. . Tom Beauchamp and David DeGrazia's principles do improve upon the 3Rs which don’t mention the need for benefits from animal experimentation, the need to compare these benefits to animal harms, and provide no hard limits on experimentation. -/- However, they present their principles as “useful” for people engaged in animal research and as a “philosophically sound” (p. 4) framework for a new ethic for animal research. Regrettably, I have doubts about both these (...) overall claims and so am pessimistic about the book. (shrink)

This book is the result of a three-year study undertaken by a multidisciplinary working party of the Institute of Medical Ethic (UK). The group was chaired by a moral theologian, and its members included biological and ethological scientists, toxicologists, physicians, veterinary surgeons, an expert in alternatives to animal use, officers of animal welfare organizations, a Home Office Inspector, philosophers, and a lawyer. Coming from these different backgrounds, and holding a diversity of moral views, the members produced the (...) agreed report as a result of detailed and rigorous discussions. The book sets out facts about animal experiments and about animal abilities to experience pain, distress and anxiety. There is a detailed examination of the moral claims related to the benefits likely to accrue from animal research, and of strategies for weighing these benefits against the harm caused to animals, in order to decide whether particular research projects ought or ought not to proceed. This leads to consideration of the statutory and non-statutory controls which safeguard standards in such research. The final section explores a variety of philosophical arguments about the use of animals in research, and offers a philosophical justification for the Working Party's more practical conclusions. Written in clear, nontechnical language, this book is accessible to lay people as well as to scientists. It is the first such document to emerge from a meeting of people with such widely differing views on this highly controversial subject, and represents a major contribution towards informing and raising the quality of contemporary debate. The book is unique in drawing together material and ideas never before found in one volume. It will interest a broad spectrum of readers, from ethicists and animal rights advocates to scientific researchers and laboratory administrators, along with general readers concerned about this compelling issue. (shrink)

Values in Bioethics (ViB), co-sponsored by the International Association of Bioethics, makes available original philosophical books in all areas of bioethics, including medical and nursing ethics, health care ethics, research ethics, environmental ethics, and global bioethics. --.

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 11.1 (2001) 91-112 [Access article in PDF] Scope Note 40 Animals in Research and Education: Ethical Issues Laura Jane Bishop and Anita Lonnes Nolen Scientific enquiry is inexorably tied to animal experimentation in the popular imagination and human history. Many, if not most, of the spectacular innovations in the medical understanding and treatment of today's human maladies have been based (...) on research using animals. However, the use of animals in research and experimentation has been debated, defended, and protested by both individuals and organizations at various levels. Responses range from personal lifestyle decisions and fervent philosophical treatises to strident arguments, violent demonstrations, and direct action. The continuum of attitudes about animals and the human relationship with animals spans the range between those who support no regulation of the human use of animals and those who advocate absolute animal liberation from all human use (see II, Orlans 1993, p. 22). History The first recorded experimentation on animals occurred in ancient Rome, but not until the Renaissance did scholars begin serious study of how the body works. Leonardo da Vinci (1452-1519) and other artists and anatomists pursued anatomical investigations of muscle and bone structure. William Harvey (1578-1657) discovered the circulation of the blood via his experiments on live deer. During this period, much live animal experimentation both in England and France was based on the view of French philosopher René Descartes (1596-1650) that animals are incapable of feeling pain. Jeremy Bentham (1748-1832), the English utilitarian philosopher, thought otherwise. In his "Introduction to the Principles of Morals and Legislation" in 1789, Bentham declared, "The question is not, can they reason? Nor, can they talk? But can they suffer? Despite Bentham and others, the belief that animals could not perceive pain persisted in many quarters into the twentieth century. Nineteenth century French physiologist Claude Bernard [End Page 91] (1813-1878)-and his teacher, François Magendie (1783-1855)-conducted wide-ranging animal experiments including surgery, use of drugs, and removal of body parts from many species. Bernard argued that while no amount of benefit could justify any harm to human research subjects, even extreme harm and pain for animal research subjects could be justified by the potential benefit to human beings. Although he did use anesthetics in his work after their discovery in 1847, even Bernard's later work was controversial because of the numbers of animals used and the repetitive nature of his research. The experiments of Magendie and Bernard both laid the foundations for animal experimentation as a practice for scientific advance and contributed in large measure to the emergence of the anti-vivisection movement. Public protests over animal experiments conducted in France and the fear that these might come to England led to the passage of the first law controlling animal experimentation, the "1876 Cruelty to Animals Act" in England. This history and the dynamic tension between scientific inquiry and public concern set the stage for the activism and scholarship of the twentieth century.Since the 1960s, the amount of attention, activism, and scholarship related to animal use has increased at a rapid pace. The modern animal protection movement, led by the Australian philosopher Peter Singer in his book, Animal Liberation (II, 1975), based its advocacy on animals' ability to experience pain and suffering (Bentham's argument). Singer's book and other investigations into animal research, such as LIFE magazine's photojournalism piece on pet theft, animal cruelty, and animal experimentation (Concentration Camps for Dogs. LIFE (4 February 1966), pp. 22-29), brought the use of animals in research, testing, and education to the attention of the general public. Activists, advocates, laypersons, scientists, lawmakers, and animals themselves, have created the interesting, complicated, and complex history of animal rights and animal welfare over the last several decades. Current Statistics Worldwide, approximately 35 million animals are used in research each year; the United States alone uses 12 million animals annually--more than any other country. In 1998, the official number of research animals recorded in the United States was 1... (shrink)

