Many Christian scholars, if not all of them, consider Genesis to be foundational texts of the Bible and the spring for all the other doctrines of the Scripture. Therefore, I'm considering the attempt to search and find arguments for cell therapy ethical issues in the fundamental text of Genesis as a challenging and educative task. Moreover, this could be the first step in analyzing the relationships between Christian religions and bioethics, in terms of finding reasonable decisions for ethical challenges, (...) raised by the current biomedical research. As for many other dilemmas of humanity, we have to recall the text of Genesis for analyzing the goodness or evilness of our actions in translational medicine, even though that is not the only way to get a reasonable ethical decision. My contribution is an essay that is trying to correlate the Genesis lessons with the needed arguments in deciding what could be good and what could be evil in the stem cell research, according to the religious convictions. The biggest challenges of biomedical research for Christian religions were due to the human cloning issue, made possible by the somatic cell nuclear transfer, but those challenges update the older debates on birth control pill, technologically assisted reproduction, or gene therapy. Issues related to in vitro fertilization, gene enhancement and gene therapy, human cell cloning, embryonic stem cell using, and chimera cell obtaining for research are being considered and related to the putative arguments extracted from the book of Genesis, describing the origins. As a matter of fact, I may conclude that the single way to reach a reasonable ethical decision in our society is to intersect ethics, science and theology and to engage large debates involving scientists, theologians, civil society representatives, ethicists (experts in applied ethics) and moral philosophers, having the two latest professionals as referees. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.3 (2002) 305-323 [Access article in PDF] Scope Note 41 Bioethics and Cloning, Part I Susan Cartier Poland and Laura Jane Bishop This is Part One of a two part Scope Note on Bioethics and Cloning. Part Two will be published in the December 2002 issue of the Kennedy Institute of Ethics Journal and as a separate reprint. Contents For Parts 1 (...) And 2 Part 1Part 2I.History of the ScienceI.Ethical PerspectivesII.Historical CommentaryII.Religious PerspectivesIII.Animal WelfareIII.Fiction and FilmIV.Laws and Legal Literature"Clone" is a collective noun (I, Stewart 1997, p. 771). A collective noun names a group and is composed of individual members, such as "herd" or "flock." Derived from the Greek kl¯on for twig or slip, "clone" was first used in biology to describe the aggregate of asexually produced progeny of an individual, either naturally occurring or man-made; the definition later expanded to mean a group of genetically identical members who originate from a single ancestor. Thus, a clone is a group that results from the process of asexual reproduction.In nature, cloning occurs either by parthenogenesis (reproduction without fertilization) or by fission (embryo splitting). In a pioneering experiment in 1952, Robert Briggs and Thomas J. King (I, 1952), cancer researchers at the Institute for Cancer Research (today part of the Fox Chase Cancer Center) in Philadelphia, demonstrated on frogs another method of cloning by transplanting nuclei into enucleated cells, a technique called "nuclear transplantation," which John B. Gurdon and colleagues (I, 1958, 1975) used to create clones of frogs.Then, in the late 1970s and early 1980s, two back-to-back frauds in cloning occurred. First, the cloning of a human described by American science journalist David Rorvik in the 1978 book In His Image was called a hoax by a court in [End Page 305] 1982. Second, the cloning of three mice, announced by German wunderkind Karl Illmensee to scientific circles in 1979 (and to the public in 1981), could not be proven to be true, according to convincing evidence by McGrath and Solter (I) published in 1984.With their pronouncement that mammalian cloning was impossible, McGrath and Solter essentially stopped cloning research and funding for such biological research. So by the mid-1980s, instead of further investigating cloning, developmental biologists studied embryology related to in vitro fertilization, while molecular biologists studied recombinant DNA under the newly relaxed NIH guidelines. These two strands of scientific investigation came together in the work of Ian Wilmut, who created in vitro embryos using nuclear transplantation to reproduce genetically engineered cattle. Wilmut was seeking a way to increase the successful birth rate when, in the 1990s, he produced identical twin sheep, Megan and Morag, cloned from an embryonic cell, followed by another sheep, Dolly, cloned from an adult cell. The birth of a mammal from an embryo whose genetic material came from an adult cell firmly re-established the possibility of cloning from adults. Prior to Dolly's birth, scientists believed that adult cells lost the ability to dedifferentiate—i.e., to become unspecialized—and so could not direct the development of an embryo through to birth.The 1997 announcement of Dolly's birth initiated the present widespread discussion of cloning. Because of its potentially vast applications across human health, medicine, agriculture, and business/economics, cloning raises a host of issues including those concerning: genetics and genetic engineering, patenting, animal rights and/or animal welfare (especially for transgenic, research, or cloned animals), organ transplantation, reproduction, eugenics, pharmacology (drug production using transgenic animals), research practices, informed consent, stem cell research, women's rights, children's rights, parental rights and responsibilities, and theology and philosophy. It fosters questions about the meaning and purpose of life, the limits of human powers to intervene in research and therapy, and what it means to be human or animal. In addition, environmentalists and organic farmers raise concerns about the effect of novel animals and plants on the environment, while nutritionists and the lay public wonder... (shrink)

The research on stem cell-based therapies has greatly expanded in recent years. Our text attempts to seek those religious and ethical challenges that stem cell therapy and research bring into debate. Our thesis is that bioethics can defend its principle without a religious background. We will develop our argumentation on three major points: firstly, a comparison between secular ethics and religious views will clarify why stem cell therapy and research are important from a scientific point of view, (...) addressing the very center of the human being; in our view, being based on secular society, bioethics can answer the challenges of stem cell therapy and research; secondly, following Hans Jonas' perspective on experimenting on humans, we seek to understand the philosophical guidance that sciences dealing with stem cell need; thirdly, we will map the ethical guidelines for clinical translational research that have been adopted by the International Society for Stem Cell Research. . (shrink)

Howard W. Jones, Jr.'s Personhood Revisited chronicles reproductive technology's debate-evoking history meanwhile exploring the ongoing moral dilemmas of the twenty-first century, including: personhood, in vitro fertilization, conjugal love, eugenics, cloning, stem cell research, and more. Balanced readings on each reproductive topic represent conflicting viewpoints from legal, religious, and scientific perspectives. And Jones' personal experiences, such as meetings with the Vatican, add a unique look into the highly political yet benevolent world of reproductive medicine. Author Howard W. Jones, (...) Jr., alongside Robert Edwards (winner of the Nobel Prize for Medicine 2010), fertilized the first human eggs in vitro. Jones and his wife, Georgeanna Seegar Jones, established the first in vitro fertilization program in the United States, which went on to develop America's first test tube baby in 1981. Book jacket. (shrink)

Debates about the legitimacy of embryonic stem-cell research have largely focused on the type of ethical value that should be accorded to the human embryo in␣vitro. In this paper, I try to show that, to broaden the scope of these debates, one needs to articulate an ontology that does not limit itself to biological accounts, but that instead focuses on the embryo’s place in a totality of relevance surrounding and guiding a human practice. Instead of attempting (...) to substantiate the ethical value of the embryo exclusively by pointing out that it has potentiality for personhood, one should examine the types of practices in which the embryo occurs and focus on the ends inherent to these practices. With this emphasis on context, it becomes apparent that the embryo’s ethical significance can only be understood by elucidating the attitudes that are established towards it in the course of specific activities. The distinction between fertilized embryos and cloned embryos proves to be important in this contextual analysis, since, from the point of view of practice, the two types of embryos appear to belong to different human practices: (assisted) procreation and medical research, respectively. In my arguments, I highlight the concepts of practice, technology, and nature, as they have been analyzed in the phenomenological tradition, particularly by Martin Heidegger. I come to the conclusion that therapeutic cloning should be allowed, provided that it turns out to be a project that benefits medical science in its aim to battle diseases. Important precautions have to be taken, however, in order to safeguard the practice of procreation from becoming perverted by the aims and attitudes of medical science when the two practices intersect. The threat in question needs to be taken seriously, since it concerns the structure and goal of practices which are central to our very self understanding as human beings. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Human Gene TherapyMary Carrington Coutts (bio)On September 14, 1990, researchers at the U.S. National Institutes of Health (NIH) performed the first approved gene therapy procedure on a four-year-old girl named Ashanti DeSilva. Born with a rare genetic disease, severe combined immune deficiency (SCID), Ashanti lacked a healthy immune system and was extremely vulnerable to infection. Children with SCID usually develop overwhelming infections and rarely survive to adulthood; even (...) a common childhood illness like chicken pox is life-threatening. Ashanti led a cloistered existence, avoiding contact with people outside her family, remaining in the sterile environment of her home, and battling frequent illnesses with massive amounts of antibiotics.In Ashanti's gene therapy procedure, her own white blood cells were genetically modified and then infused back into her bloodstream. Laboratory tests show that the therapy has strengthened Ashanti's immune system. She no longer has recurrent colds, has been allowed to attend school, and has been immunized against whooping cough. This gene therapy procedure is not a cure, however. The genetically-treated white blood cells only survive for a few months and must then be replaced, but Ashanti's future is much brighter because of the new therapy (VI, Thompson [The First] 1993).Although this simplified description of Ashanti's gene therapy procedure sounds like a happy ending, it is little more than an optimistic chapter in a long story. The road to the first approved gene therapy procedure was rocky and fraught with controversy. The biology of human gene therapy is very complex, and there are still many techniques that need to be developed and diseases that need to be understood more fully before gene therapy is well established. The public policy debate surrounding the possible use of genetically engineered material in human subjects is equally complex. Major participants in the debate come from the fields of biology, government, law, medicine, philosophy, politics, and religion, each bringing different views to the discussion.In studying the ethics of gene therapy, one should draw a distinction between [End Page 63] therapy on somatic (non-reproductive) cells and germ (reproductive) cells. Only the germ cells carry the genes that will be passed on to the next generation. Reactions to gene therapy have varied widely. Some commentators on gene therapy object to any form of genetic manipulation, no matter how well-intentioned (VI, Rifkin 1983). Another reaction is to allow the use of somatic-cell therapy, but not to approve the use of germ-line therapy, which could have unforeseeable effects on future generations. A different stance is that, with proper regulation and safeguards, germ-line gene therapy is a logical extension of the progress made to date and that it is an ethically acceptable procedure.TechniquesTo date, 43 research protocols have been approved for somatic-cell gene therapy in the United States. The techniques employed in each protocol vary, but in general a virus is used as a "vector" to insert the desired gene into the DNA of the patient's cells, in order to compensate for a defective gene. For Ashanti's gene therapy, this technique involved obtaining white blood cells and introducing properly functioning genes into as many of the cells as possible. The normal genes were delivered through the use of a specially-engineered virus.Although similar techniques are used in germ-line gene therapy, the procedure is more difficult. There are two basic ways to perform germ-line gene therapy: (1) to treat a preimplantation embryo that carries a serious genetic defect before its implantation in the mother, which necessitates the use of in vitro fertilization techniques; or (2) to treat the germ cells (sperm or egg cells) of afflicted adults so that the genetic defects would not be passed on to their offspring, which requires the technical expertise to delete the defective gene and insert a properly functioning replacement. Because of the complexity of the procedures involved and the attendant ethical controversy, germ-line therapy is not currently performed.Candidate Diseases for Gene TherapyAt present, gene therapy is likely to be most successful in treating diseases that are caused by single-gene defects and has been approved for treating diseases such... (shrink)

