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This paper analyses the information disclosures in two biobank consent documents used by biobanks operating under the General Data Protection Regulation (GDPR). The aim of the analysis is to investigate how these documents inform potential sample donors about possible future uses of biobank data. The findings suggest that the consent documents provide potentially misleading information regarding the range of possible future uses of biobank data. Based on these information disclosures, potential sample donors may reasonably believe that the data can only be used for a narrowly defined range of research purposes. However, the range of lawful uses of the data is much broader and less clearly defined. Consent provided based on misleading information is not morally transformative, even if it were legally valid. To facilitate morally transformative biobank consent, this paper provides two recommendations for information disclosure to potential sample donors regarding future uses of biobank data: first, potential sample donors should be informed about the legal scope of consent; and second, they should be informed about the full range of lawful uses of biobank data., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)

Genome Resources Banks (GRBs) represent vital repositories for the systematic collection, storage, and management of genetic material across various taxa, with a primary objective of safeguarding genetic diversity for research and practical applications. Alongside the development of assisted reproductive techniques (ART), GRBs have evolved into indispensable tools in conservation, offering opportunities for species preservation, mitigating inbreeding risks, and facilitating genetic management across fragmented populations. By preserving genetic information in a suspended state, GRBs serve as backups against population vulnerabilities, potentially aiding in the restoration of endangered species and extending their genetic lifespan. While evidence demonstrates the efficacy of GRBs, ethical considerations surrounding biobanking procedures for wildlife conservation remain largely unexplored. In this article, we will discuss possible ethical issues related to GRBs and the need to ethically monitor biobanking procedures in wildlife conservation. We will then propose a methodological tool, ETHAS, already in use for the ethical self-assessment of assisted reproduction techniques, to assess also biobanking procedures. ETHAS can make it possible to monitor a GRB from its design phase to its actual operation, helping to build biobanking procedures that meet high ethical standards., Competing Interests: Declarations of competing interest Declarations of interest: none., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

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.

Cell culture banks play a crucial role in advancing biomedical research by providing standardized, reproducible biological materials essential for various applications, from drug development to regenerative medicine. This opinion article presents a comprehensive overview of cell culture banks, exploring their establishment, maintenance, and characterization processes. The significance of ethical considerations and regulatory frameworks governing the use of cell lines is discussed, emphasizing the importance of quality control and validation in ensuring the integrity of research outcomes. Additionally, the diverse types of cell culture banks-primary cells, immortalized cell lines, and stem cells-and their specific contributions to different fields such as cancer research, virology, and tissue engineering are examined. The impact of technological advancements on cell banking practices is also highlighted, including automation and biobanking software that enhance efficiency and data management. Furthermore, challenges faced by researchers in accessing high-quality cell lines are addressed, along with proposed strategies for improving collaboration between academic institutions and commercial entities. By unlocking the potential of cell culture banks through these discussions, this article aims to underline their indispensable role in driving innovation within biomedical research and fostering future discoveries that could lead to significant therapeutic breakthroughs.

Biobanks are essential for biomedical research, particularly in the era of personalized medicine. In Germany, 36 biobanks have been established over the past decade that are connected under the German Biobank Alliance (GBA). These biobanks store high-quality biological samples along with clinical data to support research projects. Biobanks can be integrated, handling both tissue and liquid samples, or set up as separate entities depending on specific requirements.Tissue biobanking is especially complex due to the invasive nature of tissue collection and the non-replicability of the samples. Close collaboration between clinics, pathologists, IT specialists, and biobank managers is crucial to ensure the quality of samples and promote interdisciplinary research.The integration of pathology and biobanking is key, both organizationally and technically. Shared IT systems, standardized protocols, and collaborative governance structures are vital for efficient data management. Quality assurance, ethical guidelines, and data protection are critical to maintaining public trust and legal compliance.Long-term financial models are needed to ensure the sustainability of biobanks. The GBA supports emerging biobanks through its "Starterkit" initiative, offering guidance and best practices to help new biobanks develop.Tissue biobanks are indispensable for advancing the understanding of diseases and developing new therapies. However, they must adhere to strict ethical and legal standards to maximize their scientific and societal value., Competing Interests: Einhaltung ethischer Richtlinien. Interessenkonflikt: K. Steiger, A. Langer und A. Brobeil geben an, dass kein Interessenkonflikt besteht. Für diesen Beitrag wurden von den Autor/-innen keine Studien an Menschen oder Tieren durchgeführt. Für die aufgeführten Studien gelten die jeweils dort angegebenen ethischen Richtlinien. The supplement containing this article is not sponsored by industry., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

The working group set up by the SEAP-IAP addresses in this Part II some general considerations and five particular considerations to be taken into account when a biological sample of human origin, coming from our archives, acquires a different destination from the usual one, in this case for research. From this moment on, we must follow mandatory legal and ethical rules, and the different recitals provide us with guidelines to ensure good practice, both for biological material and its associated data. The traditional task of custody given to the Pathological Anatomy is approached, as always, from the point of view of responsibility and, in this article, adjusted to its time., (Copyright © 2024 Sociedad Española de Anatomía Patológica. All rights reserved.)

