Biobank Infrastructure Research Articles

Abstract PO4-13-04: Added Value from Patient Advocates in a Translational Working Group: the COMET Study

Abstract Introduction: A phase III multicenter prospective randomized clinical trial called “Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET)” (NCT02926911) assesses the risks/benefits of active monitoring (AM) versus surgery for women with low-risk ductal carcinoma in situ (DCIS). It is funded by the Patient-Centered Outcomes Research Institute and enrolled 997 women between 06/30/17 and 01/13/23. Research Patient Advocates (PAs) have been embedded from the study design stage and continue to provide guidance as part of the COMET leadership team. The COMET biobank is funded by independent foundations and is managed through monthly Translational Working Group (TWG) meetings. The TWG includes PAs, clinicians, pathologists, radiologists, and researchers from multiple institutions who discuss topics like categorization of biospecimens into discovery/validation sets; development of a pathology workflow/sample tracking process; use of small samples; and potential areas of future research/technologies that may improve DCIS diagnostics, prognostics, and care management. Methods: The TWG leveraged the existing Alliance Foundation Trials, LLC biobank infrastructure and facilitates the collection, submission, storage and analysis/use of blood, tissue, and breast images collected at specified timepoints and stored in central tissue/image repositories. PAs are active and integral in the TWG, assisting with logistical issues (contracts, transfer agreements, resource requests); communicating with sites; identifying study topics and biomarkers relevant to diverse patients; providing guidance on commercial predictive/prognostic tests; promoting effective stewardship of samples; ensuring overall focus remains on advancing clinical utility; and reporting translational study results to trial participants who agreed to donate samples/images. Results: Over 90% of requested samples/images have been submitted by ˃85 sites. Each patient’s biospecimens and pathology images are linked and de-identified for research. Use of artificial intelligence (AI) is being considered to assist in sample review. TWG members have complementary areas of expertise/experience and promote active stewardship for effective management of these scarce resources. PAs have played key roles concerning equitable data-sharing and acceleration of data and material transfer agreements. They have also been active in development of standards for discovery/training sets, validation test sets; communication procedures for patient cases that progress to future breast events; ways to catalog technologies (e.g., multi-omics, AI); and in research proposal review. Consensus has been achieved regarding major issues such as authorship, biospecimen custodianship, intellectual property, and criteria relevant to patient needs. Logistical barriers, including data sharing and technicalities of biospecimen release, have been resolved. The TWG also played an integral role in resolving recruitment challenges to COMET by creating standard pathology eligibility criteria, resulting in evidence-based protocol amendments that increased accrual. A retrospective review of biospecimens has been performed to determine adequacy for ensuing correlative molecular and spatial profiling studies. Conclusion: PAs help the COMET TWG set policy, and oversee biospecimen/image collection, and biobank use and sharing. PA input also facilitates equitable, transparent research studies and technology development that can improve personalized decisions for surgery versus AM in women with low-risk DCIS. PAs in the TWG aim to integrate the diagnostic and prognostic tools developed as part of the COMET study into future patient care. Citation Format: Deborah Collyar, Desiree Basila, Thomas Lynch, Stuart Schnitt, Jeffrey Marks, Siri Strand, Terry Hyslop, Sunil Badve, Mark Watson, H. T. Carisa Le-Petross, Lars Grimm, Robert West, Anna Weiss, Anna Rapperport, Lorraine King, Rachel Factor, Marc Ryser, Ann Partridge, E Shelley Hwang, Alastair Thompson. Added Value from Patient Advocates in a Translational Working Group: the COMET Study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-13-04.

Stability and Qualification of a Legacy Fungal Collection.

