Two Tales of Long-term Collaboration: Social Scientific Involvement in Artificial Intelligence in Japan and Synthetic Biology in the UK

The consideration of Ethical, Legal, and Social Issues (ELSI) is essential in technologically advanced countries to maximize benefits and minimize potential risks of emerging science and technologies (S&T). Currently, in scientific policy, discussions about ELSI have been conducted using the framework of Responsible Research and Innovation (RRI). This study examines a current and significant case study in Japan, Molecular Robotics (Molbot), to discuss and practice RRI in emerging science. In the case of Molbot, the research community spontaneously set out to create a framework of ethical principles in collaboration with social scientists. This was done by looking at previous similar cases and conducting workshops for the consideration of ELSI in future scenarios. This process of creating and accepting the ethical principles of Molecular Robotics by the community is significant for this field as it shows the appearance of scientific autonomy by Molbot researchers. Furthermore, this process can be regarded as the co-production of knowledge on ELSI and RRI at the early stage of research and development in an interdisciplinary research field and serve as the start of a blueprint for other emerging S&T seeking a favorable relationship with society.

This paper describes issues associated with integrating the study of Ethical, Legal and Social Issues (ELSI) into ongoing scientific and technical research and describes an approach adopted by the authors for their own work with the center for nanophase materials sciences (CNMS) at the Oak Ridge national laboratory (ORNL). Four key questions are considered: (a) What is ELSI and how should it identify and address topics of interest for the CNMS? (b) What advantages accrue to incorporating ELSI into the CNMS? (c) How should the integration of ELSI into the CNMS take place? (d) How should one judge the effectiveness of the activity? We conclude that ELSI research is not a monolithic body of knowledge, but should be adapted to the question at hand. Our approach focuses on junctures in the R&D continuum at which key decisions occur, avoids topics of a purely ethical nature or advocacy, and seeks to gather data in ways that permit testing the validity of generalization. Integrating ELSI into the CNMS allows dealing with topics firmly grounded in science, offers concrete examples of potential downstream applications and provides access to the scientists using the CNMS and their insights and observations. As well, integration provides the opportunity for R&D managers to benefit from ELSI insights and the potential to modify R&D agendas. Successful integration is dependent on the particular ELSI question set that drives the project. In this case questions sought to identify key choices, information of value to scientists, institutional attributes, key attributes of the CNMS culture, and alternatives for communicating results. The opportunity to consult with scientists on ELSI implications is offered, but not promoted. Finally, ELSI effectiveness is judged by observing the use to which research products are put within the CNMS, ORNL, and the community of external scholars.

There have been multiple calls for explicit integration of ethical, legal, and social issues (ELSI) in health technology assessment (HTA) and addressing ELSI has been highlighted as key in optimizing benefits in the Omics/Personalized Medicine field. This study examines HTAs of an early clinical example of Personalized Medicine (gene expression profile tests [GEP] for breast cancer prognosis) aiming to: (i) identify ELSI; (ii) assess whether ELSIs are implicitly or explicitly addressed; and (iii) report methodology used for ELSI integration. A systematic search for HTAs (January 2004 to September 2012), followed by descriptive and qualitative content analysis. Seventeen HTAs for GEP were retrieved. Only three (18%) explicitly presented ELSI, and only one reported methodology. However, all of the HTAs included implicit ELSI. Eight themes of implicit and explicit ELSI were identified. "Classical" ELSI including privacy, informed consent, and concerns about limited patient/clinician genetic literacy were always presented explicitly. Some ELSI, including the need to understand how individual patients' risk tolerances affect clinical decision-making after reception of GEP results, were presented both explicitly and implicitly in HTAs. Others, such as concern about evidentiary deficiencies for clinical utility of GEP tests, occurred only implicitly. Despite a wide variety of important ELSI raised, these were rarely explicitly addressed in HTAs. Explicit treatment would increase their accessibility to decision-makers, and may augment HTA efficiency maximizing their utility. This is particularly important where complex Personalized Medicine applications are rapidly expanding choices for patients, clinicians and healthcare systems.

