CRISPR is currently viewed as the central tool for future gene therapy. Yet, many prominent scientists and bioethicists have expressed ethical concerns around CRISPR gene therapy. This paper provides a critical review of concerns about CRISPR gene therapy as expressed in the mainstream academic literature, paired with replies also generally found in that literature. The expressed concerns can be categorised into three types depending on whether they stress risk/benefit ratio, autonomy and informed consent, (...) or concerns related to various aspects of justice. In the reviewed literature, we found no intrinsic objections to CRISPR gene therapy, even though many such objections were present in discussions of gene editing in the 1990s. The paper then proposes a brief outline for a practically applicable moral framework for public decision-making about CRISPR gene therapy and suggests how such a framework might be supported. We also suggest that this framework should govern public engagement about CRISPR gene therapy in order to reduce the risk that we make decisions about CRISPR gene therapy based on misperceptions, inflated views of risk, or unreasonable moral or religious views. (shrink)

With pre-implantation genetic diagnosis (PGD), genetic testing and selective transfer of embryos is possible. In the future, germ-line gene therapy (GLGT) applied to embryos before implantation, in order to introduce missing genes or replace mutant ones, may be possible. The objective of this dissertation is to analyse moral aspects of these technologies, as described by eighteen British, Italian and Swedish gynaecologists and geneticists. The objective is systematised into three parts: research interviews and qualitative analysis, philosophical analysis, (...) and elaboration of a framework that supports the combination of analytic methods. PGD was described as positive since it enabled some couples at risk for a genetic disease to have a child without the disease. PGD was described as in different senses ‘better’ than methods for prenatal diagnosis and selective termination of pregnancy. It was also described as positive since it provided couples at risk with one more option, even if it did not result in the birth of a healthy child. However, interviewees were concerned about the difficulty of defining and evaluating genetic disease. They were also concerned about patients’ choices, and about exaggerated use or misuse. Whereas PGD gave rise to ambivalence in terms of how to understand, describe and evaluate it, GLGT was often described as unrealistic or undesirable. The results of the qualitative analysis are used in a philosophical analysis of the concepts of choice, autonomous choice, ambivalence, trust and ambivalence in trust relations. A set of distinct characteristics of each concept are elaborated. The results of the philosophical analysis are used in the discussion of the results of the qualitative analysis. The study shows that the technologies imply both ‘new’ ways to perform ‘old’ medical practices and ‘new’ practices. Old moral questions are reformulated. New moral questions are added. Against the background of this, the concept of genetic identity is discussed. Key words: empirical ethics, pre-implantation genetic diagnosis, germ-line gene therapy, qualitative research, philosophical analysis, medical progress, genetic disease, choice, autonomous choice, ambivalence, trust, genetic identity. (shrink)

The prelims comprise: Introduction A (re)Defmition of what Human Gene Therapy is About Neurological Gene Therapy Ethics and Gene Therapy Acknowledgments Notes.

Despite widespread agreement that it would be ethical to use somatic cell gene therapy to correct serious diseases, there is still uneasiness on the part of the public about this procedure. The basis for this concern lies less with the procedure's clinical risks than with fear that genetic engineering could lead to changes in human nature. Legitimate concerns about the potential for misuse of gene transfer technology justify drawing a moral line that includes corrective germline (...) therapy but excludes enhancement interventions in both somatic and germline contexts. Keywords: somatic cell, germ line, genetic diseases, genetic engineering, humanness, enhancement, eugenics CiteULike Connotea Del.icio.us What's this? (shrink)