Background: Microbial culture collections are valuable repositories for qualified and diverse microorganisms, playing a pivotal role in research, education, innovation, as well as in our response to current and emerging public health and societal challenges. However, such precious holdings, when not integrated in professional biobank infrastructures, may be vulnerable to major risks such as staff retirement, changes in the institutional strategy, or natural disasters. The process of preserving and rescuing "historical" collections can be long and treacherous with a loss of a part of the collection. At the Biological Resource Center of Institut Pasteur, we undertook the challenge of rescuing the dormant legacy fungal collection. Materials and Methods: A total of 64 freeze-dried strains, including yeasts and filamentous fungi, were characterized by using a polyphasic approach combining morphological features and molecular data. We assessed the viability, purity, and authenticity of selected strains isolated from multiple sources and stored for more than 20 years. Results: Our preliminary results show long-term stability of the selected strains and successful qualification in terms of purity and authentication. Moreover, based on the most recent taxonomic revisions, we updated and revised the nomenclature, where applicable. Conclusion: Our findings demonstrated the potential value of reviving historical microbial collections for biobanking and research activities and reassure us about the collection's future reopening.

Applying Findable, Accessible, Interoperable, and Reusable Principles to Biospecimens and Biobanks.

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.

Learning from serosurveillance for SARS-CoV-2 to inform pandemic preparedness and response

Learning from serosurveillance for SARS-CoV-2 to inform pandemic preparedness and response

A Review of Major Danish Biobanks: Advantages and Possibilities of Health Research in Denmark.

Biobank research may lead to an improved understanding of disease etiology and advance personalized medicine. Denmark (population ~5.9 million) provides a unique setting for population-based health research. The country is a rich source of biobanks and the universal, tax-funded healthcare system delivers routinely collected data to numerous registries and databases. By virtue of the civil registration number (assigned uniquely to all Danish citizens), biological specimens stored in biobanks can be combined with clinical and demographic data from these population-based health registries and databases. In this review, we aim to provide an understanding of advantages and possibilities of biobank research in Denmark. As knowledge about the Danish setting is needed to grasp the full potential, we first introduce the Danish healthcare system, the Civil Registration System, the population-based registries, and the interface with biobanks. We then describe the biobank infrastructures, comprising the Danish National Biobank Initiative, the Bio- and Genome Bank Denmark, and the Danish National Genome Center. Further, we briefly provide an overview of fourteen selected biobanks, including: The Danish Newborn Screening Biobank; The Danish National Birth Cohort; The Danish Twin Registry Biobank; Diet, Cancer and Health; Diet, Cancer and Health - Next generations; Danish Centre for Strategic Research in Type 2 Diabetes; Vejle Diabetes Biobank; The Copenhagen Hospital Biobank; The Copenhagen City Heart Study; The Copenhagen General Population Study; The Danish Cancer Biobank; The Danish Rheumatological Biobank; The Danish Blood Donor Study; and The Danish Pathology Databank. Last, we inform on practical aspects, such as data access, and discuss future implications.

Training in biobanking in the context of modern medical education

The development of biomedical research based on predictive, preventive and personalized medicine has served as a challenge to the formation and rapid development of a novel interdisciplinary scientific area — biobanking, the main goal of which is the long-term proper storage of biological samples and related data for use in scientific and clinical research. Qualified personnel, along with the creation and development of biobank infrastructure, provide high-quality results required for biomedicine. Education and training must reflect the changing scope of knowledge and adapt to biobanking challenges. In this regard, there is an increasing need to develop and implement educational programs for staff working in and managing biobanks, as well as researchers, doctors and students who are not familiar with this area, but plan research using bioresources. The aim of this review is to present an analysis of the main biobanking directions and training programs in the world and in Russia in order to assess the existing problems and needs.

