Ethical, Legal, And Social Issues Research Articles

Artificial intelligence, medications, pharmacogenomics, and ethics.

Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing various scientific and clinical disciplines including pharmacogenomics (PGx) by enabling the analysis of complex datasets and the development of predictive models. The integration of AI and ML with PGx has the potential to provide more precise, data-driven insights into new drug targets, drug efficacy, drug selection, and risk of adverse events. While significant effort to develop and validate these tools remain, ongoing advancements in AI technologies, coupled with improvements in data quality and depth is anticipated to drive the transition of these tools into clinical practice and delivery of individualized treatments and improved patient outcomes. The successful development and integration of AI-assisted PGx tools will require careful consideration of ethical, legal, and social issues (ELSI) in research and clinical practice. This paper explores the intersection of PGx with AI, highlighting current research and potential clinical applications, and ELSI including privacy, oversight, patient and provider knowledge and acceptance, and the impact on patient-provider relationship and new roles.

Charting the Ethical Frontier in Newborn Screening Research: Insights from the NBSTRN ELSI Researcher Needs Survey

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.

Ethical, legal, and social issues (ELSI) and reporting guidelines of AI research in healthcare

Ethical, legal, and social issues (ELSI) and reporting guidelines of AI research in healthcare

Data linkage in public health research: a scoping review of ethical, legal and societal aspects surrounding administrative data

ObjectiveThe application of data linkage for scientific research purposes in the public health sphere requires using personal and sensitive data on an individual level while results are analyzed from a population perspective. Considering this, ethical, legal and social issues (ELSI) must be considered. In this sense, our study aims to better understand how ELSI surrounding administrative data linkage use in public health has been addressed in the scientific literature. ApproachOur scoping review is based on the Joann Briggs Institute Manual for Evidence Synthesis and will be reported according to the Preferred Report Items for Systematic Reviews and Meta-Analyses – Scoping Review Guideline. Two independent authors searched for articles published between January 2013 and December 2023 in the PubMed/MEDLINE, Web of Science, EMBASE and LILACS databases, as well as in Scielo and Google Scholar platforms. Keywords used were related to ‘data linkage’, ‘administrative data’, ‘ELSI’, “public policies’ and ‘public health’ terms. Articles were screened initially by title and abstract, then by full-text read. ResultsAfter duplicate removal and articles screening, two independent authors are performing data extraction considering ethical, legal and regulatory basis as well as procedures for data access; data management process including record linkage; type of administrative data linked; data protection strategies; and data subjects rights. ConsiderationsThis scoping is underway, we intend to have our final results by April to present at the conference, in September.

Developing a Short Course on the Ethical, Legal, and Social Issues of Biobanking Practice-A Participatory Action Research Study in South Africa.

Introduction: There is a paucity of available training opportunities on the ethical, legal, and social issues (ELSI) of biobanking in South Africa and other low- and middle-income countries. For this purpose, an online short course was developed on the ELSI of biobanking practice. Study Aims and Objectives: This study aimed to review the short course to determine its relevance for identified stakeholders in biobanking practice in South Africa. Methods: This in-depth exploratory study was conducted using a qualitative approach. Two groups of volunteers were purposively identified for the review of the course. Group 1 (Biobanking group, n = 11) comprised researchers, biobankers, postgraduate students in biobanking research, and research ethics committee members. Group 2 (Curriculum group, n = 10) comprised academics with expertise in curriculum development and review who were invited to participate in the study. A separate online open-ended questionnaire was used to collect data from each group. Both questionnaires focused on the description of the module structure and coherence. In addition, participants in Group 2 were asked to comment on the assessment strategy used. Thematic analysis was conducted on the collected data. Summary of the Study Findings: The following themes were identified as strengths and shortcomings of the developed course and suggestions to improve both the content and delivery of the course. Participants were generally satisfied with the course design and structure. The module content was seen as being clear and aligned with the learning objectives. While the course structure was seen as easy to follow, some respondents did express difficulty in navigating through the modules while others experienced varying online technical problems. The general opinion was that the assessment strategy was consistent with the course aim and objectives. Conclusion: Study participants responded positively to this course and provided constructive criticism to improve the educational offering.

