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The importance of stimulating greater sharing of data for use and reuse in health research is widely recognized. To this end, the findable, accessible, interoperable, and reusable (FAIR) principles for data have been developed and widely accepted in the research community. Research biospecimens are a resource that leads to much of this health research data but are also a form of data. Therefore, the FAIR principles should apply to biospecimens. Nevertheless, there is a widespread problem of not sharing biospecimen resources that is clearly visible within the research arena. The impacts of this are likely to include diversion of precious research funds into compiling duplicate biospecimen cohorts, detraction from research productivity as researchers compete for and create duplicate resources, and deterrence of attempts to assess research reproducibility. This article explores some of the barriers that may limit availability of FAIR biospecimens. These barriers relate to the type of biospecimen collections and the characteristics of the custodians that influence their intention and interest in sharing. Barriers also relate to the ethical, legal, and social issues concerning collections, the research context of the collections, and cost and expertise involved in repurposing collections to enable sharing. Several solutions to increase sharing are identified. Some have recently been implemented, including enhancing biospecimen locators with tools to guide researchers and facilitating transfer of research collections to centralized biobank infrastructures at the conclusion of projects. New proposed solutions include improving search capabilities within publication databases, and introduction of evidence-based justifications for all new collections into peer-reviewed grant competition processes. It is recognized that there are both scientific factors and practical reasons that can impose limits to sharing biospecimens. However, funding availability, productivity, and progress in health research all stand to benefit from improved sharing of research biospecimen collections.

Academic biobanks commonly report sustainability challenges, which may be exacerbated by a lack of information on biobank value. To better understand the costs and supported outputs that contribute to biobank value, we developed a systematic, generalizable methodology to determine biobank inputs and publications arising from biobank-supported research. We then tested this in a small cohort ( n = 12) of academic cancer biobanks in New South Wales, Australia. A proforma was developed to capture monetary and in-kind biobank costing data from biobank managers and publicly available sources. Participating biobanks were grouped and compared according to the following two classifications: open- versus restricted-access and high versus low total annual costs. Our methodology provides a feasible approach for capturing comprehensive costing data for a defined period. Characterization of biobanks using this approach showed that median total costs, as well as median staffing and in-kind costs, were comparable for open- and restricted-access biobanks, as were the quantity and journal impact metrics of supported publications. High- and low-cost biobanks supported similar median numbers of publications; however, high-cost biobanks supported publications with higher median journal impact factor and Altmetric scores. Overall, 9 of 10 biobanks had higher Field-Weighted Citation Impact scores than the global average for similar publications. This is the first tested, generalizable approach to analyze the costs and publications arising from biobank-supported research. By determining explicit cost and output data, academic biobanks, funders, and policymakers can engage in or support informed redirection of resourcing and/or benchmark setting with the aim of improving biobank support of research.

Equity, diversity, and inclusion (EDI) is an established concept and is an important issue in health research. It is now recognized that measures to address EDI in research can have a positive impact on the value of health research outputs and health outcomes based on this knowledge. EDI strategies, guidelines, and education and training are now embraced by national research funders and local research organizations. However, these initiatives are very broad and not specific to the field of biobanking. We have, therefore, set out to develop and implement a formal research biobank EDI action plan. This article describes the creation of an EDI action plan that provides an intentional approach to identifying and achieving EDI actions and priorities for our research biobank. The plan is framed by the definitions of EDI and an understanding of the topics, issues, and groups within the EDI field. The plan is founded on a set of guiding principles and delineates three pillars of work that align with team, participant, and researcher domains. The plan identifies a set of 31 actions that are categorized by implementation time frames, in order to positively address EDI issues across these pillars. The completion of these actions will help us to mitigate against bias and enrich our biobanking and research services. Ultimately, our goal is to realize more diverse participation in research supported by our biobank. This would support health research to explore and better understand differences in disease biology and the efficacy of medical treatments across all people.

