Biobanks are potential goldmines for genomics research. They have become increasingly common as a means to determine the relationship between lifestyle, environmental exposures and predisposition to genetic disease. More and more countries are developing massive national scale biobanks, including Iceland, the UK and Estonia. Now several large-scale regional and national biobanks are planned in China, such as Shanghai Biobank, which is defined as a key-element in Shanghai's twelfth five-year Development Plan of Science and Technology. It is imperative that the authors (...) who are in charge of the ethical aspect of Shanghai Biobank discuss the ethical aspects of these biobanks up front. Currently there is a great deal of heterogeneity in the approaches to informed consent taken by different countries. In the article, after briefly introducing the biobanks in China, we focus on the three most common approaches: classical informed consent, tiered consent, and one-time general (or blanket) consent, and propose a version of the latter for China, based on compelling arguments. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Informed Consent and Clinical ResearchRuth Faden (bio)Informed consent is a powerful symbol of the commitment and impact of the new, interdisciplinary field of biomedical ethics that the Kennedy Institute has been so instrumental in developing. In the early years of biomedical ethics, there was considerable discussion about the nature of the doctor-patient relationship, about how it ought to be structured, and about how competing values within that (...) relationship ought to be accommodated. By the 1970s and 1980s, the answer was for all practical purposes in. Biomedical ethics was engaged in a clearly reformist project, in step with the values of the times, to right a wrongful imbalance of power and control between physicians and patients.The agenda was clear—to establish the moral authority of the patient to participate in medical decision making by placing respect for the autonomy of patients on the moral map of the medical community. The chief strategy that biomedical ethics adopted to accomplish this agenda was, of course, informed consent. Theories of autonomous action as well as informed consent were intentionally crafted to advance this reformist agenda.In this paper, I examine how the theory of informed consent has fared in one particular realm of “the clinic” where, arguably, there has been considerable success. This is the realm of clinical research; research at the bedside where the patient is also the subject.I rely heavily on the work of President Clinton’s Advisory Committee on Human Radiation Experiments, which I chaired. The Advisory Committee was established in response to exposés in the press about alleged secret experiments during World War II and the Cold War in which patients had been injected with plutonium without their apparent knowledge or consent. As part of its work, the Advisory Committee undertook an oral history project in which we interviewed eminent physicians about the norms and practices of human research in the 1940s and 1950s.Drawing on these interviews, I argue here for two seemingly inconsistent conclusions. First, that the ethical standards for clinical research have changed dramatically in the last 50 years—particularly with respect to informed consent. Second, that despite these important changes, the human dynamics of clinical research in many respects remain unchanged.How the World of Clinical Research Has ChangedDuring the forties and fifties, duties to obtain informed consent, whether for treatment or for research, were simply not part of the doctor-patient experience. [End Page 356]As one physician told us:In 1945, ‘50, the doctor... was king or queen. It never occurred to a doctor to ask for consent for anything. Doctors weren’t in the habit of telling the patients anything (either). They were in charge and nobody questioned their authority.(Advisory Committee on Human Radiation Experiments 1996, p. 83)This unquestioned authority extended to all decisions about the management of the patient, including whether patients were to receive experimental therapies or otherwise become the subjects of research or experimentation. Physicians were trained to be concerned with risk, and harm, and benefit, in keeping with the Hippocratic tradition. But in most institutions, the permission to try something new and to take unknown risks came, not from the patient, but from the chairman of the department.In part, this broad license reflected the very newness of scientifically grounded medical practice. In the forties and fifties, many potentially therapeutic interventions were newly discovered and in this sense considered experimental, or at least innovative. The level of uncertainty about whether a treatment would work was generally high, whether the treatment was part of a research project or not. Moreover, the formalizing of medical science at the bedside was itself still in its infancy—it was not until 1948 that the first modern clinical trial in which patients were randomized to different treatment and control groups was reported in the literature. Much of the research of this period was informal and unsystematic.Thus, it is not surprising that the physician’s authority to make treatment decisions extended to treatments that were innovative or experimental, regardless of whether these innovative treatments were the subject of formal scientific investigation. What is perhaps more surprising is that physicians often acted the same way—that... (shrink)

The Nuremberg Code of ethical principles for experiments involving human beings has as its first requirement that “the voluntary consent of the human subject is absolutely essential.” Since the time of the trials that supplied its motivation the principles have been amplified and detail and distinctions have been added. For example, the Declaration of Helsinki, adopted by the World Medical Association in 1964, again laid down general principles related to voluntariness, balance of risk and benefit, and scientific (...) soundness. However, it also noted that the ethical issues with regard to two distinctly different types of human experiment vary. These two types are clinical research and nonclinical biomedical research. In actuality, we may distinguish three types of human biomedical experimentation. Two of these are therapeutic and nontherapeutic experimentation. The first is directed primarily to the benefit of the experimental subjects who are being treated with some new experimental therapy for their ailment. In the second an experiment is designed to increase medical knowledge and uses volunteers who are healthy or whose illness is not related to the experimental study. One key difference between the ethical requirements specified by the Declaration of Helsinki for therapeutic and nontherapeutic experimentation was that the second approach required participation only by volunteers whom we assume are able to and do give their informed consent. However, in the first approach if consent were not obtained, the physician must specify the reasons and present these before an independent committee. (shrink)

The new biotechnology raises expectations for modifying human behaviour through its use. This article focuses on the ethical analysis of the not so remote possibility of rehabilitating criminals by means of neurotechnological techniques. The analysis is carried out from a synthetic position of, on the one hand, the consequentialist conception of what is right and, on the other hand, the emphasis on individual liberties. As a result, firstly, the ethical appropriateness of adopting a general predisposition for allowing the neurorehabilitation (...) of prisoners only if it is safe and if they give their consent will be defended. But, at the same time, reasons will be given for requiring, in certain circumstances, the exceptional use of neurotechnology to rehabilitate severely psychopathic prisoners, even against their will, from the same ethical perspective. (shrink)

