Implementing a Data Sharing Agreement within a biomedical research consortium

Our project intends to establish a culture of data sharing in a German research consortium in the field of systems medicine by introducing a data sharing agreement as well as project-specific data usage agreements. Sharing research data is pivotal for successful research in systems medicine and in medical research in general. Our project is part of the e:Med-program, funded by the Federal Ministry of Education and Research. Building on a survey conducted among the consortium members and in further discussion within them we have developed and implemented a data sharing agreement as well as a template for project-specific data usage agreements. Data sharing in medical sciences is reported to be less likely than in other disciplines. Tenopir et al. argue that this might be the case due to the higher sensibility of the data which often includes personal data from patients. However, if restrictions can be put on the possible use of the data, the willingness to share data increases. Some actions have already been taken to improve data sharing in the medical sciences like requirements that have to be met to publish a medical trial an ICMJE-Journal or the release of new data sharing guidelines of funding organisations (EU Horizon2020, NIH, MRC). What is still missing are use cases that may serve as best practice examples for the implementation of data sharing in the field of biomedicine. There are some ideas how sharing of medical research data could be encouraged but most of them are of a theoretical kind. Our project is an actual Implementation of a data sharing concept in an active consortium, enabling us to collect hands on experiences that may be useful to other researchers in the biomedical field. The results of our survey showed that the major issues a data sharing agreement would have to address are: authorship, questions about the publication of results, the kind of metadata needed to understand a dataset, and rules and guidelines for the sharing of data in general. We also found out that the gathering, preparation and publishing as well as the analysis and evaluation of data are expected to be the main tasks regarding the publication of research results and that those tasks should be considered the most in decisions about the authorship. Those results were used to develop our data sharing agreement and the template for data usage agreements. We integrated Paragraphs concerning authorship, metadata and the division of labour in a project as mandatory parts to be addressed by every consortium-intern cooperation. As data counsellors we accompany and moderate the discussion about the individual data usage agreements between the consortium members. The experiences we already have made and we will make in the future may help other researchers in their attempt to establish a culture of sharing in biomedicine and might therefore be a valuable contribution to the Open Science Movement

Dateninfrastrukturen für die Gesundheitsforschung: ethische Rahmenbedingungen und rechtliche Umsetzung

Die Rolle von Dateninfrastrukturen für die Gesundheitsforschung beschränkt sich nicht allein darauf, als Service oder Schnittstelle für den Datenaustausch zwischen Datenerzeuger:innen und -nutzer:innen zu fungieren. Die Infrastruktur ist vielmehr selbst ein Akteur im Prozess des Datenteilens, der für diesen auch entsprechend Verantwortung trägt. Dies gilt zuallererst für die Rechtmäßigkeit der Verarbeitung personenbezogener Daten. Fußt die Datenverarbeitung auf einer Einwilligung der betroffenen Person, ist auch seitens der Infrastruktur sicherzustellen, dass sämtliche Datenverarbeitungsprozesse von dieser Einwilligung erfasst sind. Stützt sich die Datenverarbeitung auf einen gesetzlichen Erlaubnistatbestand, müssen im Rahmen der Infrastruktur v. a. technische und organisatorische Maßnahmen ergriffen werden, damit ein möglichst hohes Datenschutzniveau sichergestellt ist. Zudem fällt der Infrastruktur eine Verantwortung zu, wenn es um die Umsetzung von Betroffenenrechten wie Auskunft, Berichtigung oder Löschung von Daten geht und um den Umgang mit Zufalls- und Zusatzbefunden. Die Frage, mit welchem Selbstverständnis sich Forscher:innen in Infrastrukturprojekte einbringen und in welcher Form auch privatwirtschaftliche Unternehmen in solcherlei Projekte eingebunden werden sollen, muss sich am Gemeinwohl orientieren. Damit einher geht die Verpflichtung, dass Infrastrukturen so weit wie möglich an den Prinzipien der Partizipation, der Transparenz und der Wissenschaftskommunikation ausgerichtet sind. Die Beachtung all dieser ethischen und rechtlichen Aspekte ist vor allem auch deshalb wichtig, weil nur auf diese Weise das Vertrauen aller Stakeholder gewonnen und damit die zentrale Basis für den erfolgreichen Aufbau und Betrieb einer Dateninfrastruktur geschaffen werden kann

Applying systems biology to biomedical research and health care: a précising definition of systems medicine

