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)

Germline genome editing is often disapproved of at the international policy level because of its possible threats to human dignity. However, from a critical perspective the relationship between this emerging technology and human dignity is relatively understudied. We explore the main principles that are referred to when 'human dignity' is invoked in this context; namely, the link with eugenics, the idea of a common genetic heritage, the principle of equal birth and broader equality and justice concerns. (...) Yet the concept is also used in favour of germline genome editing as it might improve the overall well-being of future generations. We conclude that dignity concerns do not justify a complete ban on safe heritable genome editing but should inform the implementation of side constraints to ensure that the value judgements about human traits that are inherent in this practice do not result in a diminished basic respect for those people affected by them. (shrink)

Editing human germline genes may act as boon in some genetic and other disorders. Recent editing of the genome of the human embryo with the CRISPR/Cas9 editing tool generated a debate amongst top scientists of the world for the ethical considerations regarding its effect on the future generations. It needs to be seen as to what transformation human gene editing brings to humankind in the times to come.

The human genome has always been the source of a great variety in behaviour and reactions ranging from the most cruel nationalistic, racist and other social conflicts to the most innocuous family quarrels. The concept of heredity has justified racial discrimination in its harshest form; the concept of sex division has caused social and legal discrimination between men and women, while some countries even permit sex selection. Sex related family disputes are neither harmless nor without serious consequences.Since the (...) days of Mendel the human genome and its behaviour have been the subject of scientific research.1 Today, by means of gene therapy, it has become the subject of interventions to improve human health and to control the genetic quality and behaviour of the embryo. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Human Genome ProjectSharon J. Durfy (bio) and Amy E. Grotevant (bio)In recent years, scientists throughout the world have embarked upon a long-term biological investigation that promises to revolutionize the decisions people make about their lives and lifestyles, the way doctors practice medicine, how scientists study biology, and the way we think of ourselves as individuals and as a species. It is called the Human (...) class='Hi'>Genome Project, and its ultimate goal is to map and determine the chemical sequence of the three billion nucleotide base pairs that comprise the human genome. The feat is expected to take about fifteen years (see General Surveys).These three billion base pairs include an estimated 50,000 to 100,000 genes. The rest of the genome—perhaps 95 percent of it—is nongenic sequences with unknown function, sometimes called "junk." Determining the order and organization of all this material has been likened to tearing six volumes of the Encyclopaedia Brittanica into pieces, then trying to put it all back together to read the information (Surveys: Hall 1990). The effort could be well worth it, many scientists say, because it is expected to yield major insights into many common and complex diseases, including cancer, cardiovascular disease, and Alzheimer's disease (Debate: Dulbecco 1986; Koshland 1989).The Human Genome Project is not without controversy, however (Debate: Davis 1990; Leder 1990; Rechsteiner 1990). Many scientists fear that funding for it will be diverted from other areas of research, rather than obtained from new funding sources. This has enlivened the debate about the relative value of "big" versus "small" science. Also, the value of undertaking a complete sequencing of the genome has been questioned, especially given the high proportion of non-genic sequences.Advocates of the effort converted many critics by making two alterations in the original plan. Plans were included to simultaneously determine the nucleotide sequence of the genomes of other organisms; this provides comparisons and points of reference for the human sequence (U.S.: NIH/DOE 1990). Second, in response to concerns about the high cost of developing technology to sequence the whole [End Page 347] genome, the focus moved from large-scale sequencing to mapping the genome, which would hasten the search for disease genes (U.S.: NIH/DOE 1990).The ideal map would be both genetic, locating DNA markers, or signposts, at closely spaced intervals along the chromosomes, and physical, indicating the exact distance between these markers (Map: McKusick 1991). Since 1973, Human Gene Mapping workshops (HGM) have been held at least every two years to locate, compare, and compile genetic markers. This information is published and is accessible through Genome Database at Johns Hopkins University (McKusick 1991). The most recent Human Genome Mapping workshop was held in August 1991, at which the Human Genome Organization (HUGO) began to assume increased responsibility for coordination of the international mapping effort (Surveys: Maddox 1991).Historical Background of the United States EffortThe first serious discussions about sequencing the entire human genome occurred at a workshop at the University of California at Santa Cruz in 1985 (U.S.: Sinsheimer 1989). A second workshop, organized by the U.S. Department of Energy (DOE) and held in March 1986, addressed the feasibility of an organized program (U.S.: DOE 1986). Shortly thereafter, DOE instituted its own genome project (U.S.: DOE 1987). Reports in early 1988 from both the National Research Council (NRC) of the National Academy of Sciences (NAS) and Congress' Office of Technology Assessment (OTA) (U.S.: NRC 1988; OTA 1988) served as catalysts, and in fiscal year 1988, the U.S. Congress officially launched the Human Genome Project by appropriating funds to both the Department of Energy and the National Institutes of Health (NIH).To avoid potential congressional "meddling" (U.S.: Roberts 1988), NIH and DOE drafted a memorandum of understanding for interagency coordination in October 1988 (U.S.: NIH/DOE 1990). The agencies then created both separate and joint committees, and working groups to administer the project. NIH established the Office of Human Genome Research in 1988 (directed by James D. Watson) to plan and coordinate NIH genome activities. That office has evolved into the National Center for Human Genome Research (NCHGR... (shrink)

