It is widely agreed that clinical research should satisfy a number of ethical requirements. These include requirements to address a valuable question, to select subjects fairly, and to pose appropriate risks. In contrast, there remains considerable debate over the ethical relevance of investigator intentions: Does it matter ethically whether investigators intend to collect generalizable knowledge or to benefit subjects, or both? Some commentators do not mention investigator intentions when evaluating what makes clinical research ethical (Emanuel, Wendler, and Grady 2000). (...) Others regard investigator intentions as central to the ethics of clinical research (Jonas 1969). These commentators argue that .. (shrink)
It is widely held that individuals who are unable to provide informed consent should be enrolled in clinical research only when the risks are low, or the research offers them the prospect of direct benefit. There is now a rich literature on when the risks of clinical research are low enough to enroll individuals who cannot consent. Much less attention has focused on which benefits of research participation count as ‘direct’, and the few existing accounts disagree over how this crucial (...) concept should be defined. This disagreement raises concern over whether those who cannot consent, including children and adults with severe dementia, are being adequately protected. The present paper attempts to address this concern by considering first what additional protections are needed for these vulnerable individuals. This analysis suggests that the extant definitions of direct benefits either provide insufficient protection for research subjects or pose excessive obstacles to appropriate research. This analysis also points to a modified definition of direct benefits with the potential to avoid these two extremes, protecting individuals who cannot consent without blocking appropriate research. (shrink)
One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal regulations require that the “risks (...) to subjects” be “reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge” to be gained from the .. (shrink)
Although many of the issues surrounding innateness have received a good deal of attention lately, the basic concept of token innateness has been largely ignored. In the present paper, I try to correct this imbalance by offering an account of the innateness of token traits. I begin by explaining Stephen Stich's account of token innateness and offering a counterexample to that account. I then clarify why the contemporary biological approaches to innateness will not be able to resolve the problems that (...) beset Stich's account. From there, I develop an alternative understanding of the innateness of token traits, what I call a causal/explanatory account. The argument to be made is that token innateness is both a causal, and an explanatory, concept. After clarifying this understanding of innateness, and showing how it handles several counterexamples to other accounts, I end with some comments on what the causal/explanatory account suggests for our understanding of innateness in general. (shrink)
Pediatric research without the potential for clinical benefit is vital to improving pediatric medical care. This research also raises ethical concern and is regarded by courts and commentators as unethical. While at least 10 justifications have been proposed in response, all have fundamental limitations. This article describes and defends a new justification based on the fact that enrollment in clinical research offers children the opportunity to contribute to a valuable project. Contributing as children to valuable projects can benefit individuals in (...) two ways. First, individuals may come to ?embrace? the contributions they made as children. Second, contributing to valuable projects can lead to a better overall life. Because these potential benefits can outweigh small research risks, they provide a justification for pediatric research without the potential for clinical benefit, when it poses low risks and has the potential to benefit others in important ways. (shrink)
To give valid informed consent to participate in clinical research, potential participants should understand the risks, potential benefits, procedures, and alternatives. Potential participants also should understand that they are being invited to participate in research. Yet it is unclear what potential participants need to understand to satisfy this particular requirement. As a result, it is unclear what additional information investigators should disclose about the research; and it is also unclear when failures of understanding in this respect undermine the validity of (...) potential participants' informed consent. An analysis of individuals' interests suggests that potential participants need to understand three additional facts to understand that they are being invited to participate in research: 1) research contribution: those who enroll in the study will be contributing to a project designed to gather generalizable knowledge to benefit others in the future; 2) research relationship: the investigators will rely on participants' efforts to gather the generalizable knowledge to benefit others; and 3) research impact: the extent to which participating in the study will alter what participants do and what happens to them. (shrink)
: When children and incapacitated adults are enrolled in research that cannot directly benefit them, they can be exposed to no more than "minimal" risks, according to guidelines accepted around the world. We need a new standard for what "minimal" risks are, howeve--one that recognizes that participating in nonbeneficial research is like participating in a charitable activity. Such a standard appears likely to provide more stringent protections for these vulnerable populations.
