Suchergebnisse

AbstractBiobanks act as the custodians for the access to and  responsible use of human biological samples and related data that have been generously donated by individuals to serve the public interest and scientific advances in the health research realm. Risk assessment has become a daily practice for biobanks and has been discussed from different perspectives. This paper aims to provide a literature review on risk assessment in order to put together a comprehensive typology of diverse risks biobanks could potentially face. Methodologically set as a typology, the conceptual approach used in this paper is based on the interdisciplinary analysis of scientific literature, the relevant ethical and legal instruments and practices in biobanking to identify how risks are assessed, considered and mitigated. Through an interdisciplinary mapping exercise, we have produced a typology of potential risks in biobanking, taking into consideration the perspectives of different stakeholders, such as institutional actors and publics, including participants and representative organizations. With this approach, we have identified the following risk types: economic, infrastructural, institutional, research community risks and participant's risks. The paper concludes by highlighting the necessity of an adaptive risk governance as an integral part of good governance in biobanking. In this regard, it contributes to sustainability in biobanking by assisting in the design of relevant risk management practices, where they are not already in place or require an update. The typology is intended to be useful from the early stages of establishing such a complex and multileveled biomedical infrastructure as well as to provide a catalogue of risks for improving the risk management practices already in place.

AbstractData practices in biomedical research often rely on standards that build on normative assumptions regarding privacy and involve 'ethics work.' In an increasingly datafied research environment, identifiability gains a new temporal and spatial dimension, especially in regard to genomic data. In this paper, we analyze how genomic identifiability is considered as a specific data issue in a recent controversial case: publication of the genome sequence of the HeLa cell line. Considering developments in the sociotechnological and data environment, such as big data, biomedical, recreational, and research uses of genomics, our analysis highlights what it means to be (re-)identifiable in the postgenomic era. By showing how the risk of genomic identifiability is not a specificity of the HeLa controversy, but rather a systematic data issue, we argue that a new conceptualization is needed. With the notion of post-identifiability as a sociotechnological situation, we show how past assumptions and ideas about future possibilities come together in the case of genomic identifiability. We conclude by discussing how kinship, temporality, and openness are subject to renewed negotiations along with the changing understandings and expectations of identifiability and status of genomic data.

The world is facing an unprecedented public health challenge with the COVID-19 pandemic; this has necessitated numerous efforts being deployed by governments, health agencies and individual institutions – including in the biobanking community – to develop effective tests, toolkits, treatments and vaccines to stem its spread and help fight it. To achieve this goal, the collection, analysis and timely sharing of samples and related data becomes instrumental in collective global research efforts. Aligned to these efforts is the prevalence for automated data processing and digital technologies such as location data and contact tracing applications as part of the toolkits. In this respect, biobanks are important infrastructures for access to these samples and data. Besides availability, quality and technical infrastructures, also ethical, legal and societal issues (ELSI) are particularly crucial in this regard. Public health ethics, personal data protection, ethics of data sharing, protection of consent and vulnerability as well as compliance issues within international data sharing have gained urgency in COVID-19 research. Against this backdrop, BBMRI-ERIC ELSI Services & Research held a webinar that took a closer look at these issues. The webinar took place on April 24th, 2020; the recording is available here. This document not only answers the questions posed during the webinar but ventures into much detail on the topics raised as a result. It also showcases two examples from Germany (presented by Prof. Roland Jahns) and Italy (presented by Prof. Marialuisa Lavitrano), as well as a detailed commentary on contact-tracing-apps from a legal perspective (presented by Gauthier Chassang). The document thus lays the foundation for further discussion on ELSI and COVID-19 in the context of biobanking.

Avec le soutien du Comité pour la science ouverte (Ministère de l'Enseignement supérieur, de la Recherche et de l'Innovation) ; The guide on the opening of research data (or Open Data) is intended to support the employees of educational institutions and research organisations in adopting a reasonable approach to opening research data. It is the result of the study of an inter-organisation working group led by the National Institute for Agricultural Research (INRA). It is not an exhaustive guide and is intended to for information purposes alone. It attempts to answer the most common questions such employees may be faced with such as whether it is a voluntary approach or is imposed by regulations and whether it corresponds with their institution's own objectives. The legal framework is cited if it exists. However, the readers are made aware that the legal landscape on this subject is continually shifting and that they need to refer their institution's Open Data policy. ; Le guide sur l'ouverture des données de recherche (ou Open Data) a pour vocation d'accompagner les agents des établissements concernés (établissements d'enseignement et organismes de recherche) dans une démarche d'ouverture raisonnée des données de recherche. Il est issu des réflexions d'un groupe de travail inter-organismes animé par l'INRA. Il ne prétend pas à l'exhaustivité ; il est fourni uniquement à titre d'information. Il tente de répondre aux questions les plus courantes auxquelles ils pourront être confrontés que cette démarche soit volontaire et réponde aux objectifs de l'établissement ou qu'elle soit imposée par la réglementation. Le cadre légal est cité, lorsqu'il existe. L'attention du lecteur est toutefois attirée sur le paysage très mouvant du droit sur ce sujet et sur la nécessité de se référer à la politique de son établissement en matière d'Open Data.

Avec le soutien du Comité pour la science ouverte (Ministère de l'Enseignement supérieur, de la Recherche et de l'Innovation) ; The guide on the opening of research data (or Open Data) is intended to support the employees of educational institutions and research organisations in adopting a reasonable approach to opening research data. It is the result of the study of an inter-organisation working group led by the National Institute for Agricultural Research (INRA). It is not an exhaustive guide and is intended to for information purposes alone. It attempts to answer the most common questions such employees may be faced with such as whether it is a voluntary approach or is imposed by regulations and whether it corresponds with their institution's own objectives. The legal framework is cited if it exists. However, the readers are made aware that the legal landscape on this subject is continually shifting and that they need to refer their institution's Open Data policy. ; Le guide sur l'ouverture des données de recherche (ou Open Data) a pour vocation d'accompagner les agents des établissements concernés (établissements d'enseignement et organismes de recherche) dans une démarche d'ouverture raisonnée des données de recherche. Il est issu des réflexions d'un groupe de travail inter-organismes animé par l'INRA. Il ne prétend pas à l'exhaustivité ; il est fourni uniquement à titre d'information. Il tente de répondre aux questions les plus courantes auxquelles ils pourront être confrontés que cette démarche soit volontaire et réponde aux objectifs de l'établissement ou qu'elle soit imposée par la réglementation. Le cadre légal est cité, lorsqu'il existe. L'attention du lecteur est toutefois attirée sur le paysage très mouvant du droit sur ce sujet et sur la nécessité de se référer à la politique de son établissement en matière d'Open Data.