Abstract
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Each WG is chaired or co-chaired by an active ISBER member(s) and are composed of active ISBER members with expertise and experience in the respective subject areas. These volunteers dedicate their personal time and professional talents and are committed to producing work products to the discipline of biobanking that will benefit the biobanking community on a global level. WGs meet face-to-face only once per year at the annual ISBER meeting to discuss their concrete, precise, and realistic goals and deliverables. Teleconference calls are then scheduled throughout the year (i.e., monthly, bi-monthly, quarterly, etc.) as appropriate for each WG, as well as other means of communication that are used to continue working throughout the year.
Today there are nine active WGs (see Table 1). The WGs recently met during the 2014 annual ISBER meeting, May 20–24, 2014, in Orlando, Florida, to discuss their current projects as well as develop the coming year's goals and deliverables. Background information as well as the current activities for each WG is discussed here.
The Biospecimen Science WG was established as one of the first WGs in 2008. Biospecimens stored in biorepositories are intended to be used for biomarker identification and validation. The performance of such biomarkers greatly depends on the pre-analytical variations of the samples having been used for its initial identification. Quality assurance on this issue is therefore of the outmost importance and allows us to establish the right correspondence between processing methods and end-use biomarkers. This has certainly been one of the most active WGs with the development of the biospecimen science database including hundreds of references, a standard biospecimen research experimental protocol, the Standard PREanalytical Code (SPREC), the Proficiency Testing program, and the Preanalytical EQA (external quality assurance) survey tool. As well as having identified potential new quality control tools, and having performed collaborative experimental projects on RNA and viable cell stability, this WG continues to stay productive through various activities. A review article on room temperature technologies is currently in progress. In addition, the Group's projects for this year include biospecimen research collections relating to: 1) tissue heat stabilization studies; 2) robustness study of clinically relevant biomarkers; and 3) the validation of different biospecimen quality control markers/tools. A new project on low quality RNA stability at room temperature will also be launched. An experimental project on viable tumor tissue cryopreservation is being discussed and could be the opportunity for collaboration with members from the Society for Cryobiology. In addition, close contact with the Enviro-Bio WG, through permanent liaisons, are maintained in order to cross-pollinate ideas and opportunities for transdisciplinary biospecimen science. The Biospecimen Science WG welcomes interaction and collaboration with external organizations including pharmaceutical companies, the Human Proteome Organization (HUPO) and the International Organization for Standardization/Technical Committee (ISO/TC) 276.
The Informatics Working Group (IWG) was also established as one of the first WGs in 2008, with a mission to advise the ISBER community on best practices for biobanking data and information management systems. The IWG has been very active over the years, conducting annual meeting workshops and surveys of biobanking informatics. At the ISBER 2014 annual meeting the group decided to define a 2–3 year strategic plan and appoint project managers for corresponding activities. The IWG proposes to focus in the following areas for the next few years: 1) collaboratively develop IT best practices within ISBER and 2) advocate for and raise awareness of IT in biobanks. In addition to updating the IT section of the ISBER Best Practices guidelines, the IWG will write two series of best practices articles for the ISBER newsletter to review standard terminology and existing standards and their uses. To raise awareness of biobanking IT issues the IWG plans to: 1) partner with other ISBER WGs to provide cross-group updates and/or collaborations; 2) contribute informatics articles in ISBER newsletters; and 3) ultimately create an online resource (document library) for biobanking IT issues.
The Regulatory and Ethics WG (REWG) was originally established as the Informed Consent WG in 2008 but changed its name in 2013 to reflect the broader regulatory issues facing biobanks. Consent issues form a very important component of regulation in biobanking but many ethical issues across multinational regulations are involved in defining the utilization of biospecimens. Therefore the REWG felt that they were better represented by a name change that would embrace several points of interest of the members. The use and mechanics of informed consent as well as other approaches, such as opt-in or opt-out methods will continue to be discussed. However, other elements of regulations such as the definitions of identifiability, ownership, return of research results, and incidental findings, and the interpretations and comparisons of various government regulations are applicable for this WG. With these discussions, the REWG proposes to present white papers or seminar discussions based on the outcome of the data gathered and researched by this group. These papers and discussions may help to inform ISBER members, the biobanking community more generally, and the research community at large. They may also help to further define best practices as part of ISBER's Best Practices guidelines.