IntroductionHealth technology assessment (HTA) is value-laden. Consideration of ethical, legal, and social issues (ELSI), and patient values (ELSI+), is challenged by lack of conceptual clarity and the multi-disciplinary nature of ELSI + . This study used concept mapping to identify key concepts in the ELSI+ domain and their interrelationships.MethodsWe conducted a scoping review using Medline and EMBASE (2000-2016, English language) with search terms related to ethics, legal/law, social/society/patient, “ELSI”, and HTA/technology/assessment. Items from the review and additional items from an expert brainstorming session were consolidated into 80 ELSI+-related statements which were entered into Concept Systems® Global MAX software. Participants (N = 38; 36 percent researchers, 21 percent academics; 42 percent self-identified as HTA experts) sorted the statements into thematic groups that made sense to them, and rated the statements on their importance in decision-making about adoption of technologies in Canada: 1 (not at all important), 5 (extremely important), 2, 3, and 4 (unlabeled). We used Concept Systems® Global MAX software to create and analyze concept maps with four to 16 clusters, which were reviewed by the study team.ResultsWe selected the map with five clusters because its clusters represented different concepts and the statements within each cluster represented the same concept. Based on the concepts, we named these clusters: patient preferences and experiences, patient quality of life and function, patient burden/harm, fairness, and organizational. The highest mean importance ratings were for the statements in the patient burden/harm (3.82) and organizational (3.92) clusters.ConclusionsThis study suggests an alternative approach to conceptualize the domains originally described as “ELSI+”. We identified clusters of relevant concepts that focus on patient perspectives (preferences, experiences, quality of life, function), burden and harm, fairness (individual and societal), and organizational issues. Basing ELSI+ on conceptual consonance, rather than academic disciplines or traditions, provides a framework for coherent consideration of ELSI+ in HTA.

The Present and Future of Studies and Practices on Ethical, Legal, and Social Issues (ELSI) and Responsible Research and Innovation (RRI)

This chapter introduces the concept of ethical, legal, and social issues – known as ELSI – as it is relevant to security science research and security science-informed practice. After defining ethical, legal, and social issues, the chapter addresses main ELSI domains and discusses how to address those in security science. Arguments are illustrated using examples from domains such as critical infrastructure protection and novel coronavirus pandemic (COVID-19) response. Subsequently, the chapter demonstrates the relevance of ELSI analysis in security science for risk assessment and vulnerability analysis. It argues for a comprehensive approach to ELSI assessment and consideration in security science that actively involves members of the public in the process of exploring ethical, legal, and social issues. Selected public participation methods are recommended. Moreover, the chapter discusses the use of ELSI to address the security vs. liberty dilemma in security science and the real-world security practice that it may inform and offers criteria for “good security science” that embeds assessing and addressing of ELSI throughout the research and dissemination process. The chapter concludes by arguing that security science should provide a better connection of the disciplines involved in its research undertakings. Security science should establish networked expertise to foster deliberate planning and well as rapid decision support capability for crisis management.

ELSI (Ethical, Legal, and Social Issues) is a widely used acronym in the bioethics literature that encompasses a broad range of research examining the various impacts of science and technology on society. In Canada, GE3LS (Genetics, Ethical, Economic, Environmental, Legal, Social issues) is the term used to describe ELSI studies in the context of genetics and genomics research. It is intentionally more expansive in that GE3LS explicitly brings economic and environmental issues under its purview. ELSI/GE3LS research is increasingly relevant in recent years as there has been a greater emphasis on "translational research" that moves genomic discoveries from the bench to the clinic. The purpose of this chapter is to outline a range of ELSI-related work that might be conducted as part of a large scale genetics or genomics research project, and to provide some practical insights on how a scientific research team might incorporate a strong and effective ELSI program within its broader research mandate. We begin by describing the historical context of ELSI research and the development of GE3LS research in the Canadian context. We then illustrate how some ELSI research might unfold by outlining a variety of GE3LS research questions or content domains and the methodologies that might be employed in studying them. We conclude with some practical suggestions about how to build an effective ELSI/GE3LS team and focus within a broader scientific research program.

