Corruption cases that result in small state financial losses continue to end up in the Corruption Court without alternative solutions that are faster, simpler and cheaper, even though the Corruption Court is located in the provincial capital and the corruption trial process requires a lot of money. So that it is not commensurate between the costs of law enforcement incurred with the state financial losses incurred due to corruption. The method of this research approach is juridical sociological because the (...) problems studied concern the relationship between juridical factors and sociological factors. The urgency of discontinuing the prosecution of corruption crimes with small state financial losses is that the prosecution of corruption crimes with small state financial losses is inefficient and the Discontinuation of Prosecution of corruption crimes with small state financial losses does not have a legal umbrella This is because there are weaknesses in legal substance, legal structure and legal culture. The reconstruction model for the termination of prosecution of corruption crimes with small state financial losses based on Prosecutorial Discretion by the Public Prosecutor in a Progressive Legal Perspective is the Reconstruction of Legal Substance, namely adding Prosecutorial Discretion by the Public Prosecutor as a manifestation of the Dominus Litis Principle can stop the prosecution of corruption crimes with small state financial losses where this has not been regulated in Article 140 paragraph (2) of the Criminal Procedure Code, Reconstruction of legal structure, namely the delegation of authority from the Attorney General of the Republic of Indonesia to the Head of the High Prosecutor's Office as the controller of the termination of prosecution of corruption crimes with small state financial losses, Reconstruction of legal culture, namely changing the patterns of thought of public prosecutors from positivistic to progressive in exercising their authority. The recommendations in this study encourage the reform of the Criminal Procedure Code (KUHAP) related to the authority to discontinue prosecution by the Public Prosecutor and the need to make a regulation of the Attorney General related to the Discontinuation of Prosecution based on the Discretion of the Public Prosecutor. (shrink)

Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the (...) 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. (shrink)

Recently a great deal of attention has been paid to conflicts of interest in medical research, and the Institute of Medicine has called for more research into this important area. One research question that has not received sufficient attention concerns the mechanisms of action by which conflicts of interest can result in biased and/or flawed research. What discretion do conflicted researchers have to sway the results one way or the other? We address this issue from the perspective of selective inertia, (...) or an unnatural selection of research methods based on which are most likely to establish the preferred conclusions, rather than on which are most valid. In many cases it is abundantly clear that a method that is not being used in practice is superior to the one that is being used in practice, at least from the perspective of validity, and that it is only inertia, as opposed to any serious suggestion that the incumbent method is superior, that keeps the inferior procedure in use, to the exclusion of the superior one. By focusing on these flawed research methods we can go beyond statements of potential harm from real conflicts of interest, and can more directly assess actual harm. (shrink)

Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n= 124) obtained low scores (lower than 75%) on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative (...) used daily examples from the field of Agriculture because Malawi has an agro-based economy. Methods The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18) and intervention arms ( n =18). The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study. Results The findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75%) during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer’s exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001). Conclusions Potential trial participants can be assisted to understand key clinical trial procedures, their justification and personal implications by using innovative tailored local narratives. (shrink)

Philip Pettit’s conception of freedom as nondomination is modally robust in that it requires not simply reducing the probability of uncontrolled interference by others but entirely eliminating that possibility. In this article, I consider whether freedom as nondomination provides an attractive analysis of official discretion, particularly in the context of the criminal law, an area of recurring interest for Pettit. I argue that not only does the modally robust character of freedom as nondomination have some rather unattractive implications in the (...) criminal law, but that it sits poorly with Pettit’s more general ambitions to provide a consequentialist framework for the evaluation of social institutions. Drawing on recent work by Niko Kolodny, I develop an ‘anti-deference’ interpretation of nondomination and contrast it to Pettit’s modally robust conception. (shrink)

