Ethical guidelines for conducting clinical trials have historically been based on a perceived therapeutic obligation to treat and benefit the patient-participants. The origins of this ethical framework can be traced to the Hippocratic oath originally written to guide doctors in caring for their patients, where the overriding moral obligation of doctors is strictly to do what is best for the individual patient, irrespective of other social considerations. In contrast, although medicine focuses on the health of the person, public health is (...) concerned with the health of the entire population, and thus, public health ethics is founded on the societal responsibility to protect and promote the health of the population as a whole. From a public health perspective, research ethics should be guided by giving due consideration to the risks and benefits to society in addition to the individual research participants. On the basis of a duty to protect the population as a whole, a fiduciary obligation to realise the social value of the research and the moral responsibility to distribute the benefits and burdens of research fairly across society, how a public health perspective on research ethics results in fundamental re-assessments of the proper course of action for two salient topical issues in research ethics is shown: stopping trials early for reasons of efficacy and the conduct of research on less expensive yet less effective interventions. (shrink)

Electronic communication and commerce facilitate the collection of information about individual use of the Internet. Focusing on the case of Comet Systems Inc. and its data gathering practices, this paper explores the technical details of gathering personal information in databases in general and the special character of the privacy issue raised by 'anonymous' information about individual behavior on the Internet. The case analysis suggests new insights for our understanding of privacy and frames a discussion of policy alternatives with respect to (...) the privacy of Internet communication. (shrink)

Current guidelines on investigators' responsibilities to communicate research results to study participants may differ on whether investigators should proactively re-contact participants, the type of results to be offered, the need for clinical relevance before disclosure, and the stage of research at which results should be offered. Lack of consistency on these issues, however, does not undermine investigators' obligation to offer to disclose research results: an obligation rooted firmly in the principle of respect for research participants.

Considered one of the most important works of modern philosophy, Critique of Pure Reason offers a profound exploration of the nature of knowledge and perception. In this English-language translation by JMD Meiklejohn, Immanuel Kant's seminal work is made accessible to a wider audience. Illuminating and challenging, this book is an essential resource for anyone interested in the history of philosophy and the nature of human thought. This work has been selected by scholars as being culturally important, and is part of (...) the knowledge base of civilization as we know it. This work is in the "public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant. (shrink)

Authorising euthanasia and assisted suicide with advance euthanasia directives is permitted, yet debated, in the Netherlands. We focus on a recent controversial case in which a Dutch woman with Alzheimer’s disease was euthanised based on her AED. A Dutch euthanasia review committee found that the physician performing the euthanasia failed to follow due care requirements for euthanasia and assisted suicide. This case is notable because it is the first case to trigger a criminal investigation since the 2002 Dutch euthanasia law (...) was enacted. Thus far, only brief descriptions of the case have been reported in English language journals and media. We provide a detailed description of the case, review the main challenges of preparing and applying AEDs for persons with dementia and briefly assess the adequacy of the current oversight system governing AEDs. (shrink)

We are grateful to Jongsma et al 1 for their interest in our article analysing the case of ‘Mrs A’, a Dutch woman with Alzheimer’s disease who received euthanasia based on her advance euthanasia directive.2 Their commentary criticises two elements of our analysis. First, the authors believe our reasons for doubting that Mrs A had the capacity to write and revise an AED rely on ‘partial’ empirical data and rest on normative errors. Second, they use two of our statements to (...) suggest we must endorse some implausible claims, for example, that ‘… in all situations and for all people, current well-being should always take precedence over all other values’. Jongsma et al assert: ‘Miller et al argue that people with dementia are impaired to make decisions.’ This casts our probabilistic claim about Mrs A’s capacity as an absolute claim about persons with dementia in general. It also implies we are using an outdated diagnosis-based view of capacity. The accusation then becomes explicit : > … several empirical studies have shown that patients with dementia are able to actively participate in qualitative studies and can respond to open questions in a meaningful way,[2-8] as well that they are able to complete an advance directive in the early phases of dementia.[9, 10] One can therefore not simply conclude on the basis of the diagnosis of dementia …. (shrink)