The Environmental Biospecimen (Enviro-Bio) Working Group (formerly known as the Non-Human Specimens WG), was formed in 2009 and provides a forum for international collaboration on all biological and environmental samples (i.e., microbes, plants, animals, etc.) and abiotic/chemical samples of relevance to biodiversity and human health. This WG is currently developing a strategic vision. This vision will involve a targeted campaign to help increase the Enviro-Bio presence in ISBER through: 1) increased membership; 2) increased presentations at the annual ISBER meetings; and 3) new partnerships between other environmental societies. The Group discussed targeting the veterinary medicine and agricultural scientists, which are underrepresented in the ISBER community. Additional recruitment groups could include microbiology/human microbiome, cryobiology, cell culture organizations, genomics consortiums, and natural history collections. The Enviro-Bio WG also discussed collaborations with the ISBER Membership and Marketing Committee to develop a marketing survey of Enviro-Bio colleagues for targeted recruitments. This survey will be the primary work product for the coming year and discussions about its development with the Membership and Marketing Committee are currently in progress.
The Hospital-Integrated Biorepositories WG was established in 2012 and has recently taken on new leadership. This WG will focus on biorepositories that collect biospecimens for medical research, making use of the diagnostic and curative pathways of routine medical care, and how these repositories are integrated within the health care system. It aims to identify the specific problems for hospital integrated biorepositories, notify the biorepository community about these issues, and supply a platform in order to encourage collaboration in the attempt to solve them. Three white papers will be developed in the future focusing on: 1) the provision of tissue to commercial companies; 2) the determination of charge-back costs for specimens; and 3) problems with specimen distribution.
The Rare Diseases WG was established in 2012 to address issues and concerns related to the biobanking of orphan or rare disease specimens. There are approximately 7,000 rare disorders and a large percentage of them affect children during infancy and childhood with long-term effects. Rare disease specimens are generally difficult to obtain and when available, are widely dispersed across geographical regions and among various governments, academic institutes, or privately supported biorepositories. The most challenging issue that the rare disease, and even the common disease, community is facing is the lack of metrics to determine the quality of the various biobanks and the biospecimens that are archived and distributed for research. In addition, different regulations and procedures applied by different countries, such as ethical and legal issues, ownership, and patient privacy issues makes global collaborations more difficult. This WG intends to integrate, support, and serve as a guide for advocacy groups and organizations interested in banking rare disorder specimens. The WG is currently re-organizing and recruiting membership to help develop plans in order to contribute position papers, journal publications, surveys, and awards addressing specific challenges, strategies, and opportunities. Topics of interest may include biospecimens for rare diseases, quality control for biospecimens, common data elements for biobanks, and linking specimen data to patient clinical information.
The International Repository Locator (IRL) WG was established in 2012 to address the biorepository community's need for developing a catalog of many of the existing repositories supported by members of ISBER, as well as other international biorepository organizations. The availability of a searchable, online repository/specimen locator is considered a critical research infrastructure. To maximize the value of a specimen or collection, a researcher requires the ability to locate and access certain criteria associated with those specimens. Often specimens may also be needed from multiple repositories in order to generate data with statistical rigor. After analyzing the results from a survey the WG sent out to the ISBER community in 2013, it was concluded that a web resource that can be populated with basic information concerning available specimen collections needed to be established. This web resource will increase the profile of individual repositories among key stakeholders, including ISBER, researchers, funding bodies, governments and private industry. With the generosity of Information Management Services, Inc. (IMS) a website was established and the WG is in the process of populating it with useful information for all ISBER members. The IRL WG will assemble its members soon to decide collectively on the next steps.
