Research involving minors has been the subject of much ethical debate. The growing number of longitudinal, pediatric studies that involve genetic research present even more complex challenges to ensure appropriate protection of children and families as research participants. Long-term studies with a genetic component involve collection, retention and use of biological samples and personal information over many years. Cohort studies may be established to study specific conditions (e.g. autism, asthma) or may have a broad aim to research a range of (...) factors that influence the health and development of children. Studies are increasingly intended to serve as research platforms by providing access to data and biological samples to researchers over many years. (shrink)

Digital phenotyping represents an avenue of consideration in patients' self-management. This scoping review aims to explore the trends in the body of literature on ethical, legal, and social challenges relevant to the implementation of digital phenotyping technologies in healthcare. The study followed the PRISMA-ScR methodology :467–473, 2018. https://doi.org/10.7326/M18-0850). The review systematically identified relevant literature, characterised the discussed technology, explored its impacts and the proposed solutions to identified challenges. Overall, the literature, perhaps unsurprisingly, concentrates on technical rather than ethical, legal, (...) and social perspectives, which limits understanding of the more complex cultural and social factors in which digital phenotyping technologies are embedded. ELS issues mostly concern privacy, security, consent, lack of regulation, and issues of adoptability, and seldom expand to more complex ethical issues. Trust was chosen as an umbrella theme of a continuum of major ELS and technical issues. Sustained critical analysis of digital phenotyping showed to be sparse and geographically exclusive. There is a continuum and overlap between ELS issues, suggesting the need for a holistic, interdisciplinary approach to each of the challenges posed by the various technologies of digital phenotyping. (shrink)

The success of the Human Genome Project has prompted interest in advancing the nascent field of exposomics. The exposome, which is dynamic and variable and changes over time, consists of all the internal and external exposures an individual has over a lifetime beginning with the prenatal period and early childhood. Efforts are underway to decipher the human epigenome by identifying the effects of all deleterious environmental exposures according to duration of exposure and time period. In this article, we argue that (...) the deciphering of the human exposome should be accompanied by sustained efforts to address the ethical, social and legal implications (ELSI) of exposomics. This will require financial investments from the National Institutes of Health (NIH), the European Union and other public and private funding agencies, analogous to support provided by NIH to address ELSI issues in genomics. (shrink)

Mitochondrial/nuclear transfer (M/NT) to avoid the transmission of serious mitochondrial disease raises complex and challenging ethical, legal and social issues (ELSI). In February 2015, the United Kingdom became the first country in the world to legalize M/NT, making the heated debate surrounding this technology even more relevant. This critical interpretive review identified 95 relevant papers discussing the ELSI of M/NT, including original research articles, government-commissioned reports, editorials, letters to editors and research news. The review presents and synthesizes the (...) arguments present in the literature in relation to the most commonly raised themes: terminology; identity, relationships and parenthood; potential harm; reproductive autonomy; available alternatives; consent; impact on specific interest groups; resources; “slippery slope”; creation, use and destruction of human embryos; and beneficence. The review concludes by identifying those ELSI that are specific to M/NT and by calling for follow-up longitudinal clinical and psychosocial research in order to equip future ELSI debate with empirical evidence. (shrink)

Digital COVID certificates are a novel public health policy to tackle the COVID-19 pandemic. These immunity certificates aim to incentivize vaccination and to deny international travel or access to essential spaces to those who are unable to prove that they are not infectious. In this article, we start by describing immunity certificates and highlighting their differences from vaccination certificates. Then, we focus on the ethical, legal, and social issues involved in their use, namely autonomy and consent, data protection, (...) equity, and international mobility from a global fairness perspective. The main conclusion of our analysis is that digital COVID certificates are only acceptable if they meet certain conditions: that they should not process personal data beyond what is strictly necessary for the aimed goals, that equal access to them should be guaranteed, and that they should not restrict people’s autonomy to access places where contagion is unlikely. We conclude that, if such conditions are guaranteed, digital COVID certificates could contribute to mitigating some of the most severe socioeconomic consequences of the pandemic. (shrink)

