Ensuring safety, implementation and scientific integrity of clinical trials: lessons from the Criminal Justice–Drug Abuse Treatment Studies Data and Safety Monitoring Board

Data and safety monitoring boards (DSMBs) provide independent oversight to bio-medical clinical trials, ensuring safe and ethical treatment of research participants, data quality, and credibility of study findings. Recently, the type of research monitored by DSMBs has been expanded to include randomized clinical trials of behavioral and psychosocial interventions in community and justice based settings. This paper focuses on the development and role of a DSMB created by the National Institute on Drug Abuse (NIDA) to monitor six multi-site clinical trials conducted within the Criminal Justice–Drug Abuse Treatment Studies (CJ-DATS). We believe this is one of the first such applications of formal DSMBs in justice settings. Special attention is given to developing processes for measuring and monitoring a range of implementation issues for research conducted within criminal justice settings. Lessons learned and recommendations to enhance future DSMB work within this area are discussed.     

Consent forms in genomics: the difference between law and practice

Consent forms are the principal method for obtaining informed consent from biomedical research participants. The significance of these forms is increasing as more secondary research is undertaken on existing research samples and information, and samples are deposited in biobanks accessible to many researchers. We reviewed a selection of consent forms used in European Genome-Wide Association Studies (GWAS) and identified four common elements that were found in every consent form. Our analysis showed that only two of the four most commonly found elements in our sample of informed consent forms were required in UK law. This raises questions about what should be put in informed consent forms for research participants. These findings could be beneficial for the formulation of participant information and consent documentation in the future studies.     

Juror notetaking and question asking during trials

Juror notetaking and question asking is examined in 160 trials. Results do not support the hypotheses that juror notes aid memory or increase satisfaction with the trial or verdict. Jurors do not overemphasize noted evidence; their notes do not produce a distorted view of the case. Notetakers can keep pace with the trial, and they do not distract other jurors nor have an undue influence over non-notetakers. Juror notetaking does not favor either party and it consumes little time. Results support the hypothesis that jury questioning promotes juror understanding of facts and issues. Questions do not clearly help get to the truth, alert trial counsel to significant issues, or increase trial or verdict satisfaction. Potential disadvantages of questions are not supported: Jurors do not ask inappropriate questions, are not embarrassed or angered by objections, do not become advocates rather than neutrals, and do not overemphasize their own questions and answers. Counsel are not reluctant to object to juror questions. The jury does not draw inappropriate inferences from unanswered questions, and questions do not have detectable prejudicial effects.     

Affirmative Action in Women's Employment: Lessons from Canada

The use of affirmative action to increase women's representation in employment is recognized under European Community law. The European Court of Justice has identified affirmative action permissible under EC law and what constitutes reverse discrimination, deemed incompatible with the equal treatment principle. Despite these developments, gendered occupational segregation — vertical and horizontal — persists in all member states as evidenced by enduring pay gaps. It is widely argued that we now need national measures which take advantage of the appropriate framework and requisite political will which exists at the European level. Faced with a similar challenge, the Canadian government passed the Employment Equity Act 1986 which places an obligation on federal employers to implement employment equity (affirmative action) by proactive means. Although subject to some criticism, there have been some improvements in women's representation since its introduction. This article assesses what lessons might be learned from Canada's experience.     

Informed consent elements. Final rule

The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.     

Centre-periphery dynamics, global transition and criminological transfers Introductory notes inspired by V.S. Naipaul

The essay at hand aims to introduce the main issues and topics involved in the questions that will be dealt with throughout in this thematic issue. Those questions include: How do criminal justice practitioners and academics, in conditions of political or cultural transition, construct critical and reflexive knowledge about experiences of crime and control and their meaning? To what extent can ``ThirdWorld'' (TW) experiences and meanings, as well as TW knowledge about them, be of any use in ``First World'' (FW) contexts? And vice versa? To what extent are the gaps between both contexts too wide and to what extent has this divide been reduced in and through current global developments and transitions? The essay begins by focussing on postcolonial literature for a while, on one novel in particular, a novel that explores the space in–between the(post–)colony and the imperial metropolis.The second part of the essay deals withtransfers of (critical) criminologies in more detail.     

