Should the 14‐day rule for embryo research become the 28‐day rule?

The “14‐day rule”—broadly construed—is used in science policy and regulation to limit research on human embryos to a maximum period of 14 days after their creation or to the equivalent stage of development that is normally attributed to a 14‐day‐old embryo (Hyun et al, 2016; Nuffield Council on Bioethics, 2017). For several decades, the 14‐day rule has been a shining example of how science policy and regulation can be developed with interdisciplinary consensus and applied across a number of countries to help fulfil an ethical and practical purpose: to facilitate efficient and ethical embryo research. However, advances in embryology and biomedical research have led to suggestions that the 14‐day rule is no longer adequate (Deglincerti et al, 2016; Shahbazi et al, 2016; Hurlbut et al, 2017). Therefore, should the 14‐day rule be extended and, if so, where should we draw a new line for permissible embryo research? Here, we provide scientific, regulatory and ethical arguments that the 14‐day rule should be extended to 28 days (or the developmental equivalent stage of a 28‐day‐old embryo)

The unique status of first-in-human studies: strengthening the social value requirement

For clinical research to be ethical, risks need to be balanced by anticipated benefits. This is challenging for first-in-human (FIH) studies as participants are not expected to benefit directly, and risks are potentially high. We argue that this differentiates FIH studies from other clinical trials to the extent that they should be given unique status in international research ethics guidelines. As there is a general positive attitude regarding the benefits of science, it is important to establish a more systematic method to assess anticipated social value to safeguard participants not only from enrolling in risky, but also in futile trials. Here, we provide some of necessary steps needed to assess the anticipated social value of the intervention

Governing Gene Drive Technologies:A Qualitative Interview Study

Background: Gene drive technologies (GDTs) bias the inheritance of a genetic element within a population of non-human organisms, promoting its progressive spread across this population. If successful, GDTs may be used to counter intractable problems such as vector-borne diseases. A key issue in the debate on GDTs relates to what governance is appropriate for these technologies. While governance mechanisms for GDTs are to a significant extent proposed and shaped by professional experts, the perspectives of these experts have not been explored in depth. Methods: A total of 33 GDT experts from different professional disciplines were interviewed to identify, better understand, and juxtapose their perspectives on GDT governance. The pseudonymized transcripts were analyzed thematically. Results: Three main themes were identified: (1) engagement of communities, stakeholders, and publics; (2) power dynamics, and (3) decision-making. There was broad consensus amongst respondents that it is important to engage communities, stakeholders, and publics. Nonetheless, respondents had diverging views on the reasons for doing so and the timing and design of engagement. Respondents also outlined complexities and challenges related to engagement. Moreover, they brought up the power dynamics that are present in GDT research. Respondents stressed the importance of preventing the recurrence of historical injustices and reflected on dilemmas regarding whether and to what extent (foreign) researchers can legitimately make demands regarding local governance. Finally, respondents had diverging views on whether decisions about GDTs should be made in the same way as decisions about other environmental interventions, and on the decision-making model that should be used to decide about GDT deployment. Conclusions: The insights obtained in this interview study give rise to recommendations for the design and evaluation of GDT governance. Moreover, these insights point to unresolved normative questions that need to be addressed to move from general commitments to concrete obligations

How to fulfill the expert role in public dialogue:The Dutch dialogue on human germline genetic modification as a case

Over the last decades science communication theory appears to have evolved at a much faster pace than science communication practice. Scientists seem willing to step into the public domain, but a genuine two-way interaction with the public is only rarely observed. We argue that part of this discrepancy between theory and practice may actually be caused by the lacking of a clear description of the modern expert role; the role a scientist should take in contemporary science communication. In this contribution we use an example of good practice—the Dutch dialogue on human germline genetic modification—to inform theory. We analyse guiding principles for the design and execution of this dialogue and observe expert behavior in three separate dialogue sessions. With the combined findings, we present a detailed description of the modern expert role in terms of three responsibilities, with for each responsibility three prompts for behavior. For the responsibility to share these are to select expert knowledge that is relevant to the goal; to present expert knowledge in a meaningful and accessible language; and to be cautious in sharing personal considerations. For the responsibility to listen and learn these are to consider interactions with members of the public as opportunities to learn; to be patient and supportive; and to assist in stimulating in-depth dialogue. For the responsibility to invest in relationships these are to assist in creating an ambiance of safety and relevance; to preserve trust; and to convey respect for every contribution and every point of view. Each behavioral prompt is further concretized with concomitant actions and practice examples as collected from observing experts in action. The implications for scientists engaging in contemporary science communication, as well as for science communication trainers, are discussed.</p

Нарушение репродуктивной функции при простатите/синдроме хронической тазовой боли

