A multi-dimensional concept for evaluating NLP-based robots in healthcare scenarios

SPECIALTY GRAND CHALLENGE article Front. Genet., 16 August 2013 | https://doi.org/10.3389/fgene.2013.00158

The Ethical, Legal and Social Implications (ELSI) Programme is an extramural research programme at the National Human Genome Research Institute of the National Institutes of Health (NIH) designed to anticipate and address the ethical, legal and social issues raised by genetic and genomic research. The Programme funds a broad range of studies by investigators from multiple disciplines, incorporating a range of both empirical and nonempirical methods. The ELSI Programme also supports several Centres of Excellence and various studies ‘embedded’ in very large genomics projects, which provide a ‘natural laboratory’ for the rigorous exploration of many issues. Research supported by the Programme has had an impact on the practice of genomic research and medicine and on surrounding laws and regulations in a number of areas, including genetic discrimination and privacy, genetic testing and screening in various contexts, data sharing and intellectual property. The Programme has also had a discernible impact on the broader cultural milieu of genomics. Key Concepts The Ethical, Legal and Social Implications (ELSI) Programme is an extramural research programme at the National Human Genome Institute of the National Institutes of Health, designed to anticipate and address the ethical, legal and social issues raised by genetic and genomic research. The ELSI Programme receives ongoing guidance from the National Advisory Council for Human Genome Research and its Genomics and Society Working Group, as well as from periodic strategic planning processes. The ELSI Programme addresses many longstanding issues in genetic and genomic research (such as genetic discrimination and privacy) and increasingly tackles issues that were only dimly foreseeable at the Programme's inception, such as the implications of direct‐to‐consumer marketing of genetic tests, the implications of advances in the technologies that can facilitate genetic enhancement, the challenges involved in the return of incidental findings in genomic sequencing, the issues raised by the trend towards precision medicine and the increasing integration of genomic sequencing into clinical care. Most projects funded by the ELSI Programme are transdisciplinary and incorporate a wide range of both empirical and nonempirical methodologies. Most projects funded by the ELSI Programme are investigator‐initiated, reflecting in large part the Programme's desire to maintain the intellectual independence of its supported investigators. The ELSI Programme funds several Centres of Excellence to support the creation and maintenance of the infrastructure necessary to foster highly transdisciplinary research, facilitate the translation of such research into policy and practice and develop the next generation of investigators in the field. The ELSI Programme supports some ELSI studies that have been ‘embedded’ into very large genomics initiatives, providing a ‘natural laboratory’ for the rigorous empirical exploration of many ELSI issues that could previously be explored in only a hypothetical way. The impact of ELSI research frequently comes less from the direct translation of published study findings into formal policy than from ELSI investigators – operating independently as scholars – serving directly on commissions or policymaking bodies or providing expert testimony or other forms of expert analysis to those groups. ELSI research has had a discernible impact on the practice of genomic research and medicine as well as on surrounding laws and regulations in several clearly identifiable areas, such as genetic discrimination and privacy, genetic testing and screening in various contexts, data sharing and intellectual property. ELSI studies have produced incremental changes in the cultural milieu in which genomics research is conducted and genomic medicine is being delivered in the technologies and information (NHGRI ELSI Research Programme).

The Ethical, Legal and Social Implications (ELSI) research programme of the National Human Genome Research Institute (NHGRI) of the National Institutes of Health (NIH) is a grant programme that supports research designed to anticipate and address the implications of human genetics and genomics research for individuals, families, communities and society. Programme staff and the researchers the programme supports are involved in the bioethics components of major genomics research projects and in many activities that inform genomics‐related research, health and social policies. The programme operates collaboratively with the genomics research community, and in general, the supported research has brought greater depth and strength to the genomics research enterprise. The ELSI programme is a unique experiment in the annals of NIH‐funded biomedical research, and initial results indicate that the experiment has been successful. Key concepts: The Ethical, Legal and Social Implications (ELSI) research programme, within the Division of Extramural Research at the National Human Genome Research Institute of the National Institutes of Health, supports research designed to anticipate and address the implications of human genetic and genomic research, technologies and information. The ELSI programme is currently the largest governmental supporter of bioethics research in the world. Most ELSI research is investigator‐initiated, but the programme periodically issues requests for applications (RFAs) to solicit research targeted at particular high‐priority areas. Neither genomics researchers nor administrators responsible for the oversight of genomics research have controlled the content or direction of ELSI research. The research priorities of the ELSI programme have evolved and span a range of issues relating to the implications of genomics for individuals, families, communities and the broader society. ELSI research aims to be anticipatory by encouraging researchers to identify issues likely to be raised by advances in genetics and genomics research before they arise. ELSI research involves researchers from a wide range of disciplines and is often highly transdisciplinary. The involvement of ELSI programme staff and ELSI researchers in major genomics research projects makes it possible to marshal the findings of relevant ELSI studies directly to inform the design and conduct of genomics research. ELSI research has had a considerable impact on both health care and broader social policies.