Recent political developments and disclosures of serious adverse events in human gene therapy (HGT) with the death of 18‐year old Jesse Gelsinger in the USA have shown that the clinical application of HGT raises some severe ethical issues. These have either been neglected or not yet been discussed to a satisfactory extent. In this paper, we will address this deficiency and develop strategies for a safer application of HGT. Such a study must first look closely at the (...) science of HGT itself. We will evaluate the latest preclinical research, especially data on the viruses that are used as vectors and on modes of administration of vectors. We will put forward new arguments concerning the toxicity assessment of so‐called ‘gene drugs‘, the tissue and cell type specificity of the vectors, and the duration and on‐set of gene expression. Secondly, we will look at procedural aspects of applied research ethics on the way to clinical application of HGT. There, informed consent (IC) and the patient‐researcher relationship are of utmost concern. Furthermore, we will explore the problem of expertise in risk assessment and will show how current regulations foster conflicts of interests that create dilemma situations even for those researchers who act in the best interest of the patients. We will conclude the article with a set of questions for ethicists who have to decide about the quality of HGT protocols. This may contribute to the safety of patients participating in HGT trials and to achieving the aim of efficient application of HGT. (shrink)

Gene therapy and gene editing are revolutionising the treatment of genetic diseases, most notably haematological disorders. This paper evaluates the use of both techniques in hereditary blood disorders. Many studies have been conducted in this field, especially with gene therapy, with very promising results in diseases such as haemophilia, certain haemoglobinopathies and Fanconi anaemia. The application of these techniques in clinical practice and the foreseeable development of these approaches in the coming years suggest that it (...) might be useful to evaluate the results achieved thus far. It is also essential to reflect on the possible bioethical concerns raised by the use of both techniques, especially in terms of safety issues for patients, potential side effects, treatment duration, accessibility and cost of treatment, and the heritability of genetic changes produced if germline cells are used. (shrink)

Is inheritable genetic modification the new dividing line in gene therapy? The editors of this searching investigation, representing clinical medicine, public health and biomedical ethics, have established a distinguished team of scientists and scholars to address the issues from the perspectives of biological and social science, law and ethics, including an intriguing Foreword from Peter Singer. Their purpose is to consider how society might deal with the ethical concerns raised by inheritable genetic modification, and to re-examine prevailing (...) views about whether these procedures will ever be ethically and socially justifiable. The book also provides background to define the field, and discusses the biological and technological potential for inheritable genetic modification, its limitations, and its connection with gene therapy, cloning, and other reproductive interventions. For scientists, bioethicists, clinicians, counsellors and public commentators, this is an essential contribution to one of the critical debates in current genetics. (shrink)

Background: A predictive genetic test for Huntington’s disease can be used before any symptoms are apparent, but there is only sparse knowledge about the long-term consequences of a positive test result. Such knowledge is important in order to gain a deeper understanding of families’ experiences. Objectives: The aim of the study was to describe a young couple’s long-term experiences and the consequences of a predictive test for Huntington’s disease. Research design: A descriptive case study design was used with a longitudinal (...) narrative life history approach. Participants and research context: The study was based on 18 interviews with a young couple, covering a period of 2.5 years; starting 6 months after the disclosure of the test results showing the woman to be a carrier of the gene causing Huntington’s disease. Ethical considerations: Even though the study was extremely sensitive, where potential harm constantly had to be balanced against the benefits, the couple had a strong wish to contribute to increased knowledge about people in their situation. The study was approved by the ethics committee. Findings: The results show that the long-term consequences were devastating for the family. This 3-year period was characterized by anxiety, repeated suicide attempts, financial difficulties and eventually divorce. Discussion: By offering a predictive test, the healthcare system has an ethical and moral responsibility. Once the test result is disclosed, the individual and the family cannot live without the knowledge it brings. Support is needed in a long-term perspective and should involve counselling concerning the families’ everyday life involving important decision-making, reorientation towards a new outlook of the future and the meaning of life. Conclusion: As health professionals, our ethical and moral responsibility thus embraces not only the phase in direct connection to the actual genetic test but also a commitment to provide support to help the family deal with the long-term consequences of the test. (shrink)