This paper argues that research on normative issues in the life sciences will benefit from a tighter integration of philosophy of science. We examine research on ethical, legal and social issues in the life sciences (“ELSI”) and discuss three illustrative examples of normative issues that arise in different areas of the life sciences. These examples show that important normative questions are highly dependent on epistemic issues which so far have not been addressed sufficiently in ELSI, (...) RRI and related areas of research. Accordingly, we argue for the integration of research on the epistemic aspects of the relevant areas of science into ELSI research to provide a better basis for addressing normative questions. (shrink)

This paper reassess the evaluation of ethical, legal and social issues in relation to the agile development of information systems in the domain of crisis management. The authors analyse the differing assessment needs of a move from a traditional approach to the development of information systems to an agile approach, which offers flexibility, adaptability and responds to the needs of users as the system develops. In turn, the authors argue that this development requires greater flexibility and an iterative (...) approach to assessing ELSI. The authors provide an example from the Horizon 2020 EU-funded project iTRACK to exemplify this move to an iterative approach in practice, drawing on the process of undertaking an ethical and privacy impact assessment for the purpose of this project. (shrink)

Ambient assisted living technologies are increasingly presented and sold as essential smart additions to daily life and home environments that will radically transform the healthcare and wellness markets of the future. An ethical approach and a thorough understanding of all ethics in surveillance/monitoring architectures are therefore pressing. AAL poses many ethical challenges raising questions that will affect immediate acceptance and long-term usage. Furthermore, ethical issues emerge from social inequalities and their potential exacerbation by AAL, accentuating the existing access (...) gap between high-income countries and low and middle-income countries. Legal aspects mainly refer to the adherence to existing legal frameworks and cover issues related to product safety, data protection, cybersecurity, intellectual property, and access to data by public, private, and government bodies. Successful privacy-friendly AAL applications are needed, as the pressure to bring Internet of Things devices and ones equipped with artificial intelligence quickly to market cannot overlook the fact that the environments in which AAL will operate are mostly private. The social issues focus on the impact of AAL technologies before and after their adoption. Future AAL technologies need to consider all aspects of equality such as gender, race, age and social disadvantages and avoid increasing loneliness and isolation among, e.g. older and frail people. Finally, the current power asymmetries between the target and general populations should not be underestimated nor should the discrepant needs and motivations of the target group and those developing and deploying AAL systems. Whilst AAL technologies provide promising solutions for the health and social care challenges, they are not exempt from ethical, legal and social issues. A set of ELSI guidelines is needed to integrate these factors at the research and development stage. (shrink)

Abstract:Open neural tube defects or myelomeningoceles are a common congenital condition caused by failure of closure of the neural tube early in gestation, leading to a number of neurologic sequelae including paralysis, hindbrain herniation, hydrocephalus and neurogenic bowel and bladder dysfunction. Traditionally, the condition was treated by closure of the defect postnatally but a recently completed randomized controlled trial of prenatal versus postnatal closure demonstrated improved neurologic outcomes in the prenatal closure group. Fetal surgery, or more precisely maternal-fetal surgery, raises (...) a number of ethical issues that we address including who the patient is, informed consent, surgical innovation and equipoise as well maternal assumption of risk. As the procedure becomes more widely adopted into practice, we suggest close monitoring of new fetal surgery centers, in order to ensure that the positive results of the trial are maintained without increased risk to both the mother and fetus. (shrink)

Purpose: This review identifies the prominent topics in the literature pertaining to the ethical, legal, and social issues raised by research investigating personalized genomic medicine. Methods: The abstracts of 953 articles extracted from scholarly databases and published during a 5-year period were reviewed. A total of 299 articles met our research criteria and were organized thematically to assess the representation of ELSI issues for stakeholders, health specialties, journals, and empirical studies. Results: ELSI analyses were published in both (...) scientific and ethics journals. Investigational research comprised 45% of the literature reviewed and the remaining 55% comprised normative analyses. Traditional ELSI concerns dominated the discourse including discussions about disclosure of research results. In fact, there was a dramatic increase in the number of articles focused on the disclosure of research results and incidental findings to research participants. Few papers focused on particular disorders, the use of racial categories in research, international communities, or special populations. Conclusion: Considering that strategies in personalized medicine increasingly target individuals’ unique health conditions, environments, and ancestries, further analysis is needed on how ELSI scholarship can better serve the increasingly global, interdisciplinary, and diverse PGM research community. (shrink)