Background: The growing diffusion of artificial intelligence, data science and digital health has highlighted the role of collection of data and biological samples, thus raising legal and ethical concerns regarding its use and dissemination. Further, the expansion of biobanking, from the basic collection of frozen specimens to the virtual biobanks of specimens and associated data that exist today, has given a revolutionary potential on healthcare systems, particularly in the field of neurological diseases, due to the inaccessibility of central nervous system and the need of non-invasive investigation approaches. Informed Consent (IC) is considered mandatory in all research studies and specimen collections, and must specifically take into account the ethical respect to the individuals to whom the used biological material and data belong., Methods: We evaluated the attitudes of patients with neurological diseases (NP) and healthy volunteers (HV) towards the donation of biological samples to a biobank for future research studies on neurological diseases, and limitations on the use of data, related to the requirements set by the General Data Protection Regulation (GDPR). The study involved a total of 1454 subjects, including 502 HVs and 952 NPs, recruited at Santa Lucia Foundation IRCCS, Rome, from 2020 to 2024., Results: We found that (i) almost all subjects agreed with the participation in biobanking (ii) and authorization to genetic studies (HV = 99.1%; NP = 98.3%); Regarding the return of results, (iii) we found a statistically significant difference between NP and HV, the latter preferring not to be informed of potential results (HV = 43%; NP = 11.3%; p < 0.0001); (iv) a small number limited the sharing inside European Union (EU) (HV = 4.6%; NP = 6.6%), whereas patients were more likely to refuse transfer outside EU (HV = 7.4%; NP = 10.7% p = 0.05); (v) nearly all patients agreed with the use of additional health data from EMR for research purposes (98.9%)., Conclusions: Consent for the donation of material for research purposes is crucial for biobanking and biomedical research studies that use biological material of human origin. Here, we have shown that choices regarding participation in a neurological biobank can be different between HVs and NPs, even if the benefit for research and scientific progress is recognized. NP have a strong interest in being informed of possible results but limit sharing of samples, highlighting a perception of greater individual or relative benefit, while HV prefer a wide dissemination and sharing of data but not to have the return of the results, favoring a possible benefit for society and knowledge. The results underline the need to carefully manage biological material and data collected in biobanks, in compliance with the GDPR and the specific requests of donors., (© 2024. The Author(s).)

Governance infrastructures streamline scientific and ethical provenance verification of human pluripotent stem cell (SC) lines. Yet, scientific developments (e.g., SC-derived embryo models, organoids) challenge research governance approaches to stored biospecimens, questioning the validity of informed consent (IC) models. Likewise, e-health platforms are driving major transformations in data processing, prompting a reappraisal of IC. Given these developments, participatory research platforms are identified as effective tools to promote longitudinal engagement, interactive decision-making, and dynamic governance. Learning from European initiatives piloting dynamic IC for biobanking and SC research, this Perspective explores the benefits and challenges of implementing dynamic IC and governance for SC., Competing Interests: Declaration of interests The authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Biobanks' activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first-hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four-step checklist aiming to facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU., (© 2023 The Authors. Developing World Bioethics published by John Wiley & Sons Ltd.)

In the well-known case of Henrietta Lacks, cells from her tumor were taken without consent and used more than 70 years ago to create the first immortal human cell line ("HeLa" cells). That event led to many scientific breakthroughs and to the debate about the ethics of consent and requirements for compensation. May 2024 saw two decisions by US federal courts-one related to Lacks-that could narrow the scope of research allowed on tissues obtained without consent and on nonidentified tissues, with implications for biomedicine.