Introduction: It is important for many research stakeholders to know how many biobanks exist. There are several potential data sources that might be expected to provide biobank numbers, such as institutions, research funders, and literature databases (e.g., PubMed), but in practice this information is rarely available and is hard to find. However, the maturation of several online health research biobank locators (also known as directories and catalogs) that relate to 12 countries and/or states has now provided some initial data to address the question of how many health research biobanks exist in relation to population size. Methods: We have analyzed four biobank locators: the Biobanking and Biomolecular Resources Research Infrastructure-European Research Infrastructure Consortium directory, the Canadian Tissue Repository Network locator, the Australian New South Wales Australia Health Pathology locator, and the UK Clinical Research Collaboration Tissue Directory. Results: We conclude that across these locators, and in those regions with potential for high research capacity as indicated by comparable gross domestic products, there are 11-30 health research biobanks/million population (2 large biobanks with >1000 samples and a further 9-28 are medium-small biobanks). Conclusion: Many locators were established primarily to increase utilization of biobanks. However, locators may be more useful in tracking the numbers of biobanks and in assisting funders and institutions to monitor research strategy and prevent unnecessary duplication of biobank resources.

Background: Over time, researchers' demand for increased quality and quantity of biospecimens has risen. However, quality is multifaceted, ranging from simple to complex, and comes at a cost. Therefore, to be sustainable and ensure optimal utilization of their resources (supply), biobanks must consider the trends in biospecimen use to predict the needs for future biospecimen quality (demand). Methods: An unbiased selection process was used to identify research articles from across the spectrum of cancer research from the PubMed database. A set of 225 articles utilizing human biospecimens were randomly selected for review (75 articles from each of three time intervals; 2000, 2010, 2020). Criteria for determining the source and complexity of quality of biospecimens were developed and overall concordance between two independent observers abstracting the data was then confirmed ( k  = 0.87) to validate the criteria. Results: We observed increased use of dual biospecimen formats (20%-36% of articles, p  = 0.03), matched samples (16%-37% of articles, p  = 0.0033), and biospecimens with associated outcomes data (20%-49%, p  = 0.0002). In addition, the use of two or more cohorts increased over time ( p  = 0.03). The mechanism through which biospecimens were obtained also changed over time with an increase in the diversity of collection pathways used ( p  = 0.006). Conclusions: The complexity of biospecimens being used in cancer research and the diversity of collection pathways through which these are obtained has changed significantly. This observation is important for biobanks given that the cost to support the supply of biospecimens with complex extrinsic as opposed to simple intrinsic quality characteristics is greater. For biobanks to manage sustainability, optimize utilization, and meet changing research demand, they may need to adjust their operational models to better support the supply of these types of biospecimens.

Biobanks are a critical piece of Research Infrastructure (RI). However, biobanks need to accept the reality of a life cycle for RIs. Until recently, strategies to sustain biobanks have been commonly focused on ways to maintain current operational models. However, sustaining biobanks as they exist today may be increasingly challenging in the face of the disruption in health and research priorities caused by the COVID-19 pandemic. In this opinion article, we review the current and emerging future drivers of biobank value for their researchers, institutions, and funders, highlighting utilization and impact of research performed using the biobank as key measures of future value. While biobanks can only indirectly influence the specific impact of the research performed, they can transform themselves to more actively redefine utilization to their advantage. Utilization means more than the balance of samples and data in versus out. Utilization means redirecting expertise to best support end users, and importantly, closing the operating gap between biobanks and their end users who seek to find the right biospecimens and data to pursue their research. We discuss the specific role of locators (those created by public investment) in closing this gap and the need for additional tools for researchers, before and subsequent to connecting with locators. For the former, we specifically propose that more support is needed to assist researchers in the decision as to how to best obtain biospecimens and navigate the options as to whether finding existing biospecimens and data held by a biobank is the optimal solution for a given project, or whether the optimal solution is either contracting with a biobank to collect samples or creating a new biobank. We believe this type of biospecimen navigator platform will help to maximize utilization of current biobank resources, and also promote the services and expertise in biobanks to better serve researchers' needs.