Nanotechnology is an important platform technology which will add new features like improved biocompatibility, smaller size, and more sophisticated electronics to neuro-implants improving their therapeutic potential. Especially in view of possible advantages for patients, research and development of nanotechnologically improved neuro implants is a moral obligation. However, the development of brain implants by itself touches many ethical, social and legal issues, which also apply in a specific way to devices enabled or improved by nanotechnology. For researchers developing nanotechnology (...) such issues are rather distant from their daily work in the lab, but as soon as they use their materials or devices in medical applications such as therapy of brain diseases they have to be aware of and deal with them. This paper is intended to raise sensitivity for the ethical, legal and social aspects (ELSA) involved in applying nanotechnology in brain implants or other devices by highlighting the short term problems of testing and clinical trials within the existing regulatory frameworks (A), the short and medium-term questions of risks in the application of the devices (B) and the long-term perspectives related to problems of enhancement (C). To identify and address such issues properly nanotechnologists should involve ethical, legal and social experts and regulatory bodies in their research as early as possible. This will help to remove pressure from regulatory bodies, to settle public concern and to prevent non-acceptable developments for the benefit of the patients. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Ethical, Legal, and Social Implications Research Program at the National Human Genome Research InstituteEric M. Meslin (bio), Elizabeth J. Thomson (bio), and Joy T. Boyer (bio)Organizers of the Human Genome Project (HGP) understood from the beginning that the scientific activities of mapping and sequencing the human genome would raise ethical, legal, and social issues that would require careful attention by scientists, health care professionals, government (...) officials, and the public. The establishment of the ELSI (ethical, legal, and social implications) programs at the National Human Genome Research Institute (NHGRI) and the Department of Energy (DOE) was thought to be vital to the success of the HGP in the United States. It also provided a novel approach to the simultaneous study of ethical, legal, and social issues and basic scientific issues. Eric Juengst, the first director of the ELSI program, described its origins in a previous issue of the Kennedy Institute of Ethics Journal (Juengst 1991). Now in its seventh year, the ELSI program has accomplished much. This article summarizes the evolution and goals of the ELSI program at NHGRI, outlines the program’s current research priorities with examples of activities within each priority area, and provides a look to the future, including the initiation of a strategic planning process.Evolution and Goals of the ELSI Research ProgramThe HGP’s “genomic” goals are unique: to map and sequence the entire human genome—some 3 billion base pairs that make up approximately 80–100,000 genes—and the genomes of related model organisms by the year 2005. This goal was particularly ambitious since, when it was proposed, the technologies for mapping and sequencing had yet to be developed. When the HGP was first established, its organizers also elaborated a set of ELSI goals, which they saw as vital to the success of the genome project. The original ELSI goals were: (1) to anticipate and address the implications of the HGP for individuals and society and (2) to examine the ELSI consequences of mapping and sequencing the human genome in order to stimulate public discussion. To meet these goals, the NHGRI created its ELSI research program in 1990. Along with mapping, sequencing, [End Page 291] and mammalian genetics, ELSI was one of four original branches in the NHGRI Division of Extramural Research that funded research in those areas. Although the individual “branches” no longer exist, the mechanisms for funding research remain much the same. While the overall goals of the program have not changed, the specific ways of achieving the goals have continued to evolve. The importance of the ELSI program lies not in the collection of a full set of data that will be valuable in and of itself, but in the value of using and interpreting this new set of information.Early on, the NHGRI described a set of somewhat more specific goals: (1) to develop a program to help understand the ethical, legal, and social implications of the human genome project and (2) to identify and define the major issues of concern and develop policy options to address them. These more specific goals have been largely met. As the most recent biennial NHGRI Progress Report notes, “a robust ELSI research and education program has been established, many of the most urgent ELSI issues have been identified, and many policy options to address these issues have been proposed” (NCHGR 1995, p. 21). Between 1990 and 1996, ELSI provided more than $32.5 million in funding through 128 research and education grants in more than 30 states and in Canada (Table 1). The ELSI research budget is unique in that when originally created, it was specifically tied to the amount of money provided for the overall NHGRI budget. The NHGRI originally devoted 3 percent of its extramural budget to fund ELSI projects, but in FY 1991, it increased the ELSI budget to 5 percent, a figure that remains today. Table 2 lists the expenditures for each fiscal year since 1990 and the cumulative expenditures to date. The ELSI research budget at NHGRI this year will be about $7 million. When other sources of funding—e.g., co-funding arrangements with other institutes and agencies and the funding of ELSI... (shrink)