Human voice and speech, integral to personal identity and social communication, are increasingly used as biometric and digital biomarkers in healthcare. Their collection and analysis, enabled by artificial intelligence, machine learning, and natural language processing, offer promising applications in disease detection and health monitoring. This scoping review examines the ethical, legal, and social implications (ELSIs) associated with using voice and speech data in healthcare. Following a structured search of four databases and a snowball method, 65 articles published between 2009 and 2024 were analyzed. The findings are organized into three main ELSI categories: ethical concerns include privacy breaches, challenges of informed consent, and the need for data validation and respect for vulnerable populations; social issues highlight biases, representational disparities, and risks of discrimination and data misuse; legal issues include unclear regulatory frameworks, conflicting jurisdictional mandates, and challenges in defining data ownership. The review reveals that while many ELSIs mirror those of other biomarker data, the unique properties of voice and speech require adapted frameworks for consent, data governance, and privacy protection. Technological limitations, dataset scarcity, and industry-academic divides exacerbate risks and hinder equitable development. Few studies deeply explore ELSIs in underrepresented populations, and there is a lack of robust empirical research. The review argues for a contextualist, not exceptionalist, approach to voice biomarkers, acknowledging both overlapping and unique challenges. It concludes by stressing the need for harmonized regulations, inclusive datasets, and interdisciplinary collaboration to ensure responsible, equitable integration of voice and speech technologies in healthcare.

The ethical, legal, and social implications (ELSIs) of digital health are important when researchers and practitioners are using technology to collect, process, or store personal health data. Evidence underscores a strong need for digital health ELSI training, yet little is known about the specific ELSI topic areas that researchers and practitioners would most benefit from learning. To identify ELSI educational needs, a needs assessment survey was administered to the members of the Society of Behavioral Medicine (SBM). We sought to identify areas of ELSI proficiency and training need, and also evaluate interest and expertise in ELSI topics by career level and prior ELSI training history. The 14-item survey distributed to SBM members utilized the Digital Health Checklist tool (see recode.health/tools) and included items drawn from the four-domain framework: data management, access and usability, privacy and risk to benefit assessment. Respondents (N = 66) were majority faculty (74.2%) from psychology or public health. Only 39.4% reported receiving "formal" ELSI training. ELSI topics of greatest interest included practices that supported participant engagement, and dissemination and implementation of digital tools beyond the research setting. Respondents were least experienced in managing "bystander" data, having discussions about ELSIs, and reviewing terms of service agreements and privacy policies with participants and patients. There is opportunity for formalized ELSI training across career levels. Findings serve as an evidence base for continuous and ongoing evaluation of ELSI training needs to support scientists in conducting ethical and impactful digital health research.

