Ralf Müller

Definition of problem Newborn screening (NBS) is an internationally successful program for the secondary prevention of rare congenital diseases. At present, most of the target conditions in NBS are diagnosed by biochemical markers. Recent advances in genomic sequencing and in the bioinformatic evaluation of genetic variants will soon make it feasible however to expand NBS significantly by testing newborns directly for pathogenic variants. Yet, genomic newborn screening (gNBS) raises important ethical issues that require resolution, given that several pilot studies on gNBS implementation are already underway. Given a rapidly growing scholarly engagement with the ethics of gNBS, a more systematic and comprehensive mapping of the ethical issues and considerations relevant to gNBS is needed to move the debate forward at this point. - Methods In this integrative review, we survey the literature with the aim of delineating a conceptual framework for the ethics of gNBS, which organizes the ongoing debate and thereby provides guidance for further research. Here in Part I, we focus primarily on an exposition of the ethical issues and questions involved in gNBS program design. - Conclusion The ethical issues divide into issues regarding (1) the test itself and the selection of target conditions, (2) informed consent, and (3) genomic data generation, storage, and use. Regarding (1) we discuss several dimensions along which potential target conditions can differ and their ethical implications, and formulate some requirements on appropriate selection criteria with special regard to minimizing diagnostic and therapeutic uncertainty. Regarding (2) we discuss the need for informed consent, the structure and content of pre-test counseling (when, who, what, how), the suggestion of a tiered testing offer, and familial conflict. Regarding (3) we discuss liberal versus restrictive approaches to genomic data generation, parental consent to genomic raw data storage for further uses beyond the test, some candidate further uses, and the risk of abuse.

Definition of problem Newborn screening (NBS) is an internationally successful program for the secondary prevention of rare congenital diseases. At present, most of the target conditions in NBS are diagnosed by biochemical markers. Recent advances in genomic sequencing and in the bioinformatic evaluation of genetic variants will soon make it feasible however to expand NBS significantly by testing newborns directly for pathogenic variants. Yet, genomic newborn screening (gNBS) raises important ethical issues that require resolution, given that several pilot studies on gNBS implementation are already underway. Given a rapidly growing scholarly engagement with the ethics of gNBS, a more systematic and comprehensive mapping of the ethical issues and considerations relevant to gNBS is needed to move the debate forward at this point. Methods In this integrative review, we survey the literature with the aim of delineating a conceptual framework for the ethics of gNBS, which organizes the ongoing debate and thereby provides guidance for further research. Here in Part II, we outline a tentative normative framework for the ethics of gNBS by systematizing the core ethical principles advanced in the literature and offer an original contribution to the debate beyond a mere survey of considerations by proposing a substantive interpretation of these principles and how they relate to each other in the gNBS context. We demonstrate the general utility of this framework for addressing the ethical issues involved in gNBS program design by drawing out its implications for some of the issues presented in Part I. Conclusion In Part I, we formulated a requirement of informed consent for gNBS. Since newborns still lack a capacity for autonomous choice and informed consent, we approach gNBS program design through the question of what renders it ethically permissible for the child’s custodians to consent to gNBS in its name. Consequently, we discuss the authority of parents as surrogate decision-makers for their child, who are bound by a duty of care towards it. We substantiate this duty (a) by discussing several rights of the child, viz., its rights to informational self-determination, genetic ignorance, privacy, and an open future, and (b) by developing a specification of the best interest standard for children as the main principle that should guide and constrain both parental decision-making and gNBS program design. Finally, we consider concerns that gNBS could result in a harmful medicalization of healthy children.