In order to answer the question raised in the title of my paper, I first put forward a general ethical theory, which is based on the traditional maxim neminem laedere. Second, I show how this principle in conjunction with certain assumptions concerning the value of life entails certain fundamental bioethical principles. Thus killing a living being Y is morally wrong whenever the intrinsic value of the life that Y would otherwise live is positive. But procreating a living being Y is (...) prima facie morally neutral, i.e. neither bad nor good. Third I will argue that the question of moral rights should always be reduced to the question of the morality of certain corresponding actions. In particular, granting Y a right to life should be taken to mean that it would be morally wrong if someone else were to set an end to Y’s life. In a similar vein, I suggest answers to some other questions of the reproductive rights issue. Fourth, with respect to the controversial issue of therapeutic and genuine cloning, I do not see any compelling moral reasons against this utopian way of procreating full-grown individuals.Nevertheless, I think there are a lot of other good reasons not to try to produce a human Dolly. Finally, as regards the use or abuse of human embryos as potential suppliers of stem-cells for the cure of other people’s diseases, it seems morally safe to perform experiments at least with those embryos which, like spare embryos that remained from measures of in vitro fertilization, would not have a life anyway. It’s more difficult to decide, however, whether it would be morally safe to produce embryos only for the sake of using them in the aforementioned way. (shrink)

This essay has two purposes. The first is to argue that our moral duties towards human embryos should be assessed in light of the Golden Rule by asking the normative question, “how would I want to be treated if I were an embryo?” Some reject the proposition “I was an embryo” on the basis that embryos should not be recognized as persons. This essay replies to five common arguments denying the personhood of human embryos: (1) that early (...) class='Hi'>human embryos lack ontological individuation; (2) that they are members of the species Homo sapiens but not yet human persons; (3) that the argument for personhood commits the “heap argument” fallacy; (4) that since human procreation in nature is inefficient, human embryos cannot be persons; and (5) the “burning building” scenario proves that all arguments for personhood are irrational or inconsistent. The second purpose is to set forth and criticize in light of the normative judgement defended in part one the present legal situation of cryo-preserved embryos in the U.S. The essay ends by proposing legislative reforms to protect ex utero human embryos. (shrink)

James Drane's More Humane Medicine: A Liberal Catholic Bioethics is an outstanding contribution to the study of bioethics in our day. Catholics and others who are interested in the issues discussed here will benefit from this masterful treatment. The author opens with a set of definitions, starting with what he means by a “more humane medicine.” Drane contends that a more humane medicine has become necessary and desired, but not because the traditional medical ethic as “a self-declared and self-imposed ethic, (...) outlining what noble service to others entails” is no longer valid. Rather he defines it as an advance on the traditional ethic; a “new foundation” based on a “lived set of obligations derived from a felt commitment to other persons … an ethics based on the relationship between doctors and patients and essentially an ethics of virtue.” Drane's work is a “liberal Catholic Bioethics” in which he challenges his own faith tradition, the Roman Catholic Church, on such topics as sexuality, birth control, abortion, cloning, stem cell research, aging and dying, and euthanasia and physician-assisted suicide. The present article is a critical essay that analyzes the author's statements and conclusions. (shrink)

On the basis of a historical reconstruction of the stages through which the Christian notion of sin took shape in Protestantism, the significance of this term for modern bioethics is derived from its opposition to a holiness of God and his creatures, which in turn translates into the secular moral concept of dignity. This dignity imposes obligations to respect and to relationships that are sustained by faithfulness and trust. In being based on the gratuitousness of God’s grace, such relationships preclude (...) attempts at instrumentalization, denial of singularity, and subjection to market forces. Accordingly, reproductive cloning as well as exposing medicine to economical considerations can be classified as sinful. The difference between sinful acts and humans’ sinful state furthermore permits to address the problems of evil and misfortune in the world, and to acknowledge humans’ responsibility for the threats to humanity entailed by those ills. While the Christian faith relies on God’s mercy, it also imposes the task of following Christ by fighting against evil and misfortune. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 11.2 (2001) 205-209 [Access article in PDF] Bioethics Inside the Beltway Banning Human Cloning-Then What? Cynthia B. Cohen The public wonder and concern that accompanied the birth of Dolly, the cloned sheep, four years ago died down soon after her arrival. Little has been heard about human reproductive cloning since then in the public square. This silence was pierced recently (...) when two groups each announced its intention to clone a child from a human being within the next few years.The Raelians, a religious organization, disclosed in October 2000 that they had found a grieving American couple willing to pay $500,000 to clone their deceased child and that they would proceed with cloning in a secret laboratory within the United States. A few months later, an international consortium led by Pavos Zavos, Ph.D., a University of Kentucky emeritus professor of biology, and Severino Antinori, M.D., an Italian infertility specialist, declared that it intended to clone the first human within two years at an undisclosed location outside the United States. These announcements led Representative James Greenwood (R-PA), chair of the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, to convene a hearing on human cloning on 28 March 2001.Why did human reproductive cloning suddenly become of concern to the House of Representatives? What will the federal government do with regard to the development of human cloning at this point in time? And what should it do to address human cloning in the long-term? I will briefly highlight the major controversies that surfaced at the hearing and then consider the broader questions. Scientific Controversies The initial question of concern to the House subcommittee members was whether cloning science has now reached the point of application to humans. Scientists at the hearing offered widely diverging views about this. Zavos testified that only a small number of cloned animals has died after birth and declared that the key to avoiding impaired human clones is to engage in prenatal screening. Consequently, it is now safe to undertake human cloning, he maintained. He was supported in this view by Brigitte Boisselier, Ph.D., visiting assistant professor [End Page 205] of chemistry at Hamilton College and scientific director of the Raelians, who argued that human cloning would not give rise to the problems that have been encountered in nonhuman mammalian cloning.However, professor of veterinary medicine Mark Westhusin, Ph.D., of Texas A&M University, and Massachusetts Institute of Technology researcher Rudolf Jaenisch, Ph.D., maintained that the same sorts of problems that have appeared in nonhuman mammalian cloning would reappear in human cloning. Westhusin stated that mammals have incurred serious defects leading to spontaneous abortion and that mammalian newborns often display severe respiratory and circulatory problems. The most likely explanation for such abnormalities, Jaenisch hypothesized, is that in cloning, the genetic reprogramming that governs the way an organism develops must take place in a much shorter period of time than in coital or in vitro reproduction. This may result in faulty reprogramming leading to dysregulation of gene expression and consequent genetic defects in cloned animals. There is good reason to think that this also would occur in human cloning, Jaenisch maintained. Until reproductive cloning research has been carried out on several generations of primates and is better understood, he argued, human cloning should not be attempted. Even then, several generations of descendants of human clones would have to be observed before scientists could be sure that it would not have a destructive impact on humans. This process could take as long as a century. Ethical Controversy Bioethicists who testified focused on those aspects of the ethical controversy surrounding human cloning that are of particular interest to public policy makers. Thomas Murray, Ph.D., President of The Hastings Center and a member of NBAC, maintained that human cloning is still unsafe, as NBAC had predicted, and that, if carried out, would leave in its wake "damaged women, many dead fetuses, and children born with serious impairments." He expressed particular concern that couples suffering... (shrink)

