Christoph Schickhardt

The purpose of this chapter is to offer an ethical investigation into whether researchers have a duty to share pre-published bio-medical data with the scientific community. The central questions of the chapter are the following: do researchers have a prima facie duty to share pre-published data? And if so, what stakes and aspects of a concrete situation need to be taken into consideration in order to assess whether and to what extent researchers’ prima facie duty to share data applies? We will argue that based upon their basic duties to benefit society and to promote scientific knowledge, researchers have a prima facie duty to share data. We will also argue that in order to determine whether the prima facie duty applies in practice it is indispensable to take into account the stakes of the persons concerned as well as context dependent aspects. The chapter’s overall goal is to build an analytical and ethical framework that helps to assess with regard to concrete situations whether researchers’ duty to share data applies. To this end we analyse the concept of data sharing and clarify what data sharing might imply in practice. To offer an overview of the different stakeholders’ concerns we will analyse the normative-informational environment in which data producing researchers (to whom the prima facie duty to share data applies) are usually situated. In the last step we focus on the ethically relevant context dependent aspects and illustrate how they affect researchers’ prima facie duty to share data and stakeholders’ potentially conflicting stakes.

Zusammenfassung Hintergrund Die systematische Untersuchung Neugeborener auf schwere angeborene Erkrankungen begann bereits in den 1960er Jahren und ist seitdem in Form eines allgemeinen Neugeborenen Screenings eine Erfolgsgeschichte. Mit dem stetigen Fortschritt der Technologien zur Genomsequenzierung (Next Generation Sequencing) und ersten breiten Pilotstudien in verschiedenen Ländern wird in den letzten Jahren zunehmend die Frage diskutiert, ob genomisches Neugeborenen-Screening (gNBS) als Standard Public Health Maßnahme eingeführt werden sollte. Aus ethischer Sicht stellt sich dabei die Frage: Welche moralischen Kriterien sind für die Analyse des gNBS und für die ethische Bewertung seiner Implikationen bei einer möglichen Implementierung als Standardverfahren in der Neugeborenenversorgung relevant? Methode Da wir gNBS als eine Public Health Maßnahme ansehen, die Kinder betrifft, gehen wir von der Prämisse aus, dass vor allem zwei Perspektiven für die ethische Bewertung von gNBS eine zentrale Rolle spielen sollten: die Public-Health Ethik Perspektive und die Interessen der Kinder. Um einen derart ausgerichteten Rahmen für die ethische Bewertung von gNBS zu gewinnen, gehen wir konkret wie folgt vor: In einer systematischen Literaturrecherche identifizieren wir 15 allgemeine Public Health Ethik Frameworks. Diese werden einer inhaltlichen Analyse unterworfen, in deren Zuge insgesamt 119 normative Elemente (Normen, Werte, etc.) aus den allgemeinen Public Health Frameworks extrahiert werden. Diese werden induktiv thematisch gruppiert und als ausdrückliche Normen formuliert. Um diese Normen aus einer kindzentrierten Perspektive systematisch auf gNBS anwenden zu können, erarbeiten wir eine ausführliche ethische Konzeption des Kindeswohls als normativen Referenzpunkt. Wir identifizieren einige Aspekte des Kindeswohls als durch gNBS potenziell besonders betroffen und daher als besonders relevant für die ethische Bewertung: Gesundheit, das Wohlergehen der Familie und Autonomie. Zur Strukturierung der Analyse erarbeiten wir zudem ein Konzept von gNBS, in dem wir gNBS als Public Health Maßnahme in fünf Handlungsfelder untergliedern: Design, Durchführung, Follow-Up, Datenspeicherung und sekundäre Datennutzung. Ergebnisse Nach dem Ausschluss von Normen, die offensichtlich nicht anwendbar sind, wenden wir jede der verbleibenden 54 Normen (in 10 thematischen Clustern) auf gNBS an. Die einzelne Anwendung erfolgt mit Bezug auf die inhaltlich ausgearbeitete Konzeption des Kindeswohls und mit Blick auf die fünf Handlungsfelder des gNBS. Wir zeigen damit für jede einzelne Norm, was sie ethisch für gNBS bedeutet und welche die für die Norm ethisch relevanten Implikationen des gNBS als Public Health Maßnahme sind. Die Anwendung der zahlreichen, teilweise sehr spezifischen und detaillierten generellen Public Health Normen, die wir z. B. unter das Cluster Nicht-Schaden subsumiert haben, ergibt ein sehr differenziertes und konkretes Gesamtbild von Aspekten, die mit Blick auf Schadensvermeidung und -reduzierung zu beachten sind. Der Artikel bietet einen Rahmen für die ethische Bewertung von genomischen Neugeborenen-Screening-Programmen. Er zeigt auch beispielhaft für jede der generellen Public Health Normen, wie sie kindzentriert auf gNBS angewandt werden kann. Für zukünftige ethische Untersuchungen und Bewertungen von gNBS als potentielle Public Health Programme mit einem eventuell auch weitergehenden Anspruch an Breite, Tiefe und theoretische Systematik, bietet unsere Arbeit wertvolle inhaltliche, methodische und systematische Ansatzpunkte: (a) eine Liste von Public Health Normen aus bestehenden ethischen Public Health Frameworks; (b) eine substanzielle Konzeption des Kindeswohls; (c) eine Bestimmung der systematischen Rolle des Konzepts des Kindeswohls in Bezug auf die Interessen und Rechte von Kindern im Allgemeinen und (d) in Bezug auf die wichtigsten Auswirkungen von gNBS auf die Interessen und Rechte von Kindern im Besonderen.

