This article offers a justification for the continued use of jury trials. I shall critically examine the ability of juries to render just verdicts, judicial impartiality, and judicial transparency. My contention is that the judicial system that best satisfies these values is most preferable. Of course, these three values are not the only factors relevant for consideration. Empirical evidence demonstrates that juries foster both democratic participation and public legitimation of legal decisions regarding the most serious cases. Nevertheless, juries are costly (...) and, therefore, economically less efficient than competing modes of trial. I do not argue that all human beings possess an inalienable legal right to be tried by a jury. However, it is my hope that this analysis will make clear what we might gain or lose when we propose jury reforms. (shrink)

Accused persons who are subjected to a saturation level of negative media coverage may be denied an impartial hearing, which is perhaps the most important aspect of the right to a fair hearing. Despite this, the courts have generally held that the social imperative of prosecuting accused trumps the interests of the accused. The justification for an impartial hearing stems from the repugnance of convicting the innocent. Viewed dispassionately, this imperative is not absolute, given that every legal system condones (...) procedures which result in the conviction of some innocent people. While the importance of guarding against wrongful convictions has been overstated, the imperative to bring to trial all accused has been even more exaggerated. The legal system has displayed a capacity to deal with cases where the guilty walk free. The institutional integrity of the criminal justice system would be significantly compromised by convictions that are tarnished by pre-judgment. Confidence in the criminal justice system is more important than individual criminal accountability. The inability to receive an impartial hearing should result in a permanent stay. The only exception is where the alleged crime has the capacity to cause widespread fear or social unrest. This only applies in relation to serious acts of terrorism. This article focuses on recent legal fair trial developments in Australia, however, the analysis, reasoning and conclusion applies in relation to all jurisdictions where juries determine guilt and innocence. (shrink)

In this paper, I have analyzed the right to trial by jury in civil cases as reflected in decisions of the Michigan Supreme Court over approximately a 20 year period dealing with three areas affecting the right to trial by jury in civil cases: (1) entitlement to a jury trial; (2) summary disposition; and (3) directed verdicts. The study was constructed to cover cases over a substantial period of time, so that it would be possible (...) to analyze whether the changing composition of the Michigan Supreme Court, beginning in the late 1990's, impacted on the Court's decisions in these three areas.The conclusion that emerges from the is that the Court, as currently constituted, has diminished the right to trial by jury in civil cases in Michigan. The Court is more inclined than it was prior to 1999 to hold in more cases that there is no genuine issue of material fact, justifying summary disposition, and has now heard cases in which it has held that the defendant is entitled to a directed verdict. And the fact that the Court is more inclined to uphold the granting of summary disposition and directed verdicts is likely to have a demonstrable impact on these kinds cases when they are presented to the Court of Appeals and the trial courts. These courts, following the precedents of the Supreme Court and the results of the cases coming before that Court, will be more likely to rule in favor of granting motions for summary disposition and motions for directed verdicts.Given the Court's view of the diminished role of the jury in resolving factual disputes in civil cases, litigating lawyers must make the best of a bad situation and do everything that they can in order to protect the right to trial by jury in civil cases. They must try to ensure in the early stages of the litigation that their cases are strong enough to survive a motion for summary disposition and get to the jury, and at the trial they must make a determined effort to present sufficient evidence to survive a directed verdict. Hopefully the Court's view of the diminished role of the jury will not have dealt a fatal blow to the right to trial by jury in civil cases in Michigan. Time will tell how well the lawyers of Michigan have succeeded in preserving this fundamental constitutional right. (shrink)

Criminal defendants in many countries are faced with a dilemma: If they waive their right to trial and plead guilty, they typically receive charge or sentence reductions in exchange for having done so. If they exercise their right to trial and are found guilty, they often receive stiffer sanctions than if they had pled guilty. I characterize the former as ‘waiver rewards’ and the latter as ‘non-waiver penalties.’ After clarifying the two and considering the relation between (...) them, I briefly explicate the grounds for a moral right to trial. I then assess the defensibility of such rewards and penalties. In addition to considering whether waiver rewards and non-waiver penalties serve the aims of legal punishment, I address the three main arguments for permitting them. The first suggests that defendants willing to plead display more remorse for their crimes and thus are deserving of lighter sentences. The second defends waiver rewards and non-waiver penalties in cases where prosecutors are alleged to know that defendants are guilty but face problems establishing their guilt at trial. The third holds that guilty defendants who are willing to plead conserve scarce state resources and should be rewarded for it, whereas those unwilling to plead squander such resources and should be penalized accordingly. I contend that none of these arguments provides persuasive grounds for waiver rewards or non-waiver penalties, even on the assumption that we can distinguish those defendants who should waive their right to trial from those who should not. This conclusion presents a fundamental challenge to contemporary plea bargaining practices. (shrink)

