Biobank Management Research Articles

DISP-07. CURRENT NEURO-ONCOLOGY CAPACITY IN SUB-SAHARAN AFRICAN COUNTRIES: A QUESTIONNAIRE-BASED SURVEY

Abstract Brain tumors constitute significant morbidity and mortality in sub-Saharan Africa (SSA). There is no previous large-scale effort focusing on brain tumor genetics in SSA. This project aims to map out the current neuro-oncology capacity in terms of workforce and available services in SSA. This is an ongoing online survey among a cross section of neuro-oncology practitioners spread across SSA countries to capture information on the distribution, number of available neuro-oncology care practitioners, capacity for neuropathology and molecular diagnosis, management of brain tumors, cancer registration, and tumor biobanking. The survey was disseminated by the Society for Neuro-oncology in SSA (SNOSSA). There were 83 respondents representing 15 countries and 52 health institutions: 46 tertiary, 4 secondary, 1 private and 1 other. Here, we present data on the 52 institutions. The prevalence of specialties was 87% neurosurgery, 75% anatomic pathology, 69% medical oncology, 64% neurology, 60% radiation oncology, and 39% neuropathology. For radiologic evaluation, 81% of institutions were reported to have both CT and MRI, 17% CT only, and one institution neither. For molecular testing, 46% have access to IHC or NGS testing, whereas 52% were reported to have neither. A neuro-oncology tumor board was reported at 58% of institutions. A general cancer registry is available in 64% of institutions, 31% have a brain tumor specific registry and 10% have a brain tumor biorepository. This study shows that SSA has substantial potential in neuro-oncology care practice capacity and facilities. Most significant gaps remain in areas such as neuropathology and molecular testing, which makes widespread implementation of the WHO 2021 diagnosis challenging. Understanding the prevalence of CNS tumor subtypes is also difficult due to low number of brain tumor registries and biobanks in SSA. The present findings reveal strategic opportunities, especially in neuropathology, tumor registries, biobanks, and infrastructure for IHC and NGS in SSA.

Data Model for the Comprehensive Management of Biobanks and Its Contribution to Personalized Medicine.

Biobanks are infrastructures essential for research involving multi-disciplinary teams and an increasing number of stakeholders. In the field of personalized medicine, biobanks play a key role through the provision of well-characterized and annotated samples protecting at the same time the right of donors. The Andalusian Public Health System Biobank (SSPA Biobank) has implemented a global information management system made up of different modules that allow for the recording, traceability and monitoring of all the information associated with the biobank operations. The data model, designed in a standardized and normalized way according to international initiatives on data harmonization, integrates the information necessary to guarantee the quality of results from research, benefiting researchers, clinicians and donors.

An Approach to Evaluate the Costs and Outputs of Academic Biobanks.

Academic biobanks commonly report sustainability challenges, which may be exacerbated by a lack of information on biobank value. To better understand the costs and supported outputs that contribute to biobank value, we developed a systematic, generalizable methodology to determine biobank inputs and publications arising from biobank-supported research. We then tested this in a small cohort (n = 12) of academic cancer biobanks in New South Wales, Australia. A proforma was developed to capture monetary and in-kind biobank costing data from biobank managers and publicly available sources. Participating biobanks were grouped and compared according to the following two classifications: open- versus restricted-access and high versus low total annual costs. Our methodology provides a feasible approach for capturing comprehensive costing data for a defined period. Characterization of biobanks using this approach showed that median total costs, as well as median staffing and in-kind costs, were comparable for open- and restricted-access biobanks, as were the quantity and journal impact metrics of supported publications. High- and low-cost biobanks supported similar median numbers of publications; however, high-cost biobanks supported publications with higher median journal impact factor and Altmetric scores. Overall, 9 of 10 biobanks had higher Field-Weighted Citation Impact scores than the global average for similar publications. This is the first tested, generalizable approach to analyze the costs and publications arising from biobank-supported research. By determining explicit cost and output data, academic biobanks, funders, and policymakers can engage in or support informed redirection of resourcing and/or benchmark setting with the aim of improving biobank support of research.

A systematic literature review of the 'commercialisation effect' on public attitudes towards biobank and genomic data repositories.