This volume attempts to show why ontology matters for a proper grasp of issues in bioethics. -/- Contemporary discussions on bioethics often focus on seeking solutions for a wide range of issues that revolve around persons. The issues in question are multi-layered, involving such diverse aspects as the metaphysical/ontological, personal, medical, moral, legal, cultural, social, political, religious, and environmental. In navigating through such a complex web of issues, it has been said that the central problems philosophers and bioethicists face are (...) ethical in nature. In this regard, biomedical sciences and technological breakthroughs take a leading role in terms of shaping the sorts of questions that give rise to ethical problems. For example, is it ethical to keep terminally ill patients alive on dialysis machines or artificial ventilators? Is it ethical to take someone’s vital organs upon death and transplant them into another person’s body without any prior consent from a deceased person? Reproductive techniques also raise complicated ethical issues involving in vitro fertilization, contraceptives, prenatal testing, abortions, and genetic enhancements. Moreover, biomedical issues raise ethical problems in regards to research on human subjects, stem cell research, and enhancement biotechnology. The beginning and end of life issues bring up their own complicated ethical conundrums involving, among other things, terminating life support and euthanasia. -/- This book approaches such complex bioethical questions by engaging in ground-level debates about the ontology of persons. This is a non-negotiable first step in taking steps forward in seeking a plausible solution(s) for the complex ethical problems in bioethics. Although the contributors in this book advance their arguments in their own ways, they all agree on one crucial methodological point: the importance of taking the ontology of persons for bioethics seriously. This is the spirit that brings the contributors of this book together as they seek to build their case(s) concerning the nature of persons. (shrink)

Definition of the problem: This article describes the communication structure concerning the problems of genetic engineering, in-vitro fertilization and the current debate about „genetic advisory”. Arguments: Proceeding from the social systems theory, two observation types are discriminated: 1st and 2nd orders, which occur here as critical and affirmative positions. The first term refers to specific operations of the social system of medicine, the second to communication of social movements. Neither perspective can deliver total rationality or unity, and the two (...) positions cannot be put together as one rational model. They have to be put into debate structures in order to learn from each other by reciprocal observations. Conclusion: Every kind of observation, taken in a communicative frame like this one, delivers a limited, but necessary contribution to the debate. System rationality will be possible only by coupling asymmetrical observations. This goal will, however, can only be reached, if the communication proceeds in a controversy based mode. This way, the difference between critical and affirmative positions cannot be „solved” but it can be used for further recognition. (shrink)

In response to the many changes currently going on in health care, this book offers the combined insight and wisdom of a stellar group of scholars and professionals with extensive experience in the health care field. The book opens with a look at people's actual experience of health care today, from four different perspectives. It then addresses foundational questions, including the nature of medicine, nursing, and justice. Surveyed next are the changing economics of health care as well as the impact (...) of these changes on such areas as mental health care, long-term care, health care for minorities, and legal malpractice. The closing section of the book assesses from a Christian perspective available constructive alternatives, including creative funding strategies with special attention to the needs of poor persons, physician unions, and the use of "alternative medicine" therapies. (shrink)

Genomic interventions ex utero and in utero are already a reality in medicine. It is plausible to believe that this reality will lead to therapies at the preimplantation level, especially where such interventions are the only safe and effective way to truly prevent human suffering and disease in offspring. The plausibility of this type of genomic therapy is of particular interest for prospective parents who are Roman Catholic, since in vitro fertilization provides the only means by which an (...) offspring’s genome may be accessed prior to implantation. The goal of this essay is to provide a review of two traditional methodologies in Roman Catholic moral thought and the potential moral quandary they present Roman Catholic parents: adherence to moral teaching prohibiting IVF or relief of gene-based disease in their child. After finding little resolution of this quandary through these two methodologies, the essay proposes as an alternative a third approach that leans heavily on John Henry Cardinal Newman’s understanding of doctrinal development. National Catholic Bioethics Quarterly 11.4 (Winter 2011): 735–756. (shrink)

Two genetic technologies capable of making heritable changes to the human genome have revived interest in, and in some quarters a very familiar panic concerning, so-called germline interventions. These technologies are: most recently the use of CRISPR/Cas9 to edit genes in non-viable IVF zygotes and Mitochondrial Replacement Therapy the use of which was approved in principle in a landmark vote earlier this year by the United Kingdom Parliament. The possibility of using either of these techniques in humans has encountered (...) the most violent hostility and suspicion. However it is important to be aware that much of this hostility dates back to the fears associated with In Vitro Fertilization and other reproductive technologies and by cloning; fears which were baseless at the time concerning both IVF and cloning the use of both of which have proved to be highly beneficial to humanity and which have been effectively regulated and controlled. This paper argues that CRISPR should by pursued through res.. (shrink)

Stem cell research is very promising. The use of human embryos has been confronted with objections based on ethical and religious positions. The recent production of reprogrammed adult (induced pluripotent) cells does not – in the opinion of scientists – reduce the need to continue human embryonic stem cell research. So the debate continues.Islam always encouraged scientific research, particularly research directed toward finding cures for human disease. Based on the expectation of potential benefits, Islamic teachings (...) permit and support human embryonic stem cell research. The majority of Muslim scholars also support therapeutic cloning. This permissibility is conditional on the use of supernumerary early pre-embryos which are obtained during infertility treatment in vitro fertilization (IVF) clinics. The early pre-embryos are considered in Islamic jurisprudence as worthy of respect but do not have the full sanctity offered to the embryo after implantation in the uterus and especially after ensoulment.In this paper the Islamic positions regarding human embryonic stem cell research and therapeutic cloning are reviewed in some detail, whereas positions in other religious traditions are mentioned only briefly.The status of human embryonic stem cell research and therapeutic cloning in different countries, including the USA and especially in Muslim countries, is discussed. (shrink)

Are there universal ethical principles that should govern the conduct of medicine and research worldwide? -- Is it morally acceptable to buy and sell organs for human transplantation? -- Were it physically safe, would human reproductive cloning be acceptable? -- Is the deliberately induced abortion of a human pregnancy ethically justifiable? -- Is it ethical to patent or copyright genes, embryos, or their parts? -- Should minors have the right to refuse treatment, even when against the (...) will of their parents or guardians? -- Is physician-assisted suicide ever ethical? -- Should stem cell research utilizing embryonic tissue be conducted? -- Should we prohibit the use of chimpanzees and other great apes in biomedical research? -- Should the United States of America adopt universal health care? -- Is there a legitimate place for human genetic enhancement? -- Can there be agreement as to what constitutes human death? -- Is there ever a circumstance in which a doctor may withhold information? -- Should in vitro fertilization be an option for a woman? -- Are international clinical trials exploitative? (shrink)

While model organisms have had many historians, this article places studies of humans, and particularly our development, in the politics of species choice. Human embryos, investigated directly rather than via animal surrogates, have gone through cycles of attention and neglect. In the past 60 years they moved from the sidelines to center stage. Research was resuscitated in anatomy, launched in reproductive biomedicine, molecular genetics, and stem-cell science, and made attractive in developmental biology. I explain this surge of interest (...) in terms of rivalry with models and reliance on them. The greater involvement of medicine in human reproduction, especially through in vitro fertilization, gave access to fresh sources of material that fed critiques of extrapolation from mice and met demands for clinical relevance or “translation.” Yet much of the revival depended on models. Supply infrastructures and digital standards, including biobanks and virtual atlases, emulated community resources for model organisms. Novel culture, imaging, molecular, and postgenomic methods were perfected on less precious samples. Toing and froing from the mouse affirmed the necessity of the exemplary mammal and its insufficiency justified inquiries into humans. Another kind of model—organoids and embryo-like structures derived from stem cells—enabled experiments that encouraged the organization of a new field, human developmental biology. Research on humans has competed with and counted on models. (shrink)

Preface -- How brave a new world? : God, technology, and medicine -- A theological reflection on reproductive medicine -- Are our genes our fate? : genomics and Christian theology -- Persons, neighbors, and embryos : some ethical reflections on human cloning and stem cell research -- Extending human life : to what end? -- What is Christian about Christian bioethics? -- Revitalizing medicine : empowering natality vs. fearing mortality -- The future of the human (...) species -- Creation, creatures, and creativity : the Word and the final Word. (shrink)

