Our global knowledge of different cultures and the diversity of values increases almost daily. New challenges arise for ethics. This is especially true in the field of bioethics because the technological progress of medicine throughout the world is causing dramatic interactions with traditionally held values. Science and technology are rapidly advancing beyond discussions and corresponding political struggles over human rights, leaving those debates behind. This rapid development of science is at odds with the principle of sustained development that calls for (...) measured and thoughtful planning, such that no new idea should rupture the delicate fabric of communities, environment, and cultural evolution. (shrink)

It is widely maintained that a clinical trial is ethical only if some form of equipoise between the treatments being compared obtains. To be in equipoise between two treatments A and B is to be cognitively indifferent between the statement ‘A is strictly more effective than B’ and its negation. It is natural to claim that equipoise regarding A and B is necessary for randomised assignment to treatments A and B to be beneficent and non‐maleficent and is sufficient for such (...) an assignment to be fair. Cashing this out precisely is difficult, and various forms of equipoise have been discussed which consider whose equipoise is relevant to the decision. This is to make judgement of equipoise something to be managed socially, while its prima facie significance is supposedly cognitive. Recent reconstructions of equipoise‐like concepts in epistemology give clues about how to understand equipoise cognitively. In this paper I examine some of this work and discuss how successful it has been. I suggest that while this work is promising, it still has far to go, and that while equipoise remains the best theory we have of the cognitive justification for clinical trials, it is nonetheless incoherent. (shrink)

This paper argues that some of the misunderstandings surrounding the meaning and function of the concept of human dignity in bioethics arise from a lack of distinction between two different roles that this notion plays: one as an overarching policy principle, and the other as a moral standard of patient care. While the former is a very general concept which fulfils a foundational and a guiding role of the normative framework governing biomedical issues, the latter reflects a much more concrete (...) and context-specific understanding of the patient as a “person”. The importance of dignity as a policy principle will be described by appealing to the distinction between principles and rules as developed by some legal philosophers. The value of dignity as a standard of patient care will be illustrated with the help of concrete examples and by drawing on the taxonomies of dignity proposed by Jonathan Mann and other scholars. The overall scope of the article is to highlight this double and complementary role of human dignity in bioethics. (shrink)

The principle of respect for human dignity plays a crucial role in the emerging global norms relating to bioethics, in particular in the UNESCO Universal Declaration on Bioethics and Human Rights. This instrument, which is a legal, not merely an ethical document, can be regarded as an extension of international human rights law into the field of biomedicine. Although the Declaration does not explicitly define human dignity, it would be a mistake to see the emphasis put on this notion as (...) a mere rhetorical strategy. Rather, the appeal to dignity reflects a real concern about the need to promote respect both for the intrinsic worth of human beings and for the integrity of the human species. But dignity alone cannot solve most of the dilemmas posed by biomedical practice. This is why international biolaw combines, on the one hand, the appeal to human dignity as an overarching principle with, on the other hand, the recourse to human rights, which provide an effective and practical way forward for dealing with bioethical issues at a global level. (shrink)

Any view of equipoise faces perhaps the most radical and far-reaching objections from moral foundations. These objections hold that the equipoise requirement conflates the ethics of medical research and the ethics of clinical medicine. Once this conflation is recognized, this position holds, research can be given a new foundation on the imperative to avoid exploiting research participants. This article argues that what is novel in this critique is not as successful as its proponents claim and that the ultimate success of (...) this approach actually hinges on a version of the objection from utility. Nevertheless, this criticism highlights the limited scope of applicability of the equipoise requirement. The article concludes, therefore, by describing the outlines of what the article calls an ‘integrative approach’ to clinical trials. This approach represents one way in which the normative requirements of equipoise and the non-exploitation approach might be unified under a single, broad framework. (shrink)

