Information technology (IT), data systems and record administration are also critical aspects of biobanks, and efforts should be made to guarantee that these elements are effective and secure [16]. government site. As can be seen just from this overview, the topic of biobanking presents significant and distinct ethical challenges. Resources from biobanks across Europe available for research on SARS-CoV-2 and COVID-19. Edition: 7. For instance, UK Biobank states that The biotechnology and pharmaceutical industries can play an important role in realising health benefits in a practical sense by developing and improving the use of biomedical products. At present, no fully recognized guidelines for biobank classification are on record; nevertheless, a universal biobank classification system would be helpful to facilitate users in searching for biospecimens. However, while this would meet the requirements of the Declaration of Helsinki to seek consent for each individual research project impractical to the point of impossibility, the sheer numbers make this unrealistic ([22], 85). Sample, data use and protection in biobanking in Europe: legal issues. In addition, multiple representative aliquots should be obtained, when possible, because multiple freezethaw cycles may be detrimental to metabolites [76, 77]. Informed consent clearly cannot take third party rights and interests into account and thus is not fit for purpose when it comes to the ethics and governance of biobanks. Nuremberg Code. The ISO is an independent, nongovernmental international organization in which 165 national standards bodies participate, with one member per country. Therefore, biobanks can be labelled according to the type of research they intend to support: In addition, some have illustrated biobank categories based on the associated opportunities of biomarker discovery [19]: A second method of classification considers the type of samples collected, such as biobanks collecting frozen tissues, formalin-fixed paraffin-embedded (FFPE) tissues, cells, whole blood and derivatives, urine, buccal cells and saliva, bone marrow aspirate, semen, hair, nails and nucleic acids (DNA, RNA, cDNA/mRNA, microRNA) [3, 15]. Accountability, governance and biobanks: the ethics and governance committee as guardian or as toothless tiger? SPIDIA4P was recently acknowledged as one of three success stories by the European Commission. Finally, biobanks should define disaster recovery plans to avoid loss of biological material following natural and human-made disasters [3, 10, 32]. Based on these definitions, boundaries between biobanks and other research collections cannot be considered clear-cut [6]. Circulating tumour cells, nucleic acids and vesicles can be isolated from blood samples (liquid biopsy). Ethical Issues Related to Biobanking Canberra. Biobanking in health care: evolution and future directions. Methods Mol Biol1897:716. Austin, L. M., Lemmens, T. (2009). In addition, they are very time-consuming and consequently very expensive. In Respect for Autonomy: its Demands and Limits in Biobanking, Iain Law takes up the question of autonomy, more specifically the notion of autonomy employed in discussions of informed consent and the level of information required to respect such autonomy. Morals and ethical issues of biobanking In many aspects of biobanking ethical concerns are generally exist because the biobanks involved the human occupying their autonomy that produce a large number of moral issues (Budimir et al., 2011). Governing population genomics. In discussing respectful responses to participant and community interests, including benefit-sharing, GFBR participants agreed that research findings and knowledge produced should be communicated to research participants and their relevant communities in a cycle of engagement. Hence her article provides a critical view of the legal framework within which ethical issues and recommendations are discussed, and of how this framework might be improved. A lack of quality control is damaging the scientific literature by spreading misinformation [83]. However, participants may not regard no further use as full withdrawal; they might imagine full withdrawal would allow them to remove all records of their involvement. 2). The .gov means its official. BRIF systematically tracks and quantifies the use of a bioresource in the academic literature, thus enabling recognition of the work performed and encouraging stakeholders to efficiently share these resources [81, 82]. These include: understanding and responsibility for governance, lack of a legal framework and regulations, monitoring and enforcement, conflict of interest, exploitation, the remit of research ethics committees, maintenance of biobanks, technical abilities to govern, capacity and institutionalized ways of doing things that are difficult to change, lack of data expertise, long-term storage of personal health information and samples single group, institution or multiple users) [18, 20]. 