Since the human genome was decoded, great emphasis has been placed on the unique, personal nature of the genome, along with the benefits that personalized medicine can bring to individuals and the importance of safeguarding genetic privacy. As a result, an equally important aspect of the human genome – its common nature – has been underappreciated and underrepresented in the ethics literature and policy dialogue surrounding genetics and genomics. This article will argue that, just as (...) the personal nature of the genome has been used to reinforce individual rights and justify important privacy protections, so too the common nature of the genome can be employed to support protections of the genome at a population level and policies designed to promote the public's wellbeing. In order for public health officials to have the authority to develop genetics policies for the sake of the public good, the genome must have not only a common, but also a public, dimension. This article contends that DNA carries a public dimension through the use of two conceptual frameworks: the common heritage framework and the common resource framework. Both frameworks establish a public interest in the human genome, but the CH framework can be used to justify policies aimed at preserving and protecting the genome, while the CR framework can be employed to justify policies for utilizing the genome for the public benefit. A variety of possible policy implications are discussed, with special attention paid to the use of large-scale genomics databases for public health research. (shrink)

Through an examination of the actual research strategies and assumptions underlying the Human Genome Project, it is argued that the epistemic basis of the initial model organism programs is not best understood as reasoning via causal analog models. In order to answer a series of questions about what is being modeled and what claims about the models are warranted, a descriptive epistemological method is employed that uses historical techniques to develop detailed accounts which, in turn, help to reveal (...) forms of reasoning that are explicit, or more often implicit, in the practice of a particular field of scientific study. It is suggested that a more valid characterization of the reasoning structure at work here is a form of case-based reasoning. This conceptualization of the role of model organisms can guide our understanding and assessment of these research programs, their knowledge claims and progress, and their limitations, as well as how we educate the public about this type of biomedical research. (shrink)

This work examines the scientific and social objectives of the Human Genome Project. Scientific ones are “to map the human genome” while social ones are “to improve the human health and welfare”. Ten years after this project has begun, their scientific aims are fullfilled, but their social ones are still pending. The reason for that is that both scientists and policy makers have forgotten something: the current configuration for the right to intellectual property—patents —grants to (...) the discoverers of the human genetic map the possibility of using their new knowledge to obtain private profit. There is a scientific-business dynamic in this area that make difficult to reach the proclaimed social aims of the human genome project. “Human dignity” —a common topic in international and European Declarations—is also afected. (shrink)

The Human Genome Project is an expensive, ambitious, and controversial attempt to locate and map every one of the approximately 100,000 genes in the human body. If it works, and we are able, for instance, to identify markers for genetic diseases long before they develop, who will have the right to obtain such information? What will be the consequences for health care, health insurance, employability, and research priorities? And, more broadly, how will attitudes toward human differences (...) be affected, morally and socially, by the setting of a genetic “standard”? The compatibility of individual rights and genetic fairness is challenged by the technological possibilities of the future, making it difficult to create an agenda for a “just genetics.” Beginning with an account of the utopian dreams and authoritarian tendencies of historical eugenics movements, this book’s nine essays probe the potential social uses and abuses of detailed genetic information. Lucid and wide-ranging, these contributions will interest bioethicists, legal scholars, and policy makers. Essays: “The Genome Project and the Meaning of Difference,” Timothy F. Murphy “Eugenics and the Human Genome Project: Is the Past Prologue?,” Daniel J. Kevles “Handle with Care: Race, Class, and Genetics,” Arthur L. Caplan “Public Choices and Private Choices: Legal Regulation of Genetic Testing,” Lori B. Andrews “Rules for Gene Banks: Protecting Privacy in the Genetics Age,” George J. Annas “Use of Genetic Information by Private Insurers,” Robert J. Pokorski “The Genome Project, Individual Differences, and Just Health Care,” Norman Daniels “Just Genetics: A Problem Agenda,” Leonard M. Fleck “Justice and the Limitations of Genetic Knowledge,” Marc A. Lappé. (shrink)

