The interplay of ethics and genetic technologies in balancing the social valuation of the human genome in UNESCO declarations.

This study investigates changes in the social valuation of the human genome over the more than 30 years since the establishment of the Human Genome Project. It offers a descriptive sociological analysis of the three waves of this valuation, mainly by considering three key UNESCO declarations and a relevant report. These waves represent a shifting balance between collectivism and individualism, starting with a broadly constructed valuation of the human genome as common human heritage and moving toward a valuation of dynamic applications within various social and medical contexts (e.g., personalized genomic medicine and genome editing). We seek to broaden the analytical perspective by examining how the declarations' ethical foci are framed within the context of rapidly evolving genetic technologies and their social applications. We conclude by discussing continuity and change in value balancing vis-à-vis changing genomic technologies.

Race and Genetics: Somber History, Troubled Present.

Following the completion of the Human Genome Project (HGP) in 2003, advances in DNA sequencing technologies further popularized the field of genomics and brought its social ramifications to the fore. Scholars across disciplines recently voiced serious concerns about the re-emergence of genomic research that might be used to justify racism. In this piece, I trace the history of attempts to biologize the concept of race and its diffused presence in today's genomic research. I then include a brief analysis inspired by concepts from the field of Science and Technology Studies (STS) to suggest selected ways to produce better scientific knowledge. The text highlights historic landmarks of interest to science practitioners curious about the ways science of the past co-shapes science of the present. I then argue that science has never been isolated from the socio-political climate it is produced in; instead, it has been morphed by its surroundings and historically used as a potent tool to justify systemic oppression.

El impacto del Proyecto Genoma Humano y la discriminación genética: aspectos éticos, sociales y jurídicos / The impact of the Human Genome Project and genetic discrimination: Ethical, social and legal aspects / L'impacte del Projecte Genoma Humà i la discriminació genètica: aspectes ètics, socials i jurídics

El Proyecto Genoma Humano ha significado un paso trascendental en la historia de la ciencia, especialmente en el ejercicio de la medicina y en el tratamiento del paciente. Sin embargo, este hito histórico también ha repercutido con intensidad en otras áreas de la sociedad, las cuales a la fecha han comenzado a mostrar los impactos en sus diversas esferas. Este trabajo intenta analizar el estado actual de esta nueva realidad bajo el prisma de cada uno de estos agentes mencionados, con especial énfasis en el nuevo concepto de "discriminación genética" que afecta a todo individuo en razón de la información codificada en su ADN

The Human Genome Project has meant a transcendental step in the history of science, especially in the practice of medicine and in patient's treatment. However, this historical milestone has also had an impact on other areas of society, which have begun to show the effects in their various spheres. This paper analyzes the current state of this new reality under the prism of each of these mentioned agents, with special emphasis on the new concept of "genetic discrimination" that affects every individual because of the information encoded in their DNA

El Projecte Genoma Humà ha significat un pas transcendental en la història de la ciència, especialment en l'exercici de la medicina I en el tractament del pacient. No obstant això, aquesta fita històrica també ha repercutit amb intensitat en altres àrees de la societat, les quals a la data han començat a mostrar els impactes en les seves diverses esferes. Aquest treball analitza l'estat actual d'aquesta nova realitat sota el prisma de cadascun d'aquests agents esmentats, amb especial èmfasi en el nou concepte de "discriminació genética" que afecta a tot individu en raó de la informació codificada en el seu ADN

¿Modificar o no modificar el genoma de nuestra descendencia? Algunos comentarios a raiz de la Declaración del Comité de Bioética de España sobre la edición genómica en humanos / To modify or not to modify the genome of our offspring? Some comments following the Declaration of the Spanish Bioethics Committee on genomic editing in humans / Modificar o no modificar el genoma de la nostra descendència?. Alguns comentaris arran de la Declaració del Comitè de Bioètica d'Espanya sobre l'edició genòmica en humans

La modificación genética de la línea germinal humana presenta grandes problemas de carácter ético y jurídico. El Comité de Bioética de España ha publicado una Declaración ofreciendo una respuesta a estos retos. Este artículo analiza críticamente su postura, subrayando la escasa consistencia de cualquier argumento que pretenda censurar cualquier forma de mejora en la salud humana. Con tal fin, se exponen cuestiones como la relación entre dignidad humana y modificación genética o la inconsistencia de la apelación al argumento de la pendiente resbaladiza en este contexto. Asimismo, se afirma la necesidad de trazar distinciones entre las intervenciones que afectan a bienes absolutos, como la salud, y los que no lo son

Genetic modification of the human germline presents major ethical and legal problems. The Spanish Bioethics Committee has published a Declaration offering a response to these challenges. This article critically analyzes its position, underlining the scarce consistency of any argument that attempts to censor any form of improvement in human health. To this end, questions such as the relationship between human dignity and genetic modification or the inconsistency of the appeal to the argument of the slippery slope in this context are raised. At the same time, this paper highlights the need to draw distinctions between interventions that affect absolute goods, such as health, and those that are not

La modificació genètica de la línia germinal humana presenta enormes problemes de caràcter ètic i jurídic. El Comitè de Bioètica d'Espanya ha publicat una Declaració oferint una resposta a aquests reptes. Aquest article analitza críticament la seva postura, subratllant l'escassa consistència de qualsevol argument que pretengui censurar qualsevol forma de millora en la salut humana. Amb tal fi, s'exposen qüestions com la relació entre dignitat humana i modificació genètica o la inconsistència de l'apel·lació a l'argument del pendent relliscós en aquest context. Així mateix, s'afirma la necessitat de traçar distincions entre les intervencions que afecten béns absoluts, com la salut, i els que no ho són

A matter of life and longer life.

