available from ISBER and others, for example, targeted and educational tools such as the Biobank Assessment Tool (BAT), 4 Qualification in Biorepository Science (QBRS), 5 the Canadian Tissue Repository Network (CTRNet) “Essentials of Biobanking” course, 6 and standards such as ISO 20387 7 or College of American Pathologists Biorepository accreditation. 8
The Best Practices document was developed to be aligned with these other tools—the intent is that a biobank will be able to tailor a complementary set of tools for its purposes, as depicted in Figure 1.
The Biobanker's Toolbox: Types of Documentation.
Of course, Best Practices are only ever “current” best practices—technologies evolve, knowledge advances, and what used to be the cutting edge, state of the art, eventually becomes outdated and superseded by new norms. For this reason, the ISBER Best Practices document is reviewed and updated regularly.
The first edition was published in 2005, 9 was limited to human specimen biobanks, and was United States centric. In 2008, the text was revised to broaden the scope to include environmental repositories and to have a wider more international perspective to reflect the growing global membership profile. The 2012 third edition expanded again to include cost management and specimen access, utilization, and destruction of biospecimens to recognize and better support the growing professionalism in the sector. The fourth edition, published in 2018, was the first edition to be translated into languages other than English.
Volunteers translated the text into simplified Chinese, Japanese, Russian, Korean, and Spanish. It, too, was an updated and enhanced volume, reflecting the advances in biospecimen science and new technologies and, for the first time, a cryopreservation addendum was added with input from the Society for Cryobiology. The fourth edition translations 10 will be available on the ISBER website until the fifth edition translations are available.
The ISBER Best Practices 5th Edition document can be downloaded for free from ISBER's website at www.isber.org/for both ISBER members and nonmembers, and hard copies can also be purchased through Amazon. This is one of a set of tools and educational resources available on the ISBER website. It is on the reading list for the QBRS test, which was developed jointly by ISBER and The American Society for Clinical Pathology Board of Certification, and the BAT helps measure a biobank's compliance against the Best Practices document.
ISBER's mission is to “advance the expertise and quality of biorepositories and biobanking science worldwide.” The Best Practices is a key document to strengthen the position of biobanks to meet the constantly evolving needs of the research community. These guidelines help enable biobanks to provide biomaterials fit for purpose and they accelerate new biobanks in meeting the needs of users. Ultimately, they help to raise the quality of biobanks across the globe, enabling interoperability and placing the biobank community on a shared path to increase and maximize utility.