This book presents a comprehensive theory of legal interpretation, by a leading judge and legal theorist. Currently, legal philosophers and jurists apply different theories of interpretation to constitutions, statutes, rules, wills, and contracts. Aharon Barak argues that an alternative approach--purposive interpretation--allows jurists and scholars to approach all legal texts in a similar manner while remaining sensitive to the important differences. Moreover, regardless of whether purposive interpretation amounts to a unifying theory, it would still be superior to other methods of interpretation (...) in tackling each kind of text separately. -/- Barak explains purposive interpretation as follows: All legal interpretation must start by establishing a range of semantic meanings for a given text, from which the legal meaning is then drawn. In purposive interpretation, the text's "purpose" is the criterion for establishing which of the semantic meanings yields the legal meaning. Establishing the ultimate purpose--and thus the legal meaning--depends on the relationship between the subjective and objective purposes; that is, between the original intent of the text's author and the intent of a reasonable author and of the legal system at the time of interpretation. This is easy to establish when the subjective and objective purposes coincide. But when they don't, the relative weight given to each purpose depends on the nature of the text. For example, subjective purpose is given substantial weight in interpreting a will; objective purpose, in interpreting a constitution. -/- Barak develops this theory with masterful scholarship and close attention to its practical application. Throughout, he contrasts his approach with that of textualists and neotextualists such as Antonin Scalia, pragmatists such as Richard Posner, and legal philosophers such as Ronald Dworkin. This book represents a profoundly important contribution to legal scholarship and a major alternative to interpretive approaches advanced by other leading figures in the judicial world. (shrink)

Application of either the harm principle or the best interest standard to medical decision making conflicts with some types of pediatric research that pose elevated risk without the reasonable prob...

It is commonly believed in research ethics that some form of equipoise is a necessary condition for justifying randomized clinical trials, that without it clinicians are violating the moral duty to do what is best for the patient. Recent criticisms have shown how complex the concept of equipoise is, but often retain the commitment to some form of equipoise for randomization to be justified. This article rejects that claim. It first asks for what one should be equally poised (scientific or (...) clinical equipoise), then asks who should be equally poised (scientist, clinician, or subject), and finally asks why any of these players need be equally poised between treatment options. The article argues that only the subject's evaluation of the options is morally relevant and that even the subject need not be equally poised or indifferent between the options in order to volunteer for randomization. All that is needed is adequately informed, free, and unexploited consent. It concludes equipoise is irrelevant. (shrink)

The physician who upholds the Hippocratic oath is supposed to be loyal to his or her patients. This requires choosing only the therapy that the physician believes is best for the patient. However, knowing what is best requires randomized clinical trials. Thus, clinicians must be willing to recruit their patients to be assigned at random to one of two therapies in order to determine which is best based on the highest standards of pharmacological science.

Reigning regulatory frameworks for biomedical research impose on researchers and research ethics committees an obligation to protect research participants from risks that are unnecessary, disproportionate to potential research benefits, and non-minimized. Where the research has no potential to produce results of direct benefit to the subjects and the subjects are unable to give consent, these requirements are strengthened by an additional condition, that risks should not exceed a certain minimal threshold. In this article, I address the question of whether there (...) should be limits of permissible risks in non-therapeutic research involving competent and healthy subjects. Some commentators argue that competent and informed individuals should have a right to participate even in extremely risky research and that research ethics committees should never reject studies because they are too dangerous. To use David Shaw's expression, competent volunteers should have ‘a right to participate in high-risk research’. I argue that this idea is ill-founded, as it does not take into account the social mission and complex collaborative nature of research practice as well as the inequity of power between researchers and subjects. Imposition of limits on permissible risks for healthy volunteers is justified by the need to protect research enterprise and the need to protect the weaker party, namely the subjects. Also, I suggest that the best way to set boundaries on research risks is to leave the judgment of risk acceptability to research ethics committees. (shrink)

The World Medical Association’s revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the authors show that (...) there is also consensus regarding the broad conditions under which this is acceptable. (shrink)

Biomedical research involving human subjects is an arena of conflicts of interests. One of the most important conflicts is between interests of participants and interests of future patients. Legal regulations and ethical guidelines are instruments designed to help find a fair balance between risks and burdens taken by research subjects and development of knowledge and new treatment. There is an universally accepted ethical principle, which states that it is not ethically allowed to sacrifice individual interests for the sake of society (...) and science. This is the principle of precedence of individual. But there is a problem with how to interpret the principle of precedence of individual in the context of research without prospect of future benefit involving children. There are proposals trying to reconcile non-beneficial research involving children with the concept of the best interests. We assert that this reconciliation is flawed and propose an interpretation of the principle of precedence of individual as follows: not all, but only the most important interests of participants, must be guaranteed; this principle should be interpreted as the secure participant standard. In consequence, the issue of permissible risk ceiling becomes ethically crucial in research with incompetent subjects. (shrink)