Background: The permission to contact (PTC) platform is a useful mechanism to increase patient engagement and enrollment into biobanks. It provides biobanks with the ability to select specific patient cohorts and to complete consent to facilitate access to biospecimens and data. In this study, we evaluated consenting costs for a biobank to compile a research cohort based on utilizing a PTC platform to obtain consent as compared with utilizing a prospective consenting approach. Methods: In this study, we utilized a PTC platform to conduct an initial selection of potential participants for two breast cancer cohorts and to provide a "referral" to the biobank to recontact these patients to provide consent to access clinical archival biospecimens and associated data. We evaluated the effort, costs, and cohorts compiled by this approach to compare this mechanism with the alternative: compiling the same type of cohorts based on a classic biobank enrollment approach. Results: After initial diagnosis and provision of a PTC up to 12 years before, recontact was possible in 84 of 90 (74%) and 77 of 107 (72%) breast cancer patients for preinvasive (ductal carcinoma in situ [DCIS]) and invasive (triple-negative subtype) cancers. Of those recontacted, consent was completed in 42 of 84 (55%) DCIS patients and 48 of 107 (45%) triple negative breast cancer (TNBC) patients. The total cost of using PTC to recontact patients to compile these two consented cohorts was CAD $26.34 and CAD $20.11 per patient consent, respectively. Conclusions: We have demonstrated the feasibility of utilizing a PTC platform to obtain informed consent from patients for a specific study through referrals provided several years after initial PTC was provided. Depending on the existing biobank operational model and the efficiency of its processes for enrollment and obtaining broad informed consent, the implementation of a PTC platform may be an efficient and cost-effective complementary method for a biobank to enroll patients to develop criteria-specific cohorts to support research.

Impactful biobanking is underpinned by quality assurance and standardization. Several general biobank standards exist that can be associated with programs to provide different levels of conformity assessment, including the Canadian Tissue Repository Network (CTRNet) Certification program and the International Organization for Standardization (ISO) 20387 and accreditation bodies. We examined the CTRNet Required Operational Practices (2017) and ISO 20387 (2018), to compare them. Although the organization of each standard is different, both describe a set of discrete requirements (elements or subclauses) that comprise the standards that are contained in sections called chapters (CTRNet) or clauses (ISO). The standards have a similar number of requirements (CTRNet: 362, ISO: 322). To compare these standards, we reclassified the requirements in the ISO standard into 13 categories based on a combination of the chapter headings used in the ISBER and NCI Best Practices that represent important areas of biobanking activity. This categorization of requirements showed that each standard has a different emphasis reflected in different densities of requirements within distinct areas of biobanking. The ISO standard emphasizes Quality Management Systems whereas the CTRNet standard has an even coverage across the full spectrum of biobanking areas, including activities that are relevant to participant enrollment. Nevertheless, ∼60% of the requirements in the CTRNet standard match with those of the ISO standard. We conclude that these two standards have much in common but recommend that individual biobanks consider each standard carefully in the context of the purpose, focus, scale, and scope of their biobank to determine the appropriate standard to be followed.

The Canadian Tissue Repository Network (CTRNet) Biobank Certification Program was first launched in 2011 to foster translational research through improved access to high quality biospecimens. This was accomplished by creating and providing biobank education and through the establishment and deployment of common standards to harmonize biospecimen quality and approaches to governance. The CTRNet program comprises registration and certification steps as two linked phases. In the two-step registration phase, the biobank is registered into the system, and an individual completes an overview educational module. In the subsequent certification phase, biobanks undergo a seven-step process, including inviting team members, assigning and completing relevant education modules, uploading documents, and undergoing a documentation audit. As of June 2018, there were 251 biobanks engaged in the CTRNet program, 193 had completed registration, and 40 were fully certified. Over 3/4 of these biobanks completed registration within a week and over 1/3 completed certification within a month. Among registered biobanks, 163 were associated with North American institutions, while 30 were from other international locations, including Australia, Europe, and Asia. The CTRNet program enables biobanks to adopt standards with a flexible approach to accommodate different types of biobanks and a measured investment of effort, creating the foundation for increased access to high quality biospecimens.