In standard medical care, physicians select treatments for patients based on clinical judgment, considering which treatment is best for the individual patient, given the patient's history and circumstances. In contrast, investigators conducting randomized clinical trials select treatments for participants based on a random selection process. Because this process represents a significant departure from the norms of standard medical care, it is widely assumed that potential research participants must understand randomization to give valid informed consent. This assumption, together with data that (...) many research participants do not understand randomization, implies that randomized clinical trials often fail to obtain adequately informed consent. Before accepting this conclusion, and before initiating extensive efforts to improve research participants' understanding of randomization, we should assess the plausible, but rarely analyzed assumption that participants need to understand randomization to give valid informed consent for randomized clinical trials. (shrink)
Guidelines for health research focus on protecting individual research subjects. It is also vital to protect the communities involved in health research. In particular, a number of studies have been criticized on the grounds that they exploited host communities. The present paper attempts to address these concerns by providing an analysis of community exploitation and, based on this analysis, determining what safeguards are needed to protect communities in health research against exploitation. (edited).
: In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given study (the subjective (...) interpretation). The court's use of the objective interpretation to block studies like the KKI study protects individual children who are worse off than the average child. Unfortunately, this approach also may block research intended to improve the lives of these same individuals. A similar dilemma arises in the context of multinational research, suggesting that a "modified objective standard," proposed to address this dilemma in the multinational setting, may offer a framework for addressing the dilemma in the context of pediatric research as well. (shrink)
The U.S. federal regulations require investigators conducting nonbeneficial research to obtain the assent of children who are capable of providing it. Unfortunately, there has been no analysis of which children are capable of assent or even what abilities ground the capacity to give assent. Why should investigators be required to obtain the positive agreement of some children, but not others, before enrolling them in research that does not offer a compensating potential for direct benefit? We argue that the scope of (...) children's research decision making should be based on the principles of respect for autonomy and nonmaleficence. These principles imply that the threshold for assent should be fixed at 14 years of age, and a dissent requirement should be adopted for all children in the context of nonbeneficial research. (shrink)
The U.S. Federal regulations allow institutional review boards (IRBs) to approve non-beneficial pediatric research when the risks are a minor increase over minimal, provided that the research is likely to develop generalizable knowledge about the subjects' disorder or condition. This “subjects' condition” requirement is quite controversial; commentators have argued for a variety of interpretations. Despite this considerable disagreement in the literature, there have not been any attempts to apply principles of legal interpretation to determine how the subjects' condition requirement should (...) be understood. (shrink)
Clinical research is thought to be ethically problematic and is subject to extensive regulation and oversight. Despite frequent endorsement of this view, there has been almost no systematic evaluation of why clinical research might be ethically problematic. As a result, it is difficult to determine whether the regulations to which clinical research is subject address the ethical concerns it raises. Commentators who consider this question at all tend to assume that clinical research is ethically problematic because it exposes some individuals (...) to risks for the benefit of others. Yet, many other activities that expose some individuals to risks for the benefit of others are not subject to extensive regulation and oversight. This difference raises the question of whether clinical research is distinct from these activities in normatively relevant ways and, if so, what implications this difference (or differences) has for how clinical research should be regulated and conducted. The present manuscript attempts to answer this question by comparing clinical research to two other activities that expose some individuals to risks for the benefit of others. This comparison highlights an aspect of clinical research which has received relatively little attention, namely, the active role investigators play in exposing subjects to risks. I argue that this aspect explains much of the ethical concern expressed regarding clinical research. I end by considering the normative significance of this feature and the implications it has for how clinical research should be regulated and conducted. (shrink)
A good deal has been written on the ethics of peer review, especially in the scientific and medical literatures. In contrast, we are unaware of any articles on the ethics of peer review in bioethics. Recognising this gap, we evaluate the extant proposals regarding ethical standards for peer review in general and consider how they apply to bioethics. We argue that scholars have an obligation to perform peer review based on the extent to which they personally benefit from the peer (...) review process. We also argue, contrary to existing proposals and guidelines, that it can be appropriate for peer reviewers to benefit in their own scholarship from the manuscripts they review. With respect to bioethics in particular, we endorse double-blind review and suggest several ways in which the peer review process might be improved. (shrink)
David Lewis's book 'On the Plurality of Worlds' mounts an extended defense of the thesis of modal realism, that the world we inhabit the entire cosmos of which we are a part is but one of a vast plurality of worlds, or cosmoi, all causally and spatiotemporally isolated from one another. The purpose of this article is to provide an accessible summary of the main positions and arguments in Lewis's book.