In the future, the Human Genome Project could eventually open the way to perhaps the determination of the complete wiling diagram of the human brain. This kind of progress may move neuroscience forward into the next level of understanding of human neurophysiology, development and behavior. The next crucial step would be to know, exactly what are the function of this genes, and why its lack or alteration causes a certain disease. Although, genomic has in some way (...) contributed to almost every aspects of neurobiology, the results are both significant and troubling.One of the areas, where HGP will contribute to neuroscience is the mapping of qualitative or complex traits. Complex traits like appearence, intelligence and personality are likely to be affected by hundreds or thousands of different genes, rather than one or a few. On the other hand, the complex organisms are not just the simple result of the sum of their genes, nor do genes alone build the different part of organism or influence behaviour by themselves. In spite of the wide variety of misunderstanding, misinterpretation or possible misusing of these new genetic information, this sort of research may eventually lead to useful practical medical results for humans. This information can contribute to work out therapies to treat learning and memory disorders, neurological disorders like Alzheimer's disease, afflicting more and more people in an increasingly ageing population. Genetics believe, there are 3000 to 4000 hereditary diseases. Gene therapy could one day cure some of them, but only when all the details of their genetic basis are known. Biomedicine in the next century will probably have a completely new role in society based on the beginnings inherent in the HGP.There is a general agreement, that modern neuroscience raises important ethical concerns that not have been adequately addressed either by scientists themselves or by the bioethics community. Some scientists interpreted the rapid progress in neuroscience as additional conformation for a materialist account of human nature, resulting in an attack on traditional belief systems. There is a clear tension between the widely held believes and the intellectual views of many scientists. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Human Genome Project and BioethicsEric T. Juengst, Ph.D. (bio)The fifteen-year "human genome project" at the National Institutes of Health and the Department of Energy officially began on October 1, 1990. With it began a new dimension in federally supported scientific research: concurrent funding for work to anticipate the social consequences of the project's research and to develop policies to guide the use of the (...) knowledge it produces. As a result, the National Center for Human Genome Research (NCHGR) at NIH will support the largest public investment in bioethical analysis to date.NCHGR was established to work with other federal, private, and international organizations on the scientific effort to characterize the form and content of the human genome. The research will yield information—high-resolution genetic linkage and physical maps of all the human chromosomes as well as human DNA sequence data—that will be a resource for studies of gene structure and function. It will greatly increase our understanding of the genetic aspects of human health and disease. That increased understanding will eventually provide insights into the prevention and treatment of the 3,000 known inherited disorders, and of conditions caused by our (gene-governed) physiological reactions to pathogens, toxins, and mutagens of external origin.It has been clear since the conception of the human genome project, however, that professional and public deliberations concerning the responsible use of genetic information must be a part of the process. The most immediate consequence of genome research will be the development of new diagnostic and predictive tests, well in advance of corresponding therapeutic or curative advances. The implications of acquiring and using that knowledge about individuals raise policy questions at many levels within society. The primary purpose of the Ethical, Legal and Social Implications Program at the NCHGR is to anticipate and address these questions early in the life of the scientific project, to help optimize the [End Page 71] benefits to human welfare and opportunity from the new knowledge, and to guard against its misuses.The program has identified three sets of questions as particularly important to pursue as the genome initiative proceeds:1.Issues involved in the integration of new genetic tests into medical practice. Human genome research is expected to increase greatly the number of gene-based diagnostic and prognostic tests available to health professionals. The bioethical policy problems involved in integrating those tests effectively into medical practice include developing standards for:— accuracy and quality control of genetic tests;— medical indications for testing and design of testing protocols;— professional responsibilities of clinicians who perform tests;— confidentiality of information obtained from testing;— access to and use of test results by third parties, such as health insurers; and— reimbursement for testing and test-related counseling.These are problems for both those charged with regulating the use of new genetic tests and for those establishing the standards of practice within the health professions. Thus, in addition to soliciting and funding scholarly research proposals on both the factual and normative questions raised by these problems, the program is commissioning a major new study by the National Academy of Sciences/Institute of Medicine aimed at providing professional guidelines for the integration of genetic services into mainstream medical practice.2. Issues involved in educating and counseling individuals about genetic test results. The primary risk that health professionals will face in using genetic tests is the misinterpretation of their findings and the resulting potential for psychological trauma, stigmatization, and discrimination. Sometimes, out of ignorance, patients, families, and social institutions already stigmatize genetic disorders and treat those with them unfairly. This risk broadens as the genetic elements of more health problems are uncovered and gene-based tests for susceptibilities and carrier states are developed.To protect against these risks, NCHGR is soliciting and supporting projects aimed at improving professional and public understanding of these tests and their implications. For example, a philosopher is leading a team of geneticists and physicians in a scholarly effort to clarify [End Page 72] concepts of genetic susceptibility and draw out the social meaning of their different interpretations. Other projects involve social scientific studies of genetic risk perceptions, stigmatization, and discrimination. The conclusions of these studies, and... (shrink)