During the past four years, the International Institute for Indigenous Resource Management has sponsored and co-sponsored a series of discursive roundtables on the ethical, legal, social, and cultural implications of genetic research on Indian tribes and Indian people. The deliberations of the tribal leaders, legal scholars, researchers, representatives of non-governmental organizations, and others who participated in these roundtables laid out a range of barriers to informed tribal participation in genetic research and proposed a policy, legal, and scientific research agenda (...) to fill gaps in knowledge and to otherwise support indigenous peoples' decision-making on genetic research issues.An understanding of Native American attitudes toward genetic research on their community cannot be fully understood absent an appreciation of the interrelationship among native peoples, genetic research, and the landscape, contaminated as it is by governmental and other factors. The deliberations described herein present invaluable insights into tribal attitudes toward genetic research that have application to ethical, legal and social aspects of forensic DNA databanks, sample collection and retention, and, in particular, issues of secondary non-forensic uses of such DNA. (shrink)

To understand the impacts of development on native peoples requires an understanding of how their genetic make-up is implicated in their relationship with their landscapes. This is an area ripe for more research. The ASLME project on DNA Fingerprinting and Civil Liberties proposed improvements to the ethical and legal safeguards for the collection and storage of DNA-derived genetic information. Native peoples have proposed a similar examination of the ethical and legal issues related to the collection and storage of their (...) genetic information obtained via family histories and genealogies. (shrink)

Biobanks’ activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first–hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four‐step checklist aiming (...) to facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU. (shrink)

The human microbiome is the bacteria, viruses, and fungi that cover our skin, line our intestines, and flourish in our body cavities. Work on the human microbiome is new, but it is quickly becoming a leading area of biomedical research. What scientists are learning about humans and our microbiomes could change medical practice by introducing new treatment modalities. This new knowledge redefines us as superorganisms comprised of the human body and the collection of microbes that inhabit it and reveals how (...) much we are a part of our environment. The understanding that microbes are not only beneficial but sometimes necessary for survival recasts our interaction with microbes from adversarial to neighborly. This volume explores some of the science that makes human microbiome research possible. It then considers ethical, legal, and social concerns raised by microbiome research. Chapters explore issues related to personal identity, property rights, and privacy. The authors reflect on how human microbiome research challenges reigning views on public health and research ethics. They also address the need for thoughtful policies and procedures to guide the use of the biobanked human samples required for advancing this new domain of research. In the course of these explorations, they introduce examples from the history of biomedical science and recent legal cases that shed light on the issues and inform the policy recommendations they offer at the end of each topic's discussion.This volume is the product of an NIH Human Microbiome Project grant. It represents three years of conversations focused on consensus formation by the twenty-seven members of the interdisciplinary Microbiome Working Group. (shrink)

The intersection of ELSI and science forms a complicated nexus yet their integration is an important goal both for society and for the successful advancement of science. In what follows, I present a heuristic that makes boundary identification and crossing an important tool in the discovery of potential areas of ethical, legal, and social concern in science. A dynamic and iterative application of the heuristic can lead towards a fuller integration and appreciation of the concerns of ELSI and of (...) science from both sides of the divide. (shrink)