What would it look like for researchers to take non-human animal rights seriously? Recent discussions foster the impression that scientific practice needs to be reformed to make animal research ethical: just as there is ethically rigorous human research, so there can be ethically rigorous animal research. We argue that practically little existing animal research would be ethical and that ethical animal research is not scalable. Since animal research is (...) integral to the existing scientific paradigm, taking animal rights seriously requires a radical, wholesale reimagining of science.Trial registration: ClinicalTrials.gov identifier: NCT05340426. (shrink)

United States military medical ethics evolved during its involvement in two recent wars, Gulf War I (1990–1991) and the War on Terror (2001–). Norms of conduct for military clinicians with regard to the treatment of prisoners of war and the administration of non-therapeutic bioactive agents to soldiers were set aside because of the sense of being in a ‘new kind of war’. Concurrently, the use of radioactive metal in weaponry and the ability to measure the health consequences of (...) trade embargos on vulnerable civilians occasioned new concerns about the health effects of war on soldiers, their offspring, and civilians living on battlefields. Civilian medical societies and medical ethicists fitfully engaged the evolving nature of the medical ethics issues and policy changes during these wars. Medical codes of professionalism have not been substantively updated and procedures for accountability for new kinds of abuses of medical ethics are not established. Looking to the future, medicine and medical ethics have not articulated a vision for an ongoing military-civilian dialogue to ensure that standards of medical ethics do not evolve simply in accord with military exigency. (shrink)

Recent proposals to improve public communication about animal-based biomedical research have been narrowly focused on reforming biomedical journal submission guidelines. My suggestion for communication reform is broader in scope reaching beyond the research community to healthcare communicators and ultimately the general public. The suggestion is for researchers to provide journalists and public relations practitioners with concise summaries of their ‘animal use data’. Animal use data is collected by researchers and intended for the public record but (...) is rarely, if ever, given significant media exposure. By providing healthcare communicators with specific details about their animal use, researchers can play a role informing people about a matter of serious public interest and help to promote a more open and publicly accountable animal research culture. (shrink)

Research that includes non-human animal experimentation is fundamentally a dilemmatic enterprise. Humans use other animals in research to improve life for their own species. Ethical principles are established to deal with this dilemma. But despite this ethical apparatus, people who in one way or another work with animal experimentation have to interpret and understand the principles from their individual points of view. In interviews with members of Swedish animal ethics committees, different views on what (...) the term ethics really means were articulated. For one member, the difficult ethical dilemma of animal experimentation is the lack of enriched cages for mice. For another, the ethical problem lies in regulations restraining research. A third member talks about animals’ right not to be used for human interests. These different views on “ethics” intersect once a month in the animal ethics committee meetings. There is no consensus on what constitutes the ethical problem that the members should be discussing. Therefore, personal views on what ethics means, and hierarchies among committee members, characterise the meetings. But committee traditions and priorities of interpretation as well are important to the decisions. The author discusses how “ethics” becomes situated and what implications this may have for committees’ decisions. (shrink)

The use of other animals for human purposes is as contentious an issue as one is likely to find in ethics. And this is so not only because there are both passionate defenders and opponents of such use, but also because even among the latter there are adamant and diametric differences about the bases of their opposition. In both disputes, the approach taken tends to be that of applied ethics, by which a position on the issue is derived (...) from a fundamental moral commitment. This commitment in turn depends on normative ethics, which investigates the various moral theories for the best fit to our moral intuitions. Thus it is that the use of animals in biomedical research is typically defended by appeal to a utilitarian theory, which legitimates harm to some for the greater good of others; while the opposition condemns that use either by appeal to the same theory, but disagreeing about the actual efficacy of animal experimentation, or by appeal to an alternative theory, such as the right of all sentient beings not to be exploited. Unfortunately, the normative issue seems likely never to be resolved, hence leaving the applied issue in limbo. The present essay seeks to circumvent this impasse by dispensing altogether with any moral claim or argument, thereby cutting the Gordian knot of animal ethics with a meta-ethical sword. The alternative schema defended is simply to advance relevant considerations, whereupon “there is nothing left but to feel.” In a word, motivation replaces justification. (shrink)

Despite the international 3Rs principles that recommends replacing, reducing and refining the use of animals in medical experimentation, it remains difficult to obtain funding in Canada for medical research that respects these principles, particularly with regard to replacement. This observation led our team to review the literature on the arguments for and against animal experimentation in the fields of oncology and radiobiology. This article presents a synthesis of these arguments. Using the method created by McCullough and (...) colleagues to conduct critical reviews of the ethics literature, we analysed 25 texts discussing the arguments for and against animal experimentation in oncology and radiobiology. Six broad categories of arguments for animal experimentation and eleven categories of arguments against it emerged from our analyses. Furthermore, the arguments against animal testing are more convincing from both an empirical and normative perspective. Also, most arguments obtained are transferable in other fields of medicine. In addition to the literature review, a critical reflection was conducted and other arguments were discussed. It seems that a conservative culture persists in medical research, despite the scientific evidence and ethical arguments to the contrary. (shrink)