Highlights from 2022: Innovations in Digital Health, Diagnostics, and Biomarkers

The second volume of Innovations in Digital Health, Diagnostics and Biomarkers (IDDB) has successfully come to a close. The Journal was launched during a historic pandemic, and as the fields of biomedical research and healthcare are now moving into a transition period (from the pandemic emergency towards a new normal), it is evident that the pandemic has been a universal catalyst for innovative thinking. During such transition, drivers for change have ranged from introducing new technologies to developing new operating frameworks for existing capacities, anchored in a context-dependent manner. Thus, the emerging innovations vary and often reflect a regionally defined and fragmented set of requirements.Notwithstanding the latter, manuscripts published in IDDB demonstrate wide interest in digital health, diagnostics, and biomarkers research, which defines the publishing niche that we are developing through a consistent multidisciplinary approach .[1] For example, original research by Liang et al.[2] reported the phototoxicity sensitivity for cells grown in vitro, and Pardes et al.[3] introduced the use of a mobile health platform for remote assessment of suicidal ideation, depression, and anxiety. The team of Qu et al.[4] provided a detailed review of innovative technologies for healthcare application, pointing out existing gaps, challenges, and opportunities, as well as identifying key areas where immersive technologies can impact healthcare provision. Additional articles by Medina et al.,[5] and Kozlakidis et al.[6] showcase focused areas of scientific activity, namely construction and application of biobank infrastructure for infectious diseases and a state-of-the-art review of betel nut use, respectively.Innovations are often fuelled by individual perspectives, as they emerge over a specific field of scientific activity, such as in this case. The editorial by Cheong and Wang[7] describes the Chinese experience with digital health applications in public health interventions. The commentary by Xu[8] focuses on aspects of biopsy specimen acquisition during longitudinal sampling. The inclusion of such diverse subjects and expertise is one of the unique advantages of publishing with IDDB, reducing institutional blocks that stifle further connections and limits creativity. The transdisciplinary nature of innovation is aptly demonstrated in the three related manuscripts by Arnholdt-Schmitt et al.[9–11], where original observations regarding balancing of reactive oxygen and nitrogen species (ROS and RNS, respectively) in plants, which contributes to shaping a foundational mechanism of health resilience. This group conducted pilot testing of early metabolic responses in cultured primary target cells infected with influenza H3N2 and SARS-CoV-2.The achievements made by scientists are also reported in international conference proceedings. One example is the 2021 International Society for Biological and Environmental Repositories (ISBER) virtual workshop proceedings by Ivanova and Katsaounis.[12] This report summarizes key barriers, challenges, and perceptions to digital innovations with respect to informed consent in biobanking (and wider implications for longitudinal sampling and organ donation). Additionally, IDDB has been privileged to publish the abstracts presented at the 2022 Advancing Healthcare Innovation Summit (AHIS)[13] in Cincinnati, OH, USA. As with the manuscripts mentioned above, abstracts from AHIS represent a wide geographical and subject coverage, having healthcare innovation and a strong belief in the potential impact of such innovation as their common denominator.I would personally like to thank the Journal staff for their tireless support during this second year (including social media support for @EditorsIDDB). I thank my Associate Editor, Dr Daniel Catchpoole, and the entire editorial board for continuous encouragement and scientific direction of the Journal as it continues to develop. We are excited to have two young professionals (Drs Beheshta Paiman and Gowhar Rashid) who recently joined IDDB as part of a year-long editorial fellowship. A special mention should be made for the Innovative Healthcare Institute (IHCI) that shoulders the cost of operations and publication under the leadership of Dr. Abdulrahman Jazieh. Finally, I gratefully acknowledge the many reviewers[14] who actively supported the peer-review process, which was applied to all manuscripts alike and has resulted in stronger contributions to the body of literature on healthcare innovations.

The International Society for Biological and Environmental Repositories Presents Abstracts from Its 2021 Annual Meeting Connect and Collaborate through Biobanking: Powering Innovation and Discovery May 10–14, 2021

The International Society for Biological and Environmental Repositories Presents Abstracts from Its 2021 Annual Meeting Connect and Collaborate through Biobanking: Powering Innovation and Discovery May 10–14, 2021

Return of Results in Population Studies: How Do Participants Perceive Them?