European Union. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population

This document has been developed by the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use, chaired by the European Commission. The document provides recommendations on various ethical aspects of clinical trials performed in children from birth up to the legal age of adulthood. This will contribute to the protection of all children who are the subject of clinical trials. As the approval of clinical trials, including ethical approval, is performed by the Member States, any recommendations on ethical aspects of clinical trials in children will also facilitate a harmonised approach to the application of the clinical trials directive across the EU, thereby facilitating the conduct of clinical trials in the EU and in whichever country the paediatric trial occurs. The protection against the risks of research in such a vulnerable population is paramount whilst this should not lead to denying them the benefits of research. Children are not small adults and there is a need to carry out specific trials that cannot be performed in adults. In general, children (minors) are unable to consent (in the legal sense) but their assent should be sought using age appropriate information. Ethics Committees need paediatric expertise to balance the benefits and risks of research in children. The lack of legal ability to consent has implications on the design, analysis and the choice of comparators used in trials, which should only be performed by trained investigators with paediatric experience. Pain, fear, distress and parental separation should be prevented and minimised when unavoidable. The neonate represents the most vulnerable of all paediatric age groups and requires even more careful review. Finally, various other aspects relating to the performance of trials in children are discussed.     

Is Plea Bargaining in the “Shadow of the Trial” a Mirage?

It has been well established that a ??plea discount?? or ??trial penalty?? exists, such that defendants who plead guilty receive significant sentencing discounts relative to what they would receive if convicted at trial. Theorists argue that the exact value of this plea discount is determined by bargaining ??in the shadow of a trial,?? meaning that plea decision-making is premised on the perceived probable outcome of a trial. In trials, the strength of the evidence against defendants greatly impacts the probability of conviction. In the present study, we estimate the probability of conviction at the individual level for those who pled guilty. We find that, contrary to the shadow of the trial model, evidentiary factors either do not impact or negatively impact the probability of conviction, which stands in stark contrast to the impact evidence has at trials. These findings suggest that plea bargain decision-making may not occur in the shadow of the trial.     

Europe's Constitutional Engagement

Abstract.  That the European Union is in a state of constitutional engagement speaks both to an obvious and urgent truth and to a less obvious but ultimately even more significant possibility. Patently, and of immediate import, with the process of national ratification in full flow following the signing of the Constitutional Treaty in Rome in October 2004—the fruit of the deliberations and negotiations of the Convention on the Future of Europe (2002–3) and the Intergovernmental Conference (2003–4)—the new union is presently in the pre-nuptial phase, and displaying many of the signs of pre-nuptial tension. Notwithstanding the legal convolutions of some of the engagement's most ardent supporters, the marriage cannot take place unless and until all twenty five member states have signalled their consent in accordance with national constitutional requirements. These requirements are diverse, and in ten cases have been interpreted as involving either a binding or an advisory referendum. And following the reaction of the June 2005 European Council to the French and Dutch "ho" votes, we will have to wait until at least 2007 for the marriage to be solemnized. As with so many engagements, therefore, there is however a strong possibility that the whole thing will be called off at the last minute. The consequences of failure would be not insignificant for the European Union, but perhaps not as significant as some fear and others hope. In what follows, by investigating instead the deeper meaning and the longer-term ambition of Europe's constitutional engagement, I seek to demonstrate that, although clearly an important variable, the ratification of this particular Treaty at this particular moment is neither necessary to nor sufficient for the realization of the EU's full constitutional potential, but that the secular process which such an initiative reflects is of vital significance.     