While the major scientific discoveries that would extend the length and health of human lives are not yet here, the research that could create them is already underway. As prospects for a world in which extended and improved lives inches closer into reality, the discourse about what to consider as we move forward grows richer, with corporate executives, ideologues, scientists, theologians, ethicists, investigative journalists, and philosophers taking part in imagining and anticipating the rich array of humanity's possible futures. Drawing from in-depth interviews with key stakeholders (n = 22), we offer empirical insights into key values and beliefs animating the "longevity movement," including what constitutes an ideal human state, the imperative to intervene, and the role of individual liberty and concerns for equality. Emerging from these interviews are common concerns about reducing suffering, preserving diversity in visions of successful aging and how best to promote access to a future that may not remain hypothetical for long.

LeRoy Walters's Legacy of Bioethics in Genetics and Biotechnology Policy.

LeRoy Walters was at the center of public debate about emerging biological technologies, even as "biotechnology" began to take root. He chaired advisory panels on human gene therapy, the human genome project, and patenting DNA for the congressional Office of Technology Assessment. He chaired the subcommittee on Human Gene Therapy for NIH's Recombinant DNA Advisory Committee. He was also a regular advisor to Congress, the executive branch, and academics concerned about policy governing emerging biotechnologies. In large part due to Prof. Walters, the Kennedy Institute of Ethics was one of the primary sources of talent in bioethics, including staff who populated policy and science agencies dealing with reproductive and genetic technologies, such as NIH and OTA. His legacy lies not only in his writings, but in those people, documents, and discussions that guided biotechnology policy in the United States for three decades.

[The Japanese legal system and the applicability of laws and regulations on private information protection and research ethics relating to medical research].

Objectives　To clarify the structure, applicability, and objectives of the current Japanese legislation for private information protection and research ethics and to examine the clauses of the related laws/regulations for academic research purposes.Methods　The research design is a descriptive study based on a systematic literature review. Using the "e-Gov" database, the laws/regulations relating to private information protection and research ethics that apply to medical research involving human subjects and human genome/gene analysis research were included in the research. The Drugs Law (Law No. 145 of 1960) and related GCP/GPSP regulations and laws/regulations on administrative organizations, management, and procedures were excluded. Furthermore, the guidelines and Q&A relating to these laws/regulations and all 47 prefectural regulations on private information protection have been selected from the websites of the related ministries, government organizations, and prefectures.Results　Our study demonstrated that the current legal system on private information protection consists of three layers and that the applicability of the laws/regulations in this area varies according to the type of research organization. Additionally, the applicability of the laws/regulations on research ethics is different depending on the research area. While the Private Information Protection Law (PIPL) for the private sector contains two objectives, PIPL for administrative organizations and PIPL for independent administrative organizations both include three objectives. For academic research purposes, PIPL for the private sector sets out a holistic exemption clause, whereas the other two PIPLs stipulate three specific exemption clauses. Furthermore, our research revealed that the clauses of the prefectural regulations demonstrated many variances.Conclusion　This study suggests that the current Japanese legal system relating to private information protection could be defined as a "mixed model," wherein the laws/regulations concerned are not necessarily consistent. The protection of medical information is solely regulated by a few specific laws with a narrow scope of application; the ethical guidelines are not directly based on any laws; and identifying applicable laws/regulations, depending on the category of research organization, is complicated, especially in the case of collaborative research involving researchers from various organizations. Therefore, in the larger framework of legislation, it is indispensable to reconsider the protection of private medical information and its effective use, including the ethics of this process because of the sensitive and useful nature of private medical information.

GINA at Ten and the Future of Genetic Nondiscrimination Law.

May 21, 2018, marks the tenth anniversary of the signing into law of the Genetic Information Nondiscrimination Act. The Congressional deliberations for GINA were long and difficult. The original bill was introduced in 1995, and for many years, it did not look as if the bill would ever emerge from committee. Several of its provisions raised concerns for insurers, employers, and other stakeholders. After thirteen years, the controversial provisions were either deleted, revised, or clarified. At this ten-year mark, it is appropriate to take stock of GINA. In light of GINA's glacial legislative history, it is reasonable to start thinking about the necessity, wisdom, and feasibility of amending GINA or enacting new legislation to address unresolved or emerging issues of genetic discrimination and trends in genetics, genomics, precision medicine, and related technologies.

Skepticism in the Genomic Era.