Sixty-five undergraduates participating in a wide range of psychological research experiments were interviewed in depth about their research experiences and their views on the process of informed consent. Overall, 32% of research experiences were characterized positively and 41 % were characterized negatively. One major theme of the negative experiences was that experiments were perceived as too invasive, suggesting incomplete explication of negative aspects of research during the informed consent process. Informed consent experiences were viewed positively 80% of (...) the time. However, most of the participants had a limited view of the purpose of informed consent: Less than 20% viewed the process as a decision point. Results suggest a number of common pitfalls to standard informed consent practices that have not generally been recognized. Results are discussed in terms of both ethical and methodological implications. Suggestions for improving the informed consent process are also provided. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Justice and the General Will:Affirming Rousseau's Ancient OrientationDavid Lay WilliamsThere is much confusion about how to characterize the work of Jean-Jacques Rousseau. His thought has at various times been related to such dissimilar thinkers as Plato and Hobbes. From Plato he is said to have acquired his affinities for community and civic virtue. And one does not have to look too hard to find his praise for the (...) great sage of the Academy: "Plato only purified the heart of man."1 He was often eager to affiliate his ideas with those of antiquity. He yearned for modern society to rekindle the flames of a once-great civilization. "[W]hat keeps us [the moderns] from being men like them [the ancients]? Our prejudices, our base philosophy, and the passions of petty self-interest, concentrated together with egoism in all hearts by inept institutions in which genius never had any share."2 Despite his obvious admiration for the perceived greater ideas of the past, however, Rousseau also expressed some skepticism. James Miller has suggested that he held Plato's theory of the Forms to be unsustainable.3 Allan Bloom has likewise argued that Rousseau's "teaching is not... a revival of those of Plato.... If he admires the practice of antiquity, he does not accept the theory."4This has led many to argue that Rousseau is best understood as student of Thomas Hobbes. Roger D. Masters, for example, has suggested that "Rousseau's principles of political right can... be best described as a reformulation [End Page 383] of Hobbes' conception of the social contract."5 Arthur Melzer also argues, "The purpose of the doctrine Rousseau elaborates in the Social Contract is essentially the same [as Hobbes']."6 This view is argued on the grounds that the General Will is a positive or arbitrary standard, functioning as the primary principle of Rousseau's constructive political program. Yet the vision of Rousseau as a Hobbesian or modernist also merits skepticism. While he employs a social contract, as does Hobbes, he explicitly rejects traditional forms of positivism. "What is good and conformable to order is so by the nature of things and independently of human conventions."7 Whatever one might say about such passages, it at least raises the possibility that Rousseau is no modernist in the Straussian sense of defining Justice as human agreement.Much of what contributes to the conflicting interpretations of Rousseau can be attributed to different understandings of the relative priority and relationship of two central concepts in his writings. One of these is the well-discussed notion of the General Will. The dominant fashion is to read the General Will as a conventional substitute for natural law or transcendent Ideas. According to this reading, the General Will is grounded on nothing more than consent and functions as the first principle of all legitimate political societies. The other term central to Rousseau's program is the far less discussed but equally important concept of Justice. Little has been written on his understanding of Justice and, for that matter, he himself rarely discussed it explicitly. But it, too, could also be considered a primary principle. While it would be foolish to dismiss the importance of the General Will to Rousseau, it would be equally problematic to explore it independently of his Idea of Justice. The question in understanding his work is which of these two principles—the General Will or Justice—is primary or fundamental. If it is the General Will, a case can be made that the Straussians are right, and Rousseau is a positivist. If Justice is prior, on the other hand, then there is reason to believe that he was something much different.I argue that the positivist reading of Rousseau is flawed. Indeed, my thesis is that he is among the greatest and most thorough Platonists of the modern era.8 His rejection of Hobbes is not merely rhetorical. In fact, it represents the [End Page 384] true impetus of his social contract. This contract is designed explicitly to counter Hobbesian positivism. In the same way that Plato responds to Protagoras' positivism with his theory of the Forms, Rousseau responds to Hobbes... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:One Body: An Essay in Christian Sexual Ethics by Alexander R. PrussBenedict M. Guevin O.S.B.One Body: An Essay in Christian Sexual Ethics. By Alexander R. Pruss. Notre Dame, Ind.: University of Notre Dame Press, 2013. Pp. ix + 465. $45.00 (paper). ISBN: 978-0-268-03897-7.As a professor of moral theology in general and of sexual ethics in particular, I found Alexander Pruss’s largely philosophical account of sexual ethics to (...) be refreshing. As much as I try to dissuade my students from using religious legalism to justify the rightness or wrongness of certain sexual practices, I find it almost impossible to break them of the bad habit of using such phrases as “Because the Church teaches...” or “Because the Bible says...”. Even when I counter by saying, “The Church teaches that something is good because it is good and not because the Church says it is good, and such goodness is grounded in the natural law and a sound anthropology,” such legalism still persists. And so, to read Pruss’s extensive analysis of sexual ethics using both personalist and Thomistic principles as well as what we have received from divine revelation is a much-needed tonic not only for students of theology and philosophy but for all those interested in discovering the role of human reason and biology in crafting a sexual ethic.After an introduction, the proper beginning of Pruss’s analysis is found in chapter 2. Here, the author discusses love and its forms with a particular focus on the meaning of agapē in the New Testament. Pruss argues that, philosophically speaking, we should love everyone. But love should not be understood as monolithic. There are various kinds of love: agapē, philia, and erōs. The New Testament understanding of agapē contains the other two, for it is love itself. This kind of love is a love that loves the other as the other is, for the other’s sake, and in a way that is appropriate to that person in the light of objective facts. Moreover, this kind of love is not simply a feeling or an emotion but is concentrated in an action that is an expression of one’s will.In chapter 3, Pruss takes up the issue of desire. He evaluates desire in two ways: (1) desire and libido, and (2) sexual desire, need, and pleasure. He [End Page 485] concludes that sexual desire is not a need in the same way that we desire food, drink, communication, love, and to be loved. Without these latter, human life would be seriously lacking or, in the case of food and drink, quickly cut short. Second, he observes that circumstances may not be appropriate for fulfilling one’s sexual desire. Finally, while human life would be seriously compromised by the lack of food, drink, communication, love, and the need to be loved, abstaining from the fulfillment of sexual desire even over a long period of time would not be detrimental to human well-being in the same way.Pruss does not imply by the preceding that sexuality does not matter. Chapter 4, in fact, deals with the meaningfulness of sexuality. There are two sets of rules regarding sexuality and its expression. Some rules are moral in nature, like the prohibition against rape. Other rules are customs, for example, the exchanging of rings after the exchange of marital vows. With respect to the moral rules regarding sexuality, Pruss highlights casual sex, sexual assault, gay rights, and romantic love. Apart from sexual assault and rape—both of which lack consent—casual sex, homosexual sex, and romantic love have the following in common, namely, that sex is indeed innately important to human beings and that sex aspires to be romantic in nature. While, as in the case of casual sex, romantic love does not necessarily give rise to true love, romantic love is often the prelude to a deep and unique form of love. Why this is so has to do with the meaning of sexual union.Sexual union is the topic of chapter 5, presented under the title “One Flesh, One Body.” Scripture, Pruss affirms, describes the person as... (shrink)

BackgroundConsent for data research in acute and critical care is complex as patients become at least temporarily incapacitated or die. Existing guidelines and regulations in the European Union are of limited help and there is a lack of literature about the use of data from this vulnerable group. To aid the creation of a patient-centred framework for responsible data research in the acute setting, we explored views of patients and next-of-kin about the collection, storage, sharing and use of genetic and (...) health-related data for observational research.MethodsWe conducted qualitative interviews (n = 19) with Dutch sudden cardiac arrest survivors who donated clinical and socio-economic data and genetic samples to research. We also interviewed their next-of-kin. Topics were informed by ethics literature and we used scenario-sketches to aid discussion of complex issues.ResultsSudden cardiac arrest survivors displayed limited awareness of their involvement in health data research and of the content of their given consent. We found that preferences regarding disclosure of clinically actionable genetic findings could change over time. When data collection and use were limited to the medical realm, patients trusted researchers to handle data responsibly without concern for privacy or other risks. There was no consensus as to whether deferred consent should be explicitly asked from survivors. If consent is asked, this would ideally be done a few months after the event when cognitive capacities have been regained. Views were divided about the need to obtain proxy consent for research with deceased patients’ data. However, there was general support for the disclosure of potentially relevant post-mortem genetic findings to relatives.ConclusionsSudden cardiac arrest patients’ donation of data for research was grounded in trust in medicine overall, blurring the boundary between research and care. Our findings also highlight questions about the acceptability of a one-time consent and about responsibilities of patients, researchers and ethics committees. Finally, further normative investigation is needed regarding the (continued) use of participants’ data after death, which is of particular importance in this setting. Our findings are thought to be of relevance for other acute and life-threatening illnesses as well. (shrink)

Past ages of medical care are condemned in modern philosophical and medical literature as being too paternalistic. The normal account of good medicine in the past was, indeed, paternalistic in an offensive way to modern persons. Imagine a Jean Paul Sartre going to the doctor and being treated without his consent or even his knowledge of what will transpire during treatment! From Hippocratic times until shortly after World War II, medicine operated in a closed, clubby manner. The knowledge learned (...) in medicine was not shared with the patients, who were in general poorly educated and for the most part completely ignorant of the craft of medicine and the physicians. Physicians were cautioned against telling patients too much about their Illness and/or their recovery, perhaps because physicians themselves did not have an enormous armamentarium to confront disease. (shrink)

This article sets out to demonstrate the role of the ‘one-legged devil’, also called General Kassam. Kassam was one of the pioneer generals of the Mau Mau, a guerrilla movement that operated from the central Kenya forests as they participated in the war of liberation from the early 1950s to the early 1960s. Was Kassam a one-legged general from the word go? Methodologically speaking, the article is partially based on interviews conducted with the general before his death (...) at the age of 89 in 2011. Being an insider, Kassam helped to give an in-depth understanding of the Mau Mau war of independence by relating the role of the Kavirondo people of western Kenya in Mau Mau historiography. Were they enticed by the colonial government to abandon the idea of the armed struggle as a way of writing off colonialism? Or did the Kavirondo embrace the theology of non-violence and eventually left the central Kenya group to battle it alone? Or were the people of western Kenya dissuaded to take part in the struggle by the Christian ‘gospel of love’ that abhorred violence, leading to abandoning their colleagues from central Kenya at the last minute? Theoretically speaking, the article is largely informed by John Walton’s theory of reluctant rebels. Walton argues that rebels are always incited by the leading elites in a society that undergoes war or civil war at any given time in history.Contribution: The article contributes to growing knowledge by discussing the Mau-Mau Movement in Kenya’s quest for freedom, from the 1950s to early 1960s, to demonstrate the religious role of armed conflicts in Africa. In this case, General Kassam, a baptised Anglican Christian, whose loyalty to the ancestral pantheons drove him to the quasi-religious war of independence, is the key subject in this article. In this war of independence in Kenya, a seeming conflict between African religion and Christian religion appears as a key emerging issue. The article is relevant to the HTS Journal and the world of scholarship because it is a theo-anthropocentric piece of work which deals with God, creation, and inevitable human conflicts – all of which have answers before God. (shrink)