Abstract As a cornerstone of public health, epidemiology has lately undergone substantial changes enabled by, among other factors, the use of biobank infrastructures. In biobank-related research, the return of results to participants constitutes an important and complex ethical question. In this study, we qualitatively investigated how individuals perceive the results returned following their participation in cohort studies with biobanks. In our semi-structured interviews with 31 participants of two such German studies, we observed that some participants overestimate the nature of the personal information they will receive from the study. Although this misestimation does not seem to jeopardize the validity of the consent provided at recruitment, it may still represent a threat for participants’ trust in research and thus their long-term commitment, crucial for such studies. We argue that such misestimation may have ethical consequences on the principles guiding the reflection on the return of results in biobank research, i.e. autonomy, beneficence, non-maleficence and reciprocity. We suggest that shifting from the idea of directly benefiting participants through the return of research results could help focusing on benefiting society as a whole, thereby increasing research trustworthiness of population-based studies using biobanks.

Biobanks in oncology: global experience and Russian reality

One of the integral components of modern large-scale research projects in the field of medicine are biobanks. The main objective of this infrastructure is the professional collection of biological samples that can be studied with respect to a wide range of molecular biological parameters and will not lose their information value over a long storage period. These samples are made informative not only by correctly conducted preanalytical preparation at the stage of taking samples and placing them in storage, but also by detailed information support (the so-called annotated samples). The sample annotation is the fully collected personal, clinical and laboratory data about a patient. An important point of the biobank infrastructure is compliance with regulatory legal acts and ethical standards, including the procedure for signing an informed consent by a patient about voluntary donation of biological samples and the use of personal data. All this ensures the implementation of the main objective of creating biobanks the wide and uninterrupted availability of collections of biological material for researchers and developers and compliance with specific scientific tasks. This review is devoted to biobanking issues, as well as to the description and analysis of the currently existing oncological biobank infrastructure, both globally and within the Russian Federation.

Biobanks for future medicine

Abstract The use of biospecimens for biomedical research is not a new idea. Many important developments for a better understanding of diseases have been made using patient samples and related data. In former times, this was realized by individual researchers and therefore not under controlled conditions. In early times, patients were not asked for their consent and quality of biosamples and data were assessed applying subjective criteria. This has changed significantly in the past two decades especially in terms of patient consent, ethical approval and data privacy. With respect to quality, it has been extremely difficult to establish clear guidelines due to the great heterogeneity of the downstream applications. Especially in the last decade, the impact and importance of well-defined and well-organized centralized biobank infrastructures was recognized globally and enormous efforts have been undertaken to establish and operate institutional biobanks in many of the medical centers. The most recent development refers to the cooperation of biobanks at different locations. Those biobank networks enable the query for biospecimens and data across biobanks in order to collect sufficient number of samples from small disease subgroups which would not be possible for single sites. To serve this need is of utmost importance as the advances in omics technologies allow a highly sophisticated subdivision of diseases into small molecular subgroups. Moreover, the existence of many disease subgroups, which can be ideally targeted with a tailored treatment, challenges the pharma industry: in order to support the development of personalized treatment options, biobank networks offering well-defined patient samples of high quality and with rich clinical information are becoming essential partners not only in academic research but also for companies developing diagnostic tools or new therapies.

Biobanks in the Era of Genomic Data

Biobank research brings together participants, their samples and data, and researchers to provide a productive and efficient resource that advances discovery, prevention, diagnosis, and treatment. This mini-review addresses the importance of governance issues regarding consent, privacy and confidentiality, data sharing, and return of results in biobanks that utilize genomic sequencing data. With the availability of genomic sequencing data, there is renewed attention to the value of biobank research. Governance components of consent, data sharing, privacy protections, and disclosure of research results vary widely among biobanks currently established. There is no consensus standard of best practice for managing genomic data regardless of the biobank infrastructure. Understanding the various biobank research program components will aid genetics providers and other healthcare providers as they interact with biobank researchers and participants. Governance structures for biobanks will need to be informed by the engagement of participants, researchers, and regulatory agencies. Education concerning the importance of biobank research, transparency of governance structure, and the relationship of genomic data to the improvement of individual health is critical to support continued biobank research.

