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Introduction: There is a paucity of available training opportunities on the ethical, legal, and social issues (ELSI) of biobanking in South Africa and other low- and middle-income countries. For this purpose, an online short course was developed on the ELSI of biobanking practice. Study Aims and Objectives: This study aimed to review the short course to determine its relevance for identified stakeholders in biobanking practice in South Africa. Methods: This in-depth exploratory study was conducted using a qualitative approach. Two groups of volunteers were purposively identified for the review of the course. Group 1 (Biobanking group, n = 11) comprised researchers, biobankers, postgraduate students in biobanking research, and research ethics committee members. Group 2 (Curriculum group, n = 10) comprised academics with expertise in curriculum development and review who were invited to participate in the study. A separate online open-ended questionnaire was used to collect data from each group. Both questionnaires focused on the description of the module structure and coherence. In addition, participants in Group 2 were asked to comment on the assessment strategy used. Thematic analysis was conducted on the collected data. Summary of the Study Findings: The following themes were identified as strengths and shortcomings of the developed course and suggestions to improve both the content and delivery of the course. Participants were generally satisfied with the course design and structure. The module content was seen as being clear and aligned with the learning objectives. While the course structure was seen as easy to follow, some respondents did express difficulty in navigating through the modules while others experienced varying online technical problems. The general opinion was that the assessment strategy was consistent with the course aim and objectives. Conclusion: Study participants responded positively to this course and provided constructive criticism to improve the educational offering.

Biobanks are important resources for improving public health and individual care. Some legal frameworks can be more or less conducive to advancing the potential benefits of biobanks. The purpose of this article is to assess biobanking legislation and practices in Spain to determine how well they fare in such a regard. We focus here on some of the primary ethical values that ground relevant legislation and that we believe are consistent with promoting biobanking benefits: the value of scientific research; efficient use of scarce resources; and respect for the dignity of donors. We argue that although Spanish regulations advance these values in important ways, they also have provisions that undermine them and thus risk limiting the potential benefits of biobanks. We offer some suggestions for improvement.

The ethical practices for human biobanks in China are intended to safeguard the interests of all the participants, to standardize the construction, management, and resource sharing of human biobanks, to promote the development of medical research, and to improve public health and well-being. The practices contain several chapters: General Principles; Ethics Review; Informed Consent; Privacy Protection; Benefits of Sharing; and Conflict of Interest.

Biobanking plays an important role between clinical practice and translational research. In addition to the traditional biomolecular-based biobanks, there is a growing interest in establishing living biobanks, including organoid biobanks that can collect and store viable and functional tissues and proliferative cell types for long periods of time. An organoid is a three-dimensional cell complex derived by self-organization of small tissue blocks or stem cells, which can recapitulate the phenotypic and genetic characteristics of targeted human organs. Publications on brain organoids have increased recently, and several types of brain organoids have been reported to model normal and abnormal neural development, as well as different neurodegenerative diseases, neuropsychiatric disorders, and other neural conditions. Based on the current status of research, more exploration on brain organoids is needed, through technical advancements, to improve the reproducibility and scalability, as well as to decrease the diversity. Moreover, given their natural characteristics, more attention to ethical considerations is needed, considering the extent of maturation and complexity of brain organoids. Living biobanks that are engaged in collecting categories of brain organoids possessing different genetic backgrounds, and with spatial and temporal characteristics, will eventually contribute to the understanding of neural conditions and ultimately facilitate innovative treatment development.