My research work title is “A Philosophical Study of the Concept of Mind (with special reference to Rene Descartes, David Hume and Gilbert Ryle).” In this study we have discussed three conceptions of mind presented by Rene Descartes, David Hume and Gilbert Ryle. All the three thinkers are related to different philosophical traditions known as Rationalism, Empiricism and Analytical Philosophy respectively. Each of these various approaches can be seen as at least partly successful, each provides answers to questions (...) regarded as especially pressing, each apparently solved certain problems. Notoriously, however, each leaves unanswered and unsolved a host of distinct problems as well. (shrink)
David Phillips’s Sidgwickian Ethics is a penetrating contribution to the scholarly and philosophical understanding of Henry Sidgwick’s The Methods of Ethics. This note focuses on Phillips’s understanding of (aspects of) Sidgwick’s argument for utilitarianism and the moral epistemology to which he subscribes. In § I, I briefly outline the basic features of the argument that Sidgwick provides for utilitarianism, noting some disagreements with Phillips along the way. In § II, I raise some objections to Phillips’s account of the epistemology (...) underlying the argument. In § III, I reply to the claim that there is a puzzle at the heart of Sidgwick’s epistemology. In § IV, I respond to Phillips’s claim that Sidgwick is unfair in his argument against the (deontological) morality of common sense. (shrink)
The concept of the self is a highly contested topic. Traditionally it belonged to speculative metaphysics. Almost every philosopher, whether Western or Indian, has tried to explore the nature of self. Generally, the self is taken as a substance which has permanent existence, which is eternal and non-specio-temporal. In some traditions, like the Hindu tradition, it is believed to take rebirth as the body perishes. Many Western philosophers also think that it is immortal. The nature of the self also has (...) then ethical implications. The views of David Hume and Gautama Buddha on the self, which I have chosen to discuss here, are similar. Though both belong to different traditions, both are skeptical of any permanent existence of self. This is not to say that one has borrowed from the other. For the nature and purpose of denial of the self in both the philosophers is different. So a comprehensive and comparative study of their views is very interesting. It is the intention of this article to analyze and compare the philosophical positions of Gautama and Hume on the self—a problem which was of central concern to both and which has since exercised a continuing fascination for philosophers, both of the East and the West. (shrink)
David Lewis claims that his theory of modality successfully reduces modal items to nonmodal items. This essay will clarify this claim and argue that it is true. This is largely an exercise within ‘Ludovician Polycosmology’: I hope to show that a certain intuitive resistance to the reduction and a set of related objections misunderstand the nature of the Ludovician project. But these results are of broad interest since they show that would-be reductionists have more formidable argumentative resources than is (...) often thought. Lewis’s reduction depends on a set of methodological commitments each of which is fairly plausible or at least currently popular, and none of which is particular to modality. The choice of which of these commitments to reject I leave to the discerning antireductionist. The essay proceeds as follows: §1 discusses reduction generally and one or two relevant puzzles; §2 discusses Lewis’s reduction in particular; the longest section, §3 replies to four objections. (shrink)
Primary Works -/- Hume, David(1997) An Enquiry Concerning Human Understanding, from Philosophical Classics from Plato to Nietzsche, Ed. By Forrest E. Baired & Walter Kaufmann, Prentice Hall, Upper Saddle River, New Jersey. -/- ___________ (1978) A Treatise of Human Nature, Edited by L.A. Selby-Bigge Oxford University Press, London. -/- :___________( 2006) The Understanding(Treatise :Book I), Ed. by Bennettt, Jonathan , The, Radical Academy, -/- Link:http;//www.earlymoderntexts.com/pdf/humebig.pdf.Citation:20-10-2006 -/- Flew, Antony(1962) Hume on Human Nature and the Understanding, Edi. ,Collier Books, New York.