Mapping the Apps: Ethical and Legal Issues with Crowdsourced Smartphone Data using mHealth Applications

More than 5 billion people in the world own a smartphone. More than half of these have been used to collect and process health-related data. As such, the existing volume of potentially exploitable health data is unprecedentedly large and growing rapidly. Mobile health applications (apps) on smartphones are some of the worst offenders and are increasingly being used for gathering and exchanging significant amounts of personal health data from the public. This data is often utilized for health research purposes and for algorithm training. While there are advantages to utilizing this data for expanding health knowledge, there are associated risks for the users of these apps, such as privacy concerns and the protection of their data. Consequently, gaining a deeper comprehension of how apps collect and crowdsource data is crucial. To explore how apps are crowdsourcing data and to identify potential ethical, legal, and social issues (ELSI), we conducted an examination of the Apple App Store and the Google Play Store in North America and Europe to identify apps that could potentially gather health data through crowdsourcing. Subsequently, we analyzed their privacy policies, terms of use, and other related documentation to gain insights into the utilization of users’ data and the possibility of repurposing it for research or algorithm training purposes. More specifically, we reviewed privacy policies to identify clauses pertaining to the following key categories: research, data sharing, privacy/confidentiality, commercialization, and return of findings. Based on the results of these app search, we developed an App Atlas that presents apps which crowdsource data for research or algorithm training. We identified 46 apps available in the European and Canadian markets that either openly crowdsource health data for research or algorithm training or retain the legal or technical capability to do so. This app search showed an overall lack of consistency and transparency in privacy policies that poses challenges to user comprehensibility, trust, and informed consent. A significant proportion of applications presented contradictions or exhibited considerable ambiguity. For instance, the vast majority of privacy policies in the App Atlas contain ambiguous or contradictory language regarding the sharing of users’ data with third parties. This raises a number of ethico-legal concerns which will require further academic and policy attention to ensure a balance between protecting individual interests and maximizing the scientific utility of crowdsourced data. This article represents a key first step in better understanding these concerns and bringing attention to this important issue.

The relationship between the attitudes of the use of AI and diversity awareness: comparisons between Japan, the US, Germany, and South Korea

AbstractRecent technological advances have accelerated the use of artificial intelligence (AI) in the world. Public concerns over AI in ethical, legal, and social issues (ELSI) may have been enhanced, but their awareness has not been fully examined between countries and cultures. We created four scenarios regarding the use of AI: “voice,” “recruiting,” “face,” and “immigration,” and compared public concerns in Japan, the US, Germany, and the Republic of Korea (hereafter Korea). Additionally, public ELSI concerns in respect of AI were measured using four items: ethics, tradition, law and social benefit. Respondents with AI knowledge tended to exhibit stronger concern about ELSI in various situations. In terms of law concerns, Japanese respondents displayed greater concerns. In contrast, the US, when compared Japan, expressed a relatively optimistic view of the current law landscape. Regarding social benefits, Korea, compared to Japan, exhibited a more positive outlook, whereas Germany, in comparison to Japan, expressed heightened concerns about it across different scenarios.

The "Other E" in ELSI: The Use of Economic Evaluation to Inform the Expansion of Newborn Screening.

The utilization and application of genomic information generated from precision medicine continues to increase with the goal of improving health outcomes. Increasingly researchers, health care professionals, and public health teams include an examination of the ethical, legal, and social issues (ELSI) in their consideration of the use of precision medicine for newborn and pediatric health. In addition to ELSI considerations, stakeholders could benefit from an understanding of economics, the other "E" in ELSI. The use of an economic evaluation could aid decision-making on whether to screen newborns who may be at risk for disease, to diagnose newborns and children who present with symptoms, to inform the treatment and management of diagnosed individuals. In this manuscript we review the core concepts of economic evaluation, the framework of decision-analysis, and key parameters for consideration in assessing the economics of NBS program(s). We describe the common language used in the economic evaluation and provide a practical overview of health economic evaluations including 1) their purpose, 2) different types and components, 3) evaluation of the different types and components of economic evaluations (i.e., cost-effectiveness vs. cost-benefit analysis), 4) impact of societal or healthcare perspectives on the analysis, 5) health outcomes, 6) time horizon for the analysis, 7) identification of appropriate comparators, and 8) resources for economic data. We conclude with a use case to demonstrate the application and understanding of economic considerations for in the advancement and expansion of NBS.

Science fiction and ELSI: three thoughts.

