Constructing effective ethical frameworks for biobanking

This paper is about the actual and potential development of an ethics that is appropriate to the practices and institutions of biobanking, the question being how best to develop a framework within which the relevant ethical questions are first identified and then addressed in the right ways. It begins with ways in which a standard approach in bioethics – namely upholding a principle of individual autonomy via the practice of gaining donors’ informed consent – is an inadequate ethical framework for biobanking. In donating material to a biobank, the individual donor relinquishes a degree of control and knowledge over the way their material is used in large-scale and typically open ended projects; and the identifying nature of genetic material means that third parties have rights and interests which must be taken into account as well as those of the individual donor. After discussing the problems for informed consent in the biobanking context, the paper then considers three emerging alternative approaches which, broadly speaking, conceptualize the subject of biobanking ethics in communal or co-operative terms: one version sees participants in biobanking research as ‘shareholders’ whilst the other expands on the notion of participation to include the wider public beneficiaries of biobanking as ‘stakeholders’. It concludes by outlining a third view, on which the biobanking institution itself is conceived as an ethical subject whose defining function can do useful normative work in guiding and evaluating its activities

Dwarna : a blockchain solution for dynamic consent in biobanking

Dynamic consent aims to empower research partners and facilitate active participation in the research process. Used within the context of biobanking, it gives individuals access to information and control to determine how and where their biospecimens and data should be used. We present Dwarna—a web portal for ‘dynamic consent’ that acts as a hub connecting the different stakeholders of the Malta Biobank: biobank managers, researchers, research partners, and the general public. The portal stores research partners’ consent in a blockchain to create an immutable audit trail of research partners’ consent changes. Dwarna’s structure also presents a solution to the European Union’s General Data Protection Regulation’s right to erasure—a right that is seemingly incompatible with the blockchain model. Dwarna’s transparent structure increases trustworthiness in the biobanking process by giving research partners more control over which research studies they participate in, by facilitating the withdrawal of consent and by making it possible to request that the biospecimen and associated data are destroyed.peer-reviewe

Population's perspectives toward biobanks in scientific research: a study from Jordan.

BackgroundBiobanks (biorepositories) were established to compile collected bio-specimens for future research and usage. The collection/storage of bio-specimens triggers several social, legal, and ethical implications where public attitudes can represent the core measurement/parameter in defining the most acceptable practices and ethical approaches when dealing with biobanks.AimThe aim of this study was to explore and understand population's perspectives, expectations, and concerns toward biobanks in Jordan.MethodsA cross-sectional survey that included closed-ended questions was distributed among Jordanians. A total of 500 participants who are representative of the Jordanian population were included in this study.ResultsThere was overwhelming support (>85%) for the establishment of biobanks in Jordan, and most of the participants agreed on the importance of biobanks and samples' donation for promoting medical research. Enthusiasm in biobanking participation was associated with the sociodemographic characteristics of participants including age, educational level, and previous knowledge of biobanks. Moreover, considering sample donation as a religiously good deed appeared to have the strongest positive correlation with willingness to donate bio-specimens for future research. Also, participants' trust in medical and research services, especially the protection of their privacy and confidentiality, was the most critical concern when they decided to participate in biobanks.ConclusionPopulation's attitude toward biobanks in Jordan was positive and promising, and can encourage the future establishment of different biobanks. It is also necessary to take into consideration certain sociodemographic characteristics when discussing specific information with potential biobanks' donors

Biobank quality management in the BBMRI.be network

From as early as 2005, different guidelines and quality standards covering biobank activities and sample handling methods have been developed to improve and guarantee the reproducibility of biomarker research. Ten years on, the BBMRI.be Quality working group wanted to gauge the current situation of these aspects in the biobanks of the BBMRI.be network. To this end, two online surveys were launched (fall 2017 and fall 2018) to the biobank quality managers in the BBMRI.be network to determine the status and setup of their current quality management system (QMS) and how their QMS and related practices have evolved over a 14 month time period. All biobanks addressed by the two surveys provided a complete response (12 and 13, respectively). A QMS was implemented in 85% of biobanks, with 4 standards emerging as primary basis. Supplementary guidelines were used, with a strong preference for the ISBER best practices for biobanks. The Standard Preanalytical Code-an indicator of the preanalytical lifecycle of a biospecimen impacting the downstream analysis results-was already implemented in 50% of the biobanks while the other half intends future implementation. To assess and maintain the quality of their QMS, 62% of biobanks used self-assessment tools and 71% participated in proficiency testing schemes. The majority of biobanks had implemented procedures for general and biobank specific activities. However, policies regarding the business and sustainability aspect of biobank were only implemented in a limited number of biobanks. A clear desire for a peer-review audit was expressed by 69% of biobanks, with over half of them intending to implement the recently published biobank standard ISO20387. Overall, the biobanks of the BBMRI.be network have actively implemented a solid quality approach in their practices. The implementation of ISO 20387 may bring further professionalization of activities. Based on the needs expressed in this survey, the Quality working group will be setting up an audit program for the BBMRI.be biobanks, to enhance, harmonize and streamline their activities. On the whole, the biobanks in the BBMRI.be network are able to substantially contribute to translational research, as a primary facilitator guaranteeing high quality standards and reproducibility