[English version below] Diese Stellungnahme zielt darauf ab, Empfehlungen für akzeptable Rahmenbedingungen eines Genomischen-Neugeborenen-Screening (gNBS)-Programms in Deutschland zu formulieren, darunter Empfehlungen zu Auswahlkriterien für Zielkrankheiten und zum Management eines gNBS-Programms sowie zur gesetzlichen Neuregulierung. Sie ist Ergebnis eines dreijährigen Forschungsprojektes, das an den Universitäten Heidelberg und Mannheim durchgeführt wurde. An dem interdisziplinären Projekt beteiligt waren Forscher:innen aus den Bereichen Kinder- und Jugendmedizin, Humangenetik, Rechtswissenschaft, Medizinische Psychologie und Medizinethik sowie Vertreter:innen von Patient:innen-Organisationen (Kindernetzwerk e.V. und Deutsche Interessengemeinschaft Phenylketonurie und verwandte angeborene Stoffwechselstörungen e.V.). Das Projekt wurde vom Bundesministerium für Bildung und Forschung (BMBF; seit 2025 Bundesministerium für Forschung, Technologie und Raumfahrt: BMFTR) gefördert und trägt den Titel NEW_LIVES („Genomic NEWborn screening programs – Legal Implications, Value, Ethics and Society” – „Genomische Neugeborenen-Screening-Programme – Rechtliche Implikationen, Werte, Ethik und Gesellschaft“). Die Stellungnahme beginnt mit einführenden Kapiteln zum Hintergrund des gNBS aus Sicht der verschiedenen Fachbereiche und aus Sicht der Gesellschaft, gefolgt von konkreten Empfehlungen für ein zukünftig mögliches gNBS-Pro- gramm in Deutschland. In der Einleitung (1.) werden erste Ergebnisse bisheriger Forschungsprojekte zum gNBS zusammengefasst und die Zielsetzung und Methode, einschließlich der Rolle von Patient:innen-Vertreter:innen bei der Erarbeitung der Stellungnahme werden beschrieben. In Abschnitt 2 („Medizinischer Hintergrund“) werden Entwicklung, Umfang und Ablauf des derzeitigen Neugeborenen-Screening (NBS)-Programms in Deutschland beschrieben und die Besonderheiten eines gNBS-Programms erläutert. Abschnitt 3 („Perspektive von Patient:innen, Eltern und medizinischem Personal“) fasst die Ergebnisse der sozialempirischen Studien zusammen, die im Rahmen des Projektes NEW_LIVES durchgeführt wurden (Fokusgruppen, bevölkerungs-repräsentative Befragung, querschnittliche Online-Befragung) und vergleicht die Ergebnisse mit anderen, internationalen Studien. Abschnitt 3 enthält außerdem eine gemeinsame Stellungnahme der beiden Patient:innen-Organisationen, die am Projekt NEW_LIVES mitgewirkt haben, zum gNBS. Abschnitt 4 („Genomisches Neugeborenen-Screening aus rechtlicher Sicht“) skizziert den rechtlichen Regulierungsrahmen zum gNBS in Deutschland. Abschnitt 5 („Genomisches Neugeborenen-Screening aus ethischer Sicht“) benennt zentrale ethische Herausforderungen des gNBS und formuliert ethische Orientierungsmaßstäbe für ein zukünftiges gNBS-Programm in Deutschland. Da die Neugeborenen diejenigen sind, die an einem gNBS teilnehmen würden und davon profitieren könnten, stellt deren Kindeswohl den zentralen ethischen Orientierungsmaßstab für die Bewertung dar. Die sich in Abschnitt 6 anschließenden Empfehlungen sind aus Sicht aller an der Erarbeitung dieser Stellungnahme beteiligten Fachdisziplinen und der Patient:innen-Organisationen verfasst Darunter sind einerseits transparente Auswahlkriterien für Zielkrankheiten eines gNBS-Programms (Kriterien 1–11). Andererseits werden Empfehlungen für die Einführung, Qualitätssicherung und Nutzenbewertung eines gNBS-Programms formuliert (Kriterien 12–18). Zudem enthält diese Stellungnahme Empfehlungen zur gesetzlichen Neuregulierung. Eine Publikation der Empfehlungen auf Englisch findet sich in Schnabel-Besson et al.: “A multi-dimensional fra- mework for establishing and managing a genomic newborn screening program” (Arbeitstitel; zum Zeitpunkt des Verfassens dieser Stellungnahme in Vorbereitung; DOI der