The views on in vitro fertilization within Russian Orthodox Christian society are diverse. One reason for that variation is the ambiguity found in “The Basis of the Social Concept,” the document issued in 2000 by the Russian Orthodox Church and considered to be the primary guidelines for determining the Church’s stance on bioethics. This essay explores how the treatment of infertility reconciles with the Orthodox Christian faith and what methods of medical assistance for infertility may be appropriate for Orthodox (...) Christians. The focus here is on IVF because it is among the most widely used methods to overcome childlessness, and the permissibility of IVF is the object of disagreement among Orthodox. The article defines criteria that can help to discern what is absolutely wrong and must be avoided from what only falls short of the mark, but not very far, for Orthodox Christians. If treatment of the underlying causes of infertility has failed or promises no hope and a husband and a wife do not feel able to carry the Cross of infertility, then from pastoral dispensation they might be blessed to use ethically acceptable variants of IVF. IVF has many variants that are different in their spiritual influence on a person. Orthodox Christians pursuing IVF should seek spiritual guidance and a blessing to pursue IVF. They must not form more embryos than will be transferred in the same cycle. Freezing, discarding, or reduction of embryos is forbidden. Infertile couples ought to use only their reproductive cells. The use of donor gametes is unacceptable. Any embryo formed ought to be transferred into the wife’s womb, and the use of surrogates is impermissible. Only a husband and wife who are able to maintain their marital union and where the wife is still of childbearing age should be blessed to use IVF. (shrink)

In 1969, the field of human genetics was in its infancy. Amniocentesis was a new technique for prenatal diagnosis, and a newborn genetic screening program had been established in one state. There were also concerns about the potential hazards of genetic engineering. A research group at the Hastings Center and Paul Ramsey pioneered in the discussion of genetics and bioethics. Two principal techniques have emerged as being of enduring importance: human gene transfer research and genetic testing and screening. (...) This essay tracks the development and use of these techniques and considers the ethical issues that they raise. (shrink)

This book examines the field of bioethics from an international and regional legal perspective. It focuses on major international law documents such as the United Nations Universal Declaration on Bioethics and Human Rights and UNESCO declarations on human cloning and the human genome. Coverage of regional legal instruments includes the Council of Europe Convention on Human Rights and Biomedicine (the Oviedo Convention) and its Protocols on cloning, transplantation, and research with human beings. Work (...) on surrogacy issues by the Hague Conference on Private International Law is also discussed, as are some African regional legal instruments on biosafety, and stem cell research. (shrink)

The advance of medical and biological science and technology has presented us with new ethical and legal issues. Is embryonic stem cell research morally justified and legally allowed? What moral status do embryos have? Who can be a morally appropriate user of In Vitro fertilization? Who can use donated sperm and/or egg? What is the scope of reproductive liberty?” What is the meaning of a family and that of reproduction? How far does our genetic intervention go?”Scientists, lawyers, and (...) laymen are waiting for clear answers from philosophers. Unfortunately, philosophers have not seemed to give satisfactory answers to them. We may have various reasons. One of main reasons, however, seems to me that the above philosophical questions have not been the main research topics for philosophers since philosophy gave up metaphysical and/or religious questions. Thus, I argue that biomedical ethical issues urge philosophers tochange the philosopher’s attitude of doing philosophy. Those issues make them consider and rethink our fundamental concepts of life, death, family, and values pursued by human beings. In addition, it is easy to find conflicting ethical and philosophical answers to the above questions. Thus, it is very hard to reach consensus on the above ethical issues. This makes philosophers consider how we make a group decision over ethical issues showing conflicting but reasonable ethical answers in a plural society. This requires philosophers, especially scholars of ethics, develop a new ethics and its relevant concepts. This ethics must be able to work in a plural society where reasonable comprehensive belief systems coexist. In these respects, I argue that bioethics has to struggle with a newchallenge to philosophy. (shrink)

A significant number of current developments in the field of Biotechnology –such as stem cells, in vitro fertilization, embryo research, cloning, among others– are related directly or indirectly to the beginning of human life. It is important to acknowledge the biological status of the human embryo: when does its life begin and what is it from a biological standpoint. Therefore, by considering such information, informed choices could be made in moral and legal issues. The different biological (...) processes of fertilization are presented, noting particularly when human life begins. Based on these biological facts some basic principles are proposed to establish a moral and legal regulation. (shrink)

Although many scientists view cloning as a useful procedure for scientific research into early embryo development—one that cannot currently be used to produce multiple copies of humans—the popular literature has led some individuals to view it as sinister. To address the concerns of the public, various conceptions of cloning are distinguished and their basis in fact analyzed. The possible uses, benefits, and detriments of both embryo splitting and nuclear transplantation are explained. Once the nature and purposes of (...) class='Hi'>cloning are understood, and the distinctive ethical dilemmas created by embryo splitting and nuclear transplantation are sorted out, these procedures should be clinically implemented to assist in vitro fertilization treatment for those who are infertile and to further other therapeutic and investigational efforts in medicine. (shrink)

In addressing bioethical issues at the beginning of human life, such as abortion, in vitro fertilization, and embryonic stem cell research, one primary concern regards establishing when a developing human embryo or fetus can be considered a person. Thomas Aquinas argues that an embryo or fetus is not a human person until its body is informed by a rational soul. Aquinas's explicit account of human embryogenesis has been generally rejected by contemporary scholars due to (...) its dependence upon medieval biological data, which has been far surpassed by current scientific research. A number of scholars, however, have attempted to combine Aquinas's basic metaphysical account of human nature with current embryological data to develop a contemporary Thomistic account of a human person's beginning. In this article, I discuss two recent interpretations in which it is argued that a human person does not begin to exist until a fetus has developed a functioning cerebral cortex. (shrink)

Background No two countries have adopted identical regulatory measures on cloning. Understanding the complexity of these regulatory variations is essential. It highlights the challenges associated with the regulation of a controversial and rapidly evolving area of science and sheds light on a regulatory framework that can accommodate this reality. Methods Using the most reliable information available, we have performed a survey of the regulatory position of thirty countries around the world regarding the creation and use of cloned embryos (see (...) Table 1). We have relied on original and translated legislation, as well as published sources and personal communications. We have examined the regulation of both reproductive cloning (RC) and non-reproductive cloning (NRC). Results While most of the countries studied have enacted national legislation, the absence of legislation in seven of these countries should not be equated with the absence of regulation. Senator Morin was not correct in stating that the majority of recent legislation bans both RC and NRC. Recent regulatory moves are united only with regard to the banning of RC. While NRC is not permitted in seventeen of the countries examined, it could be permitted in up to thirteen countries. Conclusions There is little consensus on the various approaches to cloning laws and policies, and the regulatory position in many countries remains uncertain. (shrink)

Bioethics has been in existence now for more than twenty years. Much has changed, however, since Van Rensselaer Potter2 first used the term bioethics in 1971. For Potter, bioethics was an applied science with its roots in the biological sciences and its orientation towards the betterment of human life. Today the concept is used in a different context. It has become the name given to the ethical research that has become necessary in light of the new possibilities created by (...) revolutionary developments in medical science. Generally speaking, bioethics is concerned with the beginning and the end of life. In a certain sense, however, this is merely a de facto definition which does not possess a great deal of internal logical consistency.If we attempt to reconstruct the incredibly rapid evolution of bioethics we quickly realize how the times were truly ripe for this new discipline to begin to mature. In a very short space of time bioethics was taken seriously in just about every University and medical centre the world over. There is no part of the world which has not organised a colloquium or developed a study programme or created a Centre for Biomedical Ethics. Yet this advance is hardly surprising if we consider the fact that there have been revolutionary developments in themedical world in the 1960’s which have made it necessary to engage in serious ethical reflection on the borderline questions of human life.From the start, bioethicists have concerned themselves primarily with ethical problems related to reproductive technology such as in vitro fertilization, medically assisted fertilization with donor gametes, pregnancy termination, and the status of the embryo. More recently, however, questions concerning the end of life have entered the bioethicist’s field of interest, e.g. ethical questions related to euthanasia and the problems surrounding the artificial nutrition and hydration of persistently vegetative patients. In the meantime, of course, bioethics has broadened its field of interest beyond questions related to the beginning and end of life. Serious ethical and juridical reflection has resulted from the problems surrounding organ transplantation, transplantation of brain tissue, and the problem of AIDS.With the many recent developments in genetics, the first applications of gene therapy, and the world-wide human genome research project bioethics is assured an exciting future. It is clear that the issues which grab the bioethicist’s attention are rather disparate. Moreover, we are now beginning to realize that a whole gamut of specific questions cannot be addressed unless the broader context of the ethics of health care in general is taken into account. Such a realization has led to something of a new movement within the bioethical sphere which is interested in widening the notion of ‘medical ethics’ or ‘ethics of health’.The purpose of this article is to help familiarize the reader with the world of bioethics. Such a task is both simple and complex; bioethics has become a house with many rooms, a house, furthermore, which is being constantly renovated and rebuilt. By way of introduction, we shall take an investigative and evaluative stroll through the broad landscape bioethics has traced in the first twenty years of its existence. (shrink)