Since its publication, the Psychopathic Personality Inventory and its revision (Lilien- feld & Andrews, 1996; Lilienfeld & Widows, 2005) have become increasingly popular such that it is now among the most frequently used self-report inventories for the assessment of psychopathy. The current meta-analysis examined the relations between the two PPI factors (factor 1: Fearless Dominance; factor 2: Self-Centered Impulsivity), as well as their relations with other validated measures of psychopathy, internalizing and externalizing forms of psychopathology, general personality traits, and antisocial (...) personality disorder symptoms. Across 61 samples reported in 49 publications, we found support for the convergent and criterion validity of both PPI factor 2 and the PPI total score. Much weaker validation was found for PPI factor 1, which manifested limited convergent validity and a pattern of correlations with central criterion variables that was inconsistent with many conceptualizations of psychopathy. (shrink)

Dual-track assessment directs research ethics committees to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.Research guidelines around the world recognise that clinical research is ethical only when the risks to participants are (...) reasonable.1 Appropriate implementation of this requirement is vital to protecting research participants and allowing research to proceed when it poses acceptable risks. Unfortunately, as the US National Bioethics Advisory Commission notes: “current regulations do not further elaborate how risks and potential benefits are to be assessed, and little additional guidance is available to IRBs.”1The NBAC, as well as numerous commentators, recommend that research ethics committees , ethics review committees and institutional review boards should adopt what may be called dual-track risk assessment.2–5 Yet, dual-track assessment unnecessarily divides research interventions into two different categories before assessing their risks and relies on the unclear distinction between therapeutic and non-therapeutic interventions. As a result, dual-track assessment provides RECs with confusing guidance and has the potential to block valuable research that poses acceptable risks. This paper describes one alternative, the net risks test, and argues that this approach offers a better method for assessing research risks, one that puts RECs in a position to protect participants without blocking appropriate research studies.BACKGROUNDClinical research exposes participants to interventions and procedures to gather systematic data that may be used to improve overall health and well-being. To ensure that research is ethical, RECs must ensure that the risks and burdens to participants are not excessive and that …. (shrink)

BackgroundResearchers worry that patients in early-phase research experience unrealistic optimism about benefits and risks of participation. The standard measure of unrealistic optimism is the Comparative Risk/Benefit Assessment questionnaire, which asks people to estimate their chances of an outcome relative to others in similar situations. Such a comparative framework may not be a natural way for research participants to think about their chances.ObjectiveTo examine how people interpret questions measuring unrealistic optimism and how their interpretations are associated with their responses.MethodsUsing an early-phase (...) cancer trial vignette, we administered the CRBA to 297 adults from the general public. They estimated their comparative chances of risk and benefit, then provided rationales for their estimates.ResultsFor both CRBA benefit and risk questions, about 50% of respondents chose 0, and 50% chose a non-0 response. Respondents’ rationales for their estimates showed that overall only about 40%–44% gave comparative rationales, indicating that they interpreted the CRBA as intended. 68.7% of respondents who gave the ‘correct’ 0 rating gave comparative rationales, whereas only 11.6% of respondents who gave non-0 ratings did so. A similar trend was seen for chances of risk.ConclusionResearch participants may not understand comparative benefit and risk questions as intended; attributions of unrealistic optimism may require additional evidence that the respondents’ estimates are intended to be comparative. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Incoherence of Determining Death by Neurological Criteria: A Commentary on Controversies in the Determination of Death, A White Paper by the President’s Council on Bioethics*Franklin G. Miller** (bio) and Robert D. Truog (bio)Traditionally the cessation of breathing and heart beat has marked the passage from life to death. Shortly after death was determined, the body became a cold corpse, suitable for burial or cremation. Two technological changes (...) in the second half of the twentieth century prompted calls for a new, or at least expanded, definition of death: the development of intensive care medicine, especially the use of mechanical ventilators, and the advent of successful transplantation of vital organs. Patients with profound neurological damage, leaving them incapable of breathing on their own and in an irreversible coma, could be maintained for some period of time with the aid of mechanical ventilation. The situation of these patients posed two ethical questions. Is it appropriate to stop life-sustaining treatment? If so, is it acceptable to retrieve vital organs for transplantation to save the lives of others before stopping treatment?In 1968, the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death proposed that death could be determined on the basis of neurological criteria, thus providing a positive answer to these two questions (Ad Hoc Committee 1968). According to the position of this committee, patients diagnosed with the cessation of brain function are dead, despite the fact that they breathe and circulate blood with the aid of mechanical ventilation. [End Page 185] Because they are dead, it is appropriate, indeed imperative, to stop mechanical ventilation. And because they are dead, it becomes ethical to procure vital organs for transplantation before stopping what otherwise would be life-sustaining treatment. Remarkably, this innovative neurological determination of death became, with little debate or controversy, the established position in medical ethics and the law throughout the United States.The Harvard Committee articulated the diagnosis of “irreversible coma,” but merely asserted that this condition constituted death. No explanatory rationale was provided. It fell to the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research to provide an authoritative rationale in its 1981 report, Defining Death. The second paragraph of the report set the stage as follows: “The question addressed here is not inherently difficult or complicated. Simply, it is whether the law ought to recognize new means for establishing that the death of a human being has occurred” (President’s Commission 1981, p. 3). The Commission claimed that “death is a unitary phenomenon” (p. 7) and that the determination of death by neurological criteria, in terms of the absence of all brain function, is consistent with the traditional conception of death as the cessation of vital functioning of the organism as a whole. The key issue is the integrative functioning of the human organism, which ceases to exist, according to the Commission, when the whole brain, including higher cortical areas and the brain stem, fails to function. Although “brain-dead” patients do not appear to be dead—i.e., the reality of their death is “masked” by the activity of mechanical ventilation—the patient’s body has irreversibly lost all capacity for integrative functioning. In the words of the Commission: “When artificial means of support mask this loss of integration as measured by the old methods [cessation of respiration and heart beat], brain-oriented criteria and tests provide a new window on the same phenomenon” (p. 33). The President’s Commission was instrumental in developing and establishing “The Uniform Definition of Death Act”: “An individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead” (p. 2).Although the question posed by the President’s Commission was easy to articulate, the answer, over time, has proved complicated and controversial. The coherence and cogency of determining death by neurological criteria has been challenged. Various experts have demonstrated that “brain-dead” patients maintained on mechanical ventilation display a range of vital, integrative, functioning, which conflicts with the judgment that they are dead (Truog and... (shrink)