Background: There is a lack of empirical data on lay attitudes toward different sorts of deception in medicine. However, lay attitudes toward deception should be taken into account when we consider whether deception is ever permissible in a medical context. The objective of this study was to examine lay attitudes of U.S. citizens toward different sorts of deception across different medical contexts. Methods: A one-time online survey was administered to U.S. users of the Amazon “Mechanical Turk” website. Participants were (...) asked to answer questions regarding a series of vignettes depicting different sorts of deception in medical care, as well as a question regarding their general attitudes toward truth-telling. Results: Of the 200 respondents, the majority found the use of placebos in different contexts to be acceptable following partial disclosure but found it to be unacceptable if it involved outright lying. Also, 55.5% of respondents supported the use of sham surgery in clinical research, although 55% claimed that it would be unacceptable to deceive patients in this research, even if this would improve the quality of the data from the study. Respondents supported fully informing patients about distressing medical information in different contexts, especially when the patient is suffering from a chronic condition. In addition, 42.5% of respondents believed that it is worse to deceive someone by providing the person with false information than it is to do so by giving the person true information that is likely to lead them to form a false belief, without telling them other important information that shows it to be false. However, 41.5% believed that the two methods of deception were morally equivalent. Conclusions: Respondents believed that some forms of deception were acceptable in some circumstances. While the majority of our respondents opposed outright lying in medical contexts, they were prepared to support partial disclosure and the use of placebos when it is in the patient's interests or when it is what the person would want. These results support the position that physicians should be allowed a greater degree of authority to make a professional judgment about whether deception might be morally warranted by the circumstances, provided that it doesn't involve outright lying. (shrink)

Although the issue of consent in medical practice has grown immensely in recent years, and it is generally believed that historical cases are unknown, our research amongst original ancient Greek and Byzantine historical sources reveals that it is a very old subject which ancient philosophers and physicians have addressed. Plato, in ancient Greece, connected consent with the quality of a free person and even before him, Hippocrates had advocated seeking the patient's cooperation in order to combat the disease. (...) In Alexander the Great's era and later on in Byzantine times, not only was the consent of the patient necessary but physicians were asking for even more safeguards before undertaking a difficult operation.Our study has shown that from ancient times physicians have at least on occasion been driven to seek the consent of their patient either because of respect for the patient's autonomy or from fear of the consequences of their failure. (shrink)

The rest-frame of the universe determines a universal, or absolute time, that given by a clock at rest in it. The question is raised whether one can have a satisfactory universal time in general relativity if a gravitational field is present, i.e., whether there are coordinates such that the coordinate time is the time given everywhere by a clock at rest and they provide the correct description of our everyday experience. Several attempts are made to (...) find such coordinates, but the results are unsatisfactory. The question is still open, but it may be that there is no significance to such a universal time in general relativity, because to have a clock at rest in a gravitational field requires nongravitational forces. (shrink)

This paper critically analyses ‘the paradox of autonomy and consent in maternity care’. It argues that maternity care has certain features that increase the need for explicit attention to, and respect for, both autonomy and rigorous informed consent processes. And, moreover, that the resulting need is considerably greater than in almost all other areas of medicine. These features are as follows: (1) maternity care involves particularly socially sensitive body parts that are regularly implicated in consent‐centred procedures, as (...) well as in unconsented interventions, in ordinary, non‐medical life; and (2) much of maternity care (especially intervening in childbirth) is medically unique, in that it harms one patient (the mother) not primarily for the promotion of her own health but for the benefit of another (the baby). The apt comparison, within medicine, is therefore with non‐therapeutic research and transplantation medicine—both of which have elevated consent requirements characterized by very rigorous consent processes. At the same time—and this delivers the titular paradox—the importance of autonomy and consent in maternity care is at particular risk of being denied or disregarded. Jointly, these considerations make a very strong case for change: attention to and respect for autonomy and consent should be (1) core values; (2) key points of practical attention in the years ahead; and (3) central quality indicators in maternity care. (shrink)

This paper emphasizes a need to recognize sexual refusals both in public discourse and in the context of particular interactions. I draw on sociolinguistic work on the structure of refusals to illuminate a much-discussed case of alleged sexual violence as well as to inform how we ought to think and talk about sexual consent and refusal more generally. I argue on empirical and ideological grounds that we ought to impute the same significance to refusals uttered in sexual contexts as (...) we do to those uttered in nonsexual contexts. Finally, I propose an amendment to the definition of affirmative consent that would put it in line with the conclusions drawn in the rest of the paper. (shrink)

ABSTRACT In Mexico informed consent is a legal requirement that ensures that patients who are invited to participate in clinical trials are provided with all the information needed to decide whether to participate, or not, in a research protocol. To improve our understanding of the problems physicians in developing countries encounter, when obtaining informed consent (IC), we examined their opinion on the importance of IC in clinical research, the quantity and quality of the information provided to the participant, (...) and the conditions in which the IC is obtained. Investigators considered that IC was useful to the patients, providing information that helped the patient to make a decision about his/her participation. Nevertheless, they felt that for some aspects of the research, like drug development in general, the use of placebos, and the randomization process, many of the patients were not capable of fully understanding the information provided, referring to the complexity of the information and illiteracy as the main reasons. Many investigators were not acquainted with some of the guidelines established in the Mexican General Law of Health,1 36% of them admitting to not having completed their IC letters. Most investigators gave only minutes to the patient to make a decision and 20% of ICs were obtained while the patient was hospitalized. Except for one investigator, all of them considered that specific training in medical ethics would be useful for the daily clinical work. (shrink)

The general perception of how innovative assisted reproductive technologies are introduced is through a carefully controlled series of experiments in an animal model, such as the mouse. Only after the technique has been proven can one consider confirmatory studies on mammals closely related to humans, such as rhesus monkeys or other nonhuman primates. With this background of a peer-reviewed body of well-established published data, there is sufficient foundation and rationale to propose a clinical investigation to a responsible human subjects (...) institutional review board. IRBs weigh the benefits and risks of the new methods to human subjects, and then consider the appropriate informed consent procedures for the particular case. Only after a large number of clinical studies are performed at multiple sites and are peer reviewed can the efficacy and safety of the innovative approach be clearly evaluated. At that time, the potential therapy can be responsibly offered to suitable beneficiaries. (shrink)

Peter Abelard’s (1079-1142) conception of moral sin contains a fundamental element from Stoicism, which is the notion of “consent” (consensus). After the presentation of the essentials of that Abelardian theory, we return to the source of that same idea in ancient and imperial Stoicism. According to their main representatives, “consent” or “assent” (sugkata/qesij) has a determining function not only in ethics, but also in the process of knowledge as well. We emphasize in passing the resemblance between some important (...) components of Stoic epistemology and the theory expounded by Aristotle in the Posterior Analytics on the origin of knowledge. Augustine represents without any doubt one of the main intermediaries through whom this notion of consent is transmitted up to the time of Abelard in the 12th century. Even if he was influenced by the Bishop of Hippo on moral questions in general, Abelard seems to distance himself from Augustine by considering that consent is more a rational matter than a volitional one. (shrink)

The history of the theory of general relativity presents unique features. After its discovery, the theory was immediately confirmed and rapidly changed established notions of space and time. The further implications of general relativity, however, remained largely unexplored until the mid 1950s, when it came into focus as a physical theory and gradually returned to the mainstream of physics. This essay presents a historiographical framework for assessing the history of general relativity by taking into account in (...) an integrated narrative intellectual developments, epistemological problems, and technological advances; the characteristics of post–World War II and Cold War science; and newly emerging institutional settings. It argues that such a framework can help us understand this renaissance of general relativity as a result of two main factors: the recognition of the untapped potential of general relativity and an explicit effort at community building, which allowed this formerly disparate and dispersed field to benefit from the postwar changes in the scientific landscape. (shrink)

Re-consent in research, the asking for a new consent if there is a change in protocol or to confirm the expectations of participants in case of change, is an under-explored issue. There is little clarity as to what changes should trigger re-consent and what impact a re-consent exercise has on participants and the research project. This article examines applicable policy statements and literature for the prevailing arguments for and against re-consent in relation to longitudinal cohort (...) studies, tissue banks and biobanks. Examples of re-consent exercises are presented, triggers and non-triggers for re-consent discussed and the conflicting attitudes of commentators, participants and researchers highlighted. We acknowledge current practice and argue for a greater emphasis on ‘responsive autonomy,’ that goes beyond a one-time consent and encourages greater communication between the parties involved. A balance is needed between respecting participants' wishes on how they want their data and samples used and enabling effective research to proceed. (shrink)