Preprint-Version: 10.1101/2025.06.17.25329 471). - This position paper has the aim of formulating recommendations for what would be an acceptable framework for a genomic newborn screening (gNBS) programme in Germany, including recommendations for selection criteria for target diseases, and for the management of a gNBS programme, as well as for revision of legislation. It is the result of a research project conducted at the Universities of Heidelberg and Mannheim over the course of three years. This interdisciplinary project brought together researchers from the fields of paediatrics and adolescent medicine, human genetics, law, medical psychology, and medical ethics, as well as representatives of patient organisations (Kindernetzwerk e.V., and Deutsche Interessenge- meinschaft Phenylketonurie und verwandte angeborene Stoffwechselstörungen e.V.). The project was funded by the German Federal Ministry of Education and Research (BMBF; since 2025 Federal Ministry of Research, Technology and Space: BMFTR) and is called NEW_LIVES (“Genomic NEWborn screening programs – Legal Implications, Value, Ethics and Society”). The position paper begins with introductory chapters on gNBS from the perspective of the different disciplines, and from a societal viewpoint, followed by concrete recommendations for a possible future gNBS programme in Germany. The Introduction (1.) summarises the initial results of previous research projects on gNBS, and describes the objectives, and methodology, including the role of patient representatives, in the development of the position paper. Section 2 (“Medical Background”) describes the development, scope, and process of the current NBS programme in Germany, and explains the specific features of a gNBS programme. Section 3 (“Perspectives of Patients, Parents, and Medical Staff”) summarizes the results of the social-empirical studies conducted as part of the NEW_LIVES project (focus groups, population-representative survey, cross-sectional online survey), and compares the results with other, international studies. Section 3 also contains a joint statement on gNBS by the two patient organisations that participated in the NEW_LIVES project. Section 4 (“Genomic Newborn Screening from a Legal Perspective”) outlines the legal regulatory framework for gNBS in Germany. Section 5 (“Genomic Newborn Screening from an Ethical Perspective”) identifies key ethical challenges of gNBS, and formulates ethical guidelines for a future gNBS programme in Germany. Since newborns are the ones who would participate in, and benefit from gNBS, their welfare represents the central ethical guideline for the evaluation. The recommendations in Section 6 are written from the perspective of all disciplines, and patient organisations involved in the development of this position paper. These recommendations reflect the consensus of the inter-, and transdisciplinary group of authors, and form the core of the position paper. They comprise 18 criteria for a possible future gNBS programme in Germany. These include, on the one hand, transparent selection criteria for target diseases of a gNBS programme (criteria 1–11). On the other hand, recommendations are formulated for the introduction, quality assurance, and benefit assessment of a gNBS programme (criteria 12–18). This position paper also contains recommendations for new legal regulations. An English version of the recommendations, including the 11 criteria for selecting target diseases and the 7 criteria for programme management can be found in Schnabel-Besson E, Dikow N, Alex K et al.: “A multidimensional framework for establishing and managing a genomic newborn screening program” (working title; in preparation at the time of writing this position paper; doi of preprint version: 10.1101/2025.06.17.25329471).