A substantial fraction of biomedical research depends on the reliability of human biospecimens but variations in sample manipulation during collection, processing, and storage can differentially alter molecular integrity and influence interpretation of the resulting derived data. Details of biobanking processes are rarely adequately described in research publications, preventing reviewers, readers, and scientists seeking to replicate the findings, from appreciating and adequately considering preanalytical variations contributing to results. To address these shortcomings, a set of reporting guidelines, the Biospecimen Reporting for Improved Study Quality (BRISQ) criteria, were developed in 2011. In this study we evaluated the uptake and reporting of BRISQ criteria in 324 articles across four leading biomedical journals using human biospecimens and published before (161; in 2010) and after (163; in 2014) the delineation of the BRISQ guidelines. We found that even within journals recommending use of BRISQ, manuscript-level uptake. and reporting of the relevant biospecimen information is not widespread or uniform. In the future, an enhanced biospecimen reporting strategy to better serve the needs of researchers, reviewers, and journals may be considered to strengthen research reproducibility for the benefit of the research community at large.

Tumor biobanks have become critical components of the cancer research infrastructure. Consideration of how to place appropriate values on tumor biobanks is important for all stakeholders. At the level of individual biobanks, value is important in determining how to contribute to, utilize, and fund biobanks. At the level of the research system, value is important in determining how to evaluate, rationalize, and sustain or modify the investments in this infrastructure. This review considers approaches and indicators for evaluation of a biobank with a particular focus on utilization, as one important indicator of value, from the perspective of the researcher and funder. The patterns of utilization and the influence of different phases and approaches of research, and types of biobank are described, as well as strategies for biobanks to increase utilization and therefore their value to research.

Biospecimens are critical in driving health research. There is increased demand for scale and quality of biospecimens that in turn drives biobanking operational costs, influences utilization, and threatens the sustainability of individual biobanks. Biospecimen research has begun to inform the details of new biobanking standards and the steps of the biobanking process that are most important to focus on to achieve higher quality. This focus on quality is currently centered mostly on intrinsic features of biospecimens and their annotating data. This review highlights additional quality features that are important to researchers in determining the fit for purpose in their research. First, we define complex qualities as those that are mostly extrinsic to the individual biospecimen and data, and second, we provide data on the growth in demand for biospecimens with this type of quality in cancer research biobanks. Finally, we discuss why biospecimen complexity is a challenge for biobanks and utilization of existing collections, and provide examples of strategies biobanks can consider to improve their focus on this aspect of quality, as we predict that researcher demand for complex biospecimens will continue to expand in the future.

Human biospecimens are used in 40% of cancer research publications. Tumor biobanks are an important source for these biospecimens and support both prospective and retrospective research studies. Supporting retrospective research requires tumor tissue biobanks to accrue an adequate inventory, or stock, of cases comprising tumor biospecimens and associated treatment and outcomes data. We propose a model to establish appropriate targets for stocks of frozen tissue biospecimens in tumor biobanks, sufficient to support cancer research needs. Our model considers national levels of investment in academic cancer research relative to research use of cases described in publication output, and scales this to the local context of the BC Cancer Agency Tumour Tissue Repository (TTR) as an example. Adjustment factors are then applied to correct for the primary intended user base of the biobank, as well as variables intrinsic to all biobanking operations and case collection. On this basis we estimate a current target stock for the TTR of approximately 4500 cases. Local research demand derived from case release data can then be applied to fine-tune accrual targets and refine the biobank's relative portfolio of cases from different tumor sites. We recognize that current targets will need regular remodeling as research demands change over time and that our initial model has some limitations related to the need to extrapolate from available research and biobank utilization data, and does not incorporate biospecimen/case contributions within the context of a network. However, we believe the lack of models to estimate inventory targets for tumor biobanks and to better balance research demand with biospecimen supply, contributes to the hesitation of funders to provide support, and also the problems of sustainability faced by many biobanks. Creating tangible inventory targets will improve biobank efficiency, sustainability, and may also encourage increased and stable funding.