Performance of Finnish biobanks in nationwide pulmonary carcinoid tumour research

Finnish hospital-integrated biobanks administer millions of formalin-fixed paraffin-embedded tissue samples collected within the clinical diagnostics. According to the Finnish Biobank Act, these samples can be coupled with patients’ clinical follow-up data and the data retrieved from national health registries. We collected a nationwide pulmonary carcinoid tumour series from Finnish biobanks to study prognostic factors as well as to explore how the number of tumours found in the Finnish biobanks corresponds to the number of tumours registered by the Finnish Cancer Registry (FCR). Finnish biobanks identified 88% of the tumours registered by the FCR and were able to deliver 63%. The main reasons for lacking samples were paucity of resected primary tumour tissue, incompatible primary diagnosis, and the absence of tissue blocks in the archives. The main bottleneck in the sample application process was retrieving patient data. Altogether, we received 224 tumour samples with appropriate patient data and identified six prognostic factors for shorter disease-specific survival: age over 56 years at the time of diagnosis, tumour size over 2.5 cm, atypical histology, Ki-67 proliferation index higher than 2.5%, hilar/mediastinal lymph node involvement at the time of diagnosis, and the presence of metastatic disease. In conclusion, the Finnish biobank infrastructure offers excellent opportunities for tissue-based research. However, to be able to develop the biobank operations further, involving more medical knowledge in the sample and data acquisition process is a necessity. Also, when working with tissue samples collected over decades, histological expertise is essential for re-evaluation and re-classification of the samples.

Impact of biobanks on research outcomes in rare diseases: a systematic review

BackgroundAlleviating the burden of rare diseases requires research into new diagnostic and therapeutic strategies. We undertook a systematic review to identify and compare the impact of stand-alone registries, registries with biobanks, and rare disease biobanks on research outcomes in rare diseases.MethodsA systematic review and meta-aggregation was conducted using the preferred reporting items for systematic reviews and meta-analyses (the PRISMA statement). English language publications were sourced from PubMed, Medline, Scopus, and Web of Science. Original research papers that reported clinical, epidemiological, basic or translational research findings derived from data contained in stand-alone registries, registries with biobanks, and rare disease biobanks were considered. Articles selected for inclusion were assessed using the critical appraisal instruments by JBI-QARI. Each article was read in its entirety and findings were extracted using the online data extraction software from JBI-QARI.ResultsThirty studies including 28 rare disease resources were included in the review. Of those, 14 registries were not associated to biobank infrastructure, 9 registries were associated with biobank infrastructure, and 6 were rare disease biobank resources. Stand-alone registries had the capacity to uncover the natural history of disease and contributed to evidence-based practice. When annexed to biobank infrastructure, registries could also identify and validate biomarkers, uncover novel genes, elucidate pathogenesis at the Omics level, and develop new therapeutic strategies. Rare disease biobanks in this review had similar capacity for biological investigations, but in addition, had far greater sample numbers and higher quality laboratory techniques for quality assurance processes.DiscussionWe examined the research outcomes of three specific populations: stand-alone registries, registries with biobanks, and stand-alone rare disease biobanks and demonstrated that there are key differences among these resources. These differences are a function of the resources’ design, aims, and objectives, with each resource having a distinctive and important role in contributing to the body of knowledge for rare disease research. Whilst stand-alone registries had the capacity to uncover the natural history of disease, develop best practice, replace clinical trials, and improve patient outcomes, they were limited in their capacity to conduct basic research. The role of basic research in rare disease research is vital; scientists must first understand the pathways of disease before they can develop appropriate interventions. Rare disease biobanks, on the other hand (particularly larger biobanks), had the key infrastructure required to conduct basic research, making novel Omics discoveries, identify and validate biomarkers, uncover novel genes, and develop new therapeutic strategies. However, these stand-alone rare disease biobanks did not collect comprehensive data or impact on clinical observations like a rare disease registry.Rare disease research is important not only for rare diseases, but also for also common diseases. For example, research of low-density lipoprotein (LDL)-receptors in the rare disease known as familial hypercholesterolemia led to the discovery of statins, a drug therapy that is now used routinely to prevent heart disease.ConclusionsRare diseases are still under-researched worldwide. This review made the important observation that registries with biobanks had the function of both stand-alone registries (the capacity to collect comprehensive clinical and epidemiological data) and stand-alone rare disease biobanks (the ability to contribute to Omics research). We found registries with biobanks offer a unique, practical, cost-effective, and impactful solution for rare disease research. Linkage of stand-alone registries to rare disease biobanks will provide the appropriate resources required for the effective translation of basic research into clinical practice. Furthermore, facilitators such as collaboration, engagement, blended recruitment, pro-active marketing, broad consent, and “virtual biobank” online catalogues will, if utilised, add to the success of these resources. These important observations can serve to direct future rare diseases research efforts, ultimately improve patient outcomes and alleviate the significant burden associated with rare disease for clinicians, hospitals, society, and most importantly, the patients and their families.