ZusammenfassungDieser Beitrag widmet sich der Frage, wie mit Blutproben, die im Rahmen eines (genomischen) Neugeborenen-Screenings gewonnen werden, rechtlich umzugehen ist. Können oder müssen diese Proben aufbewahrt werden, um das Testergebnis zu überprüfen? Und können an ihnen weitere Analysen zu medizinischen Zwecken vorgenommen werden? Auch ist der Frage nachzugehen, ob die Proben zu Forschungszwecken verwendet werden und ob die Eltern ihre Einwilligung zur Übereignung der Proben an Forschungseinrichtungen erteilen dürfen. Schließlich soll die Rekonstruktion der Rechtslage aus einer ethischen und praktischen Perspektive auf ihre Angemessenheit hin bewertet werden. Dabei stellt sich insbesondere die Frage, ob die gegenwärtige Rechtslage den Anforderungen eines genomischen Neugeborenen-Screenings gerecht wird oder insoweit Anpassungen erforderlich sind.

Definition of the problem This article discusses the legal challenges associated with the use and storage of blood samples collected as part of newborn screening programs. A key question is whether these samples can or must be stored and used beyond their immediate purpose for further medical analysis or research. Arguments In principle, newborn blood samples can be used and stored for the intended purpose of screening, as they were collected for this purpose. For use and storage beyond this, German law requires either parental consent or a legal basis, either for further medical purposes or for research. Parental consent must always be given in the best interest of the child, with particular regard to its fundamental rights. For further research purposes, there are national laws that legitimize use for these purposes if research interests predominate. Conclusion The handling of blood samples from newborn screening for purposes other than screening has many legal and ethical implications. These issues would remain with the introduction of genomic newborn screening.

In the writings of the Japanese Pure Land Buddhist Shinran 親鸞 (1173–1263) we read: “I, Shinran, do not have a single disciple of my own” (SZ Supplement: 10; Saitō 2010: 242; Yuien 1996: 6). Is he simply being modest? Does Shinran defy discipleship? Does he rule out the possibility of the reception of his thought? The answer to these questions is not clear; nevertheless, what we do know is that the reader of his writings is supposed to arrive at the Buddha’s original teaching. Shinran’s voluminous works, however, exhibit more than an introduction to, or simple interpretation of, the Buddha’s preaching. We may say that Shinran has given us sermons and treatises that manifest an authentic and unique appropriation of the Buddhist tradition, and, therefore, his works offer the possibility of a thoughtful reception for his interpreters and disciples. The philosopher KUKI Shūzō 九鬼周造 (1888–1941) wrote remarkable verses about Shinran seven centuries after his death: “I will have no disciple, said Shinran; as for me [Kuki], I long to have his soul” (KSZ Supplement, 146; Saitō 2010: 242). Kuki’s poetic reflections express Shinran’s quest for an authentic life, and echo back the existentialist aspect of his philosophy. More than this, his words commit him to Shinran as his teacher. Do these words not enact the most authentic discipleship possible? In fact, SAITŌ Takako takes Kuki’s verses as empirical evidence of his receiving the intellectual legacy of Shinran. Thus, at the end of her article, the proof of historical facticity of reception retroactively justifies Saitō’s careful comparison of Kuki’s thought with Shinran’s, which began based on presuming similarities in content. In other words, the factual findings prove the validity of comparing Shinran and Kuki, although a truthful reading is impossible to verify historically. Be that as it may, Kuki’s poetic expression demonstrates the history of the reception of a pre-modern Buddhist by a modern philosopher in Japan, regardless of whether this discipleship was ultimately judged to be authentic and perfected, or an untimely failure.

What does it mean to be human? We invite the reader to discuss this most fundamental issue in philosophy and to do so in an intercultural framework. The question of the human was the starting point for a legendary discussion between two German philosophers who met in Davos in 1929. We return to this historical event and re-imagine the debate between Martin Heidegger and Ernst Cassirer from a global perspective. Generating twenty papers from elaborate discussions, our authors contribute to the thought experiment by inviting the Japanese philosopher Nishida Kitarō from Kyoto and other Japanese thinkers into the debate to overcome the challenge of Eurocentrism inherent to these historic days in Davos.

© 1966-2012 IEEE.Emerging applications in brain-machine interface systems require high-resolution, chronic multisite cortical recordings, which cannot be obtained with existing technologies due to high power consumption, high invasiveness, or inability to transmit data wirelessly. In this paper, we describe a microsystem based on electrocorticography that overcomes these difficulties, enabling chronic recording and wireless transmission of neural signals from the surface of the cerebral cortex. The device is comprised of a highly flexible, high-density, polymer-based 64-channel electrode array and a flexible antenna, bonded to 2.4 mm × 2.4 mm CMOS integrated circuit that performs 64-channel acquisition, wireless power and data transmission. The IC digitizes the signal from each electrode at 1 kS/s with 1.2 μV input referred noise, and transmits the serialized data using a 1 Mb/s backscattering modulator. A dual-mode power-receiving rectifier reduces data-dependent supply ripple, enabling the integration of small decoupling capacitors on chip and eliminating the need for external components. Design techniques in the wireless and baseband circuits result in over 16× reduction in die area with a simultaneous 3× improvement in power efficiency over the state of the art. The IC consumes 225 μW and can be powered by an external reader transmitting 12 mW at 300 MHz, which is over 3× lower than IEEE and FCC regulations.