Bioethics has been in existence now for more than twenty years. Much has changed, however, since Van Rensselaer Potter2 first used the term bioethics in 1971. For Potter, bioethics was an applied science with its roots in the biological sciences and its orientation towards the betterment of human life. Today the concept is used in a different context. It has become the name given to the ethical research that has become necessary in light of the new possibilities created by (...) revolutionary developments in medical science. Generally speaking, bioethics is concerned with the beginning and the end of life. In a certain sense, however, this is merely a de facto definition which does not possess a great deal of internal logical consistency.If we attempt to reconstruct the incredibly rapid evolution of bioethics we quickly realize how the times were truly ripe for this new discipline to begin to mature. In a very short space of time bioethics was taken seriously in just about every University and medical centre the world over. There is no part of the world which has not organised a colloquium or developed a study programme or created a Centre for Biomedical Ethics. Yet this advance is hardly surprising if we consider the fact that there have been revolutionary developments in themedical world in the 1960’s which have made it necessary to engage in serious ethical reflection on the borderline questions of human life.From the start, bioethicists have concerned themselves primarily with ethical problems related to reproductive technology such as in vitro fertilization, medically assisted fertilization with donor gametes, pregnancy termination, and the status of the embryo. More recently, however, questions concerning the end of life have entered the bioethicist’s field of interest, e.g. ethical questions related to euthanasia and the problems surrounding the artificial nutrition and hydration of persistently vegetative patients. In the meantime, of course, bioethics has broadened its field of interest beyond questions related to the beginning and end of life. Serious ethical and juridical reflection has resulted from the problems surrounding organ transplantation, transplantation of brain tissue, and the problem of AIDS.With the many recent developments in genetics, the first applications of gene therapy, and the world-wide human genome research project bioethics is assured an exciting future. It is clear that the issues which grab the bioethicist’s attention are rather disparate. Moreover, we are now beginning to realize that a whole gamut of specific questions cannot be addressed unless the broader context of the ethics of health care in general is taken into account. Such a realization has led to something of a new movement within the bioethical sphere which is interested in widening the notion of ‘medical ethics’ or ‘ethics of health’.The purpose of this article is to help familiarize the reader with the world of bioethics. Such a task is both simple and complex; bioethics has become a house with many rooms, a house, furthermore, which is being constantly renovated and rebuilt. By way of introduction, we shall take an investigative and evaluative stroll through the broad landscape bioethics has traced in the first twenty years of its existence. (shrink)

There are an increasing number of cell therapy approaches being studied and employed world‐wide. An emerging area in this field is the use of human pluripotent stem cell (hPSC) products for the treatment of injuries/diseases that cannot be effectively managed through current approaches. However, as with any cell therapy, vast numbers of functional and safe cells are required. Bioreactors provide an attractive avenue to generate clinically relevant cell numbers with decreased labour and decreased batch to (...) batch variation. Yet, current methods of performing quality control are not readily scalable to the cell densities produced during bioreactor scale‐up. One potential solution is the application of inducible/controllable suicide genes that can trigger cell death in unwanted cell types. These types of approaches have been demonstrated to increase the quality and safety of the resultant cell products. In this review, we will provide background on these approaches and how they could be used together with bioreactor technology to create effective bioprocesses for the generation of high quality and safe hPSCs for use in regenerative medicine approaches. (shrink)

Many who believe that human embryos have moral status are convinced that their use in human embryonic stem cell (hESC) research can be morally justified as long as they are discarded embryos left over from fertility treatments. This is one reason why this view about discarded embryos has played such a prominent role in the debate over publicly funding hESC research in the United States and other countries. Many believe that this view offers the best chance of (...) a compromise between the different sides in this debate. This paper focuses on what seems to be the most plausible argument for this view about discarded embryos. It shows that this argument is unsound regardless of how one understands the claim that embryos have moral status. It also discusses the implications of this conclusion for attempts to use this argument as a basis for public policy. (shrink)

ABSTRACT With the controversial ethical issues on the creation of human embryos through cloning for therapeutic research, which holds more promise for medical breakthroughs that the world could ever imagine and the acknowledgement by many scientists that this biotechnology may not lead in the near future to therapies; this country report discusses the approach Singapore takes on human stem cell research, interjected with the authors’ own arguments and suggestions especially on research compensation injuries, an often neglected (...) important issue. International comparative viewpoints taken by the major countries in the world are also included in the appendix. (shrink)

This book from the Center for Bioethics and Human Dignity provides a faith-based evaluation of recent technologies and trends in bioethics--including the current debate surrounding stem cell research. Fifteen noted scholars and medical practitioners discuss some of today's new and controversial work in biomedicine--xenotransplantation, artificial intelligence, cybernetics, and more--and evaluate from a Christian perspective both the science and the ethical questions it raises. Designed to orient general readers to the current state of biomedical research, Cutting-Edge Bioethics is must (...) reading for anyone wishing to confront and wrestle with the challenging moral issues posed by this ever-advancing field. (shrink)

This chapter contains sections titled: References and Further Reading.

The article investigates the validity of two different versions of the slippery slope argument construed in relation to human gene therapy: the empirical and the conceptual argument. The empirical version holds that our accepting somatic cell therapy will eventually cause our accepting eugenic medical goals. The conceptual version holds that we are logically committed to accepting such goals once we have accepted somatic cell therapy. It is argued that neither the empirical nor the conceptual version of the (...) argument can provide a conclusive moral reason for banning somatic cell therapy. According to a third interpretation, referred to as the arbitrary result argument, the many apparent similarities between somatic cell therapy and eugenic-based human genetic engineering drive us to make principled choices concerning what differences and similarities between the two practices should be regarded as morally (ir)relevant. Decisions of this kind are likely to have unpredictable moral consequences. Thus formulated, the slippery slope argument has much plausibility. One objects to somatic cell therapy not so much because of what is at the bottom of the slope on which it lies, but because it is on a slope of which one does not know what is at the bottom. While the arbitrary result argument does not provide a conclusive reason for prohibiting human gene therapy, it reminds of a very important thing: when making bioethical decisions, we should be as specific and as consistent as possible about our basic moral and medical concepts. (shrink)

The author, a member of the U.S.President's Council on Bioethics, discussesethical issues raised by human cloning, whetherfor purposes of bringing babies to birth or forresearch purposes. He first argues that everycloned human embryo is a new, distinct, andenduring organism, belonging to the speciesHomo sapiens, and directing its owndevelopment toward maturity. He then distinguishesbetween two types of capacities belonging toindividual organisms belonging to this species,an immediately exerciseable capacity and abasic natural capacity that develops over time. He argues that (...) it is the second type ofcapacity that is the ground for full moralrespect, and that this capacity (and itsconcomitant degree of respect) belongs tocloned human embryos no less than to adulthuman beings. He then considers and rejectscounter-arguments to his position, includingthe suggestion that the capacity of embryos isequivalent to the capacity of somatic cells,that full human rights are afforded only tohuman organisms with functioning brains, thatthe possibility of twinning diminishes themoral status of embryos, that the fact thatpeople do not typically mourn the loss of earlyembryos implies that they have a diminishedmoral status, that the fact that earlyspontaneous abortions occur frequentlydiminishes the moral status of embryos, andthat his arguments depend upon a concept ofensoulment. He concludes that if the moralstatus of cloned human embryos is equivalent tothat of adults, then public policy should bebased upon this assumption. (shrink)

What role should religion play in a religiously pluralistic liberal society? Public bioethics unavoidably raises this question in a particularly insistent fashion. As the 20 papers in this collection demonstrate, the issues are complex and multifaceted. The authors address specific and highly contested issues as assisted suicide, stem cell research, cloning, reproductive health, and alternative medicine as well as more general questions such as who legitimately speaks for religion in public bioethics, what religion can add to our understanding (...) of justice, and the value of faith-based contributions to healthcare. Christian (Catholic and Protestant), Jewish, Islamic, and Buddhist viewpoints are represented. The first book to focus on the interface of religion and bioethics, this collection fills a significant void in the literature. (shrink)

After the typical theological and bioethical questions about in vitro fertilization (IVF) are vetted, there remains a three-dimensional understanding of responsibility that is not typically considered in Christian bioethics. This paper will explore responsibility to the spouses’ loving union, their bodies, and society in order to ascertain the morality of IVF. In a marriage partnership, the spouses’ primary responsibility is to each other. Although in matrimony physical union is essential to marriage, children are not. The second dimension of responsibility (...) focuses on the body—“the temple of God”—and on our responsibility to care for it. This concerns the woman, her husband, and even the newborn. Finally, the third understanding of responsibility leads us to address social concerns, with an emphasis on social dynamics, especially the cost of IVF procedures and how they siphon medical resources away from more urgent human needs in health care and within society. (shrink)