Through expanded access protocols, the Food and Drug Administration (FDA) allows patients with serious or immediately life-threatening diseases access to experimental drugs outside the clinical trial setting when no satisfactory alternative treatment is available. While the FDA has established a mechanism for providing patients with unapproved drug access, the regulations do not require the pharmaceutical company to provide the drug. The drug company’s permission to use its experimental drug is a necessary prerequisite to using the FDA’s expanded access mechanism. (...) Increasingly, drug companies are coming under scrutiny regarding the programs governing that decision-making power. Historically, disclosing whether a company has an expanded access program, and whether or how it would respond to an expanded access request, has been left to discretion of the drug companies themselves. Few manufacturers publish adequate expanded access protocols. As a result, patients were provided with little insight into how companies evaluate expanded access requests and are naturally skeptical as to the ethical integrity of the process. The recently passed 21st Century Cures Act changes that practice by requiring drug companies to have, and make publically available, their expanded access procedures including criteria for evaluating and responding to patient requests. In this article, we contend that complying with the new transparency provisions will require drug companies to respond to several unresolved expanded access issues. Namely, how to reconcile a patient’s desire to access lifesaving experimental therapies alongside the company and society’s interest in the efficient development of new drugs. Even more challenging, how can companies devise practices for evaluating and processing expanded access requests that also fairly and equitably acknowledge those concerns? In addressing these questions, this article explores the legal, regulatory, business, and societal influences that have shaped expanded access policies and practices. From there, we provide companies a framework that balances appropriately the desires of individuals and gaining the requisite approvals ensure access not just for one person but for society. (shrink)

The Fatwā-house, which was within the body of Meshihat in the Ottoman Empire, gave answers to the questions posed to it by focusing on the Hanafi sect and the preferred fatwās of this sect for centuries. These questions and answers were also duly recorded. In this study, based on The Record for the Legal Responses of the Supreme Fatwā Office, which is registered at records numbered 378 in the Meshihat Archive of the Istanbul Mufti, one of the records containing the (...) answers given by the institution. It is an attempt to create an imagination about the scope and sphere of influence of the fatwā activity in the last period of the Ottoman Empire. Accordingly, in the last thirteen years of the state, Fatwā-house has been the addressee of questions from individuals, state and private institution directors, societies, ministries and the Grand Vizier. While some of these questions came from the provinces within the Ottoman borders or from the countries that had an administrative ties with the Ottoman Empire, some of them were submitted to the Fatwā-house by the Muslims of other states from the lost lands or simply because the caliphate center was the official fatwā organ. At the records, there is also a record of the questions coming from muslims who are Ottoman citizens but residing in other countries. Looking at the subjects, it was determined that most of the questions were asked about foundations. In addition, the permissibility of obtaining interest by bank facility or depositing money in the bank, the establishment of modern schools and whether the ways to create resources for these schools are permissible, whether teaching in Latin letters is possible, the provision of life insurance, the importance of cleanliness in the fight against cholera, the fight against innovations (bidʻas) in mosques. It is seen that questions on different issues, from issues such as whether the wife of the lost (mafqud) can be separated by the judge or not; to the issues of whether the fulfillment of judgment can be regarded as the end of the judgment or not. As it is mentioned in some fatwā records at the record book, it is obligatory to decide on fatwā and its fulfillment in the Ottoman Empire with the most authentic and preferred view of the Hanafi sect. The last two fatwā questions mentioned above are handled as examples of giving up the act with the will of the head of state, with the preferred fatwâs discussed in this article. It is only possible with the will of the head of state to make a decision with an opinion other than preferred fatwâ or an other opinion out of the sect. According to the first example, some of those of the citizens of other states outside the Ottoman Empire came to the Ottoman lands for reasons like trade etc. and married to Muslim women there and then left them suffering. This was also true for the wives of men who went to wars and did not return. Although the drawbacks of the Hanafi sect's preferred view, that one should wait until the age of ninety, one hundred, one hundred and twenty, or until the death of their peers, were resolved by appointing a regent from other sects, continuity could not be ensured in this practice either, finding people has not always been possible. For this reason, in the time of Shaykh al-Islam Hayri Efendi, a statement of change was prepared and submitted to the will of the sultan. In the issue of whether the signature of the head of state can be counted as the end of the judgment, another subject in which the will of the head of state is applied, the stages of abandoning the preferred view can be followed much more clearly. In the case of the dismissal of the judge or the expiration of the term of office before the execution of the judgment, especially in the distant provinces of the state, in the case of the judge's dismissal or the expiration of his term, according to the preferred view of the sect, which was based on juristic discretion, the closure of the cases took many years. It is seen that the judgment reached by analogy was submitted to the will of the sultan, with an article added to the script regarding the prepared procedure of reasoning, although there is no preferred view since it is the most suitable opinion for the interests of the people and the necessities of the century due to the increase in complaints. Effective from the time it was approved by the head of state, the execution of the sentence is no longer a requirement for the trial to be completed. The changes in the provisions of these matters also show that, although it was important for the Ottoman State to comply with the preferred view of the Hanafi sect - as in the previous Shaykh al-Islams' fatwās in the form of ma'ruzat - it was considered more necessary to look after the interests of the Muslims and different opinions were enacted and put into practice. (shrink)