Introduction: Informed consent for research biospecimen donations is traditionally obtained through a face-to-face interaction with research staff and by signing an Institutional Review Board (IRB)-approved printed form. Electronic signatures (eSign) are routinely used in the electronic medical record (EMR) for the consenting of clinical services after patients review printed documentation. Our goal was to develop an electronic self-consenting workflow that mimicked clinical services. Specifically, we tested a research consent process for the biobanking of remnant clinical samples that relies solely on clinical resources in a busy outpatient practice. Materials and Methods: The Biorepositories Core Resource (BCR) unit initiated a new enterprise-wide biobanking infrastructure for consenting patients, termed Biospecimen Use for Research-Related Investigations and Translational Objectives (BURRITO). BURRITO is modeled after an established clinical process called Terms and Conditions of Service (TACOS). The TACOS requires patients to annually review printed documentation and self-consent electronically for clinical services. BURRITO also requires patients to review printed documentation and self-consent with eSign to opt-in for remnant biospecimen banking, but patients must complete this process only once. We captured eSign for consents directly into the EMR without research staff. Results: Patients reviewed the IRB-approved documents and self-consented during their cardiology clinic visit. At checkout, their participation preferences were electronically documented by clinic staff. During a 6-month period, 123 patients agreed to donate. After a review of process, a second 3-month period identified 202 patients agreeing to donate. BURRITO did not require face-to-face interactions with research staff, used a "no-paper" eSign for consent, and created discrete fields in the clinical EMR of the patient's preference. Conclusions: BURRITO electronically documents informed consent using an EMR functionality and the least amount of clinical and research resources. Our results show promise for developing institutionally adopted processes, which could leverage existing clinical workflows for universal research consenting and scalability.

Introduction: Community engagement (CE) is an ethical imperative in research, but the knowledge base for what constitutes effective and ethically sound CE is limited. Ubuntu, as a component of responsive communitarianism where communal welfare is valued together with individual autonomy, is useful in furthering our understanding of effective CE and how it could best be achieved. Similarly, a relative solidarity model serves as a compromise between extreme individualism and extreme communalism and is more appropriate in a heterogenous African context. Approaching CE from an Ubuntu philosophical perspective in southern Africa is particularly important in genomic biobanking, given the implications for individuals, families, and communities. Discussion: CE is often implemented in a tokenistic manner as an ancillary component of research. Understanding consent information is challenging where genomic biobanking is concerned due to scientific complexity. We started a process of CE around genomic biobanking and conducted empirical research in an attempt to develop a model to promote effective and ethically sound CE, using relative solidarity to create a nuanced application of Ubuntu. The TRUCE model is an eight-step model that uses social mapping to identify potential communities, establishes the scope of CE, and requires that communities are approached early. Co-creation strategies for CE are encouraged and co-ownership of knowledge production is emphasized. Recruiting and engaging communities at each stage of research is necessary. Evaluation and adaptation of CE strategies are included. Discussion and dissemination of results after the research is completed are encouraged. Conclusions: There is a significant gap between the theory of CE and its authentic application to research in Africa. This Ubuntu-inspired model facilitates bridging that gap and is particularly suited to genomic biobanking. The CE model enhances and complements the consent process and should be integrated into research as a funding and regulatory requirement where applicable.

With the ethical, legal, and societal issues (ELSI) Knowledge Base, we introduce a key element of the Biobanking and Biomolecular Resources Research Infrastructure-European Research Infrastructure Consortium (BBMRI-ERIC) Common Service ELSI, which provides ethical, legal, and societal support for researchers and biobankers involved in transnational research. In contrast to the customized support provided by the ELSI Helpdesk, the ELSI Knowledge Base will be available to the user on a self-serve basis. The information that is made available through a knowledge base comes from multiple sources, usually from several expert contributors who are well versed in the subject matter. The knowledge base provides users with a first orientation on the subject matter, as well as allowing them to explore more detailed information if desired in a self-service manner. It is crucial that the information and knowledge provided are shared in a manner that is user friendly. Long lists of links, legalistic language, and multiple links have to be avoided wherever possible. The long-term sustainability and accuracy of a knowledge base need to be ensured by placing its expert curation and technical maintenance under the responsibility of an organization rather than a research consortium. In its core, it builds on a scenario-based approach using a nonlegalistic language. In addition, the knowledge base connects to frequently asked questions, promotes contract and informed consent templates, how-to-guides, best-practice models, and scripts. The ELSI Knowledge Base is a key element of the BBMRI-ERIC Common Service ELSI, which currently serves biobanks but will be enlarged to serve the biological and medical sciences community. In contrast to the ELSI Helpdesk, which provides customized support, the ELSI Knowledge Base is available to the user on a self-serve basis. The conceptualization of the ELSI Knowledge Base builds on assessments of several ethical, legal, and societal guidance tools that favor a single sustainable knowledge base for closing the knowledge gap by providing practical hands-on guidance for researchers. Ultimately, the ELSI Knowledge Base aims at promoting practical know-how and skills for conducting responsible research.