The traditional view of divine conservation holds that it is simply a continuation of the initial act of creation. In this essay, I defend the continuous-creation tradition against William Lane Craig's criticism that continuous creation fundamentally misconstrues the intuitive distinction between creation and conservation. According to Craig, creation is the unique causal activity of bringing new patient entities into existence, while conservation involves acting upon already existing patient entities to cause their continued existence. I defend continuous creation by challenging Craig's (...) intuitive distinction and by showing that the alternative account of creation and conservation he bases upon it is fraught with serious internal difficulties. (shrink)

The prefrontal cortex has long been suspected to play an important role in cognitive control, in the ability to orchestrate thought and action in accordance with internal goals. Its neural basis, however, has remained a mystery. Here, we propose that cognitive control stems from the active maintenance of patterns of activity in the prefrontal cortex that represent goals and the means to achieve them. They provide bias signals to other brain structures whose net effect is to guide the flow of (...) activity along neural pathways that establish the proper mappings between inputs, internal states, and outputs needed to perform a given task. We review neurophysiological, neurobiological, neuroimaging, and computational studies that support this theory and discuss its implications as well as further issues to be addressed. (shrink)

The first-ever multivolume treatment of the issues in legal philosophy and general jurisprudence, from both a theoretical and a historical perspective. The work is aimed at jurists as well as legal and practical philosophers. Edited by the renowned theorist Enrico Pattaro and his team, this book is a classical reference work that would be of great interest to legal and practical philosophers as well as to jurists and legal scholar at all levels. The work is divided in two parts. The (...) theoretical part, consisting of five volumes, covers the main topics of the contemporary debate; the historical part, consisting of six volumes, accounts for the development of legal thought from ancient Greek times through the twentieth century. The entire set will be completed with an index. Volume 6: A History of the Philosophy of Law from the Ancient Greeks to the Scholastics 2nd revised edition, edited by Fred D. Miller, Jr. and Carrie-Ann Biondi Volume 6 is the first of the Treatise’s historical volumes and is dedicated to the philosophers’ philosophy of law from ancient Greece to the 16th century. The volume thus begins with the dawning of legal philosophy in Greek and Roman philosophical thought and then covers the birth and development of European medieval legal philosophy, the influence of Judaism and the Islamic philosophers, the revival of Roman and Christian canon law, and the rise of scholastic philosophy in the late Middle Ages, which paved the way for early-modern Western legal philosophy. This second, revised edition comes with an entirely new chapter devoted to the later Scholastics and an epilogue on the legacy of ancient and medieval thought for modern legal philosophy, as well as with updated references and indexes. (shrink)

