Background Non-invasive prenatal testing (NIPT), which can screen for aneuploidies such as trisomy 21, is being implemented in several public healthcare systems across Europe. Comprehensive communication and information have been highlighted in the literature as important elements in supporting women’s reproductive decision-making and addressing relevant ethical concerns such as routinisation. Countries such as England and France are adopting broadly similar implementation models, offering NIPT for pregnancies with high aneuploidy probability. However, we do not have a deeper understanding of how professionals’ (...) counselling values and practices may differ between these contexts. Methods In this paper, we explore how professionals in England and France support patient decision-making in the provision of NIPT and critically compare professional practices and values. We draw on data from semi-structured interviews with healthcare professionals. Results Both English and French professionals emphasised values relating to patient choice and consent. However, understandings and application of these values into the practice of NIPT provision differed. English interviewees placed a stronger emphasis on interpreting and describing the process of counselling patients and clinical care through a “principle” lens. Their focus was on non-directiveness, standardisation, and the healthcare professional as “decision-facilitator” for patients. French interviewees described their approach through a “procedural” lens. Their focus was on formal consent, information, and the healthcare professional as “information-giver”. Both English and French professionals indicated that insufficient resources were a key barrier in effectively translating their values into practice. Conclusion Our findings illustrate that supporting patient choice in the provision of NIPT may be held as an important value in common on a surface level, but can be understood and translated into practice in different ways. Our findings can guide further research and beneficially inform practice and policy around NIPT provision. (shrink)

Digital farming technologies promise to help farmers make well-informed decisions that improve the quality and quantity of their production, with less labour and less impact on the environment. This future, however, can only become a reality if farmers are willing to share their data with agribusinesses that develop digital technologies. To foster trust in data sharing, in Europe the EU Code of Conduct for agricultural data sharing by contractual agreement was launched in 2018 which encourages transparency about data use. This (...) article looks at the EU Code through the lens of literature on trust and contract agreements. We agree with the makers of the EU Code that a contract can make an important contribution to trust relationships as it is needed to mitigate the detrimental effects of power relationships between experts and non-experts. Building on Onora O’Neills perspective to trust, however, we argued that a contract can only be successful in fostering trust when information is comprehended by the more vulnerable party in this relationship who has to sign the contract, the more powerful partner takes responsibility to provide that information, and information is tailored to the information needs of the party signing the contract, even when data are re-used over a longer period. In addition, we think that differences between trust relationships and relationships of accountability, give reason to add to informed consent other more substantive ethical components in a more encompassing code of conduct. (shrink)

As a psychologist and an ethicist, we have explored empirically newborn screening consent and communication processes. In this paper we consider the impact on families if newborn screening uses whole genome sequencing. We frame this within the World Health Organization’s definition of health and contend that proposals to use whole genome sequencing in newborn screening take into account the ethical, practical and psychological impact of such screening. We argue that the important psychological processes occurring in the neonatal phase necessitate a (...) clear justification that providing risk information at this stage provides a health benefit. We illustrate how research on current newborn screening can inform whole genome sequencing debates, whilst highlighting important gaps. Obtaining explicit, voluntary, and sufficiently informed consent for newborn screening is challenging, however we stress that such consent is ethically and legally appropriate and psychologically and practically important. We conclude by outling how this might be done. (shrink)

In the near future developments in non-invasive prenatal testing may soon provide couples with the opportunity to test for and diagnose a much broader range of heritable and congenital conditions than has previously been possible. Inevitably, this has prompted much ethical debate on the possible implications of NIPT for providing couples with opportunities for reproductive choice by way of routine prenatal screening. In view of the possibility to test for a significantly broader range of genetic conditions with NIPT, the European (...) Society of Human Genetics and American Society of Human Genetics recommend that, pending further debate, prenatal screening for reproductive choice should only be offered where concerning serious congenital conditions and childhood disorders. In support of this recommendation, the ESHG and ASHG discuss a number of ethical issues on which they prompt further debate: the informational privacy of the future child, the trivialization of abortion, the risk of information overload, and issues of distributive justice. This paper responds to this call with further reflection on each ethical issue and how it relates to the moral justification of providing couples with opportunities for meaningful reproductive choice. The paper concludes that whilst there may be good reasons for qualifying the scope of any unsolicited prenatal screening offer to serious congenital conditions and childhood disorders, if prenatal screening is justified for providing couples with opportunities for meaningful reproductive choice, then health services may have obligations to empower couples with the same opportunity where concerning other conditions. (shrink)

Publics are key stakeholders in population genomic screening and their perspectives on ethical considerations are relevant to programme design and policy making. Using semi-structured interviews, we explored social views and attitudes towards possible future provision of personalised genomic risk information to populations to inform prevention and/or early detection of relevant conditions. Participants were members of the public who had received information on their personal genomic risk of melanoma as part of a research project. The focus of the analysis presented here (...) is participants’ views regarding ethical considerations relevant to population genomic screening more generally. Data were analysed thematically and four key themes related to ethical considerations were identified: personal responsibility for health: ‘forewarned is forearmed’; perceptions of, and responses to, genetic fatalism; implications for parenting and reproduction; divided views on choosing to receive genomic risk information. Ethical considerations underlying these themes include the valorisation of information and choice, paternalism, non-directiveness and increasing responsibilisation of individuals in health and healthcare. These findings arguably indicate a thin public conceptualisation of population genomic testing, which draws heavily on how these themes tend to be described in existing social discourses. Findings suggest that further public engagement is required to increase complexity of debate, to consider the appropriate place of individual and social interests in population genomic testing. Further discernment of relevant ethical approaches, drawing on ethical frameworks from both public health and clinical settings, will also assist in determining the appropriate implementation of population genomic screening for complex conditions. (shrink)

