Ethical, Legal, And Social Implications Research Research Articles

A conjunctural analysis of the origins of ‘embedded ELSI’ in U.S. genomic medicine

ABSTRACT Calls to identify, explore, and address ethical and social issues as part of the design and implementation of scientific research are now widespread. One way of doing so is through an embedded approach, where ethical, legal, and social implications (ELSI) researchers are situated within larger scientific research studies. We trace the emergence of the ‘embedded ELSI’ approach to integration alongside the development of genomic medicine. In particular, we conduct a conjunctural analysis that draws attention to contests and struggles over the forms and meanings of good science – in this case, genomics – and the role(s) of ELSI scholars and researchers in producing good science. We demonstrate that the embedded ELSI approach emerged from these contests, which left ELSI research and interventions constrained – institutionally, topically, and methodologically. We end by calling for an opening up of embedded approaches to integration so that they might better meet calls for justice and equity in the present conjuncture.

디지털 헬스케어에 관한 국내 ELSI(Ethical, Legal, and Social Implications) 연구경향: 인문학, 법학, 사회과학 연구의 성과와 과제

Digital healthcare, which provides medical services using information and communication technology (ICT), is emerging as a new paradigm, replacing traditional methods of healthcare. This study investigates research trends in digital healthcare through an analysis of studies published in South Korea on the ethical, legal, and social implications (ELSI) of digital healthcare. To this end, a total of 471 articles drawn from Korean academic journals in the humanities, law, and social sciences, were selected as research subjects, and the current status, characteristics, and research tasks were identified. The results show that Korean ELSI research on digital healthcare emerged about 20 years ago and has steadily increased, with in-depth analyses of various sub-topics such as telemedicine, big data, artificial intelligence, wearable devices, and digital therapeutics. Additionally, notable differences were found among studies in the three fields examined concerning research purposes, methods, and major findings. This study comprehensively reviews the research outcomes of studies in each academic field and proposes future tasks for ELSI research.

ELSI-Forschende für technische Innovationen in der Pflege: Perspektiven zwischen kritischer Distanz und anwendungsbezogener Einflussnahme

This article presents the results of a self-reflective analysis of the role of research on ethical, legal, and social implications (ELSI) in projects that aim to develop and implement technology solutions for care. Four perspectives of ELSI research are used to examine their significance for this endeavor: (1) ELSI research as a ‘contribution to promoting acceptance,’ (2) ELSI research as a ‘seal of approval for new technologies,’ (3) ELSI research as ‘distanced-critical observation,’ (4) ELSI research as a ‘component of integrated research’. It becomes clear that these perspectives differ according to how they cope with the tension between the demands of a scientifically sound self-image and the fulfillment of practical and normative requirements of the field of investigation. Insights into these differences provide clues for the design of ELSI research that can self-critically reflect on its mediating role in the transfer of knowledge between technology development and technology use.

Understanding the Gap: A Cross-Sectional Survey of ELSI Scholars’ Dissemination Practices and Translation Goals

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.

Developing a community-led rare disease ELSI research agenda.

Research priorities are best defined through engagement with communities who will be impacted by the research and have lived experience of the topics to be studied. We aimed to establish a pediatric rare disease community stakeholder group and empower them in (1) eliciting perspectives from affected families in the wider region and (2) synthesizing collective ideas into a research agenda focused on shared ethical, legal, and social implications (ELSI) across rare disease. This two-year project utilized a community-centered approach to engage rare disease community members as equal partners in developing a research agenda for ELSI in rare disease. We established "Rare Voices" (RV), a 22-member stakeholder group of patients, parents, clinicians and researchers. Following capacity-building trainings, RV designed and conducted listening sessions with teen patients and parents of children with rare diseases to explore challenges, positive experiences, and ethical concerns. Listening session findings were synthesized and contextualized into research topics, which RV members further refined and prioritized. We used established measures to assess RV member engagement and satisfaction. From 14 listening sessions with parents (n = 52) and teen patients (n = 13), RV identified eight core research topics as most important for future rare disease research: coordinating care, communication, accessing resources and care, impact on family unit, community and support in society, mental health and identity, ethical aspects of care, and uncertainty. RV members were highly engaged throughout the two-year project and reported high levels of satisfaction with the experience and research agenda. Through capacity-building and authentic engagement, this project resulted in a community-led rare disease research agenda to guide future rare disease ELSI research that aligns with patients' and families' priorities. An environment of equal partnership and respect created a space for mutual learning where community members were empowered to shape the research agenda based on their collective experiences. The agenda recognizes the shared psychosocial and healthcare experiences of rare disease and offers practical areas of research to address patient and family needs.

