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There are ongoing concerns of social justice regarding inequalities in the distribution of access to potential genome editing technologies. Working within non-ideal theory, Colin Farrelly advances a justification for the use of patents to speed up the arrival of safe and effective interventions for all, including the socially disadvantaged. This paper argues that such success is less assured when one considers the actual functioning of patents and the practical implications of the patent system in the context of biotechnological innovations. I suggest that non-ideal theoretical approaches risk reverting back to a form of ideal theory if they simply refer to such real-world constraints — e.g. patents — but do not critically assess and fully examine how such constraints manifest themselves in practice. I highlight some considerations that would be important in order to develop and foster a more robust non-ideal approach to justice in biotechnological developments.

Item does not contain fulltext OBJECTIVE: To assess the impact of milrinone administration on time spent on nitric oxide (iNO) in infants with acute pulmonary hypertension (aPH). We hypothesized that intravenous milrinone used in conjunction with iNO would reduce the time on iNO therapy and the time spent on invasive ventilation in infants ≥34 weeks gestation with a diagnosis of aPH. We aimed to assess the practicality of instituting the protocol and contributing to a sample size calculation for a definitive multicentre study. STUDY DESIGN: This was a multicentre, randomized, double-blind, two arm pilot study, with a balanced (1:1) allocation. Infants with a gestation ≥34 weeks and a birth weight ≥2000 grams aPH, an oxygenation index of ≥10, and commenced on iNO were eligible. Participants on iNO were assigned to either a milrinone infusion (intervention) or a normal saline infusion (placebo) for up to 35 h. The primary outcome was time on iNO and feasibility of conducting the protocol. RESULTS: The trial was terminated early after 4 years of enrollment due to poor recruitment. Four infants were allocated to the intervention arm and 5 to the placebo arm. The groups were well matched for baseline variables. No differences were seen in any of the primary or secondary outcomes. CONCLUSION: Conducting an interventional trial in the setting of acute pulmonary hypertension in infants is not feasible using our current approach. Future studies in this area require alternative trial design to improve recruitment as this topic remains understudied in the neonatal field. TRIAL REGISTRATION: www.isrctn.com ; ISRCTN:12949496; EudraCT Number:2014-002988-16. 01 februari 2023

The effective collection and management of personal data of rapidly migrating populations is important for ensuring adequate healthcare and monitoring of a displaced peoplesâ health status. With developments in ICT data sharing capabilities, electronic personal health records (ePHRs) are increasingly replacing less transportable paper records. ePHRs offer further advantages of improving accuracy and completeness of information and seem tailored for rapidly displaced and mobile populations. Various emerging initiatives in Europe are seeking to develop migrant-centric ePHR responses. This paper highlights their importance and benefits, but also identifies a number of significant ethical, legal and social issues (ELSI) and challenges to their design and implementation, regarding (1) the kind of information that should be stored, (2) who should have access to information, and (3) potential misuse of information. These challenges need to be urgently addressed to make possible the beneficial use of ePHRs for vulnerable migrants in Europe.

We express our sincere thanks to all those who submitted comments on our article and to the editors of AJOB for allowing us to comment in reply.Boggio and Ho’s (2018) comment is centered on the “hu...

How should we regulate genome editing in the face of persistent substantive disagreement about the moral status of this technology and its applications? In this paper, we aim to contribute to resolving this question. We first present two diametrically opposed possible approaches to the regulation of genome editing. A first approach, which we refer to as “elitist,” is inspired by Joshua Greene’s work in moral psychology. It aims to derive at an abstract theoretical level what preferences people would have if they were committed to implementing public policies regulating genome editing in a context of ethical pluralism. The second approach, which we refer to as the democratic approach, defended by Francoise Baylis and Sheila Jasanoff et al., emphasizes the importance of including the public’s expressed attitudes in the regulation of genome editing. After pointing out a serious shortcoming with each of these approaches, we propose our own favored approach—the “enlightened democracy” approach—which attempts to combine the strengths of the elitist and democratic approaches while avoiding their weaknesses.

The revolutionary potential of the CRISPR-Cas9 gene editing technique has created a resurgence in enthusiasm and concern in genetic research perhaps not seen since the mapping of the human genome at the turn of the century. Some such concerns and anxieties revolve around crossing lines between somatic and germline interventions as well as treatment and enhancement applications. Underpinning these concerns, there are familiar concepts of safety, unintended consequences and damage to genetic identity and the creation of designer children through pursuing human enhancement and eugenics. In the policy realm, these morally laden distinctions and anxieties are emerging as the basis for making important and applied measures to respond to the fast-evolving scientific developments. This paper argues that the dominant normative framing for such responses is insufficient for this task. This paper illustrates this insufficiency as arising from a continued reliance on misleading genetic essentialist assumptions that generate groundless speculation and over-reactionary normative responses. This phenomenon is explicit with regard to prospective human (germ line) genetic enhancements. While many normative theorists and state-of-the-art reports continue to gesture toward the influence of environmental and social influences on a person and their traits and capacities, this recognition does not extend to the substance of the arguments themselves which tend to revert to the debunked genetic determinist framework. Given the above, this paper argues that there is a pressing need for a more central role for sociological input into particular aspects of this “enhancement myth” in order to give added weight, detail and substance to these environmental influences and influence from social structures.