A global socio‐bioethics is called upon to address the ethical challenges arising from the revolutionary gene editing technologies such as CRISPR‐Cas9, which offers the capability to rewrite the human genome. The ethical inquiry Françoise Baylis has undertaken in the book Altered Inheritance: CRISPR and the Ethics of Human Genome Editing (Harvard University Press, 2019) operates at individual, societal and global levels. Baylis has not only presented insights on how to practice “slow science” and achieve broad societal (...) consensus through empowering the public, but she also shown what a global socio‐bioethics approach can offer for the further development of bioethics. (shrink)

BackgroundHuman genome editing technologies offer much potential benefit. However, central to any conversation relating to the application of such technologies are certain ethical, legal, and social difficulties around their application. The recent misuse, or inappropriate use, by certain Chinese actors of the application of genome editing technologies has been, of late, well noted and described. Consequently, caution is expressed by various policy experts, scientists, bioethicists, and members of the public with regard to the appropriate use of human (...) germline genome editing and its possible future effect on future generations.Main textAs concerns about the applications of heritable genome editing have grown, so too have the questions around what is to be done to curtail ‘rogue actors’. This paper explores various ways in which to regulate genomic editing that are socially beneficial, while being cognisant of legal and ethical principles and rights values. This is done by evolving regulatory frameworks across jurisdictions in an attempt to raise issues, address common principles, and set responsible standards for stewardship of the novel technology.ConclusionsIt is suggested that robust and concrete regulatory measures be introduced that are culturally and contextually sensitive, inclusive, appropriate, and trustworthy – and are based on public empowerment and human rights objectives. Doing so will ensure that we are perfectly positioned to harness and promote the benefits that novel technologies have to offer, while safeguarding public health and curtailing the ambitions of rogue actors. This it is acknowledged is no easy task, so, as a point of departure, this paper sets out a path forward by means of certain, practical recommendations – by constructing genome editing regulation in a manner that both fulfils the desire to better progress human health and that can withstand legal and ethical scrutiny.The following observations and recommendations are made: Firstly, that a solution of effective, legitimate governance should consist of a combination of national and supranational legislative regulation or ‘hard’ law, in combination with ‘soft’ ethics, firmly anchored in and underpinned by human rights values. Second, that efforts to support legal and ethical solutions should be rigorous, practical, and robust, contribute to a reaffirmation of human rights in a contextually sensitive manner, and be transnational in reach. Lastly, that greater harmonisation across jurisdictions and increased public engagement be sought. This it is proposed will address the question of how to implement a normative framework which in turn can prevent future rogue actors. (shrink)

The Human Genome Decoding Project is progressing rapidly and the full sequences of the 3.2 bilions bases and its representation on the 23 chromosomes will be completed by 2003. The ethical impact of such innovative knowledge for Humankind is relevant. Who will detect the property of this informations and which organization will decide on its potential applications? The anthropological and philosophical implications of these innovative knowledges are presented and discussed.

In the opening years of the 21st century, it became fashionable to describe the human genome as belonging to the common heritage of humanity. The United Nations, in its Universal Declaration on the Human Genome and Human Rights, now identifies the human genome as part of the common heritage, as does the international Human Genome Organization and the Council of Europe. The common heritage concept has played a prominent role in arguments (...) against patenting the human genome or portions thereof. This essay considers whether the common heritage designation will advance the political and legal goals of its proponents. (shrink)

This essay identifies two legal lineages underlying the common heritage concept, and applies each to the human genome. The essay notes some advantages and disadvantages of each approach, and argues that patenting of human genes would be allowable under either approach.

Madole & Harden argue that the Mendelian reshuffling of genes and genomes is analogous to randomised controlled trials. We are not convinced by their arguments. First, their recipe for meeting the demands on randomised experiments is inherently inconsistent. Second, disequilibrium across chromosomes conflicts with their assumption of statistical independence. Third, the genome-wide association study (GWAS) method has many pitfalls, including low repeatability.

This contribution will be organized in three parts conceptually linked to each other. The first one will concern the ancient question “what is life?” seen according to a modern systemic view, the second with evolution based on Darwinian natural selection, the third with the notion of “being human” in relation to our genome.