Initiatives that collect and share genomic data to advance health research are widespread and accelerating. Commercial interests in these efforts, while vital, may erode public trust and willingness to provide personal genomic data, upon which these initiatives depend. Understanding public attitudes towards providing genomic data for health research in the context of commercial involvement is critical. A PRISMA-guided search of six online academic databases identified 113 quantitative and qualitative studies using primary data pertaining to public attitudes towards commercial actors in the management, collection, access, and use of biobank and genomic data. The presence of commercial interests yields interrelated public concerns around consent, privacy and data security, trust in science and scientists, benefit sharing, and the ownership and control of health data. Carefully considered regulatory and data governance and access policies are therefore required to maintain public trust and support for genomic health initiatives.

Examining the Proposed Revisions to the Human Biobank Management Act

<p>人體生物資料庫為發展精準醫療之基石，考量科技發展之快速變遷、大數據與人工智慧於醫療領域之應用，人體生物資料庫管理條例之修訂亦將引領我國健康資料治理法治之建立。本文將分析探討目前人體生物資料庫管理條例之重要修訂內容，亦盼能完善我國人體生物資料庫之相關治理規範。</p> <p> </p><p>Biobanks play a pivotal role in advancing precision medicine, given the swift evolution of technology, the utilization of big data, and the integration of artificial intelligence. The proposed amendments to the Human Biobank Management Act are poised to establish a robust legal framework for health data governance in Taiwan. This article will delve into the significant revisions and regulations within the Human Biobank Management Act, offering recommendations with the aim of enhancing the governing processes pertaining to biobanks.</p> <p> </p>

Toward Professionalism of Biobanking in China: A Survey on Working Status, Career Development, Challenges, and Prospects of Biobankers.

Biobanking has become an increasingly important activity to provide resources for medical research support. In China, establishing and maintaining a biobank have been the latest trend in a research hospital. However, biobanking is still an emerging young field in terms of professionalization and professionalism. The development of professionalization in biobanking faces many challenges involving the development of skills, identities, norms, and values associated with becoming part of a professional group. Biobanking professionals (i.e., biobankers) are the most important factor and driving force toward professionalization in biobanking. To better understand biobankers' performance, needs, concerns, and career development, we conducted two comprehensive surveys among biobankers in China in 2019 and 2021, respectively. The questionnaires covered four major areas: (1) basic information and the status of biobankers; (2) job performance evaluation, salary, recognitions, rewards, and so on; (3) occupational training and career development; and (4) challenges and prospects and so on. The surveys revealed that most biobankers in China have positive working attitudes and a high desire for their future career development, but due to the uncertain evaluation mechanisms and promotion routes, etc., the participants were more optimistic about biobanking development compared to the biobanker's career development (77.0% and 57.4% respectively in 2021, p < 0.05). The biobankers expected more training opportunities and salary packages. Because biobankers are an integral factor and driving force to ensure the successful biobanking operation and advancement, the survey data analysis revealed interesting findings and references for the development of professionalism in biobanking. This survey will provide first-hand information to governments, biobank management teams, and the general public to further support, promote, or optimize (1) biobanking operation and sustainability, (2) biobankers' career development, (3) biobank management and quality control, and (4) strategic plans and approaches to establish a higher quality professional team of biobankers.

Developing cancer biobanks in Romania: understanding the knowledge and recommendations in assessing a clinical dataset for biospecimens

Background and aims. In the context of the novelty of personalized medicine and biobanking in Romania, there is an acute need to analyze the degree of knowledge of the key actors in the domain. The present study sought to investigate the understanding of ‘biobanking’ and ‘personalized medicine’ in three categories of&#x0D; participants in the development of a biobank – health professionals (clinicians/diagnosticians), scientific researchers, and patients, in order to identify possible faults regarding the level of information. The secondary objective of this study was to identify key elements and relevant data that should be detailed in the clinical dataset that accompanies a biological sample.&#x0D; Methods. A total of 120 participants were included in this study that were divided into three categories that represent key actors in the development and management of a cancer biobank – clinicians (n=40), scientific researchers (n=40), and oncology patients (n=40).&#x0D; Results. The survey indicated that the terms ‘biobank’ and ’personalized medicine’ are unknown only in a proportion of patients, while for the other two groups, these terms are already known. The second questionnaire allowed the arrangement of a recommended clinical dataset to be filled when a biological sample is provided to&#x0D; be included in a cancer biobank.&#x0D; Conclusions. The trust of patients and healthcare professionals in building biobanks that adhere to ethical and operational standards in Romania is important, as the development of artificial intelligence and databases allows advanced knowledge and connection of findings from different databases and, therefore, brings the concept of personalized medicine closer to the clinical practice. The information included in this dataset will be integrated and constitutes a comprehensive biobank database. All these aspects are meant to increase the utility of the specimens in cancer research, as clearly annotated samples, along with prospective data, bring valuable knowledge that helps scientific researchers and clinicians make the clinical connection between the molecular alterations and the phenotype of particular patients or a disease.