In 2012, a new and promising gene manipulation technique, CRISPR-Cas9, was announced that seems likely to be a foundational technique in health care and agriculture. However, patents have been granted. As with other technological developments, there are concerns of social justice regarding inequalities in access. Given the technologies' "foundational" nature and societal impact, it is vital for such concerns to be translated into workable recommendations for policymakers and legislators. Colin Farrelly has proposed a moral justification for the use of patents to speed up the arrival of technology by encouraging innovation and investment. While sympathetic to his argument, this article highlights a number of problems. By examining the role of patents in CRISPR and in two previous foundational technologies, we make some recommendations for realistic and workable guidelines for patenting and licensing.

Persistent pulmonary hypertension of the newborn (PPHN) is a relatively common condition which results in a mortality of up to 33%. Up to 40% of infants treated with nitric oxide (iNO) either have a transient response or fail to demonstrate an improvement in oxygenation. Milrinone, a selective phosphodiesterase 3 (PDE3) inhibitor with inotropic and lusitropic properties may have potential benefit in PPHN. This pilot study was developed to assess the impact of milrinone administration on time spent on iNO in infants with PPHN. This is a multicentre, randomized, double-blind, two arm pilot study, with a balanced (1:1) allocation of 20 infants. In this pilot study, we hypothesise that infants ≥34 weeks gestation and ≥ 2000 g with a clinical and echocardiography diagnosis of PPHN, intravenous milrinone used in conjunction with iNO will result in a reduction in the time spent on iNO. In addition, we hypothesise that milrinone treatment will lead to an improvement in myocardial performance and global hemodynamics when compared to iNO alone. We will also compare the rate of adverse events associated with the milrinone, and the pre-discharge outcomes of both groups. The purpose of this pilot study is to assess the feasibility of performing the trial and to obtain preliminary data to calculate a sample size for a definitive multi-centre trial of milrinone therapy in PPHN. Trial registration: www.isrctn.com; ISRCTN:12949496; EudraCT Number:2014–002988-16. Electronic supplementary material The online version of this article (10.1186/s40748-018-0093-1) contains supplementary material, which is available to authorized users.

Potential applications of genome editing in assisted reproductive technology (ART) raise a vast array of strong opinions, emotional reactions and divergent perceptions. Acknowledging the need for caution and respecting such reactions, we observe that at least some are based on either a misunderstanding of the science or misconceptions about the content and flexibility of the existing legal frameworks. Combining medical, legal and ethical expertise, we present and discuss regulatory responses at the national, European and international levels. The discussion has a EU starting point and is meant as a contribute to the general international regulatory debate. Overall, this paper concludes that gene editing technologies should not be regulated autonomously. Rather, potential uses should be regulated under general, existing frameworks and where applicable by reference to sufficiently equivalent technologies and techniques already subject to specific regulation. To be clear, we do not argue for the hasty introduction of gene editing as a reproductive treatment option in the immediate future. We call for caution with regard to overreaching moratoria and prohibitions which will also affect basic research. We recommend flexible regulations that allow for further responsible research into the potential development of the technology. We call for an open and inclusive debate and argue that scientific communication should claim a more prominent role to counter the danger of widespread misinformation. A high level of transparency and accuracy should guide scientific communication while simultaneously global-scale responsibility and governance should be fostered by promoting cross-disciplinary thinking and multi-level stakeholder involvement in legal and regulatory processes. (Less)

Background Increasing evidence is demonstrating that a patient’s unique genetic profile can be used to detect the disease’s onset, prevent its progression, and optimize its treatment. This led to the increased global efforts to implement personalized medicine (PM) and pharmacogenomics (PG) in clinical practice. Here we investigated the perceptions of students from different universities in Bosnia and Herzegovina (BH) towards PG/PM as well as related ethical, legal, and social implications (ELSI). This descriptive, cross-sectional study is based on the survey of 559 students from the Faculties of Medicine, Pharmacy, Health Studies, Genetics, and Bioengineering and other study programs. Results Our results showed that 50% of students heard about personal genome testing companies and 69% consider having a genetic test done. A majority of students (57%) agreed that PM represents a promising healthcare model, and 40% of students agreed that their study program is well designed for understanding PG/PM. This latter opinion seems to be particularly influenced by the field of study (7.23, CI 1.99–26.2, p = 0.003). Students with this opinion are also more willing to continue their postgraduate education in the PM (OR = 4.68, CI 2.59–8.47, p