This article traces the rapid progression of policy pertaining to human genome germline modifications using genome editing. It provides an overview of how one fertility physician implemented and advertised experimental techniques as part of his fertility clinic services, examines US law and policy, and assesses the impact of rhetoric influencing global policy and interpretation of the law. This article provides an in-depth examination of the medical rationale driving the acceptance of genome editing human embryos in (...) two contexts: to cure disease and treat infertility. It describes complexities in genomics and outlines risks currently associated with genome editing, asserting the available evidence fails to demonstrate genome editing constitutes a curative therapy. (shrink)

In “Human germline genome editing: On the nature of our reasons to genome edit,” Robert Sparrow (2022) presents a central claim and a secondary one. The central claim is that, for the foreseeable f...

In this paper I claim that the goal of mapping and sequencing the human genome is not wholly new, but rather is an extension of an older project to map genes, a central aim of genetics since its birth. Thus, the discussion about the value of the HGP should not be posed in global terms of acceptance or rejection, but in terms of how it should be developed. The first section of this paper presents a brief history of (...) the project. The second section distinguishes among four kinds of issues relevant to an evaluation of the HGP: those economic and organizational issues related to the feasibility of the project; the ethical questions arising in the development of the project and the application of the data gathered; the empirical issues relevant to the scientific value of the project; and conceptual issues like reductionism and determinism relevant to understand the nature and scope of the project. In a third section, I analyze in detail whether the HGP and, more generally, molecular biology is reductionistic. (shrink)

The major transcript variants of human protein‐coding genes are annotated to a certain degree of accuracy combining manual curation, transcript data, and proteomics evidence. However, there is considerable disagreement on the annotation of about 2000 genes—they can be protein‐coding, noncoding, or pseudogenes—and on the annotation of most of the predicted alternative transcripts. Pure transcriptome mapping approaches seem to be limited in discriminating functional expression from noise. These limitations have partially been overcome by dedicated algorithms to detect alternative spliced micro‐exons (...) and wobble splice variants. Recently, knowledge about splice mechanism and protein structure are incorporated into an algorithm to predict neighboring homologous exons, often spliced in a mutually exclusive manner. Predicted exons are evaluated by transcript data, structural compatibility, and evolutionary conservation, revealing hundreds of novel coding exons and splice mechanism re‐assignments. The emerging human pan‐genome is necessitating distinctive annotations incorporating differences between individuals and between populations. (shrink)

Should we change the human genome? The most general arguments against changing the human genome are here in focus. Distinctions are made between positive and negative gene therapy, between germ-line and somatic therapy, and between therapy where the intention is to benefit a particular individual (a future child) and where the intention is to benefit the human gene-pool.Some standard arguments against gene-therapy are dismissed. Negative somatic therapy is not controversial. Even negative, germ-line therapy is endorsed, (...) if the intention is to cure a certain individual (a future child). In rare cases, positive therapy on somatic cells may be warranted. Germ-line therapy may become a valuable method of preventing harm, through genetic vaccination. If safe methods evolve, it is harmless (though vain), to try to achieve more ambitious goals. Prospective parents should not be prevented from exercising this harmless kind of parental authority. (shrink)

In the Museum of Science and Technology in San Jose, California, there is a display dedicated to advances in biotechnology. Most prominent in the display is a double helix of telephone books stacked in two staggered spirals from the floor to the ceiling twenty-five feet above. The books are said to represent the current state of our knowledge of the eukaryotic genome: the primary sequences of DNA polynucleotides for the gene products which have been discovered so far in the (...) twenty years since cloning and sequencing the genome became possible. (shrink)

The Guidelines for Stem Cell Research and Clinical Translation, recently issued by the International Society for Stem Cell Research (ISSCR), include a number of substantive revisions. Significant changes include: (1) the bifurcation of ‘Category 3 Prohibited research activities’ in the 2016 Guidelines into ‘Category 3A Research activities currently not permitted’ and ‘Category 3B Prohibited research activities’ in the 2021 guidelines and (2) the move of heritable human genome editing research out of the ‘prohibited’ category and into the ‘currently (...) not permitted’ category. These changes are noteworthy because of the absence of a clear demarcation line between the two categories insofar as, by definition, that which is ‘prohibited’ is ‘currently not permitted’, and vice versa. Permanence is not part of the definition of ‘prohibition’. In principle, a prohibition can be rescinded at any time. This begs the question ‘Why make a policy change that has no apparent practical effect?’ One hypothesis is that the recategorisation of specific ‘prohibited’ research activities as ‘currently not permitted’ is meant to seed intuitions about which prohibited research activities should ‘soon’ be permitted subject to specialised scientific and ethics review and approval. (shrink)