Can the view that medical science is more important than the individual properly persuade recruitment to trials? This paper considers the nature and interests of the person and their relationships to the concepts of science and society; and analyses a conception of value used to balance the interests of science and research subjects. The implications of arguments opposing the primacy of the individual are set out to indicate their implausibility; while the primacy principle is described to show its necessity in (...) any moral society. Finally, the importance of fully informed consent to participate is explained with the requirement that the individual human life provide the criteria of moral value for human life. (shrink)

When may a physician enroll a patient in clinical research? An adequate answer to this question requires clarification of trust-based obligations of the state and the physician-researcher respectively to the patient-subject. The state relies on the voluntarism of patient-subjects to advance the public interest in science. Accordingly, it is obligated to protect the agent-neutral interests of patient-subjects through promulgating standards that secure these interests. Component analysis is the only comprehensive and systematic specification of regulatory standards for benefit-harm evaluation by research (...) ethics committees (RECs). Clinical equipoise, a standard in component analysis, ensures the treatment arms of a randomised control trial are consistent with competent medical care. It thus serves to protect agent-neutral welfare interests of the patient-subject. But REC review occurs prior to enrolment, highlighting the independent responsibility of the physician-researcher to protect the agent-relative welfare interests of the patient-subject. In a novel interpretation of the duty of care, we argue for a “clinical judgment principle” which requires the physician-researcher to exercise judgment in the interests of the patient-subject taking into account evidence on treatments and the patient-subject‘s circumstances. (shrink)

: When may a physician legitimately offer enrollment in a randomized clinical trial (RCT) to her patient? Two answers to this question have had a profound impact on the research ethics literature. Equipoise, as originated by Charles Fried, which we term Fried's equipoise (FE), stipulates that a physician may offer trial enrollment to her patient only when the physician is genuinely uncertain as to the preferred treatment. Clinical equipoise (CE), originated by Benjamin Freedman, requires that there exist a state of (...) honest, professional disagreement in the community of expert practitioners as to the preferred treatment. FE and CE are widely understood as competing concepts. We argue that FE and CE offer separable and, in themselves, incomplete justifications for the conduct of clinical trials. FE articulates conditions under which the fiduciary duties of physician to patient may be upheld in the conduct of research. CE sets out a standard for the social approval of research by institutional review boards. Viewed in this way, FE and CE are not necessarily competing notions, but rather address complementary moral concerns. (shrink)

Heated debate surrounds the question whether the relationship between physician-researcher and patient-subject is governed by a duty of care. Miller and Weijer argue that fiduciary law provides a strong legal foundation for this duty, and for articulating the terms of the relationship between physician-researcher and patient-subject.

Bioethics is currently witnessing unprecedented debate over the moral and legal norms governing the conduct of clinical research. At the center of this debate is the duty of care in clinical research, and its most widely accepted specification, clinical equipoise. In recent work, we have argued that equipoise and cognate concepts central to the ethics of clinical research have been left unnecessarily vulnerable to criticism. We have suggested that the vulnerability lies in the conspicuous absence of an articulated foundation in (...) moral and legal theory of the physician-researcher's duty of care to the patient-subject. We have repeatedly suggested that the requisite foundation is in the ethics of trust and the law of fiduciaries.Curiously, despite the absence of a published thorough exposition of our position, some have preemptively criticized our suggestion that the relationship between physician-researcher and patient-subject is fiduciary. Others have offered their own accounts of the implications of fiduciary law for the relationship. (shrink)

Franklin G. Miller and colleagues have stimulated renewed interest in research ethics through their work criticizing clinical equipoise. Over three years and some twenty articles, they have also worked to articulate a positive alternative view on norms governing the conduct of clinical research. Shared presuppositions underlie the positive and critical dimensions of Miller and colleagues' work. However, recognizing that constructive contributions to the field ought to enjoy priority, we presently scrutinize the constructive dimension of their work. We argue that it (...) is wanting in several respects. (shrink)