Mapping international research output within ethical, legal, and social implications (ELSI) of assisted reproductive technologies.

Research about ethical, legal, and social implications (ELSI) of assisted reproductive technologies (ART) is influenced by cultural and value-based perspectives. It impacts regulations, funding, and clinical practice, and shapes the perception of ART in society. We analyze trends in the global literature on ELSI of ART between 1999 and 2019. As most output is produced by North America, Western Europe, and Australia, we focus on international research, i.e., academic articles studying a different country than that of the corresponding author. The corpus, extracted from PubMed, Web of Science, and Scopus, includes 7714 articles, of which 1260 involved international research. Analysis is based on titles, abstracts and keywords, classification into ART fields and Topic Modeling, the countries of corresponding author, and countries mentioned in abstracts. An absolute increase in the number of international studies, and their relative proportion. Trends of decentralization are apparent, yet geographic centralization remains, which reflects an unequal distribution of research funds across countries and may result in findings that do not reflect global diversity of norms and values. Preference for studying conceptual challenges through philosophical analysis, and for fields that concern only a portion of ART cycles. Less attention was dedicated to economic analysis and barriers to access, or to knowledge of and attitudes. International studies provide an opportunity to expand and diversify the scope of ELSI research. We call on the research community to promote international collaborations, focus on less explored regions, and divert more attention to questions of cost, access, knowledge, and attitudes.

The ELSI Virtual Forum, 30 Years of the Genome: Integrating and Applying ELSI Research.

This paper reports our analysis of the ELSI Virtual Forum: 30 Years of the Genome: Integrating and Applying ELSI Research, an online meeting of scholars focused on the ethical, legal, and social implications (ELSI) of genetics and genomics.

The New Precision Stewards?

The precision health era is likely to reduce and respond to antimicrobial resistance (AMR). Our stewardship and precision efforts share terminology, seeking to deliver the “right drug, at the right dose, at the right time.” Already, rapid diagnostic testing, phylogenetic surveillance, and real-time outbreak response provide just a few examples of molecular advances we dub “precision stewardship.” However, the AMR causal factors range from the molecular to that of global health policy. Mirroring the cross-sectoral nature of AMR science, the research addressing the ethical, legal and social implications (ELSI) of AMR ranges across academic scholarship. As the rise of AMR is accompanied by an escalating sense of its moral and social significance, what is needed is a parallel field of study. In this paper, we offer a gap analysis of this terrain, or an agenda for “the ELSI of precision stewardship.” In the first section, we discuss the accomplishments of a multi-decade U.S. national investment in ELSI research attending to the advances in human genetics. In the next section, we provide an overview of distinct ELSI topics pertinent to AMR. The distinctiveness of an ELSI agenda for precision stewardship suggests new opportunities for collaboration to build the stewardship teams of the future.

Ethical, Legal, and Social Implications (ELSI) Research: Methods and Approaches.

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.

Power Sharing, Capacity Building, and Evolving Roles in ELSI: The Center for the Ethics of Indigenous Genomic Research.

Persistent, unresolved issues stemming from a legacy of scientific exploitation and bio-colonialism have kept many tribal nations from participating in genomic research. The Center for the Ethics of Indigenous Genomic Research (CEIGR) aims to model meaningful community engagement that moves toward more inclusive and equitable research practices related to genomics. This article reflects on key successes and challenges behind CEIGR’s efforts to shape Ethical, Legal and Social Implications (ELSI) research in ways that are informed by Indigenous perspectives, to locate community partnerships at the center of genomics research, and to conduct normative and empirical research with Indigenous communities that is grounded in the concepts of reciprocity, transparency and cultural competency. The structure of CEIGR represents an important shift away from a traditional model centered on a university-based principal investigators toward a partner-centered research approach that emphasizes equity and community control by distributing power and decision-making across all CEIGR partner sites. We discuss three features of CEIGR that have contributed to this shift towards an equitable, community-driven partnership: 1) balancing local priorities with collective goals; 2) distributing power in ways that promote equitable partnerships; and 3) capacity building and co-learning across partner sites. The discussion of these three areas in this article speaks to a particular strength of our Center: the interdependence among partners and collective willingness to maintain a plasticity of leadership that creates space for all of our partners to lead, support, exchange and strengthen ELSI research.