I propose a general geometric framework in which to discuss the existence of time observables. This framework allows one to describe a local sense in which time observables always exist, and a global sense in which they can sometimes exist subject to a restriction on the vector fields that they generate. Pauli׳s prohibition on quantum time observables is derived as a corollary to this result. I will then discuss how time observables can be regained in (...) modest extensions of quantum theory beyond its standard formulation. (shrink)

BackgroundStigma refers to a distinguishing personal trait that is perceived as or actually is physically, socially, or psychologically disadvantageous. Little is known about the opinion of those who have more or less stigmatizing health conditions regarding the need for consent for use of their personal information for health research.MethodsWe surveyed the opinions of people 18 years and older with seven health conditions. Participants were drawn from: physicians' offices and clinics in southern Ontario; and from a cross-Canada marketing panel of (...) individuals with the target health conditions. For each of five research scenarios presented, respondents chose one of five consent choices: (1) no need for me to know; (2) notice with opt-out; (3) broad opt-in; (4) project-specific permission; and (5) this information should not be used. Consent choices were regressed onto: demographics; health condition; and attitude measures of privacy, disclosure concern, and the benefits of health research. We conducted focus groups to discuss possible reasons for observed consent choices.ResultsWe observed substantial variation in the control that people wish to have over use of their personal information for research. However, consent choice profiles were similar across health conditions, possibly due to sampling bias. Research involving profit or requiring linkage of health information with income, education, or occupation were associated with more restrictive consent choices. People were more willing to link their health information with biological samples than with information about their income, occupation, or education.ConclusionsThe heterogeneity in consent choices suggests individuals should be offered some choice in use of their information for different types of health research, even if limited to selectively opting-out. Some of the implementation challenges could be designed into the interoperable electronic health record. However, many questions remain, including how best to capture the opinions of those who are more privacy sensitive. (shrink)

Clinical research with adults who are unable to provide informed consent has the potential to improve understanding and care of a number of devasting conditions. This research also has the potential to exploit some of society's most vulnerable members. Recently, a number of task forces and individual writers have proposed guidelines to ensure that such research is both possible and ethical. Yet, there is widespread disagreement over which safeguards should be adopted. In the present paper, I consider to what (...) extent these disagreements can be resolved by appeal to a general account of the interests of subjects who are unable to consent and the conditions that must be satisfied for research enrollment to constitute exploitation of their inability to make their own decisions. (shrink)

Source: Author: Leonila C. Crisostomo, Ma. Teresa G. Generales, Amelita L. de Guzman The primary purpose of this study is to ascertain the benefits of the National Service Training Program implementation and to identify the problems encountered by its implementers. Results showed that the benefits derived from the program were topped by enhancement of skills on basic leadership with emphases on the ability to listen and ability to communicate which were rated very important and very much benefited among other training (...) aspects of the program. Results also revealed that students are aware of the importance of physical, mental and social health as well as the observance of proper hygiene for overall sense of well-being. Although recreation is one aspect that the respondents find important, appreciation of it underscores the need to have more time for assignments and projects as most of the respondents are enrolled in their respective courses with 29 units, making them unable to appreciate the perks of involving themselves into various recreational activities. Problems in the implementation showed lack of provision of materials and equipment and of budgetary allocation which rendered full implementation weak as students and faculty involved in the community immersion have to rely on their own resources, in addition to the indifference and passivity of the local government officials. Based on the findings, the researchers recommended that: the school administrators need to allocate adequate budget for materials and equipment; periodic faculty development trainings and; to look into the passive attitude of the local officials to ensure that implementation NSTP projects will benefit both clients and implementers. ]]>. (shrink)

Professional ethics, in general, deals with justified moral values that govern the work of professionals. Profession is an expertise who is committed to promote a distinctive public good, such as learning or education. Professionals are committed to special duties to make services available, maintain confidentiality, secure informed consent for services, and be loyal to clients, employers, and others with whom one has fiduciary relationship. Professional ethics deals with theoretical issues which seek to understand how the justified moral values (...) governing professionals are linked to wider values. It also deals with practical issues as to how to apply duties in particular contexts. Professional values include principles of obligation and rights, virtues, personal moral ideals as manifested in the great lives. Given such a Western idea of professional ethics, it is indeed fascinating to trace professional ethics in the Upaniṣads. The Upaniṣadic sages since time immemorial have shown the path to peace and progress for all humanity, not only by laying down theoretical ideals or speculation, but by actually applying truths in their practical life. They have demonstrated the practical application of the ethical ideals or moral values in the personal and professional life and proved that self-realization alone can not only save man from misery but promote to the state of highest bliss. The standards laid down by them have been followed practically by people even today. Gītoponiṣad states that whatever action is performed by the great is imitated by the common people; whatever standard is set by him is followed by them. The Kaṭha Upaniṣad prescribes professional values to the extent that not he who has not ceased from evil conduct can obtain Him by knowledge. Good conduct as a value is thus emphasized here. In Taittirīya Upaniṣad, for instance, the teacher prescribes certain values in the form of commandments: speak the truth and practice virtue. Thus, it is evident that the Upaniṣadic teacher is not only concerned about the intellectual progress of the student but also its personal and professional life as well. The paper is a humble attempt to explore the roots of professional ethics in the Upaniṣadic ethics. (shrink)

Every day is full of "what would you do?" moments. They can be as simple as times when you're considering whether to bother saying thank you to the taxi driver before getting out of the cab. Or they can be more complicated, such as when you've witnessed discriminating mistreatment of someone and you have to decide whether to speak up. We've all been there. What Would You Do?-Doing the Right Thing Even When You Think No One's Watching is full of (...) real-life stories and staged ones from the highly rated ABC News program. Author John Quiñones takes readers on a journey of self-discovery and inspires them to act in ways they would if they thought a hidden camera was focused on them. (shrink)

In General Relativity in Hamiltonian form, change has seemed to be missing, defined only asymptotically, or otherwise obscured at best, because the Hamiltonian is a sum of first-class constraints and a boundary term and thus supposedly generates gauge transformations. Attention to the gauge generator G of Rosenfeld, Anderson, Bergmann, Castellani et al., a specially _tuned sum_ of first-class constraints, facilitates seeing that a solitary first-class constraint in fact generates not a gauge transformation, but a bad physical change in electromagnetism (...) or General Relativity. The change spoils the Lagrangian constraints, Gauss's law or the Gauss-Codazzi relations describing embedding of space into space-time, in terms of the physically relevant velocities rather than auxiliary canonical momenta. But the resemblance between the gauge generator G and the Hamiltonian H leaves still unclear where objective change is in GR. Insistence on Hamiltonian-Lagrangian equivalence, a theme emphasized by Castellani, Sugano, Pons, Salisbury, Shepley and Sundermeyer among others, holds the key. Taking objective change to be ineliminable time dependence, one recalls that there is change in vacuum GR just in case there is no time-like vector field xi^a satisfying Killing's equation L_xi g_mn=0, because then there exists no coordinate system such that everything is independent of time. Throwing away the spatial dependence of GR for convenience, one finds explicitly that the time evolution from Hamilton's equations is real change just when there is no time-like Killing vector. The inclusion of a massive scalar field is simple. No obstruction is expected in including spatial dependence and coupling more general matter fields. Hence change is real and local even in the Hamiltonian formalism. The considerations here resolve the Earman-Maudlin standoff over change in Hamiltonian General Relativity: the Hamiltonian formalism is helpful, and, suitably reformed, it does not have absurd consequences for change and observables. Hence the classical problem of time is resolved. The Lagrangian-equivalent Hamiltonian analysis of change in General Relativity is compared to Belot and Earman's treatment. The more serious quantum problem of time, however, is not automatically resolved due to issues of quantum constraint imposition. (shrink)