To discern the ethical issues involved incurrent gene therapy research, to explore theproblems inherent in possible future genetherapies, and to encourage debate within thescientific community about ethical questionsrelevant to both, we surveyed American Societyof Human Genetics scientists who engage inhuman genetics research. This study of theopinions of U.S. scientific experts about theethical issues discussed in the literature ongene therapy contributes systematic data on theattitudes of those working in the field as wellas elaborative comments. Our survey finds thatrespondents are highly (...) supportive of thepotential use of somatic cell gene therapy tocure serious diseases in adults and children aswell as prospective offspring. A clearmajority, however, believe that using suchgenetic techniques for enhancement purposes isunacceptable. Delineating the line betweendisease/disorder and improvement/enhancementposes a problem not easily resolved and oneconducive to the growth of slippery-slopeapprehensions. The majority of respondents alsoadvocate germ-line therapy, in theory at least,and under similar restrictions, but theyrecognize the roadblock that the existence ofunanticipated negative consequences currentlypresents. Another complex matter involvestrying to determine appropriate reasons forchoosing target diseases for research, forwhich the dichotomy between rare single-geneand common multifactorial diseases reveals anongoing dilemma. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Private Bioethics Forums:Counterpoint to Government BodiesCynthia B. Cohen (bio) and Elizabeth Leibold McCloskey (bio)Ethical issues associated with reproductive technologies quickly gain public attention. The front pages of newspapers have featured stories about grandmothers giving birth to their own grandchildren, couples "renting" wombs from surrogates, and researchers prepared to transplant fetal ovaries into women unable to produce viable eggs. With each new and bolder foray into reproductive realms, the question (...) of whether to set limits on the use of such technologies surfaces. An ancillary debate inevitably ensues about the proper forum for discussing and deciding such limits. The recent announcement of human embryo splitting or cloning research is no exception to this pattern. Articles in both the popular press and academic circles in the wake of the reported research contain lamentations about the absence of a national ethics body that could address the ethical issues raised by the cloning experiment. This research also breathed new life into congressional calls to create a government bioethics commission.1At times, it appears that the substantive questions raised by a procedure like cloning are subsumed under the debate about whether this ethics group or that should be convened to study the matter. But the forum in which options are discussed is as crucial to the development of sound ethical thought and public policy as are the conclusions themselves. Thus, we address the question of whether a private, as opposed to a public, bioethics body provides a distinctively useful forum for reaching an understanding of issues such as cloning that have significant ethical and public policy implications.A 1993 Office of Technology Assessment report, in which the authors suggest that a new federal bioethics commission might be useful, has helped to frame recent discussions about the value of government-sponsored bioethics bodies (Office of Technology Assessment 1993). To most people, the question of whether a national forum for bioethics is needed is synonymous with the question of whether a new federal body should be convened. Yet the existence of the National Advisory Board on Ethics in Reproduction (NABER) suggests that the scope of the question should be broadened. [End Page 283]NABER was born in 1992, in part as a response to an Institute of Medicine report on infertility. That document endorsed the formation of a nongovernment body to develop guidelines for assisted reproductive measures and fetal research in the event that a government body was not forthcoming (Institute of Medicine 1989). NABER, which was founded by the American College of Obstetricians and Gynecologists and the American Fertility Society, now functions wholly independently of those groups and is supported by private foundations including the Ford, Greenwall, and Josiah Macy, Jr., Foundations and the Walter and Elise Haas Fund. NABER has issued a report on ethical issues related to the use of fetal tissue (Cohen and Jonsen 1993), is about to publish a report and background papers on oocyte donation, and presents a report on human cloning in this issue of the Kennedy Institute of Ethics Journal. In addition, it has developed a protocol for NABER review of research proposals from federal agencies subject to federal guidelines on the use of human subjects in research.Thus, in function and form, NABER was envisioned as a substitute for a government body, and it now functions in a manner similar to several types of government bioethics groups. Like the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) and the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (President's Commission), NABER functions primarily through the publication of reports intended for a broad audience of practitioners, patients, policymakers, and the general public. Just as the Ethics Advisory Board of the late 1970s examined ethical issues related to specific protocols or types of research as they arose, NABER's purposes include scrutinizing the ethics of various research efforts in the reproductive area.NABER also parallels past government bodies in form. Like these groups, NABER is a multidisciplinary board that meets regularly and is supplemented by consultants and staff who provide research and writing for the board. Its members are nationally recognized in... (shrink)

This article assesses the role of an important Russian public institution, the Russian Orthodox Church (ROC), in shaping the religious discourse on bioethics in Russia. An important step in this process was the approval of ‘The Basis of the Social Concept of the Russian Orthodox Church’ (2000), one chapter of which is devoted to bioethics. However, certain inadequacies in the creation of this document resulted in the absence of a clear position of the Russian Orthodox Church on some end-of-life issues, (...) reproductive technologies, embryo stem cells, and other topics.Using the example of reproductive dilemmas, the author researches how the ROC clarifies its teaching on issues relating to bioethics. In the 2010s the ROC introduced a new method of taking into account the views of believers and the articulation of the church’s position. This article examines the extensive public discussion of a new document, ‘Ethical issues Associated with In Vitro Fertilization’. (shrink)