Background: Although biobanks have become fundamental to many research centers and contribute to medical development, they generate many ethical and legal issues that may discourage patients from donating., Materials and Methods: To understand patients' perception of ethical and legal issues related to biobanks we conducted a survey among 548 Polish patients with cancer., Results: While 93.1% of patients with cancer declared themselves willing to donate biospecimens left over after a medical procedure to a biobank, most opted for one-time consent or study-specific consent, blanket consent being less frequently preferred. Many patients believed that future use of previously collected tissues require second contact. Most patients preferred pseudonymization over anonymization of the data, and supported donors' right to withdraw informed consent at any given moment. Finally, while personal health information was the most expected form of compensation for donation, most patients suggested that all parties, including the biobank concerned, the sponsors of the research, and the donors, should own the rights to cancer tissues donated and profit from the biobank research. Patients' opinions on the ethical and legal issues related to biobank research were associated with age, sex, religiosity, education level, and place of residence., Conclusions: Since biobanks generate ethical and legal issues related to informed consent, data protection and storage, as well as the sharing of biosamples, tissue ownership, and profit sharing, that may discourage patients from donation, when asking a patient for a donation, healthcare professionals should communicate in a donor-centered manner and address patients' ethical and moral concerns related to donation and offer resources to help manage these concerns., (© The Author(s) 2024. Published by Oxford University Press.)

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.

Bio-banking in research elicits numerous ethical issues related to informed consent, privacy and identifiability of samples, return of results, incidental findings, international data exchange, ownership of samples, and benefit sharing etc. In low and middle income (LMICs) countries the challenge of inadequate guidelines and regulations on the proper conduct of research compounds the ethical issues. In addition, failure to pay attention to underlying indigenous worldviews that ought to inform issues, practices and policies in Africa may exacerbate the situation. In this paper we discuss how the African context presents unique and outstanding cultural thought systems regarding the human body and biological materials that can be put into perspective in bio-bank research. We give the example of African ontology of nature presented by John Samwel Mbiti as foundational in adding value to the discourse about enhancing relevance of bio-bank research in the African context. We underline that cultural rites of passage performed on the human body in majority of communities in Africa elicit quintessential perspective on beliefs about handling of human body and human biological tissues. We conclude that acknowledgement and inclusion of African indigenous worldviews regarding the human body is essential in influencing best practices in biobank research in Africa., (© 2023 John Wiley & Sons Ltd.)

The availability of biomaterials is a key component of health research and the development of new health-technologies (including, diagnostics, medicines, and vaccines). People are often encouraged by biobanks to donate samples altruistically to such biobanks. While empirical evidence suggests many donors are motivated by the desire to contribute towards developing new health-technologies for society. However, a tension can arise as health-technologies whose development is contributed to by donors' biomaterials will often be protected by intellectual property rights (IPRs), including patents. Patents give rightsholders control over how patented technologies are used and can be used in a way that impedes public access to technologies developed. Yet, there are no binding European legal obligations mandating disclosure to donors of how IPRs can operate over downstream health-technologies and how they could impact access to health-technologies developed, nor are there legally binding obligations to ensure public accessibility of technologies developed. Focusing on the bioethical implications posed, this article argues that the current situation can impact donors' autonomy and dignity interests. A more holistic approach is needed for biobank donation, which embeds a consideration of donors' expectations/interests from the point of donation through to how such samples are used and how health-technologies developed are accessed. We put forward avenues that seek to address such issues., (© The Author(s) 2024. Published by Oxford University Press.)

Biobanking-the storage of human biological samples, including tissue, blood, urine, and genetic data-raises many ethical, legal, and social issues, including confidentiality and privacy. Pediatric biobanking is more complicated, with difficulties arising because children lack capacity to consent and acquire this capacity upon maturity when the research is still ongoing. Yet given the limited availability of pediatric samples, the translational nature of biobanking presents a unique opportunity to share samples and produce clinically necessary information about pediatric development and diseases. Guidance on navigating these legal and ethical difficulties is needed for those involved in pediatric biobanking-including researchers, participants, and families, and those involved in biobank governance. This paper seeks to map the current regulatory framework governing pediatric biobanking to determine what guidance is currently offered. Regulatory mapping of current international and national guidelines on pediatric biobanking addressing the ethical, legal, and social nuances of pediatric biobanking was undertaken. This paper finds that international guidelines around biobanking are mostly for adults, and even when pediatric-specific, documents are non-binding, inconsistent, or only limited guidance is offered on a range of important issues specific to pediatric biobanks.   Conclusion: This paper shows a need for consistent, comprehensive, and clear regulation on pediatric biobanking so that research can more quickly, efficiently, and ethically be translated to useful information and treatment in pediatric care. What is Known: • Pediatric biobanking presents new opportunities to conduct valuable translational research to benefit pediatric populations. However, the storage of pediatric biological samples raises many ethical, legal and social issues-in part because child participants may be considered to lack capacity to consent but can acquire this capacity upon maturity when the research is still ongoing. Pediatric biobanks must grapple with issues of consent, confidentiality and privacy, and long-term participation regarding child participants. What is New: • Regulatory guidance on these ethical, legal, and social issues is needed for researchers, participants, and families and those involved in biobank governance. This paper identifies nationally specific and international guidance on biobanking and summarizes the guidance provided in relation to these pediatric specific issues. It finds that most guidance is non-binding and inconsistent between guidance documents and may offer only limited guidance to stakeholders. A need for consistent, comprehensive, and clear regulation on pediatric biobanking is needed at an international level to enable research., (© 2024. The Author(s).)