Preclinical xenotransplantation research using genetically engineered pigs has begun to show some promising results and could one day offer a scalable means of addressing organ shortage. While it is a fundamental tenet of ethical human subject research that participants have a right to withdraw from research once enrolled, several scholars have argued that the right to withdraw from xenotransplant research should be suspended because of the public health risks posed by xenozoonotic transmission. Here, we present a comprehensive critical (...) evaluation of the claim that xenotransplant recipients should be required to waive their right to withdraw from lifelong biosurveillance. We conclude that if xenotransplantation requires participants to waive their right to withdraw, then clinical trials may not be justifiable, given the ethical and legal obstacles involved with doing so. Consequently, if clinical trials are permitted with a right to withdraw, then they may pose a significant public health risk. (shrink)

The purpose of this study is to examine the importance that real patients attach to their right to withdraw from an on-going feasibility randomised trial (RCT) evaluating types and timings of breast reconstruction (two parallel trials) following mastectomy for breast cancer. Our results show that, while some respondents appreciated that exercising the right to withdraw would defeat the scientific objective of the trial, some patients with a surgical preference consented only given the knowledge they could withdraw (...) if they were not allocated to their preferred treatment. (shrink)

In his Rights Forfeiture and Punishment, Christopher Heath Wellman argues that his preferred ‘strong’ version of rights forfeiture theory makes the moral rights of due process and a fair trial null and void for guilty offenders. They may still possess legal rights to due process, but these are not strong pre-institutional moral rights. I explain here why I disagree with Wellman. I also suggest that he is not entitled, by his own lights, to affirm strong forfeiture theory, at least (...) in our social world. (shrink)

ObjectivesTo determine to which degree industry partners in randomised clinical trials own the data and can constrain publication rights of academic investigators.MethodsCohort study of trial protocols, publication agreements and other documents obtained through Freedom of Information requests, for a sample of 42 trials with industry involvement approved by ethics committees in Denmark. The main outcome measures used were: proportion of trials where data was owned by the industry partner, where the investigators right to publish were constrained and if (...) this was mentioned in informed consent documents, and where the industry partner could review data while the trial was ongoing and stop the trial early.ResultsThe industry partner owned all data in 20 trials (48%) and in 16 trials (38%) it was unclear. Publication constraints were described for 30 trials (71%) and this was not communicated to trial participants in informed consent documents in any of the trials. In eight trials (19%) the industry partner could review data during the trial, for 20 trials (48%) it was unclear. The industry partner could stop the trial early without any specific reason in 23 trials (55%).ConclusionsPublication constraints are common, and data is often owned by industry partners. This is rarely communicated to trial participants. Such constraints might contribute to problems with selective outcome reporting. Patients should be fully informed about these aspects of trial conduct. (shrink)

Substituted judgment has increasingly become the accepted standard for rendering decisions for incapacitated adults in the USA. A broad exception exists with regard to patients with diminished capacity secondary to depressive disorders, as such patients’ previous wishes are generally not honoured when seeking to turn down life-preserving care or pursue aid-in-dying. The result is that physicians often force involuntary treatment on patients with poor medical prognoses and/or low quality of life as a result of their depressive symptoms when similarly situated (...) incapacitated patients without such depressive symptoms would have their previous wishes honoured via substituted judgment. This commentary argues for reconsidering this approach and for using a substituted judgment standard for a subset of EMP/LQL patients seeking death. (shrink)

Xenotransplantation pits clinical research ethics against public health needs because recipients must undergo long-term, perhaps life-long, surveillance for infectious diseases. This surveillance requirement is effectively an abrogation of the right to withdraw from a clinical trial. Ulysses contracts, which are advance directives for future care, may be an ethical mechanism by which to balance public health needs against limitation of individual rights.