We present a method for decreasing the duration of artifacts present during intra-cortical microstimulation recordings by using techniques developed for digital communications. We replace the traditional monophasic or biphasic current stimulation pulse with a patterned pulse stream produced by a Zero Forcing Equalizer filter after characterizing the artifact as a communications channel. The results find that using the ZFE stimulus has the potential to reduce artifact width by more than 70%. Considerations for the hardware implementation of the equalizer are presented.

This book addresses the question of how to properly handle Dōgen’s texts, a core issue that became critical during the Meiji period in which the philosophical appropriation of Dōgen became apparent inside and outside of the monastery. In present day Dōgen studies, most scholarship is informed by a number of factions representing Dōgen. The chapters herein address: the Zennist (j. zenjōka) emphasising practice, the Genzōnians (j. genzōka) shifting the attention to the close reading of Dōgen’s texts, the laity movement opening up both the texts and the practice to people in modern society, and the Genzō researchers (j. genzō kenkyūka) searching for the authenticity and truth of Dōgen’s writings. The book aims to clarify the rightful place of Dōgen: in the monastery, in denominational studies, or in modern academic philosophy? It brings forth various viewpoints on Dōgen, and analyzes the relations of these viewpoints from the premodern to modern times. The collected volume appeals to students and researchers in the field while establishing hermeneutic standards of reading and proposing new, original, and critical interpretations of Dōgen’s texts. Chapter From Uji to Being-time (and Back): Translating Dōgen into Philosophy is available open access under a Creative Commons Attribution 4.0 International License via link.springer. com.

This chapter focuses on modern commentators close to or from the Kyoto school. According to Müller, there have been two approaches within the so-called Kyoto school regarding Dōgen's work. Initially, there were philosophically ambitious interpretations, such as those by Watsuji Tetsurō and Tanabe Hajime. They were ambitious insofar as they attempted to bridge the gap between philosophy and religion. However, from the 1940s onwards, these seminal works tended to recede into the background since they were criticised for assimilating a medieval monk into modern secular thought. Müller discusses the second approach that was put forward by thinkers such as Nishida Kitarō (1870-1945), Nishitani Keiji (1900-1990) and Ueda Shizuteru (1926-2019). They furthered the questioning of religion and philosophy by developing a specific style of reading Dōgen.

Ernst Cassirer’s (1874–1945) lecture »Structuralism in Modern Linguistics«, given in 1945, not only represents a kind of late return to his intellectual origins in thetradition of Leibniz, Kant and Humboldt. It also provides a diagnosis of the importance of linguistics in his time. This diagnosis should prove far-sighted from the vantage point of both the history and philosophy of science. The thesis presented in this article is that for Cassirer, modern linguistics represents a scientific paradigm that encompasses various fields in academia and even transcends the divide between the humanities and the sciences, i. e. Geisteswissenschaften and Naturwissenschaften. In order to verify this thesis, the present essay analyzes Cassirer’s lecture and places him in a dialogue with the most important addressee of Cassirer’s: the linguist Roman Jakobson (1896–1982), who lived in New York at the same time as Cassirer.