ABSTRACT I argue that this examination and appreciation for the shift to abductive reasoning should be extended to the intersection of neuroscience and novel brain-computer interfaces too. This paper highlights the implications of applying abductive reasoning to personalized implantable neurotechnologies. Then, it explores whether abductive reasoning is sufficient to justify insurance coverage for devices absent widespread clinical trials, which are better applied to one-size-fits-all treatments. INTRODUCTION In contrast to the classic model of randomized-control trials, often with a large number of (...) subjects enrolled, precision medicine attempts to optimize therapeutic outcomes by focusing on the individual.[i] A recent publication highlights the strengths and weakness of both traditional evidence-based medicine and precision medicine.[ii] Plus, it outlines a tension in the shift from evidence-based medicine’s inductive reasoning style (the collection of data to postulate general theories) to precision medicine’s abductive reasoning style (the generation of an idea from the limited data available).[iii] The paper’s main example is the application of precision medicine for the treatment of cancer.[iv] I argue that this examination and appreciation for the shift to abductive reasoning should be extended to the intersection of neuroscience and novel brain-computer interfaces too. As the name suggests, brain-computer interfaces are a significant advancement in neurotechnology that directly connects someone’s brain to external or implanted devices.[v] Among the various kinds of brain-computer interfaces, adaptive deep brain stimulation devices require numerous personalized adjustments to their settings during the implantation and computation stages in order to provide adequate relief to patients with treatment-resistant disorders. What makes these devices unique is how adaptive deep brain stimulation integrates a sensory component to initiate the stimulation. While not commonly at the level of sophistication as self-supervising or generative large language models,[vi] they currently allow for a semi-autonomous form of neuromodulation. This paper highlights the implications of applying abductive reasoning to personalized implantable neurotechnologies. Then, it explores whether abductive reasoning is sufficient to justify insurance coverage for devices absent widespread clinical trials, which are better applied to one-size-fits-all treatments.[vii] ANALYSIS I. The State of Precision Medicine in Oncology and the Epistemological Shift While a thorough overview of precision medicine for the treatment of cancer is beyond the scope of this article, its practice can be roughly summarized as identifying clinically significant characteristics a patient possesses (e.g., genetic traits) to land on a specialized treatment option that, theoretically, should benefit the patient the most.[viii] However, in such a practice of stratification patients fall into smaller and smaller populations and the quality of evidence that can be applied to anyone outside these decreases in turn.[ix] As inductive logic helps to articulate, the greater the number of patients that respond to a particular therapy the higher the probability of its efficacy. By straying from this logical framework, precision medicine opens the treatment of cancer to more uncertainty about the validity of these approaches to the resulting disease subcategories.[x] Thus, while contemporary medical practices explicitly describe some treatments as “personalized”, they ought not be viewed as inherently better founded than other therapies.[xi] A relevant contemporary case of precision medicine out of Norway focuses on the care of a patient with cancer between the ventricles of the heart and esophagus, which had failed to respond to the standard regimen of therapies over four years.[xii] In a last-ditch effort, the patient elected to pay out-of-pocket for an experimental immunotherapy (nivolumab) at a private hospital. He experienced marked improvements and a reduction in the size of the tumor. Understandably, the patient tried to pursue further rounds of nivolumab at a public hospital. However, the hospital initially declined to pay for it given the “lack of evidence from randomised clinical trials for this drug relating to this [patient’s] condition.”[xiii] In rebuttal to this claim, the patient countered that he was actually similar to a subpopulation of patients who responded in “open‐label, single arm, phase 2 studies on another immune therapy drug” (pembrolizumab).[xiv] Given this interpretation of the prior studies and the patient’s response, further rounds of nivolumab were approved. Had the patient not had improvements in the tumor’s size following a round of nivolumab, then pembrolizumab’s prior empirical evidence in isolation would have been insufficient, inductively speaking, to justify his continued use of nivolumab.[xv] The case demonstrates a shift in reasoning from the traditional induction to abduction. The phenomenon of ‘cancer improvement’ is considered causally linked to nivolumab and its underlying physiological mechanisms.[xvi] However, “the weakness of abductions is that there may always be some other better, unknown explanation for an effect. The patient may for example belong to a special subgroup that spontaneously improves, or the change may be a placebo effect. This does not mean, however, that abductive inferences cannot be strong or reasonable, in the sense that they can make a conclusion probable.”[xvii] To demonstrate the limitations of relying on the abductive standard in isolation, commentators have pointed out that side effects in precision medicine are hard to rule out as being related to the initial intervention itself unless trends from a group of patients are taken into consideration.[xviii] As artificial intelligence (AI) assists the development of precision medicine for oncology, this uncertainty ought to be taken into consideration. The implementation of AI has been crucial to the development of precision medicine by providing a way to combine large patient datasets or a single patient with a large number of unique variables with machine learning to recommend matches based on statistics and probability of success upon which practitioners can base medical recommendations.[xix] The AI is usually not establishing a causal relationship[xx] – it is predicting. So, as AI bleeds into medical devices, like brain-computer interfaces, the same cautions about using abductive reasoning alone should be carried over. II. Responsive Neurostimulation, AI, and Personalized Medicine Like precision medicine in cancer treatment, computer-brain interface technology similarly focuses on the individual patient through personalized settings. In order to properly expose the intersection of AI, precision medicine, abductive reasoning, and implantable neurotechnologies, the descriptions of adaptive deep brain stimulation systems need to deepen.[xxi] As a broad summary of adaptive deep brain stimulation, to provide a patient with the therapeutic stimulation, a neural signal, typically referred to as a local field potential,[xxii] must first be detected and then interpreted by the device. The main adaptive deep brain stimulation device with premarket approval, the NeuroPace Responsive Neurostimulation system, is used to treat epilepsy by detecting and storing “programmer-defined phenomena.”[xxiii] Providers can optimize the detection settings of the device to align with the patient’s unique electrographic seizures as well as personalize the reacting stimulation’s parameters.[xxiv] The provider adjusts the technology based on trial and error. One day machine learning algorithms will be able to regularly aid this process in myriad ways, such as by identifying the specific stimulation settings a patient may respond to ahead of time based on their electrophysiological signatures.[xxv] Either way, with AI or programmers, adaptive neurostimulation technologies are individualized and therefore operate in line with precision medicine rather than standard treatments based on large clinical trials. Contemporary neurostimulation devices are not usually sophisticated enough to be prominent in AI discussions where the topics of neural networks, deep learning, generative models, and self-attention dominate the conversation. However, implantable high-density electrocorticography arrays (a much more sensitive version than adaptive deep brain stimulation systems use) have been used in combination with neural networks to help patients with neurologic deficits from a prior stroke “speak” through a virtual avatar.[xxvi] In some experimental situations, algorithms are optimizing stimulation parameters with increasing levels of independence.[xxvii] An example of neurostimulation that is analogous to the use of nivolumab in Norway surrounds a patient in the United States who was experiencing both treatment-resistant OCD and temporal lobe epilepsy.[xxviii]Given the refractory nature of her epilepsy, implantation of an adaptive deep brain stimulation system was indicated. As a form of experimental therapy, her treatment-resistant OCD was also indicated for the off-label use of an adaptive deep brain stimulation set-up. Another deep brain stimulation lead, other than the one implanted for epilepsy, was placed in the patient’s right nucleus accumbens and ventral pallidum region given the correlation these nuclei had with OCD symptoms in prior research. Following this, the patient underwent “1) ambulatory, patient-initiated magnet-swipe storage of data during moments of obsessive thoughts; (2) lab-based, naturalistic provocation of OCD-related distress (naturalistic provocation task); and (3) lab-based, VR [virtual reality] provocation of OCD-related distress (VR provocation task).”[xxix] Such signals were used to identify when to deliver the therapeutic stimulation in order to counter the OCD symptoms. Thankfully, following the procedure and calibration the patient exhibited marked improvements in their OCD symptoms and recently shared her results publicly.[xxx] In both cases, there is a similar level of abductive justification for the efficacy of the delivered therapy. In the case study in which the patient was treated with adaptive deep brain stimulation, they at least had their neural activity tested in various settings to determine the optimum parameters for treatment to avoid them being based on guesswork. Additionally, the adaptive deep brain stimulation lead was already placed before the calibration trials were conducted, meaning that the patient had already taken on the bulk of the procedural risk before the efficacy could be determined. Such an efficacy test could have been replicated in the first patient’s cancer treatment, had it been biopsied and tested against the remaining immunotherapies in vitro. Yet, in the case of cancer with few options, one previous dose of a drug that appeared to work on the patient may justify further doses. However, as the Norwegian case presents, corroboration with known responses to a similar drug (from a clinical trial) could be helpful to validate the treatment strategy. (It should be noted that both patients were resigned to these last resort options regardless of the efficacy of treatment.) There are some elements of inductive logic seen with adaptive deep brain stimulation research in general. For example, abductively the focus could be that patient X’s stimulation parameters are different from patient Y’s and patient Z’s. In contrast, when grouped as subjects who obtained personalized stimulation, patients X, Y, and Z demonstrate an inductive aspect to this approach’s safety and/or efficacy. The OCD case holds plenty of abductive characteristics in line with precision medicine’s approach to treating cancer and as more individuals try the method, there will be additional data. With the gradual integration of AI into brain-computer interfaces in the name of efficacy, this reliance on abduction will continue, if not grow, over time. Moving forward, if a responsive deep brain stimulation treatment is novel and individualized (like the dose of nivolumab) and there is some other suggestion of efficacy (like clinical similarities to other patients in the literature), then it may justify insurance coverage for the investigative intervention, absent other unrelated reasons to deny it. III. Ethical Implications and Next Steps While AI’s use in oncology and neurology is not yet as prominent as its use in other fields (e.g., radiology), it appears to be on the horizon for both.[xxxi] AI can be found in both the functioning of the neurotechnologies as well as the implementation of precision medicine. The increasing use of AI may serve to further individualize both oncologic and neurological therapies. Given these implications and the handful of publications cited in this article, it is important to have a nuanced evaluation of how these treatments, which heavily rely on abductive justification, ought to be managed. The just use an abductive approach may be difficult as AI infused precision medicine is further pursued. At baseline, such technology relies on a level of advanced technology literacy among the general public and could exclude populations who lack access to basic technological infrastructure or know-how from participation.[xxxii] Even among nations with adequate infrastructure, as more patients seek out implantable neurotechnologies, which require robust healthcare resources, the market will favor patient populations that can afford this complex care.[xxxiii] If patients already have the means to pay for an initial dose/use of a precision medicine product out of pocket, should insurance providers be required to cover subsequent treatments?[xxxiv] That is, if a first dose of a cancer drug or a deep brain stimulator over its initial battery life is successful, patients may feel justified in having the costs of further treatments covered. The Norwegian patient’s experience implies there is a precedent for the idea that some public insurance companies ought to cover successful cancer therapies, however, insurance companies may not all see themselves as obligated to cover neurotechnologies that rely on personalized settings or that are based on precision/abductive research more than on clinical trials. CONCLUSION The fact that the cases outlined above rely on abductive style of reasoning implies that there may not be as strong a justification for coverage by insurance, as they are both experimental and individualized, when compared to the more traditional large clinical trials in which groups have the same or a standardized protocol (settings/doses). If a study is examining the efficacy of a treatment with a large cohort of patients or with different experimental groups/phases, insurance companies may conclude that the resulting symptom improvements are more likely to be coming from the devices themselves. A preference for inductive justification may take priority when ruling in favor of funding someone’s continued use of an implantable neurostimulator. There are further nuances to this discussion surrounding the classifications of these interventions as research versus clinical care that warrant future exploration, since such a distinction is more of a scale[xxxv] than binary and could have significant impacts on the “right-to-try” approach to experimental therapies in the United States.[xxxvi] Namely, given the inherent limitations of conducting large cohort trials for deep brain stimulation interventions on patients with neuropsychiatric disorders, surgically innovative frameworks that blend abductive and inductive methodologies, like with sham stimulation phases, have traditionally been used.[xxxvii] Similarly, for adaptive brain-computer interface systems, if there are no large clinical trials and instead only publications that demonstrate that something similar worked for someone else, then, in addition to the evidence that the first treatment/dose worked for the patient in question, the balance of reasoning would be valid and arguably justify insurance coverage. As precision approaches to neurotechnology become more common, frameworks for evaluating efficacy will be crucial both for insurance coverage and for clinical decision making. ACKNOWLEDGEMENT This article was originally written as an assignment for Dr. Francis Shen’s “Bioethics & AI” course at Harvard’s Center for Bioethics. I would like to thank Dr. Shen for his comments as well as my colleagues in the Lázaro-Muñoz Lab for their feedback. - [i] Jonathan Kimmelman and Ian Tannock, “The Paradox of Precision Medicine,” Nature Reviews. Clinical Oncology 15, no. 6 (June 2018): 341–42, https://doi.org/10.1038/s41571-018-0016-0. [ii] Henrik Vogt and Bjørn Hofmann, “How Precision Medicine Changes Medical Epistemology: A Formative Case from Norway,” Journal of Evaluation in Clinical Practice 28, no. 6 (December 2022): 1205–12, https://doi.org/10.1111/jep.13649. [iii] David Barrett and Ahtisham Younas, “Induction, Deduction and Abduction,” Evidence-Based Nursing 27, no. 1 (January 1, 2024): 6–7, https://doi.org/10.1136/ebnurs-2023-103873. [iv] Vogt and Hofmann, “How Precision Medicine Changes Medical Epistemology,” 1208. [v] Wireko Andrew Awuah et al., “Bridging Minds and Machines: The Recent Advances of Brain-Computer Interfaces in Neurological and Neurosurgical Applications,” World Neurosurgery, May 22, 2024, S1878-8750(24)00867-2, https://doi.org/10.1016/j.wneu.2024.05.104. [vi] Mark Riedl, “A Very Gentle Introduction to Large Language Models without the Hype,” Medium (blog), May 25, 2023, https://mark-riedl.medium.com/a-very-gentle-introduction-to-large-language-models-without-the-hype-5 f67941fa59e. [vii] David E. Burdette and Barbara E. Swartz, “Chapter 4 - Responsive Neurostimulation,” in Neurostimulation for Epilepsy, ed. Vikram R. Rao (Academic Press, 2023), 97–132, https://doi.org/10.1016/B978-0-323-91702-5.00002-5. [viii] Kimmelman and Tannock, 2018. [ix] Kimmelman and Tannock, 2018. [x] Simon Lohse, “Mapping Uncertainty in Precision Medicine: A Systematic Scoping Review,” Journal of Evaluation in Clinical Practice 29, no. 3 (April 2023): 554–64, https://doi.org/10.1111/jep.13789. [xi] Kimmelman and Tannock, “The Paradox of Precision Medicine.” [xii] Vogt and Hofmann, 1206. [xiii] Vogt and Hofmann, 1206. [xiv] Vogt and Hofmann, 1206. [xv] Vogt and Hofmann, 1207. [xvi] Vogt and Hofmann, 1207. [xvii] Vogt and Hofmann, 1207. [xviii] Vogt and Hofmann, 1210. [xix] Mehar Sahu et al., “Chapter Three - Artificial Intelligence and Machine Learning in Precision Medicine: A Paradigm Shift in Big Data Analysis,” in Progress in Molecular Biology and Translational Science, ed. David B. Teplow, vol. 190, 1 vols., Precision Medicine (Academic Press, 2022), 57–100, https://doi.org/10.1016/bs.pmbts.2022.03.002. [xx] Stefan Feuerriegel et al., “Causal Machine Learning for Predicting Treatment Outcomes,” Nature Medicine 30, no. 4 (April 2024): 958–68, https://doi.org/10.1038/s41591-024-02902-1. [xxi] Sunderland Baker et al., “Ethical Considerations in Closed Loop Deep Brain Stimulation,” Deep Brain Stimulation 3 (October 1, 2023): 8–15, https://doi.org/10.1016/j.jdbs.2023.11.001. [xxii] David Haslacher et al., “AI for Brain-Computer Interfaces,” 2024, 7, https://doi.org/10.1016/bs.dnb.2024.02.003. [xxiii] Burdette and Swartz, “Chapter 4 - Responsive Neurostimulation,” 103–4; “Premarket Approval (PMA),” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100026. [xxiv] Burdette and Swartz, “Chapter 4 - Responsive Neurostimulation,” 104. [xxv] Burdette and Swartz, 126. [xxvi] Sean L. Metzger et al., “A High-Performance Neuroprosthesis for Speech Decoding and Avatar Control,” Nature 620, no. 7976 (August 2023): 1037–46, https://doi.org/10.1038/s41586-023-06443-4. [xxvii] Hao Fang and Yuxiao Yang, “Predictive Neuromodulation of Cingulo-Frontal Neural Dynamics in Major Depressive Disorder Using a Brain-Computer Interface System: A Simulation Study,” Frontiers in Computational Neuroscience 17 (March 6, 2023), https://doi.org/10.3389/fncom.2023.1119685; Mahsa Malekmohammadi et al., “Kinematic Adaptive Deep Brain Stimulation for Resting Tremor in Parkinson’s Disease,” Movement Disorders 31, no. 3 (2016): 426–28, https://doi.org/10.1002/mds.26482. [xxviii] Young-Hoon Nho et al., “Responsive Deep Brain Stimulation Guided by Ventral Striatal Electrophysiology of Obsession Durably Ameliorates Compulsion,” Neuron 0, no. 0 (October 20, 2023), https://doi.org/10.1016/j.neuron.2023.09.034. [xxix] Nho et al. [xxx] Nho et al.; Erik Robinson, “Brain Implant at OHSU Successfully Controls Both Seizures and OCD,” OHSU News, accessed March 3, 2024, https://news.ohsu.edu/2023/10/25/brain-implant-at-ohsu-successfully-controls-both-seizures-and-ocd. [xxxi] Awuah et al., “Bridging Minds and Machines”; Haslacher et al., “AI for Brain-Computer Interfaces.” [xxxii] Awuah et al., “Bridging Minds and Machines.” [xxxiii] Sara Green, Barbara Prainsack, and Maya Sabatello, “The Roots of (in)Equity in Precision Medicine: Gaps in the Discourse,” Personalized Medicine 21, no. 1 (January 2024): 5–9, https://doi.org/10.2217/pme-2023-0097. [xxxiv] Green, Prainsack, and Sabatello, 7. [xxxv] Robyn Bluhm and Kirstin Borgerson, “An Epistemic Argument for Research-Practice Integration in Medicine,” The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine 43, no. 4 (July 9, 2018): 469–84, https://doi.org/10.1093/jmp/jhy009. [xxxvi] Vijay Mahant, “‘Right-to-Try’ Experimental Drugs: An Overview,” Journal of Translational Medicine 18 (June 23, 2020): 253, https://doi.org/10.1186/s12967-020-02427-4. [xxxvii] Michael S. Okun et al., “Deep Brain Stimulation in the Internal Capsule and Nucleus Accumbens Region: Responses Observed during Active and Sham Programming,” Journal of Neurology, Neurosurgery & Psychiatry 78, no. 3 (March 1, 2007): 310–14, https://doi.org/10.1136/jnnp.2006.095315. (shrink)