Including ELSI research questions in newborn screening pilot studies

BackgroundThe evidence review processes for adding new conditions to state newborn screening (NBS) panels rely on data from pilot studies aimed at assessing the potential benefits and harms of screening. However, the consideration of ethical, legal, and social implications (ELSI) of screening within this research has been limited. This paper outlines important ELSI issues related to newborn screening policy and practices as a resource to help researchers integrate ELSI into NBS pilot studies. ApproachMembers of the Bioethics and Legal Workgroup for the Newborn Screening Translational Research Network facilitated a series of professional and public discussions aimed at engaging NBS stakeholders to identify important existing and emerging ELSI challenges accompanying NBS. ResultsThrough these engagement activities, we identified a set of key ELSI questions related to (1) the types of results parents may receive through newborn screening and (2) the initiation and implementation of NBS for a condition within the NBS system. ConclusionIntegrating ELSI questions into pilot studies will help NBS programs to better understand the potential impact of screening for a new condition on newborns and families, and make crucial policy decisions aimed at maximized benefits and mitigating the potential negative medical or social implications of screening.

Normative and conceptual ELSI research: what it is, and why it’s important

The Ethical, Legal, and Social Implications (ELSI) Research Program of the National Human Genome Research Institute sponsors research examining ethical, legal, and social issues arising in the context of genetics/genomics. The ELSI Program endorses an understanding of research not as the sole province of empirical study, but instead as systematic study or inquiry, of which there are many types and methods. ELSI research employs both empirical and nonempirical methods. Because the latter remain relatively unfamiliar to biomedical and translational scientists, this paper seeks to elucidate the relationship between empirical and nonempirical methods in ELSI research. It pays particular attention to the research questions and methods of normative and conceptual research, which examine questions of value and meaning, respectively. To illustrate the distinct but interrelated roles of empirical and nonempirical methods in ELSI research, including normative and conceptual research, the paper demonstrates how a range of methods may be employed both to examine the evolution of the concept of incidental findings (including the recent step toward terming them ‘secondary findings’), and to address the normative question of how genomic researchers and clinicians should manage incidental such findings.

Challenges and opportunities for ELSI early career researchers.

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 translational potential of research on the ethical, legal, and social implications of genomics.

Federally funded research on the ethical, legal, and social implications (ELSI) of genomics includes a programmatic charge to consider policy-relevant questions and to communicate findings in venues that help inform the policy-making process. In addressing this goal, investigators must consider the range of policies that are relevant to human genetics; how foundational research in bioethics, law, and the social sciences might inform those policies; and the potential professional issues that this translational imperative raises for ELSI investigators. We review these questions in light of experiences from a consortium of federally funded Centers of Excellence in ELSI Research, and offer a set of policy recommendations for program design and evaluation of ELSI research. We conclude that it would be a mistake to require that ELSI research programs demonstrate a direct impact on science or health policy; however, ELSI researchers can take steps to increase the relevance of their work to policy makers. Similarly, funders of ELSI research who are concerned with facilitating policy development can help by building cross-disciplinary translational research capacities, and universities can take steps to make policy-relevant research more rewarding for scholars in the humanities, social sciences, and law.

The Ethical, Legal, and Social Implications Program of the National Human Genome Research Institute: reflections on an ongoing experiment.

For more than 20 years, the Ethical, Legal, and Social Implications (ELSI) Program of the National Human Genome Research Institute has supported empirical and conceptual research to anticipate and address the ethical, legal, and social implications of genomics. As a component of the agency that funds much of the underlying science, the program has always been an experiment. The ever-expanding number of issues the program addresses and the relatively low level of commitment on the part of other funding agencies to support such research make setting priorities especially challenging. Program-supported studies have had a significant impact on the conduct of genomics research, the implementation of genomic medicine, and broader public policies. The program's influence is likely to grow as ELSI research, genomics research, and policy development activities become increasingly integrated. Achieving the benefits of increased integration while preserving the autonomy, objectivity, and intellectual independence of ELSI investigators presents ongoing challenges and new opportunities.