This book presents the first collection of essays on the philosophy of Ueda Shizuteru in a Western language. Ueda, the last living member of the Kyoto school, has fostered the East-West dialogue in all his works and has helped to open up the Western image of philosophy by engaging the Zen tradition. The book reflects this particular trait of Ueda’s philosophy, but it also covers all thematic fields of his writings. Contributions from both young and established scholars and experts from Japan, Europe and the U.S. make this a unique introduction to and reception of Ueda’s philosophy. Readers will discover discussions of mysticism in the East and West, and consideration of modern philosophy topics including self-awareness, nature and poetic language. The book also presents a focussed look at language and nothingness, considering silence and nihilism. Chapters allow the reader to understand the timeliness of a thinking that mediates and transcends the dichotomy of East and West. This volume will appeal not only to scholars of Nishida, Japanese philosophy, mysticism and religious experience in Japan, but also to scholars of Western philosophy, especially those interested in Meister Eckhart, Martin Heidegger and Martin Buber. It makes an ideal introduction to Zen philosophy and presents important contributions to scholarship on language and experience.

The conference in a nutshell: philosophy in times of crises returned to a crisis in philosophy. The pandemic throws us back on our feet and makes us rethink the question raised at the Davos Disputation between Martin Heidegger and Ernst Cassirer in 1929: “What is a human being?” While both had agreed that the initial question was the crucial question to tackle, neither of them could put forth a solution to the question given that their own thought paths proved to have led them into a dead end and to the necessity to turn in a new direction in order to overcome a philosophical crisis. So, in 2020, why not move beyond the scope of this German–German disputation in Davos, and even beyond the horizon of Europe to look for new pathways of thought?

In the writings of the Japanese Pure Land Buddhist Shinran 親鸞 we read: “I, Shinran, do not have a single disciple of my own”. Is he simply being modest? Does Shinran defy discipleship? Does he rule out the possibility of the reception of his thought? The answer to these questions is not clear; nevertheless, what we do know is that the reader of his writings is supposed to arrive at the Buddha’s original teaching. Shinran’s voluminous works, however, exhibit more than an introduction to, or simple interpretation of, the Buddha’s preaching. We may say that Shinran has given us sermons and treatises that manifest an authentic and unique appropriation of the Buddhist tradition, and, therefore, his works offer the possibility of a thoughtful reception for his interpreters and disciples. The philosopher KUKI Shūzō 九鬼周造 wrote remarkable verses about Shinran seven centuries after his death: “I will have no disciple, said Shinran; as for me [Kuki], I long to have his soul”. Kuki’s poetic reflections express Shinran’s quest for an authentic life, and echo back the existentialist aspect of his philosophy. More than this, his words commit him to Shinran as his teacher. Do these words not enact the most authentic discipleship possible? In fact, SAITŌ Takako takes Kuki’s verses as empirical evidence of his receiving the intellectual legacy of Shinran. Thus, at the end of her article, the proof of historical facticity of reception retroactively justifies Saitō’s careful comparison of Kuki’s thought with Shinran’s, which began based on presuming similarities in content. In other words, the factual findings prove the validity of comparing Shinran and Kuki, although a truthful reading is impossible to verify historically. Be that as it may, Kuki’s poetic expression demonstrates the history of the reception of a pre-modern Buddhist by a modern philosopher in Japan, regardless of whether this discipleship was ultimately judged to be authentic and perfected, or an untimely failure.

The present papers brings up Cassirer’s idea of philosophy through the few and scattered remarks that he makes about non-European traditions of thought. While Cassirer’s philosophy of culture theorizes symbolic functions through an examination of symbolic forms, he only implicitly talks about culture as such. However, since culture is the unity of symbolic forms and in and by itself a cultural form, culture is always related to other cultures. And hence, one culture is not the sole possible and implies – to cite Wilhelm von Humboldt – a particular Weltansicht. So, firstly, how does Cassirer’s philosophy of culture relate to what is always present as its background, i.e. to European culture? And, secondly, how does his notion of philosophy relate to the cultural setting that it emerges from? To address these question, two paths seem possible: on the one hand, the top-down analysis from his philosophy of culture through to a determination of cultures based on different, but complementary modes of symbolization; and on the other hand, a bottom up analysis by beginning from Cassirer’s own comments and thoughts on non-European traditions. Since this path is rather unsystematic, it can serve as a counter narrative to Cassirer’s own systematic position. While both paths are pertinent and not mutually exclusive, in the present paper only the bottom-up analysis will be discussed.