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. Nevertheless, following the description provided by the European Commission biobanks: In addition, biobanks are focused on the public interest rather than being concerned with individual benefits for the participants themselves and aim to provide a public benefit for future generations [6] through the translation and application of research findings [9]. A culmination of these efforts can be found in NCI's Best Practices for Biospecimen Resources. Biobanking: Potential Applications and Ethical Concerns - JEAS Kalkman S, Mostert M, Gerlinger C, et al. (2004). A guidance document produced by the government of South Australia suggests that a defined purpose or business plan is key, and governance, funding and other financial considerations, data and specimen management and consent must be considered [9]. Lost property? van de Wetering M, Francies HE, Francis JM, et al. Ethics. NHMRC (2010) National Health and Medical Research Council Biobanks information paper. Section24. http://www.wma.net/en/30publications/10policies/b3/index.html. Conte N, Mason JC, Halmagyi C, et al. 7, 193194. and transmitted securely. The IARC document provides detailed guidance on how to define the recovery plan and what are the key steps to be considered. Just as with property and profiteering there is as yet no one way which is viewed as best practice and, as in so much of biobanking practice, what is good ethics and governance is yet to be determined in this area. Guerrera F, Tabbo F, Bessone L, et al. From the perspective of precision and personalized medicine, it is necessary that even biobanks start to move towards a patient-centred approach [26]. Final Report Summary - BBMRI (Biobanking and biomolecular resources research infrastructure) - report summary - FP7 - CORDIS - European Commission. Knowledge, perceptions and attitude of Egyptian physicians - PLOS The importance of moral legal and issues of society are mainly found in society as confirmed by the many . The Global Forum on Bioethics in Research (GFBR) convened in Stellenbosch, South Africa in November 2018, to explore the ethics of data sharing and biobanking in health research. A. COVID-19 biospecimen guidelines - University of California San Francisco. A possible way to prevent consequences of the SARS-CoV-2 pandemic on the future use of materials from biobanks for research activities is for biobanks to separately store all human samples collected during the COVID-19 outbreak [85]. Interestingly, and worryingly for Sterckx and Van Assche, such material is deemed residual if it was extracted for diagnostic purposes, but unless the patient explicitly requests otherwise their consent to its use in research is, apparently, not merely tacitly assumed but presumed.Tacit consent to certain instances of research is one thing when a donor has agreed that their material at least may be used in some kind of research, but it is quite another in cases where no such agreement obtains. Within CEN/Technical Committee 140 for In vitro medical devices, the SPIDIA results enabled the development and introduction of the first 9 CEN Technical Specifications (CEN/TS) for preanalytical workflows in Europe. Improving the value to society and public benefit, addressing the interests of funders, researchers and participants, may help enhance the value of biobank resources and improve their long-term sustainability [34]. 2008. Health Care Anal 19, 207219 (2011). 10.1007/978-1-4939-8935-5_2. Indeed, metabolomics and lipidomics can provide useful data on disease evolution and prognosis or on reactions to nutrition or drug compounds [76]. (2004 para 80) However, given the unknown nature of future biobank research this alone is rarely thought satisfactory. 7, and very few research institutions in these countries have formal data sharing policies. To do this would not only be administratively cumbersome but more importantly overly burdensome on the donors to the point of impossibility. Whats in a sample? Additionally, BBRB and NCI have convened several workshops to identify key recommendations relevant to ethics in biospecimen collection, dissemination, and use in research. a collection of biological material and the associated data and information stored in an organized system, for a population or a large subset of a population, was introduced by the Organization for Economic Cooperation and Development (OECD) [5, 7]. However, getting this right is crucial for the survival of biobanking as participants in biobanks have a tendency to regard their contribution as a duty to other and part of being a good citizen. Such risks include the discovery of information that will affect the health of the subjects genetic relations and the possible discriminatory use of the information discovered against certain cultural, geographical and age-related groups [1]. Whilst it has been suggested that broad consent can be seen as a means of maximising autonomy ([13], p. 196) in the biobanking context, it could be taken to be its opposite: a wholesale abrogation of individual autonomy, particularly with regard to knowledge future use of their material. In pathology laboratories and biobank facilities, the possibility of optimizing access to the samples by aliquoting the tissues embedded in OCT and by performing cryostatic sections and making the frozen sections instead of the entire block available can be offered. The same applies to metastatic lesions that are typically investigated to confirm the origin of the disease and to perform biomarker analyses for additional therapeutic strategies. The pathway of a given patient is illustrated depicting the possible