I joined The Hastings Center this past summer, after graduating from Duke University, where I researched advancements in neuroscience and genomics and their import for law, ethics, and policy. This research required, to an extent, faith in the idea that researchers can identify pathways by which genes combine with epigenetic and environmental factors to affect neuronal activity and influence behaviors. Throughout my first months here, I have puzzled over broad critiques of "genomic hype" in recent literature, which clash with the optimistic rhetoric found in the Human Genome Project and the Precision Medicine Initiative.

Are Data Sharing and Privacy Protection Mutually Exclusive?

We review emerging strategies to protect the privacy of research participants in international epigenome research: open consent, genome donation, registered access, automated procedures, and privacy-enhancing technologies.

Ethical, Legal, and Social Implications of Personalized Genomic Medicine Research: Current Literature and Suggestions for the Future.

PURPOSE: This review identifies the prominent topics in the literature pertaining to the ethical, legal, and social issues (ELSI) raised by research investigating personalized genomic medicine (PGM). METHODS: The abstracts of 953 articles extracted from scholarly databases and published during a 5-year period (2008-2012) 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 (135 articles) and the remaining 55% (164 articles) 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 (e.g., adolescents, elderly patients, or ethnic groups). 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.

Integrating Public Health and Deliberative Public Bioethics: Lessons from the Human Genome Project Ethical, Legal, and Social Implications Program.

Public health policy works best when grounded in firm public health standards of evidence and widely shared social values. In this article, we argue for incorporating a specific method of ethical deliberation--deliberative public bioethics--into public health. We describe how deliberative public bioethics is a method of engagement that can be helpful in public health. Although medical, research, and public health ethics can be considered some of what bioethics addresses, deliberative public bioethics offers both a how and where. Using the Human Genome Project Ethical, Legal, and Social Implications program as an example of effective incorporation of deliberative processes to integrate ethics into public health policy, we examine how deliberative public bioethics can integrate both public health and bioethics perspectives into three areas of public health practice: research, education, and health policy. We then offer recommendations for future collaborations that integrate deliberative methods into public health policy and practice.

Balancing Benefits and Risks of Immortal Data: Participants' Views of Open Consent in the Personal Genome Project.

An individual's health, genetic, or environmental-exposure data, placed in an online repository, creates a valuable shared resource that can accelerate biomedical research and even open opportunities for crowd-sourcing discoveries by members of the public. But these data become "immortalized" in ways that may create lasting risk as well as benefit. Once shared on the Internet, the data are difficult or impossible to redact, and identities may be revealed by a process called data linkage, in which online data sets are matched to each other. Reidentification (re-ID), the process of associating an individual's name with data that were considered deidentified, poses risks such as insurance or employment discrimination, social stigma, and breach of the promises often made in informed-consent documents. At the same time, re-ID poses risks to researchers and indeed to the future of science, should re-ID end up undermining the trust and participation of potential research participants. The ethical challenges of online data sharing are heightened as so-called big data becomes an increasingly important research tool and driver of new research structures. Big data is shifting research to include large numbers of researchers and institutions as well as large numbers of participants providing diverse types of data, so the participants' consent relationship is no longer with a person or even a research institution. In addition, consent is further transformed because big data analysis often begins with descriptive inquiry and generation of a hypothesis, and the research questions cannot be clearly defined at the outset and may be unforeseeable over the long term. In this article, we consider how expanded data sharing poses new challenges, illustrated by genomics and the transition to new models of consent. We draw on the experiences of participants in an open data platform-the Personal Genome Project-to allow study participants to contribute their voices to inform ethical consent practices and protocol reviews for big-data research.

A post-genomic surprise. The molecular reinscription of race in science, law and medicine.

The completion of the first draft of the Human Genome Map in 2000 was widely heralded as the promise and future of genetics-based medicines and therapies - so much so that pundits began referring to the new century as 'The Century of Genetics'. Moreover, definitive assertions about the overwhelming similarities of all humans' DNA (99.9 per cent) by the leaders of the Human Genome Project were trumpeted as the end of racial thinking about racial taxonomies of human genetic differences. But the first decade of the new century brought unwelcomed surprises. First, gene therapies turned out to be far more complicated than any had anticipated - and instead the pharmaceutical industry turned to a focus on drugs that might be 'related' to population differences based upon genetic markers. While the language of 'personalized medicine' dominated this frame, research on racially and ethnically designated populations differential responsiveness to drugs dominated the empirical work in the field. Ancestry testing and 'admixture research' would play an important role in a new kind of molecular reification of racial categories. Moreover, the capacity of the super-computer to map differences reverberated into personal identification that would affect both the criminal justice system and forensic science, and generate new levels of concern about personal privacy. Social scientists in general, and sociologists in particular, have been caught short by these developments - relying mainly on assertions that racial categories are socially constructed, regionally and historically contingent, and politically arbitrary. While these assertions are true, the imprimatur of scientific legitimacy has shifted the burden, since now 'admixture research' can claim that its results get at the 'reality' of human differentiation, not the admittedly flawed social constructions of racial categories. Yet what was missing from this framing of the problem: 'admixture research' is itself based upon socially constructed categories of race.