Bioethics Methods in the Ethical, Legal, and Social Implications of the Human Genome Project Literature

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).

Grand challenge: ELSI in a changing global environment

Grand challenge: ELSI in a changing global environment

Funding and Forums for ELSI Research: Who (or What) Is Setting the Agenda?

Background: Discussion of the influence of money on bioethics research seems particularly salient in the context of research on the ethical, legal, and social implications (ELSI) of human genomics, as this research may be financially supported by the ELSI Research Program. Empirical evidence regarding the funding of ELSI research and where such research is disseminated, in relation to the specific topics of the research and methods used, can help to further discussions regarding the appropriate influence of specific institutions and institutional contexts on ELSI and other bioethics research agendas. Methods: We reviewed 642 ELSI publications (appearing between 2003 and 2008) for reported sources of funding, forum for dissemination, empirical and nonempirical methods, and topics of investigation. Results: Most ELSI research is independent of direct grant-based funding sources; 66% reported no such sources of funding. The National Human Genome Research Institute (NHGRI) is the most dominant source of funding; 16% of publications acknowledged at least one source of NHGRI grant funding. Funding is acknowledged more frequently in empirical than nonempirical publications and more frequently in publications in public health journals than in any other ELSI research dissemination forums. Dominant research topics vary by publication forum and by reported funding. Conclusions: ELSI research is surprisingly independent of direct grant-based funding, yet correlations are apparent between this type of funding and publication placement, topics addressed, and methods used, implying a not insignificant influence on ELSI research agenda setting. However, given the relatively low percentage of publications acknowledging external grant-based funding, as well as other significant correlations between publication placement and topics addressed, additional institutional contexts, perhaps related to professional advancement or valuation, may shape research agendas in ways that potentially exceed the direct influences of grant-based funding in this area. In some cases, grant-based funding may actually counter other potentially problematic institutional influences.

ELSIfication in Canada: Legal Modes of Reasoning

ELSI (Ethical, Legal and Social Implications) initiatives are frequently attached to major science programmes. The expectation is that ELSI research will produce a practical advanced assessment of the impacts of technological development. Williams' overview of the field demonstrates that this encourages a mechanistic understanding of technological development leading to compressed foresight, i.e. the notion that the future is imminent in the present. The development of the ELSI domain in Canada has been characterised by an affinity between the types of knowledge valorised by the field and modes of legal reasoning, suggesting a legal variant of compressed foresight. The concept of juridification and an analysis of two related modes of legal reasoning (analogy and reflective equilibrium) shed light on the connection between legal reasoning and the ELSI field in Canada. The deployment of the aforementioned modes of legal reasoning enables law to define and operationalise difficult questions by drawing on currently existing principles and precedents. Thus, when legal modes of reasoning are brought to bear on ELSI questions, the future is made a calculable and manageable extension of the present, dovetailing with the ELSI field's requirement of pragmatic, advanced assessment.

Charting ELSI’s future course: lessons from the recent past

PurposeWe sought to examine the ethical, legal, and social implications (ELSI) literature research and scholarship types, topics, and contributing community fields of training as a first step to charting the broader ELSI community’s future priorities and goals. MethodsWe categorized 642 articles and book chapters meeting inclusion criteria for content in both human genetics or genomics and ethics or ELSI during a 5-year period (2003–2008) according to research and scholarship types, topics, and the area of advanced training of the first-listed author. Research and scholarship type categories were developed and characterized through in-depth review of 95 randomly sampled publications from the larger group. ResultsThere is a single dominant approach to ELSI, which focuses on ethical and other social issues “downstream” of advances in genomics, the contributors to which predominately have advanced training in medicine or science fields other than social science. A comparatively low percentage of publications primarily offer policy recommendations, and these are much more likely to be written by those with advanced training in law than is the case for the literature as a whole. Social science studies predominately employ qualitative methods and vary significantly with respect to the extent and types of recommendations offered. Two further types of ELSI research and scholarship offer alternative models for so-called “normative” work in this field. ConclusionConsidering topics, training, and types of ELSI research and scholarship from the most recent past allows for a baseline perspective that is sorely needed in charting this field’s future course.Genet Med 2012:14(2):259–267