The doctrine of clinical equipoise is appealing because it appears to permit physicians to maintain their therapeutic obligation to offer optimal medical care to patients while conducting randomized controlled trials (RCTs). The appearance, however, is deceptive. In this article we argue that clinical equipoise is defective and incoherent in multiple ways. First, it conflates the sound methodological principle that RCTs should begin with an honest null hypothesis with the questionable ethical norm that participants in these trials should never be randomized (...) to an intervention known to be inferior to standard treatment. Second, the claim that RCTs preserve the therapeutic obligation of physicians misrepresents the patient-centered orientation of medical care. Third, the appeal to clinical equipoise as a basic principle of risk-benefit assessment for RCTs is incoherent. Finally, the difficulties with clinical equipoise cannot be resolved by viewing it as a presumptive principle subject to exceptions. In the final sections of the article, we elaborate on the non-exploitation framework for the ethics clinical research and indicate issues that warrant further inquiry. (shrink)

A predominant ethical view holds that physician‐investigators should conduct their research with therapeutic intent. And since a physician offering a therapy wouldn't prescribe second‐rate treatments, the experimental intervention and the best proven therapy should appear equally effective. "Clinical equipoise" is necessary. But this perspective is flawed. The ethics of research and of therapy are fundamentally different, and clinical equipoise should be abandoned.

Globalization is often discussed as if it were a recent phenomenon relating primarily to the development of world financial markets and improvements in information and travel technologies. But globalization is an ancient process, beginning with mercantile and cultural exchanges and facilitated by advances in transportation. In the twentieth century, the results of globalization can be seen in the rise of global capitalism and in the construction of a global economy. Most recently, the process of globalization has moved beyond the world (...) of finance, however, into areas still traditionally thought of as national concerns, such as culture and healthcare. It is no surprise, therefore, that increasingly the challenges the United States is confronting in healthcare, biotechnology, and the environment are simultaneously faced by the international community as a whole. In the wake of the HIV pandemic, growing environmental consciousness, and a series of sensational advances in biotechnology, there is a dawning realization that problems such as improving public health, regulating advances in biotechnology, and achieving sustainable environmental development transcend national borders. In other words, bioethics concerns are global in nature. (shrink)

The American Journal of Bioethics, Volume 12, Issue 1, Page 44-46, January 2012.

In the research ethics literature, there is strong disagreement about the ethical acceptability of placebo-controlled trials, particularly when a tested therapy aims to alleviate a condition for which standard treatment exists. Recently, this disagreement has given rise to debate over the moral appropriateness of the principle of clinical equipoise for medical research. Underlying these debates are two fundamentally different visions of the moral obligations that investigators owe their subjects.Some commentators and ethics documents claim that physicians, whether acting as care givers (...) or researchers, have the same duty of beneficence towards their patients and subjects: namely, that they must provide optimal medical care. In discussing placebo surgery in research on refractory Parkinson's disease, Peter Clark succinctly states this view: “The researcher has an ethical responsibility to act in the best interest of subjects.”. (shrink)

In the research ethics literature, there is strong disagreement about the ethical acceptability of placebo-controlled trials, particularly when a tested therapy aims to alleviate a condition for which standard treatment exists. Recently, this disagreement has given rise to debate over the moral appropriateness of the principle of clinical equipoise for medical research. Underlying these debates are two fundamentally different visions of the moral obligations that investigators owe their subjects.Some commentators and ethics documents claim that physicians, whether acting as care givers (...) or researchers, have the same duty of beneficence towards their patients and subjects: namely, that they must provide optimal medical care. In discussing placebo surgery in research on refractory Parkinson's disease, Peter Clark succinctly states this view: “The researcher has an ethical responsibility to act in the best interest of subjects.”. (shrink)