Science fiction can be useful to those who analyze ethical, legal, and social issues (ELSI) in genetics and the biosciences more broadly. It can provide examples of possible technological changes, which are occasionally valuable as predictions of the future but more often helpful as indicators of the likely social consequences of such technologies. This "what-if" approach to science fiction can also provide a good pathway to exploring such issues. Science fiction can also allow a more distant, less realistic, and non-culture-specific context for exploring deep questions about humanity, ethics, and other major issues. At the same time, science fiction also has some negative effects on such analysis or its reception as a result of the need for fiction to hold its audience by providing drama through conflict. This necessity for successful fiction often leads to technological or cultural changes being portrayed as catastrophic and dystopian, much more often than beneficial or utopian. This imbalance can predispose public opinion against innovations unfairly, in part by providing "examples" from fiction of similar innovations, leading to bad outcomes. ELSI researchers should keep this fiction-induced bias in mind in their work.

Looking ahead: ethical and social challenges of somatic gene therapy for sickle cell disease in Africa.

Somatic gene therapy will be one of the most exciting practices of genetic medicine in Africa and is primed to offer a "new life" for persons living with sickle cell disease (SCD). Recently, successful gene therapy trials for SCD in the USA have sparked a ray of hope within the SCD community in Africa. However, the high cost, estimated to exceed 1.5 million USD, continues to be a major concern for many stakeholders. While affordability is a key global health equity consideration, it is equally important to reflect on other ethical, legal and social issues (ELSIs) that may impact the responsible implementation of gene therapy for SCD in Africa. These include informed consent comprehension, risk of therapeutic misestimation and optimistic bias; priorities for SCD therapy trials; dearth of ethical and regulatory oversight for gene therapy in many African countries; identifying a favourable risk-benefit ratio; criteria for the selection of trial participants; decisional conflict in consent; standards of care; bounded justice; and genetic tourism. Given these ELSIs, we suggest that researchers, pharma, funders, global health agencies, ethics committees, science councils and SCD patient support/advocacy groups shouldwork together to co-develop: (1) patient-centric governance for gene therapy in Africa, (2) public engagement and education materials, and (3) decision making toolkits for trial participants. It is also critical to establish harmonised ethicaland regulatory frameworks for gene therapy in Africa, and for global health agencies to accelerate access to basic care for SCD in Africa, while simultaneously strengthening capacity for gene therapy.

NBSTRN Tools to Advance Newborn Screening Research and Support Newborn Screening Stakeholders.

Rapid advances in the screening, diagnosis, and treatment of genetic disorders have increased the number of conditions that can be detected through universal newborn screening (NBS). However, the addition of conditions to the Recommended Uniform Screening Panel (RUSP) and the implementation of nationwide screening has been a slow process taking several years to accomplish for individual conditions. Here, we describe web-based tools and resources developed and implemented by the newborn screening translational research network (NBSTRN) to advance newborn screening research and support NBS stakeholders worldwide. The NBSTRN's tools include the Longitudinal Pediatric Data Resource (LPDR), the NBS Condition Resource (NBS-CR), the NBS Virtual Repository (NBS-VR), and the Ethical, Legal, and Social Issues (ELSI) Advantage. Research programs, including the Inborn Errors of Metabolism Information System (IBEM-IS), BabySeq, EarlyCheck, and Family Narratives Use Cases, have utilized NBSTRN's tools and, in turn, contributed research data to further expand and refine these resources. Additionally, we discuss ongoing tool development to facilitate the expansion of genetic disease screening in increasingly diverse populations. In conclusion, NBSTRN's tools and resources provide a trusted platform to enable NBS stakeholders to advance NBS research and improve clinical care for patients and their families.

The need to consider ethical, legal and social issues (ELSI) in "Mibyo" (pre-symptomatic conditions) research

The need to consider ethical, legal and social issues (ELSI) in "Mibyo" (pre-symptomatic conditions) research

Practice of responsible research and innovation in the formulation and revision of ethical principles of molecular robotics in Japan

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.