The result of two key social developments in recent years are examined here: the partial dismantling of the welfare state and the progress of genetics. Genetic insights are increasingly valuable for risk assessment, and insurers would like to use these insights to help determine premiums. Combined with the fact that social welfare is being curtailed, this could potentially create an uninsured high-risk population. Along with considerations of autonomy and privacy, this is the basis for an ethical critique of (...) insurer's access to information. The result has often been regulation of such information; but the authors argues that due to adverse selection, regulation will not solve these problems, and this may jeopardize the survival of private personal insurance. Instead, we should look towards the resurrection of social insurance, a key component of the welfare state. This will interest academic researchers as well as professionals involved with genetics and insurance. (shrink)

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 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. (shrink)

Pre-implantation genetic diagnosis became well known in Malaysia after the birth of the first Malaysian ‘designer baby’, Yau Tak in 2004. Two years later, the Malaysian Medical Council implemented the first and only regulation on the use of Pre-implantation Genetic Diagnosis in this country. The birth of Yau Tak triggered a public outcry because PGD was used for non-medical sex selection thus, raising concerns about PGD and its implications for the society. This study aims to explore participants’ perceptions of the (...) future implications of PGD for the Malaysian society. We conducted in-depth interviews with 21 participants over a period of one year, using a semi-structured questionnaire. Findings reveal that responses varied substantially among the participants; there was a broad acceptance as well as rejection of PGD. Contentious ethical, legal and social issues of PGD were raised during the discussions, including intolerance to and discrimination against people with genetic disabilities; societal pressure and the ‘slippery slope’ of PGD were raised during the discussions. This study also highlights participants’ legal standpoint, and major issues regarding PGD in relation to the accuracy of diagnosis. At the social policy level, considerations are given to access as well as the impact of this technology on families, women and physicians. Given these different perceptions of the use of PGD, and its implications and conflicts, policies and regulations of the use of PGD have to be dealt with on a case-by-case basis while taking into consideration of the risk–benefit balance, since its application will impact the lives of so many people in the society. (shrink)

Wearable robots and exoskeletons are relatively new technologies designed for assisting and augmenting human motor functions. Due to their different possible design applications and their intimate connection to the human body, they come with specific ethical, legal, and social issues, which have not been much explored in the recent ELS literature. This paper draws on expert consultations and a literature review to provide a taxonomy of the most important ethical, legal, and social issues of wearable robots. (...) These issues are categorized in wearable robots and the self, wearable robots and the other, and wearable robots in society. (shrink)

Pre-implantation genetic diagnosis became well known in Malaysia after the birth of the first Malaysian ‘designer baby’, Yau Tak in 2004. Two years later, the Malaysian Medical Council implemented the first and only regulation on the use of Pre-implantation Genetic Diagnosis in this country. The birth of Yau Tak triggered a public outcry because PGD was used for non-medical sex selection thus, raising concerns about PGD and its implications for the society. This study aims to explore participants’ perceptions of the (...) future implications of PGD for the Malaysian society. We conducted in-depth interviews with 21 participants over a period of one year, using a semi-structured questionnaire. Findings reveal that responses varied substantially among the participants; there was a broad acceptance as well as rejection of PGD. Contentious ethical, legal and social issues of PGD were raised during the discussions, including intolerance to and discrimination against people with genetic disabilities; societal pressure and the ‘slippery slope’ of PGD were raised during the discussions. This study also highlights participants’ legal standpoint, and major issues regarding PGD in relation to the accuracy of diagnosis. At the social policy level, considerations are given to access as well as the impact of this technology on families, women and physicians. Given these different perceptions of the use of PGD, and its implications and conflicts, policies and regulations of the use of PGD have to be dealt with on a case-by-case basis while taking into consideration of the risk–benefit balance, since its application will impact the lives of so many people in the society. (shrink)

Simonet, Emanuel Nicolas Cortes; Herbert, Dilinie The Caroline Chisholm Centre for Health Ethics1 was established through the collaboration of private catholic hospitals in Victoria, namely: Cabrini Health, Calvary Health Care Bethlehem, Caritas Christi Hospice, Mercy Hospital for Women, Mercy Werribee Hospital, Mercy Palliative Care, St John of God Health Care, St Vincent's Hospital Melbourne, and St Vincent's Private Hospital Melbourne. Our role is to develop, review and respond to policies and procedures affecting Catholic Health Care; provide educational resources and formation (...) in ethics and offer ethics consultation and advisement. The Chisholm Health Ethics Bulletin is our quarterly publication that reports on ethical issues arising in health care as well as literature reviews of pertinent research topics that effect national and international interests. (shrink)