Xenotransplantation is defined as “any procedure that involves the transplantation, implantation, or infusion into a human recipient of either live cells, tissues, or organs from a nonhuman animal source, or human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.” Xenotransplantation has been viewed by desperate patients and their surgeons as a solution to the problem of the paucity of human organs available for transplantation. Foes of xenotransplantation argue that (...) the use of animal organs degrades the human race and should be avoided.In this paper, we briefly review the cultural context of xenotransplantation and explore the infectious disease risk of xenotransplantation. The United States Code of Federal Regulations requires life-long surveillance of a xenotransplantation recipient due to the largely unknown risk of novel infectious disease transmitted across species, known as xenogeneic infectious disease. We argue that despite being in the interest of protecting the public health, the imposition of lifelong surveillance requirements on xenotransplant recipients effectively abrogates the right to withdraw from a clinical trial after the transplantation has taken place. Moreover, we argue that a waiver of the right to withdraw should be made explicit in the interest of full disclosure, out of respect for the research subject’s right of self-determination. (shrink)

Time-limited trials of intensive care have arisen in response to the increasing demand for intensive care treatment for patients with a low chance of surviving their critical illness, and the clinical uncertainty inherent in intensive care decision-making. Intensive care treatment is reported by most patients to be a significantly unpleasant experience. Therefore, patients who do not survive intensive care treatment are exposed to a negative dying experience. Time-limited trials of intensive care treatment in patients with a low chance of surviving (...) have both a small chance of benefiting this patient group and a high chance of harming them by depriving them of a good death. A ‘rule of rescue’ for the critically unwell does not justify time-limiting a trial of intensive care treatment and overlooks the experiential costs that intensive care patients face. Offering time-limited trials of intensive care to all patients, regardless of their chance of survival, overlooks the responsibility of resource-limited intensive care clinicians for suffering caused by their actions. A patient-specific risk–benefit analysis is vital when deciding whether to offer intensive care treatment, to ensure that time-limited trials of intensive care are not undertaken for patients who have a much higher chance of being harmed, rather than benefited by the treatment. The virtue ethics concept of human flourishing has the potential to offer additional ethical guidance to resource-limited clinicians facing these complex decisions, involving the balancing of a quantifiable survival benefit against the qualitative suffering that intensive care treatment may cause. (shrink)

Clinical trials of xenotransplantation may begin early in the next decade, with kidneys from genetically modified pigs transplanted into adult humans. If successful, transplanting pig hearts into children with advanced heart failure may be the next step. Typically, clinical trials have a specified end date, and participants are aware of the amount of time they will be in the study. This is not so with XTx. The current ethical consensus is that XTx recipients must consent to lifelong monitoring. While this (...) presents challenges to the right to withdraw in the adult population, additional and unanswered questions also linger in the paediatric population. In paediatric XTx, parents or guardians consent not only to the initial treatment of the child but also to lifelong monitoring, thus making a decision whose consequences will remain present as the child develops the capacity for assent, and finally the capacity for informed consent or refusal. This article presents and evaluates unanswered paediatric ethical questions in regard to the right to withdraw from XTx follow-up in the paediatric population. (shrink)

The right to withdraw from research without penalty is well established around the world. However, it has been challenged in some corners of bioethics based on concerns about various harms—to participants, to scientific integrity, and to research bystanders—that may stem from withdrawal. These concerns have become particularly salient in emerging debates about the ethics of controlled human infection (CHI) studies in which participants are intentionally infected with pathogens, often in inpatient settings with extensive follow‐up. In this article, I provide (...) support for preserving the right to withdraw from research without penalty and demonstrate that it is also typically justified in the specific context of CHI studies. The right is well aligned with individual freedoms outside the research setting, where autonomous individuals are permitted to engage in behaviors that will foreseeably cause them harm; where they cannot be compelled to satisfy contracts for their services, nor penalized for failure to do so; and where their behavior is not constrained by public health authorities except in extreme circumstances. These freedoms are supported by U.S. law, as well as by ethical analysis that is more globally relevant. The problems associated with the right to withdraw, however, remain. The best approach to addressing them is not to restrict the right but rather to avoid initiating research when withdrawal would be especially problematic. If research proceeds, steps can still be taken to minimize participant withdrawal without infringing the right. Investigators can avoid participant surprise through informed consent focused on a study’s most burdensome aspects and promote study completion through financial incentives. Should participants nonetheless seek to withdraw, investigators may attempt to persuade them not to do so by encouraging consideration of the range of potential harms that may result. Researchers conducting CHI studies and other research from which withdrawal might be especially problematic should prepare for the possibility of participant withdrawal, respect participant requests to withdraw without penalty, and incorporate various measures to avoid such requests. (shrink)