Abstract:Highly immersive virtual reality (VR) systems have been introduced into the consumer market in recent years. The improved technological capabilities of these systems as well as the combination with biometric sensors, for example electroencephalography (EEG), in a closed-loop hybrid VR-EEG, opens up a range of new potential medical applications. This article first provides an overview of the past and current clinical applications of VR systems in neurology and psychiatry and introduces core concepts in neurophilosophy and VR research (such as agency, (...) trust, presence, and others). Then, important adverse effects of highly immersive VR simulations and the ethical implications of standalone and hybrid VR systems for therapy in neurology and psychiatry are highlighted. These new forms of VR-based therapy may strengthen patients in exercising their autonomy. At the same time, however, these emerging systems present ethical challenges, for example in terms of moral and legal accountability in interactions involving “intelligent” hybrid VR systems. A user-centered approach that is informed by the target patients’ needs and capabilities could help to build beneficial systems for VR therapy. (shrink)

Today, advances in medicine and biotechnology occur at a rapid pace and have a profound impact on our lives. Mechanical devices can sustain an injured person's life indefinitely. Computed tomography (CT) and magnetic resonance imaging (MRI) scans of the body and brain can reveal disorders before symptoms appear. Genetic testing of embryos can predict whether people will have diseases earlier or later in life. It may even become possible to clone human beings. These and other developments raise difficult ethical (...) questions. Biomedical Ethics is an engaging philosophical introduction to the most important ethical positions and arguments in six areas of biomedicine: the patient-doctor relationship, medical research on humans, reproductive rights and technologies, genetics, medical decisions at the end of life, and the allocation of scarce medical resources. Concisely capturing the historical, contemporary, and future-oriented aspects of the field, author Walter Glannon discusses both perennial issues in medicine, such as doctors' duties to patients, and recent and emerging issues in scientific innovation, including gene therapy and cloning. Ideal for undergraduate courses in contemporary moral problems, introduction to ethics, and introduction to bioethics, Biomedical Ethics is accessible to students who have little or no background in ethical theory, medicine, or biotechnology. (shrink)

Reflexión sobre los problemas éticos que plantea la aplicación de la ingeniería genética a los seres humanos, con la intención de conducir a la toma de decisiones prudentes en su utilización.

The main purpose of this article is to explore, from an ethical perspective, one particular branch of what is today called “spiritual medicine”: namely, prayer therapy. Several landmark studies in the literature will be thoroughly examined, respectively the classical study of Byrd (1988), the replica of Harris et al. (1999), and the controversial study of Leibovici (2001). Beginning with these studies and the related controversies surrounding them, the religious features and ethical consequences of prayer therapy are (...) investigated. The ethical aspects of prayer therapy – the informed consent issue, the issue of respecting bioethical principles, and the issue of medical competence in offering such techniques – are thoroughly addressed. Finally, an alternative way of framing the prayer therapy discussion is offered, in the context of public-private dichotomy. (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)

Gene therapy research and its clinical application raise a large number of ethical, legal, and social questions. Many of these are discussed in Nordgren's anthology. The contributions come from a number of different disciplines, including bioethics, genetics, social science, and theology. The book is divided into five main sections (following a short introduction): scientific aspects of gene therapy; the history of, and prospects for, gene therapy; conceptual issues; gene therapy in (...) a German and Japanese context, and a section on the uses of gene therapy in relation to, for example, testing and screening. The contributions are quite diverse and mostly well worth reading. From the perspective of medical ethics the contributions by LeRoy Walters, Eric Juengst, Karen Lebacqz, Nikolaus Knoepffler, and Christian Munthe are of particular interest. Walters's contribution focuses in part on the issue of …. (shrink)

The authors find it more useful to payattention to relationships than to boundaries.By focusing attention on bounded, individualpsychological issues, the metaphor ofboundaries can distract helping professionalsfrom thinking about inequities of power. Itoversimplifies a complex issue, inviting us toignore discourses around gender, race, class,culture, and the like that support injustice,abuse, and exploitation. Making boundaries acentral metaphor for ethical practice can keepus from critically examining the effects ofdistance, withdrawal, and non-participation.The authors describe how it is possible toexamine the practical, moral, (...) and ethicaleffects of our participation in relationshipsby focusing on just relationships rather thanon boundaries. They give illustrations andclinical examples of relationally-focusedethical practices that derive from a narrativeapproach to therapy. (shrink)