The effective collection and management of personal data of rapidly migrating populations is important for ensuring adequate healthcare and monitoring of a displaced peoples’ health status. With developments in ICT data sharing capabilities, electronic personal health records (ePHRs) are increasingly replacing less transportable paper records. ePHRs offer further advantages of improving accuracy and completeness of information and seem tailored for rapidly displaced and mobile populations. Various emerging initiatives in Europe are seeking to develop migrant‐centric ePHR responses. This paper highlights their (...) importance and benefits, but also identifies a number of significant ethical, legal and social issues (ELSI) and challenges to their design and implementation, regarding (1) the kind of information that should be stored, (2) who should have access to information, and (3) potential misuse of information. These challenges need to be urgently addressed to make possible the beneficial use of ePHRs for vulnerable migrants in Europe. (shrink)

As the recent inaugural Ethical, Legal, and Social Issues 2.0 conference made clear, the effects of information communication technology are pervasive in biomedical research. Data initiatives are arising in all corners of biomedicine. Data sharing efforts already promised to surpass even the ambitious goals of the National Human Genome Research Institute, only 5 years after publication of its 10-year vision. ELSI research was established, in part, to address challenges of open data access and data sharing. However, by and (...) large, ELSI research projects address particular concerns of a given population, jurisdiction, type of research practice or type of data. This does not necessarily facilitate coherent data policy for sustainable data stewardship. Forward-looking, data friendly strategies need to be considered. Orchestration strategies are needed which overcome barriers to collective action. Here we present challenges policymakers face, and suggest three basics steps towards meeting them. First, policymakers must recognise the systematic change that occurs when ICT enables dataflow itself to become an organising principle of biomedical research. Second, methods for identifying and gathering types of metadata suitable for ELSI research ought to be developed and regulated. Third, policymakers need to organise in ways that mirror the new vision for data-enabled research that data technologies are making possible, as ELSI 2.0 encourages researchers to do. Taking these steps will help ensure research evolves in ways that warrants trust of the public while still supporting widespread ethical access to necessary data, research subjects, samples and findings. (shrink)

The rapid advances made in genetic research and technology over the last few decades have led to a host of important discoveries that have allowed for the detection (and hopefully soon the treatment) of a number of genetic conditions and diseases. Not surprisingly, these advances have also raised numerous ethical concerns about how result­ ing technologies will be implemented, and the impact they will have on different com­ munities. One particular concern is the enormous costs involved in conducting genetic research (...) and the fact that the private sector has become heavily involved; the desire to commercialize the results and technology derived from genetic research is considered problematic. In September 1998, the Second International Conference on DNA Sampling, titled "The Commercialization of Genetic Research: Ethical, Legal and Policy Issues," was held of the conference, and of this book, was to in Edmonton, Alberta, Canada. The goal facilitate an interdisciplinary discussion of the legal, ethical, and policy implications arising from the commercialization of genetic research. We solicited contributions for the book from authors in fields as diverse as ethics, law, medicine, health policy, and the social sciences. The papers included, while based on presentations given at the conference, have been substantially expanded and enhanced by the commentary received and discussions held at the conference. (shrink)

Nanotechnology: Considering the Complex Ethical, Legal, and Societal Issues with the Parameters of Human Performance Content Type Journal Article Pages 265-275 DOI 10.1007/s11569-008-0047-6 Authors Linda MacDonald Glenn, Albany Medical College/Center Alden March Bioethics Institute Albany NY 12208 USA Jeanann S. Boyce, Montgomery College Dept. of Computer Science and Business 7600 Takoma Avenue Takoma Park MD 20912 USA Journal NanoEthics Online ISSN 1871-4765 Print ISSN 1871-4757 Journal Volume Volume 2 Journal Issue Volume 2, Number 3.