Objective: To examine the factors that may influence Chinese parent's willingness to donate their children's biospecimens for use in pediatric research. Study Design: Parents or caregivers of the patients in the neurosurgery ward, oncological surgery ward, and internal medical wards at Shanghai Children's Medical Center were recruited during the period of March 1, 2016 to July 8, 2018. The questionnaire included the willingness to provide consent for donating their children's clinical biospecimens, their attitudes toward and motivations for donating their children's clinical biospecimens, opinions of contributing specimens, and an ethical consideration for their children's future willingness to donate biospecimens. Participants' demographic data and children's basic information were collected. Results: The majority of the participants agreed to donate the patients' biospecimens for research. Parents with pronounced religious beliefs, less education, who had only one child, child with a more severe disease, and living in an urban district were associated with negative attitudes toward biospecimen donation, but none of other parents' sociodemographic characteristics and some of the children's basic characteristics disclosed significant differences in donation attitudes. In five different types of biospecimens, parents were more reluctant to donate specific blood biospecimens. Physical pain and privacy protection were of most concern to parents when it came to donating their child's biospecimens. It was widely believed in parents that reconsent would be necessary for the 18-year-old adolescent. Conclusions: Our findings explored the factors that were of greatest worry to parents related to parents' willingness to donate their child's biospecimens in China. We recommend greater patient explanation to enhance the participant's engagement in the biospecimen donation, and the adolescent's attitude toward biospecimen donation needs further consideration.

The growing complexity of biobanking requires dedicated professional staff who are trained in multiple aspects of the biobanking process, including technical, managerial, regulatory, and ethical aspects, and who have a good understanding of the challenges of biospecimen research, but also of the challenges related to the sustainability of future biobanks. Up to the present, biobanking staff have been trained in an ad-hoc manner, usually through specific short duration courses, for example, summer schools. In this article, we describe the development/establishment of a systematic 2-year training program at the Master level intended for students with a background in life sciences and providing them with a professional qualification as a "Biobank Manager." This course was developed in 2010 as a joint initiative of the Catholic University of Lyon and the University of Nice-Sophia-Antipolis (France). The multidisciplinary training offers courses on biobank design and infrastructure, on pre- and postanalytical processing of different types of biospecimens, on protocol development, on ethical and regulatory aspects, as well as an introduction to epidemiology and translational research. In parallel, students also receive generic training in management, budget planning, data analysis, and statistics, as well as 11 months of hands-on training in various biobanks handling human, animal, plant, or microbial biospecimens. Four groups of students have graduated since 2012, for a total of 44 students, who all found jobs in biobanking within 6 months of graduation.

The past 15 years has seen considerable changes in the research environment. These changes include the development of new sophisticated genetic and genomic technologies, a proliferation of databases containing large amount of genotypic and phenotypic data, and wide-spread data sharing among many institutions, nationally and internationally. These changes have raised new questions regarding how best to protect the participants of biobanking research. In response to these questions, best practices for addressing the legal, ethical, and social issues of biobanking have been developed. In addition, new ethical guidelines related to biobanking have been established, as well as new regulations regarding privacy and human subject protections. Finally, changes in the science and the research environment have raised complex ethical issues related to biobanking, such as questions about the most appropriate consent models to use for biobanking research, commercial use and ownership issues, and whether and how to return individual research results to biobank participants. This article reviews some of the developments over the past 15 years related to the ELSI of biobanking with a look toward the future.

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.