Biologists are faced two questions which are new in their fields. How far to go in genetical research? How should new findings be applied?Theoretically, the answers are not so difficult to find. Research should not be halted or even slowed down. On which basis should we limit knowledge, it would even be on topics such as cancer, AIDS, ageing,…, a crime against humanity not to develop research. Also theoretically, findings would be applied for the good of humanity and for a (...) better health. But, negative consequences can, however, be expected if applications of research, and research itself, serves interests of private companies or of individuals. We cannot deny the advantages of the HGP which are considerable indeed in discovering, isolating, describing, sequencing genes, using in genie therapy,…, developing a better predictive medicine.But rules, and probably laws, will have to be developed to protect the confidentiality of genetical information, the risk being present that insurance companies or employers would use it to discriminate the individuals. People can not be defined only by their genomes. Individuals or populations cannot be stigmatised or ostracised by their genes. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Human Genome Research in an Interdependent WorldAlexander Morgan Capron (bio)This has been the year of agenda-setting conferences for the ambitious ELSI (ethical, legal and social issues) program of the Human Genome Project (HGP). But of the dozen or more major meetings of this sort held across the country, the one held at the National Institutes of Heakh (NIH) in Bethesda, MD, June 2-4, 1991, was (...) distinctive in several respects.1As its name implies, "Human Genome Research in an Interdependent World" was a global look at the issues raised by gene mapping and sequencing. Unlike previous conferences, however, this meeting looked beyond a comparative analysis of clinical and domestic legal issues, and concentrated on topics that may require responses on a truly international level if they are to be successfully resolved.The meeting's organizers gathered an impressive group of more than seventy participants from fifteen countries, including the first significant contingent of Soviet and Japanese scientists, physicians, and philosophers at an ELSI meeting. In addition to talks by the heads of the genome projects in the Soviet Union, Japan, and the United States, the meeting was keynoted by Dr. James Wyngaarden, director general of the Human Genome Organization (HUGO), and I had the honor of serving as its general chairman.The goal of the meeting was to consider an array of issues that scientists, philosophers, and lawyers from around the world suggested might have international significance, with an eye to deciding three things: (1) Does the issue deserve further attention? (2) Is the issue best addressed in an international or domestic context? and (3) Do structures exist to which the issue can be referred for resolution? In the final sessions, the entire group debated proposed resolutions on the various topics and narrowed the list needing further, intensive exploration.To provide an international framework for this process, the conference [End Page 247] established a Global Steering Committee on Ethical and Social Issues in Genome Research, which will coordinate the efforts of several task forces charged with refining the tentative resolutions adopted by the conference participants on June 4. The task forces are expected to be able to complete work on some topics by the time of the steering committee's first meeting, which was described by one participant as a "check point," probably within the coming year; on other topics, the task forces will provide interim reports and arrange to continue their analysis. Several topics—less complex or more embryonic—were referred directly to the steering committee. On all issues, a major objective will be to ascertain what existing or newly created structure or structures are capable of implementing the group's recommendations and then to monitor the issue to ensure that appropriate implementation is occurring.Issues to be Explored by Task ForcesInsurance and EmploymentWhile individuals may derive medically useful information from the expanded range of genetic tests that will flow from the HGP, they could also be harmed if test results become a basis for discrimination. An area of particular concern at the conference in Bethesda was whether genetic information should be used to decide eligibility for employment or the scope and cost of health and life insurance. The complexity of this issue is increased as barriers to worker migration fall (especially in Europe) and as more firms carry on business internationally. Furthermore, questions arise about the limits of required testing and whether individuals may decline to be informed of the results of tests.The task force will not only gather information on practices and legal standards throughout the world—especially in light of the differences among nations with regard to the linkage of employment and various forms of insurance—but will also examine international anti-discrimination laws as a possible means of supplementing domestic statutes and regulations. As a starting point, the Bethesda meeting agreed on a set of principles for the task force to refine.2ForensicsAlthough their legal status is not fully resolved, DNA tests are being used increasingly in judicial proceedings and civil and criminal investigations as a highly probative means to identify people. Most forensic uses of "DNA fingerprints" are domestic, but international cooperation among investigative bodies... (shrink)