This article argues that there is a great divide between semantics and metaphysics. Much of what is called metaphysics today is still stuck in the linguistic turn. This is illustrated by showing how Fraser MacBride misunderstands David Armstrong's theory of modality.
To enhance the plausibility of naturalistic moral realism, David Copp develops an argument from epistemic defeaters aiming to show that strongly a priori synthetic moral truths do not exist. In making a case for the non-naturalistic position, I locate Copp’s account within the wider literature on peer disagreement; I identify key points of divergence between Copp’s doctrine and conciliatorist doctrines; I introduce the notion of ‘minimal moral competence’; I contend that some plausible benchmarks for minimal moral competence are grounded (...) in substantive moral considerations; and I discuss two forms of spinelessness that Copp’s moral naturalism could result in. (shrink)
La obra del filósofo estadounidense David H. Finkelstein, Expression and the Inner, publicada originariamente en 2003 por Harvard University Press (2ª ed. 2008) puede ahora leerse en la versión española de Lino San Juan, editada por la ovetense KRK Ediciones con el título: La expresión y lo interno. Finkelstein propone en La expresión y lo interno un análisis expresivista del autoconocimiento. Podría parecer cuando menos sorprendente y aún más admirable que con tan sólo dos capítulos (“Detectivismo y constitutivismo” y (...) “Expresión”) y un Epílogo (“Deliberación y transparencia”), Finkelstein haya conseguido presentar en esta obra un planteamiento calificado por muchos como una auténtica renovación de la discusión analítica en torno al tema del autoconocimiento, o sea, acerca del problema de qué clase de autoridad quepa atribuir a las expresiones sobre nuestros propios estados de ánimo y/o nuestros estados mentales sin más. (shrink)
In his most recent book, National Responsibility and Global Justice, David Miller presents an account of human rights grounded on the idea of basic human needs. Miller argues that his account can overcome what he regards as a central problem for human rights theory: the need to provide a ‘non-sectarian’ justification for human rights, one that does not rely on reasons that people from non-liberal societies should find objectionable. The list of human rights that Miller’s account generates is, however, (...) minimal when compared to those found in human rights documents, such as the Universal Declaration of Human Rights and the European Convention on Human Rights. This article argues that contrary to what Miller claims, his account is ‘sectarian’, since it relies on reasons that some non-liberals should find objectionable given their divergent values. It goes on to question whether ‘sectarianism’, as Miller defines it, is, in any case, a problem for human rights theory. The article concludes that Miller provides us with no reason to abandon commitment to a more extensive list of human rights. (shrink)
This paper analyses the early history of David Bohm’s mechanics from the perspective of Ludwik Fleck’s thought-collectives and shows how the thought-style of the scientific community limits the possible modes of thinking and what new possibilities for the construction of a new theory arise if these limits are removed.
Argues that on an interpretation of the Enlightenment which emphasises its radical potential and importance for the development of democracy Catharine Macaulay should be recognised as a more centrally Enlightenment historian than David Hume.
This article is an exploration of David Hume's philosophy of custom and habit as a way of living with skepticism. For Hume, man is a habit-forming animal, and all politics and history take place within a history of custom and habit. This is not a bad thing: life without custom and habit would be a nightmare. Hume draws on the "new science" of thinkers such as Locke, Shaftesbury, Mandeville, Hutcheson, and Butler to foreground the importance of custom and habit. (...) His own contribution is a detailed exploration of philosophical psychology that brings out the role of habits of action such as politeness and manners and habits of thinking such as opinion and reasoning. Finally, life in accordance with customs and habits is not inherently conservative or quietist: there are endogenous and exogenous sources of change and progress in custom and habits. (shrink)