Donation of human tissues for research and ELSI (ethical, legal, and social issues) of biobanking are increasingly debated issues. While several studies have highlighted patients' concerns, little is known about opinions and preferences of healthy potential donors. Further investigations in this respect may allow communication procedures tailored to participants' needs. Based on the Italian Twin Registry, a cross-sectional survey was conducted among twins who had not yet donated biological samples for research. The objective was to assess the importance these potential donors attributed to specific procedures and pieces of communication related to research biobanking. A self-administered questionnaire was constructed and validated. Items were as follows: potential agreement on use of biological samples for research; knowledge of biobanks; and importance given to privacy protection and to communication of general and individual tests results, study objectives, type and amount of participant involvement, location and duration of sample storage, and benefits and potential risks. Multivariate analysis was performed to estimate the association of these items with sociodemographic factors as well as with perceived health status and chronic or long-term diseases. The questionnaire was mailed to 4894 twins aged 18-65 (response rate 34%). One-third of subjects already knew about biobanks, 52% had some knowledge, and 20% were uninformed. A majority expressed unconditional agreement to sample use for research. Only 6% of respondents considered privacy protection not important in research biobanking. Knowledge of biobanks predicted attention to most of the issues. Higher education was associated with more frequent concern about type and amount of involvement, but less frequent concern about place and time of storage, and presence of benefits. Women were more attentive to research biobanking. This study supports the need of procedures tailored on different donors' concerns and highlights the social value of population biobanks. Furthermore, the results call for greater efforts in the promotion of research biobanking.

The secondary use of research and health data for purposes that differ from the original purpose of the collection is becoming a major trend in research, since it allows for the optimal use of already available resources, and reduces the costs of research activities. However, the consent provided at the time of the initial data collection might not have foreseen these new uses of the data. This is especially true for biobanks having collected data under a restricted or a disease-specific consent, and for data linkage, which allows researchers to combine research data with information from the medical record of participants. To protect the participants' privacy, confidentiality, and autonomy, the use of identifiable research and clinical data for secondary research purposes is governed by a rather complex legal and ethical framework. This article aims to: (1) provide a comprehensive analysis of the legal and bioethical framework governing the secondary use of data at the international level, and; (2) identify points of convergence and divergence with regard to the secondary use of data for research purposes, in five countries (Australia, Canada, France, United Kingdom, and United States). While the secondary use of already collected data carries benefits and drawbacks, the international and national legal framework provide guidance to promote a wider (although limited) secondary use of data, while protecting research participants' rights and interests. Despite some differences, the similarities between international and national regulations and norms reveal the emergence of a common set of criteria for the secondary use of data in international research.

Availability of and access to data and biosamples are essential in medical and translational research, where their reuse and repurposing by the wider research community can maximize their value and accelerate discovery. However, sharing human-related data or samples is complicated by ethical, legal, and social sensitivities. The specific ethical and legal requirements linked to sensitive data are often unfamiliar to life science researchers who, faced with vast amounts of complex, fragmented, and sometimes even contradictory information, may not feel competent to navigate through it. In this case, the impulse may be not to share the data in order to safeguard against unintentional misuse. Consequently, helping data providers to identify relevant ethical and legal requirements and how they might address them is an essential and frequently neglected step in removing possible hurdles to data and sample sharing in the life sciences. Here, we describe the complex regulatory context and discuss relevant online tools-one which the authors co-developed-targeted at assisting providers of sensitive data or biosamples with ethical and legal questions. The main results are (1) that the different approaches of the tools assume different user needs and prior knowledge of ethical and legal requirements, affecting how a service is designed and its usefulness, (2) that there is much potential for collaboration between tool providers, and (3) that enriched annotations of services (e.g., update status, completeness of information, and disclaimers) would increase their value and facilitate quick assessment by users. Further, there is still work to do with respect to providing researchers using sensitive data or samples with truly 'useful' tools that do not require pre-existing, in-depth knowledge of legal and ethical requirements or time to delve into the details. Ultimately, separate resources, maintained by experts familiar with the respective fields of research, may be needed while-in the longer term-harmonization and increase in ease of use will be very desirable.