In the dissertation we study the complexity of generalized quantifiers in natural language. Our perspective is interdisciplinary: we combine philosophical insights with theoretical computer science, experimental cognitive science and linguistic theories. -/- In Chapter 1 we argue for identifying a part of meaning, the so-called referential meaning (model-checking), with algorithms. Moreover, we discuss the influence of computational complexity theory on cognitive tasks. We give some arguments to treat as cognitively tractable only those problems which can be computed in polynomial (...) class='Hi'>time. Additionally, we suggest that plausible semantic theories of the everyday fragment of natural language can be formulated in the existential fragment of second-order logic. -/- In Chapter 2 we give an overview of the basic notions of generalized quantifier theory, computability theory, and descriptive complexity theory. -/- In Chapter 3 we prove that PTIME quantifiers are closed under iteration, cumulation and resumption. Next, we discuss the NP-completeness of branching quantifiers. Finally, we show that some Ramsey quantifiers define NP-complete classes of finite models while others stay in PTIME. We also give a sufficient condition for a Ramsey quantifier to be computable in polynomial time. -/- In Chapter 4 we investigate the computational complexity of polyadic lifts expressing various readings of reciprocal sentences with quantified antecedents. We show a dichotomy between these readings: the strong reciprocal reading can create NP-complete constructions, while the weak and the intermediate reciprocal readings do not. Additionally, we argue that this difference should be acknowledged in the Strong Meaning hypothesis. -/- In Chapter 5 we study the definability and complexity of the type-shifting approach to collective quantification in natural language. We show that under reasonable complexity assumptions it is not general enough to cover the semantics of all collective quantifiers in natural language. The type-shifting approach cannot lead outside second-order logic and arguably some collective quantifiers are not expressible in second-order logic. As a result, we argue that algebraic (many-sorted) formalisms dealing with collectivity are more plausible than the type-shifting approach. Moreover, we suggest that some collective quantifiers might not be realized in everyday language due to their high computational complexity. Additionally, we introduce the so-called second-order generalized quantifiers to the study of collective semantics. -/- In Chapter 6 we study the statement known as Hintikka's thesis: that the semantics of sentences like ``Most boys and most girls hate each other'' is not expressible by linear formulae and one needs to use branching quantification. We discuss possible readings of such sentences and come to the conclusion that they are expressible by linear formulae, as opposed to what Hintikka states. Next, we propose empirical evidence confirming our theoretical predictions that these sentences are sometimes interpreted by people as having the conjunctional reading. -/- In Chapter 7 we discuss a computational semantics for monadic quantifiers in natural language. We recall that it can be expressed in terms of finite-state and push-down automata. Then we present and criticize the neurological research building on this model. The discussion leads to a new experimental set-up which provides empirical evidence confirming the complexity predictions of the computational model. We show that the differences in reaction time needed for comprehension of sentences with monadic quantifiers are consistent with the complexity differences predicted by the model. -/- In Chapter 8 we discuss some general open questions and possible directions for future research, e.g., using different measures of complexity, involving game-theory and so on. -/- In general, our research explores, from different perspectives, the advantages of identifying meaning with algorithms and applying computational complexity analysis to semantic issues. It shows the fruitfulness of such an abstract computational approach for linguistics and cognitive science. (shrink)

This paper argues that we can see our lives as a snapshot happening now or as a moving picture extending across time. These dual ways of seeing our lives inform how we conceive of the problem of age group justice. A snapshot view sees age group justice as an interpersonal problem between distinct age groups. A moving picture view sees age group justice as a first-person problem of prudential choice. This paper explores these different ways of thinking about age (...) group justice and illustrates them using a principle of respect for human dignity, understood in terms of reasonable support for floor level central human capabilities at each stage of life. I argue that different frames are suitable for different kinds of decisions, and each provides a true, but partial, picture of aging and age group justice. (shrink)

Background: Ethical climate and moral distress have been shown to affect nurses’ ethical behaviour. Despite the many ethical issues in paediatric oncology nursing, research is still lacking in the field. Research aim: To investigate paediatric oncology nurses’ perceptions of ethical climate and moral distress. Research design: In this cross-sectional study, data were collected using Finnish translations of the Swedish Hospital Ethical Climate Survey–Shortened and the Swedish Moral Distress Scale–Revised. Data analysis includes descriptive statistics and non-parametric analyses. Respondents and research context: (...) Ninety-three nurses, working at paediatric oncology centres in Finland, completed the survey. Ethical considerations: According to Finnish legislation, no ethical review was needed for this type of questionnaire study. Formal research approvals were obtained from all five hospitals. Return of the questionnaire was interpreted as consent to participate. Results: Ethical climate was perceived as positive. Although morally distressing situations were assessed as highly disturbing, in general they occurred quite rarely. The situations that did appear often reflected performing procedures on school-aged children who resist such treatment, inadequate staffing and lack of time. Perceptions of ethical climate and frequencies of morally distressing situations were inversely correlated. Discussion: Although the results echo the recurrent testimonies of busy work shifts, nurses could most often practise nursing the way they perceived as right. One possible explanation could be the competent and supportive co-workers, as peer support has been described as helpful in mitigating moral distress. Conclusion: Nurturing good collegial relationships and developing manageable workloads could reduce moral distress among nurses. (shrink)

Mirrors for princes, in general, give advices to the rulers about the subtleties of political art. Another aim of these books is to define and explain the administration of the state and the duties of rulers based on experience. In consequence of this they reflect the practical ethics of the period in which they were written. As such, they resemble practical handbooks written for rulers. Another point regarding the mirrors for princes works in which the political understanding of the (...) era can be observed is that they generally use sacred texts in order to prove the political legitimacy or invalidity of the power, as well as the rightfulness or the unlawfulness of the claims to the throne. Evidences from the Qurʾān and the ḥadīth literature was almost always used to support such advocated opinions. In fact, during the Middle Ages when religion and politics were considered coupled, it was unthinkable that religious elements should not be included in the works of state administration. The important point here is that the verses and ḥadīths were sometimes removed from their contexts and interpreted and explained in a way to support the ideology of the author or the ruler whom the author presented his work. In this study, we will try to reveal the subjects in which the verses and ḥadīths used in the mirrors for princes, which is a genre that has emerged within the Islamic culture and civilization. Thus, we aim to prepare a background for the future studies, which will focus on a specific verse or ḥadīth.Summary: The first political splits in Islamic history occurred immediately after the death of prophet Muḥammad. These differences were resolved by the agreement of the majority of Muslims on Abu Bakr's name. Until the second half of the rule of the third caliph ʿUthmān, Muslims came together around the unifying power of the idea of conquest. Nevertheless, substantially as a result of economically based problems the period of tranquility in Islamic society came to an end and was replaced by disputes. Disputes turned into conflict and ultimately seperation fused with the massacre of ʿUthmān in the capital Medina turned into a big fire with the Battles of the Camel and Ṣiffīn, the emergence of Khārijīs, the formation of the Shia and the deepening of the intellectual divisions after the all of these. Islamic history has witnessed a clash of different religious views and beliefs. along with deepening of intellectual disagreements as a result of political debatesIn the Islamic political thought, especially the first two centuries process was formed around the views of the jurists, muḥaddiths and theologians. The first sources used by those who tried to justify their opinion in the differences of opinion experienced during this period were the Qurʾān and ḥadīth literature which Muslims accepted as the determining factor in all their acts. The views based on the Qur'an and the hadiths, which are the two main sources of Islamic religion, had been used to influence the people, legitimize the actions and refute the claims of the opponents. On the other hand the sort who gave direction to political thought changed and political thought adhered a new path with Turks and Persians served as bureaucrats and soldiers and took an active position in the state. Especially Persians carried the culture of advice to Islamic thought, which is the product of both Greek and Hind civilization. Such books had brought in the İslamic society with translation movements began in the Umayyad period and peaked with the Bayt al-Ḥikma in the Abbasid period. Together with these books, the ideas of these civilizations on ideal state administration, politics and morality were recognized by Muslim scholars.These type of works, which are famous in terms of Islamic thought as mirrors for princes, have been written by Muslim scholars since the middle of the eighth century. Mirrors for princes are political, moral and religious content books that gives the rulers practical advice to maintain their power in accordance with the religious orders and prohibitions, and to the consent of Allāh’s who grant them this authority and people which appointed for their administration. Mirrors for princes are mostly theoretical books since they are mostly focused on what should be. In addition, since they are written for names that currently hold power, they are centered on how the rulers can maintain and increase their power and with which practices the state will maintain its existence for a longer period. The basic point of political thought and political interpretation are concepts and definitions. When the concept meaning of a word is mentioned, it is generally considered that there is a general definition. However, the concepts reflect the meaning that the user assigns to him in the context of his thoughts, perceptions, criticisms, explanations and analyzes. Concepts such as fair, honest, brave, hero, beautiful, rich, good and clean express what the person imposes on the meaning. In other words, everyone’s experience determines the content of the concept so far. The meaning of the concepts varies with the age and its user of that concept. Even concepts such as justice, merit and consultation can change meaning in different periods and geographies. The concepts, which are often used to facilitate understanding, are sometimes used to judge, to mold or mislead the interlocutor. In this context, it is imperative to enter the mind of the user in order to make concept analysis.In Islamic civilization, the principles of management are explained with concepts. The idiosyncrasies that Muslims expect from an ideal ruler are defined as justice, consultation, merit, trust and legitimacy and a broad corpus has been written about the concepts related to the administration, especially those mentioned. One type of this corpus is mirrors for princes.In Islamic history, there are many Mirrors for princes who are written in different time periods by names coming from different geographies and different backgrounds. Although the advice given in Mirrors for princes indicate a great similarity to each other, the preferred arguments and examples in the foundation of the counsel are different. While the persons in active politics mostly based their opinions on political arguments, scholars with scientific tradition supported their advices with religious arguments.Verses are the leading religious elements highlighted in Mirrors for princes. While explaining the concepts and emphasizing the importance of the advices, many verses have been exploited. Some verses are used only by one author, while some verses are the subject of their work by many authors. In the same way, ḥadīths and the sentences accepted as ḥadīths were also used to reinforce the emphasis and meaning. At this point, sometimes the context of the verses and ḥadīths were not taken care of. In this study, we aim to address the use of religious elements.In the literature, different opinions have emerged about who is ülü’l-emr and the limits of obedience to ülü’l-emr that used describe the names of senior executives and leaders of society. The reason for the difference is that each sect or religious school provides an interpretation on the basis of grounding its own views in explaining the verse. Justice is the most emphasized concept among the advices given to the rulers in mirrors for princes. Justice, which is shown as the most important feature of a sovereign, has been regarded as extremely important for the state to existences until the Doomsday. In addition, justice has been described as the most important condition for the maintenance of the state/sovereign authority. Consultation was important to make the right decision.Verses and ḥadīths were used in the explanations about the personal characteristics of the sovereign. Some features such as being compassionate, keeping promise, controlling anger, patience, honesty, blessing, extravagance, self-esteem, break a promise, revoke a promise and arrogance have become the subject of politics. When the mirrors for princes are considered as a whole, it is seen that religion and state are considered as inseparable twin brothers, taken one step further the understanding that accepts religion and the world as brothers especially is a product of the old Persian tradition. In this understanding, religion was accepted as the root and was given the duty of its patronage to political authority. It is seen that in the Mirrors for princes verses and ḥadīths hold a significant amount. As the reason for this can be said that along with religion takes place on the basis of morality, the authors of the Mirrors for princes, which put deep meanings on the relationship between religion and the state in the period that we are dealing with, consider both institutions to be complementary and integrative. (shrink)