Equipoise is an essential condition to justify a clinical trial. The term, describes a state of uncertainty: the data suggest but do not prove a drug's safety and efficacy The only way to resolve this uncertainty is further study In many cases, a clinical trial seems to be the most efficient way to prove safety and efficacy Equipoise is therefore not an esoteric philosophic construct applied to research ethics. Rather, since it is vital for the justification of clinical trials, it (...) is part of how society regulates medical progress. Where there is equipoise, drug design and development proceeds according to Food and Drug Administration and Health and Human Services regulations. When that equipoise ends, a drug is either not approved or becomes standard care. (shrink)

: Some commentators have recently proposed that "clinical equipoise," although widely accepted, is not necessary for morally acceptable research on human subjects. If this concept is rejected, however, we may find that trials not in the best medical interests of their subjects--bad deal trials--could be justified. To avoid exploiting participants, we must find a way to distribute the risks fairly, even if it means embracing radical changes in the way clinical research is conducted.

Some commentators have recently proposed that “clinical equipoise,” although widely accepted, is not necessary for morally acceptable research on human subjects. If this concept is rejected, however, we may find that trials not in the best medical interests of their subjects—”bad deal trials”—could be justified. To avoid exploiting participants, we must find a way to distribute the risks fairly, even if it means embracing radical changes in the way clinical research is conducted.

In a previous paper in the Journal of Medical Ethics, the authors argued that the research ethical principle stating that the individual shall have priority over science, found in many guidelines, is utterly unclear and because of this should be explicated or otherwise deleted. In a recent commentary, Parker argued that this leaves us defending a position that would allow totalitarian regimes to pursue glory at the expense of its citizens. The present response addresses this and similar accusations.

This paper critically examines a particular strategy for resolving the central ethical dilemma associated with randomized clinical trials — the “community equipoise” strategy . The dilemma is that RCTs appear to violate a physician's duty to choose that therapy which there is most reason to believe is in the patient's best interest, randomizing patients even once evidence begins to favor one treatment. The community equipoise strategy involves the suggestion that our judgment that neither treatment is to be preferred is to (...) be assessed according to a community rather than an individual standard. Thus, though a physician may personally believe that there is some reason to prefer one treatment, patients can legitimately be randomized if there remains disagreement in the community of medical professionals. Rationales in favor of this conception include the following: medical knowledge is best understood as residing in the community, the judgments of others count as evidence, and so should change one's own opinion, subjects would not be better off outside the trial, and the point of any trial is the resolution of dispute in the medical community. I critically examine these rationales and argue that they are insufficient. Amongst the problems are tensions between various of these underlying rationales, and important ambiguities in just what the CE criterion is to amount to. Finally, I argue that even if use of CE was justified, it would not justify carrying out RCTs anywhere near long enough to discharge our duty to gain reliable knowledge on which to base safe and effective medical practice. Hence, we need some different justification for carrying out RCTs. (shrink)

This paper highlights a feature common to many ethical guidelines—namely, the idea that the interests of the individual shall always prevail over the interests of science and society. The paper presents how some major ethical guidelines treat the balancing of research interests against those of research subjects and spells out the difficulties in interpreting the principle of the primacy of the individual in a way that can be action-guiding. It suggests various alternative interpretations of the primacy of the individual and (...) argues that they do not hold. Finally, the implications of this analysis for ethical guidelines are discussed. (shrink)

The use of statistics in medical research has been compared to a religion: it has its high priests, supplicants, and orthodoxy. Although the comparison may be more unfair to religion than to research, a useful lesson can nonetheless be drawn: the practice of clinical research may benefit—as does the spirit—from critical self-examination. Arguably, no aspect of the conduct of clinical trials is currently more controversial—and thus in as dire need of critical examination—than the use of placebo controls. The ethical and (...) scientific controversies associated with placebo-controlled trials, never far below the surface, have once again seized public attention. Clearly, concern about these issues within the professional community runs deep and wide, as evidenced by the volume of response generated by Kenneth Rothman and Karin Michels's recent Critique. Criticisms of the use of placebo controls in clinical research are scattered through the literatureo; our objective is to present the case against placebos in a compendious form that takes account of scientific and statistical as well as normative issues. (shrink)

Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration, to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo controls in clinical research. The (...) continued use of placebo controls in clinical trials on diseases for which accepted treatment exists raises equally important ethical, legal, and regulatory issues for which various justifications have been given. Defense of this practice relies on normative as well as empirical myths.In their attack on the prevailing use of placebo controls, Kenneth Rothman and Karin Michels emphasize that this practice stands in violation of the World Medical Association's guidelines on the ethics of human experimentation, most commonly known as the Helsinki Declaration. (shrink)

The use of statistics in medical research has been compared to a religion: it has its high priests, supplicants, and orthodoxy. Although the comparison may be more unfair to religion than to research, a useful lesson can nonetheless be drawn: the practice of clinical research may benefit—as does the spirit—from critical self-examination. Arguably, no aspect of the conduct of clinical trials is currently more controversial—and thus in as dire need of critical examination—than the use of placebo controls. The ethical and (...) scientific controversies associated with placebo-controlled trials, never far below the surface, have once again seized public attention. Clearly, concern about these issues within the professional community runs deep and wide, as evidenced by the volume of response generated by Kenneth Rothman and Karin Michels's recent Critique. Criticisms of the use of placebo controls in clinical research are scattered through the literatureo; our objective is to present the case against placebos in a compendious form that takes account of scientific and statistical as well as normative issues. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and BiomedicineCouncil of EuropePreambleThe Member States of the Council of Europe, the other States and the European Community signatories hereto,Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;Bearing in mind the (...) Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;Bearing in mind the European Social Charter of 18 October 1961;Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;Bearing in mind the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data of 28 January 1981;Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;Conscious of the accelerating developments in biology and medicine;Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being; [End Page 277]Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;Affirming that progress in biology and medicine should be used for the benefit of present and future generations;Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;Wishing to remind all members of society of their rights and responsibilities;Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;Have agreed as follows:Chapter IGeneral provisionsArticle 1. (Purpose and object)Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.Article 2. (Primacy of the human being)The interests and welfare of the human being shall prevail over the sole interest of society or science.Article 3. (Equitable access to health care)Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality. [End Page 278]Article 4. (Professional standards)Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.Chapter IIConsentArticle 5. (General rule)An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.The person concerned may freely withdraw consent at any time.Article 6. (Protection of persons not able to consent)1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or... (shrink)

The understanding of appropriate ethical protections for participants of biomedical research has not been static. It has evolved over time, with the evolution of biomedical research as well as social values. Since World War II, there have been four major paradigms of research and research oversight operative in the United States. These paradigms incorporate different values and provide different approaches to research oversight and the protection of research participants.

Global bioethics is a bold project. In its moderate form, it aims to find solutions to the dilemmas posed by modern medicine and the biological sciences through intercultural understanding of human obligations and opportunities. In its more ambitious form, it endeavors to cover all possible ethical problems arising with regard to life and living things on earth. Given the ambitiousness of even the moderate aim, it is unsurprising that disputes are frequent and agreements are scarce. One of the most contentious (...) issues is whether human rights should play an important role in global bioethics or not. a. (shrink)

This paper introduces taxonomy of clinical uncertaintes and argues that the choice of scientific method should match the underlying level of uncertainty. Clinical trial is one of these methods aiming to resolve clinical uncertainties. Whenever possible these uncertainties should be quantified. The paper further shows that the still ongoing debate about the usage of "equipoise" vs. "uncertainty principle" vs. "indifference" as an entry criterion to clinical trials actually refers to the question "whose uncertainty counts". This question is intimately linked to (...) the control of research agenda, which is not quantifiable and hence is not solvable to equal acceptability to all interested parties. The author finally shows that there is a predictable relation between [acknowledgement of] uncertainty (the moral principle) on which trials are based and the ultimate outcomes of clinical trials. That is, [acknowledgement of] uncertainty determines a pattern of success in medicine and drives clinical discoveries. (shrink)