In the fall of 1979, I was asked by Serge Thion, a libertarian socialist scholar with a record of opposition to all forms of totalitarianism, to sign a petition calling on authorities to insure Robert Faurisson's "safety and the free exercise of his legal rights." The petition said nothing about his "holocaust studies", apart from noting that they were the cause of "efforts to deprive Professor Faurisson of his freedom of speech and expression." It did not specify the steps taken (...) against him, which include suspension from his teaching position at the University of Lyons after the threat of violence, and a forthcoming court trial for falsification of history and damages to victims of Nazism. (shrink)

The presumption of innocence has often been understood as a doctrine that can be explained primarily by instrumental concerns relating to accurate fact-finding in the criminal trial and that has few if any implications outside the trial itself. In this paper, I argue, in contrast, that in a liberal legal order everyone has a right to be presumed innocent simply in virtue of being a person. Every person has a right not to be subjected to criminal (...) punishment unless and until he or she has done something that is criminally wrong. Since disagreements about allegations of criminal wrongdoing are inevitable, the liberal legal order requires a process for determining whether wrongdoing has occurred. In order to preserve the right not to be punished without wrongdoing, the accused person must be presumed innocent throughout this process. The presumption of innocence is therefore as much a basic human right as, for example, the right to bodily integrity or the right to freedom of expression. Specifications of and limitations on the right should therefore be justified not primarily in terms of their instrumental effectiveness in fact-finding or crime control but in terms of the role of the criminal process in a liberal legal order. I consider some implications of this view of the presumption of innocence for the pre-trial process and for substantive criminal law. I argue that the presumption of innocence, understood as a basic human right, should condition the entire pre-trial process; it has, however, minimal implications for the definition of offences. (shrink)

Fragmented social relations, the twin demise of authority and tradition, the breakdown of behavioural norms and constraints: all these are the outcome, according to their critics, of the uses and abuses of human rights in contemporary democratic societies. We are, they say, seeing the perverse effects of a 'religion of human rights' to which Europe has rashly devoted its heart and mind; and the supposed burgeoning of rights, which goes hand in hand with an unchecked rise of expectations, is catapulting (...) Western democracies into an age of never-ending demands. This emerged clearly in France in Spring 2013 during the demonstrations against equal marriage ('mariage pour tous') whose opponents deplored the excesses of a movement-driven left striving for an unbounded extension of rights - from the right to same-sex marriage to the enfranchisement of non-nationals or the right of same-sex couples to adopt. (shrink)

Do terminally ill patients who have exhausted all other available, government-approved treatment options have a constitutional right to experimental treatment that may prolong their lives? On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, held “Yes.” The plaintiffs, Abigail Alliance for Better Access to Developmental Drugs and Washington Legal Foundation, sought to enjoin the Food and (...) Drug Administration from refusing to allow the sale of investigational new drugs that had not yet received FDA approval. The terminally ill plaintiffs contended that they quite literally could not wait that long for the drugs. With no other treatment options available, the plaintiffs urged the court to recognize a fundamental, constitutional right to take potentially life-saving or life-prolonging drugs, even though the treatment had not been fully tested through human trials for safety and effectiveness and could not be legally marketed to the public. (shrink)