Ethical considerations for the banking of oocytes for nonautologous use are discussed., (Copyright © 2021 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Disease-relevant human induced pluripotent stem cells (iPSCs) are generated worldwide for research purposes; however, without robust and practical ethical, legal, and quality standards, there is a high risk that their true potential will not be realized. Best practices for tissue procurement, iPSC reprogramming, day-to-day cultivation, quality control, and data management aligned with an ethical and legal framework must be included into daily operations to ensure their promise is maximized. Here we discuss key learning experiences from 7 years of operating the European Bank for induced Pluripotent Stem Cells (EBiSC) and recommend how to incorporate solutions into a daily management framework., (Copyright © 2021 Fraunhofer Institut fû¥r Biomedizinische Technik. Published by Elsevier Inc. All rights reserved.)

The term "biobanking" is often misapplied to any collection of human biological materials (biospecimens) regardless of requirements related to ethical and legal issues or the standardization of different processes involved in tissue collection. A proper definition of biobanks is large collections of biospecimens linked to relevant personal and health information (health records, family history, lifestyle, genetic information) that are held predominantly for use in health and medical research. In addition, the International Organization for Standardization, in illustrating the requirements for biobanking (ISO 20387:2018), stresses the concept of biobanks being legal entities driving the process of acquisition and storage together with some or all of the activities related to collection, preparation, preservation, testing, analysing and distributing defined biological material as well as related information and data. In this review article, we aim to discuss the basic principles of biobanking, spanning from definitions to classification systems, standardization processes and documents, sustainability and ethical and legal requirements. We also deal with emerging specimens that are currently being generated and shaping the so-called next-generation biobanking, and we provide pragmatic examples of cancer-associated biobanking by discussing the process behind the construction of a biobank and the infrastructures supporting the implementation of biobanking in scientific research., (© 2021. The Author(s).)

Aim: Organoid technology has enormous potential for precision medicine, such as has recently been demonstrated in the field of cystic fibrosis. However, storage and use of organoids has been associated with ethical challenges and there is currently a lack of harmony in regulation and guidelines to govern the rapid emergence of 'organoid medicine'. Developing sound governance demands incorporation of the perspectives of patients as key stakeholders. Materials & methods: We conducted 17 semi-structured interviews with people with cystic fibrosis to explore their perspectives on the ethics and governance of organoid biobanking. Results: We identified three themes: prioritization of research and trust, ambivalent views on commercial involvement and transparency and control. Conclusion: Our study offers important insights for ethically robust governance of 'organoid medicine'.

Various forms of private investment are considered necessary for the sustainability of biobanks, yet pose significant challenges to public trust. To manage this tension, it is vital to identify the concerns of relevant stakeholders to ensure effective and acceptable policy and practice. This research examines the aspects of commercialisation that are of most concern to the Australian public (n = 800) and patients who had donated their tissue to two large disease specific (cancer) public biobanks (n = 564). Overall, we found a commercialisation effect (higher support for public relative to private) in relation to funding, research location and access to stored biospecimens. The effect was strongest for research locations and access compared to funding. A latent class analysis revealed the pattern of concern differed, with the majority (34.1%) opposing all aspects of commercialisation, a minority supporting all (15.7%), one quarter (26.8%) opposing some (sharing and selling tissue) but not others (research locations and funding), and a group who were unsure about most aspects but opposed selling tissue (23.5%). Patient donors were found to be more accepting of and unsure about most aspects of commercialisation. Members of the (general) public who were motivated to participate in biobanking were more likely to oppose some aspects while supporting others, while those who indicated they would not donate to a biobank were more likely to oppose all aspects of commercialisation. The results suggest that approaches to policy, engagement and awareness raising need to be tailored for different publics and patient groups to increase participation.

In the early days of a pandemic, repurposing biospecimens from established research projects could prove to be extraordinarily useful in achieving substantial and timely public health benefits. Nonetheless, there are potential ethical and regulatory uncertainties that may impede access to those valuable biospecimens. In this article, we argue that there should be a presumption in favor of using previously collected identifiable research biospecimens without reconsent to directly address an infectious disease pandemic, assuming certain conditions are met. This argument fills a unique yet critical gap in decision-making where the specific consent accompanying the identifiable biospecimens would not otherwise permit repurposing. Further, it suggests that even if gaining reconsent is feasible, doing so in a fast-moving crisis is not necessary. This analysis also attempts to address the ethical concerns of public health authorities who already may have the power to use such specimens but are reluctant to do so., (© 2021 by The Hastings Center. All rights reserved.)

