Abstract
Introduction
ISBER Best Practices for Repositories (Best Practices) reflects the collective experience of its members and provides repository professionals with a comprehensive tool to guide them in all their repository activities. Best Practices focuses on the establishment and day-to-day management of a repository and is applicable to repositories that manage either human or non-human origin material. The document considers regulatory compliance as well as the ethical, legal and social issues relevant to repositories. It covers both managerial and technical aspects; providing practical details on several aspects such as repository development, facilities and equipment, cost management, security and training. Best Practices is periodically reviewed and revised to reflect advances in research and technology.
Adherence to ISBER Best Practices is strictly on a voluntary basis. It is important to note that some aspects of specimen management are governed by national, regional and local regulations and repositories should refer directly to those governances, as appropriate.
Areas of Expansion and New Topics
The third edition of the ISBER Best Practices builds on the foundation established in the first and second editions, which were published in 2005 and 2008, respectively. These previous editions were the work product of the ISBER Education and Training Committee. For the third edition, a task force of former and current Education and Training Committee members was formed to work solely on the expansion and revision of Best Practices with the goals of including new areas of interest to the biobanking community and presenting a more international perspective to reflect the growing diversity of the ISBER membership.
New sections included in the third edition include “Cost Management” and “Specimen Access, Utilization, and Destruction”. Cost Management provides guidance on assessing costs during the development of a repository and analyzing the on-going costs associated with the maintenance and operation of the repository. Access and use policies for biospecimens are included to address issues on data sharing, such as the proper transfer of specimen-specific and donor-specific data and security concerns for the distribution of data. These additions to the document help provide a comprehensive guide to the overall establishment, management and operations of a repository.
The third edition includes significant expansions in sections addressing facilities, storage equipment and environments, and safety. Important additions were made in “Biological Material Tracking” to include security, interoperability, and reporting of inventory systems. The “Quality Management” section includes important updates in quality standards and additional information relevant to a variety of specimens and processing methods to reflect the growing field of biospecimen science. Additional specimen types and processes were also added to the “Specimen Collection, Processing, and Retrieval” section. “Legal and Ethical Issues for Biospecimens” now includes collection of animal biospecimens and expands on special considerations from various human sources.
Development and Process/Community Involvement
Revisions for the third edition of Best Practices began in 2008, shortly after the publication of the second edition. The Task Force discussed new topics to be included that would reflect the growing field of repository management and biospecimen science. After the identification of key areas to be addressed, a request for interest to participate in the development of the document was sent to the ISBER membership-at-large. Section editors from the Task Force were chosen to spearhead discussions and incorporate contributions from individuals into a single, working draft later reviewed by the entire Task Force.
In the spring of 2011, a draft was submitted for additional input and comments to the ISBER Publications Committee. Upon incorporation of suggested changes and subsequent approval, the ISBER membership was then invited to perform a second review of the document. Additional edits and suggestions were made and the final draft submitted to the Publications Committee and ISBER Council for approval and submission for publication.
International Perspective
ISBER serves as an international resource for the development, management, and operations of repositories representing over 30 countries worldwide. Since it is impossible to incorporate the national/federal, regional and local regulations that apply to each repository. Best Practices strives to address areas of commonality among all repositories. Members of the Task Force represent a variety of repositories focusing on biological materials (human, animal, and plant) that are based in locations around the world. In addition, great effort was made to seek input from the diverse ISBER membership for contributions and to prevent any national/federal or regional biases.
Next Steps
ISBER's mission is to provide an international forum that addresses the technical, legal, ethical, and managerial issues relevant to repositories of biological and environmental specimens. The organization seeks to create opportunities for sharing ideas and harmonizing approaches to evolving challenges in biobanking and repository operation. This is accomplished by fostering collaborations, creating education and training opportunities, and providing an international showcase for state-of-the-art research findings and cutting-edge technologies, products and services. Together, these activities promote best practices that cut across the broad range of repositories that ISBER serves. ISBER members who would like to be involved in the fourth edition of the ISBER Best Practices should contact the Education and Training Committee to volunteer to be a contributor.