Purpose: This study examined acceptability of two biobank consent models and evaluated the impact of beliefs about privacy and genetic safeguards on acceptance., Methods: U.S. adults surveyed online in English and Spanish were randomly assigned to one of two scenarios examining acceptance of broad consent (n=1528), or narrow consent (n=1533)., Results: Overall, willingness to provide broad (76%) and narrow (74%) consents were similar. African Americans were as likely as white non-Hispanics to accept narrow consent (72% vs. 77%, p=0.35) but significantly less likely to accept broad consent (69% vs. 81%, p=0.004). Education, insurance, and blood donation history were also related to acceptance. Adjusting for beliefs about privacy and policy protections (Genetic Information Nondiscrimination Act, GINA), the effects of the variables were reduced. Respondents who drew comfort from GINA were more likely to support both consent (both p<0.001); those who believed it is impossible to maintain privacy were less likely to find both broad (p=0.04) and narrow models acceptable (p=0.02)., Conclusions: Choice of consent model matters when engaging diverse populations in biobank research. Beliefs underlying concerns about privacy and genetic protections should be considered when constructing biobank protocols.

The Ethical Management Guidelines for the Shanghai Disease-Based Biobank Network are intended to safeguard the interests of all the participants, to standardize the construction, management, and resource sharing of the Shanghai Disease-based Biobank Network, to promote the development of medical research, and to improve public health and well-being. The guidelines contain seven chapters: General Principles; Informed Consent; Use of Bio-samples from Persons without the Capacity to Consent; Privacy and Confidentiality; Applications of Use of Biological Samples and Data; Intellectual Property and Resource Sharing; and Conflict of Interest.

The high burden of infectious diseases and the growing problem of noncommunicable and metabolic disease syndromes in South Africa (SA) forces a more focused research approach to facilitate cutting-edge scientific growth and public health development. Increased SA research on these diseases and syndromes and the collection of associated biospecimens has ensured a plethora of biobanks created by individuals, albeit without the foresight of prospective and collective use by other local and international researchers. As the need for access to high-quality specimens in statistically relevant numbers has increased, so has the necessity for the development of national human biobanks in SA and across the Continent. The prospects of achieving sustainable centralized biobanks are still an emerging and evolving concept, primarily and recently driven by the launch of the H3Africa consortium, which includes the development of harmonized and standardized biobanking operating procedures. This process is hindered by a myriad of complex societal considerations and ethico-legal challenges. Efforts to consolidate and standardize biological sample collections are further compromised by the lack of full appreciation by national stakeholders of the biological value inherent in these collections, and the availability of high quality human samples with well-annotated data for future scientific research and development. Inadequate or nonexistent legislative structures that specifically regulate the storage, use, dispersal, and disposal of human biological samples are common phenomena and pose further challenges. Furthermore, concerns relating to consent for unspecified future uses, as well as access to information and data protection, are all new paradigms that require further consideration and public engagement. This article reviews important fundamental issues such as governance, ethics, infrastructure, and bioinformatics that are important foundational prerequisites for the establishment and evolution of successful human biobanking in South Africa.

Although biobanks are gaining importance as tools in the field of biomedical research, enabling investigators to access large numbers of catalogued samples and/or data, most have not reached their full potential. Numerous obstacles may prohibit the efficient sharing of, and access to their sample and data collections. In order to minimize or overcome these obstacles while meeting ethical criteria, the first step is to identify the challenges to sharing between biobanks and between biobanks and researchers, thus enabling targeted solutions to be implemented. To date, no one has specifically catalogued the full scope of the barriers to sample sharing currently identified in the literature, yet such a list is essential if these matters are to be addressed. We have reviewed the literature on biobanks in order to identify the issues mentioned as barriers to sample sharing with or without data. Our literature search identified 15 barriers, including logistical, ethical, and legal issues. In this article, we provide a description of these barriers, discuss key themes, and conclude that empirical research is required to determine the full extent of the challenges addressed in the literature.

The creation of socially and technically robust biobank privacy regimes presupposes knowledge of and compliance with legal rules, professional standards of the biomedical community, and state-of-the-art data safety and security measures. The strategies in privacy management and data protection presented in this review show a trend that goes beyond searching for compromises or efforts of balancing scientific demands for efficiency and societal demands for effective privacy regimes. They focus on developing synergies that facilitate cooperative use of biomaterials and data and enhance sample search efficiency for researchers on the one hand, and protect rights and interests of donors and citizens on the other hand. Among the issues covered are: a) ethical sensitivities and public perceptions on privacy in biobanking b) tools and procedures that allow maintenance of the rights and dignity of donors, without jeopardizing legitimate information needs of researchers and autonomy of biobanks, and c) a privacy sensitive framework for sharing of data and biomaterials in the research context.