Pediatric biobanks are an indispensable resource for the research needed to bring advances in personalized medicine into pediatric medical care. It is unclear how or when these advances in medical care may reach children, but it is unlikely that research in adults will be adequate. We conducted the screening for a hypothetic problem in various European and American pediatric biobanks based on online surveys through e-mail distribution based on the Biobank Economic Modeling Tool (BEMT) questionnaire model. Participants in the survey had work experience in biobanking for at least 3 years or more. Contact information about the survey participants was confirmed on the social networks profiles (LinkedIn), as well as on generally available websites. First, we tried creating a model which can show the pediatric preclinical and basic clinical phase relationship and demonstrate how pediatric biobanking is linked to this process. Furthermore, we tried to look for new trends, and the final goal is to put the acquired knowledge into practice, so medical experts and patients could gain usable benefit from it. We concluded that leading positions must take into account ethical and legal aspects when considering the decision to include children in the biobank collection. However, communication with parents and children is essential. The biobank characteristics influence the biobank's motives to include children in the consent procedure. Moreover, the motives to include children influence how the children are involved in the consent procedure and the extent to which children are able to make voluntary decisions as part of the consent procedure., (©2020 JOURNAL of MEDICINE and LIFE.)

Research in genetics relies heavily on voluntary contributions of personal data. We aimed to acquire insights into the differences between participants and refusers of participation in a Dutch population-based biobank. Accordingly, we assessed the demographic and prosocial intrapersonal characteristics of respondents who participated (n = 2615) or refused to participate (n = 404) in the Lifelines biobank and databank. Our results indicated that health-related values critically influence participation decisions. The participation threshold for Lifelines was determined by an absence of health-related values and of trust in government. Therefore, considering these factors in communication and recruitment strategies could enhance participation in biomedical research. No indications were found of a stronger general prosociality of participants or their trust in researchers beyond the context of biobanking. This emphasizes the contextual understanding of the decision of participation in biobanking. Our findings may contribute to improving recruitment strategies by incorporating relevant values and/or highlighting prosocial benefits. Moreover, they foreground the need to address trust issues in collaborations between data repositories and commercial companies. Future research should explore how prosocial intrapersonal characteristics drive participation and withdrawal decisions and relate to contextual attributes.

Background: Biobanks are highly organized infrastructures that allow the storage of human biological specimens associated with donors' personal and clinical data. These infrastructures play a key role in the development of translational medical research. In this context, we launched, in November 2015, the first biobank in Morocco (BRO Biobank) in order to promote biomedical research and provide opportunities to include Moroccan and North African ethnic groups in international biomedical studies. Here, we present the setup and the sample characteristics of BRO Biobank., Methods: Patients were recruited at several departments of two major health-care centers in the city of Oujda. Healthy donors were enrolled during blood donation campaigns all over Eastern Morocco. From each participant, personal, clinical, and biomedical data were collected, and several biospecimens were stored. Standard operating procedures have been established in accordance with international guidelines on human biobanks., Results: Between November 2015 and July 2020, 2446 participants were recruited into the BRO Biobank, of whom 2013 were healthy donors, and 433 were patients. For healthy donors, the median age was 35 years with a range between 18 and 65 years and the consanguinity rate was 28.96%. For patients, the median age was 11 years with a range between 1 day and 83 years. Among these patients, 55% had rare diseases (hemoglobinopathies, intellectual disabilities, disorders of sex differentiation, myopathies, etc.), 13% had lung cancer, 4% suffered from hematological neoplasms, 3% were from the kidney transplantation project, and 25% had unknown diagnoses. The BRO Biobank has collected 5092 biospecimens, including blood, white blood cells, plasma, serum, urine, frozen tissue, FFPE tissue, and nucleic acids. A sample quality control has been implemented and suggested that samples of the BRO Biobank are of high quality and therefore suitable for high-throughput nucleic acid analysis., Conclusions: The BRO Biobank is the largest sample collection in Morocco, and it is ready to provide samples to national and international research projects. Therefore, the BRO Biobank is a valuable resource for advancing translational medical research., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2020 Saida Lhousni et al.)