Background: Establishing the importance of biobanking in cancer research is important for research funders and for planning health research infrastructure. This study delineates the importance of biobanking to the cancer research landscape in Canada and relative to other forms of health research infrastructure., Methods: The Cancer Research Society (CRS) is a Canadian organization with a broad mission and national portfolio that funds studies across the spectrum of cancer research. We selected all 35 investigators who received CRS grants in the 2010/11 competition and then analyzed their publications from 2010 to 2014. Articles were categorized by overall research area, acknowledged source of funding, specific scientific focus, and the presence of any data that involved an 'indicator' (human biospecimens, cell lines, animal models, advanced microscopy, flow cell sorters, and next generation sequencing) of dependence on different kinds of health research infrastructures. Publications involving biobanking and utilizing biospecimens were further classified by biospecimen provenance and type of biospecimen used., Results: These investigators generated 502 (from a total of 749) papers that were related to the field of cancer research. Amongst 445 papers that contained primary data, we found no significant differences between CRS funded and 'other funded' papers in terms of biospecimen use, which occurred in 38% of articles. Overall biospecimens were mostly obtained directly from patients (17%), or indirectly from biorepositories (31%) and hospitals (46%). The proportions of studies using other tools was as follows: 54% cell lines, 32% animal models, 14% advanced microscopy, 14% flow sorters, and 8% next generation sequencing. The spectrum of research was very similar to the overall profile of cancer research in Canada in 2010., Conclusions: This study suggests that biorepositories that coordinate the activity of biobanking rank amongst the most important of established health research infrastructures as contributors to research publications.

Background: Establishing targets for case accrual is an important component of a strategic plan for a biobank. We have previously assessed overall patterns of biospecimen use in cancer research publications in selected journals. Here we extend this analysis to consider patterns of biospecimen use in relation to cancer research programs developed by individual investigators., Methods: We selected three individual cancer research investigators whose independent research programs began circa 1986, have been characterized by extensive use of human tumor biospecimens, and have primarily involved translational research in the areas of breast, lung, and ovarian cancer. We analyzed biospecimen and data usage in their career publications categorized by numbers, type, and format, and accompanying annotating data in terms of conformance with BRISQ reporting and ethics related criteria., Results: Biospecimens were used in 313/474 (66%) of publications analyzed. The average number of biospecimens used by these research programs increased six-fold from less than 1000 in 2001-2003 to greater than 6000 in 2010-2012, and the average cohort sizes per article also increased from approximately 50 to 200 cases per study over the same period in most biospecimen categories (p<0.05). The relative proportions of different formats of biospecimens used has varied significantly and continues to change with the emergence of digital biospecimen derived data. In these three translational research programs, BRISQ elements relating to 'Biobank' categories were significantly less well reported for biospecimens used in publications than data corresponding to 'Clinical chart' categories (p<0001)., Conclusions: This study shows that overall use of biospecimens in cancer research has increased significantly and that dynamic variation in the relative use of different biospecimen formats has also occurred. This study also confirms our previous findings on patterns of biospecimen use and also those concerning incomplete reporting of relevant data elements that has not improved in the past decade.

