An official website of the United States government. Author Marianna J Bledsoe 1 Affiliation 1Independent Consultant, Silver Spring, Maryland. and social issues; best practices; biobanking; ethical; informed consent; legal; regulations. Participatory and procedurally fair processes are needed to develop equitable approaches to sharing which are responsive to the interests of study participants, communities, researchers, and national institutions involved in collecting and curating data, as well as the broader public which will potentially benefit from sharing. While most of the articles looked at biobanking in general, 11 documents (37.9%) discussed biobanking within genetics/genomics research. Appropriate Consent and the use of human material for research purposes: The competent adult. Ethical challenges in biobanking: moving the agenda forward in India. 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. Loft S, Poulsen HE. 1). Science, . In this editorial we will briefly review insights relating to each of these three themes. Fortin, S., Pathmasiri, S., Grintuch, R., & Deschenes, M. (2011). (This image was created with BioRender: https://biorender.com/). Hence the issue of informed consent in relation to biobank research is one where it should be more precise. Bravo E, Calzolari A, de Castro P, et al. This article outlines the main ethical issues debated in relation to population-based genetic research biobanks. Article 14, 104114. Although guidelines are part of a body of soft law, legally non-binding recommendations, they nevertheless often carry the weight of a wide consensus of actors involved . IARCs recommendations are based on guidelines that incorporate the knowledge gained from projects such as Standardization and Improvement of Generic Preanalytical Tools and Procedures for In Vitro Diagnostics (SPIDIA), BBMRI Large Prospective Cohorts (BBMRI-LPC) and the International Genomics Consortium (IGC) as well as the European Committee for Standardization (French, Comit Europen de Normalisation, CEN), Technical Specifications for molecular in vitro diagnostic examinations and International Organization for Standardization (ISO) norm [3]. June 2, 2023. Concerns have arisen that international data-sharing mandates are insufficiently responsive to LMIC country perspectives, interests and contexts, and that the disproportionate availability of resources in wealthy institutions means that while high income countries (HICs) are well equipped to make use of data shared from LMICs, the reverse is less often true Sachs N, de Ligt J, Kopper O, et al. The role of infrastructures in biobanking is to arrange encounters among researchers, biobanks, industry and patients to offer tools, software, quality management services and support with ethical and legal issues. Undoubtedly, the COVID-19 pandemic has led to a new, critical and urgent challenge in the field of biobanking and has highlighted the power of biobanking as well as the need for accurate quality assurance, traceability and financial investment in biobanking to allow scientific research to be conducted while guaranteeing the safety of all procedures and personnel. Thus the ethical worry is that if consent is to something as yet unknown, how can it be informed so as to respect individual autonomy [12]? 8600 Rockville Pike Especially for biobanks which are large-scale and intended to build and expand over a significant amount of time, such a model of seeking consent at the beginning of every individual research project is just not possible. Epub 2022 Jun 27. The charitable trust as a model for genomic biobanks. 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. Campbell LD, Astrin JJ, DeSouza Y, et al. There is little yet written on how recontact should be managed. Common minimum technical standards and protocols for biobanks dedicated to cancer research, IARC Techn. Between the individual and the community: The impact of genetics on ethical models. 4. There are a series of interrelated but distinct social, political and ethical issues raised by biobanking: the challenges of creating governance structures that win public confidence in these novel and uncertain scientific initiatives; the establishment of appropriate systems of consent; determining the rights of ownership, commercial . Whats in a sample? International Standard ISO for biobanking: scopes and structure, The requirements defined by ISO 20387:2018 concern resources, processes, manipulation, QC of biological material and associated data and the quality management system, The document contains a Confidentiality section stating that biobanks should protect the confidential information and proprietary rights of providers/donors, recipients and users, A biobank should have procedures for safe handling, packaging, transport and reception relevant to the biological material concerned and should ensure the traceability of biological material and associated data from collection and acquisition or reception to distribution and disposal or destruction, The specimen collection procedure should follow workflows based on existing ISO documents, ISO 20387:2018 emphasizes that when the material for the biobank coincides with samples requiring clinical assessment and/or diagnosis, the process should be performed by qualified personnel and that specimen collection should never affect patient care, The reliability of the collected specimens is assured by QC activities that biobanks should perform to demonstrate the fitness for the intended purpose of the biological material and associated data and to provide objective evidence of the comparability and quality of biological material, To provide support in the implementation of the requirements by ISO 20,387:2018, To achieve staff expertise and the proper quality of biological material and data collections, Interpretation of ISO 20387:2018 requirements, Legend: ISO, International Organization for Standardization; QC, quality control, A new document has been published, ISO/TR 22758:2020 Biotechnology - Biobanking - Implementation guide for ISO 20,387, which provides support for implementing the requirements of ISO 20387:2018 [96] (Table (Table11). COVID-19 Research | BBMRI-ERIC: making new treatments possible. 