Ethical, Legal, And Social Issues Research Articles

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)

Applications of Digital Twin Technology in the Medical and Health Field and Ethical, Legal and Social Issues (ELSI)

Applications of Digital Twin Technology in the Medical and Health Field and Ethical, Legal and Social Issues (ELSI)

Online Training as a Means to Improve the Understanding of Ethical, Legal, and Social Aspects of Biobanking Research: Stakeholder Perspectives from South Africa.

Introduction: The proliferation of biobanking activities demand a review of current training opportunities for service providers and researchers, specifically related to the ethical, legal, and social issues (ELSI) of biobanking research. Such information could be useful for planning and developing an educational course. However, it is equally important to explore the platform for offering such a course. Aim and Objectives: This study explored stakeholder perspectives on training needs in biobanking research and the use of an online training platform for such educational purposes. Methods: An exploratory study design using qualitative data was used. The study sample comprised selected stakeholders (n = 25) including biobankers, clinicians, researchers, postgraduate students, and research ethics committee members. Semi-structured in-person or Skype interviews were conducted and all ethical considerations were upheld. The interview focused on participants' perspectives on the accessibility and applicability of current available courses, and advantages and disadvantages of online biobanking courses. Data were analyzed using thematic analysis. Results and Discussion: The following themes arose from data analysis: inadequate availability of online courses, and advantages and disadvantages of online courses and opportunities for a successful training course. There was general consensus regarding the limited availability of context-specific training opportunities on the ELSI of biobanking. The majority of participants were previously self-taught and therefore relied on existing literature and collaborations with international biobanking groups for ongoing learning. Some respondents indicated that the costs of such available training courses were exorbitant. Some respondents also felt that available courses were not tailored to the specific needs of a diverse audience in biobanking. Apart from access, respondents reported possible challenges with internet connectivity and availability of data. Conclusion: Respondents expressed a need for affordable and focused online educational opportunities in biobanking, but highlighted that these courses need to be contextualized and integrated into other learning activities.

Genomic medicine implementation protocols in the PhenX Toolkit: tools for standardized data collection

PurposeThe PhenX Toolkit (www.phenxtoolkit.org), an online catalog of recommended measurement protocols, facilitates cross-study analyses for research with human participants. The PhenX Steering Committee recommended genomic medicine implementation as a new research domain, with the following scope: genomic knowledge and education (both patients and providers); implementation science; changes in management and treatment; return of results; patient outcomes; and ethical, legal, and social issues (ELSI) associated with genomic research. MethodsA seven-member expert Working Group convened in October 2019 to identify well-established measurement protocols for a new genomic medicine implementation domain and used the established PhenX consensus process to select measurement protocols for inclusion in the PhenX Toolkit. ResultsThe Working Group recommended 15 measurement protocols for inclusion in the PhenX Toolkit, with priority given to those with empirical evidence supporting validity. Consortia funded by the National Institutes of Health, and particularly the National Human Genome Research Institute, proved critical in identifying protocols with established utility in this research domain, and identified protocols that were developed through a rigorous process for scope elements that lacked formally validated protocols. ConclusionUse of these protocols, which were released in September 2020, can facilitate standard data collection for genomic medicine implementation research.

新型コロナウィルス感染症（COVID-19）をめぐる倫理的・法的・社会的課題（ELSI）の視点

新型コロナウィルス感染症（COVID-19）をめぐる倫理的・法的・社会的課題（ELSI）の視点

A policy Delphi study to validate the key implications of data sharing (KIDS) framework for pediatric genomics in Canada

BackgroundThe highly sensitive nature of genomic and associated clinical data, coupled with the consent-related vulnerabilities of children together accentuate ethical, legal and social issues (ELSI) concerning data sharing. The Key Implications of Data Sharing (KIDS) framework was therefore developed to address a need for institutional guidance on genomic data governance but has yet to be validated among data sharing practitioners in practice settings. This study qualitatively explored areas of consensus and dissensus of the KIDS Framework from the perspectives of Canadian clinician-scientists, genomic researchers, IRB members, and pediatric ethicists.MethodsTwelve panelists participated in a three-round online policy Delphi to determine the desirability, feasibility, relative importance and confidence of twelve individual statements of the KIDS Framework. Mean and IQR were calculated from panelists’ ratings to determine the strength of consensus and polarity. Qualitative content analysis of panelists’ written responses was used to assess degree of support. Statements were validated when their combined ratings and qualitative rationales indicated high-moderate consensus (at least 70% agreement across two contiguous categories), low to no polarity (IQR at least 1.0) and strong support.ResultsNine original, and one new statement reached consensus. These statements outlined essential elements of the informed consent process, including a realistic evaluation of benefits and risks and assurance of future ethics oversight for secondary data use. Discrepant views on appropriate protections for anonymized and coded i.e. de-identified genomic data were primary sources of dissensus.ConclusionsThe validated statements provide institutions with empirically supported best practices for sharing genomic and associated clinical data involving children from the perspectives of key stakeholders. Concerted efforts to quantify informational risks that can be conveyed to patients and families are further needed to align data sharing policy with stakeholder priorities.