BackgroundIn clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant’s true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers of participants of a clinical (...) class='Hi'>trial on Pemba Island, Tanzania.MethodsA total of 254 caregivers were assigned to receive (i) a pamphlet (n = 63), (ii) an oral information session (n = 62) or (iii) a pamphlet and an oral information session (n = 64) about the clinical trial procedures, their rights, benefits and potential risks. Their post-intervention knowledge was assessed using a questionnaire. One group of caregivers had not received any information when they were interviewed (n = 65).ResultsIn contrast to the pamphlet, attending an information session significantly increased caregivers’ knowledge for some of the questions. Most of these questions were either related to the parasite (hookworm) or to the trial design (study procedures).ConclusionsIn conclusion, within our trial on Pemba Island, a pamphlet was found to not be a good form of conveying clinical trial information while an oral information session improved knowledge. Not all caregivers attending an information session responded correctly to all questions; therefore, better forms of communicating information need to be found to achieve a truly informed consent. (shrink)

This methodological discussion invites critical reflection about the procedures used to analyze the contribution of qualitative and mixed methods research to nursing trials by mounting an argument that these should rest on multiple publications produced about a project, rather than a single article. We illustrate the value‐added of this approach with findings from a qualitative, cross‐case analysis of three critical case exemplars from nursing researchers that each used a qualitative approach with a mixed method phase. The holistic lens afforded by (...) a case‐based approach informs nursing inquiry by documenting that the critical case exemplars presented evidence of (a) a sustained commitment of resources and expertise for the qualitative methods that extended across more than one phase of the trial, (b) the impact of the qualitative methods on the trial or its aftermath, (c) deploying a theoretical or conceptual framework for a variety of purposes, and (d) integrating qualitative and quantitative data for purposes of extending explanatory power. Findings challenge the practice of linking purposes served by qualitative and mixed methods to a single trial phase. (shrink)

: This paper provides a simultaneously reflexive and analytical framework to think about obstacles to truly informed consent in social science and biomedical research. To do so, it argues that informed consent often goes awry due to procedural misconceptions built into the research context. The concept of procedural misconception is introduced to describe how individuals respond to what is familiar in research settings and overlook what is different. In the context of biomedical research, procedural misconceptions can be seen to function (...) as root causes of therapeutic misconceptions. (shrink)

This review discusses the thesis advanced by Sarah Summers in her recent book. In particular it examines the three radical claims that structure her argument. First, that the commonly used analytical distinction between adversarial and inquisitorial traditions in criminal procedure should be abandoned. Secondly, that since the Continental reforms of the 19th century, criminal procedure can best be understood in terms of a single European procedural tradition. Thirdly, that the European Court of Human Rights has misconstrued the logic (...) of that single European procedural tradition by failing to understand that it involves the rejection of a ‘determinative’ pre-trial phase. Each of Summers’ three arguments is subjected to critical analysis and ultimately rejected as innovative and stimulating but flawed. (shrink)

If definitive evidence concerning treatment effectiveness becomes available from an ongoing randomized clinical trial, then the trial could be stopped early, with the public release of results benefiting current and future patients. However, stopping an ongoing trial based on accruing outcome data requires methodological rigor to preserve validity of the trial conclusions. This has led to the use of formal interim monitoring procedures, which include inefficacy monitoring that will stop a trial early when the experimental (...) treatment appears not to be working. For participants, inefficacy monitoring is especially important as it ensures that they are not being treated worse than if they had not enrolled on the trial. We discuss the importance of reporting with trial results the formal interim inefficacy monitoring guidelines that were utilized, and, if none were used, the reasons for their absence. A survey of two leading medical journals suggests that this is not current practice. (shrink)

Regulatory offences are a complex phenomenon, presenting problematic aspects both at the level of criminalisation and at the level of enforcement. The literature abounds in works that study the phenomenon. There is, however, an aspect that has remained largely unexplored. It concerns the relationship between the regulatory framework within which the crime occurs and the procedural safeguards that defendants normally enjoy at trial or at the pre-trial stage: defendants tried for regulatory offences are often denied safeguards that are (...) generally considered as important constituents of trial fairness. Relying on a new conceptualisation of regulatory offences, this paper advances a theory that justifies these exceptional rulings. (shrink)