Medicine in the twenty-first century is increasingly reliant on research to guarantee the safety and efficacy of medical interventions. As a result, the need to understand the ethical issues that research generates is becoming essential. This volume introduces the principal areas of concern in research on human subjects, offering a framework for understanding research ethics, and the relationship between ethics and compliance. Research Ethics brings together leading scholars in bioethics and the topics covered include the unique concerns that arise (...) in specific areas of research such as gene therapy and stem cell research. Individual chapters also address the ethical issues that arise when conducting research with specific populations such as infants or adolescents, and the volume looks at important emerging issues in human subjects research, namely financial conflicts of interest and the interpretation of scientific data. (shrink)

The text is extensively referenced, but practical in its approach, giving real life examples and cases based on therapeutic practice.

This study investigates the ethical aspects of deploying and researching into so-called climate engineering methods, i.e. large-scale technical interventions in the climate system with the objective of offsetting anthropogenic climate change. The moral reasons in favour of and against R&D into and deployment of CE methods are analysed by means of argument maps. These argument maps provide an overview of the CE controversy and help to structure the complex debate.

The therapy-enhancement distinction occupies a central place in contemporary discussions of human genetics and has been the subject of much debate. At a recent conference on gene therapy policy, scientists predicted that within a few years researchers will develop techniques that can be used to enhance human traits. In thinking about the morality of genetic interventions, many writers have defended somatic gene therapy, and some have defended germline gene therapy, but only a handful (...) of writers defend genetic enhancement, or even give it a fair hearing. The mere mention of genetic enhancement makes many people cringe and brings to mind the Nazi eugenics programs, Aldous Huxley's BraveNewWorld, or the recent movie Although many people believe that gene therapy has morally legitimate medical uses, others regard genetic enhancement as morally problematic or decidedly evil. (shrink)

Given the recent developments in biotechnology and genetic engineering, the ability to eliminate genetic diseases from the human genome seems more and more possible each day. Being able to do so would mean a better quality of life for those who would otherwise suffer from incurable genetic diseases. However, even though the success of such a procedure would bring benefits that cannot be obtained by other means, the consequences for humans are still unknown. As such, the people involved should be (...) held responsible. The responsibility needs to be collective, not individual, because the decisions leading to the edition of a human genome and someone being born as a result of it are not made by a single individual, but several people, from the prospective parents interested in the intervention for their future child to the ones in charge of performing said intervention. The addition of the human genome can bring significant benefits, and it seems to be the only way to avoid certain genetic diseases; however, collective responsibility should be taken by those involved in the decisions that lead to a person being born with a modified genome. (shrink)

This paper reports on the meeting of the Sounding Board of the EU Reprogenetics Project that was held in Budapest, Hungary, 6–9 November 2005. The Reprogenetics Project runs from 2004 until 2007 and has a brief to study the ethical aspects of human reproductive cloning and germline gene therapy. Discussions during The Budapest Meeting are reported in depth in this paper as well as the initiatives to involve the participating groups and others in ongoing collaborations with (...) the goal of forming an integrated network of European resources in the fields of ethics of science. (shrink)

In this essay I seek to show that a philosophy of modesty informs core aspects of both Nietzsche’s critique of morality and what he intends to replace morality with, namely, an ethics of self-cultivation. To demonstrate this I focus on Dawn: Thoughts on the Prejudices of Morality, a largely neglected text in his corpus where Nietzsche carries out a quite wide-ranging critique of morality, including Mitleid. It is one of Nietzsche’s most experimental works and is best read, I claim, (...) as an Epicurean-inspired critique of the present and an exercise in moral therapy. In the opening sections I draw attention to the wider social dimension of the text and its concern with a morality of compassion, which is rarely done in the literature. I then turn to highlighting Nietzsche’s Epicurean moment, followed by two sections on Nietzsche on the self in which I aim to bring to light his ethics of self-cultivation and show in what ways his revaluation makes central to ethics a modest egoism and care of self. In the conclusion to the essay I provide a contrast between Nietzsche and Kant and deal with reservations readers might have about his ethics. Overall, the essay seeks to make a contribution to an appreciation of Dawn as a work of moral therapy. (shrink)