Various special investigative methods are more often applied nowadays; their use is unavoidably induced by today’s reality in combating organised crime in the spheres such as corruption, prostitution, drug trafficking, trafficking in persons, money counterfeit and etc. Therefore, special secret investigative methods are more often used and they are very effective in gathering evidence for the purpose of detecting and investigating very well-organised or latent crimes. Both the Convention on the Protection on Human Rights and Fundamental Freedoms itself, i.e. its (...) Article 6, and other international instruments, such as the Council of Europe’s Criminal Law Convention, the Council of Europe’s Convention on Laundering, Search, Seizure and Confiscation of the Proceeds from Crime and others, do not prohibit the use of special investigative methods, provided that their use does not violate human rights. The use of special investigative methods, such as undercover agents or other undercover investigative methods, cannot in itself infringe human rights and the right to a fair trial; however, its use must have clear limits and safeguards. The recent judgements of the European Court of Human Rights regarding the use of undercover agents confirm that the use of undercover agents in certain types of cases is often unavoidable and also very problematic, because the Court imposes on the member states of the Convention increasingly wider obligations. Partly this is determined by the fact that the current jurisprudence of the Court is still in the state of formation, therefore many questions are left unanswered. (shrink)

On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have (...) lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices. (shrink)

Ravelingien et al1 argue that, given the restrictions that must be imposed on recipients of xenotransplanted organs, we should conduct clinical trials of xenotransplantation only on patients in a persistent vegetative state. I argue that there is no ethical barrier to using terminally ill patients instead. Such patients can choose to waive their rights to the liberties that xenotransplantation would probably restrict; it is surely rational to prefer to waive your rights rather than to die, and permissible to allow patients (...) to make this choice.Perhaps the single most important advance in the history of moral thought occurred when it came to be generally recognised that all people are protected by rights that are inviolable, at least without their consent. The precise nature and content of these rights is controversial, but there is a consensus among reasonable people over their core. We all have a right to life, to liberty, to security of person and to equality before the law. Other rights—so-called positive rights, such as the right to economic security, or cultural rights, for instance—may be controversial, but we all agree at least on these.Ravelingien et al1 therefore seem to be on solid ground when they conclude that it would not be permissible to use living persons as subjects in clinical trials of xenotransplantation, as such trials, potentially or actually, result in the violation of the core human rights of the subjects. Their argument is as follows:" Xenotransplantation carries with it a currently unquantifiable risk of the transmission of viruses, from the animal that is the source of the organ transplanted, to the human recipient. Such viruses could have potentially catastrophic consequences, up to and including triggering a global and devastating pandemic. Therefore, it would be necessary to monitor the health status of recipients of … ". (shrink)

The “Universal Declaration of Human Rights” and the “Geneva Declaration” by the World Medical Association, both in 1948, were preceded by the foundation of the United Nations in New York (1945), the World Medical Association in London (1946) and the World Health Organization in Geneva (1948). After the end of World War II the community of nations strove to achieve and sustain their primary goals of peace and security, as well as their basic premise, namely the health of human beings. (...) All these associations were well aware of the crimes by medicine, in particular by the accused Nazi physicians at the Nuremberg Doctors Trial (1946/47, sentence: August 1947). During the first conference of the World Medical Association (September 1947) issues of medical ethics played a major role: and a new document was drafted concerning the values of the medical profession. After the catastrophe of the War and the criminal activities of scientists, the late 1940s saw increased scrutiny paid to fundamental questions of human rights and medical ethics, which are still highly relevant for today’s medicine and morality. The article focuses on the development of medical ethics and human rights reflected in the statement of important persons, codes and institutions in the field. (shrink)

The reporting of clinical trial data is necessary not only for doctors to determine treatment efficacy, but also to explore new questions without unnecessarily repeating trials, and to protect patients and the public from dangers when data are withheld. This issue is particularly salient in those trials involving invasive neurosurgical interventions, such as deep brain stimulation (DBS), for ‘treatment refractory’ psychiatric disorders. Using the federal database ClinicalTrials.gov, it was discovered that out of the completed or unknown‐status trials related to (...) psychiatric DBS up to November 2018, only two had submitted results to ClinicalTrials.gov. These results suggest that, despite federal requirements to report clinical trial data, reporting on psychiatric DBS trials is problematically minimal. It is argued that a human rights approach to this problem establishes a legal and ethical foundation for the need to report clinical trial results in this area. (shrink)