Purpose This study aims to investigate the ethical, legal and social implications (ELSI) of digital transformation within digital innovation ecosystems (DIEs), particularly in the context of the Twin Transition, which integrates digital and green transformation. It seeks to highlight the agency and heterogeneity of actors within DIEs, emphasizing their active role in implementing strategies that align innovation with sustainability. By moving beyond a technology-centered perspective, the study contributes to the discourse on how DIE stakeholders navigate the intersection of digitalization and sustainability through collaborative innovation. Design/methodology/approach Using a three-phase qualitative research approach, this study first conducts a thematic analysis of academic literature on ELSI within DIEs, conceptualizing them as multi-actor ecosystems. It then applies a strengths, weaknesses, opportunities and threats (SWOT) analysis to identify the internal challenges and external pressures faced by the diverse participants in DIEs. Finally, it employs the TOWS framework to develop strategic, actor-specific recommendations for navigating the Twin Transition. Findings The research underscores that addressing ELSI is fundamental to achieving a responsible digital transformation that aligns with sustainable development. It highlights that the success of DIEs is not driven by centralized decision-making but by the collective actions and strategic choices of diverse stakeholders. By leveraging ecosystem-wide strengths and opportunities while mitigating weaknesses and threats, DIE participants can foster inclusive, ethical and socially responsible value creation. Practical implications The findings provide actionable insights for participants within DIEs, demonstrating how ELSI-informed strategies can guide digital transformation while ensuring technological progress remains equitable and responsible. It provides a structured methodology for ecosystem actors to assess risks, identify ethical challenges and develop governance mechanisms that support sustainable innovation. Social implications By addressing the broader societal consequences of digital transformation, this research highlights the governance-related dimension of ELSI, stressing the need for a clear vision of the type of society that digital transformation seeks to build. It reinforces that DIEs must engage in active, inclusive decision-making to ensure that digital innovation contributes to equity, safety and long-term social welfare, ultimately shaping a responsible and sustainable digital future. Originality/value This study advances a human-centered, actor-driven approach to DIEs, moving beyond the implicit assumption of DIEs as self-governing entities. By embedding ELSI into strategic frameworks like SWOT and TOWS, the study advocates for a holistic approach that transcends mere technological adoption, respectively, a politically engaged and ethically grounded perspective on digital transformation. It argues that strategic planning must actively involve stakeholders in defining a sustainable, inclusive and ethically responsible digital future.

ObjectivesGenomic advancements affect people with disabilities. This paper presents the findings of a scoping literature review on the ethical, legal, and social implications (ELSI) of genomic technologies for people with disability. The human rights implications of the ELSI findings are then discussed briefly with reference to the United Nations Convention on the Rights of Persons with Disabilities (UNCRPD).MethodsA systematic search of the ELSI literature was conducted. Via a process of abstract screening and full-text review, 288 sources of evidence were included in the review. Data extraction involved identifying the ELSI discussed in each source, which were thematically analysed to generate ELSI themes and to identify relevant linkages to the UNCRPD.ResultsTen ELSI themes were identified as having relevant UNCRPD linkages including reproductive autonomy, issues related to cost and access, the downside of knowing about one’s genetic makeup, lagging legislation in light of the rapid advancement of genomic technologies, genetic discrimination, the stigmatisation and devaluation of people with disabilities, the potential resurgence of eugenics and the medical model of disability, and the involvement of people with disabilities in conversations about genomic technologies. These themes have relevant and direct linkages to several UNCRPD rights including equality, non-discrimination, diversity, accessibility, full participation, identity, and freedom of expression.ConclusionsThe review findings highlight that there is scope for the development of a charter on human rights specific to genomic technologies in the context of disability, which could guide ethical and socially appropriate developments in the field of genomic technologies in future.

BackgroundOver the past 25 years, there has been growing recognition of the importance of studying the Ethical, Legal and Social Implications (ELSI) of genetic and genomic research. A large investment into ELSI research from the National Institutes of Health (NIH) Human Genomic Project budget in 1990 stimulated the growth of this emerging field; ELSI research has continued to develop and is starting to emerge as a field in its own right. The evolving subject matter of ELSI research continues to raise new research questions as well as prompt re-evaluation of earlier work and a growing number of scholars working in this area now identify themselves as ELSI scholars rather than with a particular discipline.Main textDue to the international and interdisciplinary nature of ELSI research, scholars can often find themselves isolated from disciplinary or regionally situated support structures. We conducted a workshop with Early Career Researchers (ECRs) in Oxford, UK, and this paper discusses some of the particular challenges that were highlighted. While ELSI ECRs may face many of the universal challenges faced by ECRs, we argue that a number of challenges are either unique or exacerbated in the case of ELSI ECRs and discuss some of the reasons as to why this may be the case. We identify some of the most pressing issues for ELSI ECRs as: interdisciplinary angst and expertise, isolation from traditional support structures, limited resources and funding opportunities, and uncertainty regarding how research contributions will be measured. We discuss the potential opportunity to use web 2.0 technologies to transform academic support structures and address some of the challenges faced by ELSI ECRs, by helping to facilitate mentoring and support, access to resources and new accreditation metrics.ConclusionAs our field develops it is crucial for the ELSI community to continue looking forward to identify how emerging digital solutions can be used to facilitate the international and interdisciplinary research we perform, and to offer support for those embarking on, progressing through, and transitioning into an ELSI research career.