Galton defined eugenics as the science of improvement of the human race germ plasm through better breeding and claimed that the study of agencies under social control which may improve or impair the racial qualities of future generations should be pursued. Eugenic theoretical approaches and eugenic state political policies are deliberate intentions of adopting eugenic measures, whether or not they have been actually implemented and no matter how successful the results of those practices might have been. They involve agents (...) and goals to be achieved. Some eugenists intended that eugenic programmes should be enforced by state agencies; others defended that those programmes might be implemented on a voluntary choice. The eugenic consequences of practices that were not deliberately designed to have eugenic goals are also considered. This latter category is very often relevant while discussing eugenics as related to a number of new biotechnologies. The concern with eugenics today does not focus so much on the risks of population improvement programmes to be implemented by central powers; nevertheless, practices adopted by health institutions, insurance and legal agencies may lead to eugenic consequences. The social and eugenic implications of the Human Genome Project are discussed. (shrink)

The human genome is commonly regarded as a ‘natural’ connection between all human beings, as it has been handed down to us by our predecessors. As such, it is believed to represent common heritage of humanity, e.g. a resource of outstanding value that should be the object of special protection and international concern. Some critics argue that germline manipulation would disrupt this natural heritage and that we have a duty to preserve the integrity of the human (...) germline. However, a closer look reveals that the concept of common heritage of humanity does not necessarily imply the impermissibility of germline manipulation. If it is restricted to the prevention of severe diseases, germline manipulation does not represent a threat to the unity and identity of the human species, even though this would create a new form of relationship between human beings, namely that between a designer and a genetically designed person. (shrink)

The Human Genome Project has raised many issues regarding the contributions of genetics to a variety of diseases and societal conditions. With genetic testing now easily conducted with lowered costs in nonmedical domains, a variety of privacy issues must be considered. Such testing will result in the loss of significant privacy rights for the individual. Society must now consider such issues as the ownership of genetic data, confidentiality rights to such information, limits placed on genetic screening, and legislation (...) to control genetic testing and its applications. There is often a conflict between individual rights to privacy and the need for societal protection. (shrink)

In the Museum of Science and Technology in San Jose, California, there is a display dedicated to advances in biotechnology. Most prominent in the display is a double helix of telephone books stacked in two staggered spirals from the floor to the ceiling twenty-five feet above. The books are said to represent the current state of our knowledge of the eukaryotic genome: the primary sequences of DNA polynucleotides for the gene products which have been discovered so far in the (...) twenty years since cloning and sequencing the genome became possible. (shrink)

For the first time in history, genetics will enable science to completely identify each human as genetically unique. Will this knowledge reinforce the trend for more individual liberties or will it create a ‘brave new world’? A law policy approach to the problems raised by the human genome project shows how far our democratic institutions are from being the proper forum to discuss such issues. Because of the fears and anxiety raised in the population, and also because (...) of its wide implications on the everyday life, the human genome analysis more than any other project needs to succeed in setting up such a social assessment. Keywords: human genome project, judiciary law policy, legislative activity, new ethics institutions, methodology in law reform, public debate, social consensus CiteULike Connotea Del.icio.us What's this? (shrink)

The Human Genome Project (HGP) brings genetics and genetic knowledge to the point of paradoxical counterproductivity. Population-wide genetic screens, replacing specific tests intended for and useful to those at risk, become counterproductive when the HGP's "normal human " defines everybody as at risk. More over, the knowledge generated by the HGP disables those whom it is meant to serve: We are rendered impotent as a laity, subject to expertise regarding the truth of our being. The standard response (...) here is that we need more science education and easier access to scientific knowledge. But that is simply to beg the question. The question to ask about knowledge is not whether it is true or properly scientific (which it may very well be) but rather whether it is good. The good of knowledge must be demonstrated and not uncritically assumed. Thus, more education can, too, be paradoxically counterproductive. What, then, are our prospects? (shrink)

This paper questions the prevailing historical understanding that scientific racism “retreated” in the 1950s when anthropology adopted the concepts and methods of population genetics and race was recognized to be a social construct and replaced by the concept of population. More accurately, a “populational” concept of race was substituted for a “typological one”—this is demonstrated by looking at the work of Theodosius Dobzhansky circa 1950. The potential for contemporary research in human population genetics to contribute to racism needs to (...) be considered with respect to the ability of the typological-population distinction to arbitrate boundaries between racist society and nonracist, even anti-racist, science. I point out some ethical limits of “population thinking” in doing so. (shrink)

A paper by Andorno and colleagues, recently published in Trends in Biotechnology, condemns support for heritable human genome editing (HHGE) that is claimed to be premature and to have occurred without sufficient public consultation. The general message of the paper is welcome in its emphasis on the importance of gaining broader perspectives on the uses and regulation of HHGE before calls for clinical use are made. However, some problematic arguments for their position lead them to seemingly condemn not (...) only current premature calls for clinical use of HHGE but also any analysis of the ways in which it might be appropriately regulated in the future. (shrink)