The Hellenic medical ideas have found appreciation among people over centuries. Though the initial concept remained the same, methods or ways to achieve desired aims have changed. Since Hippocrates, new generations of physicians have worked hard to find more powerful types of therapies to relieve their patients and make treatment less burdensome. The struggle of medicine is very specific and requires, apart from practical skills, a clear personal commitment to help people wisely. From the Early Antiquity, both medicine and medical (...) ethics go together. Wherever Hippocratic medicine is practiced, an appropriate moral pattern accompanies it because the Hellenic doctor offered purely clinical data and his art should not be separated from anthropology, ethics and religion. (shrink)

Oversight of human gene transfer research presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution and at the federal level by the Office for Human Research Protections. The Food and Drug Administration's Center for Biologics Evaluation and Research (...) oversees human gene transfer research in parallel, including approval of protocols and regulation of products. This article traces the evolution of this dual oversight system; describes how the system is already addressing nanobiotechnology in gene transfer: evaluates gene therapy oversight based on public opinion, the literature, and preliminary expert elicitation; and offers lessons of the gene therapy oversight experience for oversight of nanobiotechnology. (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)

It may be unethical to deny children with cystic fibrosis access to ethically approved clinical trials from which they might benefitDespite advances in nutritional management, aggressive antibiotic usage, and physiotherapy, cystic fibrosis remains a life limiting illness with high morbidity that imposes considerable burdens on children and families.1 Although survival to 40 years is predicted for children born in 1990s, the median age of death in 2003 was 24.2 years .The pathophysiological features of CF are produced by a defective (...) class='Hi'>gene on chromosome 7, resulting in the defective production of a protein that regulates cellular ion transport. Defective ion transport is thought to lead to increased mucus viscosity , with poor airway clearance, recurrent bacterial infection, lung damage, and death.Gene therapy , the insertion of a normally functioning gene into deficient host cells using a suitable vector, is a potential treatment or cure for diseases produced by single gene defects—for example, CF. Gene therapy does, however, have potential or actual risks, leading many to suggest that evidence of efficacy in adults should be demonstrated before trials are conducted in children. Many serious diseases in adults such as CF have their onset in childhood. If early treatment provides greater hopes of benefit, children may be more appropriate targets for GT in CF than adults. It may be unethical to deny them access to properly constructed, ethically approved clinical trials from which they might benefit.Since research in children should be scientifically valid, in the child’s best interests, and the subject of valid consent, this article will consider these parameters in relation to trials of GT in children with CF. Because of the importance of consumer participation in the design of research we present the results of a questionnaire about GT trials delivered …. (shrink)

Educational philosophers and sociologists have pointed out the potential risks of an educational trend of therapy, which seems to have connotations with Western macro-discourses of individualisation, popularised psychology and privatisation of the public room. The overall purpose of this article is to discuss potential risks and possibilities regarding moral aspects of therapeutic approaches in education from a teacher perspective. I will present the non-mandatory Swedish topic Livskunskap, life competence education (LCE), in a case study in the field (...) of therapeutic education. The article is based on a small, qualitative empirical study of teachers’ experiences of teaching LCE and observations of LCE lessons. The empirical material is analysed through two theoretical lenses, the first being critical aspects of therapeutic education, the second being an educational theory of the ethics of care, mainly developed by Nel Noddings. (shrink)

This paper reports on the meeting of the Sounding Board of the EU Reprogenetics Project that was held in Budapest, Hungary, 6–9 November 2005. The Reprogenetics Project runs from 2004 until 2007 and has a brief to study the ethical aspects of human reproductive cloning and germline gene therapy. Discussions during The Budapest Meeting are reported in depth in this paper as well as the initiatives to involve the participating groups and others in ongoing collaborations with (...) the goal of forming an integrated network of European resources in the fields of ethics of science. (shrink)