A practical checklist for return of results from genomic research in the European context

An increasing number of European research projects return, or plan to return, individual genomic research results (IRR) to participants. While data access is a data subject’s right under the General Data Protection Regulation (GDPR), and many legal and ethical guidelines allow or require participants to receive personal data generated in research, the practice of returning results is not straightforward and raises several practical and ethical issues. Existing guidelines focusing on return of IRR are mostly project-specific, only discuss which results to return, or were developed outside Europe. To address this gap, we analysed existing normative documents identified online using inductive content analysis. We used this analysis to develop a checklist of steps to assist European researchers considering whether to return IRR to participants. We then sought feedback on the checklist from an interdisciplinary panel of European experts (clinicians, clinical researchers, population-based researchers, biobank managers, ethicists, lawyers and policy makers) to refine the checklist. The checklist outlines seven major components researchers should consider when determining whether, and how, to return results to adult research participants: 1) Decide which results to return; 2) Develop a plan for return of results; 3) Obtain participant informed consent; 4) Collect and analyse data; 5) Confirm results; 6) Disclose research results; 7) Follow-up and monitor. Our checklist provides a clear outline of the steps European researchers can follow to develop ethical and sustainable result return pathways within their own research projects. Further legal analysis is required to ensure this checklist complies with relevant domestic laws.

Positive association between research competitiveness of Chinese academic hospitals and the scale of their biobanks: A national survey.

Biobanks are important research infrastructure developed rapidly by Chinese hospitals. The objective of this study is to investigate the association between the comprehensive research competitiveness of hospitals and the development of hospital biobanks. In 2018, we conducted a national survey among Chinese biobank managers and directors. An online questionnaire was used to collect data of biobank characteristics. Of the 70 academic hospital biobanks responded to our survey, 49 of their hospitals were listed in the Science and Technology Evaluation Metrics (STEM) and 46 of their hospitals were listed in the Fudan Hospital Rankings, respectively, in 2018. Hospital scores from the STEM and Fudan Hospital Rankings were identified from their official websites. Multivariate linear regression analyses were used to assess the associations of STEM scores and Fudan Hospital Rankings with the scale of biobanks. The overall STEM score, Scientific and Technological Output, and Academic Impact in hospitals with large-scale biobanks were 48.35%, 55.16%, and 58.65% higher than those with small-scale biobanks, respectively. The scale of biobanks was positively associated with STEM score (β=0.367, p=0.009), Scientific and Technological Output (β=0.441, p=0.001), and Academic Impact (β=0.304, p=0.044) after adjustment for potential confounders. For Fudan Hospital Rankings, the comprehensive score and sustainable development ability score were higher in hospitals with large-scale biobanks. Further analyses showed that the scale of the biobanks was positively associated with a higher comprehensive score (β=0.313, p=0.037) and a sustainable development ability score (β=0.463, p < 0.001). The scale of hospital biobanks was positively associated with the research competitiveness of Chinese hospitals.

Brief Reports Prepared by Students and Graduates of Master of Science in Biobanking.

Brief Reports Prepared by Students and Graduates of Master of Science in Biobanking.

Governance through scientism: Taiwan Biobank and public controversy

Based on the concept of “governance through scientism”, this article aims to reveal the tacit practices of the institutional culture of scientism among Taiwan Biobank’s elite scientists, whose imaginaries have shaped the dominance of a deficit model of the public in dealing with public controversy and establishing regulatory mechanisms. Examining three periods of ELSI controversies from 2000 to 2021, we identify three types of scientific imaginaries of publics, namely the silent public (2000–2004), the anti-science public (2005–2010), and the EGC as the lawful public supervisory body (2010–2021). In 2010, the Human Biobank Management Act (HBMA) was passed in Taiwan as a solution to public controversy and as a strategy to bypass public engagement. However, the overemphasis on formative legislation caused actors to overlook the processual approach in which ongoing critical reflections are required for the changing operations of TBB