Assesses the presuppositions underlying Aristotle's political theory. The principle of teleology holds that human beings strive to fulfil certain natural ends such as rationality and social cooperation; the principle of perfectionism holds that the good for human beings consists in the attainment of these ends; the principle of community holds that individuals can attain the good only if they are subject to the authority of the community, including the state ; and the principle of rulership holds that the community can (...) function successfully only if order is imposed on it by rational agents. This chapter considers the extent to which these principles may be defended against powerful objections that have been raised by modern philosophers and scientists. Finally, it is pointed out that the modern theory of rights, which assumes a version of extreme individualism, faces serious difficulties, so that Aristotle's theory of rights, based on a moderately individualistic theory of justice, is an alternative still worthy of serious consideration. (shrink)

No one doubts that Kierkegaard's Concluding Unscientific Postscript is one of the most important, one of the most artistically contrived, and certainly one of the wittiest works in the history of philosophy. Further, the Postscript has often been accorded a kind of centrality in the Kierkegaardian corpus. Kierkegaard himself seems to have assigned it some such role. He informs the reader in the ‘First and Last Declaration’ that he originally intended the Postscript to be his last word before retiring from (...) his authorship . In The Point of View for My Work as an Author he himself calls it both ‘the turning-point’ and ‘the middle point’ in the sense that ‘this work concerns itself with and sets “the Problem”, which is the problem of the whole authorship: how to become a Christian’. Aside from the way in which Kierkegaard may have conceived the Postscript as being central or pivotal to his whole enterprise, certainly scholars have sometimes treated the Postscript as, at least in some ways, his magnum opus and summum verbum – as I would also. But our concern here is not with the centrality of the Postscript but with the centrality within the Postscript. Most everyone would, I think, acknowledge that a central section of the Postscript may be identified, though I would go farther and claim that within this a central, pivotal, solitary statement may be identified. (shrink)

Aristotle's constitutional theory applies his theory of justice and rights to the unifying institutions of the polis. He defines a citizen as one who has a liberty right to partake in deliberative or judicial office. He distinguishes between constitutions in terms of whether they are correct or deviant and on the basis of whether political rights are assigned to one, few, or many persons––resulting in a six‐fold classification of constitutions: kingship versus tyranny, aristocracy versus oligarchy, and polity versus democracy. In (...) Politics IV, Aristotle develops a more complicated system of classification involving different modes of deliberation, adjudication, and magistracy. The chapter concludes with a discussion of the tasks of politics, including legislation in ideal and realistic situations and reform of defective constitutions. (shrink)

In addition to his study of correct constitutions, Aristotle investigated the entire spectrum of regimes existing in his day. Aristotle believes that it is a proper task for politics and legislation to deal with deviant or imperfect constitutions such as oligarchy and democracy. In seeking to preserve and reform imperfect constitutions and prevent revolution, Aristotle employs a maxim of superiority: that the part of the polis that supports the constitution ought to be superior to the part that does not. Although (...) this maxim can clearly come into conflict with justice, Aristotle regards it as a defensible normative precept when it is the closest feasible approximation to justice that is attainable under adverse circumstances. (shrink)

Justice is central to Aristotle's political theory because he holds that all constitutions are a form of justice. In so far as it is just in the universal sense, the constitution aims at the happiness of the political community; in so far as it is just in the particular sense of distributive justice, the constitution assigns rights to offices, property, or honours to the citizens in accordance with their worth. Aristotle also claims that political justice is partly natural and partly (...) legal, but adds that ‘one constitution only is everywhere according to nature the best’, thus implying that the polis is in a natural condition when it has the best constitution and laws. Aristotle recognizes that justice may exist outside the polis, but he regards political justice as the highest form of justice. (shrink)