As Next Generation Sequencing technologies are increasingly implemented in biomedical research and care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice. In a first step we clarify some central concepts such as “raw data”; in a second step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one’s raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data. In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom. Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects’ legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations.

Secondary use of clinical data in research or learning activities (SeConts) has the potential to improve patient care and biomedical knowledge. Given this potential, the ethical question arises whether physicians have a professional duty to support SeConts. To investigate this question, we analyze prominent international declarations on physicians’ professional ethics to determine whether they include duties that can be considered as good reasons for a physicians’ professional duty to support SeConts. Next, we examine these documents to identify professional duties that might conflict with a potential duty of physicians to support SeConts.

Sharing research data has great potential to benefit science and society. However, data sharing is still not common practice. Since public research funding agencies have a particular impact on research and researchers, the question arises: Are public funding agencies morally obligated to promote data sharing? We argue from a research ethics perspective that public funding agencies have several pro tanto obligations requiring them to promote data sharing. However, there are also pro tanto obligations that speak against promoting data sharing in general as well as with regard to particular instruments of such promotion. We examine and weigh these obligations and conclude that all things considered funders ought to promote the sharing of data. Even the instrument of mandatory data sharing policies can be justified under certain conditions.

Der Begriff des moralischen Status bringt allgemein viele Herausforderungen und Schwierigkeiten mit sich und ist umstritten. Manche Autoren fordern sogar den völligen Verzicht auf den Begriff des MS. Die Anwendung des Begriffs auf Kinder birgt darüber hinaus eine Reihe von spezifischen Schwierigkeiten. Knüpft man den MS an bestimmte höhere geistige Fähigkeiten wie Vernunft oder Sprachfähigkeit – wie es in einigen weit verbreiteten Ethiken der Fall ist –, so stellt sich mit Blick auf sehr junge Kinder sogleich die Frage, ob diese entsprechend keinen oder nur einen niedrigeren MS zugesprochen bekommen.

Research question The secondary research use of treatment data has the potential to expand medical knowledge and improve patient care. Hospitals play an important role in systematic secondary research use: they generate large amounts of treatment data and are supposed to establish the necessary structures for their use in research. This raises the ethical question: do hospitals have a moral duty to support secondary research use of treatment data by establishing and operating the necessary resources and infrastructure? Procedure Our aim is to outline a conceptual framework to discuss the question and to propose a first normative position. Building on insights from business and organizational ethics, we develop a conceptual framework in which we view hospitals as moral actors. Our normative-ethical analysis is based on a reconstructive stakeholder approach, in which we identify the following general duties of hospitals: orientation towards patient wellbeing; cost efficiency; enabling employees to act in accordance with professional ethical standards; supporting public health and research. We examine whether these general duties provide reasons for a specific duty of hospitals to support secondary research use of treatment data. We discuss potential objections to such a duty arising from other, potentially conflicting general duties of hospitals (e.g., data protection), from practice (e.g., costs/resources), or related discourses (data ownership). Conclusion Certain general duties (orientation towards patient wellbeing, cost efficiency, support of public health) justify a duty of hospitals to support secondary research use of treatment data. The duty to enable employees to act in accordance with professional ethical standards is only an indirect reason; the duty to support research applies solely to university hospitals. Potential objections apply to a certain extent but can be mitigated through targeted measures.