349, 11801184. . OECD best practice guidelines for biological resource centres - OECD. An official website of the United States government. This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Genetics and confidentiality. In addition to tracking the involvement of biobanks in scientific production, it would also be advisable to be able to verify the origin and quality of specimens used in scientific papers. There is not enough time to do much more than to list these and outline the ethical debate, but this in itself is sufficient to show why biobanking challenges traditional ethical assumptions and has been given so much attention in the field of ethics. 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). Before Biobanks raise many ethical concerns, to which authorities are responding by introducing specific 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]. Governing population genomics. Increasing recognition of the need for collective action to address global health issues is driving a rapid expansion of multinational research activities incorporating biobanking and data sharing. Recommendations for collaborative paediatric research including biobanking in Europe: a Single Hub and Access point for paediatric Rheumatology . Starting from cancer, biobanks were linked to the ambitious chance of screening and treating any disease [1]. When working with PDXs and PDOs, it may also be useful to know about the activity of The Living Biobank at the Princess Margaret (PMLB) Cancer Centre [71], which is a collaboration between PM researchers and the UHN Biospecimen Core to establish a central repository and provide services for the use of PDO and PDX models. Clment B, Yuille M, Zaltoukal K et al (2014) Public biobanks: calculation and recovery of costs. The research partly leading to the discussed results has received funding from FONDAZIONE AIRC under 5 per Mille 2018 ID 21091 programme P.I. PubMed Accordingly biobanks have largely rejected informed consent and moved to other models of consent, such as broad and blanket consent, often supplemented with additional ethics and governance mechanisms. the contents by NLM or the National Institutes of Health. Therefore, one solution to the problems of attaining consent for future projects is to ask for informed consent not for participating in the biobank in general, but for the specific research projects. Critical financial challenges for biobanking: report of a National Cancer Institute Study. Medical Law Review, BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based expert centres. Lazzari L, Corti G, Picco G, et al. ISO standards comprise therefore rules, guidelines, processes, specifications or characteristics to standardize procedures and allow users to perform tasks in consistent and repeatable ways. ISO (2018) International Standard ISO 20387:2018 - Biotechnology - Biobanking - General requirements for biobanking, First Edit. These range from participant and/or consultative panels, patient and public decision-making groups, citizens inquiries, participant and public shareholding in the biobank, to participant and public seats on the biobank board. Holub P, Swertz M, Reihs R, et al. Standards set minimum requirements for safety, reliability, efficiency and trust. Bioethics, Chalmers D, Nicol D, Kaye J, et al. This would allow scientists to obtain details on how the samples were processed, to find suitable collections for their experiments and to know the details of the treatment to compare the results obtained with samples from different biobanks [84]. Ethical Legal and Social Issues of Biobanking: Past, Present, and Future Biopreserv Biobank. Sapey T, Py JY, Barnoux M, et al. Interim guidelines for clinical specimens for COVID-19 | CDC. Improving academic biobank value and sustainability through an outputs focus. Rethinking informed consent in bioethics. Exploring topics ranging from lethal autonomous weapons to the opportunity costs of segregated neighborhoods to the ethics of conservation movements, our eight Honors students enjoyed . All of the authors agreed on the final version of the manuscript. Has the biobank bubble burst? (2002). American Journal of Bioethics, Unlike the initial visit the data which will be collected from the MRI is not easily available elsewhere (as blood pressure results are, for example), thus this scan might be the only point at which access to these results might be possible. Careers. Allen, J., & McNamara, B. Haslacher H, Gerner M, Hofer P, et al. Declaration of Helsinki (2008). Casado Da Rocha, A., & Seoane, J. Thus the public interest must be a determining criterion when it comes to allowing access to the resource. Article However, there are reasons for adhering to the no property rule when it is applied to samples in biobanks: Some reasons are practical as allowing property in biobank samples would hinder the practice of research to the extent it would be likely to become untenable; and some are ethical, they reject property in samples as this might lead to the commodification of persons [5]. Health Care Analysis 1): Malsagova and colleagues reported that large-scale epidemiological research or collections from clinical trials of new medical interventions can represent a biobank [17]. Federal government websites often end in .gov