The average cohort size for tissue biospecimens used in cancer research studies has increased significantly over the last 20 years. To understand some of the factors behind changes in biospecimen use, we examined cancer research publications to characterize the relationship between specific assay techniques and biospecimen formats and products. We assessed a representative cross section of 378 publications in the journal Cancer Research that used tissue biospecimens, selected from 6 intervals between 1988 and 2010. Publications were categorized by biospecimen utilization, format type (Frozen, Formalin-Fixed Paraffin-Embedded, and Fresh), product type (RNA, DNA, Protein, Cells, and Metabolites), and types of research techniques performed. There was an increase in average biospecimen cohort size (p=0.001); relative use of Formalin-Fixed Paraffin-Embedded biospecimens (24%-68%, p<0.0001); and the proportion of techniques assaying RNA products from biospecimens (Frozen and Fresh formats, p<0.05), from 1988 to 2008. However, these trends have not continued and there has been no further increase from 2008 to 2010. While specific techniques such as 'tissue microarray' analysis appear to have driven some changes in format requirements, there is an overall trend towards techniques requiring RNA products across all formats of biospecimens in basic cancer research. Since pre-analytical variables influence gene expression (RNA levels) more than gene structure (DNA sequence), recognition of these research trends is important for biobanks when deciding priorities for the optimal preservation format and annotation of biospecimens.

Human research biobanks have rapidly expanded in the past 20 years, in terms of both their complexity and utility. To date there exists no agreement upon classification schema for these biobanks. This is an important issue to address for several reasons: to ensure that the diversity of biobanks is appreciated, to assist researchers in understanding what type of biobank they need access to, and to help institutions/funding bodies appreciate the varying level of support required for different types of biobanks. To capture the degree of complexity, specialization, and diversity that exists among human research biobanks, we propose here a new classification schema achieved using a conceptual classification approach. This schema is based on 4 functional biobank "elements" (donor/participant, design, biospecimens, and brand), which we feel are most important to the major stakeholder groups (public/participants, members of the biobank community, health care professionals/researcher users, sponsors/funders, and oversight bodies), and multiple intrinsic features or "subelements" (eg, the element "biospecimens" could be further classified based on preservation method into fixed, frozen, fresh, live, and desiccated). We further propose that the subelements relating to design (scale, accrual, data format, and data content) and brand (user, leadership, and sponsor) should be specifically recognized by individual biobanks and included in their communications to the broad stakeholder audience.

Demand for biospecimens in cancer research has increased but there are relatively few data on the trends in biospecimen usage. These data are needed to enable projection of future demand. We analyzed biospecimen usage in publications published at five-year intervals (2008, 2003, 1998, 1993, and 1988) in four cancer research journals (Cancer Research, Clinical Cancer Research, British Journal of Cancer and International Journal of Cancer). We categorized publications in three ways: 1) biospecimen utilization yes/no; 2) biospecimen cohort size; and 3) format of biospecimens used including frozen tissue, Formalin-Fixed Paraffin-Embedded (FFPE) tissue, fresh tissue, fluids, and hematological biospecimens. Biospecimens were used in 1292/3307 (39%) of publications analyzed and sufficient information was available to further classify biospecimen usage in 1228 publications. The proportion of publications in each journal using biospecimens ranged from 23% to 61% between journals, with no significant change within each journal over time. A more detailed review of tissue biospecimen use showed a significant increase in cohort sizes from 1988 to 2008 (mean 52 to 198, respectively; P < 0.0001). This reflected increased cohort sizes for both frozen and FFPE tissues from 1993 to 2008 (frozen, 59 to 119; FFPE, 66 to 194) but not fresh tissues. The relative proportion of studies using frozen or fresh tissues alone has decreased (71% to 24%) while those using FFPE alone or combined FFPE/frozen tissue cohorts has increased (24% to 72%) over this period. We conclude that the overall demand for biospecimens in cancer research has increased significantly (almost fourfold) over the past 20 years. We predict that average cohort sizes will increase by at least twofold for frozen and FFPE biospecimens over the next ten years, and that the majority of studies will be based on FFPE tissues or combined FFPE/Frozen tissue cohorts.