Explore the vast range of titles available.

Prenatal therapies represent an emerging frontier in healthcare, enabling medical intervention at the fetal stage to address severe congenital conditions before irreversible harm occurs. As these transformative interventions transition from bench to bedside, significant ethical, legal, and governance challenges arise, particularly concerning maternal-fetal risk-benefit dynamics, informed consent, and regulatory oversight. Recognizing the need for structured and adaptive ethical guidance, we propose a “Points to Consider” (P2C) Framework, developed through a multidisciplinary initiative involving experts in drug development, bioethics norms, human rights, and governance, based on a review of international scientific, regulatory, and ethical literature. The P2C integrates those considerations into nine thematic points addressing: maternal and fetal well-being; risk-benefit assessment, responsible research and clinical care, emerging technology, public engagement, funding sustainability, public health integration, lifecycle governance, and international collaboration. The P2C is designed to support the entire research-to-clinic continuum, fostering multidisciplinary global dialogue. By anchoring prenatal therapeutic innovations within international human rights norms, bioethics standards, and anticipatory governance practices, the P2C aims to ensure that future interventions are safe, ethically robust, and socially aligned. This initiative lays the groundwork for responsibly navigating the complex ethical landscape of prenatal medicine, with implications for policy, clinical practice, and global health equity.

The Precision Medicine Initiative (PMI) is an innovative approach to developing a new model of health care that takes into account individual differences in people’s genes, environments, and lifestyles. A cornerstone of the initiative is the PMI All of Us Research Program (formerly known as PMI-Cohort Program) which will create a cohort of 1 million volunteers who will contribute their health data and biospecimens to a centralized national database to support precision medicine research. The PMI All of US Research Program is the largest longitudinal study in the history of the United States. The designers of the Program anticipated and addressed some of the ethical, legal, and social issues (ELSI) associated with the initiative. To date, however, there is no plan to call for research regarding ELSI associated with the Program-PMI All of Us program. Based on analysis of National Institutes of Health (NIH) funding announcements for the PMI All of Us program, we have identified three ELSI themes: cohort diversity and health disparities, participant engagement, and privacy and security. We review All of Us Research Program plans to address these issues and then identify additional ELSI within each domain that warrant ongoing investigation as the All of Us Research Program develops. We conclude that PMI's All of Us Research Program represents a significant opportunity and obligation to identify, analyze, and respond to ELSI, and we call on the PMI to initiate a research program capable of taking on these challenges. Genet Med advance online publication 01 December 2016

Induced pluripotent stem cells (iPSCs) can self-renew indefinitely in culture and differentiate into all specialized cell types including gametes. iPSCs do not exist naturally and are instead generated (“induced” or “reprogrammed”) in culture from somatic cells through ectopic co-expression of defined pluripotency factors. Since they can be generated from any healthy person or patient, iPSCs are considered as a valuable resource for regenerative medicine to replace diseased or damaged tissues. In addition, reprogramming technology has provided a powerful tool to study mechanisms of cell fate decisions and to model human diseases, thereby substantially potentiating the possibility to (i) discover new drugs in screening formats and (ii) treat life-threatening diseases through cell therapy-based strategies. However, various legal and ethical barriers arise when aiming to exploit the full potential of iPSCs to minimize abuse or unauthorized utilization. In this review, we discuss bioethical, legal, and societal concerns associated with research and therapy using iPSCs. Furthermore, we present key questions and suggestions for stem cell scientists, legal authorities, and social activists investigating and working in this field.

The evolving evidence base for the interpretation of variants identified in genetic and genomic testing has presented the genetics community with the challenge of variant reinterpretation. In particular, it is unclear whether an ethical duty of periodic reinterpretation should exist, who should bear that duty, and what its dimensions should be. Based on an analysis of the ethical arguments for and against a duty to reinterpret, we conclude that a duty should be recognized. Most importantly, by virtue of ordering and conducting tests likely to produce data on variants that cannot be definitively interpreted today, the health-care system incurs a duty to reinterpret when more reliable data become available. We identify four elements of the proposed ethical duty: data storage, initiation of reinterpretation, conduct of reinterpretation, and patient recontact, and we identify the parties best situated to implement each component. We also consider the reasonable extent and duration of a duty, and the role of the patient’s consent in the process, although we acknowledge that some details regarding procedures and funding still need to be addressed. The likelihood of substantial patient benefit from a systematic approach to reinterpretation suggests the importance for the genetics community to reach consensus on this issue.

Social robots, those that exhibit personality and communicate with us using high-level dialogue and natural cues, will soon be part of our daily lives. In this paper, we gather expert opinions from different international workshops exploring ethical, legal, and social (ELS) concerns associated with social robots. In contrast to literature that looks at specific challenges, often from a certain disciplinary angle, our contribution to the literature provides an overview of the ELS discussions in a holistic fashion, shaped by active deliberation with a multitude of experts across four workshops held between 2015 and 2017 held in major international workshops (ERF, NewFriends, JSAI-isAI). It also explores pathways to address the identified challenges. Our contribution is in line with the latest European robot regulatory initiatives but covers an area of research that the latest AI and robot governance strategies have scarcely covered. Specifically, we highlight challenges to the use of social robots from a user perspective, including issues such as privacy, autonomy, and the dehumanization of interactions; or from a worker perspective, including issues such as the possible replacement of jobs through robots. The paper also compiles the recommendations to these ELS issues the experts deem appropriate to mitigate compounding risks. By then contrasting these challenges and solutions with recent AI and robot regulatory strategies, we hope to inform the policy debate and set the scene for further research.