Risk management in biobanking

Risk management is a key aspect of the organization and management of biobanks, which is part of the overall quality management system aimed at early detection, analysis and minimization of events, that can lead to negative consequences for the biobank, as well as affect the quality of biosamples and related data. The article presents the biobanking risk classification with the description of each category.Aim. To develop and implement the methodology for identification, analysis, evaluation and development of risk management measures for the biobanking process in the biobank of the National Medical Research Center for Therapy and Preventive Medicine.Material and methods. We present the methodology of the risk management process developed on the basis of the literary data, world experience and experience of the biobank of the National Medical Research Center for Therapy and Preventive Medicine.Results. The biobanking risk management procedure was developed and implemented in the biobank of the National Medical Research Center for Therapy and Preventive Medicine in 2020. The work carried out made it possible to identify, analyze and evaluate a wide range of potential negative events and actions that could lead to biobank damage, both in the form of financial losses and ethical and technical issues related to the biobanking process. A significant reduction in the frequency of emergency events and the high stability of the biobank operation under the influence of various external factors prove the effectiveness of the approach used.Conclusion. The creation and maintenance of a risk management system in the biobank allows, in combination with other measures, to ensure the safety and high quality of the procedures for collecting, processing and long-term storage of biomaterial and related data by creating an environment that rules out or minimizes the impact of various risks.

Biobanks in the low- and middle-income countries of the Arab Middle East region: challenges, ethical issues, and governance arrangements—a qualitative study involving biobank managers

BackgroundBiobanks have recently been established in several low- and middle-income countries (LMICs) in the Arab region of the Middle East. We aimed to explore the views of biobank managers regarding the challenges, ethical issues, and governance arrangements of their biobanks.MethodsIn-depth semi-structured qualitative interviews were conducted with a purposive sample of eight biobank managers from Egypt (6), Jordan (1), and Sudan (1). Interviews were performed either face-to-face, by phone, or via Zoom and lasted approximately 45–75 min. After verbal consent, interviews were recorded and then transcribed. The authors performed a thematic analysis of the transcripts independently and then integrated the themes via a consensus process.ResultsBiobank managers discussed the main challenges in establishing their biobanks. These included the staff’s lack of experience and training, limited funds, deficit awareness of biobanks, obtaining funding from different sources. Only four reported they were active in distributing biospecimens and health data to researchers. Six biobanks used a broad consent model, one used tiered consent, and another allowed participants to opt-out of being recontacted. Five managers avoided partnerships with pharmaceutical companies due to concerns with unfavorable reactions from the community. Five managers did not have clear policies for returning research results to the donors. Five expressed challenges with sample and data sharing with international collaborators; all five used material transfer agreements. The biobank managers revealed variable governance arrangements and activities with community involving awareness and educational efforts rather than active engagement. Several expressed the importance of transparency with the operations of their biobanks and gaining the trust of their stakeholders.ConclusionManagers of biobanks in LMICs in the Arab Middle East encounter financial, operational, and social challenges toward their sustainability efforts. Discussions with key stakeholders are warranted to manage ethical issues involving informed consent, privacy, data sharing, and the return of results. We recommend that biobank managers in the Arab Middle East form collaborative networks within the region and internationally, develop trusting governance relationships with their stakeholders, and pursue engagement activities with their communities to enhance trust.

Covariate adjustment of spirometric and smoking phenotypes: The potential of neural network models.

To increase power and minimize bias in statistical analyses, quantitative outcomes are often adjusted for precision and confounding variables using standard regression approaches. The outcome is modeled as a linear function of the precision variables and confounders; however, for many complex phenotypes, the assumptions of the linear regression models are not always met. As an alternative, we used neural networks for the modeling of complex phenotypes and covariate adjustments. We compared the prediction accuracy of the neural network models to that of classical approaches based on linear regression. Using data from the UK Biobank, COPDGene study, and Childhood Asthma Management Program (CAMP), we examined the features of neural networks in this context and compared them with traditional regression approaches for prediction of three outcomes: forced expiratory volume in one second (FEV1), age at smoking cessation, and log transformation of age at smoking cessation (due to age at smoking cessation being right-skewed). We used mean squared error to compare neural network and regression models, and found the models performed similarly unless the observed distribution of the phenotype was skewed, in which case the neural network had smaller mean squared error. Our results suggest neural network models have an advantage over standard regression approaches when the phenotypic distribution is skewed. However, when the distribution is not skewed, the approaches performed similarly. Our findings are relevant to studies that analyze phenotypes that are skewed by nature or where the phenotype of interest is skewed as a result of the ascertainment condition.