This paper discusses the discrete symmetries of off-shell electromagnetism, the Stueckelberg–Schrodinger relativistic quantum theory and its associated 5D local gauge theory. Seeking a dynamical description of particle/antiparticle interactions, Stueckelberg developed a covariant mechanics with a monotonically increasing Poincaré-invariant parameter. In Stueckelberg’s framework, worldlines are traced out through the parameterized evolution of spacetime events, which may advance or retreat with respect to the laboratory clock, depending on the sign of the energy, so that negative energy trajectories appear as antiparticles when (...) the observer describes the evolution using the laboratory clock. The associated gauge theory describes local interactions between events (correlated by the invariant parameter) mediated by five off-shell gauge fields. These gauge fields are shown to transform tensorially under under space and time reflections—unlike the standard Maxwell fields—and the interacting quantum theory therefore remains manifestly Lorentz covariant. Charge conjugation symmetry in the quantum theory is achieved by simultaneous reflection of the sense of evolution and the fifth scalar field. Applying this procedure to the classical gauge theory leads to a purely classical manifestation of charge conjugation, placing the CPT symmetries on the same footing in the classical and quantum domains. In the resulting picture, interactions do not distinguish between particle and antiparticle trajectories—charge conjugation merely describes the interpretation of observed negative energy trajectories according to the laboratory clock. (shrink)

BackgroundWe describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512). This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European (...) provisions were evaluated. Descriptive analysis, Wilcoxon Rank-Sum test and General Linear Model analysis were used to determine factors potentially influencing the timelines. The Cluster Analysis procedure was used to identify homogenous groups of cases.ResultThe authorisation process was completed in 7.7 to 53.8 months in European countries and in 17.1 to 27.1 months in non-European countries. The main factors influencing these timelines were the requests for changes/clarifications in European countries and the different national legislations in non-European countries.ConclusionThis work confirms that the procedures and requirements for the clinical trial application of a paediatric trial are different. In the European Union, the timeframes for submission were generally harmonised but longer. In non-European countries, delays were caused by national dispositions but the entire authorisation process resulted faster with less requests from ECs/cas. The upcoming application of Regulation (EU) 536/2014 is expected to harmonise practices in Europe and possibly outside. Networks on paediatric research acting at international level will be crucial in this effort. (shrink)

There is an ongoing investigation by scholars of ethics and economics into whether human decision making and the resultant acts should be guided by rules and procedures or by judgment and discretion. Although each of these modes offers advantages and disadvantages to decision makers, they are by no means neutral in their effect on professional development. The paper presents an in-depth view of discretionary decisions using an Aristotelian-Thomistic framework. This is the first of the series of papers which focus on (...) the application of realistic philosophical principles to ethical professional behaviour and decision making in daily practice. Results indicate that classical philosophical theories which use virtues and truth as indispensable components still may give rise to desirable and moral conduct among individuals who apply them. (shrink)

After reporting in detail Aristotle’s texts and comments on the well-known motion paradoxes Arrow, Dichotomy, Achilles and Stadium, tracking back to the 5th century BCE and credited by Aristotle to Zeno of Elea, we next explain and dis-cuss traditional continuous solutions of the paradoxes, based on Cauchy’s limit concept. Afterward, the heated philosophical debate on supertasks and infinity machines is reported before the paradoxes are examined within the context of modern quantum theory. Already in 1905, Einstein concluded that matter could (...) not be a continuous thing. Classical continuous spacetime is replaced by ‘granular’ spacetime, and the concept of distance in granular spacetime is discussed. This is followed by a detailed presentation of modern discrete solutions in granular spacetime, several of which are published here for the first time. Finally, a procedure is presented to determine when traditional continuous methods suffice instead of discrete methods, and the handling of discrete versus continuous in physics is briefly reported. (shrink)

The ‘continuous’ and the ‘discrete’ in nature and in science live and fight forever. The questionnaires and the Lickert scales are indispensable and widely used tools in social sciences research. Vougiouklis & Vougiouklis bar is a new tool introduced as an alternative to Lickert scales. We believe that such an alternative might offer some solutions to problems that crop up during the fight between continuous and discrete. Nevertheless, the greatest contribution of the V&V bar is that it offers (...) the researchers freedom in all stages of the research procedure using a questionnaire. (shrink)

Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients’ to give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants. Whereas the Declaration of Helsinki, Good (...) Clinical Practice guideline, Additional Protocol to the European Bioethical Convention concerning Biomedical Research, as well as appropriate regulations adopted by the Food and Drugs Administration (USA) allow waivers from participants’ consent or deferred consent for emergency research, the regulations of most European Community countries following the Clinical Trial Directive (2001/20/EC) do not give space for a deferred consent or a waiver from consent for adult patients (unless surrogate consent is made use of). This is even more confusing in case of Poland, where conflicting regulations on a waiver from a participant’s consent in emergency research exist and the regulations on surrogate consent of temporarily incompetent adults are too restrictive and authorise only the guardianship courts to consent, which is not or hardly feasible in practice. European Community regulations need to be amended to allow for implementation of the deferred consent or waivers from consent for emergency research in order to enable ethical research of emergency conditions that should become a large part of important public health priorities. (shrink)

This article takes issue with procedural reductionism, which is the inclination to reduce all matters of judgement and responsibility to the following of some procedure or rule. Two scenarios provide content for a discussion of professional discretion in the context of accountability. The author shows that in professional life there will always be situations that stand beyond the rules of procedures and require the unique judgement of the professional at the time. While this judgement may be determined by the (...) facts available in a situation of uncertainty, it cannot be reduced to the facts (including facts about rules and procedures). The moral judgement will still have an essential indeterminancy about it. (shrink)

Against a remarkable hardware oblivion in discussions of algorithmic intelligence, this article insists that algorithmic thought, or abstract computation, cannot be separated from its technological implementation. It requires a material medium for an abstract mechanism to become a procedural event. Temporality is both the condition and the limiting (and irritating) factor in the computational function. ‘Radical’ media archaeology is proposed as a method for such an analysis, and the neologism of techno lógos to describe some aspects of algorithmic reason which (...) only unfold in the moment of its techno-processual coming-into-being. Some core operations, such as the time-discrete rhythm of actual computing algorithms, are discussed, where the ‘tempoReal’ flashes up in computing. In a wider sense, the time-discreteness of digital computing is related to an aesthetics of existence which acknowledges the machine element within human reasoning itself, while at the same time re-actualizing previous cultural techniques of non-narrative chronology. Turing the ‘man’ himself, in the sense of the Turing machine, can be addressed ‘itself’, in its archival sense as a sequence of expressions by symbols. (shrink)

In this essay, I argue that absent special circumstances, there are no moral, judicial procedural rights. I divide this essay into four main sections. First, I argue that there is no general moral right against double jeopardy. Next, I explain why punishing a criminal without first establishing her guilt via a fair trial does not necessarily violate her rights. In the third section, I respond to a number of possible objections. And finally, I consider the implications of my arguments (...) for the human right to due process. (shrink)

This short article discusses the nature of research and art practice and makes a case for the necessary intermingling of these activities. It does not attempt to define a space for art to operate as research, quite the opposite: research is an operating structure for the process and production of, among other things, art. It is regarded as integral to the processes of thinking, making, and reflecting, and it is important to note that curiosity, creative enquiry, and critical reflection underpin (...) much that is considered research in various fields. The author asserts that these processes are not necessarily discipline-specific although particular disciplines have specific procedures and goals. It is argued that "provisionality" is central to what art can offer other disciplines; it can make a virtue of incompleteness. The author suggests that art open itself up to quizzical scrutiny and help others to recognise that research has long been, and will continue to be, a driving force within its makeup. The article posits an expanded notion of the artwork that is essentially provisional and reliant on spectatorial involvement. (shrink)

Physicians are expected to engage patients as partners in identifying the possible benefits and harms associated with treatment options and selecting from among medically appropriate treatment options, rather than simply dictating what treatments patients will and will not receive. This collaborative model reflects the recognition that citizens in multicultural societies have diverse values and are likely to have different views about whether the possible benefits of a medical intervention outweigh the possible harms. However, there are circumstances in which the collaborative (...) process breaks down due to irresolvable disagreement. Especially challenging are cases in which patients are expected to die if they do not receive a treatment and either the patients or their surrogates insist on the treatment despite the physician's belief that providing it is ill advised. The source of disagreement is often differing appraisals of the risks and potential benefits. In such cases, physicians generally judge that there is insufficient likelihood or magnitude of benefit to justify the burdens or expense of treatment, while patients or surrogates believe that the small chance of preventing the patient's death is sufficient to justify the costs and potential burdens to the patient.There is a perception that surgeons enjoy considerable discretion in deciding when the risks of a procedure outweigh the expected benefits. An important contrast can be drawn between surgeons and intensivists—physicians who specialize in the medical management of critically ill patients. We will argue that there are good reasons for subjecting the decisions of both surgeons and intensivists to some oversight. We begin by showing that, for many cases, major professional society guidelines for intensivists recommend oversight via a procedural mechanism rather than unilateral decision‐making by individual clinicians. Next, we present reasons for adopting a procedural approach to dispute resolution, and we argue that these reasons apply to situations in which intensivists believe that patients or surrogates are requesting inappropriate life support as well as to many disagreements between surgeons and surrogates. Finally, we present and respond to several objections. (shrink)

Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention. We explored women’s and staff views about the consent procedures used during the internal pilot of a trial, where the protocol permitted staff to gain verbal consent at recruitment. Interviews with (...) staff and participating women. Data were analysed thematically and interviews were cross-compared to identify differences and similarities in participants’ views about the consent procedures used. Women and some staff highlighted benefits to obtaining verbal consent at trial enrolment, including expediting recruitment and reducing the burden on those left exhausted by their births. However, most staff with direct responsibility for taking consent expressed extreme reluctance to proceed with enrolment until they had obtained written consent, despite being comfortable using verbal procedures in their clinical practice. To account for this resistance, staff drew a strong distinction between research and clinical care and suggested that a higher level of consent was needed when recruiting into trials. In doing so, staff emphasised the need to engage women in reflexive decision-making and highlighted the role that completing the consent form could play in enabling and evidencing this process. While most staff cited their ethical responsibilities to women, they also voiced concerns that the absence of a signed consent form at recruitment could expose them to greater risk of litigation were an individual to experience a complication during the trial. Inexperience of recruiting into peripartum trials and limited availability of staff trained to take consent also reinforced preferences for obtaining written consent at recruitment. While alternative consent pathways have an important role to play in advancing emergency medicine research, and may be appreciated by potential recruits, they may give rise to unintended ethical and logistical challenges for staff. Staff would benefit from training and support to increase their confidence and willingness to recruit into trials using alternative consent pathways. This qualitative research was undertaken as part of the GOT-IT Trial. Date of registration 26/03/2014. (shrink)

Relations between discrete and continuous complexity models are considered. The present paper is devoted to combine both models. In particular we analyze the 3-Satisfiability problem. The existence of fast decision procedures for this problem over the reals is examined based on certain conditions on the discrete setting. Moreover we study the behaviour of exponential time computations over the reals depending on the real complexity of 3-Satisfiability. This will be done using tools from complexity theory over the integers.

Contrary to the widely accepted consensus, Christopher Heath Wellman argues that there are no pre-institutional judicial procedural rights. Thus commonly affirmed rights like the right to a fair trial cannot be assumed in the literature on punishment and legal philosophy as they usually are. Wellman canvasses and rejects a variety of grounds proposed for such rights. I answer his skepticism by proposing two novel grounds for procedural rights. First, a general right against unreasonable risk of punishment grounds rights to (...) an institutionalized system of punishment. Second, to complement and extend the first ground, I more controversially propose a right to provision of the robust good of security. People have a right to others' protecting for avoiding wrongfully harming them: when I take an action that is reasonably expected to threaten the protected interests of others, I must take appropriate care to avoid setting back those interests. Inflicting punishment on someone--intentionally harming them in response to a violation--is prima facie wrongful, so I can only count as taking appropriate care in punishing when I follow familiar procedures that reliably and redundantly test whether they are liable to such punishment, i.e. whether they have forfeited their right against punishment through a culpable act. (shrink)

More than 95 per cent of criminal convictions in the USA never go to trial, as the vast majority of defendants forfeit their constitutional rights to due process in the pervasive practice of plea bargaining. This article analyses the relationship between American mass incarceration and this mass forfeiture of procedural justice by situating the practice of plea bargaining in the normative framework drawn by recent Supreme Court rulings and the proliferation of criminal statutes, including mandatory minimum sentencing legislation. Looking (...) at systemic racial disparities in sentence severity and incarceration rates for otherwise similarly situated defendants, I argue that, rather than a voluntary waiver of constitutional rights, this mass forfeiture of due process rights ought to be conceptualized as the product of an entrenched system of procedural entrapment. Such entrapment, I argue, ought to be abolished not only on grounds of procedural injustice, but because the practice refashions rather than redresses forms of racial domination derived from prior eras. The article concludes by exploring the tactic of mass conscientious plea refusal through the collectively organized assertion of constitutional due process rights as a strategy of resisting mass incarceration. (shrink)