Benefit sharing is an ethical issue that underscores the need to find a balance between access to genetic resources and the provision of fair benefits in exchange for access. The Human Genome Organisation (HUGO) is one of the few initiatives to have engaged with the topic of benefit sharing in human genomics. However, there is a lack of clarity on what benefit sharing entails in human genomics research and how it could be implemented in practice. This paper reports on a qualitative study that explored the views and expectations of benefit sharing by a group of genomics researchers in sub-Saharan Africa. Overall, while there was little awareness of benefit sharing among the researchers, there was support for benefit sharing in human genetics, and this was based on principles of fairness, solidarity, and reciprocity. This in-depth explorative study demonstrates the need for genomics research consortia in Africa to have open discussions on benefit sharing and to develop ethics frameworks for benefit sharing in population genomics studies in Africa. HUGO's statement on benefit sharing and the Nagoya Protocol could provide guidance., (© 2020 by The Hastings Center. All rights reserved.)

Freezers with biospecimen deposits became biobanks and later were networked at the pan-European level in 2013 under the Biobanking and BioMolecular Resources Research Infrastructure-European Research Infrastructure Consortium (BBMRI-ERIC). Drawing on document analysis about the BBMRI-ERIC and multi-sited fieldwork with biobankers in Spain from a science and technology studies approach, we explore what biobanks are expected to do and become under the BBMRI-ERIC framework, and how infrastructural transitions promote particular transformations in biobanking practices. The primary purpose of biobanks in Europe is presented as being to become mediators in contemporary biomedical research (global sharing nodes) distribution, and distributed nodes of samples and their associated data. We argue that infrastructural transitions are complicated and heterogeneous, giving rise to unattended local concerns on adjusting their practices to fit into the BBMRI-ERIC framework, even for non-members, as the case of Spain illustrates, where "old practices" of collection and storage are questioned. In this article, we aim to encourage qualitative studies to explore the lags between pan-European policies and prospects, different contextual interpretations, and biobanking reconfigurations as an opportunity to explore what that lag is made of (e.g. tensions with "old practices," unresolved conflicts with the national agendas, reservations on a possible centralization of the biobanking practices by regional biobanks, lack of funding, etc.). Such research could enrich not only policy guidance, but also the understanding of technoscientific infrastructures' scalability.

Direct-to-consumer (DTC) genetic testing has been a major ethical controversy related to clinical utility, the availability of pre- and post-genetic counseling, privacy concerns, and the risk of discrimination and stigmatization. The development of direct-to-consumer genetic testing cannot leave aside some considerations on how the samples are managed once the analyses have been completed and the customer has received a response. The possibility that these samples are maintained by the structure for future research uses, explains the definition, which has been proposed in the literature, of these structures such as private genetic biobanks. The most relevant aspects that may impact ethical aspects, allowing a comparison between the public and private dimensions of genetic biobanks, are mainly transparency and participant/donor trust. The article aims to analyze the main line of ethical debate related to the mentioned practices and to explore whether market-based and consumer rights regarding DTC genetic testing can be counterbalanced by healthcare system developments based on policies that encourage the donation of samples in the context of public biobanks. A platform for dialogue, both technical-scientific and ethical, is indispensable between the public sector, the private sector and citizens to truly maximize both transparency and public trust in both contexts.

Forensic Science International: Genetics and Forensic Science International: Reports communicate research on a variety of biological materials using genetics and genomic methods. Numerous guidelines have been produced to secure standardization and quality of results of scientific investigations. Yet, no specific guidelines have been produced for the ethical acquisition of such data. These guidelines summarize universally adopted principles for conducting ethical research on biological materials, and provide details of the general procedures for conducting ethical research on materials of human, animal, plant and environmental origin. Finally, the minimal ethics requirements for submission of research material are presented., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Dynamic consent has been proposed as a strategy for addressing the limitations of traditional, broad consent for biobank participation. Although the argument for dynamic consent has been made on theoretical grounds, empirical studies evaluating the potential utility of dynamic consent are needed to enhance deliberations about the merits of dynamic consent. Few studies have assessed such considerations as whether donor preferences may change over time or if participants would use a dynamic consent mechanism to modify preferences when they change. We administered a 66-item survey to participants in a large DNA biobank. The survey sought to gauge the stability of donor preferences specified at the time of biobank enrollment, specifically the stability of donors' preference regarding posthumous availability of biospecimens to next-of-kin. We received 1164 completed surveys for a response rate of 72%. Forty percent of respondents indicated a preference regarding sample availability on the survey (T2) that was inconsistent with the preference they had expressed when they enrolled in the biobank (T1). Most (94%) individuals with inconsistent preferences regarding sample availability had initially restricted sample availability at T1 but were comfortable with broader availability when asked at the time of the survey (T2). Our findings demonstrate that preferences regarding sample use expressed at the time of enrollment in a DNA biobank may not be reliable indicators of donor preferences over time. These findings lend empirical support to the case for a dynamic consent model in which biobank participants are approached over time to clarify their views regarding sample use.