From engaging publics to engaging knowledges: Enacting "appropriateness" in the Austrian biobank infrastructure.

While there is consensus on the essential importance of public engagement in further developments of biobanking, the related investigation of public views predominantly focused on the concerns expressed by the publics, and the concrete formats of public engagement, without delving into the ways these concerns are constituted. In this article, we summarize recent research on public engagement in order to describe the constitution of respective concerns as "engagement of knowledges." By shifting the focus of analysis from "publics" to "knowledges," we draw attention to the interaction dynamic through which citizens embed the new knowledge they receive during expert interactions into the stock of knowledge they already possess. Analyzing our recent investigation of public views on biobanking in the form of citizen-expert panels in the Austrian infrastructure of biobanks (BBMRI.at), we trace this dynamic through citizens' recurrent concerns that the research and consent practices related to biobanking should be "appropriate."

Taking the next step in biobanking research infrastructures: A narrative overview

BioBanking and Molecular Resource Infrastructure in Sweden (BBMRI.se) was set up in 2009 in order to harmonise the standards and processes of biobanking. The present study is a qualitative narrative overview aimed at evaluating published studies on medical and/or biobank research infrastructure. Web of Science (WOS) and PubMed databases were searched to find studies on largescale medical research infrastructures. A total of 145 articles were found, but only merely 17 made it past the exclusion criteria. Eleven of the 17 articles listed first authors affiliated with European countries. Most of the articles discussed the need for “research infrastructures” while not addressing the subject in any detail. Consequently, this study concluded that there is a pressing need for deeper and more extensive multidisciplinary collaboration, especially on how research infrastructures are structured, managed, and branded.

Biobanking 3.0: Evidence based and customer focused biobanking

Biobanking is a new and very dynamic field. To achieve long term financial sustainability of biobank infrastructures we propose that a new focus is needed on activities, products and services provided by the biobank that relate to the external stakeholder: biobanking 3.0. Earlier stages of biobanking are biobanking 1.0 (primary focus on the number of biospecimens and data) and biobanking 2.0 (primary focus on the quality of biospecimens and data). Both stages 1.0 and 2.0 are predominantly product oriented areas and have required a mostly internal focus on operational development within the biobank itself.In this paper we will introduce our concept of biobanking 3.0 which capitalizes on the earlier stages but dictates a shift in focus to enhancing the value and impact for the three major sets of external stakeholders (people/patients, funders, and research customers) and creating a path to balanced and planned investment in biobank infrastructure and the sustainability of biobanking.Biobanking 3.0 will improve real understanding as well as perceptions of value across different stakeholders. Patients and donors will appreciate seeing how their biospecimens and data are effectively used for research. Funders will value the ability to plan efficient targeting of funding and to monitor the impact of their support. Researchers will capitalize on the ability to translate their ideas into effective knowledge. Ultimately adoption of biobanking 3.0 will impact on the sustainability in the three main dimensions relevant to biobanking: social sustainability (acceptability), operational sustainability (efficiency), and financial sustainability (accomplishment).