This book shows the surprising dynamism of the field of civil procedure through its examination of a cross section of recent developments within civil procedure from around the world. It explores the field through specific approaches to its study, within specific legal systems, and within discrete sub-fields of civil procedure. The book reflects the latest research and conveys the dynamism and innovations of modern civil procedure - by field, method and system. The book's introductory chapters (...) lay the groundwork for researchers to appreciate the flux and change within the field. The concluding chapters bring the many different identified innovations and developments together to show the field's ability to adapt to modern circumstances, while retaining its coherence even across different legal systems, traditions, fields and analytic approaches. Specifically, in this book the presence of dynamism is explored in the legal systems of the EU, France, the US, Brazil, Australia, the UK and China. So too that dynamism is explored in the contributions' analyses and discussions of the changes or need for change of specific aspects of civil procedure including litigation costs, class actions, derivative actions, pleadings, and res judicata. Furthermore, most of the individual contributions may be considered to be comparative analyses of their respective subjects and, when considered as a whole, the book presents the dynamism of civil procedure in comparative perspective. Those discrete and aggregated comparative analyses permit us to better understand the dynamism in civil procedure - for change in the abstract can be less visible and its significance and impact less evident. While similar conclusions may have been drawn through examinations in isolation, employing comparative analytic methods provided a richer analysis and any identified need for change is correspondingly advanced through comparative analysis. Furthermore, if that analysis leads to a conclusion that change is necessary then comparative law may provide pertinent examples for such change - as well as methodologies for successfully transplanting any such changes. In other words, as this book so well reflects, comparative law may itself usefully contribute to dynamism in civil procedure. This has long been a raison d'être of comparative law and, as clear from this book's contributions, in this particular time and field of study we find that it is very likely to achieve its lofty promise. (shrink)

Incentivising has shown to improve participation in clinical trials. However, ethical concerns suggest that incentives may be coercive, obscure trial risks and encourage individuals to enrol in cli...

We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision‐making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and to discuss it with (...) partners or relatives; and perceived benefits such as quality of care, non‐cost provision of methods and medical care. For some women, participation was an opportunity to express altruism. The main obstacles for participation were perceived side effects or risks. The final risk‐benefit balance was strongly influenced by women’s needs. Women perceived that the consent form benefited the clinic, proving that participants had made a free decision, and benefited the volunteers by warranting their right to free medical care. The most important problem detected was occasional misunderstanding of the information given on the form. We concluded that a full decision‐making process enhances women’s ability to exercise their right to choose, and assures research institutions that trials are conducted without coercion and that the participants are committed to the study. Researchers have the responsibility of conducting this process. (shrink)

Endeavours of politicians, representatives of law enforcement institutions and courts to create simplified, accelerated and less human and time resources requiring legal procedures in criminal cases prompted the authors of this article to assess the possibilities to develop the written form of procedure in Lithuania. The goal of the authors of this article is to assess the origin and goals of the written form of procedure, as well as to define the main rules and points for discussions on (...) the possibilities to develop the written form of procedure in the Lithuanian criminal procedural law. The conclusion is drawn in this article to the effect that written form of procedure is seen as a condition for simplifying and accelerating the legal process, and choosing this form of procedure is not considered as denying or restraining the expectations of participants of criminal procedure towards a fair trial. The analysis provides the basis for the authors to make a conclusion on the appropriate limits of applying written or oral procedures for hearing criminal cases: Oral procedure must be guaranteed in cases where questions of criminal liability and personal guilt are solved at the first instance court hearings; Oral procedure usually has to be guaranteed in cases where during the procedure at the first instance court hearing the questions of criminal liability and personal guilt are solved, although oral procedure may be limited and the procedure may be conducted in written form if new evidence are not investigated and there is no doubt for deciding whether oral procedure is better for understanding the case; Oral procedure need not be guaranteed only in cases where questions of application of the law are solved and if oral procedure was guaranteed during the procedure at the court of first instance; Written procedure may guarantee the right to a fair trial, where the participants of the procedure are allowed to provide various explanations and written documents or a person is allowed to ask for an oral court hearing. (shrink)