Aristotle's politics may be characterized as ‘naturalistic’, in the sense that it assigns a fundamental role to the concept of nature in the explanation and evaluation of the political community. Aristotle's naturalism is summed up in three claims: the polis exists by nature, human beings are by nature political animals, and the polis is by nature prior to the individual. Aristotle has been accused of inconsistency because he also asserts that the human lawgiver brings the polis into existence. This chapter, (...) however, defends Aristotle's theory by arguing that his complex natural teleology permits nature and legislation to be cooperative causes of the political community. Also compares and contrasts his political naturalism with modern theories on the state. (shrink)

Supports Ernest Barker's interpretation that Aristotle offers a ‘vindication of the right of private property.’ Although Aristotle emphasizes the common interests of the citizens, he also provides a place for private property in all of his constitutions, including the best constitution. The chapter argues that Aristotle gives a basic account of property ownership that is similar to modern concepts of property rights. He offers justifications of private property, states conditions under which property may be justly acquired, defends private property against (...) Plato's communism, and argues that property is indispensable for the exercise of citizenship. (shrink)

Although past commentators saw Aristotle as recognizing the rights of individuals, recent interpreters have objected that no single Greek word corresponds to the modern word ‘rights’. In reply, it is shown with evidence from Aristotle and other writers that the ancient Greek discourse of law and politics included distinct locutions corresponding to the different senses of ‘rights’ distinguished by the jurist W. N. Hohfeld: to dikaion corresponds to Hohfeld's claim right, exousia to a liberty or privilege, kurios to authority or (...) power, and adeia and ateleia to immunity. A right for Aristotle is essentially a just claim that a person has against other members of the same community, and a natural right is a just claim based in nature. Recent arguments that rights have theoretical implications inimical to Aristotle's principles are also found to be unpersuasive, because they rely on tendentious assumptions that would rule out many modern theories of rights as well. The chapter also indicates how a respect for the rights of others might be justified on the basis of Aristotelian practical wisdom. (shrink)

Describes Aristotle's life and historical context. Discusses the place of politics––the science of the polis ––within Aristotle's taxonomy of science and of virtue. Provides an overview of Aristotle's argument, emphasizing the role of nature, justice, and rights. Describes the four main presuppositions of Aristotle's argument: natural teleology, perfectionism, community, and rulership. Also distinguishes and explains the different modes of interpretation employed in this book and in other works on the history of political thought.

Aristotle states that ‘there is only one constitution which is everywhere according to nature the best.’ This constitution is unqualifiedly just and ‘according to nature’ because it promotes the common advantage. The interpretation of ‘common advantage’ is problematic: does it consist in the advantage of the citizens considered as distinct individuals or the advantage of the polis considered as a whole? Only on the former, individualistic interpretation would the best constitution be deeply committed to individual rights, and it is argued (...) that a moderate version of individualism is the correct interpretation of Aristotle's best constitution. The chapter goes on to consider difficulties in Aristotle's account of the best constitution, including his views on education and the question of which is better: virtuous kingship or the rule of law. (shrink)

Recognizing that the best or ideal constitution is generally unattainable, Aristotle employs a principle of proximity: although the highest end is best, if it is unattainable, legislation should aim at the result that is closest to the end and thus the best attainable outcome. In politics, this is called the ‘second sailing’, and Aristotle discusses such a constitution under the headings of polity, mixed constitution, and middle constitution. Although this constitution is correct and just, the standard is lowered in the (...) face of necessity. Still, the second‐best constitution serves as a norm for evaluating the various deviant constitutions that are forms of democracy and oligarchy. The second‐best constitution emulates the ideal constitution and it satisfies the maxim of unanimity, which in its strongest form requires that if a constitution is to be preserved, all the citizens should wish that it exist and continue unchanged. (shrink)

The disagreement over whether Aristotle recognized rights in some form unavoidably involves disagreement over what rights are, and the theory of rights itself is still highly contested. There is no consensus concerning how " right'? is to be defined, how rights are to be theoretically grounded, or how rights theory is to be applied in particular circumstances. This is not, however, a good reason to dismiss the issue of whether there are rights in Aristotle: for Aristotle, like modern rights theorists, (...) is concerned about the moral and legal status of the individual within the community, and he expresses this in terms of claims of justice. The issue is worthy of study not only because it can lead to a deeper understanding of Aristotle's conceptions of justice and the common good, but also because it may shed valuable light on the theoretical foundations of human rights, since he offers a theory of political justice which is based on a metaphysical theory of human nature. (shrink)