ELSI (Ethical, Legal, and Social Issues) is a widely used acronym in the bioethics literature that encompasses a broad range of research areas involved in examining the various impacts of science and technology on society. In Canada, GE3LS (Genetics, Ethical, Economic, Environmental, Legal, Social issues) is the term used to describe ELSI studies. It is intentionally more expansive in that GE3LS explicitly brings economic and environmental issues under its purview. ELSI/GE3LS research has become increasingly important in recent years as there has been a greater emphasis on "translational research" that moves genomics from the bench to the clinic. The purpose of this chapter is to outline a range of ELSI-related work that might be conducted as part of a large scale genetics or genomics research project, and to provide some practical insights on how a scientific research team might incorporate a strong and effective ELSI program within its broader research mandate. We begin by describing the historical context of ELSI research and the development of GE3LS research in the Canadian context. We then illustrate how some ELSI research might unfold by outlining a variety of research questions and the various methodologies that might be employed in addressing them in an area of ELSI research that is encompassed under the term "public engagement." We conclude with some practical pointers about how to build an effective ELSI/GE3LS team and focus within a broader scientific research program.

From 2008 to 2024, the Newborn Screening Translational Research Network (NBSTRN), part of the National Institute of Child Health and Human Development (NICHD) Hunter Kelly Newborn Screening Program, served as a robust infrastructure to facilitate groundbreaking research in newborn screening (NBS), public health, rare disease, and genomics. Over its sixteen years, NBSTRN developed into a significant international network, supporting innovative research on novel technologies to screen, diagnose, treat, manage, and understand the natural history of more than 280 rare diseases. The NBSTRN tools and resources were used by a variety of stakeholders including researchers, clinicians, state NBS programs, parents, families, and policy makers. Resources and expertise for the newborn screening community in ethical, legal, and social issues (ELSI) has been an important area of focus for the NBSTRN and this includes efforts across the NBS system from pilot studies of candidate conditions to public health implementation of screening for new conditions, and the longitudinal follow-up of NBS-identified individuals to inform health outcomes and disease understanding. In 2023, the NBSTRN conducted a survey to explore ELSI issues in NBS research, specifically those encountered by the NBS community. Since NBS research involves collaboration among researchers, state NBS programs, clinicians, and families, the survey was broadly designed and disseminated to engage all key stakeholders. With responses from 88 members of the NBS community, including researchers and state NBS programs, the survey found that individuals rely most on institutional and collegial resources when they encounter ELSI questions. Most survey responses ranked privacy as extremely or very important in NBS research and identified the need for policies that address informed consent in NBS research. The survey results highlight the need for improved collaborative resources and educational programs focused on ELSI for the NBS community. The survey results inform future efforts in ELSI and NBS research in the United States (U.S.) and the rest of the world, including the development of policies and expanded ELSI initiatives and tools that address the needs of all NBS stakeholders.

R medicinal research utilizing induced stem cells (iPSCs) is one of the cutting-edge research areas in Japan. It is an element of Japan’s New Growth Strategy and a 110-billion-Yen budget created in 2013 to strengthen and accelerate stem cell research over a ten-year period. With the Japanese government’s support, nationwide stem cell research projects have been conducting and the first human clinical trial using iPSC conducted on an age-related macular degeneration patient in 2014. Under these circumstances, iPSC banking projects have been undertaken. Notably, the iPSC stock project collects HLA homogeneous cells to create clinically applicable iPSC lines. iPSC banking is a relatively new system and now faces new ethical, legal, and social issues (ELSI) and its governance. ELSI on umbilical cord blood banking for clinical use and ELSI on DNA banking for research use been actively discussed. However, ELSI on iPSC banking is not been thoroughly examined yet in Japan. Without saying anything that there has not been much research on ELSI pertaining to iPSC banking targeting children and minors, such as returning results to minors and parents. Therefore, our poster examines the ELSI on iPSC banking in paediatrics based on our experience with the ethical supports in iPSC banking for basic research. In addition, we will introduce and examine the new guidelines outlined in ‘Ethical Guidelines for Human Medical Research’ that will be enacted in April 2015, as a reference as it elaborates on clinical research pertaining to minors and the relevant assent issues.