Management of biobanking for medical genetics research

Biobanking is one of the most important elements of the modern infrastructure for biomedical research. Organization of a biobank on the basis of the N. P. Bochkov Medical Genetics Research Center provides a centralized infrastructure for preparing biomaterial for research. Biobank has the format of a research equipment sharing center and works with two types of unique biomaterials from patients with genetic diseases: blood/blood components and vital cells of various tissue origin. The storage facility of the Biobank is equipped with low-temperature (-80° C) and cryostorage (-196° C) systems. Identification and search of samples is carried out using a bar-coding system and is implemented through the information interface of the biobank, which is integrated into the general database of patients at the Medical Genetics Research Center. Information on biomaterial samples is presented in periodically updated catalogs on the page of equipment sharing center “Biobank”. Biobank collection is available to internal and external users.

Development of “Biosearch System” for biobank management and storage of disease associated genetic information

ObjectiveDatabases and softwares are important to manage modern high-throughput laboratories and store clinical and genomic information for quality assurance. Commercial softwares are expensive with proprietary code issue while academic versions have adaptation issue. Our aim was to develop an adaptable in-house software that can stores specimen and disease-associated genetic information in biobank to facilitate translational research. MethodsPrototype was designed as per the research requirements and computational tools were used to develop software under three tiers; Visual Basic and ASP.net for presentation tier, SQL server for data tier, and Ajax and JavaScript for business tier. We retrieved specimens from biobank using this software and performed microarray based transcriptomic analysis to detect differentialy expressed genes (DEGs) with FC ±2 and P-value <0.05 in triple negative breast cancer cases. Ingenuity pathway analysis tool was used to predict canonical molecular pathways associated with disease. Overall performance and utility of software was evaluated by JMeter software, CRUD function test and set of feedback questioners. ResultsWe developed “Biosearch System”, a web-based software enabling management of biobank samples (tissue, blood, FTTP slides) and their extracts (DNA, RNA and proteins) with clinical and experimental details. The client satisfaction feedback was excellent with score 4.7/5. We identified a total of 1181 DEGs including both upregulated (IFI6, LEF1, FANCI, CASC5, PLXNA3 etc.) and down-regulated (ADH1B, LYVE1, ADH1C, ADH1B, ADIPOQ, PLIN1, LYVE1 etc.) genes in triple negative breast cancer. Pathway analysis of DEGs revealed significant activation of interferon signaling (z-score 2.646) and kinetochore metaphase signaling pathway (z-score 2.138) in cancer. ConclusionBiosearch System is a user friendly LIMS for collection, storage and retrieval of specimen and clinical information. It is secure, efficient, and very convenient in sample tracking and data analysis. We illustrated its utility in transcriptomic study of breast cancer. Additionally, it can facilitate and speed up any genomic study and translational research publications.

The BA-BCS 2021: An Initial "Trial" for Integrating Basic Science and Medical Progress on Breast Cancer in a Latin-American Country.

The first Buenos Aires Breast Cancer Symposium (BA-BCS) was held in a virtual format, between the 17th and the 21st of May 2021. The main goal of the meeting was to facilitate the interaction among physicians and basic researchers from South America and with peers from the rest of the world. To embrace their different interests and concerns, the congress included not only talks on basic, translational and clinical research, but also round tables to discuss diagnostic methods, research financing and biobank management, as well as virtual poster sessions in which the youngest fellows presented their recent findings. This report provides a brief overview of the talks delivered during the meeting, which addressed a wide variety of vital issues for breast cancer research mostly focused on the accurate diagnosis, prevention and treatment of this illness. The presentations included a wide spectrum of themes including hormone receptors and the relevance of their mutations, immunotherapy, cancer stem cells, mouse models, environmental hazards, genetics and epigenetics, local and systemic therapies, liquid biopsies, the metastatic cascade, therapy resistance and dormancy, among others.