How to Think (Like a Lawyer) About Rape

From the American Law Institute to college campuses, there is a renewed interest in the law of rape. Law school faculty, however, may be reluctant to teach this deeply debated topic. This article begins from the premise that controversial and contested questions can be best resolved when participants understand the conceptual architecture that surrounds and delineates the normative questions. This allows participants to talk to one another instead of past each other. Accordingly, in this article, we begin by diffusing two non-debates: the apparent conflict created when speakers use “consent” to mean two different things and the question of whether rape law ought to be formulated in terms of consent or force. From here, we turn to the conceptual apparatuses that surround the normative questions of freedom from force, knowledge, and capacity. Here, we suggest how better understanding these concepts can frame the underlying discussions as to what sorts of coercion undermine consent, what kinds of deception invalidate consent, and when the victim is too incapacitated to consent. Finally, we turn to different formulations of consent, demonstrating that one conception better captures the harm of rape but that other formulations may better protect victims. We show how clarifying these questions allows discussants to see why different formulations are valuable and to debate the best all-things-considered formulation. Although this article is framed as a question of how (to teach students) to think like lawyers about rape, its ambition is to set forth a framework that is useful to reformers as well.     

The role of coronial autopsies in a context of decreasing hospital autopsies: an investigation of the issues

This article scrutinises the argument that decreasing hospital autopsy rates are outside the control of medical personnel, based as they are on families' unwillingness to consent to autopsy procedures, and that, as a consequence, the coronial autopsy is the appropriate alternative to the important medical and educational role of the autopsy It makes three points which are well supported by the research. First, that while hospital autopsy rates are decreasing, they have been doing so for more than 60 years, and issues beyond the simple notion of consent, like funding formulae in hospitals, increased technology and fear of litigation by doctors are all playing their part in this decline. Secondly, the issue of consent has as much to do with families not being approached as with families declining to give consent. This is well supported by recent changes in hospital policy and procedures which include senior medical personnel and detailed consent forms, both of which have been linked to rising consent rates in recent years. Finally, the perception that coronial autopsies are beyond familial consent has been challenged recently by legislative changes in both Australia and the United States of America which allow objections based on religion and culture to be heard by coroners. For these reasons, it is argued that medical personnel need to focus on increasing hospital autopsy rates, while also addressing the complex ethical issues associated with conducting medical research within the context of the coronial autopsy.     

Better Regulation of Industry-Sponsored Clinical Trials Is Long Overdue

Regulating clinical trials for testing new drugs is fraught with risk. Misregulation can slow development of innovative and useful new drugs, but in other ways misregulation can foster trials that are inefficient and unethical, driven by commercial rather than scientific ends, and that can harm patients. In this paper, we argue not for more but for better regulation, based on the goal of rapidly producing innovative and safe products that represent significant advances in medical care. Data on industry-funded, late-stage clinical trials demonstrate an urgent need for dramatic changes in how these trials are designed, conducted, and analyzed. On the one hand, current patent rules can dissuade development of innovative new products with smaller markets and press trial designers to create positive results too rapidly. But at the same time, numerous studies show that when the pharmaceutical industry sponsors clinical trials, the results are systematically biased in favor of the sponsor's product, often to the detriment of patients and the public. The reasons for this bias are both complex and unavoidable, and the ways in which clinical trial design, conduct, and reporting can be inappropriately influenced are so varied and nuanced, that efforts to manage this conflict of interest and prevent harms are inevitably unsuccessful. Instead, we conclude such conflict should be avoided and a strong firewall should exist between drug developers and the final stages of clinical testing in humans. All financial support for phase III clinical trials should pass through a public-private partnership organization — perhaps tied to a broader clinical effectiveness research enterprise — which would be charged with designing, funding, and monitoring late-stage human clinical trials of new pharmaceutical products.     

Korean citizen participation in criminal trials: The present situation and problems