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause the research involves (...) the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

There have been serious controversies in the latter part of the 20th century about the roles and functions of scientific and medical research. In whose interests are medical and biomedical experiments conducted and what are the ethical implications of experimentation on subjects unable to give competent consent? From the decades following the Second World War and calls for the global banning of medical research to the cautious return to the notion that in controlled circumstances, medical research on human subjects is (...) in the best interest of the given individual and the broader population, this book addresses the key implications of experimentation on humans. This volume covers major ethical themes within biomedical research providing historical, philosophical, legal and policy reflections on the literature and specific issues in the field of research on human subjects. Focusing on special populations (the elderly, children, prisoners and the cognitively impaired) it represents the most up-to-date review of the special ethical and legal conflicts that arise with relation to experimentation on subjects from these groups. In the light of current initiatives for law reform pertaining to research ethics the world over, this volume provides a timely, comprehensive and provocative exploration of the field. The volume has been carefully organized to present important philosophical perspectives on organizing principles that should underlie any practical application. A forward-looking historical review of the regulatory regimes of principal jurisdictions, including of the legal controls already in place, provides the backdrop for future policy initiatives. Additionally, in the light of global restructuring of health care systems, several chapters have been devoted to epidemiological research and related issues. (shrink)

Self-driving vehicles offer great potential to improve efficiency on roads, reduce traffic accidents, increase productivity, and minimise our environmental impact in the process. However, they have also seen resistance from different groups claiming that they are unsafe, pose a risk of being hacked, will threaten jobs, and increase environmental pollution from increased driving as a result of their convenience. In order to reap the benefits of SDVs, while avoiding some of the many pitfalls, it is important to effectively determine what (...) challenges we will face in the future and what steps need to be taken now to avoid them. The approach taken in this paper is the construction of a likely future, through the process of a policy scenario methodology, if we continue certain trajectories over the coming years. The purpose of this is to articulate issues we currently face and the construction of a foresight analysis of how these may develop in the next 6 years. It will highlight many of the key facilitators and inhibitors behind this change and the societal impacts caused as a result. This paper will synthesise the wide range of ethical, legal, social and economic impacts that may result from SDV use and implementation by 2025, such as issues of autonomy, privacy, liability, security, data protection, and safety. It will conclude with providing steps that we need to take to avoid these pitfalls, while ensuring we reap the benefits that SDVs bring. (shrink)

In _Bioethics in Context_, Gary Jones and Joseph DeMarco connect ethical theory, medicine, and the law, guiding readers toward a practical and legally grounded understanding of key issues in health-care ethics. This book is uniquely up-to-date in its discussion of health-care law and unpacks the complex web of American policies, including the Patient Protection and Affordable Care Act. Useful case studies and examples are embedded throughout, and a companion website offers a thorough, curated database of relevant legal precedents as (...) well as additional case studies and other resources. (shrink)

Critical Issues in Business Conduct addresses the legal, ethical, and social issues that will dominate business in the 1990s. From the impact of AIDS and problems of drug and alcohol in the workplace to financial accounting, employee rights, and sexual harassment, the book explores topical issues arising from the relationship between business organizations and their external constituencies as well as those that characterize relationships between firms and their own managers, employees, directors, and shareholders. The aim throughout (...) is to provide practical guidelines for dealing with the most critical business conduct issues facing managers and executives today. (shrink)

Recent national calls for ethical, legal, and social implications (ELSI) research to “assess and address how ethical, historical, social, economic, legal, regulatory, socio-cultural, and contextual...

Symptom Checker Applications (SCA) are mobile applications often designed for the end-user to assist with symptom assessment and self-triage. SCA are meant to provide the user with easily accessible information about their own health conditions. However, SCA raise questions regarding ethical, legal, and social aspects (ELSA), for example, regarding fair access to this new technology. The aim of this scoping review is to identify the ELSA of SCA in the scientific literature. A scoping review was conducted to identify the (...) ELSA of SCA. Ten databases (e.g., Web of Science and PubMed) were used. Studies on SCA that address ELSA, written in English or German, were included in the review. The ELSA of SCA were extracted and synthesized using qualitative content analysis. A total of 25,061 references were identified, of which 39 were included in the analysis. The identified aspects were allotted to three main categories: (1) Technology; (2) Individual Level; and (3) Healthcare system. The results show that there are controversial debates in the literature on the ethical and social challenges of SCA usage. Furthermore, the debates are characterised by a lack of a specific legal perspective and empirical data. The review provides an overview on the spectrum of ELSA regarding SCA. It offers guidance to stakeholders in the healthcare system, for example, patients, healthcare professionals, and insurance providers and could be used in future empirical research to investigate the perspectives of those affected, such as users. (shrink)