Advances in genomic platforms have led to the need for well-characterized, high quality biospecimens for research. Bladder cancer, despite being a major epidemiological concern, has been under-represented in genomic programs due to unique challenges in collection of clinical informatics and tissues. Currently no targeted therapy exists for management of the disease. We report our experiences and lessons learnt in establishing an integrated model of bladder cancer that uses a dedicated bladder cancer team and relational databases. It streamlines both clinical activity and serial harvesting of biospecimens to obtain tissue that is consistently suitable for high-throughput genomic research. Fresh tissue, blood, and urine samples were prospectively collected and stored. RNA and DNA were extracted simultaneously, quality control was performed, and whole transcriptome sequencing also performed using the illumina series of platforms. Over a 15-month period, urine was banked for 209 patients, plasma and whole blood for 185 patients, and tissue for 71 patients. The collections included normal mucosa from patients with and without bladder cancer and cancer tissue across the entire histopathogical spectrum of bladder cancer from low-grade noninvasive cancers to metastatic lymph nodes. We used a relational database to link clinical information to tumor inventory and provide access to richly annotated specimens and matched clinical informatics. We found that tumor tissue was successfully banked more often in patients who had macroscopic papillary disease compared to those without. We also show that the median RNA integrity number (RIN) scores are significantly higher in patients whose tissues were banked using cold-cup biopsies compared to those banked using electrocautery. Transcriptome sequencing of all samples banked using cold-cup biopsies passed bioinformatics quality assessment and had a mean Q30 quality score well over the illumina quality control benchmark. Such an infrastructure will allow genomic profiling of bladder cancer to help us understand the "global picture" in bladder cancer pathogenesis.

Biobank Ireland Trust (BIT) was established in 2004 to promote and develop an Irish biobank network to benefit patients, researchers, industry, and the economy. The network commenced in 2008 with two hospital biobanks and currently consists of biobanks in the four main cancer hospitals in Ireland. The St. James's Hospital (SJH) Biobank coordinates the network. Procedures, based on ISBER and NCI guidelines, are standardized across the network. Policies and documents-Patient Consent Policy, Patient Information Sheet, Biobank Consent Form, Sample and Data Access Policy (SAP), and Sample Application Form have been agreed upon (after robust discussion) for use in each hospital. An optimum sequence for document preparation and submission for review is outlined. Once consensus is reached among the participating biobanks, the SJH biobank liaises with the Research and Ethics Committees, the Office of the Data Protection Commissioner, The National Cancer Registry (NCR), patient advocate groups, researchers, and other stakeholders. The NCR provides de-identified data from its database for researchers via unique biobank codes. ELSI issues discussed include the introduction of prospective consent across the network and the return of significant research results to patients. Only 4 of 363 patients opted to be re-contacted and re-consented on each occasion that their samples are included in a new project. It was decided, after multidisciplinary discussion, that results will not be returned to patients. The SAP is modeled on those of several international networks. Biobank Ireland is affiliated with international biobanking groups-Marble Arch International Working Group, ISBER, and ESBB. The Irish government continues to deliberate on how to fund and implement biobanking nationally. Meanwhile BIT uses every opportunity to promote awareness of the benefits of biobanking in events and in the media.

While the development of large scale biobanks continues, ethics and policy challenges persist. Debate surrounds key issues such as giving and withdrawing consent, incidental findings and return of results, and ownership and control of tissue samples. Studies of public perception have demonstrated a lack of consensus on these issues, particularly in different jurisdictions. We conducted a telephone survey of members of the public in Alberta, Canada. The survey addressed the aforementioned issues, but also explored public trust in the individuals and institutions involved in biobanking research. Results show that the Alberta public is fairly consistent in their responses and that those who preferred a broad consent model were also less likely to desire continuing control and a right to withdraw samples. The study raises questions about the role of public perceptions and opinions, particularly in the absence of consensus.