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 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.

Die sekundäre Forschungsnutzung von Behandlungsdaten hat großes Potenzial, biomedizinisches Wissen zu erweitern und die Patientenversorgung zu verbessern. Gleichzeitig sind für eine bessere Ausschöpfung dieses Potenzials diverse Herausforderungen zu bewältigen. Dies gilt insbesondere in Deutschland, wo im Vergleich zu anderen Ländern, wie z.B. Dänemark oder Finnland, die sekundäre Forschungsnutzung von Behandlungsdaten unterentwickelt ist. Die Intensivierung der Nutzung der Daten aus Diagnose und Therapie von Patienten und die Entwicklung der dafür notwendigen Strukturen in Deutschland ist ethisch und politisch geboten: für die Verbesserung der Gesundheitsversorgung durch neue Erkenntnisse, Therapien und Qualitätssicherung. Aus diesem Grund fordern die Autor:innen alle Akteure des Gesundheitssystems, von der Bundes- und den Landesregierungen über die Krankenkassen, Kliniken, Ärzt:innen und Patient:innen dazu auf, einen Beitrag dazu leisten, eine Kultur der sekundären Forschungsnutzung von Behandlungsdaten zu etablieren. Basierend auf den Ergebnissen eines dreijährigen Verbundprojekts beantworten die Autor:innen aus den Bereichen Medizin, Rechtswissenschaften, Ethik und Sozialwissenschaften die Frage was notwendig ist, damit in Deutschland die Daten von Patient:innen systematisch für medizinische Forschung und die Analyse der klinischen Versorgungsqualität verwendet werden können und wirklich auch verwendet werden. Sie nennen zehn zentrale Forderungen und legen eine Liste von 23 Empfehlungen mit konkreten Maßnahmen vor, welche von den genannten Akteuren umgesetzt werden sollten.

This volume contributes to the ongoing interdisciplinary controversies about the moral, legal and political status of children and childhood. It comprises essays by scholars from different disciplinary backgrounds on diverse theoretical problems and public policy controversies that bear upon different facets of the life of children in contemporary liberal democracies. The book is divided into three major parts that are each organized around a common general theme. The first part (“Children and Childhood: Autonomy, Well-Being and Paternalism”) focusses on key concepts of an ethics of childhood. Part two (“Justice for Children”) contains chapters that are concerned with the topics of justice for children and justice during childhood. The third part (“The Politics of Childhood”) deals with issues that concern the importance of `childhood´ as a historically contingent political category and its relevance for the justification and practical design of political processes and institutions that affect children and families.

Background Research using data from medical care promises to advance medical science and improve healthcare. Academia is not the only sector that expects such research to be of great benefit. The research-based health industry is also interested in so-called ‘real-world’ health data to develop new drugs, medical technologies or data-based health applications. While access to medical data is handled very differently in different countries, and some empirical data suggest people are uncomfortable with the idea of companies accessing health information, this paper aims to advance the ethical debate about secondary use of medical data generated in the public healthcare sector by for-profit companies for medical research (ReuseForPro). Methods We first clarify some basic concepts and our ethical-normative approach, then discuss and ethically evaluate potential claims and interests of relevant stakeholders: patients as data subjects in the public healthcare system, for-profit companies, the public, and physicians and their healthcare institutions. Finally, we address the tensions between legitimate claims of different stakeholders in order to suggest conditions that might ensure ethically sound ReuseForPro. Results We conclude that there are good reasons to grant for-profit companies access to medical data if they meet certain conditions: among others they need to respect patients’ informational rights and their actions need to be compatible with the public’s interest in health benefit from ReuseForPro.

Molecular tumour boards (MTBs) offer recommendations for potentially effective, but potentially burdensome, molecularly targeted treatments to a patient's treating physician. In this paper, we discuss the question of who is responsible for ensuring that there is an adequate evidence base for any treatments recommended to a patient. We argue that, given that treating oncologists cannot usually offer a robust evaluation of the evidence underlying an MTB's recommendation, members of the MTB are responsible for ensuring that the evidence level is adequate. We explore two models for how to share responsibility between MTB members. According to the first model, each MTB member, as well as the treating physician, should be held maximally and equally responsible for the recommendations. We argue that this insufficiently accounts for differences in roles and expertise of MTB members. We propose instead that responsibility is delegated via relationships of trust. We argue if these relationships of trust are to be instances of reasonable trust, (a) MTBs should offer a clinical representative to whom a treating physician may delegate the responsibility of ensuring there is sufficient evidence for treatment recommendations, (b) the relationships of trust between the representative and the other MTB members should be clearly defined, and (c) MTB members should be carefully selected. Treating oncologists retain a responsibility to consider general limitations of the evidence for targeted treatments in assessing whether the treatment recommendation offered by an MTB's representative is adequate for a given clinical situation.