IntroductionChatGPT, a recently released chatbot from OpenAI, has found applications in various aspects of life, including academic research. This study investigated the knowledge, perceptions, and attitudes of researchers towards using ChatGPT and other chatbots in academic research.MethodsA pre-designed, self-administered survey using Google Forms was employed to conduct the study. The questionnaire assessed participants’ knowledge of ChatGPT and other chatbots, their awareness of current chatbot and artificial intelligence (AI) applications, and their attitudes towards ChatGPT and its potential research uses.ResultsTwo hundred researchers participated in the survey. A majority were female (57.5%), and over two-thirds belonged to the medical field (68%). While 67% had heard of ChatGPT, only 11.5% had employed it in their research, primarily for rephrasing paragraphs and finding references. Interestingly, over one-third supported the notion of listing ChatGPT as an author in scientific publications. Concerns emerged regarding AI’s potential to automate researcher tasks, particularly in language editing, statistics, and data analysis. Additionally, roughly half expressed ethical concerns about using AI applications in scientific research.ConclusionThe increasing use of chatbots in academic research necessitates thoughtful regulation that balances potential benefits with inherent limitations and potential risks. Chatbots should not be considered authors of scientific publications but rather assistants to researchers during manuscript preparation and review. Researchers should be equipped with proper training to utilize chatbots and other AI tools effectively and ethically.

Inborn errors of immunity (IEI) are a group of over 450 genetically distinct conditions associated with significant morbidity and mortality, for which early diagnosis and treatment improve outcomes. Newborn screening for severe combined immunodeficiency (SCID) is currently underway in several countries, utilising a DNA-based technique to quantify T cell receptor excision circles (TREC) and kappa-deleting recombination excision circles (KREC). This strategy will only identify those infants with an IEI associated with T and/or B cell lymphopenia. Other severe forms of IEI will not be detected. Up-front, first-tier genomic-based newborn screening has been proposed as a potential approach by which to concurrently screen infants for hundreds of monogenic diseases at birth. Given the clinical, phenotypic and genetic heterogeneity of IEI, a next-generation sequencing-based newborn screening approach would be suitable. There are, however, several ethical, legal and social issues which must be evaluated in detail prior to adopting a genomic-based newborn screening approach, and these are discussed herein in the context of IEI.

(1) Background: Data literacy is becoming increasingly important for healthcare professionals in both outpatient care and research. Since healthcare data and the possibilities for its use and misuse are increasing in these areas, healthcare professionals need diverse knowledge regarding the collection, use and evaluation of data. A core component of this is an understanding of the ethical, legal, and social implications (ELSI) of working with health data. (2) Methods: Within the DIM.RUHR project (Data Competence Center for Interprofessional use of Health Data in the Ruhr Metropolis), the challenge of training in data literacy for different healthcare professionals is addressed. Based on a learning objectives matrix for interprofessional data literacy education, an ELSI concept was developed through collaboration with interprofessional project partners. The study was conducted between December 2024 and April 2025. (3) Results: The foundational structure of the ELSI concept was based on the learning objectives matrix and an unstructured literacy search for ELSI concepts in similar contexts. Using an iterative design-based research approach, a group of experts from different fields (didactics, applied ethics, health sciences, law, sociology, informatics, and psychology) developed an ELSI concept for healthcare professionals. The following categories were identified as crucial: 1. philosophy of science: a basic understanding of science and the hurdles and opportunities; 2. ethics: an overview of the biomedical principles and a technological assessment; 3. law: an overview of the reservation of permission and self-determination; 4. social aspects: an overview of health inequalities and different forms of power relations and imbalances. (4) Conclusions: The ELSI concept can be used in the orientation of healthcare professionals in outpatient care and research—regardless of their profession—to develop data competencies, with the aim of providing a holistic view of the challenges and potential in the collection, use, and evaluation of healthcare data. The DIM.RUHR project’s approach is to develop open educational resources that build on the ELSI concept to teach specific skills at different competence levels.

Ethical, legal and societal implications (ELSI) in the development of wearable robots (WRs) are currently not explicitly addressed in most guidelines for WR developers. Previous work has identified ELSI related to WRs, e.g., impacts on body and identity, ableism, data protection, control and responsibilities, but translation of these concerns into actionable recommendations remains outstanding. This paper provides practical guidance for the implementation of ELSI in WR design, development and use. First, we identify the need for domain-specific recommendations against the context of current ELSI guidance. We then demonstrate the feasibility and usefulness of taking a domain-specific approach by successively transforming currently identified ELSI into an action-guiding flowchart for integration of ELSI specific to the different stages of WR development. This flowchart identifies specific questions to be considered by WR development teams and suggests actions to be taken in response. By tailoring ELSI guidance to WR developers, centring it on user needs, their relation to others and wider society, and being cognizant of existing legislation and values, we hope to help the community develop better WRs that are safer, have greater usability, and which impact positively on society.

The Earth BioGenome Project (EBP) is an audacious endeavor to obtain whole-genome sequences of representatives from all eukaryotic species on Earth. In addition to the project’s technical and organizational challenges, it also faces complicated ethical, legal, and social issues. This paper, from members of the EBP’s Ethical, Legal, and Social Issues (ELSI) Committee, catalogs these ELSI concerns arising from EBP. These include legal issues, such as sample collection and permitting; the applicability of international treaties, such as the Convention on Biological Diversity and the Nagoya Protocol; intellectual property; sample accessioning; and biosecurity and ethical issues, such as sampling from the territories of Indigenous peoples and local communities, the protection of endangered species, and cross-border collections, among several others. We also comment on the intersection of digital sequence information and data rights. More broadly, this list of ethical, legal, and social issues for large-scale genomic sequencing projects may be useful in the consideration of ethical frameworks for future projects. While we do not—and cannot—provide simple, overarching solutions for all the issues raised here, we conclude our perspective by beginning to chart a path forward for EBP’s work