Background: In Hospital Emergency Department and Emergency Medical Services professionals experience situations in which they face difficulties or barriers to know patient’s advance directives and implement them. Objectives: To analyse the barriers, facilitators, and ethical conflicts perceived by health professionals derived from the management of advance directives in emergency services. Research design, participants, and context: This is a qualitative phenomenological study conducted with purposive sampling including a population of nursing and medical professionals linked to Hospital Emergency Department and Emergency (...) Medical Services. Three focus groups were formed, totalling 24 participants. We performed an inductive-type thematic discourse analysis. Ethical considerations: This study was approved by ethical committees of Ethical Commitee of Clínic Hospital (Barcelona) and Comittee of Emergency Medical Services (Barcelona). The participants received information about the purpose of the study. Patients’ anonymity and willingness to participate in the study were guaranteed. Findings: There were four types of barriers that hindered the proper management of patients’ advance directives in Hospital Emergency Department and Emergency Medical Services: personal and professional, family members, organisational and structural, and those derived from the health system. These barriers caused ethical conflicts and hindered professionals’ decision-making. Discussion: These results are in line with those of previous studies and indicate that factors such as gender, professional category, and years of experience, in addition to professionals’ beliefs and the opinions of colleagues and family members, can also influence the professionals’ final decisions. Conclusion: The different strategies described in this study can contribute to the development of health policies and action protocols to help reduce both the barriers that hinder the correct management and implementation of advance directives and the ethical conflicts generated. (shrink)

The definitive book on ethics for chemical dependency treatment professionals.

This chapter contains sections titled: Promise and Disappointment Ethical Issues Resource Allocation References.

In response to adverse events in retroviral gene therapy clinical trials conducted in France to correct for X-linked severe combined immune deficiency disorder (X-SCID), an advisory committee of the Food and Drug Administration convened in October 2002, February 2003, and March 2005, to deliberate and provide recommendations for similarly sponsored research in the United States. A similar National Institutes of Health committee met in February 2003. In this article, I review the transcripts and/or minutes of these meetings to (...) evaluate the extent to which the ethical dimension of the research was engaged even as the molecular and clinical evidence was reviewed. I then provide representative ethical arguments to demonstrate the sort of ethical reasoning that should be included as part of the agenda of such committee meetings. (shrink)

The decision-making environment in intensive care units (ICUs) is influenced by the transformation of intensive care medicine, the staffing situation and the increasing importance of patient autonomy. Normative implications of time in intensive care, which affect all three areas, have so far barely been considered. The study explores patterns of decision making concerning the continuation, withdrawal and withholding of therapies in intensive care. A triangulation of qualitative data collection methods was chosen. Data were collected through non-participant observation on a surgical (...) ICU at an academic medical centre followed by semi-structured interviews with nurses and physicians. The transcribed interviews and observation notes were coded and analysed using qualitative content analysis according to Mayring. Three themes related to time emerged regarding the escalation or de-escalation of therapies: influence of time on prognosis, time as a scarce resource and timing in regards to decision making. The study also reveals the ambivalence of time as a norm for decision making. The challenge of dealing with time-related efforts in ICU care results from the tension between the need to wait to optimise patient care, which must be balanced against the significant time pressure which is characteristic of the ICU setting. (shrink)

The Japanese government took significant steps in making decisions about a newly developing clinical application of gene therapy when, on April 15, 1993, the Government officially accepted the Guidelines for Clinical Research on Gene Therapy submitted by the Health Science Council of the Ministry of Health and Welfare of Japan to the Minister.