Courts and jurors sometimes refuse to assign liability to defendants on the basis of statistics alone, despite their apparent reliability. I argue that this refusal is best understood as a recognition of defendants’ right to security. Understood as a robust good in Philip Pettit’s sense, security requires that someone risking harm to others’ protected interests adopt a disposition of concern that controls against wrongfully harming them. Since trials risk harm, the state must adopt such a disposition. Statistics leave open (...) the possibility of innocence and so wrongful harm in a way that the state cannot ignore; if it does use such statistics, it makes defendants wrongfully insecure. This explanation of the problem of bare statistical evidence is especially apt because security grounds the right to a fair trial and judicial procedural rights more generally. (shrink)

In “Assessing the Remedy: The Case for Contracts in Clinical Trials,” Sarah Edwards (2011) proposes that research participants acquire contractual obligations to investigators, thus opening the doo...

The claim that individuals legitimately differ with respect to their values seems to be uncontroversial among bioethicists, yet many bioethicists nevertheless oppose right-to-try laws. This seems to be due in part to a failure to recognize that such laws are intended primarily to be political, not legal, instruments. The right-to-try movement seeks to build political support for increasing access to newly developed drugs outside of clinical trials. Opponents of right-to-try laws claim that increasing access outside of clinical (...) trials would undermine evidence-based medicine. They seek to maximize overall gains to patients by protecting them from adverse drug reactions and ensuring that drugs are more effective on average. In contrast, right-to-try activists have a point that regulatory judgments of drug safety and effectiveness impose one set of trade-offs on all individuals, regardless of their different values. That might be acceptable if determinations of safety and effectiveness were black and white, but that does not seem to be the case. This article argues that judgments of safety and effectiveness are in an important respect normative and reflect the perceived value of those ends relative to others. Such judgments, when universally imposed, harm patients who would readily make do with less knowledge of drug safety and effectiveness in exchange for more time and self-determination. The relevant moral principle is that of respect for individual autonomy. Just as that principle should lead one to substitute collective decisions for individual ones to regulate a natural monopoly, the same principle should lead one to substitute individual decisions for collective ones to avoid a government monopoly on access to newly developed drugs. It is argued that reforms should increase the number of treatment options available to patients outside of clinical trials. The final section of the article discusses ways in which current regulations might be reformed so as to provide more treatment options outside of clinical trials, without undermining evidence-based medicine. (shrink)

It may be unethical to deny children with cystic fibrosis access to ethically approved clinical trials from which they might benefitDespite advances in nutritional management, aggressive antibiotic usage, and physiotherapy, cystic fibrosis remains a life limiting illness with high morbidity that imposes considerable burdens on children and families.1 Although survival to 40 years is predicted for children born in 1990s, the median age of death in 2003 was 24.2 years .The pathophysiological features of CF are produced by a defective gene (...) on chromosome 7, resulting in the defective production of a protein that regulates cellular ion transport. Defective ion transport is thought to lead to increased mucus viscosity , with poor airway clearance, recurrent bacterial infection, lung damage, and death.Gene therapy , the insertion of a normally functioning gene into deficient host cells using a suitable vector, is a potential treatment or cure for diseases produced by single gene defects—for example, CF. Gene therapy does, however, have potential or actual risks, leading many to suggest that evidence of efficacy in adults should be demonstrated before trials are conducted in children. Many serious diseases in adults such as CF have their onset in childhood. If early treatment provides greater hopes of benefit, children may be more appropriate targets for GT in CF than adults. It may be unethical to deny them access to properly constructed, ethically approved clinical trials from which they might benefit.Since research in children should be scientifically valid, in the child’s best interests, and the subject of valid consent, this article will consider these parameters in relation to trials of GT in children with CF. Because of the importance of consumer participation in the design of research we present the results of a questionnaire about GT trials delivered …. (shrink)

Sometimes doing what’s right depends on anticipating how people will react when you do the right thing. Consider two aspects of challenge trial payments discussed by Lynch and colleagues. Th...

