Biobanks in personalized medicine

Zatloukal, Kurt; Stumptner, Cornelia; Kungl, Penelope; Mueller, Heimo

doi:10.1080/23808993.2018.1493921

Cited by 10 publications

(6 citation statements)

References 57 publications

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“…Combining different types of HD from large populations makes it possible to explore the complex relationships between genes and environment in the development of a disease. Using large numbers of biobanked HBM and HD, researchers can also identify disease genes, which are hoped to lead to early, more accurate diagnoses as well as individualized therapeutic and preventive options (Liu & Pollard, 2015 ; Zatloukal et al, 2018 ).…”

Section: Introductionmentioning

confidence: 99%

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

2021

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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.

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Section: Introductionmentioning

confidence: 99%

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

2021

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“…The “omics” technologies have made unprecedented progress thanks to the availability of “high quality biospecimens” and have contributed to a better understanding of human health and diseases. The development of personalized medicine [ 13 , 14 ] was made possible by the developments of genomic and proteomic platforms, molecular imaging and bioinformatics. Most of our current knowledge on diseases is based on the systematic investigation of human biological samples and medical data.…”

Section: Discussion and Resultsmentioning

confidence: 99%

New Challenges for Biobanks: Accreditation to the New ISO 20387:2018 Standard Specific for Biobanks

Blasio

Biunno

2021

BioTech

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Background: The emergence of “multi-omics” and “multi-parametric” types of analysis based on a high number of biospecimens enforces the use of a great number of high-quality “Biological Materials and Associated Data” (BMaD). To meet the demands of biomedical research, several Biological Resource Centers (BRCs) or Biobanks world-wide have implemented a specific Quality Management System (QMS) certified ISO 9001:2015 or accredited by CAP9 ISO 20387:2018. For the first time, ISO, with the support of several Biobanking experts, issued the ISO 20387:2018 which is the first ISO norm specific for Biobanks. The fundamental difference with present certification/accreditation standards is that the ISO 20387:2018 focuses not only on the operational aspects of the Biobank, but also on the “competence of the Biobank to carry our specific Biobanking tasks”. Methods: The accreditation process for ISO 20387:2018 required the definition of: (1) objectives, goals and organizational structure of the Biobank, including procedures for governance, confidentiality and impartiality policies; (2) standard operating procedures (SOPs) of all activities performed, including acquisition, analysis, collection, data management, distribution, preparation, preservation, testing facility and equipment maintenance, calibration, and monitoring; (3) procedures for control of documents and records, the identification of risks and opportunities, improvements, corrective actions, nonconforming records and evaluation of external providers (4) an internal audit and management reviews, verification of QMS performance, monitoring of quality objectives and personnel qualification and competency in carrying out specific Biobanking tasks. Results: The accreditation process is performed by an independent authorized organization which certifies that all processes are performed according to the QMS, and that the infrastructure is engineered and managed according to the GDP and/or GMP guidelines. Conclusion: Accreditation is given by an accreditation body, which recognizes formally that the Biobank is “competent to carry out specific Biobanking tasks”.

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“…The use of standardized methods during registration is important to ensure quality. For example, the use of the BRISQ (Biospecimen Reporting for Improved Study Quality) reporting system allows for better storage, recording and comparison of the data records (Table II) (76)(77)(78).…”

Section: Quality Control Program In Biobanksmentioning

confidence: 99%

Pathology and biobanking

Talu

Toper²,

Şahi̇n³

et al. 2020

TJPATH

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Biobanks are units where high quality and long-term protection of biomaterials is maintained. This system, in which biological materials and data are systematically recorded and stored, is a unique resource for the study of the pathophysiology of disease, the development of diagnostic biomarkers, and working with human tissues for the potential discovery of targeted therapeutic agents. At this point, the pathology unit plays a unifying and complementary role between the clinical and core disciplines and offers optimal management of the patients' biomaterials for diagnostic and research projects. The aim of this article is to present general information with regard to a biobank constructed for the storage of tumor tissue and blood biospecimens. Ethical issues (informed consent, protection of confidentiality and privacy, and secondary use of biospecimens) and the information technology system (collection, systematic recording, backup and protection of clinical information) are important issues in biobanking. The selection of freezers to be used in storage (mechanical freezers, liquid-vapor nitrogen tanks), and if mechanical freezers are preferred the establishment of the relevant infrastructure and support team (such as additional power units for protection from power outages), the preservation of materials by aliquoting in different freezers, ensuring financing so as to afford the cost of the infrastructure, and implementation of all these dynamics while adhering to international guidelines are of the utmost importance.

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Biobanks in personalized medicine

Cited by 10 publications

References 57 publications

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

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

New Challenges for Biobanks: Accreditation to the New ISO 20387:2018 Standard Specific for Biobanks

Pathology and biobanking

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