A common assumption in the selection of nonhuman animal subjects for research and the approval of research is that, if the risks of a procedure are too great for humans, and if there is a so-called scientific necessity, then it is permissible to use nonhuman animal subjects. I reject the common assumption as neglecting the central ethical issue of the permissibility of using nonhuman animal subjects and as being inconsistent with the principle of justice used (...) in human subjects research ethics. This principle requires that certain classes of individuals not be subjected to a disproportionate share of the burdens or risks of research. I argue for an extension of this principle to nonhuman animal research and show that a prima facie violation of the principle occurs because nonhuman animals bear an overwhelmingly disproportionate share of the risks of research without sufficient justification or reciprocal benefit. (shrink)

This book examines the controversies surrounding biomedical research in the twenty-first century from a human rights perspective, analyzing the evolution and ...

Over 115 000 people are waiting for life-saving organ transplants, of whom a small fraction will receive transplants and many others will die while waiting. Existing efforts to expand the number of available organs, including increasing the number of registered donors and procuring organs in uncontrolled environments, are crucial but unlikely to address the shortage in the near future and will not improve donor/recipient compatibility or organ quality. If successful, organ bioengineering can solve the shortage and improve functional outcomes. Studying (...) manufactured organs in animal models has produced valuable data, but is not sufficient to understand viability in humans. Before risking manufactured organ experimentation in living humans, study of bioengineered organs in recently deceased humans would facilitate evaluation of the function of engineered tissues and the complex interactions between the host and the transplanted tissue. Although such studies do not pose risk to human subjects, they pose unique ethical challenges concerning the previous wishes of the deceased, rights of surviving family members, effective operation and fair distribution of medical services, and public transparency. This article investigates the ethical, legal and social considerations in performing engineered organ research on the recently deceased. (shrink)

Committees established for the ethical review of research involving animals have become a widespread legal standard around the world. Despite many differences in their composition, powers, and institutional settings, they share many common problems related to the well-established standards of procedural justice in administrative practice. The paper adapts the general theory of procedural justice to the specific context of ethical review committees. From this perspective, the main concerns over the procedural aspects of the ethical evaluation of research projects (...) are identified and examined. They include in particular the standards of the committees’ composition, impartiality, fair hearing, appeal, transparency, and benevolence. Their proper reflection in the regulatory regimes of animal ethics committees is necessary to secure the standards of fairness of the ethical review itself. This, in turn, is a condition of the moral and social legitimacy of all administrative and quasi-administrative procedures, including the committees’ operations. (shrink)

Increasing European co-operation must take place in many areas, including medical ethics. Against the background of common cultural norms and pluralistic variation within political traditions, religion and lifestyles, Europe will have to converge towards unity within the field of medical ethics. This article examines how such convergence might develop with respect to four major areas: European research ethics committees, democratic health systems, the human genome project and rules for stopping futile treatments.

Bioethics: The Basics is an introduction to the foundational principles, theories and issues in the study of medical and biological ethics. Readers are introduced to bioethics from the ground up before being invited to consider some of the most controversial but important questions facing us today. Topics addressed include: The range of moral theories underpinning bioethics Arguments for the rights and wrongs of abortion, euthanasia and animal research Healthcare ethics including the nature of the practitioner-patient (...) relationship Public policy ethics and the implications of global and public health Concise, readable and authoritative, this is the ideal primer for anyone interested in the study of bioethics. (shrink)

The Catholic Church proscribes methods of birth control other than sexual abstinence. Although the U.S. Food and Drug Administration (FDA) recognizes abstinence as an acceptable method of birth control in research studies, some pharmaceutical companies mandate the use of artificial contraceptive techniques to avoid pregnancy as a condition for participation in their studies. These requirements are unacceptable at Catholic health care institutions, leading to conflicts among institutional review boards, clinical investigators, and sponsors. Subjects may feel coerced by such mandates (...) to adopt contraceptive techniques inconsistent with their personal situation and beliefs; women committed to celibacy or who engage exclusively in non-heterosexual activities are negatively impacted. We propose principles to insure informed consent to safeguard the rights of research subjects at Catholic institutions while mitigating this ethical conflict. At the same time, our proposal respects the interests of pharmaceutical research agencies and Catholic moral precepts, and fully abides by regulatory guidance. (shrink)

Scientific research and ethics -- Ethical theory and decision making -- Data acquisition and management -- Mentoring and professional relationship -- Collaboration in research -- Authorship -- Publication and peer review -- Misconduct in research -- Intellectual property -- Conflicts of interest and scientific objectivity -- The use of animals in research -- The use of human subjects in research -- The use of vulnerable subjects in research -- Genetics, cloning, and stem cell (...) research -- International research. (shrink)

Fifteen years ago, Peter Singer published Animal Liberation: A New Ethics for Our Treatment of Animals. In it, he proposed to end “the tyranny of humans over nonhuman animals” by “thinking through, carefully, and consistently, the question of how we ought to treat animals” (p. ix). On this anniversary of the book's publication, a critical analysis shows that the logic he presents, though popularly appealing, is philosophically flawed. Though influential in slowing and in some cases stopping biomedical (...) class='Hi'>research involving animals, the animal rights movement in the United States has yet to offer a clear and compelling argument for the equlity of species. (shrink)

The first history of American medical ethics published in more than a half century, Before Bioethics tracks the evolution of American medical ethics from colonial midwives and physicians' oaths to current bioethical controversies over abortion, AIDS, animal rights, and physician-assisted suicide.