Biobanks and Individual Health Related Findings: from an Obstacle to an Incentive

Despite the benefits biobanks are expected to bring, there have recently been concerns raised that the public and private non-profit biobanks still prevailing in Europe often fail to reach their initial objectives due to a variety of reasons, including a shortage of funding and insufficient utilization of collections. The necessity to find new ways to manage biobanks has been clearly recognized and one way to do this is to follow the success of some commercial direct-to-consumer genetic testing (DTC GT) companies in the biobanking field. This paper is focused on a double role the return of individual health related findings (IHRF) detected through the biobanking activities can play in the management of biobanks. These findings can be seen as an untapped opportunity to offer health related information to biobank participants. At the same time, the IHRF policy can also serve as an additional tool that can improve biobanking governance. This paper aims to consider diverse IHRF approaches as well as to explore some key ethical concerns related to them. In particular, it reveals how different accounts of personal autonomy shape consent policies related to IHRF and emphasizes ethical controversies related to the commercial DTC GT initiatives as well as some non-profit biobanks.

The Scale, Collections, and Biospecimen Distribution of Grade A Tertiary Hospital Biobanks in China: A National Survey.

Chinese clinical biobanks were built rapidly in grade A tertiary hospitals. However, the general information of biorepositories in China remained largely unknown. The aim of this study was to investigate the size, collections, biospecimens distribution and other characteristics of Chinese biobanks in grade A tertiary hospitals. In 2018, we launched a national survey among biobank leaders to provide a comprehensive understanding of Chinese grade A tertiary hospital biobanks. A total of 70 biobank managers or directors completed an online questionnaire to collect information about the biorepositories. Nearly 20% of biobanks stored over one million specimens, while almost one-third of biobanks stored 50–200,000 specimens. In general, plasma and serum were the specimens most commonly stored. For the use of collections, biospecimens were most commonly applied by internal clinical departments. Further analyses revealed that the large-scale biobanks were characterized by earlier establishment, more types of specimens in storage and distribution compared with small-scale biobanks. Moreover, specimens in large-scale biobanks were more commonly used for basic research (62.86% vs. 34.29%, P = 0.017) and clinical research (57.14% vs. 28.57%, P = 0.016). Large-scale biobanks also had more opportunities to cooperate with domestic research institutes (34.29% vs. 5.71%, P = 0.003). Our survey revealed diversity in collections, distribution and utilization of biospecimens among Chinese grade A tertiary hospital biobanks. Although the biobanks had relatively large collections, the underutilization of stored biospecimens and lack of sharing could hamper clinical and biological research.

Правове регулювання відносин у біомедичній сфері в контексті євроінтеграції

Стаття присвячена аналізу проблемних питань приведення у відповідність законодавства України до європейських стандартів у контексті діяльності зі створення та використання біобанків в Україні. На підставі аналізу положень відповідних Директив ЄС і їх зіставлення із чинним законодавством України визначено ступінь імплементації норм права ЄС у національне законодавство України та виокремлено питання, які ще потребують уніфікації.&#x0D; Автор наголошує на важливості прийняття нової редакції Закону про трансплантацію, як нормативно-правового кроку для імплементації Директив в українське законодавство. Виключення ст. 3 Закону про трансплантацію зі сфери його регулювання питання трансплантації репродуктивних клітин, аутотран-сплантації та діяльності банків пуповинної крові, що входить в обсяг регулювання Директиви, не сприяє процесу адаптації українського законодавства до європейських стандартів.&#x0D; Аналізуючи правове регулювання репродуктивної медицини одного із видів діяльності управителів біо-банків в Україні, зроблено наголос на тому, що сьогодні ані в чинному законодавстві, ані в законопроєктах не сформовано дієвих правових механізмів для вирішення питання щодо забезпечення захисту ембріонів, зокрема від їхнього створення із дослідницькою чи комерційною метою, не встановлено чітких умов і порядку подальшого використання / застосування невикористаних із репродуктивною метою ембріонів і їхньої утилізації.&#x0D; Зроблено висновок про те, що українське законодавство необхідно привести у відповідність до Директив в тому, що стосується запровадження системи якості в установах, які працюють із людськими тканинами та клітинами, включаючи навчання персоналу, процедури повідомлення про серйозні негативні випадки та реакції, інформування донорів і їх обстеження перед забором тканин або клітин. Також необхідно доповнити критерії відбору донорів, доопрацювати стандарти підготовки тканин і клітин, їхньої обробки та розподілу прямої поставки окремих тканин і клітин реципієнту.