Ethical issues in genetics and infectious diseases research: An interdisciplinary expert review

Research in genetics and infectious diseases (ID) presents novel configurations of ethical, legal, and social issues (ELSIs) related to the intersection of genetics with public health regulations and the control of transmissible diseases. Such research includes work both in pathogen genetics and on the ways that human genetics affect responses to ID. This paper identifies and systematizes the unique issues at this intersection, based on an interdisciplinary expert review. This paper presents results of a formal issue-spotting exercise among twenty experts in public health, law and genomics, biobanking, genetic epidemiology, ID medicine and public health, philosophy, ethics and ID, ethics and genomics, and law and ID. The focus of the exercise was on the collection, storage, and sharing of genetic information relating to ID. The issue-spotting exercise highlighted the following ELSIs: risks in reporting to government authorities, return of individual research results, and resource allocation - each taking on specific configurations based on the balance between public health and individual privacy/protection. The public health implications of interactions between genomics and ID frame considerations for equity and justice. In the context of the COVID-19 pandemic, these issues are especially pressing.

Emerging ethical issues raised by highly portable MRI research in remote and resource-limited international settings

Smaller, more affordable, and more portable MRI brain scanners offer exciting opportunities to address unmet research needs and long-standing health inequities in remote and resource-limited international settings. Field-based neuroimaging research in low- and middle-income countries (LMICs) can improve local capacity to conduct both structural and functional neuroscience studies, expand knowledge of brain injury and neuropsychiatric and neurodevelopmental disorders, and ultimately improve the timeliness and quality of clinical diagnosis and treatment around the globe. Facilitating MRI research in remote settings can also diversify reference databases in neuroscience, improve understanding of brain development and degeneration across the lifespan in diverse populations, and help to create reliable measurements of infant and child development. These deeper understandings can lead to new strategies for collaborating with communities to mitigate and hopefully overcome challenges that negatively impact brain development and quality of life. Despite the potential importance of research using highly portable MRI in remote and resource-limited settings, there is little analysis of the attendant ethical, legal, and social issues (ELSI). To begin addressing this gap, this paper presents findings from the first phase of an envisioned multi-staged and iterative approach for creating ethical and legal guidance in a complex global landscape. Section 1 provides a brief introduction to the emerging technology for field-based MRI research. Section 2 presents our methodology for generating plausible use cases for MRI research in remote and resource-limited settings and identifying associated ELSI issues. Section 3 analyzes core ELSI issues in designing and conducting field-based MRI research in remote, resource-limited settings and offers recommendations. We argue that a guiding principle for field-based MRI research in these contexts should be including local communities and research participants throughout the research process in order to create sustained local value. Section 4 presents a recommended path for the next phase of work that could further adapt these use cases, address ethical and legal issues, and co-develop guidance in partnership with local communities.

Recommendations for the development of Egyptian human biobanking ethical guidelines.

Background: The development of biobanks is associated with the emergence of new ethical challenges. In Egypt, several biobanks have been established, but there are no specific local ethical guidelines to guide their work. The aim of this study is to develop recommendations for the Egyptian human biobanking ethical guidelines, which take into consideration the specific cultural and legal framework in Egypt. Methods: We searched the literature for available biobanking ethical guidelines. Six themes were the concern of search, namely; informed consent, data protection, return of results, sharing of samples and data, community engagement, and stakeholder engagement. If a document refers to another guideline, the new source is identified and the previous step is repeated. Results: Ten documents were identified, which were analyzed for the themes mentioned above. Guidelines and best practices were identified, and then compared with the published documents about ethical, legal and social issues (ELSI) related to biomedical research in Egypt to reach best recommendations. Conclusions: We have proposed, by way of recommendations, key characteristics that a national ethics framework in Egypt could have. On informed consent, the practice of broad consent may be harmonized among biobanks in Egypt. Clear policies on return of research results, training requirements and availability of genetic counseling could also be instituted through the national framework. Additionally, such a framework should facilitate community and stakeholders engagement, which is important to secure trust and build consensus on contentious issues arising from sample and data sharing across borders and commercialization, among other concerns.