Some animal research is arguably morally wrong, and some animal research is morally bad but could be improved. Who is most likely to be able to identify wrong or bad animal research and advocate for improvements? I argue that philosophical ethicists have the expertise that makes them the likely best candidates for these tasks. I review the skills, knowledge and perspectives that philosophical ethicists tend to have which makes them ethical experts. I argue that, (...) insofar as IACUCs are expected to ensure that research is ethical, they must have philosophical ethicists as members. (shrink)

Human-nonhuman chimeric research—research on nonhuman animals who contain human cells—is being used to understand human disease and development and to create potential human treatments such as transplantable organs. A proposed advantage of chimeric models is that they can approximate human biology and therefore allow scientists to learn about and improve human health without risking harms to humans. Among the emerging ethical issues being explored is the question of at what point chimeras are “human enough” to have human rights (...) and thus be owed higher standards of research protection than that currently afforded to nonhuman animals. However, this question and other related questions assume that the ethics of experimenting on nonhuman animals have been settled, which they have not. In this essay, we argue that it is imperative to give adequate attention to familiar questions about nonhuman animal research as well as new questions about chimera research and that failure to do so will result in a distorted understanding of the ethics of chimera research. (shrink)

Sacrificial dilemmas such as the trolley problem play an important role in experimental philosophy (x-phi). But it is increasingly argued that, since we are not likely to encounter runaway trolleys in our daily life, the usefulness of such thought experiments for understanding moral judgments in more ecologically valid contexts may be limited. However, similar sacrificial dilemmas are experienced in real life by animal research decision makers. As part of their job, they must make decisions about the suffering, and (...) often the death, of many non-human animals. For this reason, a context-specific investigation of so-called “3R dilemmas” (i.e., dilemmas where there is a conflict between the principles of replacement, reduction, and refinement of the use of animals in research) is essential to improve the situation of both non-human animals and human stakeholders. An approach well suited for such investigation is experimental philosophical bioethics (“bioxphi”), which draws on methods similar to x-phi to probe more realistic, practical scenarios with an eye to informing normative debates and ethical policy. In this article, we argue for a need to investigate 3R dilemmas among professional decision-makers using the tools of bioxphi. In a first step, we define 3R dilemmas and discuss previous investigations of professionals’ attitudes in such cases. In a second step, we show how bioxphi is a promising method to investigate the whys and hows of professional decision-making in 3R dilemmas. In a last step, we provide a bioxphi template for 3R dilemmas, give recommendations on its use, explore the normative relevance of data collected by such means, and discuss important limitations. (shrink)

What is understood by the term “bioethics” varieswidely. Whereas in Germany the focus of the discussioncentres on biotechnological issues like PreimplantationGenetic Diagnosis , research on human stem cellsand cloning, in Asia the concept is understood morebroadly including among others environmental ethics,animal rights and medical ethics. This article tries to setout the discussion going on in Germany on two ratherdifferent levels: On the one hand, it is a legal discussionon whether research on human stem cell (...) should beallowed and whether to put forward PGD. On the otherhand, this discussion is entangled with a highlyspeculative discussion on the issue of manipulation thehuman genes – if ever possible – in order to improve thehuman genes. The main aim of giving this account ofthe ongoing deliberations in Germany is to introducethis discussion to the Asian context in order to enrich thediscourse in bioethics going on here. (shrink)

A dictionary definition of Bioethics is, 'the ethics, or moral principles and rules of conduct, of medical and biological research'. This book is an introductory text of just biological and not medical bioethics. It covers the ethics of experimentation, including genetic manipulation, in plants and animals; ethics and biodiversity, ethics and the environment. There is increasing interest in bioethics - both in academia and by the media and the general public. Awareness of bioethics (...) is incorporated into Biological / Environmental Science courses, plus the first dedicated modular courses on bioethics are starting up. Includes case studies Has questions for students Chapters include environmental, animal, agricultural and reproductive ethics as well as a wide range of issues regarding genetic manipulation. (shrink)

Since emotions give contradictory signals about animal experimentation in medical science, man's relationship to animals must be based upon reason. Thomas Aquinas argues that man is essentially different from animals because man's intellectual processes show evidence of an abstract mechanism not possessed by animals. Man's rights arise in association with this essential difference. The consequence is that only man possesses true rights by Aquinas's definition; animals have them only by analogy. However, cruelty to animals is illicit and they (...) should be protected, principally not because they have rights, but because he who is cruel to animals is more likely to be cruel to his fellowman. If there is a need for animal experimentation in science for the good of man, this approach gives philosophical justification for experimentation, since man's well-being must come before that of animals because of his unique possession of rights. However, those experiments should be carried out in the kindest way possible, to promote kindness towards man. To see man as solely part of a biological continuum in competition for rights with those beings close to him biologically, detracts from man's dignity. (shrink)