While pediatric biobanks are a precious resource for scientific research to improve our understanding of genetic pathologies, the value of these studies should be considered together with the value of the privacy rights of pediatric donors, as they are particularly vulnerable and in many cases unable to discern the meaning of the donation of biological material and the related implications of the research. Thus this work calls for reflection on the numerous ethical and legal issues involved in the development and regulation of these biobanks. In particular, it explores what form of consent best balances the intangible rights of the minor, on the one hand, and the development of technological progress and scientific research, on the other, and examines the implications of the collection of biological material of minors in biobanks. It focuses on solutions to bridge the gaps in current Italian legislation, especially in light of the current lack of attention to the interests of fragile subjects. In addition, this work presents an overview of the pediatric biobanks in Italy.

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.

Broad consent is increasingly recommended as an acceptable consent model for biobanking human samples and health data with a view to their future use in research. Empirical evidence on the practice of broad consent and its implementation in the hospital setting, however, is still very limited. We analyse and discuss results from a qualitative study of perceptions of a sample of patients and biobank recruiters regarding broad consent to participate in a hospital-based biobank for prospective research on genomic and health data. Our findings suggest that contextual and relational factors play an important role in the practice of broad consent, and illustrate that broad consent relies as much on intuition as on reasoning. Moreover, we show that seeking broad consent in the hospital affects patient-recruiter interaction and that "conditional" trust plays a significant role in broad-consent decision-making. In conclusion, we provide recommendations to improve patient autonomy in the context of hospital-based broad consent.

Background: Human-based biobanks have been presented as intermediary agents between donors/participants, the scientific community, the healthcare system, and patients. The objective of this systematic review was to contribute with an updated thematic synthesis in Spanish of the international literature (2011-2018) regarding ethical, legal, and social issues on contemporary biobanks., Methods: A scoping review and thematic analysis were carried out on biobanks' ethical, legal, and social issues. The following databases were searched: Web of Science, SciELO, and Dialnet. The review included 2011-2018 publications with the term "biobank" or "biobanco" in English, Spanish, Portuguese, and French., Results: A total of 153 publications were analyzed. The most published themes were: informed consent, biobanks as a scientific tool, other ethical issues, public engagement, and regulation. While documents published in English provide studies with a broader anthropologic approach and display the participatory turn, in Spanish a technical approach is more common. Aportar datos y cifras principales., Conclusions: Publications confirm and support biobanks' relevance in current and future biomedical research, but also illustrate the entanglement of a diverse range of healthcare institutions and relations. Biobanks' techno-scientific issues cannot be split from the ethical, legal, and social ones or place them as secondary; all of them are co-produced. This review points to current topics and challenges which need to be addressed to establish transparent, accountable, dynamic, and trust-worthy biobanks.

Organoids are three-dimensional multicellular structures grown in vitro from stem cells and which recapitulate some organ function. They are derivatives of living tissue that can be stored in biobanks for a multitude of research purposes. Biobank research on organoids derived from patients is highly promising for precision medicine, which aims to target treatment to individual patients. The dominant approach for protecting the interests of biobank participants emphasizes broad consent in combination with privacy protection and ex ante (predictive) ethics review. In this paradigm, participants are positioned as passive donors; however, organoid biobanking for precision medicine purposes raises challenges that we believe cannot be adequately addressed without more ongoing involvement of patient-participants. In this Spotlight, we argue why a shift from passive donation towards more active involvement is particularly crucial for biobank research on organoids aimed at precision medicine, and suggest some approaches appropriate to this context., Competing Interests: Competing interestsThe authors declare no competing or financial interests., (© 2020. Published by The Company of Biologists Ltd.)

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.

The development and use of large and dynamic health data repositories designed to support research pose challenges to traditional informed consent models. We used semi-structured interviewing (n=44) to elicit diverse research stakeholders' views of a model of consent appropriate to participation in initiatives that entail collection, long-term storage, and undetermined future research use of multiple types of health data. We demonstrate that, when considering health data repositories, research stakeholders replace a concept of consent as informed with one in which consent is engaged. In engaged consent, a participant's ongoing relationship with a repository serves as a substitute or adjunct to information exchange at enrollment. We detail research stakeholders' views of the risks of engaged consent and suggest questions for further study about engagement and consent procedures in initiatives that aim to store data for future unspecified research purposes.

Development of biobanks in Africa raises ethical questions related to particular features of African cancer research contexts, such as underresourced health care and research infrastructures and low-average research literacy. This article describes ethical challenges of informed consent, benefit sharing, and stigmatization and proposes navigating these challenges by developing a comprehensive governance framework to ensure African leadership in biobanking research programs in Africa., (© 2020 American Medical Association. All Rights Reserved.)