Aldehyde dehydrogenase 2 (ALDH2) deficiency constitutes one of the most common hereditary enzyme deficiencies, affecting 35% to 40% of East Asians and 8% of the world population. It causes the well-known Asian Alcohol Flush Syndrome, characterized by facial flushing, palpitation, tachycardia, nausea, and other unpleasant feelings when alcohol is consumed. It is also associated with a marked increase in the risk of a variety of serious disorders, including esophageal cancer and osteoporosis. Our recent studies with murine models have demonstrated that (...) a one-time administration of an adeno-associated virus (AAV) gene transfer vector expressing the human ALDH2 coding sequence (AAVrh.10hALDH2) will correct the deficiency state and prevent alcohol-induced abnormalities of the esophagus and bone. If successful in humans, such strategy would reduce the increased risk-associated disorders such as esophageal cancer and osteoporosis, but also prevent the Asian Alcohol Flush Syndrome. This treatment thus raises ethical concerns: although it would potentially prevent fatal disease, it could also allow affected individuals to drink alcohol without suffering the Asian Alcohol Flush Syndrome and, hence, potentially enable personal destructive behavior. Here we explore the ethical arguments against the development of a gene therapy for ALDH2 deficiency and we find them wanting. We contend that development of such treatments is ethically appropriate and should be part and parcel of the solutions offered against the condition. (shrink)

In this paper, we present a comprehensive case study analysis of a specific legal order issued by the Court of First Instance Number 6 of Santiago de Compostela on March 21, 2023. The focal point of the case study is the utilization of Electroconvulsive Therapy (ECT), a specific neurotechnology, in an emergency clinical situation. The objective of this article is to examine the legal and bioethical dimensions surrounding the use of ECT, shedding light on the ethical implications and (...) decision‐making processes involved in such cases. The analysis delves into the legal aspects of the case, considering relevant laws and regulations governing the use of ECT. The examination includes an exploration of the court's interpretation of the legal framework within the context of emergency situations, highlighting the specific legal arguments presented in the court judgment. Additionally, the article provides an in‐depth bioethical analysis, exploring the ethical principles that come into play when making decisions about ECT in emergency clinical scenarios. The examination considers the delicate balance between respecting patient autonomy and promoting beneficence, while also addressing potential harms and adverse effects associated with ECT. We also consider the moral issues created by the court judgment, specifically those involving patient autonomy and the invasive nature of the process, particularly in cases of mental illness. (shrink)

As the potential for the first human trials of somatic cell gene therapy nears, two ethical issues are examined: (1) problems of moral choice for members of institutional review boards who consider the first protocols, for parents, and for the clinical researchers, and the special protections that may be required for the infants and children to be involved, and (2) ethical objections to somatic cell therapy made by those concerned about a putative inevitable progression (...) of genetic knowledge from therapy to mass genetic engineering in human reproduction. The author's viewpoint is that a consensus exists on the required moral approach to somatic cell therapy, but that no moral approach yet exists for experiments beyond this level, especially in the germline cells of human beings. Keywords: gene therapy, somatic cells, germ cells, institutional review boards, genetic engineering CiteULike Connotea Del.icio.us What's this? (shrink)

Most books about ethics focus either on the origins of ethics, or on the application of ethical thinking to a single form of therapy. This book sets out to span a range of very different forms of therapy and explores the similarities and the differences between the ethical thinking of the practitioners concerned. By looking at ethical issues in different therapeutic settings the reader is challenged to reconsider the working assumptions which underpin familiar therapeutic practice. (...) Readers of Forms of Ethical Thinking in Therapeutic Practice are offered the unique opportunity to gain insights into the ethical thinking of experienced practitioners offering strikingly different services to their clients and working in contrasting contexts. Essential reading for all practitioners in counselling and the therapies, students, trainers, supervisors and providers of therapeutic services. (shrink)