The use of experimental animals, mostly rodents, in biomedical research and especially in oncology and immunology should be acknowledged with respect, recognizing the contribution of animal experimentation in the fascinating scientific progress in these disciplines of research. It is an obligation of the investigator to justify the scientific and ethical aspects of each study requiring the use of animals. The international guiding principles for using animals in biomedical research are well defined and have been distributed worldwide (...) by the International Council for Laboratory Animal Science (ICLAS) since 1956, when this Organization was founded. In Poland the ICLAS philosophy and principles are highly respected and were implemented firstly by the members of the Commission on Biology of Experimental Animals appointed in 1962 by the Department of Medical Science of the Polish Academy of Science in Warsaw. Animal Protection Acts, first proclaimed in 1928 were gradually modified and improved. Actual legislation (enacted in 1997, 2003 and 2005) is consistent with EU Directives (86/609/EEC) and follows the internationally recommended principles that include ICLAS guidelines concerning animal welfare and care condition in biomedical research. The problem of “alternative methods” is briefly discussed. Dr. Donald Boisvert, CCAC — Canadian Council on Animal Care. (shrink)

The practical problem of assuaging the opponents of animal research may be solved without formally addressing (or resolving) the underlying ethical questions of the debate. Specifically, a peaceful boycott of the "fruits" of animal research may lead to a wider cessation of such research, than, say, vocal or even violent protest. To assist those who might wish to participate in such a boycott- and, moreover, to critically inform them of the implications of their actions-1 offer (...) a modest proposal: the use of an "animal research advance directive", a form which enumerates precisely which "fruits of research" are declined. (shrink)

A dictionary definition of Bioethics is, 'the ethics, or moral principles and rules of conduct, of medical and biological research'. This book is an introductory text of just biological and not medical bioethics. It covers the ethics of experimentation, including genetic manipulation, in plants and animals; ethics and biodiversity, ethics and the environment. There is increasing interest in bioethics - both in academia and by the media and the general public. Awareness of bioethics (...) is incorporated into Biological / Environmental Science courses, plus the first dedicated modular courses on bioethics are starting up. * Includes case studies * Has questions for students * Chapters include environmental, animal, agricultural and reproductive ethics as well as a wide range of issues regarding genetic manipulation. (shrink)

In the field of medically assisted reproduction (MAR), there is a growing emphasis on the importance of introducing new assisted reproductive technologies (ARTs) only after thorough preclinical safety research, including the use of animal models. At the same time, there is international support for the three R’s (replace, reduce, refine), and the European Union even aims at the full replacement of animals for research. The apparent tension between these two trends underlines the urgency of an explicit justification (...) of the use of animals for the development and preclinical testing of new ARTs. Considering that the use of animals remains necessary for specific forms of ART research and taking account of different views on the moral importance of helping people to have a genetically related child, we argue that, in principle, the importance of safety research as part of responsible innovation outweighs the limited infringement of animal wellbeing involved in ART research. (shrink)

This volume offers a carefully argued, compelling theory of bioethics while eliciting practical implications for a wide array of issues including medical assistance-in-dying, the right to health care, abortion, animal research, and the definition of death. The authors' dual-value theory features mid-level principles, a distinctive model of moral status, a subjective account of well-being, and a cosmopolitan view of global justice. In addition to ethical theory, the book investigates the nature of harm and autonomous action, personal identity (...) theory, and the 'non-identity problem' associated with many procreative decisions. Readers new to particular topics will benefit from helpful introductions, specialists will appreciate in-depth theoretical explorations and a novel take on various practical issues, and all readers will benefit from the book's original synoptic vision of bioethics. This title is also available as Open Access on Cambridge Core. (shrink)

In 2017 and 2019, two research teams claimed ‘proof of principle’ for artificial womb technology (AWT). AWT has long been a subject of speculation in bioethical literature, with broad consensus that it is a welcome development. Despite this, little attention is afforded to more immediate ethical problems in the development of AWT, particularly as an alternative to neonatal intensive care. To start this conversation, I consider whether experimental AWT is innovative treatment or medical research. The research–treatment (...) distinction, pervasive in regulation worldwide, is intended to isolate research activities and subject them to a greater degree of oversight. I argue that there is a tendency in the literature to conceptualize AWT for partial ectogenesis as innovative treatment. However, there are sufficiently serious ethical concerns with experimental AWT that mean that it must not be first used on humans on the basis that it is a ‘beneficial treatment’. First, I outline the prospects for translation of AWT animal studies into treatment for human preterms. Second, I challenge the conceptualizations of experimental AWT as innovative treatment. It must be considered medical research to reflect the investigatory nature of the process and guarantee sufficient protections for subjects. Identifying that AWT is research is crucial in formulating further ethico‐legal questions regarding the experimental use of AWT. Third, I demonstrate that clinical trials will be a necessary part of the clinical translation of AWT because of requirements laid out by regulators. I consider the justification for clinical trials and highlight some of the crucial ethical questions about the conditions under which they should proceed. (shrink)