Introduction: To address ethical concerns about the of future research authorization, biobanks employing a broad model of consent can design ongoing communication with contributors. Notifying contributors at the time of sample distribution provides one form of communication to supplement broad consent. However, little is known about how community-informed governance might anticipate contributor responses and inform communication efforts., Objective: We explored the attitudes of members of a three-site Community Advisory Board (CAB) network. CAB members responded to a hypothetical proposal for notifying biobank contributors at the time of sample distribution to researchers utilizing the biobank., Methods: We used regularly scheduled CAB meetings to facilitate 3 large-group and 6 small-group discussions. Discussions were audio-recorded, transcribed, and analyzed for thematic content using descriptive thematic analysis., Results: The results challenged our expectation of general support for the proposed communications. While CAB members identified some advantages, they were concerned about several potential harms to biobank contributors and the biobank. The CABs understood biobank communication in terms of an ongoing relationship with the biobank and a personal contribution to research., Conclusion: Our findings contribute to the emerging literature on community engagement in biobanking. Additional communication with biobank contributors can serve a variety of value-based objectives to supplement broad consent. Design of communication efforts by biobanks can be improved by CAB members' anticipation of the unintended consequences of additional contact with contributors. CAB members' holistic interpretation of communication efforts suggests that biobank leadership considers all communication options as part of a more comprehensive communications strategy., (© 2020 S. Karger AG, Basel.)

In response to the 2013-2016 Ebola virus disease (EVD) outbreak primarily affecting Guinea, Sierra Leone, and Liberia, the World Health Organization (WHO) set out Guidance for Managing Ethical Issues in Infectious Disease Outbreaks , which covered social distancing, research in outbreak settings, and clinical care. This article assesses the Guidance 's recommendations on research and long-term storage of biological specimens during infectious disease outbreaks and argues that the Guidance does not provide adequate direction for responders', researchers', and organizations' actions. It considers local persons' access to benefits of research in the aftermath of outbreaks and preparedness for outbreaks, drawing on lessons from both the 2013-2016 EVD outbreak and ongoing research in the Democratic Republic of the Congo., (© 2020 American Medical Association. All Rights Reserved.)

Genomic research and the biobanking capacity it requires are experiencing considerable growth on the continent of Africa. However genomic research and biobanking raise a range of legal, ethical, social, and cultural issues, including concerns about broad consent, confidentiality, community stigmatization, discrimination, indefinite storage, and long-term use. There is a need to establish governance frameworks that address these issues, and many international health research ethics and biobanking guidelines now recommend that the best way to do so is by involving potential research participants and key community stakeholders in the research development and the process of acquiring samples and data through active community engagement (CE). This article describes the experience and challenges in developing an educational tool as part of a CE initiative in South Africa and the commentaries reflect on how this process may be improved going forward.

The use of human biological materials (HBMs) involves a number of issues from both an ethical and a legal point of view. In recent decades, the purposes for which this material has been used have increased. The development of therapeutic products has led to the configuration of a market in which products have acquired an economic value. As soon as the private sector crosses the threshold of access to the use of human cells and tissues, a conflict may arise between the altruistic principles motivating the act of donation and the profit-making objectives . When donated material emerges from the public management setting and becomes a source of profit, the instrument of informed consent may not adequately protect the dignity of the donors. In the era of medical biotechnology revolution, any use of the donated material must be justified and consistent with the values motivating the act of donation.

This article provides a review of the ethical considerations that drive research policy and practice related to the genetic study of suicide. As the tenth cause of death worldwide, suicide constitutes a substantial public health concern. Biometrical studies and population-based molecular genetic studies provide compelling evidence of the utility of investigating genetic underpinnings of suicide. International, federal, and institutional policies regulating research are explored through the lenses of the ethical principles of autonomy, beneficence, non-maleficence, and justice. Trapped between the Common Rule's definition of human subjects, and the Health Insurance Portability and Accountability Act's protected information, suicide decedent data occupy an ethical gray area fraught with jurisdictional, legal, and social implications. Two avenues of research, biobanks and psychological autopsies, provide tangible application for the ethical principles examining the risks to participants and their families. Additionally, studies surveying public opinion about research methods, especially broad consent, are explored. Our approach of applying the four ethical principles to policy, sample collection, data storage, and secondary research applications can also be applied to genetic research with other populations. We conclude that broad consent for secondary research, as well as next-of-kin at the time of autopsy, serve to satisfy privacy and confidentiality under the ethical principle of autonomy. We recommend ongoing ethical evaluation of research policy and practice., (© 2019 Wiley Periodicals, Inc.)

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.