Background The screening of newborns for severe congenital diseases has been a success story since the 1960s. With the upsurge of genomic sequencing technologies, the question arises: Should _genomic_ Newborn Screening (gNBS) be introduced as general public health measure for all newborns? From an ethical perspective, this leads to the question: What are the relevant moral criteria and points to consider when analyzing and evaluating gNBS as a standard public health procedure in neonatal care? Method We investigated genomic newborn screening from a child-centered public health ethics perspective. We conducted a systematic literature search and identified 15 general ethical frameworks for public health. Based upon text analysis, we extracted all relevant normative elements and grouped them inductively. Furthermore, we developed a detailed substantial concept of the child’s best interest to serve as central and systematic reference point for a child-centered ethical assessment of gNBS. Matching the peculiarities of gNBS with this concept of the child’s best interest, we identified three aspects that are particularly affected by gNBS: _health, family welfare_ and _autonomy_. Results Having excluded all norms not applicable to gNBS we illustrate the meaning and most important implications of each of the remaining 54 general public health ethics norms from a child-centered perspective. The article thereby offers a framework for an assessment of gNBS from a child-centered public health ethics perspective. It also provides substantive and methodological guidance for further systematic ethical inquiry into gNBS.

Research question The secondary use of clinical data for research and learning activities has the potential to significantly improve medical knowledge and clinical care. To realize this potential, an ethical and legal basis for data use is needed, preferably in the form of patient consent. This raises the question: Do patients have a moral duty to provide their clinical data for research and learning activities? Methods On the basis of an ethical approach that we call “caring liberalism,” we evaluate plausibility and moral weight of the following arguments in favor of a duty on patients to provide their clinical data for research and learning activities: the general duty to help; solidarity; the duty to act in the public interest; the free-rider argument; transgenerational justice; the principle of giving back; the do-not-harm principle; freedom of research and the value of science. Results The general duty to help and the duty to act in the public interest are strong reasons for a moral duty of patients to provide their clinical data for research and learning activities. Transgenerational justice and the principle of giving back are ethically weak reasons for such a duty but might be motivational factors. The other reasons are not appropriate to justify a duty. The results are relevant in several respects: for patients who are asked to consent to the secondary use of their clinical data; for the ethical discussion of the question whether and to what extent deviations from the classical specific consent are ethically justifiable under certain conditions; for the legal discussion of the conditions for a proportionate secondary use of clinical data for research and learning activities.

ZusammenfassungSystemmedizinische Ansätze zeichnen sich durch die Integration großer Datenmengen aus vielfältigen Datenquellen aus und führen systembiologische und medizinische Forschungsansätze mit informationswissenschaftlichen Methoden und prädiktiven Verfahren mathematischer Modellierung zusammen. Hieraus resultiert eine enge Kooperation von Ärzten und Naturwissenschaftlern, wobei insbesondere die Expertise nicht-ärztlicher Forscher zunehmend an Bedeutung für die Datenaufbereitung und -interpretation gewinnt. Aus ethischer Perspektive wirft diese Entwicklung Fragen nach der konkreten Gestaltung einer systemmedizinischen Zusammenarbeit sowie möglichen Rollenveränderungen und neuen Verantwortungszuschreibungen an Ärzte und nicht-ärztliche Forscher auf. Um diese Fragen mit Blick auf die Erfahrungen und Perspektiven der beteiligten Akteursgruppen zu beleuchten, führten wir eine qualitative Interviewstudie mit Ärzten und nicht-ärztlichen Forschern aus unterschiedlichen systemmedizinischen Kontexten durch. Aus dem Interviewmaterial ließen sich zwei Konzeptionen von Systemmedizin rekonstruieren. Die erste ist durch eine eindeutige arbeitsteilige Rollentrennung zwischen Ärzten und Forschern charakterisiert: Der Forscher fungiert als Dienstleister, der Arzt als translationaler, interdisziplinär ausgerichteter Mediziner. Die zweite zeichnet sich durch eine weitreichende Aufhebung der Rollentrennung von Ärzten und Forschern aus: Die Berufsgruppen agieren als interdisziplinäres Team mit einer engen wechselseitigen inhaltlichen und methodischen Zusammenarbeit der Akteure. In beiden Konzeptionen werden Rollenkonflikte von Ärzten und Forschern deutlich, die insbesondere auf die Diskrepanz zwischen dem Arzt- und Forscherethos und die mit ihnen je verknüpften spezifischen Handlungsnormen und Ziele zurückzuführen sind. Ferner besteht mit Blick auf die dem Arzt und Forscher jeweils zukommende Verantwortung gegenüber Patienten vielfältiger normativer Klärungsbedarf, insbesondere hinsichtlich der Frage, welche Verantwortung den Akteursgruppen gerechtfertigter Weise zugeschrieben werden kann. Diesbezüglich erscheint eine Differenzierung von versorgungsnäheren und grundlagenforschungsorientierten Arbeitsfeldern angeraten.