Rapid advances in microarray and sequencing technologies are making genotyping and genome sequencing more affordable and readily available. There is an expectation that genomic sequencing technologies improve personalized diagnosis and personalized drug therapy. Concurrently, provision of direct-to-consumer genetic testing by commercial providers has enabled individuals’ direct access to their genomic data. The expanded availability of genomic data is perceived as influencing the relationship between the various parties involved including healthcare professionals, researchers, patients, individuals, families, industry, and government. This results in a need to revisit their roles and responsibilities. In a 1-day agenda-setting meeting organized by the COST Action IS1303 “Citizen’s Health through public-private Initiatives: Public health, Market and Ethical perspectives,” participants discussed the main challenges associated with the expanded availability of genomic information, with a specific focus on public-private partnerships, and provided an outline from which to discuss in detail the identified challenges. This paper summarizes the points raised at this meeting in five main parts and highlights the key cross-cutting themes. In light of the increasing availability of genomic information, it is expected that this paper will provide timely direction for future research and policy making in this area. Funding Deborah Mascalzoni is supported under Grant Agreement number 305444. Álvaro Mendes is supported by the FCT—The Portuguese Foundation for Science and Technology under postdoctoral grant SFRH/BPD/88647/2012. Isabelle Budin-Ljøsne receives support from the National Research and Innovation Platform for Personalized Cancer Medicine funded by The Research Council of Norway (NFR BIOTEK2021/ES495029) and Biobank Norway funded by The Research Council of Norway—grant number 245464. Heidi Carmen Howard is partly supported by supported by the Swedish Foundation for Humanities and Social Science under grant M13-0260:1), the Biobanking and Molecular Resource Infrastructure of Sweden (BBMRI.se) and the BBMRI-ERIC. Brígida Riso is supported by the Portuguese Foundation for Science and Technology (FCT) under the PhD grant SFRH/BD/100779/2014. Heidi Beate Bentzen receives support from the project Legal Regulation of Information Processing relating to Personalized Cancer Medicine funded by The Research Council of Norway BIOTEK2021/238999.

The introduction of Web 2.0 technology, along with a population increasingly proficient in Information and Communications Technology (ICT), coupled with the rapid advancements in genetic testing methods, has seen an increase in the presence of participant-centred research initiatives. Such initiatives, aided by the centrality of ICT interconnections, and the ethos they propound seem to further embody the ideal of increasing the participatory nature of research, beyond what might be possible in non-ICT contexts alone. However, the majority of such research seems to actualise a much narrower definition of ‘participation’—where it is merely the case that such research initiatives have increased contact with participants through ICT but are otherwise non-participatory in any important normative sense. Furthermore, the rhetoric of participant-centred initiatives tends to inflate this minimalist form of participation into something that it is not, i.e. something genuinely participatory, with greater connections with both the ICT-facilitated political contexts and the largely non-ICT participatory initiatives that have expanded in contemporary health and research contexts. In this paper, we highlight that genuine (ICT-based) ‘participation’ should enable a reasonable minimum threshold of participatory engagement through, at least, three central participatory elements: educative, sense of being involved and degree of control. While we agree with criticisms that, at present, genuine participation seems more rhetoric than reality, we believe that there is clear potential for a greater ICT-facilitated participatory engagement on all three participatory elements. We outline some practical steps such initiatives could take to further develop these elements and thereby their level of ICT-facilitated participatory engagement., This study was funded by COST (grant number = COST Action IS1303); Brigida Riso is supported by FCT-the Portuguese Foundation for Science and Technology under the PhD grant SFRH/BD/100779/2014.

Rawls’ principle of fair equality of opportunity has been regularly discussed and criticized for being inadequate regarding natural inequalities. In so far as this egalitarian goal is sound, the purpose of the paper is to see how the prospect of radical genetic intervention might affect this particular inadequacy. I propose that, in a post-genetic setting, an appropriate response would be to extend the same rules regulating societal inequalities to a regulation of comparable genetic inequalities. I defend this stance against recent arguments from the authors of From Chance to Choice and from Colin Farrelly’s alternative of the genetic difference principle.

In most discussions of the social justice implications of new genetic technologies, enhancements are considered to be highly contentious. This is particularly so when we speak of enhancements that benefit the recipient in positional terms and enhancements that are germ-line and which can be passed on to future generations. I argue that the egalitarian reluctance, as displayed by Max Mehlman (2003:2005), to permitting enhancements is overblown. Recent writings from Buchanan (2008) and Farrelly (2004) highlight a more positive, context-dependent, role for permitting the socio-economically advantaged the freedom to gain access to enhancements, including enhancements of traits associated with positional or competitive advantage. I argue that this reasoning also (necessarily) applies to germ-line enhancements or, at least, to 'effective germ-line enhancements.' In other words, I argue that such enhancements should be more seriously considered in terms of this positive context-dependent role. Nevertheless, this support is not unqualified. I critically re-examine concerns regarding the notion of the genetic underclass and I raise some worries about the possible adverse consequence of such a regulatory framework on sustaining the required egalitarian ethos. Importantly, such worries (and suggestions to address them) will be focused on the adverse effects of inequalities, rather than germ-line enhancements themselves.