The Ethical, Legal, and Social Implications (ELSI) program of the Human Genome Project stands as a model for how to organize bioethical inquiry for a rapidly changing field. Neuroscience has experienced significant growth in recent years and there is increasing interest in organizing critical reflection on this field, as evidenced by the creation of “neuroethics.” A nascent framework for reflection on the implications of neuroscience is emerging but significant work remains, given the pace and scope of neuroscientific developments. The adoption of an ELSI program, modeled on that of the ELSI program of the Human Genome Project, promises a way for neuroscience to meet important organizational, educational, and policy objectives. Review of recent criticisms of the HGP ELSI program suggests that an ELSI program for neuroscience would face certain obstacles. Those interested in a neuroscience ELSI program will need to develop appropriate resources to overcome these obstacles.

The article provides an overview of select methodologies that are commonly used in ELSI ("ethical, legal, and social implications") research. ELSI is a field that focuses on the analysis of the societal implications of cutting-edge biomedical research and technologies. The article aims to provide an accessible reference on well-established research methods that aspiring and seasoned ELSI researchers can rely on as a starting point for exploring how to design and conduct ELSI studies. © 2022 Wiley Periodicals LLC.

A cybernetic avatar (CA) is a concept that encompasses not only avatars representing virtual bodies in cyberspace but also information and communication technology (ICT) and robotic technologies that enhance the physical, cognitive, and perceptual capabilities of humans. CAs can enable multiple people to remotely operate numerous avatars and robots together to perform complex tasks on a large scale and create the necessary infrastructure for their operation and other related activities. However, due to the novelty of this concept, the ethical, legal, and social implications (ELSI) of CAs have not been discussed sufficiently. Therefore, the objective of this paper is to provide an overview of ELSI in the context of a CA, taking into account the implications from fields similar to that of CAs, such as robotic avatars, virtual avatars, metaverses, virtual reality, extended reality, social robots, human–robot interaction, telepresence, telexistence, embodied technology, and exoskeletons. In our review of ELSI in related fields, we found common themes: safety and security, data privacy, identity theft and identity loss, manipulation, intellectual property management, user addiction and overdependence, cyber abuse, risk management in a specific domain (e.g., medical applications), regulatory gaps, balance between free expression and harmful content, accountability, transparency, distributive justice, prevention of inequalities, dual use, and conceptual changes of familiarity. These issues should not be ignored when considering the social implementation of CAs.

While bioethics as a field has concerned itself with methodological issues since the early years, there has been no systematic examination of how ethics is incorporated into research on the Ethical, Legal and Social Implications (ELSI) of the Human Genome Project. Yet ELSI research may bear a particular burden of investigating and substantiating its methods given public funding, an explicitly cross-disciplinary approach, and the perceived significance of adequate responsiveness to advances in genomics. We undertook a qualitative content analysis of a sample of ELSI publications appearing between 2003 and 2008 with the aim of better understanding the methods, aims, and approaches to ethics that ELSI researchers employ. We found that the aims of ethics within ELSI are largely prescriptive and address multiple groups. We also found that the bioethics methods used in the ELSI literature are both diverse between publications and multiple within publications, but are usually not themselves discussed or employed as suggested by bioethics method proponents. Ethics in ELSI is also sometimes undistinguished from related inquiries (such as social, legal, or political investigations).