Ethical, legal, and social issues associated with using existing airports as spaceports

Background Progress in precision medicine relies on the access to, use of, and exchange of genomic and associated clinical data, including from children. The ethical, legal, and social issues (ELSI) of such data access, use, and exchange may be accentuated in the pediatric context due in part to the highly sensitive nature of genomic data, children’s consent-related vulnerabilities, and uncertain risks of reidentification. Systematic analyses of the ELSI and scientific reasons for why and how genomic data may be shared responsibly are, however, limited. Methods: We conducted a modified systematic review of reasons according to Sofaer and Strech to examine the ELSI and scientific reasons for “responsible” sharing of children’s genomic and associated clinical data. Empirical articles, commentaries, and data-sharing policies indexed in Medline, Scopus, Web of Science, and BIOSIS were included in the analysis if they discussed ELSI and were published between 2003 and 2017 in English. Results: One hundred and fifty-one records met our inclusion criteria. We identified 11 unique reasons and 8 subreasons for why children’s genomic data should or should not be shared. Enhancing the prospect of direct and indirect benefits and maximizing the utility of children’s data were top reasons why data should be shared. Inadequate data privacy protection was the leading reason why it should not. We furthermore identified 8 reasons and 30 subreasons that support conditional data sharing, in which recontact for the continued use of children’s data once they reach the age of majority was the most frequently endorsed condition. Conclusions: The complete list of ELSI reasons and responsible conditions provides an evidentiary basis upon which institutions can develop data-sharing policies. Institutions should encourage the sharing of children’s data to advance genomic research, while heeding special reconsent and data protection mechanisms that may help mitigate uncertain longitudinal risks for children and families.

Banking of biomedical tissues or information related to them has been conducted around the world for clinical, research and/or commercial purposes. In addition to stem cells in the differentiated tissues such as cord blood and bone marrow, pluripotent stem cells are also subjects of banking. Human embryonic stem cells (hES cells) are one type of these cells, but induced pluripotent stem cells (iPS cells) are now also subjects of banking for various purposes.In Japan, the Center for iPS Cell Research and Application (CiRA), led by Dr Shinya Yamanaka, was established in 2010 to conduct research on iPS cells. In order to realize iPS cell based therapies, CiRA is now working to establish a new iPS cell bank. The bank aims to establish clinical-grade, HLA-matched iPS cell lines from healthy volunteers and store them to provide for therapeutic or research use. Although some iPS cell banks in Japan or in other countries, including the one in CiRA, are already established, these banks store and provide basically disease-specific iPS cell lines. Therefore, the planned iPS cell bank at CiRA is unique in that it is going to store and provide clinical-grade iPS cells derived from healthy volunteers.We have been collaborating with researchers at CiRA to establish appropriate procedures for the recruitment of healthy volunteers. We have found that there are a variety of ethical, legal, and social issues (ELSI) that need to be addressed. Since iPS cells are pluripotent stem cells, some ELSI are similar to those already identified in hES cell banks. However, there are other issues that are relatively novel and specific to iPS cells, especially when the donor is a healthy volunteer, not a patient. These ELSI identified arise because: 1. these cells are derived from healthy volunteers; 2. these cells expand infinitely; and 3. the bank deals not only with information such as genome sequence but also with other aspects of the cells.In this presentation, we will summarize and discuss the ELSI we encountered while establishing the process of healthy-volunteer recruitment for the iPS cell bank.

The Precision Medicine Initiative's All of Us Research Program: an agenda for research on its ethical, legal, and social issues.

Recent interest in personalized medicine has highlighted the importance of research in ethical, legal, and social issues (ELSI). Issues in ELSI research may be magnified in the rare diseases population (i.e., small numbers of affected individuals, challenges in maintaining confidentiality, and paucity of treatments for diseases where natural history information may be limited). More than other areas of research, potential barriers include the lack of funding opportunities and appropriate review processes for applications to funding agencies. The ELSI Working Group of the International Rare Diseases Research Consortium (IRDiRC) performed an informal survey on ELSI funding initiatives to learn more about different funding mechanisms and to identify potential gaps in funding opportunities. The Working Group discusses these challenges and highlights the role of funding agencies and partners such as patient advocacy groups, specialists in social sciences and humanities, and clinicians to advance ELSI research in rare diseases.