or .mil. Biobanking best practices for COVID-19 specimens and the role of LIMS. 2022 Dec 1;23(1):122. doi: 10.1186/s12910-022-00855-z. official website and that any information you provide is encrypted Though, she readily attests that there are limits. Since preanalytics and processing methods may impact the sample quality, some have proposed an approach to encourage transparency and improve reproducibility in science by suggesting biorepositories to deposit their SOPs in a centralized database. (2006) ESFRI European roadmap for research infrastructures report 2006. Marchi Caterina. BBMRI-ERIC has included an important disclaimer in its document that samples should be collected only by biobanks that are properly equipped [87]. For instance, UK biobank is in the process of attaining funding to carry out Magnetic Resonance Imaging (MRI) on a sub-section of the original participants to enhance the biobank resource. Finally, considering that all types of biospecimens and organs are potentially affected by COVID-19, these precautions should be applied to all samples. National Library of Medicine This is an issue that requires further analysis and debate. Accessibility (2007). The third problem is that biobanks are not a research project but rather a resource for research or a research library. For instance, UK Biobank grants participants the right to withdraw: at any time and without having to explain why and without penalty ([19], p. 6). For example, if an individual tests positive for a genetic condition, such as Huntingtons disease, or as a carrier of the BRCA1 or BRCA2 (indicators for breast cancer) this information has relevance for family members (consanguineous relations may wish to be tested themselves, and sexual partners may desire the information when making reproductive decisions) [21]. Received 2021 Mar 13; Revised 2021 Jun 24; Accepted 2021 Jun 30. Thus, the future-orientated nature of biobank research makes it is impossible for consent in biobanking ever to be informed consent. Overview of issues [ edit] The following table shows many of the leading controversial issues related to biobanking. and transmitted securely. 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. No data are associated with this article. The Use of Human Tissues for Research: What Investigators Need to Know. The instrument was tested by 16 European biobanks, and this experience demonstrated that financial sustainability can only be achieved if the biobank applies a cost recovery policy based on user fees that reflect the true costs faced by biobanks [35]. Rothstein, M. A. Manson, N. C., & ONeill, O. Privacy, consent, and governance. Herpel E, Koleganova N, Schreiber B, et al. 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]. To fulfil these requirements, ISO standards, which are documents that comprise rules, guidelines, processes, specifications or characteristics to standardize procedures and allow users to perform tasks in consistent and repeatable ways, are available. Catchpoole DR, Florindi F, Ahern C, et al. OECD (2009) Organization for Economic Cooperation and Development OECD guidelines on human biobanks and genetic research databases (HBGRDs). Annaratone L, Marchi C, Sapino A. Tissues under-vacuum to overcome suboptimal preservation. 1). In effect broad consent can be regarded as permission to do anything the recipient biobank sees fit with genetic material. Sapino A, Annaratone L, Marchi C. Current projects in pre-analytics: where to go? In addition it is also hoped that the wide and inter-disciplinary nature of this collection will underline and reflect both the interest in, and the importance of, biobanking, a topic that potentially impinges on so many areas of human life. Biobanks aim to support those who are working on COVID-19; however, adherence to best practices for the safe handling, processing, storage and shipment of biospecimens to reduce health risks to biobank staff is mandatory and of the utmost importance [88]. 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. PMC In this context, BBMRI-ERIC has produced a document to provide a list of resources that researchers working against COVID-19 can access via the BBMRI-ERIC network [86, 87]. Certain issues can only be tackled at scale, with cooperation and compromise from many different vectors of power, and AI is one of them. The focus on ethical aspects is strongly present through the whole biobanking research field. The bioresource research impact factor/framework (BRIF) initiative has addressed the issue of the value of biobanks in terms of research impact [81]. Alternative consent models for Biobanks: The new Spanish law on biomedical research. Public Health Genomics, The ethics of biobanking is one of the most controversial issues in current bioethics and public health debates. At the time of consent it is likely that there is little knowledge about what specific research will be done using the research subjects data. HHS Vulnerability Disclosure, Help In the preoperative phase, samples can be obtained through fine-needle aspiration and core-needle biopsy. Autonomy and trust in bioethics. The 2018 revision of the ISBER best practices: summary of changes and the editorial teams development process. However, there are different possible understandings and levels of withdrawal. The McCoy Family Center for Ethics in Society is excited to highlight our undergraduate Honors Program students and the completion of their theses. retrospective or prospective accrual, size and scope), the features of the biospecimens (e.g. Attaining these standards of informed consent is problematic for a number of reasons in biobanking. The https:// ensures that you are connecting to the As biobanks have proliferated in number and size over the past decade or more (Hoeyer 2012), they, and the "biobank research system" (Wolf et al. (This image was created with BioRender: https://biorender.com/). Epub 2016 Jun 21. government site. LaBaer J, Miceli JF, Freedman LP. Berrino E, Annaratone L, Miglio U, et al. Federal regulations governing. This system enables the categorization of biobanks following four functional elements: the type of donor/participant, the collection methods and design (e.g. PubMed Data sharing, biobanking, governance, global health, LMIC, ethics. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Malsagova K, Kopylov A, Stepanov A, et al. electronic repositories of biological samples and other related data, regardless of where the real specimens are stored (Fig. Rao A, Vaught J, Tulskie B, et al. In addition, new ethical guidelines related to biobanking have been established, as well as new regulations regarding privacy and human subject protections. In addition, they are very time-consuming and consequently very expensive. Comprehensive catalog of European biobanks. Clinical Ethics, Rush A, Catchpoole DR, Ling R, et al. 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. Biothque donneur de ltablissement franais du sang Centre-Atlantique (EFSCA): dix annes dactivits. Unauthorized use of these marks is strictly prohibited. Wichmann HE, Kuhn KA, Waldenberger M, et al. Four primary topics related to biobanking will be discussed: (i) evolution, (ii) bioethical issues, (iii) organization, and (iv) imaging. The Patient-Centered Outcomes Research Institute (PCORI) has established pathways for funding practical research by considering the patients interests [27, 28]. International standards represent documents that offer guidance, practical information and best practices created by people who will use and be impacted by them, so-called experts (Fig. In C. Lenk, N. Hoppe, & R. Andorno (Eds. But since paternalism is a feature of research ethics legislation already, incorporating AWIC should not pose an insurmountable challenge. The rationale given for the low level of feedback relates both the quality of the feedback, its usefulness and its possible negative effects ([19], p. 7). the contents by NLM or the National Institutes of Health. Acknowledging good reasons of objectivity and independent perspectives for ethics committees to exist, McHale expresses the worry that the ethics committee is nevertheless all too toothless. However, there are different models of possible engagement, from those where participants (and in some biobanks the public) are very involved in the biobankin terms of directing future research and enhancements to the resourceto a model where there is no engagement as such but the biobank merely keeps participants informed. 2008. Prospective derivation of a living organoid biobank of colorectal cancer patients. 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]. 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. 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]. Section24. http://www.wma.net/en/30publications/10policies/b3/index.html. However, even in this minimal feedback model it is judged that even in this research context, there may be occasions when staff consider there to be a professional or ethical obligation to draw attention to abnormal measurements (such as elevated blood pressure) or incidental findings (such as possible melanoma) ([19], p. 7). 2. 2008 Jun;9(6):773-81. doi: 10.2217/14622416.9.6.773. Sci Transl Med 6.10.1126/scitranslmed.3010444 [. A living biobank of breast cancer organoids captures disease heterogeneity. Biological samples that are stored for research purposes are indeed changing: one example is vital cells (e.g. May 30 (Reuters) - A New York lawyer is facing potential sanctions over an error-riddled brief he drafted with help from ChatGPT. As a library, NLM provides access to scientific literature. Cambridge Law Journal, Thus this trust is maintained by the ethics and governance procedures which accompany informed consent, but also by ensuring that the public good is actually served. FOIA Thus, UK Biobanks participants give broad consent that their samples can be used in ways which fit the stated purpose of UK Biobank; that is, to build a major resource that can support a diverse range of research intended to improve the prevention, diagnosis, and treatment of illness and the promotion of health throughout society ([19], p. 3). Conte N, Mason JC, Halmagyi C, et al. Incidental findings in brain imaging research. The Declaration of Helsinki, and other models of informed consent, assume that consent takes place at the beginning of a specific research project and the aims, benefits and risks are fully known. Developing a guideline to standardize the citation of bioresources in journal articles (CoBRA). Final Report Summary - BBMRI (Biobanking and biomolecular resources research infrastructure) - report summary - FP7 - CORDIS - European Commission. Biobank quality management in the BBMRI.be Network. Naden C (2020) ISO - Injecting quality into biobanks. sharing sensitive information, make sure youre on a federal 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). 13 Citations 5 Altmetric Metrics Abstract The development of human organoid culture models has led to unprecedented opportunities to generate self-organizing, three-dimensional miniature organs. Yuille M, van Ommen GJ, Brchot C, et al. Harati MD, Williams RR, Movassaghi M, et al (2019) An introduction to starting a biobank. Some ethicists do argue that broad or blanket consent alone is a solution to the problems of informed consent in biobanking, but most do not see this as an ethical solution on its own as it offers so little protection and few guarantees.
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