In March 2019, the German Gemeinsamer Bundesausschuss (G‑BA; Federal Joint Committee) presented the result of the method assessment process on non-invasive prenatal testing (NIPT). The aim of this method assessment process was to decide whether NIPT should become a publicly funded procedure of routine prenatal care. The G‑BA decided in favor of NIPT, making the implementation of NIPT very likely, provided that other healthcare and political institutions also agree. This development could be interpreted as empowering from the perspective of reproductive (...) autonomy, since NIPT allows pregnant women to obtain valuable information on the health of the fetus in a fast and easy manner and without the risks of invasive methods. However, the routinization of NIPT also implies ethical challenges. Will the routinization lead to a normalization of prenatal quality control? Will it lead to an expansion to women outside the high-risk group? What would be the ethical implications of such a development? How should physicians, geneticists, and patients deal with the increased amount of obtainable information? What are the implications for choice and decision-making in the prenatal care context? In this paper, we analyze the ethical aspects of the routinization of NIPT, focusing on information and the counseling process, the burden of choice, and the threats to reproductive autonomy by societal interests linked to NIPT. (shrink)

In March 2019, the German Gemeinsamer Bundesausschuss (G‑BA; Federal Joint Committee) presented the result of the method assessment process on non-invasive prenatal testing (NIPT). The aim of this method assessment process was to decide whether NIPT should become a publicly funded procedure of routine prenatal care. The G‑BA decided in favor of NIPT, making the implementation of NIPT very likely, provided that other healthcare and political institutions also agree. This development could be interpreted as empowering from the perspective of reproductive (...) autonomy, since NIPT allows pregnant women to obtain valuable information on the health of the fetus in a fast and easy manner and without the risks of invasive methods. However, the routinization of NIPT also implies ethical challenges. Will the routinization lead to a normalization of prenatal quality control? Will it lead to an expansion to women outside the high-risk group? What would be the ethical implications of such a development? How should physicians, geneticists, and patients deal with the increased amount of obtainable information? What are the implications for choice and decision-making in the prenatal care context? In this paper, we analyze the ethical aspects of the routinization of NIPT, focusing on information and the counseling process, the burden of choice, and the threats to reproductive autonomy by societal interests linked to NIPT. (shrink)

In March 2019, the German Gemeinsamer Bundesausschuss (G‑BA; Federal Joint Committee) presented the result of the method assessment process on non-invasive prenatal testing (NIPT). The aim of this method assessment process was to decide whether NIPT should become a publicly funded procedure of routine prenatal care. The G‑BA decided in favor of NIPT, making the implementation of NIPT very likely, provided that other healthcare and political institutions also agree. This development could be interpreted as empowering from the perspective of reproductive (...) autonomy, since NIPT allows pregnant women to obtain valuable information on the health of the fetus in a fast and easy manner and without the risks of invasive methods. However, the routinization of NIPT also implies ethical challenges. Will the routinization lead to a normalization of prenatal quality control? Will it lead to an expansion to women outside the high-risk group? What would be the ethical implications of such a development? How should physicians, geneticists, and patients deal with the increased amount of obtainable information? What are the implications for choice and decision-making in the prenatal care context? In this paper, we analyze the ethical aspects of the routinization of NIPT, focusing on information and the counseling process, the burden of choice, and the threats to reproductive autonomy by societal interests linked to NIPT. (shrink)

Over the past decade, non-invasive prenatal testing (NIPT) has been adopted into routine obstetric care to screen for fetal sex, trisomies 21, 18 and 13, sex chromosome aneuploidies and fetal sex determination. It is predicted that the scope of NIPT will be expanded in the future, including screening for adult-onset conditions (AOCs). Some ethicists have proposed that using NIPT to detect severe autosomal AOCs that cannot be prevented or treated, such as Huntington’s disease, should only be offered to prospective parents (...) who intend to terminate a pregnancy in the case of a positive result. We refer to this as the ‘conditional access model’ (CAM) for NIPT. We argue against CAM for NIPT to screen for Huntington’s disease or any other AOC. Next, we present results from a study we conducted in Australia that explored NIPT users’ attitudes regarding CAM in the context of NIPT for AOCs. We found that, despite overall support for NIPT for AOCs, most participants were not in favour of CAM for both preventable and non-preventable AOCs. Our findings are discussed in relation to our initial theoretical ethical theory and with other comparable empirical studies. We conclude that an ‘unconditional access model’ (UAM), which provides unrestricted access to NIPT for AOCs, is a morally preferable alternative that avoids both CAM’s fundamental practical limitations and the limitations it places on parents’ reproductive autonomy. (shrink)