Abstract A30: Informed consent for cancer biobank research: Case series of patients with cancer disparities in rural Maine.

Abstract One critical issue in cancer research biobanking is improving representation of America's minority and medically underserved populations. Rural populations often suffer disparities related to poverty and healthcare access, limiting their participation in cancer research. We report a case series of newly diagnosed cancer patients at Eastern Maine Medical Center (EMMC), a rural comprehensive medical center. Of 85 eligible cases, 83 (98%) consented to participate in biobanking research; 2 years later, survivors (87%) consented to 2 additional requests. We used NCI/ISBER Best Practices to create biobank infrastructure after approval by EMMC IRB and OHP HRPO. Informed consent forms were at Flesch-Kincaid 8th Grade reading level, and supplemented by NCI educational brochures. Cases lived 50-150 miles from EMMC. Of 108 candidates, 83 eligible cases (49 lung cancer; 21 breast cancer; 13 other cancers) consented to questionnaires and donation of blood and/or tissue. Of the remaining 23 cases, 2 declined; cancer was not confirmed in 12; 4 died, and 7 were ineligible. Within 2 years, 14 cases died. Of those alive, 60/69 (87%) were re-contacted and consented to additional data collection, and transfer of biospecimens to NCI's biorepository. Most cases exhibited co-morbidities with 1-3 chronic diseases (mostly cardiovascular), prior cancer history and long-term tobacco and/or alcohol consumption. Nearly 90% reported 1+ relative with cancer, while 69%, reported 1+ prior cancers. Anecdotally, willingness to consent was based on altruistic hopes that research would generate knowledge to reduce cancer incidence. In summary, cancer patients from disadvantaged rural communities will consent to participate in biobank research. Citation Format: Janet M. Hock, Deborah G. Morrison, Christopher C. Farah. Informed consent for cancer biobank research: Case series of patients with cancer disparities in rural Maine. [abstract]. In: Proceedings of the Fifth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2012 Oct 27-30; San Diego, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2012;21(10 Suppl):Abstract nr A30.

ELSI challenges and strategies of national biobank infrastructures

National biobank infrastructures are now being implemented in several European countries. Individually, biobanks are invaluable as national research resources; collectively, they are the critical elements needed for the actualization of the pan-European biobank infrastructure. The national biobank infrastructures are confronted with a number of challenges of legal, ethical, political, societal, financial and educational nature which must be articulated and addressed in order to optimize the use of the biobanks in national and international research. The community of researchers involved with these biobanks has charted the most pressing issues experienced by the national biobanks in their nascent stages of development. Our findings reveal great commonalities in the nature of the challenges that the national hubs are facing. These challen ges and the strategies developed to address them are described in this paper

Embedding biobanks as tools for personalised medicine

Many governments are seeking to improve the translation of medical research innovation by developing mechanisms to aid the flow of information between the laboratory and the clinic. The intention is that the combination of new research insights and the use of next generation sequencing technology in the clinic will lead to more and better personalised medicine outcomes. However, existing healthcare structures often maintain the sharp line between research and the clinic, which slows down the bidirectional flow of information that is needed to enable effective translation. At the same time, within the biobanking field, infrastructures are being built to enable more efficient and better quality research. As with translational research, there are a number of challenges for these biobanking initiatives. Questions remain as to the best way to utilise biobanks for translational research. Other challenges are how to ensure the sustainability of individual biobanks and the biobank infrastructures that are being developed. Sustainability requires public support for long-term funding, as well as the on-going commitment of patients and research participants to provide the raw material for biobanks and regular use by researchers. One possible solution to the challenges that are found in these two areas is to embed a biobank within the healthcare structure and to use it for healthcare and research purposes simultaneously. This paper discusses the CuraRata and the EnCoRe dynamic consent models that in combination could provide sustainability for biobanks and at the same time enable translational research.