The argument that a permanent vegetative state equates to death because it marks the death of the person is not a new one, but I wonder whether Ravelingien et al1 need to regard those in a PVS as dead to make a case for animal to human transplantation trials taking place in such people. It is not an argument likely to convince anyone who refuses to accept that only human persons have inherent value, dignity or a right to life, and (...) the arguments on both sides have been well rehearsed, with no sign of reconciliation. My own view is that people in a PVS are still alive, albeit with a poor quality of life. I see no objection in principle to the proposal that competent people can decide, in advance, to participate in research when they become incompetent. At the present time, it is generally accepted that an advance refusal of consent should be respected. Some controversy exists on whether someone can insist on treatment in advance, but in Ravelingien et al’s1 paper, what is being proposed is not that people can insist on becoming research participants, but rather that they can signal a willingness to become such a participant in the future. Indeed, this principle can be extended to competent people such as those with early …. (shrink)

Obtaining informed consent from patients prior to a medical or surgical procedure is a fundamental part of safe and ethical clinical practice. Currently, it is routine for a significant part of the consent process to be delegated to members of the clinical team not performing the procedure (eg, junior doctors). However, it is common for consent-taking delegates to lack sufficient time and clinical knowledge to adequately promote patient autonomy and informed decision-making. Such problems might be addressed (...) in a number of ways. One possible solution to this clinical dilemma is through the use of conversational artificial intelligence using large language models (LLMs). There is considerable interest in the potential benefits of such models in medicine. For delegated procedural consent, LLM could improve patients’ access to the relevant procedural information and therefore enhance informed decision-making.In this paper, we first outline a hypothetical example of delegation of consent to LLMs prior to surgery. We then discuss existing clinical guidelines for consent delegation and some of the ways in which current practice may fail to meet the ethical purposes of informed consent. We outline and discuss the ethical implications of delegating consent to LLMs in medicine concluding that at least in certain clinical situations, the benefits of LLMs potentially far outweigh those of current practices. (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)

That consent could wholly explain – either descriptively or normatively – the legitimacy of the structure of political community and it’s most important and influential institutions and practices is deeply implausible. There are two general sorts of considerations adduced against such a proposition. First, history simply refutes it: force is an essential feature of the founding of any political society, and arguably, for its continued existence, and power relations, in all their complexity, are imperfectly tracked by consent. (...) Moreover, there are deep questions about what people are actually consenting to, given the plurality and changing nature of political collectivities over time. Second, in modern societies (perhaps in just any complex human society) our conduct is shaped and governed in so many ways so as to influence not only the options we have, but also the interests, desires and capabilities constitutive of our ability to act in relation to them in the first place. This undermines any easy connection between the presence of consent and my being free. A familiar conundrum for consent as a standard of legitimacy is that if it means literally that individual consent is required for non-arbitrariness in public decision-making, then public decision-making – indeed almost any form of collective action –becomes almost impossible. If only tacit or implicit consent is required, then we can find it everywhere, and thus nowhere, and the standard is empty. (shrink)

Broad consent – the act of gaining one consent for multiple potential future research projects – sits at the core of much current genomic research practice. Since the 25th May 2018, the General Data Protection Regulation (GDPR) has applied as valid law concerning genomic research in the EU and now occupies a dominant position in the legal landscape. Yet, the position of the GDPR concerning broad consent has recently been cause for concern in the genomic research (...) community. Whilst the text of the GDPR apparently supports the practice, recent jurisprudence contains language which is decidedly less positive. This article takes an in-depth look at the situation concerning broad consent under the GDPR and – despite the understandable concern flowing from recent jurisprudence – offers a positive outlook. This positive outlook is argued from three perspectives, each of which is significant in defining the current, and ongoing, legitimacy and utility of broad consent under the GDPR: the principled, the legal technical, and the practical. (shrink)

This article explores the meaning and moral significance of presumed consent with particular reference to an opt-out policy for postmortem organ donation. It does so under two general categories: circumstances where we believe consent to have been given and those where we have no reason to believe that it has either been given or been refused. In the context of an opt-out policy, the first category would relate to the idea of tacit consent. It is argued (...) both that substituting the term ‘presumed consent’ would be misleading and that it is unlikely that the conditions for tacit consent would be met in practice. Regarding the second category, where the claim would be one regarding counterfactual consent, two main points are made: that claims about consent are unwarranted, and also that they are unnecessary to moral argument, given that the moral work is done by reasons other than any supposedly provided by a presumption of consent. (shrink)