The Trans-Omics WG is one of the newest ISBER WGs and was formed in 2013. Trans-omics is a term used to define the combination of a series of -omics studies (i.e., genomics, transcriptomics, proteomics, metabolomics, etc.). This WG aims at sharing valuable experiences on sample collection, processing, analysis and application, cooperating with the individual members to develop relative guidance documents and standard operating procedures (SOPs), developing databases and resources, as well as associated analysis methods for Trans-Omics. Developing these guidance documents and SOPs for Trans-Omics data storage, management and application are important and could provide insight into the fundamental biology and disease development.
The Integrated Biobanking WG is also one of the newest WGs and was formally established in December of 2013. This WG will take an integrated look at the establishment and operation of biobanks as they relate to: 1) bioprocessing and analytical instruments; 2) consumables; and 3) biospecimen-related data. The initiative recognizes the importance of considering these three areas be in a comprehensive and systematic approach that entails the close collaboration of respective subject matter experts, and a coordinated framework. Currently, individual aspects of the overall coordination of a biobanking workflow are often designed in an ad-hoc and iterative rather than prospective and systematic fashion. This is neither cost effective nor conducive to resulting in optimal integration of workflows and processes, and ultimately limits the value that can be derived from a biobank. Experts representing biobank users, biobank operators, and providers of biobank supplies and biobanking services will focus on developing a compilation of biobank case studies, both ones where lack of upfront coordination has led to unsuccessful or painful post-hoc integration of workflows, as “real world biobank” failure stories, and, conversely, of examples where careful upfront planning resulted in cost savings and successful performance. Based on these experiences, practical guidelines will be developed in the form of technical specifications. These would be integrated in the next edition of the ISBER's Best Practices guidelines. The WG will interact closely with a number of the other WGs, particularly the Hospital-Integrated Biorepositories WG and the Informatics WG, and leverage complementarities between the WGs mission and its goals. The Integrated Biobanking WG will also reach out to and welcome interaction and collaboration with external organizations such as the Laboratory Robotics Interest Group (LRIG) and the ISO/TC 276.
WG guidelines have been established in order to help an ISBER member establish a new WG. These guidelines define the purpose of a WG as well as provide general information on the leadership, composition, meetings, reporting, and WG publication requirements. The ISBER Head Office also provides tools to help facilitate each of the WGs activities and provides these resources to ensure successful outputs. This includes a private Group Forum and login page on the ISBER website, a group roster to help organize the WGs membership, new teleconference lines and online calendar to allow for teleconference bookings, and a new reporting schedule to coincide with the In-Person Board of Directors meetings. This information as well as contact information for each of the WG Chairs and/or Co-Chairs listed in Table 1 can be found on the ISBER website, http://www.isber.org/?page=WorkingGroups.
In addition, the ISBER Working Group Oversight Advisory Committee, which is composed of the current ISBER Directors-At-Large, was formed to oversee the establishment and functioning of each WG and SIG and ensure these Groups activities are advancing the Society's exempt purpose. In addition to the biannual reports that are submitted by the WG Chairs and/or Co-Chairs to the Board of Directors, there is also an open communication line between the Chair of the Oversight Advisory Committee and each of the WG Chairs and/or Co-Chairs to help foster successful WG products. As shown above, the past and future development of position papers, journal publications, analytical survey tools, contributions to Best Practice guidelines, web resources, and increased ISBER membership, internationally as well as underrepresented biobanking communities, to name a few, all tackling important and often unresolved biobanking issues, are being identified with realistic solutions. The hard work and dedication from the members of each WG, as well as the cross-pollinating between ISBER WGs and the collaborations outside of ISBER to other global biobanking communities, organizations, and societies, will help advance the science and research being conducted on specimens that come from a biorepository. This not only strengthens the importance of these biorepositories but also, as stated by the ISBER Past-President, Dr. Fay Betsou, “leads to better scientific decisions and enhanced global and environmental health.”
Footnotes
Acknowledgments
I would like to thank each of the ISBER Working Group Chairs and/or Co-Chairs for providing minutes and notes from their WG meetings as well as for providing helpful and insightful comments and additions during the compilation of this report.