The 20th century produced overwhelming advances in biomedicine with the 1990s introducing 148,000 patents as part of the mapping and sequencing of the human genome. Bioethical realities and debates of prenatal genetic testing, new reproductive technologies, stem cell research, human cloning and DNA data banks have obscured the less provocative public and social issues of gun control, immunization, employee leave programs to assist care for dying relatives, emergency room use as primary care sites by the uninsured, and medical (...) care provision to the homeless. With the events of September 11, the focus has shifted to bioterrorism: an international and global concern that portends broad environmental consequences while requiring a local, community response of which the business enterprise is a part. The tension that results from a required local and global response to bioterrorism and biotechnology by the business community forms a dialectic and provides a venue for addressing business ethics in an international forum. This paper explores the relationship of events and its meaning for business. Part I provides the background of biotechnology and bioterrorism and how the two form a dialectic reality that shapes ethical debate. Part II presents provocations and questions for an emerging ethic based on the integrative response from the public health, medical, business and religious communities. Four areas for business contribution in shaping emerging ethics in the age of biotechnology—bioterrorism are suggested. (shrink)

Allograft shortage is a formidable obstacle in organ transplantation. Xenotransplantation, the interspecies transplantation of cells, tissues, and organs, or ex vivo interspecies exchange between cells, tissues, and organs is a frequently suggested alternative to this allograft shortage. As xenotransplantation steadily improves into a viable allotransplantation alternative, several bioethical considerations coalesce. Such considerations include the Helsinki declaration’s guarantee of patients’ rights to privacy; political red tape that may select for undermined socioeconomic groups as the first recipients of xenografts; industry incentives in (...) xenotransplantation investments; conflicts of interest when a clinician supervises a patient as a research subject; the psychosocial impact of transplantation on the xenograft recipient, and the rights of animals. This review illuminates these issues through a conglomeration of expert opinion and relevant experimental studies. (shrink)

Animal Suffering and Public Relations conducts an ethical assessment of public relations, mainly persuasive communication and lobbying, as deployed by some of the main businesses involved in the animal industrial complex - the industries participating in the systematic and institutionalized exploitation of animals. Society has been experiencing a growing ethical concern regarding humans' (ab)use of other animals. This is a trend first promoted by the development of animal ethics - which claims any sentient being, because of (...) sentience, deserves moral consideration - and more recently by other approaches from the social sciences, including critical animal studies. In this volume, we aim to start an entirely unaddressed discussion within the field of public relations: the need to problematize the ethics of persuasion when nonhuman animal suffering is involved, particularly the impact of persuasion and lobbying on compassion towards other animals in the cases of food, experimentation, entertainment and environment management. The books provides an interdisciplinary, theoretical discussion illustrated with international case studies from experts in strategic communication, public relations, lobbying and advocacy, animal ethics, philosophy of law, political philosophy and social psychology. This unique book merges the fields of critical public relations, animal ethics and critical animal studies and will be of direct appeal to a wide range of researchers, academics and doctoral students across related fields. (shrink)

The Research Excellence Framework of the Higher Education Funding Council for England is taking place in 2013, its three key elements being outputs, impact, and “quality of the research environment”. Impact will be assessed using case studies that “may include any social, economic or cultural impact or benefit beyond academia that has taken place during the assessment period.”1 Medical ethics in the UK still does not have its own cognate assessment panel—for example, bioethics or applied (...) class='Hi'>ethics—unlike in, for example, Australia. Several researchers in medical ethics have reported to the Institute of Medical Ethics that during the internal preliminary stage of the Research Excellence Framework several medical schools have decided to include only research that entails empirical data gathering. Thus, conceptual papers and ethical analysis will be excluded. The arbitrary exclusion of reasoned discussion of medical ethics issues as a proper subject for medical research unless it is based on empirical data gathering is conceptually mistaken. “Empirical ethics” is, of course, a legitimate component of medical ethics research, but to act as though it is the only legitimate component suggests, at best, a partial understanding of the nature of ethics in general and medical ethics in particular. It also mistakenly places medicine firmly on only one side of the science/humanities “two cultures” divide instead of in its rightful place bridging the divide. Given the emphasis by the General Medical Council on medical ethics in properly preparing “tomorrow’s doctors,” we urge medical schools to find a way of using the upcoming Research Excellence Framework to highlight the expertise residing in their ethicist colleagues. We are confident that appropriate assessment will reveal work of high quality that can be shown to have social and cultural impact and benefit beyond academia, as required by the framework. (shrink)

Frey sets the challenge for the other authors: to explain why, morally, no humans can be subject to the kinds of experiments that animals are subject to and to explain how researchers can reliablyuse animal models to understand and cure human disease. He thinks that the first challenge has not been met; the second challenge is, unfortunately, not directly addressed in this book. Adrian Morrison states that he “abhors” positions like Frey’s, Peter Singer’s and Tom Regan’s. He asserts that (...) all “human beings stand apart in a moral sense from all other species” and that all are worthy of “special consideration”. Regrettably he fails to defend his view by identifying the morally-relevant characteristics that all humans possess and all animals lack that might make his claim true. That omission prevents him from rationally criticizing opposing views. (shrink)

Although Cultural Studies has directed sustained attacks against sexism and racism, the question of the animal has lagged behind developments in broader society with regard to animal suffering in factory farming, product testing, and laboratory experimentation, as well in zoos, rodeos, circuses, and public aquariums. The contributors to Animal Subjects are scholars and writers from diverse perspectives whose work calls into question the boundaries that divide the animal kingdom from humanity, focusing on the medical, biological, (...) cultural, philosophical, and ethical concerns between non-human animals and ourselves. The first of its kind to feature the work of Canadian scholars and writers in this emergent field, this collection aims to include the non-human-animal question as part of the ethical purview of Cultural Studies and to explore the question in interdisciplinary terms. (shrink)

