Incorporating Equity, Diversity and Inclusion in a Canadian Biobank.

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.

Principles of reproducible metabolite profiling of enriched lymphocytes in tumors and ascites from human ovarian cancer.

Identifying metabolites and delineating their immune-regulatory contribution in the tumor microenvironment is an area of intense study. Interrogating metabolites and metabolic networks among immune cell subsets and host cells from resected tissues and fluids of human patients presents a major challenge, owing to the specialized handling of samples for downstream metabolomics. To address this, we first outline the importance of collaborating with a biobank for coordinating and streamlining workflow for point of care, sample collection, processing and cryopreservation. After specimen collection, we describe our 60-min rapid bead-based cellular enrichment method that supports metabolite analysis between T cells and tumor cells by mass spectrometry. We also describe how the metabolic data can be complemented with metabolic profiling by flow cytometry. This protocol can serve as a foundation for interrogating the metabolism of cell subsets from primary human ovarian cancer.

Finding the Value in Biobanks: Enhancing the CTRNet Locator.

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.

A Permission to Contact Platform Is an Efficient and Cost-Effective Enrollment Method for a Biobank to Create Study-Specific Research Cohorts.

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.

Is Your Biobank Up to Standards? A Review of the National Canadian Tissue Repository Network Required Operational Practice Standards and the Controlled Documents of a Certified Biobank.

Ongoing quality management is an essential part of biobank operations and the creation of high quality biospecimen resources. Adhering to the standards of a national biobanking network is a way to reduce variability between individual biobank processes, resulting in cross biobank compatibility and more consistent support for health researchers. The Canadian Tissue Repository Network (CTRNet) implemented a set of required operational practices (ROPs) in 2011 and these serve as the standards and basis for the CTRNet biobank certification program. A review of these 13 ROPs covering 314 directives was conducted after 5 years to identify areas for revision and update, leading to changes to 7/314 directives (2.3%). A review of all internal controlled documents (including policies, standard operating procedures and guides, and forms for actions and processes) used by the BC Cancer Agency's Tumor Tissue Repository (BCCA-TTR) to conform to these ROPs was then conducted. Changes were made to 20/106 (19%) of BCCA-TTR documents. We conclude that a substantial fraction of internal controlled documents require updates at regular intervals to accommodate changes in best practices. Reviewing documentation is an essential aspect of keeping up to date with best practices and ensuring the quality of biospecimens and data managed by biobanks.

Business Planning for a Campus-Wide Biobank.

Biobanks are resources that facilitate research. Many biobanks exist around the world, but most tend to focus on a specific disease or research area. BC Children's Hospital and BC Women's Hospital are located on the same campus (Oak Street Campus) in Vancouver, BC, Canada. A campus-wide biobank has been established on the site of these two hospitals to collect specimens and annotated data from children or women seeking medical care at either of the hospitals. Such an initiative requires careful planning and consideration of many factors such as buy in and support of key stakeholders, governance, financial planning, and optimizing specimen collection. We developed a business plan to account for the many aspects associated with integrating the "BC Children's Hospital BioBank." This document describes the approach our business plan took for the implementation of our biobank and the progress, including deviations from the business plan. We also provide a perspective on the current status with a focus on sustainability.

The importance of biobanking in cancer research.

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.

Permission to contact (PTC)--a strategy to enhance patient engagement in translational research.

UNLABELLED: Improving patient recruitment and consent to participate in clinical studies is an important issue. The process of consent involves three steps: patient referral for contact, the preliminary interview to determine patient interest, and the informed consent discussion. We hypothesized that putting the first step of the consent process into a 'Permission to Contact' (PTC) platform would improve patient engagement, would improve the efficiency of the other steps of the process, and would be acceptable to diverse patient groups. METHODS: To test this hypothesis, four PTC platforms were established in three types of outpatient health clinics (cancer, cardiac, maternal health) in different British Columbia health centers. Each began as a research project where clinic personnel were engaged, clinic flow processes were mapped, and a design for each PTC was derived by consensus. All patients at these clinics were asked for 'permission to be contacted for future research purposes.' Patient approach and permission response rates were assessed and operational costs were estimated. RESULTS: Overall permission rates were high for all projects, but ranged from 94% of 'cancer' patients to 80% of 'congenital heart' patients who were approached (p<0.0001). Sustainability was demonstrated by stable enrollment levels after several years, and ongoing costs averaged $25 (range $12-$39) for each 'permission' across all four platforms. CONCLUSIONS: A PTC platform is a feasible mechanism to engage patients in research programs such as biobanking. It is well supported by clinic staff and receives high engagement and acceptance from patients. Patient-approach rates vary in different clinics, likely due to both clinic and PTC process factors, but this strategy provides an efficient means of engaging patients in research and sets the stage for enhanced enrollment into translational research programs.

Impact of a Permission to Contact (PTC) platform on biobank enrollment and efficiency.

The consent process involves three steps; referral for contact, preliminary interview, and informed consent discussion. We propose that the efficiency and frequency of the consent process for individual biobank related projects increases when the referral for contact is conducted by an independent "Permission to Contact" (PTC) platform within a health research organization. A PTC platform established at our center in 2007 obtains "permission to be contacted about future cancer research" from approximately 1200 patients annually. With ethics board approval, the British Columbia (BC) Cancer Agency's Tumour Tissue Repository (TTR) deployed a post-procedure consent protocol designed to obtain initial referrals from the PTC platform. This protocol was initially deployed for breast and gastrointestinal (GI) cancer patients (48% of patients), and later expanded as an option for all patients. We examined the impact on biobank accrual over a 4-year period spanning implementation of the post-procedure protocol. Within the first 2 years, while deploying an existing pre-procedure consent protocol, the TTR received, on average, 38.5 referrals/month, and consented 36.5 patients/month. Over the next 24 months, referral and consent rates increased to 68.5/month and 45.6/month, respectively, while operating both pre-procedure and post-procedure protocols. This represents a significant increase in overall referrals (1.78 fold) and consented patients (1.25 fold). For breast and GI cancer patients, referrals and consents, increased even further (2.4 and 1.6 fold, respectively). Overall, the consented/declined/unknown decision rates in the first period were 95.3%/1.2%/3.5% (n=918 approached patients), while rates in the second period were 86%/2.3%/11.7% (n=1272 approached patients). Overall, consent process costs fell by 14% per case. Patient engagement can be positively influenced by connecting a biobank with a PTC platform enhancing efficiency in obtaining consent, which is a key determinant of tumor biobank costs.