The Potential Role of Flying Vehicles in Progressing the Energy Transition

An energy transition is in progress around the globe, notably led by an increase in the deployment of renewable energy and a shift toward less emissions-intense options, notably in the transportation sector. This research investigates the potential role that new transportation options, namely flying vehicles, may play toward progressing the energy transition. As flying vehicles are a relatively new technology yet to penetrate the market, it is also prudent to consider the ethical, legal, and social issues (ELSI) associated with their implementation, alongside the potential energy and environmental impacts. Through a review of ELSI and energy and environmental literature, we identify research gaps and identify how flying vehicles may impact upon the energy transition over time. Our research identifies several critical aspects of both ELSI and energy and environmental academia relevant to the future deployment of flying vehicles and describes a deployment timeline and the resultant societal outcomes. We find that flying vehicles could drive the energy transition and the hydrogen economy and that their widespread adoption could engender shared socio-environmental benefits. Our findings are relevant to transportation and environmental policymakers and identify critical considerations for the planned introduction of new, shared transportation options to the market, conducive to a sustainable energy transition.

Researcher perspectives on ethics considerations in epigenetics: an international survey

Over the past decade, bioethicists, legal scholars and social scientists have started to investigate the potential implications of epigenetic research and technologies on medicine and society. There is growing literature discussing the most promising opportunities, as well as arising ethical, legal and social issues (ELSI). This paper explores the views of epigenetic researchers about some of these discussions. From January to March 2020, we conducted an online survey of 189 epigenetic researchers working in 31 countries. We questioned them about the scope of their field, opportunities in different areas of specialization, and ELSI in the conduct of research and knowledge translation. We also assessed their level of concern regarding four emerging non-medical applications of epigenetic testing—i.e., in life insurance, forensics, immigration and direct-to-consumer testing. Although there was strong agreement on DNA methylation, histone modifications, 3D structure of chromatin and nucleosomes being integral elements of the field, there was considerable disagreement on transcription factors, RNA interference, RNA splicing and prions. The most prevalent ELSI experienced or witnessed by respondents were in obtaining timely access to epigenetic data in existing databases, and in the communication of epigenetic findings by the media. They expressed high levels of concern regarding non-medical applications of epigenetics, echoing cautionary appraisals in the social sciences and humanities literature.

Ethical, legal and social issues raised by human brain banks.

Based on the research methods of literature review and philosophical reflection, this article points out the deficiencies and problems in the current research of brain banks: lack of nature analysis of brain banks and human brains; insufficient discussion of ethical, legal and social issues (ELSI) in the process of brain bank implementation - which has become the main research goal of this article. The article firstly clarifies the formation process of modern brain banks and briefly introduces the current development status of brain banks in the UK, the US and China, as well as the different types of modern brain banks. Next, the nature of brain banks and human brain samples are analyzed through an analogical model. Then, the ELSI issues at different stages are analyzed according to three stages: recruitment of donors, acquisition and storage of human brain tissue samples, and release and use of human brain tissue samples. Last, in the conclusion section, the main ideas of this paper are reiterated and questions for further reflection are presented.

Selecting venues for AMIA events and conferences: guiding ethical principles.

A discussion and debate on the American Medical Informatics Association's (AMIA) Ethical, Legal, and Social Issues (ELSI) Working Group listserv in 2021 raised important issues related to a forthcoming conference in Texas. Texas had recently enacted a restrictive abortion law and restricted voting rights. Several AMIA members advocated for a boycott of the state and the scheduled conference. The discussion led the AMIA Board of Directors to request that the organization's Ethics Committee provide general guidance for principle-based venue selection. This document recommends overarching principles for the venue selection for future AMIA events and conferences. Discussions by the AMIA Board, the Ethics Committee, and the ELSI Working Group informed these recommendations, and this document on guiding principles was approved by the AMIA Board of Directors in April 2022.

Ethical, legal, and social issues in the Earth BioGenome Project

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.

Ethics, Guidelines, Standards, and Policy: Telemedicine, COVID-19, and Broadening the Ethical Scope.

The coronavirus crisis is causing considerable disruption and anguish. However, the COVID-19 pandemic and consequent explosion of telehealth services also provide an unparalleled opportunity to consider ethical, legal, and social issues (ELSI) beyond immediate needs. Ethicists, informaticians, and others can learn from experience, and evaluate information technology practices and evidence on which to base policy and standards, identify significant values and issues, and revise ethical guidelines. This paper builds on professional organizations' guidelines and ELSI scholarship to develop emerging concerns illuminated by current experience. Four ethical themes characterized previous literature: quality of care and the doctor-patient relationship, access, consent, and privacy. More attention is needed to these and to expanding the scope of ethical analysis to include health information technologies. An applied ethics approach to ELSI would addresses context-specific issues and the relationships between people and technologies, and facilitate effective and ethical institutionalization of telehealth and other health information technologies.

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

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