contribution of biobanking in the patients clinical history, either in early or advanced disease stage. Received 2021 Mar 13; Revised 2021 Jun 24; Accepted 2021 Jun 30. June 2, 2023. They argue that this is particularly the case in the rare situation where the research reveals that an individual or his family is at risk of a serious yet treatable condition ([10], p. 267). Central to the creation of PDXs and PDOs is the viability of tissues that are sampled from excised organs. Less than half of the documents reviewed (12/29; 41.4%) addressed benefit sharing as a stand-alone subject [30, 32, 33, 36-44] while the rest discussed it as one of several ethical issues in biobanking. Disclaimer. Vaught J, Rogers J, Carolin T, Compton C. Biobankonomics: developing a sustainable business model approach for the formation of a human tissue Biobank. The .gov means its official. It is additionally important to look broadly at what kinds of benefits may be generated by sharing data and samples, and the development of appropriate and accountable approaches to sharing benefits amongst researchers, communities and participants. The bioresource research impact factor/framework (BRIF) initiative has addressed the issue of the value of biobanks in terms of research impact [81]. Results Most biobanks were founded as local units to support specific research projects, so they evolved in a decentralized manner. There are two points at which the feedback of incidental findings might be an issue: when material is collected (if this is done specifically for the purposes of use in the biobank) and at some future point in research. 54. In contrast, a biobank typically handles human biospecimens and information about donors, such as demographic and lifestyle information, history of illness, treatment and clinical outcomes. For instance, research which posed a public health risk would be unacceptablewhatever the expected scientific benefitas perhaps would be research leading to developments which the donor group would not have access to (for instance, due to a high cost). Selby JV, Lipstein SH. Since the concentration of metabolites can be affected by several factors, i.e. Risk Group discusses Biobanking Trends with Dr. K. Stephen Suh, a Precision Medicine Expert, based in the United States. Understanding Ethical, Legal and Societal Issues (ELSIs) in Human Biobanking and Genomics for Research and Healthcare in Zimbabwe: The Genomics Inheritance Law Ethics and Society (GILES) initiative - PMC Journal List AAS Open Res v.2; 2019 PMC7194152 As a library, NLM provides access to scientific literature. Science, Possible consequences of the COVID-19 pandemic on the use of biospecimens from cancer biobanks for research in academia and bioindustry. Conceptualising the self in the genetic Era. In H. Widdows & C. Mullen (Eds. Biobanks are large collections of human biological materials linked to relevant personal and health information, which may include health records, family history, lifestyle and genetic information that are held predominantly for use in health and medical research [6, 9] (Fig. You can also search for this author in A valuable economic model should consider the needs of the market and the key processes of biobanking, i.e. Exploring Ethical Issues in Commercialized Biobanking Biobanking - Ethical issues & future use of samples - Healthtalk Has the biobank bubble burst? Thus what has been generally suggested is that broad consent is supplemented by other ethics and governance mechanisms which ensure that ethics is ongoing over time and that the rights and interests of wider groups, beyond just the participants, are respected [2, 12, 24]. 2023 Springer Nature Switzerland AG. We would like to acknowledge support from all collaborators participating in the Working Group Pathology and Biobanking. Widely discussed ethical issues in literature include: nature of consent (broad, restricted, tiered); who can give informed consent; information to be contained in consent forms [ 3, 5, 6, 7 ]; privacy and confidentiality issues [ 3, 8 ]; ownership of samples [ 7 ]; the role of regulation in biobanking [ 9, 10] among others. 1, 195199. This approach highlights how the role of patients in biobanking is changing: from simple donors to an active part [26]. The social and ethical issues of post-genomic human biobanks Introduction. the contents by NLM or the National Institutes of Health. OECD (2006) Organization for Economic Cooperation and Development Creation and governance of human genetic research databases. (2007). Marchi Caterina. Matzke EAM, ODonoghue S, Barnes RO, et al. New England Journal of Medicine, For instance, the SPIDIA project was launched by the European Union FP7 programme in 2008, with the participation of leading academic institutions, international organizations and life sciences companies. To have a practical idea of the biobanks available across the European area and of the type of samples they have at disposal, it may be useful to refer to the directory of the Biobanking and BioMolecular resources Research Infrastructure - European Research Infrastructure Consortium (BBMRI-ERIC) [22, 23]. Given this full confidentiality should never be promised in biobanking (or indeed in other areas of genetic research, although the linkages and scale of biobanking make the risks more likely).