This book begins the discourse on post-trial access to drugs in developing countries. Underlying ethical issues in global health inequalities and global health research serve as the context of the debate. Due to rampant allegations of violations of rights of research participants, especially in developing countries, it discusses the regulatory infrastructure and ethical oversight of international clinical research, thus emphasizing the priority of safeguarding the rights of research participants and host populations as desiderata in conducting clinical trials in developing (...) countries. This is the first book that analyzes the major obstacles of affordable access to drugs in developing countries - patent and non-patent factors and how they can be overcome through a middle ground approach and a new paradigm to establish global health justice which includes national and global health responsibilities. The book also deals extensively with all complex aspects of the discourse on affordable access to drugs in developing countries, including intellectual property law, international regulations, political and cultural systems, international trade agreements. Furthermore it contains a robust ethical debate and in-depth analysis. The book crafts a paradigm of global health justice involving a sliding scale of national and global responsibilities for the realization of the right to health in general and access to drugs in particular. (shrink)

Most rights claims are capable of being analysed in terms of both the competing theories of rights, the will theory and the interest theory. Discussion hitherto has concentrated on particular instances of rights claims which are easily accommodated by the one theory but accommodated only with difficulty (if at all) by the other. Such problematic examples have served to illuminate what is at stake between the rival theories. However, in the case of the right to a public trial, (...) I argue that neither theory is capable of accommodating that particular ‘right’. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Index to Volume Fifty-SixArticlesBernier, Bernard, National Communion: Watsuji Tetsurō's Conception of Ethics, Power, and the Japanese Imperial State, 1 : 84-105Between Principle and Situation: Contrasting Styles in the Japanese and Korean Traditions of Moral Culture, Chai-sik Chung, 2 : 253-280Buxton, Nicholas, The Crow and the Coconut: Accident, Coincidence, and Causation in the Yogavāiṣṭha, 3 : 392-408Chan, Sin Yee, The Confucian Notion of Jing (Respect), Sin Yee Chan, 2 : (...) 229-252Chong, Kim-chong, Zhuangzi and the Nature of Metaphor, 3 : 370-391Chung, Chai-sik, Between Principle and Situation: Contrasting Styles in the Japanese and Korean Traditions of Moral Culture, 2 : 253-280The Confucian Ideal of Harmony, Chenyang Li, 4 : 583-603The Confucian Notion of Jing.(Respect), Sin Yee Chan, 2 : 229-252The Conventional Status of Reflexive Awareness: What's at Stake in a Tibetan Debate? Jay L. Garfield, 2 : 201-228The Crisis of Knowledge in Islam (I): The Case of al-'āmirī, Paul L. Heck, 1 : 106-135The Crow and the Coconut: Accident, Coincidence, and Causation in the Yogavāiṣṭha, Nicholas Buxton, 3 : 392-408De Reu, Wim, Right Words Seem Wrong: Neglected Paradoxes in Early Chinese Philosophical Texts, 2 : 281-300The Desire You Are Required to Get Rid of: A Functionalist Analysis of Desire in the Bhaga-vadgītā, Christopher Framarin, 4 : 604-617Framarin, Christopher, The Desire You Are Required to Get Rid of: A Functionalist Analysis of Desire in the Bhagavadgītā, 4 : 604-617Garfield, Jay L., The Conventional Status of Reflexive Awareness: What's at Stake in a Tibetan Debate? 2 : 201-228Heck, Paul L., The Crisis of Knowledge in Islam (I): The Case of al-'ā mirī, 1 : 106-135Heidegger's Comportment toward East-West Dialogue, Lin Ma and Jaap van Brakel, 4 : 519-566Ho, Chien-hsing, Saying the Unsayable, 3 : 409-427Kantor, Hans-Rudolf, Ontological Indeterminacy and Its Soteriological Relevance: An Assessment of Mou Zongsan's (1909-1995) Interpretation of Zhiyi's (538-597) Tiantai Buddhism, 1 : 16-68Lai, Karyn, Li in the Analects: Training in Moral Competence and the Question of Flexibility, 1 : 69-83Li, Chenyang, The Confucian Ideal of Harmony, 4 : 583-603Li in the Analects: Training in Moral Competence and the Question of Flexibility, Karyn Lai, 1 : 69-83Ma, Lin, and Jaap van Brakel, Heidegger's Comportment toward East-West Dialogue, 4 : 519-566National Communion: Watsuji Tetsurō's Conception of Ethics, Power, and the Japanese Imperial State, Bernard Bernier, 1 : 84-105Ontological Indeterminacy and Its Soteriological Relevance: An Assessment of Mou Zongsan's (1909-1995) Interpretation of Zhiyi's (538- 597) Tiantai Buddhism, Hans-Rudolf Kantor, 1 : 16-68Right Words Seem Wrong: Neglected Paradoxes in Early Chinese Philosophical Texts, Wim De Reu, 2 : 281-300The Role of Time in the Structure of Chinese Logic, Jinmei Yuan, 1 : 136-152Sakya Pandita and the Status of Concepts, Jonathan Stoltz, 4 : 567-582Saying the Unsayable, Chien-hsing Ho, 3 : 409-427Schiltz, Elizabeth, Two Chariots: The Justification of the Best Life in the Katha Upanishad and Plato's Phaedrus, 3 : 451-468Spackman, John, The Tiantai Roots of Dōgen's Philosophy of Language and Thought, 3 : 428-450Stevenson, Frank W., Zhuangzi's Dao as Background Noise, 2 : 301-331Stoltz, Jonathan, Sakya Pandita and the Status of Concepts, 4 : 567-582The Tiantai Roots of Dōgen's Philosophy of Language and Thought, John Spackman, 3 : 428-450 [End Page 709]Two Chariots: The Justification of the Best Life in the Katha Upanishad and Plato's Phaedrus, Elizabeth Schiltz, 3 : 451-468van Brakel, Jaap, and Lin Ma, Heidegger's Comportment toward East-West Dialogue, 4 : 519-566Yuan, Jinmei, The Role of Time in the Structure of Chinese Logic, 1 : 136-152Zhuangzi and the Nature of Metaphor, Kim-chong Chong, 3 : 370-391Zhuangzi's Dao as Background Noise, Frank W. Stevenson, 2 : 301-331Book NotesFenner, David E. W., Introducing Aesthetics (note by James McRae), 3 : 515-516Introducing Aesthetics, by David E. W. Fenner (note by James McRae), 3 : 515-516McRae, James, a book... (shrink)

