Non-invasive prenatal testing in Germany: a unique ethical and policy landscape

Non-invasive prenatal testing (NIPT) has been available commercially in Europe since approximately 2012. Currently, many countries are in the process of integrating NIPT into their publicly funded healthcare systems to screen for chromosomal aneuploidies such as trisomy 21 (Down syndrome), with a variety of implementation models. In 2019, the German Federal Joint Committee (G-BA), which plays a significant role in overseeing healthcare decisions in Germany, recommended that NIPT be reimbursed through public insurance. Following this recommendation, NIPT will be offered on a case-by-case basis, when a pregnant woman, after being counselled, makes an informed decision that the test is necessary in her personal situation. This model differs significantly from many other European countries, where NIPT is being implemented either as a first-tier screening offer available for all pregnancies, or a contingent screen for those with a high probability of foetal aneuploidy (with varying probability cut-offs). In this paper we examine how this unique approach to implementing NIPT in Germany is produced by an ethical and policy landscape resulting from a distinctive cultural and historical context with a significant influence on healthcare decision-making. Due in part to the specific legal and regulatory environment, as well as strong objections from various stakeholders, Germany did not implement NIPT as a first-tier screen. However, as Germany does not currently publicly fund as standard other forms of prenatal aneuploidy screening (such as combined first trimester screening), neither can it be implemented as a screen contingent on specific probability cut-offs. We discuss how German policy reflects the echoes of the past shaping approaches to new biotechnologies, and the implications of this unique model for implementing NIPT in a public healthcare system

Off-label, off-limits? Parental awareness and attitudes towards off-label use in paediatrics

Off-label drug use in paediatrics is associated with an increased risk of adverse drug reactions. Any risk–benefit analysis has to be based on value judgments that should include parents' views. However, nothing is known so far about the parents' perspective on this critical issue. Therefore, a quantitative survey with parents of healthy and chronically ill children was carried out (n = 94). Knowledge about the practise of off-label use is generally poor in both groups. Surprisingly, this is also true for the parents of children with chronic disease. Nine percent of the parents of chronically ill children and 20% of the parents of healthy children would refuse treatment with an off-label drug. Parents who have poor knowledge about the practise of off-label use tend to refuse to volunteer their child for study participation. Therefore, the information of parents on the off-label use of drugs is important to meet ethical standards and to increase the parents' acceptance of medical studies with children

Should Postponing Motherhood via “Social Freezing” Be Legally Banned? An Ethical Analysis

In industrial societies, women increasingly postpone motherhood. While men do not fear a loss of fertility with age, women face the biological boundary of menopause. The freezing of unfertilized eggs can overcome this biological barrier. Due to technical improvements in vitrification, so-called “social freezing” (SF) for healthy women is likely to develop into clinical routine. Controversial ethical debates focus on the risks of the technique for mother and child, the scope of reproductive autonomy, and the medicalization of reproduction. Some criticize the use of the technique in healthy women in general, while others support a legally defined maximum age for women at the time of an embryo transfer after oocyte cryopreservation. Since this represents a serious encroachment on the reproductive autonomy of the affected women, the reasons for and against must be carefully examined. We analyze arguments for and against SF from a gendered ethical perspective. We show that the risk of the cryopreservation of oocytes for mother and future child is minimal and that the autonomy of the women involved is not compromised. The negative ethical evaluation of postponed motherhood is partly due to a biased approach highlighting only the medical risks for the female body without recognizing the potential positive effects for the women involved. In critical accounts, age is associated in an undifferentiated way with morbidity and psychological instability and is thus used in a discriminatory way. We come to the conclusion that age as a predictor of risk in the debate about SF is, from an ethical point of view, an empty concept based on gender stereotypes and discriminatory connotations of aging. A ban on postponing motherhood via SF is not justified

"Sensory Fit Panel" – Development of a new Advertising Claim Support method to assess aesthetic diaper fit performance in an objective, reliable and reproducible way

For the product design of diapers, the fit on the baby plays a significant role. In particular, innovation in the areas of fit and freedom of movement have become increasingly important as lower order needs like leakage are sufficiently met by most products. Today’s methods to measure diaper fit focus on technical measurements (engineering and technical fit) and parents’ subjective perceptions. While these methods are useful tools for product development purposes, they are not seen as sufficient for Advertising Claim Support needs. However, when a new fit innovation should be advertised, particularly when this is done in a competitive way, a robust technical support is needed to defend this claim in case of challenges by competitors or regulatory bodies. For this purpose, methods need to be objective and technically sound in order to be acceptable to advertising regulatory bodies. Independent, objective ratings would substantiate claims on a more reliable and reproducible base. To meet this need, the diaper fit sensory panel method was developed. This test reapplies the established sensory methodology used, e.g. to assess taste or smell in food and beverages

Socio-Informatics

Contents Editorial Thematic Focus: Socio-Informatics Introduction to the Thematic Focus “Socio-Informatics” / Claudia Müller Digitalisation in Small German Metal-Working Companies. Appropriation of Technology in a “Traditional” Industrial Domain / Bernhard Nett, Jennifer Bönsch Travelling by Taxi Brousse in Madagascar: An Investigation into Practices of Overland Transportation / Volker Wulf, Kaoru Misaki, Dave Randall, and Markus Rohde Mobile and Interactive Media in the Store? Design Case Study on Bluetooth Beacon Concepts for Food Retail / Christian Reuter, Inken Leopold Facebook and the Mass Media in Tunisia / Konstantin Aal, Marén Schorch, Esma Ben Hadj Elkilani, Volker Wulf Book Review Symposium Charles Goodwin Charles Goodwin’s Co-Operative Action: The Idea and the Argument / Erhard Schüttpelz, Christian Meyer Multi-Modal Interaction and Tool-Making: Goodwin’s Intuition / Christian Meyer, Erhard Schüttpelz Co-Operation is a Feature of Sociality, not an Attribute of People : “We inhabit each other’s actions.” (Goodwin, cover) / Jutta Wiesemann, Klaus Amann The Making of the World in Co-Operative Action. From Sentence Construction to Cultural Evolution / Jürgen Streeck On Goodwin and his Co-Operative Action / Jörg R. Bergman

Media ethnography

Contents Editorial Thematic Focus: Media Ethnography Media Ethnography and Participation in Online Practices / David Waldecker, Kathrin Englert, Wolfgang Ludwig-Mayerhofer, Oliver Schmidtke The Story is Everywhere. Dispersed Situations in a Literary Role Play Game / Wolfgang Reißmann Co-operation and/as Participant Observation: Reflections on Ethnographic Fieldwork in Morocco / Simon Holdermann Ethnomethodological Media Ethnography: Exploring Everyday Digital Practices in Families with Young Children / Clemens Eisenmann, Jan Peter, Erik Wittbusch Cooperation and Difference. Camera Ethnography in the Research Project ‘Early Childhood and Smartphone’ / Bina E. Mohn, Pip Hare, Astrid Vogelpohl, Jutta Wiesemann Reports Coordinations, or Computing is Work / Sebastian Gießman