Samples and data accessibility in research biobanks. An explorative survey

Biobanks, which contain human biological samples and/or data, provide a crucial contribution to the progress of biomedical research. However, the effective and efficient use of biobank resources depends on their accessibility. In fact, making bio-resources promptly accessible to everybody may increase the benefits for society. Furthermore, optimizing their use and ensuring their quality will promote scientific creativity and, in general, contribute to the progress of bio-medical research. Although this has become a rather common belief, several laboratories are still secretive and continue to withhold samples and data. In this study, we conducted a questionnairebased survey in order to investigate sample and data accessibility in research biobanks operating all over the world. The survey involved a total of 46 biobanks. Most of them gave permission to access their samples (95.7%) and data (85.4%), but free and unconditioned accessibility seemed not to be common practice. The analysis of the guidelines regarding the accessibility to resources of the biobanks that responded to the survey highlights three issues: (i) the request for applicants to explain what they would like to do with the resources requested; (ii) the role of funding, public or private, in the establishment of fruitful collaborations between biobanks and research labs; (iii) the request of co-authorship in order to give access to their data. These results suggest that economic and academic aspects are involved in determining the extent of sample and data sharing stored in biobanks. As a second step of this study, we investigated the reasons behind the high diversity of requirements to access biobank resources. The analysis of informative answers suggested that the different modalities of resource accessibility seem to be largely influenced by both social context and legislation of the countries where the biobanks operate

Biosamples as gifts? How participants in biobanking projects talk about donation.

Funded by National Institute for Health Research (NIHR) Oxford Biomedical Research Centre based at Oxford University Hospitals NHS Trust University of Oxford Oxford Biomedical Research Centre FellowshipPeer reviewedPublisher PD

Enhancing reuse of data and biological material in medical research : from FAIR to FAIR-Health

The known challenge of underutilization of data and biological material from biorepositories as potential resources formedical research has been the focus of discussion for over a decade. Recently developed guidelines for improved data availability and reusability—entitled FAIR Principles (Findability, Accessibility, Interoperability, and Reusability)—are likely to address only parts of the problem. In this article,we argue that biologicalmaterial and data should be viewed as a unified resource. This approach would facilitate access to complete provenance information, which is a prerequisite for reproducibility and meaningful integration of the data. A unified view also allows for optimization of long-term storage strategies, as demonstrated in the case of biobanks.Wepropose an extension of the FAIR Principles to include the following additional components: (1) quality aspects related to research reproducibility and meaningful reuse of the data, (2) incentives to stimulate effective enrichment of data sets and biological material collections and its reuse on all levels, and (3) privacy-respecting approaches for working with the human material and data. These FAIR-Health principles should then be applied to both the biological material and data. We also propose the development of common guidelines for cloud architectures, due to the unprecedented growth of volume and breadth of medical data generation, as well as the associated need to process the data efficiently.peer-reviewe

From waste product to blood, brains and narratives : developing a pluralist sociology of contributions to health research

Funded by National Institute for Health Research (NIHR) Oxford Biomedical Research CentrePeer reviewedPublisher PD

Ethics of Clear Health Communication: Applying the CLEAN Look Approach to Communicate Biobanking Information for Cancer Research

Cancer innovations, such as biobanking technologies, are continuously evolving to improve our understanding and knowledge about cancer prevention and treatment modalities. However, the public receives little communication about biobanking and is often unaware about this innovation until asked to donate biospecimens. It is the researchers’ ethical duty to provide clear communications about biobanking and biospecimen research. Such information allows the public to understand biobanking processes and facilitates informed decision making about biospecimen donation. The aims of this paper are 1) to examine the importance of clear communication as an ethical imperative when conveying information about cancer innovations and 2) to illustrate the use of an organizing framework, the CLEAN (Culture, Literacy, Education, Assessment, and Networking) Look approach for creating educational priming materials about the topic of biobanking