Показано, что нелеченное хроническое воспаление предстательной железы приводит к нарушению показателей спермограммы и в ряде случаев к бесплодию при нормальном развитии половых желез и достаточном гормональном обеспечении организма. Бактерии, вирусы, лейкоциты, свободные радикалы, цитокины, иммунологические изменения и обструкция семявыводящих путей при простате являются кофакторами в развитии бесплодия.It is shown that untreated chronic inflammation of the prostate gland causes disturbances of spermogram count and strility in a number of cases at normal development of sex glands and sufficient hormone supply of the organism. Bacteria, viruses, leukocytes, free radicals, cytokines, immunological changes and obstruction of the deferent ducts in prostatitis are co−factors of sterility development

Personalized 3D printed scaffolds:The ethical aspects

Personalized 3D printed scaffolds are a new generation of implants for tissue engineering and regenerative medicine purposes. Scaffolds support cell growth, providing an artificial extracellular matrix for tissue repair and regeneration and can biodegrade once cells have assumed their physiological and structural roles. The ethical challenges and opportunities of these implants should be mapped in parallel with the life cycle of the scaffold to assist their development and implementation in a responsible, safe, and ethically sound manner. This article provides an overview of these relevant ethical aspects. We identified nine themes which were linked to three stages of the life cycle of the scaffold: the development process, clinical testing, and the implementation process. The described ethical issues are related to good research and clinical practices, such as privacy issues concerning digitalization, first-in-human trials, responsibility and commercialization. At the same time, this article also creates awareness for underexplored ethical issues, such as irreversibility, embodiment and the ontological status of these scaffolds. Moreover, it exemplifies how to include gender in the ethical assessment of new technologies. These issues are important for responsible development and implementation of personalized 3D printed scaffolds and in need of more attention within the additive manufacturing and tissue engineering field. Moreover, the insights of this review reveal unresolved qualitative empirical and normative questions that could further deepen the understanding and co-creation of the ethical implications of this new generation of implants.</p

How Smart are Smart Materials?:A Conceptual and Ethical Analysis of Smart Lifelike Materials for the Design of Regenerative Valve Implants

It may soon become possible not just to replace, but to re-grow healthy tissues after injury or disease, because of innovations in the field of Regenerative Medicine. One particularly promising innovation is a regenerative valve implant to treat people with heart valve disease. These implants are fabricated from so-called 'smart', 'lifelike' materials. Implanted inside a heart, these implants stimulate re-growth of a healthy, living heart valve. While the technological development advances, the ethical implications of this new technology are still unclear and a clear conceptual understanding of the notions 'smart' and 'lifelike' is currently lacking. In this paper, we explore the conceptual and ethical implications of the development of smart lifelike materials for the design of regenerative implants, by analysing heart valve implants as a showcase. In our conceptual analysis, we show that the materials are considered 'smart' because they can communicate with human tissues, and 'lifelike' because they are structurally similar to these tissues. This shows that regenerative valve implants become intimately integrated in the living tissues of the human body. As such, they manifest the ontological entanglement of body and technology. In our ethical analysis, we argue this is ethically significant in at least two ways: It exacerbates the irreversibility of the implantation procedure, and it might affect the embodied experience of the implant recipient. With our conceptual and ethical analysis, we aim to contribute to responsible development of smart lifelike materials and regenerative implants.</p

The Ethical Aspects of Exposome Research: A Systematic Review

In recent years, exposome research has been put forward as the next frontier for the study of human health and disease. Exposome research entails the analysis of the totality of environmental exposures and their corresponding biological responses within the human body. Increasingly, this is operationalized by big-data approaches to map the effects of internal as well as external exposures using smart sensors and multi-omics technologies. However, the ethical implications of exposome research are still only rarely discussed in the literature. Therefore, we conducted a systematic review of the academic literature regarding both the exposome and underlying research fields and approaches, to map the ethical aspects that are relevant to exposome research. We identify five ethical themes that are prominent in ethics discussions: the goals of exposome research, its standards, its tools, how it relates to study participants and the consequences of its products. Furthermore, we provide a number of general principles for how future ethics research can best make use of our comprehensive overview of the ethical aspects of exposome research. Lastly, we highlight three aspects of exposome research that are most in need of ethical reflection: the actionability of its findings, the epidemiological or clinical norms applicable to exposome research and the meaning and action-implications of bias

Визначення вальпроєвої кислоти у крові методом реакційної високоефективної рідинної хроматографії

Здійснена взаємодія вальпроєвої кислоти з 3-(2'-бромацетил)-7-метоксикумарином і розроблено її визначення у крові методом реакційної високоефективної рідинної хроматографії. Вивчений вплив різних методів депротоїнізації на вивільнення вальпроєвої кислоти та оптимізовані умови пробопідготовки.Осуществлено взаимодействие вальпроевой кислоты с 3-(2'-бромацетил)-7-метоксикумарином и разработано ее определение в крови методом реакционной высокоэффективной жидкостной хроматографии. Изучено влияние различных методов депротеинизации на выходы вальпроевой кислоты и оптимизированы условия пробоподготовки.The interaction of the valproic acid with 3-(2'-bromoacetyl)-7-methoxicoumarin has been carried out and its determination in blood by the reaction high performance liquid chromatography method has been developed. The influence of various methods of deproteinization on the yields of the valproic acid has been studied and the conditions of the sample preparing has been optimized