Animal research has long been a source of biomedical aspirations and moral concern. Examples of both hope and concern are abundant today. In recent months, as is common practice, monkeys have served as test subjects in promising preclinical trials for an Ebola vaccine or treatment 1 , 2 , 3 and in controversial maternal deprivation studies. 4 The unresolved tension between the noble aspirations of animal research and the ethical controversies it often generates motivates the present (...) issue of the Cambridge Quarterly of Healthcare Ethics. As editors of this special section, we hope that these original and timely articles will push the professional discussion of animal research ethics in a positive direction that will benefi t research scientists and others interested in moral problems in animal research. We also look forward to a day when animal research will genuinely meet both appropriate scientifi c and appropriate ethical criteria—criteria that themselves can be improved by critical scrutiny. Animal research—that is, the use of live animals as experimental subjects in biomedical and behavioral fi elds of learning—has been deeply entrenched for well over half a century. One signal development was the enactment in the late 1930s of federal product safety legislation in the United States and other nations that required animal testing of food, drugs, and medical devices prior to use by human subjects or consumers. 5 Another development was the publication of codes of research ethics that called for animal research prior to human research. The Nuremberg Code, published by an American military tribunal in 1947–48 after scrutiny of Nazi medical atrocities, stated that experiments involving the use of human subjects should be " based on the results of animal experimentation. " 6 The Declaration of Helsinki, fi rst published in 1964, reaffi rmed this assumption and added, rather imprecisely, that " the welfare of animals used for research must be respected. " 7 Against the background of such statements, the institutionalization and widespread acceptance of animal research in the twentieth century rested on two basic assumptions, one factual and one moral. The factual assumption was that animal research is suffi ciently reliable as a basis for predicting the effects of drugs, products, and other materials on human beings that animal trials can be expected to yield signifi cant scientifi c conclusions and medical benefi ts to humanity. (shrink)

Wild animal reproduction poses an important moral problem for animal rights theorists. Many wild animals give birth to large numbers of uncared-for offspring, and thus child mortality rates are far higher in nature than they are among human beings. In light of this reproductive strategy – traditionally referred to as the ‘r-strategy’ – does concern for the interests of wild animals require us to intervene in nature? In this paper, I argue that animal rights theorists should embrace (...) fallibility-constrained interventionism: the view that intervention in nature is desirable but should be constrained by our ignorance of the inner workings of ecosystems. Though authors sometimes assume that large-scale intervention requires turning nature into an enormous zoo, I suggest an alternative. With sufficient research, a new form of gene editing called CRISPR promises to one day give us the capacity to intervene without perpetually interfering with wild animals’ liberties. (shrink)

The history of the regulation of animal research is essentially the history of the emergence of meaningful social ethics for animals in society. Initially, animal ethics concerned itself solely with cruelty, but this was seen as inadequate to late 20th-century concerns about animal use. The new social ethic for animals was quite different, and its conceptual bases are explored in this paper. The Animal Welfare Act of 1966 represented a very minimal and in (...) many ways incoherent attempt to regulate animal research, and is far from morally adequate. The 1985 amendments did much to render coherent the ethic for laboratory animals, but these standards were still inadequate in many ways, as enumerated here. The philosophy underlying these laws is explained, their main provisions are explored, and future directions that could move the ethic forward and further rationalize the laws are sketched. (shrink)

Records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of new and especially challenging ethical issues. These include issues raised by international collaborative trials of drugs in developing (...) countries, especially expensive drugs, and the use of placebo controls in randomized clinical trials. Others arise from the complexity of research in human genetics, including stem-cell research, and in reproductive biology. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV. The International Ethical Guidelines for Biomedical Research Involving Human Subjects set out a code of research ethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct of research. The revision of the Guidelines is being coordinated by CIOMS, in collaboration with WHO. The consultation centered on seven specially commissioned papers, authored by international experts that explore some of the more difficult issues in depth. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate. The first paper, on justice in international research, deals with the question of whether proposals for research to be conducted in a developing country should make provision for future access of the population involved to the interventions under investigation. Also considered are questions that arise when research uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. Case studies of recent drug trials and their research protocols are discussed to illustrate circumstances in which use of populations in developing countries is justified or constitutes exploitation. Ethical challenges of the randomized controlled trial are considered in the second paper, which includes a discussion on the equitable distribution of benefits and risks, the use of placebo for controls, and the obligation to ensure that the participation of controls does not compromise their medical care or endanger their health. A paper on informed consent in international health research considers how cultural factors influence communication and language in the informed-consent process and respect for privacy and confidentiality in the research. Subsequent papers address issues in genetics research and reproductive biology, including the moral status of fetuses and the use of embryos in research, and examine the contribution which international human rights instruments can make in the application of the general principles of ethics to research involving human subjects. The final paper gives an overview of capacity building and the role of communities in international biomedical research. (shrink)