BackgroundNew disease-modifying ways to treat Parkinson’s disease (PD) may soon become a reality with intracerebral transplantation of cell products produced from human embryonic stem cells (hESCs). The aim of this study was to assess what factors influence preferences of patients with PD regarding stem-cell based therapies to treat PD in the future.MethodsPatients with PD were invited to complete a web-based discrete choice experiment to assess the importance of the following attributes: (i) type of treatment, (ii) aim of (...) treatment, (iii) available knowledge of the different types of treatments, (iv) effect on symptoms, and (v) risk for severe side effects. Latent class conditional logistic regression models were used to determine preference estimates and heterogeneity in respondents’ preferences.ResultsA substantial difference in respondents’ preferences was observed in three latent preference patterns (classes). “Effect on symptoms” was the most important attribute in class 1, closely followed by “type of treatment,” with medications as preferred to other treatment alternatives. Effect on symptoms was also the most important attribute in class 2, with treatment with hESCs preferred over other treatment alternatives. Likewise for class 3, that mainly focused on “type of treatment” in the decision-making. Respondents’ class membership was influenced by their experience in treatment, side effects, and advanced treatment therapy as well as religious beliefs.ConclusionsMost of the respondents would accept a treatment with products emanating from hESCs, regardless of views on the moral status of embryos. Preferences of patients with PD may provide guidance in clinical decision-making regarding treatments deriving from stem cells. (shrink)

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)

While other parts of medicine and health care seems traditionally to be primarily directed at preventing losses of bodily functions, repairing said functions in the case of such losses, or at least to provide ailment for unpleasant symptoms, sports medicine has allready from the beginning been involved with the project of enhancing bodily functions with regard to sports performance. First, when sports medicine involve itself in the traditional health care activity of prevention, therapy and ailment, the aim is often very (...) different from ordinary medical activities in that it tries to secure bodily functions far beyond what is required to reach what would normally be seen as a non-pathological state of a person. Second, sports medicine actively involves itself in the project of extending and enhancing human performance capacities through medical knowledge and technology. This raises several issues both with regard to medical ethics and the ethics of sports. For example, how should the goals of sports medicine be viewed from the perspective of rationing scarce health care resources? Should sports medicine be restricted by rules from the sports community as to which performance enhancing activities are tolerated in that sector? Or should sports medicine rather direct what is to be accepted within the world of sports? Both lines of reasoning are to be found in debates about, e.g., doping, controversial training methods and the potential use of gene technology in sports. The paper will address these issues and analyse them from a philosophical point of view. (shrink)

The momentum of advances in biology is evident in the history of patents on life forms. As we proceed forward with greater understanding and technological control of developmental biology there will be many new and challenging dilemmas related to patenting of human parts and partial trajectories of human development. These dilemmas are already evident in the current conflict over the moral status of the early human embryo. In this essay, recent evidence from embryological studies is considered and (...) the unbroken continuity of organismal development initiated at fertilization is asserted as clear and reasonable grounds for moral standing. Within this frame of analysis, it is proposed that through a technique of Altered Nuclear Transfer, non-organismal entities might be created from which embryonic stem cells could be morally procured. Criteria for patenting of such non-organismal entities are considered. (shrink)

A central principle of bioethics is “subject autonomy,” the acknowledgement of the primacy of the informed consent of the subject of research. Autonomy requires informed consent — the assurance that the research participant is informed about the possible risks and benefits of the research. In fact, informed consent is difficult when a single drug is being tested, although subjects have a baseline understanding of the testing of a pharmacological agent and the understanding that they can stop taking the drug if (...) there were an adverse event. However, informed consent is even less easily achieved in the modern arena of complex new molecular and cellular therapies. In this article, we argue that as science confronts new issues such as transplantation of stem cell products, which may live within the participant for the rest of their lives, researchers must carefully consider and constantly re-examine how they properly inform subjects considering participation trials of these novel therapeutic strategies.For example, the manufacture of a vial of a cell product that consists of a collection of growing cells is very different than the production of a vial of identical pills, which can be presumed to be identical. The scientific concepts on which these cellular approaches are based may seem alien and incomprehensible to a research subject, who thinks of a clinical trial as simply the selection and testing of the most efficacious pharmaceutical agent already proven to work in preclinical animal studies. The research subject would be wrong. (shrink)