The integration of genomic sequencing into newborn screening (genomic newborn screening; gNBS) has the potential to identify more presymptomatic babies who could benefit from early intervention compared to traditional universal newborn screening (NBS). Realizing these benefits requires careful navigation of ethical, legal, and social implications (ELSI) to minimize harms, promote equity, and maintain trust in NBS programs. The primary objective of this scoping review is to synthesize the ELSI discussed in the gNBS literature, to support implementation and identify knowledge gaps. A secondary objective is to characterize the landscape and contours of the gNBS field. This review, conducted in July 2025, includes academic literature addressing genomic sequencing as a first‑line NBS screen. ELSI were identified within each publication, and these informed the development of a set of decision points with ELSI dimensions within gNBS. A total of 485 publications met inclusion criteria, with the first published in 1987. The volume of publications increased over time, with growing proportions of empirical studies and work associated with gNBS projects, alongside a decreasing proportion of publications from North America. In total, 3781 ELSI considerations were charted using AI-assisted methods, relevant to 59 decision points organized into nine areas. Current scholarship is concentrated on early implementation questions, while long‑term operational needs-such as data stewardship, clinical follow‑up, and sustainable governance-remain underexplored. These gaps, together with limited contributions from many regions due to a multitude of factors, highlight the need for more diverse, empirically grounded, and forward‑looking research to support responsible decisions around gNBS.

PurposePreimplantation Genetic Testing (PGT) has attracted considerable ethical, legal, and social scrutiny, but academic debate often fails to reflect clinical realities.MethodsAddressing this disconnect, a review of 506 articles from 1999 to 2019 across humanities and social sciences was conducted to synthesize the Ethical, Legal, and Social Implications (ELSI) of PGT. This review mined PubMed, WoS, and Scopus databases, using both MeSH terms and keywords to map out the research terrain.Results The findings reveal a tenfold increase in global research output on PGT’s ELSI from 1999 to 2019, signifying rising interest and concern. Despite heightened theoretical discourse on selecting “optimal” offspring, such practices were scarcely reported in clinical environments. Conversely, critical issues like PGT funding and familial impacts remain underexplored. Notably, 86% of the ELSI literature originates from just 12 countries, pointing to a research concentration.ConclusionThis review underscores an urgent need for ELSI research to align more closely with clinical practice, promoting collaborations among ethicists, clinicians, policymakers, and economists. Such efforts are essential for grounding debates in practical relevance, ultimately steering PGT towards ethical integrity, societal acceptance, and equitable access, aiming to harmonize PGT research with real-world clinical concerns, enhancing the relevance and impact of future ethical discussions.

Background Researchers engaged in the study of the ethical, legal, and social implications (ELSI) of genetics and genomics are often publicly funded and intend their work to be in the public interest. These features of U.S. ELSI research create an imperative for these scholars to demonstrate the public utility of their work and the expectation that they engage in research that has potential to inform policy or practice outcomes. In support of the fulfillment of this “translational mandate,” the Center for ELSI Resources and Analysis (CERA), funded by the National Human Genome Research Institute (NHGRI), aims to facilitate community-informed, ELSI research results synthesis and dissemination. However, little is known about how ELSI research scholars define the goals of translation and imagine the intended users of their research findings. Methodology We distributed a Qualtrics survey to ELSI scholars that aimed to determine: (1) researchers’ expectations for their research findings in relation to policy or practice outcomes, (2) the stakeholder groups researchers believe could benefit from their research findings, and (3) the methods researchers use to foster the uptake of their findings by those stakeholders. Results Most ELSI researchers surveyed thought there were stakeholders that could benefit from their research findings, including health care professionals, at-risk individuals, patients, and their family members, policy-makers, and researchers/scientists, and expected their research findings to inform the creation or revision of laws, policies, or practice guidelines. Most researchers planned to disseminate findings directly to relevant stakeholders, with fewer expecting dissemination support from research funders, universities, or other entities. Conclusion The broad range of research topics, disciplines, and set of potential end users represented in ELSI reseach complicate the work of a knowledge broker. Nonetheless, the CERA can play an important role in disseminating ELSI results to relevant stakeholders. Further research should explore outreach mechanisms.