Background: Systems medicine has become a key word in biomedical research. Although it is often referred to as P4-(predictive, preventive, personalized and participatory)-medicine, it still lacks a clear definition and is open to interpretation. This conceptual lack of clarity complicates the scientific and public discourse on chances, risks and limits of Systems Medicine and may lead to unfounded hopes. Against this background, our goal was to develop a sufficiently precise and widely acceptable definition of Systems Medicine. Methods: In a first step, PubMed was searched using the keyword “systems medicine”. A data extraction tabloid was developed putting forward a means/ends-division. Full-texts of articles containing Systems Medicine in title or abstract were screened for definitions. Definitions were extracted; their semantic elements were assigned as either means or ends. To reduce complexity of the resulting list, summary categories were developed inductively. In a second step, we applied six criteria for adequate definitions (necessity, non-circularity, non-redundancy, consistency, non-vagueness, and coherence) to these categories to derive a so-called précising definition of Systems Medicine. Results: We identified 185 articles containing the term Systems Medicine in title or abstract. 67 contained at least one definition of Systems Medicine. In 98 definitions, we found 114 means and 132 ends. From these we derived the précising definition: Systems Medicine is an approach seeking to improve medical research (i.e. the understanding of complex processes occurring in diseases, pathologies and health states as well as innovative approaches to drug discovery) and health care (i.e. prevention, prediction, diagnosis and treatment) through stratification by means of Systems Biology (i.e. data integration, modeling, experimentation and bioinformatics). Our study also revealed the visionary character of Systems Medicine. Conclusions: Our insights, on the one hand, allow for a realistic identification of actual ethical as well as legal issues arising in the context of Systems Medicine and, in consequence, for a realistic debate of questions concerning its matter and (future) handling. On the other hand, they help avoiding unfounded hopes and unrealistic expectations. This especially holds for goals like improving patient participation which are intensely debated in the context of Systems Medicine, however not implied in the concept

So rare we need to hunt for them: reframing the ethical debate on incidental findings

Incidental findings are the subject of intense ethical debate in medical genomic research. Every human genome contains a number of potentially disease-causing alterations that may be detected during comprehensive genetic analyses to investigate a specific condition. Yet available evidence shows that the frequency of incidental findings in research is much lower than expected. In this Opinion, we argue that the reason for the low level of incidental findings is that the filtering techniques and methods that are applied during the routine handling of genomic data remove these alterations. As incidental findings are systematically filtered out, it is now time to evaluate whether the ethical debate is focused on the right issues. We conclude that the key question is whether to deliberately target and search for disease-causing variations outside the indication that has originally led to the genetic analysis, for instance by using positive lists and algorithms

Implications of secondary findings in clinical context

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Zeitschrift für Praktische Philosophie / Kinder im Wahlrecht und in Demokratien : Für eine elterliche Stellvertreterwahlpflicht

In Demokratien gibt es gewöhnlich ein gesetzliches Mindestalter, durch das Kinder und Jugendliche von politischen Wahlen ausgeschlossen werden. Je nach Altersstruktur der Bevölkerung dürfen ungefähr 20 bis 25 Prozent der Staatsbürger eines Landes nicht wählen. In diesem Aufsatz werden der Ausschluss Minderjähriger von Wahlen in Demokratien sowie mögliche alternative Stellungen Minderjähriger im Wahlrecht einer ethischen Analyse unterzogen. Die erste zentrale These des Aufsatzes lautet, dass der Ausschluss und die Nichtrepräsentation von Minderjährigen ungerecht ist, dass die Regierungsgewalt über Minderjährige in demokratischen Staaten nicht ausreichend legitimiert ist und dass Kinder und Jugendliche (bzw. ihre Stellvertreter) gute Gründe dafür haben, sich gegen Gesetze und Maßnahmen ihrer Regierung mit Akten des zivilen Ungehorsams zu wehren. Die zweite zentrale These des Aufsatzes lautet, dass der beste Weg zur Aufhebung dieses Zustands der Ungerechtigkeit und mangelnden Legitimation in der Einführung einer Pflicht der Eltern besteht, stellvertretend für ihre Kinder zu wählen. Diese elterliche Pflicht sollte durch ein Vetorecht der Minderjährigen ab 14 Jahren ergänzt werden.Democracies usually have a legal minimal age, which excludes children and teenagers from political elections. Depending on the age structure of the population, around 20 to 25 percent of the citizens of a country are not allowed to vote. This essay analyses the exclusion of minors from elections in democracies as well as possible alternative positions of minors in the voting rights from an ethical perspective. The first central thesis of this essay is that the exclusion and non-representation of minors is unjust, and that the governmental power over minors in democratic nations is not sufficiently legitimised, and that children and teenagers (respectively their deputies) have good reasons to resist governmental laws and measures through acts of civil disobedience. The second main thesis is that the best way to resolve this state of injustice and lack of legitimacy is to implement an obligation for parents to vote representatively for their children. This parental obligation should be complemented by a right of veto for minors from the age of 14 up