Until 2008, if doctors followed the General Medical Council's (GMC's) guidance on providing information prior to obtaining a patient's consent to treatment, they would be going beyond what was technically required by the law. It was hoped that the common law would catch up with this guidance and encourage respect for patients' autonomy by facilitating informed decision-making. Regrettably, this has not occurred. For once, the law's inability to keep up with changing medical practice and standards is not the (...) problem. The authors argue that while the common law has moved forward and started to recognise the importance of patient autonomy and informed decision-making, the GMC has taken a step back in their 2008 guidance on consent. Indeed, doctors are now required to tell their patients less than they were in 1998 when the last guidance was produced. This is an unfortunate development and the authors urge the GMC to revisit their guidance. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Citizenship and Culture in Early Modern EuropePeter N. MillerCharlotte Wells, Law and Citizenship in Early Modern France (Baltimore: The Johns Hopkins University Press, 1995), xviii, 198p.Paula Findlen, Possessing Nature: Museums, Collecting, and Scientific Culture in Early Modern Italy (Berkeley, Los Angeles, and London: University of California Press, 1994), xviii, 449p.Steven Shapin, The Social History of Truth: Civility and Science in Seventeenth-Century England (Chicago and London: University of Chicago Press, (...) 1994), xxiv, 483p.Anne Goldgar, Impolite Learning: Conduct and Community in the Republic of Letters 1680–1775 (New Haven and London: Yale University Press, 1995), xv, 395p.Lawrence Klein, Shaftesbury and the Culture of Politeness: Moral Discourse and Cultural Politics in Early Eighteenth-Century England (Cambridge, U.K., 1994), xiii, 217p.Daniel Gordon, Citizens Without Sovereignty: Equality and Sociability in French Thought, 1670–1789 (Princeton: Princeton University Press, 1994), viii, 270p.Dena Goodman, The Republic of Letters: A Cultural History of the French Enlightenment (Ithaca and London: Cornell University Press, 1994), xiii, 338p.E. J. Hundert, The Enlightenment’s “Fable”: Bernard Mandeville and the Discovery of Society (Cambridge: Cambridge University Press, 1994), xii, 284p.The pre-modern political world was broken and remade in the two centuries that separate Montaigne from Jefferson. The long agony of the mixed constitution that began in the civil wars which raged in Iberia, France, the Low Countries, and England and seemed settled by the widespread adoption of the maxims of reason of state, revived at the end of the period, with revolution in Poland, Denmark, Sweden, Geneva, and, more famously, [End Page 725] British North America and France. The problem, classically, turned on the location of sovereignty, or supreme authority, in political systems designed to balance and diffuse rather than concentrate power. When budget deficits and fratricidal culture wars raised the cry of “necessity”—with the knowledge, of course, that necessity knew no law—estates and kings across Europe found themselves at daggers drawn. The claim that the ruler, who naturally was wholly committed to the common good, had therefore the ability to take emergency action was used both by those accustomed to rule and those newly attained to it by force. The pursuit of an “interest” that was identified with the nation’s effectively marginalized discussions of right and law while still serving an essentially constitutional, justificatory role in political debate. But if unchecked authority was necessary in order to meet the challenge of a world characterized by change and chance and thus had to reside somewhere, was there anything that made its exercise by one body more appropriate than another? This was the question that lay behind the late eighteenth-century repudiation of the reason of state “solution” to the problem of the mixed constitution. The answer, which clearly underpinned the establishment in fact of what had first been theorized already a century earlier, was that only consent could legitimate the exercise of sovereignty in time of necessity.1Representation, in one form or another, was the acknowledged solution to the problem formulated by Hobbes: “the name of Tyranny, signifieth nothing more, nor less, than the name of Sovereignty, be it in one, or many men, saving that they that use the former word are understood to be angry with them they call Tyrants.” But representation also acknowledged the reality behind the charged category of “citizenship”: most people in most places could not be said to live the life of the active citizen celebrated in Roman republican literature. Hence Hobbes’s attack on recourse to classical exempla in general, and the Libertas of Lucca in particular. The idea of civis as law-abiding subject was as radical a redrawing of the terms of debate as the identification of human nature with unsociability. Insofar as politics, classically, justified itself as the means for individual self-perfection, the practice of the ancient citizen could be conceived of as the practice of that best life speculated upon by philosophers. For the represented citizen, however, politics necessarily occupied a more subsidiary position. What, then, defined the best life to which he could aspire?There is no simple answer to this question, and the early modern ambivalence has persisted into our own time... (shrink)

At one time, specialized health privacy laws represented the bulk of the rules regulating genetic privacy, Today, however, as both the field of genomics and the content of privacy law change rapidly, a new generation of general-purpose privacy laws may impose new restrictions on collection, storage, and disclosure of genetic data. This article surveys these laws and considers implications.

In lieu of an abstract, here is a brief excerpt of the content:The Recuperation of the Theory-Death of the Avant-GardeRobert Radin (bio)Paul Mann. The Theory-Death of the Avant-Garde. Bloomington: Indiana UP, 1991.It is difficult to respond to an essay that so thoroughly lays bare (and thereby challenges) what it is we do when we respond to another writer’s writing. I find it hard to begin, caught somewhere in that terminal state between speech and silence, that moment Beckett captures at the (...) end of the The Unnamable: “I can’t go on, I’ll go on.” Should I follow every word I write with “[sic],” at once quote myself and distance myself from what I have just written, indicate that I am aware of what it is I’m doing even as I’m doing it? I’ll go on.The fact that Paul Mann’s The Theory-Death of the Avant-Garde has received relatively little critical response since its publication in 1991 may in fact be a measure of its success. Nevertheless, this lack of response seems worthy of attention, given that Mann devotes so much of his essay to making the point that art’s (and theory’s) raison d’être is to generate further discourse, to keep the discursive economy going, however resistant to dominant culture that art or theory may appear to be.After repeatedly, painstakingly pointing out the status of his own essay in the discursive economy he describes—the discourse of the avant-garde—Mann anticipates the likely response to his work:It is not difficult to imagine whatever little response this essay is liable to. For the most part dismissals of what will be taken as its nihilism, its cynicism, its defeatism, its adherence to this or that dubious theory, its outmoded obsession with recuperation. But the essay was not written for those who reject an insistence on recuperation only in order to conceal from themselves the extent of their own recuperation.[141]And further on in the same passage: “it [the essay] was also written precisely so that it could be dismissed” [141]. Mann, to varying degrees, has correctly diagnosed the critical reception of his work thus far. When the essay is dismissed in reviews it is because it is seen as both passé and nihilistic. Even in one of the favorable reviews of Mann’s essay the question of nihilism arises. It is this “specter of nihilism” that I want to take up here—after first reviewing some of the more salient features of Mann’s argument—as I think it is a response most readers will have to struggle through (as Mann correctly points out), and it might tell us something about the larger discursive economy of which The Theory-Death of the Avant-Garde is now a part. That Mann’s position is seen as outmoded is less of an issue for me. It may be that his essay was already “old” by the time it was published, [End Page 41] his position already dismissable under the aegis of other names: Baudrillard, Barthes, Derrida. But that his essay is no longer new, that his position has exhausted its discursive currency, only further makes his point: in the discourse of the avant-garde, and in the discursive economy generally, the new supersedes all other values. More important, Mann’s position in particular must exhaust itself quickly if the discursive economy is to continue to thrive.In The Pleasure of the Text Roland Barthes delineates what he calls the “versus myth”:Art seems compromised, historically, socially. Whence the effort on the part of the artist himself to destroy it.... Unfortunately, this destruction is always inadequate; either it occurs outside the art, but thereby becomes impertinent, or else it consents to remain within the practice of the art, but quickly exposes itself to recuperation (the avant-garde is that restive language which is going to be recuperated). The awkwardness of this alternative is the consequence of the fact that destruction of discourse is not a dialectic term but a semantic term: it docilely takes its place within the great semiological “versus” myth (white versus black); whence the destruction of art is doomed to only paradoxical formulae... (shrink)

Consent transforms an otherwise illegitimate act into a legitimate one. To be valid, however, it must be adequately informed. The legal requirement is vague and provides little assistance in predicting when it will be satisfied. This is particularly so when a patient consents to a procedure and the physician subsequently varies one of the components of that procedure. Using three legal judgments and one General Medical Council decision as a springboard, I have explored the concept of a medical (...) procedure within the context of consent and developed a theoretical model to elucidate a more predictable and consistent informational requirement. (shrink)

Under current UK law, an embryo cannot be transferred to a woman's uterus without the consent of both of its genetic parents, that is both of the people from whose gametes the embryo was created. This consent can be withdrawn at any time before the embryo transfer procedure. Withdrawal of consent by one genetic parent can result in the other genetic parent losing the opportunity to have their own genetic children. We argue that offering couples only (...) one type of consent agreement, as happens at present, is too restrictive. An alternative form of agreement, in which one genetic parent agrees to forego the right to future withdrawal of consent, should be available alongside the current form of agreement. Giving couples such a choice will better enable them to store embryos under a consent agreement that is appropriate for their circumstances. Allowing such a choice, with robust procedures in place to ensure the validity of consent, is the best way to respect patient autonomy. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Mere ReadingEva T. H. BrannI recall reading in college, some half a century ago, that the first Queen Elizabeth once represented herself to her people as “mere English.” She meant that she was English pure and simple, nothing but English. I want to set out a way with books, primarily but not only those ranged under “literature,” that I think of as mere reading. Neither the phrase “mere reading” (...) or “mere close reading” is new with me, nor is the mode, and I do not imagine myself on a lonely quest for some lost hermeneutic Eden. Children and the literate public merely read all the time. So do scholars liberated from the professional impositions of graduate school; they have achieved what Thomas Mann calls “the second ingenuousness.” They have read the articles claiming that all books and all approaches to books are of necessity theoretically or ideologically skewed and that a job of rectification, thorough enough perhaps even to postpone the actual reading indefinitely, is a precondition of liberation from the author’s subtle or unconscious agenda. Yet they have liberated themselves from the liberators, well knowing that if it’s a gift to be simple, it is also an achievement.I am, therefore, far from thinking that facing a book simply—facing it without “confronting” it—is an obsolescent activity or that either the straight and trustful reading of books or the making of books that present themselves to be so read is in real danger. I no more fear an impending cultural Armageddon than I long for a past interpretational paradise. For one thing, this is a golden age for the English novel, the premier genre of the present. All the assimilated immigrants and quondam colonials, with their delight in the elegancies of mere high English and their loving mastery of its local varieties, are writing their way into the center of English novelistic literature. They seem quite [End Page 383] aware of all those “readings”—Marxist, feminist, deconstructionist, etc. Nevertheless they write merrily on for an ingenuous yet discerning public.Consequently, the following baker’s dozen of preconditions and precepts are presented not with a sense of fending off impending doom, but for the pleasure of recognition they might give to those who have come to similar conclusions. In these pages I am apt to be preaching to the choir and, truth to tell, I feel no vocation to convert the unbelievers, the more so since I am convinced that it takes all kinds.1. The First-Person PluralThe coopting “we” is more insidiously imperial than ever was the regal first-person plural. Recall all the sentences in public intellectual speech that tell us what “we” all are thinking or are no longer permitted to think or are now required to think (or do) in matters intellectual in general and in matters interpretational in particular, by reason of our historical situation.When I read one of these dicta pushing and pulling me into my place in time or society, every aversive fiber tenses and signals “who ‘we’?—not me!” For the very thing said in our name to be needful may well be the thing most harmful and the impermissible move the one really required. It seems to me worth considering that in an analysis of “our historical situation” it might be the “our” that is the vitiating flaw.Precept: Don’t say “we” unless you have obtained consent. Try “I” or “some of us.” In particular, always qualify announcements of apocalypse so as to leave room for non-participants. This frame of mind is good for turning from sophisticated to mere reading.2. Critical SuperiorityJudges on their benches sit over the sinners arraigned before them, but that the critics in their studies should be above the writers who are their “subject” is plain comical. For one thing, judging is a social necessity, while criticizing is a discretionary activity; some of us could live without it. Some professors make students believe that criticism is work while writing is a self-indulgence that needs to be curbed. In truth, it is the other way around: the critic is parasitic on the writer; if nothing... (shrink)