The risks associated with the techniques of medically assisted procreation (MAP) rapidly became well-known, and in such a short space of time that no biomedical domain remained untouched by the great deal of thinking and the expression of a multitude of opinions it provoked. MAP is evolving between two poles: quality/misuse (even violation) and evidence/fantasy. The ethics will be evoked in the clinical reality from which they spring and where their justification lies. The three objects common to these ethics, the (...) oocyte, the embryo and the child, are illustrated in this context. MAP has as its corollary access to the oocyte, the fertilization of which will take place in vitro. Access to the embryo, on the other hand, enables the clinician, for the purposes of diagnosis [preimplantation genetic diagnosis (PGD), predictive medicine], or even soon for therapeutic purposes (gene therapy) to draw close to a boundary, to trespass beyond which may be seen by humanity to threaten its very origins and integrity: the alienation of the human genome. For the infertile couple, the missing child may take on a dimension of which they would have been unaware, had they not been forced to express their desire. The burden of the imaginary child may, in this way, become a heavier load to bear when, after such desire, he comes into being. MAP puts the goal of normalisation within reach and, in doing so, accentuates the risk of the burden of the attributed representation of the child. On the one hand, MAP offers a tremendous diagnostic and therapeutic potential, while on the other it opens the door to excess and delirium. In this melting pot, ethics, catalysed by this new source of problematics, has discovered a favourite area in which to define and redefine itself. We propose the intervention of ethics on three different levels. Before the elaboration of the law: on first reflection, ethics may influence the responsibilities of the legislator, by taking care that the law does not obscure the biomedical and socioeconomic contexts of MAP and, thereby, also include other related and complementary aspects dealing with the same subject. The secondary discussion of ethics should influence the application of legal protection, by taking into account the rapid technological and social development of MAP, there too, by discussing the whole, rather than the details which will obscure the object. The ethical reflection of the clinician, who is aware of these difficulties, is guided by elements that are specific to his position as a doctor. The cohesion of the team around the clinician and the ethics specialist enables us to develop consensual clinical ethics that are transmissible and therefore teachable. This complex role can, in our view, only be acted out directly in the clinical situation, where the constant, direct relationship with the object of the reflection and the treatment allows ethics to take into account the contingencies of medical practice: we invite the ethics specialist to take part in our clinical activity on a daily basis. (shrink)

Acting on what started as a hunch, Dr. Francis Martin has cataloged well over 20,000 distinct approaches to counseling and psychotherapy that are advertised on the webpages of licensed, practicing mental health providers. No doubt some portion of them are harmful, but the sheer volume of advertised practices and techniques, often with names deceptively similar to actual evidence-based practices, should be cause for concern among all stakeholders in the helping professions - from educators and researchers to policy makers and insurance (...) companies and, especially, consumers. Based on this significant original study, and drawing from other research and supports, Therapy Thieves describes a near-universal crisis in the field and recommends ways to rescue mental health care from itself. The crisis is caused by declining competence among counselors and psychotherapists who have failed to regulate themselves and who, therefore, deliver inadequate - if not harmful - services. In presenting a simple, yet powerful indictment of the field, Dr. Martin advocates for major reforms in several areas of mental health care, including how prospective licensees are trained, supervised and licensed, a major reworking of professional ethics, and the need to establish regulations for mental health care providers. In short, the book calls for major, specific, and urgently needed reforms. (shrink)

The psychosocial morbidity associated with HIV infection and responses to such infection may exceed morbidity associated with medical sequelae of such infection. This paper argues that negative judgements on those with HIV infection or in groups associated with such infection will cause avoidable psychological and social distress. Moral judgements made regarding HIV infection may also harm the common good by promoting conditions which may increase the spread of HIV infection. This paper examines these two lines of argument with regard (...) to the ethical aspects of psychological bases of health care, clinical contact, public perceptions of AIDS and the comparative perspective. It is concluded that the psychosocial aspects of HIV infection impose ethical psychological, as well as medical, obligations to reduce harm and prevent the spread of infection. (shrink)

In this paper, I discuss some central ethical aspects of self-forgiveness. A first comparison is made between interpersonal forgiveness and self-forgiveness. It would seem that self-forgiveness follows much of the same structure as interpersonal forgiveness, although with some exceptions. One noticeable difference is that with self-forgiveness, the forgiver and forgiven is one and the same person. The main ethical question discussed is when self-forgiveness is morally permissible. I argue that self-forgiveness is only morally permissible when the wrongdoer (...) acknowledges wrongdoing and display genuine repentance. He must also, insofar as possible, ask the victim for forgiveness before contemplating self-forgiveness. (shrink)