Dieser Beitrag geht von dem Standpunkt aus, daß das menschliche Genom nicht als Privateigentum der jeweils betroffenen Person, sondern als Gemeingut der Menschheit anzusehen ist. Es wird weiter dargestellt, daß die Genomforschung selbst sowie die Anwendung der durch sie entwickelten Handlungsmöglichkeiten sowohl positive als auch negative Aspekte hat. Angesichts ihres Potentials zum Guten wäre es jedoch verfehlt, aufgrund von meist religiös basierten oder kurzsichtigen tutioristischen Bedenken, die nur auf die Möglichkeit eines Mißbrauchs des so erworbenen Wissens ausgerichtet sind, die Forschung (...) selbst oder die Weiterentwicklung und Anwendung des errungenen Wissens vollständig zu unterbinden. Andererseits wäre es jedoch auch verfehlt, auf die Einsicht und den guten Willen der Forscher allein zu bauen, oder gar die Forschung und die Entwicklung des damit verbundenen Wissenstransfers sich selbst steuern zu lassen, da ein solcher Standpunkt das Erbgut der Menschheit der Willkür eines unkontrollierbaren Prozesses aussetzen würde, der allzu leicht den skrupellosen Interessen einer voreingenommenen und nur am eigenen Vorteil interessierten Minderheit anheim fallen könnte. Es wäre daher angemessen, der Forschung klare Grenzen zu setzen und den Wissenstransfer durch entsprechende Regeln strengen Kontrollen zu unterwerfen. Es gäbe hierbei verschiedene Möglichkeiten, angemessene Regeln zu entwickeln und Kontrollen einzuschalten: z.B. durch die koordinierte Entwicklung diesbezüglicher nationaler Gesetze, deren Einhaltung dann den jeweiligen Ländern als nationale Pflicht zukommen würde; durch das Abschließen von internationalen Abkommen, deren Einhaltung von internationalen Gremien überprüft werden könnte; durch die Entwicklung angemessener Regeln seitens der internationalen wissenschaftlichen und medizinischen Gemeinschaft, welche dann die Einhaltung dieser Regeln als Bedingung zur Teilnahme am internationalen wissenschaftlichen Austausch machen könnte; usw. Der vorliegende Beitrag unterwirft diese und ähnliche Vorschläge einer kurzen kritischen Analyse und gelangt zu dem Schluß, daß Regulierung und Kontrolle nur insoweit vertretbar sind, als sie auf ethische Grundprinzipien zurückgeführt werden können und damit auf ethischer Basis beruhen. Die diesbezüglichen ethischen Grundprinzipien werden identifiziert und auf die vorliegende Problematik angewandt. Ferner wird der Schluß nahegelegt, daß eine ethisch basierte Regulierung allein nicht zur angemessenen Kontrolle genügt, sondern daß es auch einer international akkreditierten Instanz bedarf, welche über genügend Mittel verfügt, um die Befolgung dieser ethisch basierten Regeln zu überprüfen und, falls erforderlich, durch angemessene Maßnahmen zu erzwingen. (shrink)

_Gender issues arise in relation to the human genome across a number of dimensions: the level of attention given to the nuclear genome as opposed to the mitochondrial; the level of basic scientific research; decision-making in the clinic related to both reproductive decision-making on the one hand, and diagnostic and predictive testing on the other; and wider societal implications. Feminist bioethics offers a useful perspective for addressing these issues._.

In this paper we discuss the scientific value of the human genome project. To what extent is the data obtained by sequencing the entire human genome useful in the gene dicovery process? Responding to Alex Rosenberg' skepticism about the value of such data, we maintain that brute sequence data is much more useful than he suggests.

High‐capacity sequencing technologies have dramatically reduced both the cost and time required to generate complete human genome sequences. Besides expanding our knowledge about existing diversity, the nature of these technologies makes it possible to extend knowledge in yet another dimension: time. Recently, the complete genome sequence of a 4,000‐year‐old human from the Saqqaq culture of Greenland was determined to 20‐fold coverage. These data make it possible to investigate the population affinities of this enigmatic culture and, by (...) identifying several phenotypic traits of this individual, provide a limited glimpse into how these people may have looked. While undoubtedly a milestone in ancient DNA research, the cost to generate an ancient genome, even from such an exceptionally preserved specimen, remains out of reach for most. Nonetheless, recently developed DNA capture methods, already applied to Neanderthal and fossil human mitochondrial DNA, may soon make large‐scale genome‐wide analysis of ancient human diversity a reality, providing a fresh look at human population history. (shrink)