One of Bratman’s aims in Planning, Time, and Self-Governance is to develop his insights regarding planning to shed light on temptation. I focus on the main case of temptation Bratman appeals to in supporting his conclusion that it can be rational for an agent facing temptation to stick to her prior plan even if she finds herself with an evaluative judgment that favors deviating. Bratman’s reasoning is meant to be consistent with the priority of present evaluation, and to be (...) sensitive to Smart’s insight that, as Bratman puts it, ‘inference from the advantages of the general habit [of non-reconsideration] directly to a specific conclusion about what to do on the present occasion, once the question of what to do on the present occasion is raised, is fraught.’ My reasoning suggests that, interpreted in one way, the case Bratman uses to make his argument is not clearly a case of giving in to temptation (or else not a case that requires the sort of novel contribution Bratman thinks is needed); and interpreted otherwise, the case does not raise exactly the challenges Bratman suggests it does, and the challenges it does raise are not directly addressed by the solution Bratman provides. (shrink)

Fichte's reputation at the present time is in some respects a curious one. On the one hand, he is by common consent acknowledged to have exercised a dominant influence upon the development of German thought during the opening decades of the nineteenth century. Thus from a specifically philosophical point of view he is regarded as an innovator who played a decisive role in transforming Kant's transcendental idealism into the absolute idealism of his immediate successors, while at a more (...) general level he is customarily seen as having put into currency certain persuasive conceptions which contributed—less directly but no less surely—to the emergence and spread of romanticism in some of its varied and ramifying forms. On the other hand, however, it is noticeable that detailed consideration of his work has not figured prominently in the recent revival of concern with post-Kantian thought as a whole which has been manifested by philosophers of the English-speaking world. Although his name is frequently mentioned in that connection, one suspects that his books may not be so often read. In part this may be due to his particular mode of expounding his views, which at times attains a level of opacity that can make even Hegel's obscurest passages seem comparatively tractable. It is also true that Fichte's principal theoretical works—if not his semipopular writings—are largely devoid of the allusions to scientific, historical, psychological or cultural matters with which his German contemporaries were prone to illustrate their philosophical doctrines and enliven their more abstract discussions: there is a daunting aridity about much of what he wrote which can raise nagging doubts in the modern reader's mind about the actual issues that are in question. Yet the fact remains that by the close of the eighteenth century his ideas had already made a profound impact, capturing the imagination of a host of German thinkers and intellectuals. The problem therefore arises as to what preoccupations, current at the time, they owed their indubitable appeal and to what puzzles they were welcomed as proffering a solution. If these can be identified, it may become at least partially intelligible that Fichte should have been widely regarded as having provided a framework within which certain hitherto intractable difficulties could be satisfactorily reformulated and resolved. Let me accordingly begin by saying something about them. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 171-174 [Access article in PDF] Bioethics Inside the Beltway The Oversight of Human Gene Transfer Research LeRoy Walters Jesse Gelsinger's death last September in a gene transfer study being conducted at the University of Pennsylvania has helped to spark a national debate. In part, this debate parallels the broader discussion of how human subjects research should be reviewed and regulated in the (...) United States. However, human gene transfer research is one of a handful of biomedical technologies that seem to deserve special attention, at least in the early years of their development.The major participants in the national debate on human gene transfer include the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Bioethics Advisory Commission, members of Congress, biotechnology and pharmaceutical companies, disease-oriented advocacy groups, reporters, and academics. At the December 1999 meeting of the NIH Recombinant DNA Advisory Committee (RAC), the protocol that involved Jesse Gelsinger was a central focus of discussion, but other topics emerged as well. One ad hoc panel reviewed adverse events that had occurred in other research protocols using adenovirus vectors, while a second proposed changes in the general system for reporting adverse events to NIH and the RAC.During the first several months of the year 2000, the United States Congress also became involved in the human gene transfer debate. In February, Senator Bill Frist (R-TN) convened a hearing to which Jesse Gelsinger's father, representatives of NIH and FDA, and several other witnesses were invited. At approximately the same time, the House Commerce Committee and its Subcommittee on Oversight and Investigations initiated their own inquiries, asking the Office of Inspector General at the Department of Health and Human Services to review the oversight roles of NIH and FDA. In March and April, the House committee also wrote directly to the NIH Director, the FDA Commissioner, and the President of the University of Pennsylvania, requesting extensive documentation on gene transfer, in general, and the trial in which Jesse Gelsinger was involved, in particular. Congressman Henry Waxman (D-CA) and Senator Edward Kennedy (D-MA) have also raised questions and proposed solutions in multiple letters to the NIH Director and the Secretary of Health and Human Services. [End Page 171]The major general questions that have emerged from this discussion are the following:(1) What kinds of information about adverse events should be reported by researchers or sponsors during the course of human gene transfer trials?(2) To what group or groups should adverse-event information be reported? How often and in what ways should the information be analyzed?(3) Should the information about adverse events remain confidential, or should it be discussed publicly?(4) How can the disclosure and consent process in gene transfer trials be improved?(5) Which federal agency should have primary responsibility for overseeing human gene transfer research, and how can it best fulfill its oversight role?How these questions are answered will have immediate relevance to the field of human gene transfer research as it enters into its next phase. At the same time, the models that are created for this important cutting-edge field also may be useful in other complex or controversial arenas of biomedical research, for example, xenotransplantation or human embryonic stem-cell research. In addition, the lessons learned from this one important area of human subjects research may suggest ways to improve protections for all the volunteers who make clinical research--and medical progress--possible.In the remainder of this article, I will turn from reporting, in as objective a way as possible, on the status of the public policy debate about human gene transfer research to suggesting measures for improving the current oversight system for such research. My initial general recommendation is that we should not expect a single regulatory agency to be solely responsible for a field as large and dynamic as human gene transfer research. Rather, there should be some helpful redundancy or, to change the metaphor, checks and balances in the public oversight of this field. Thus, an... (shrink)

1 This book is the product of a one-year project conducted by the Hastings Center, Institute of Society, Ethics and the Life Sciences, during 1976-1977. The Behavior Control Research Group-an ongoing, interdisciplinary working group com posed of philosophers, psychiatrists, psychologists, social sci entists, and lawyers-met four times over the course of the year with special consultants with expertise in the field of mental retardation. At those meetings, participants gave in formal presentations, which were followed by group discus sion. As the (...) project progressed, formal papers were delivered and subjected to further critical commentary. This volume, in two related parts, represents the deliberations of the group as a whole, and then offers individual papers prepared by some scholars in order to give a sense of the kind of specific arguments on which the general conclusions were based. We undertook the project to examine: (1) questions of competence and consent; and (2) the practical implications, lThe project, entitled "Ethical Issues in the Care and Treatment of the Mildly Mentally Retarded," was supported by the EVI5T program of the National Science Foundation under Grant No. 05576-14793. Any Opinions, findings, conclusions, or recommendations expressed herein are those of the authors and do not necessarily reflect the views of the National Science Foundation. ix x PREFACE in terms of care and treatment, that evolve from differing definitions and models applied to mental retardation. (shrink)