This study aims to identify artificial intelligence (AI) technologies that are applied in climate-smart agricultural practices and address ethical concerns of deploying those technologies from legal perspectives. As climate-smart agricultural AI, the study considers those AI-based technologies that are used for precision agriculture, monitoring peat lands, deforestation tracking, and improved forest management. The study utilized a systematic literature review approach to identify and analyze AI technologies employed in climate-smart agriculture and associated ethical and legal concerns. The study findings indicate several (...) ethical concerns for deploying AI in climate-smart agricultural practices pertaining to data inaccuracy, other technical errors based on wrong recommendations or wrongful acts, data ownership and intellectual property issues, and economic issues resulting in digital division and privacy and security related issues. In this study, the ethical concerns were further examined based on criminal law, tort law, privacy and data protection law, and intellectual property law. In this regard, the study finds that the current tort law pattern is more suitable than the criminal law pattern to address some major ethical concerns, such as data inaccuracy and other technical errors based on wrong recommendations or wrongful acts. Finally, the study recommends that at the global level, all countries need to fill up the current gap of international law on climate-smart agriculture through agreeing on a standard set of legal provisions and enhancing collaboration in innovation and deployment of climate-smart agricultural AI. It further recommends that at the local level, countries need to adopt suitable regulations addressing multi-stakeholders’ interests associated with the deployment of climate-smart agricultural AIs. (shrink)

The legal requirements and justifications for collecting patient-identifiable data without patient consent were examined. The impetus for this arose from legal and ethical issues raised during the development of a population-based disease register. Numerous commentaries and case studies have been discussing the impact of the Data Protection Act 1998 and Caldicott principles of good practice on the uses of personal data. But uncertainty still remains about the legal requirements for processing patient-identifiable data without patient consent for research purposes. This (...) is largely owing to ignorance, or misunderstandings of the implications of the common law duty of confidentiality and section 60 of the Health and Social Care Act 2001. The common law duty of confidentiality states that patient-identifiable data should not be provided to third parties, regardless of compliance with the DPA1998. It is an obligation derived from case law, and is open to interpretation. Compliance with section 60 ensures that collection of patient-identifiable data without patient consent is lawful despite the duty of confidentiality. Fears regarding the duty of confidentiality have resulted in a common misconception that section 60 must be complied with. Although this is not the case, section 60 support does provide the most secure basis in law for collecting such data. Using our own experience in developing a disease register as a backdrop, this article will clarify the procedures, risks and potential costs of applying for section 60 support. (shrink)

Human microbiome research has revealed that legions of bacteria, viruses, and fungi live on our skin and within the cavities of our bodies. New knowledge from these recent studies shows that humans are superorganisms and that the microbiome is indispensible to our lives and our health. This volume explores some of the science on the human microbiome and considers the ethical, legal, and social concerns that are raised by this research.

Conventional forensic DNA analysis involves a matching principle, which compares DNA profiles from evidential samples to those from reference samples of known origin. In casework, however, the accessibility to a reference sample is not guaranteed which limits the use of DNA as an investigative tool. This has led to the development of phenotype prediction, which uses SNP analysis to estimate the physical appearance of the sample donor. Physical traits, such as eye, hair and skin colour, have been associated with certain (...) alleles within specific genes involved in the melanogenesis pathways. These genetic markers are also associated with ancestry and their trait prediction ability has mainly been assessed in European and North American populations. This has prompted research investigating the discriminatory power of these markers in other populations, especially those exhibiting admixture. South Africa is well known for its diversity, and the viability of these particular SNPs still needs to be assessed within this population. South African law currently restricts the use of DNA for molecular phenotyping, and there are also numerous ethical and social considerations, all of which are discussed. (shrink)