Purpose This paper aims to formalize long-term trajectories of human civilization as a scientific and ethical field of study. The long-term trajectory of human civilization can be defined as the path that human civilization takes during the entire future time period in which human civilization could continue to exist. -/- Design/methodology/approach This paper focuses on four types of trajectories: status quo trajectories, in which human civilization persists in a state broadly similar to its current state into the distant future; catastrophe (...) trajectories, in which one or more events cause significant harm to human civilization; technological transformation trajectories, in which radical technological breakthroughs put human civilization on a fundamentally different course; and astronomical trajectories, in which human civilization expands beyond its home planet and into the accessible portions of the cosmos. -/- Findings Status quo trajectories appear unlikely to persist into the distant future, especially in light of long-term astronomical processes. Several catastrophe, technological transformation and astronomical trajectories appear possible. -/- Originality/value Some current actions may be able to affect the long-term trajectory. Whether these actions should be pursued depends on a mix of empirical and ethical factors. For some ethical frameworks, these actions may be especially important to pursue. (shrink)

One standard criticism of the doctrine of continuous creation is that it entails the occasionalist position that God alone is a true cause and that the events we commonly identify as causes are merely the occasions upon which God brings about effects. I begin by clearly stating Malebranche's argument from continuous creation to occasionalism. Next, I examine two strategies for resisting Malebranche's argument ??? strong and weak concurrentism ??? and argue that weak concurrentism is the more promising strategy. Finally, I (...) argue that weak concurrentism requires a necessitarian approach to secondary causation. (shrink)

Transplantation of vital organs has been premised ethically and legally on "the dead donor rule" (DDR)—the requirement that donors are determined to be dead before these organs are procured. Nevertheless, scholars have argued cogently that donors of vital organs, including those diagnosed as "brain dead" and those declared dead according to cardiopulmonary criteria, are not in fact dead at the time that vital organs are being procured. In this article, we challenge the normative rationale for the DDR by rejecting the (...) underlying premise that it is necessarily wrong for physicians to cause the death of patients and the claim that abandoning this rule would exploit vulnerable patients. We contend that it is ethical to procure vital organs from living patients sustained on life support prior to treatment withdrawal, provided that there is valid consent for both withdrawing treatment and organ donation. However, the conservatism of medical ethics and practical concerns make it doubtful that the DDR will be abandoned in the near future. This leaves the current practice of organ transplantation based on the "moral fiction" that donors are dead when vital organs are procured. (shrink)

Human life and death should be defined biologically. It is important not to conflate the definition of death with the criteria for when it has occurred. What is distinctively "human" from a scientific or normative perspective has nothing to do with what makes humans alive or dead. We are biological organisms, despite the fact that what is meaningful about human life is not defined in biological terms. Consequently, as in the rest of the realm of living beings, human beings die (...) when they no longer function biologically as organisms. In contrast, a determination of exactly when death has occurred, required to serve various social purposes, combines social and normative considerations with biological facts. (shrink)

Data monitoring committees often are employed to review interim findings of randomised controlled trials. Interim findings are kept confidential until the data monitoring committee finds that they provide sufficiently compelling evidence regarding efficacy, typically because they have crossed the pre-defined statistical boundaries, or they raise serious concerns about safety. While this practice is vital to maintaining the scientific integrity of controlled trials and thereby ensuring their social value, it has been criticised as unethical. Commentators argue that withholding interim findings from (...) research participants is deceptive, inconsistent with valid informed consent, and a violation of respect for participants’ autonomy. The present article examines these arguments, focusing specifically on confidential data monitoring for efficacy. This practice need not be deceptive provided its use is disclosed to prospective research participants. In addition, confidential data monitoring does not make research participants worse off than they would be in the clinical setting and represents an acceptable limitation on the options available to prospective research participants. Taken together, these considerations suggest confidential data monitoring, subject to adequate safeguards, is ethically acceptable. (shrink)