Well-being occupies a central role in ethics and political philosophy, including in major theories such as utilitarianism. It also extends far beyond philosophy: recent studies into the science and psychology of well-being have propelled the topic to centre stage, and governments spend millions on promoting it. We are encouraged to adopt modes of thinking and behaviour that support individual well-being or 'wellness'. What is well-being? Which theories of well-being are most plausible? In this rigorous and comprehensive introduction to the topic, (...) Guy Fletcher unpacks and assesses these questions and many more, including: Are pleasure and pain the only things that affect well-being? Is desire-fulfilment the only thing that makes our lives go well? Can something be good for someone who does not desire it? Is well-being fundamentally connected to a distinctive human nature? Is happiness all that makes our lives go well? Is death necessarily bad for us? How is the well-being of a whole life related to well-being at particular times? Also included is a glossary of key terms, and annotated further reading and study and comprehension questions follow each chapter, making _The Philosophy of Well-Being_ essential reading for students in ethics and political philosophy, and also suitable for those in related disciplines such as psychology, politics and sociology. (shrink)

The concept of well-being is one of the oldest and most important topics in philosophy and ethics, going back to ancient Greek philosophy and Aristotle. Following the boom in happiness studies in the last few years it has moved to centre stage, grabbing media headlines and the attention of scientists, psychologists and economists. Yet little is actually known about well-being and it is an idea often poorly articulated. The Routledge Handbook of Philosophy of Well-Being provides a comprehensive, outstanding guide and (...) reference source to the key topics and debates in this exciting subject. Comprising over forty chapters by a team of international contributors, the Handbook is divided into six parts: well-being in the history of philosophy current theories of well-being, including hedonism, and perfectionism examples of well-being and its opposites, including friendship and virtue and pain and death theoretical issues such as well-being and value, harm, identity and well-being and children well-being in moral and political philosophy well-being and related subjects including law, economics, and medicine. Essential reading for students and researchers in ethics and political philosophy, it will also be an invaluable resource for those in related disciplines such as psychology, politics and sociology. (shrink)

The concept of human dignity is increasingly invoked in bioethical debate and, indeed, in international instruments concerned with biotechnology and biomedicine. While some commentators consider appeals to human dignity to be little more than rhetoric and not worthy of serious consideration, the authors of this groundbreaking new study give such appeals distinct and defensible meaning through an application of the moral theory of Alan Gewirth.

Federal efforts beginning in the 1990's have successfully increased pediatric research to improve medical care for all children. Since 1997, the FDA has requested 800 pediatric studies involving 45,000 children. Much of this research is "non-beneficial"; that is, it exposes pediatric subjects to risk even though these children will not benefit from participating in the research. Non-beneficial pediatric research (NBPR) seems, by definition, contrary to the best interests of pediatric subjects, which is why one state supreme court has essentially prohibited (...) it. It also appears that the only plausible rationale for this research is utilitarian, as it risks some children for the good of all. But that rationale is troubling. This Article answers two related questions: (1) What is the appropriate legal relationship between NBPR and the "best interests of the child" standard? (2) What is the ethical justification for this research? I argue that courts should hold that the "best interests" standard governs pediatric research. But, contrary to existing case law, courts must consider the benefits to each child, including pediatric subjects, from a policy that permits NBPR, and not simply consider that a non-beneficial protocol presents more risk than potential benefit to a child. Moreover, I argue that the justification for the practice need not be utilitarian. There is no need to appeal to the greater good to justify the research because each child has reason to endorse a policy permitting NBPR where there is a very low ceiling on acceptable risk, and each child has reason to participate in a practice from which she benefits. More controversially, I argue that each child, like other persons, has reason to help others when she can do so at little to no cost to herself. The Article then highlights practical implications of the offered justifications. (shrink)

The physician who upholds the Hippocratic oath is supposed to be loyal to his or her patients. This requires choosing only the therapy that the physician believes is best for the patient. However, knowing what is best requires randomized clinical trials. Thus, clinicians must be willing to recruit their patients to be assigned at random to one of two therapies in order to determine which is best based on the highest standards of pharmacological science.

Since 1964, through 7 revisions, the World Medical Association’s Declaration of Helsinki has stood as an important statement regarding the ethical principles guiding medical research with human participants. It is consulted by ethics review committees, funders, researchers, and research participants. It has been incorporated into national legislation and is routinely invoked to ascertain the ethical appropriateness of clinical trials. There is much to praise about the revision process and the latest revision, which coincides with the declaration’s 50th anniversary. Nevertheless, the (...) proposed declaration contains persistent flaws... (shrink)