As citizen participation in criminal trials was first introduced in 2008, it is advisable to keep the present form of an all-citizen jury system rather than introduce or adopt aspects of the Continental mixed tribunal system because the former system makes the best use of the meaning of Article 1 of the Act of Citizen Participation in Criminal Trials in Korea. Though previously professional judges participated in the deliberation process, under the current system, the new procedure should allow only jurors to engage in deliberations and render verdicts, with sentencing still left to professional judges. The new law should also eliminate a consent agreement required for a defendant in jury trial, thereby making jury trial mandatory for certain classes of heinous crimes like murder or even political crimes; juvenile cases, however, may still be excluded from jury trial. In addition, the exclusion right of the court should also be recognized, but the current comprehensive rule (Article 9 (1) (3)) should be eliminated. It is necessary for the jury verdict to have legal binding force such that the prosecutor cannot appeal the acquittal if the verdict was decided unanimously. Lastly, as for the use of victim participation programs, it is enough to simply allow victims to make statements as witness. This year, on March 6, 2013, the revised system of civil participation in criminal trials has been ready based on the evaluation of the current system by the Committee on Civil Judicial Participation, which was comprised of members from the judiciary, the academia, and civil organizations. The new amendment will be submitted to the National Assembly within this year.     

Punishment and the Duties of Offenders

This paper offers a partial critique of one of the central lines of argument in Victor Tadros’ The Ends of Harm: his attempt to show that a system of deterrent punishment can avoid the objection that it treats those who are punished ‘merely as means’ to our goals, by arguing that we may legitimately use someone as a means if in doing so we are simply forcing her to do what she anyway had an enforceable duty to do. I raise some questions about the idea of forcing someone to do what she has a duty to do; about what duties a wrongdoer incurs towards his victim, and how they may be enforced; and about whether we can move from such duties to a justification of criminal punishment as a deterrent.     

The Structure of Social Practices and the Connection between Law and Morality*

In his work, Jules Coleman has held that the rule of recognition, if conceived of as a shared cooperative activity, should be the gateway through which to incorporate moral constraints on the content of law. This analysis, however, leaves unanswered two important questions. For one thing, we do not know when or even why morality becomes a criterion of legality. And, for another thing, we still do not know what conception of morality it is that we are dealing with. In this article, we will attempt to clarify in greater depth what relations there are between the social practice of law and morality. We will thus see how the cooperative nature of social practices imbues law with a moral force, and how this makes it possible to establish a “weak” connection between law and morality: To see this, we will need to single out some basic features of cooperative social practices, thus setting out a suitable framework for the view just mentioned.     

Trial complexity

A field experiment is reported that examines the effects of trial complexity and trial procedures on jury performance. Juror question asking and notetaking were randomly assigned to 75 civil and 85 criminal trials. Principal components analyses of judges' responses revealed three components of trial complexity: evidence complexity, legal complexity, and quantity of information. None of these components was significantly related to judge-jury verdict agreement. Each component uniquely affected jurors' assessment of the trial, but none affected theirs or the judges' verdict satisfaction. Interactions reveal that juror questions were most beneficial for assisting the jurors with legal complexity and evidence complexity. Natural variation in judges' commenting on the weight and credibility of witnesses, or summarizing the evidence, use of special verdict forms, pattern instructions, and juror orientation was also measured. Of these, the use of special verdict forms appeared to provide the greatest benefits.     

The right to be forgotten – a Dutch perspective

This paper will be investigate to what extent the right to be forgotten as proposed by the European Commission is already recognized in Dutch tort law. The focus of this paper will be on the existence and the desirability of such a right and not on questions of enforcement. It is submitted that although Dutch law does not recognize the right to be forgotten as such, several judicial decisions can be identified that afford protection to interests that are also protected by the proposed right to be forgotten. This indicates that in the Netherlands a right to be forgotten in some form or another might have developed over time but this would have been a lengthy affair. A more precise formulation of this right by the legislator is therefore welcomed. It has been remarked that the name ‘right to be forgotten’ may give rise to unrealistic expectations but the Dutch experience shows that people do not seem to be very aware of their rights. ‘A right to be forgotten’ – however imprecise from a legal viewpoint – might be catchy enough to remedy this.     

医疗行为中患者承诺的一般效力与例外——个人自决权与社会连带之限制的平衡

本文从患者承诺作为医疗行为的正当性根据出发,从比较法的视角观察了医疗行为中患者承诺的一般有效要件及特殊情形下的豁免与例外等诸种情形,用尊重个人自决权和社会连带之限制的理论阐释了前述情形,最后通过对＂安乐死＂的简要分析初步回答了如何平衡患者的个人自决权与社会连带之限制这一问题。