The view that research with competent adults requires valid consent to be ethical perhaps finds its clearest expression in the Nuremberg Code, whose famous first principle asserts that “the voluntary consent of the human subject is absolutely essential.” In a similar vein, the United Nations International Covenant on Civil and Political Rights states that “no one shall be subjected without his free consent to medical or scientific experimentation.” Yet although some formulations of the consent principle allow no exceptions, (...) others hold that informed consent is not always strictly necessary for ethical research. The U.S. federal regulations known as the “Common Rule,” which govern research with human subjects, lists several conditions for waiving consent. However, neither guidance documents on the ethics of clinical research nor the literature in bioethics contains a general justification of research without consent. The purpose of this paper is to advance a justificatory framework that will explain why research without consent is permissible in paradigmatic cases and that can be useful in analyzing cases about which there is disagreement. We argue that research without consent can be justified on two grounds: if it stands to infringe no right of the participants and obtaining consent is impracticable, or if the gravity of the rights infringement is minor and outweighed by the expected social value of the research and obtaining consent is impracticable. (shrink)

This book provides a current review of Medical Research Ethics on a global basis. The book contains chapters that are historically and philosophically reflective and aimed to promote a discussion about controversial and foundational aspects in the field. An elaborate group of chapters concentrates on key areas of medical research where there are core ethical issues that arise both in theory and practice: genetics, neuroscience, surgery, palliative care, diagnostics, risk and prediction, security, pandemic threats, finances, (...) technology, and public policy.This book is suitable for use from the most basic introductory courses to the highest levels of expertise in multidisciplinary contexts. The insights and research by this group of top scholars in the field of bioethics is an indispensable read for medical students in bioethics seminars and courses as well as for philosophy of bioethics classes in departments of philosophy, nursing faculties, law schools where bioethics is linked to medical law, experts in comparative law and public health, international human rights, and is equally useful for policy planning in pharmaceutical companies. (shrink)

Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits of research. Because these assessments (...) often involve value judgments for which there are no agreed-upon objective standards, we rely on deliberative procedures thought to have the greatest likelihood of producing the right or best outcomes. Concerns about the potential for improperly functioning IRBs to waste scarce human and institutional resources and impede biomedical progress have motivated a surge in empirical research assessing their procedures and outcomes. Yet within this literature, there has been minimal attention paid to the social scientific evidence regarding how individuals and deliberating groups make decisions, nor how those data might inform IRB practice. This essay seeks to fill that gap, locating recent empirical data on IRB composition and process within the context of data regarding what I call “deliberative pathologies,” or instances when deliberation fails to live up to one or more aspect of the deliberative ideal because of systematic biases in the ways participants interact. The paper goes on to make evidence-based recommendations to reduce the vulnerability of IRB deliberations to the kinds of pathologies discussed and indicate directions for future research. (shrink)

In Principles of Animal Research Ethics, Tom Beauchamp and David DeGrazia (hereafter B&D) aim to replace the well-known “3Rs”—Replacing animal research with non-animal methods, Reducing the numbers of animals, and Refining experiments to reduce harms and improve welfare—as the guiding principles regulating animal research. . . B&D present their principles as “useful” for people engaged in animal research and as a “philosophically sound” (p. 4) framework for a new ethic for (...) animal research. Regrettably, I have doubts about both these overall claims and so am pessimistic about the book. (shrink)

In December 2014, Physicians for Human Rights released their analysis of the summary of the Committee Report of the Central Intelligence Agency’s Detention and Interrogation Program. PHR focused on the involvement of health care professionals in the CIA torture program, concluding that the health professionals’ commissions and omissions violated the prescriptions of many fundamental bioethical documents, including international declarations of bioethics and medical research ethics. The medical doctors’ involvement evokes some thoughts concerning bioethical education. It seems (...) that instead of developing virtues through practicing morally good habits, the experience of clinical training undermines the moral ideals that medical students identified themselves with at the commencement of their medical education. The hostile response they sometimes get from their mentors when trying to question morally troubling situations may shape the habit of ‘turning a blind eye’ to unethical behaviour, since the students do not want to jeopardize their grades and future medical career. Maybe it was the development of this habit and the failure to develop the habit of moral courage instead that prevented the medical doctors participating in torture programs from defending moral ideals of their profession more effectively. (shrink)

No matter how far medicine advances, incurable disease will inevitably exist; and the dying patient's last resort will likewise look to medical research. In this report, we examine a case concerning the use of experimental medical therapy on a critically ill child. We discuss the ethical argument pertaining to the recommending of experimental medical therapy to the family of a dying patient.Under the circumstances of having to face the impending death of one's own child, parents of (...) a terminally ill child are extremely vulnerable to suggestion and often loose the ability to make a composed decision._Moreover, there exists the possibility of not only patients, but also medical staff and researchers, to fall into therapeutic misconception. Likewise, for the terminal patient and his/her family though, experimental medical therapy is often the only hope, which is, however, always accompanied by a factor of uncertainty and is considered to be merely an unapproximated gamble. The proposing of experimental medical therapy can result in being cruel by shattering the parent's expectations of saving their child._We examine the issues involved in proposing an experimental medical therapy to patients who are in dire need of a last hope; and conclude that, in times of emergency, we must take great consideration in recommending an experimental medical therapy as an "innovative treatment." In extreme circumstances where an individual's life is on the line, doing nothing can be quite trying; yet, what is right is not necessarily doing something, but rather making the right decision. (shrink)