Data-sharing among genomic researchers is promoted for its potential to accelerate our understanding of the molecular basis of cancer. However, with genomic data sharing the risks of re-identifying study participants, revealing personal genomic information and data misuse might increase. This study aims at exploring perceptions of patients and physicians in Oncology regarding their assessment of the informational risks resulting from participating in whole genomic research studies in order to improve the informed consent process. For this purpose, we conducted a qualitative focus group study at the National Center for Tumor Diseases (NCT). Patients and oncologists assessed the informational risks either as minimal or as greater than minimal, depending on the context factors of occupational status, age, and patients’ prognosis. Interestingly, even patients who assumed a greater risk did not refrain from participating in genomic research, provided that certain informational and institutional safeguards are implemented. Moreover, they expected comprehensive disclosure of the risks resulting from genomic data sharing. These results suggest (1) comprehensive disclosure of the risks of genomic research to potential study participants in genomic research to facilitate risk assessment and sound decision making, (2) establishing independent governance entities in order to minimize the informational risks of genomic research, and (3) implementing data sharing policies which offer guidance for physicians and researchers involved in genomic research.

Data-sharing among genomic researchers is promoted for its potential to accelerate our understanding of the molecular basis of cancer. However, with genomic data sharing the risks of re-identifying study participants, revealing personal genomic information and data misuse might increase. This study aims at exploring perceptions of patients and physicians in Oncology regarding their assessment of the informational risks resulting from participating in whole genomic research studies in order to improve the informed consent process. For this purpose, we conducted a qualitative focus group study at the National Center for Tumor Diseases. Patients and oncologists assessed the informational risks either as minimal or as greater than minimal, depending on the context factors of occupational status, age, and patients’ prognosis. Interestingly, even patients who assumed a greater risk did not refrain from participating in genomic research, provided that certain informational and institutional safeguards are implemented. Moreover, they expected comprehensive disclosure of the risks resulting from genomic data sharing. These results suggest comprehensive disclosure of the risks of genomic research to potential study participants in genomic research to facilitate risk assessment and sound decision making, establishing independent governance entities in order to minimize the informational risks of genomic research, and implementing data sharing policies which offer guidance for physicians and researchers involved in genomic research.

Research question The secondary research use of treatment data has the potential to expand medical knowledge and improve patient care. Hospitals play an important role in systematic secondary research use: they generate large amounts of treatment data and are supposed to establish the necessary structures for their use in research. This raises the ethical question: do hospitals have a moral duty to support secondary research use of treatment data by establishing and operating the necessary resources and infrastructure? Procedure Our aim is to outline a conceptual framework to discuss the question and to propose a first normative position. Building on insights from business and organizational ethics, we develop a conceptual framework in which we view hospitals as moral actors. Our normative-ethical analysis is based on a reconstructive stakeholder approach, in which we identify the following general duties of hospitals: orientation towards patient wellbeing; cost efficiency; enabling employees to act in accordance with professional ethical standards; supporting public health and research. We examine whether these general duties provide reasons for a specific duty of hospitals to support secondary research use of treatment data. We discuss potential objections to such a duty arising from other, potentially conflicting general duties of hospitals (e.g., data protection), from practice (e.g., costs/resources), or related discourses (data ownership). Conclusion Certain general duties (orientation towards patient wellbeing, cost efficiency, support of public health) justify a duty of hospitals to support secondary research use of treatment data. The duty to enable employees to act in accordance with professional ethical standards is only an indirect reason; the duty to support research applies solely to university hospitals. Potential objections apply to a certain extent but can be mitigated through targeted measures.