The Helsinki Declaration is a very important document regarding the protection of patients’ rights in clinical trials and one of the fundamental sources of operational principles for every ethics committee. Although they have been updated, the international guidelines for ethics committees continually fail to address certain issues pertaining to the protection of patients’ rights in clinical trials. These issues include, most significantly, the method of electing ethics committees (a free, secret ballot should be preferred to direct appointment), the avoidance of (...) conflict of interest during the election of ethics committee members, and the necessary insurance coverage for the participants of clinical trials. Polish law should, on the other hand, be developed in such way as to not limit the effectiveness of ethics committees in protecting patients’ rights in clinical trials. The ideal solution would be to draft a uniform law concerning not only clinical trials, but all medical experiments. The opinions of experts who have been reviewing medical research projects for several years may prove to be especially valuable in this setting. (shrink)

This note analyses a recent case of the European Court of Justice in which the applicant, a 14-year old rape victim, alleged that Bulgarian criminal law violated her rights under Articles 3 and 8 of the European Convention of Human Rights in pursuing a practice of only prosecuting rape where there was evidence of the use of physical force and active resistance. In upholding the applicant’s claims, the Court re-affirmed the positive obligation on states to adopt measures to ensure that (...) fundamental rights under the Convention were secured. In particular, in the case of rape, this required the enactment and application of criminal laws effectively prescribing all acts of non-consensual sex and not just those involving physical violence. In this way the Court affirmed not only that rape was, in essence, a violation of personal sexual autonomy but also that legal systems which failed adequately to protect against all forms of rape risked operating in breach of Convention obligations. (shrink)

Using the case of Ebola Virus Disease as an example, this paper shows why patients at high risk for death have a defensible moral claim to access unregistered medical interventions, without having to enrol in randomized placebo controlled trials.A number of jurisdictions permit and facilitate such access under emergency circumstances. One controversial question is whether patients should only be permitted access to UMI after trials investigating the interventions are fully recruited. It is argued that regulatory regimes should not prioritise (...) class='Hi'>trial recruitment over patient access, even if this results in drug research and development delays.We describe how the moral duty to rescue impacts on others' duties to oblige patients seeking emergency access to unregistered medical interventions. The view that eligible patients are owed the provision of access to UMI regardless of their willingness to enrol in a randomised controlled trial is defended. (shrink)