The clinical trial research participant as an inside trader: a legal and policy analysis

This Article examines whether a participant in a clinical research trial for a drug obtains material nonpublic information about the drug and its manufacturer or licensor and, if so, whether the participant may lawfully trade securities based on that information. This issue has been noted but not examined in depth in several articles in recent years. After an introduction to the federal law of insider trading and a discussion of relevant aspects of a supervised research trial, the Article concludes that, absent an agreement to the contrary, the participant would be free to trade securities based on any material nonpublic information learned in the trial. The author evaluates the extent to which the information is material and nonpublic and then presents the policy issues surrounding whetherthe participantshould be precluded from trading when in possession of material nonpublic information gained as a result of participation in the trial. While not resolving the competing policy considerations, including the value of allowing participants to make disclosure of their experiences in the trial before publication of the results in a peer reviewed journal, the Article presents an approach for preventing the misuse of material nonpublic information gained in the clinical trial context, by obtaining an agreement from the participant, and an agreement from the limited circle of persons to whom the participant should be allowed to make disclosure in any event (such as his personal physician and family members), that would render any trading by them unlawful under the federal law of insider trading.     

Independent medical review: expanding legal remedies to achieve managed care accountability

Author Leatrice Berman-Sandler reports on independent medical review (IMR), a state-based statutory remedy used to resolve disputes over coverage between patients and their health plans. Ms. Berman-Sandler explores the connection between ERISA preemption and IMR, and opines that in light of recent Supreme Court decisions, the stage has been set for expansion of IMR. Accordingly, Ms. Berman-Sandler concludes that there are strong legal and policy reasons for state legislatures to broaden the application of IMR and for the Court to continue to narrow ERISA preemption in order to increase accountability in the managed care arena.     

Mediation,financial remedies,information provision and legal advice: the post-LASPO conundrum*

The near-total collapse in numbers of solicitors providing legal advice and assistance to publicly-funded clients attempting to settle private family law issues through mediation since the legal aid reforms implemented in 2013 raises important questions about how, if at all, clients in mediation can receive legal information and advice other than from lawyers in financial cases following divorce. This article explores, in a preliminary way, this aspect of mediation practice, drawing on small-scale qualitative data from a study conducted shortly prior to the legal aid reforms concerning the settlement of such cases. It explores how mediators then approached their (permissible) function of providing clients with legal information and how they dealt with cases where they felt that the proposed outcome was particularly unfair to one party or unlikely to be endorsed by a court, and asks how mediation practice – and legal practice – may come under pressure to change in this brave new world.     

Black attitudes in prison: A sociological analysis

This study examined attitudes of black inmates at two institutions located in different sections of the United States. The attitudinal dimensions considered were black radicalism, race cohesiveness, class consciousness, the soul orientation, and allegiance to the inmate code. It was determined that despite the regional location of the institutions, there was considerable similarity regarding the relationship of the attitude sets to various pre-prison experiences and background factors, violence in prison, and type of offense. With respect to socialization effects, the nature of the institutional environment appeared to have a major impact upon the inmate's attitudinal orientation. The implications of the findings for the “Importation vs. Functional Adaptation” debate concerning the origins of inmate attitudes and behaviors are discussed.     

信用证欺诈法律救济的理论发展过程及其评述

信用证欺诈的频频发生,引起了人们关于对信用证欺诈的法律救济措施和法律救济理论的关注。本文重点论述了信用证欺诈法律救济理论及其发展的三个阶段,即:“禁止法院干预学说”阶段、“限制法院干预说”阶段和“法院依法救济说”阶段。本文还结合具体的案例对三个阶段的理论进行了具体和深入的分析。     

Serious assaults on prison staff: A descriptive analysis

Objective

The current study sought to illuminate the patterns associated with serious inmate-on-staff assaults, as well as the characteristics of perpetrators and victims.

Material and methods

This study examined 79 assaults on prison staff requiring more than first aid treatment, perpetrated by 96 inmates, in a large state correctional department during a 14-month period (September 1, 2007 through October 31, 2008).

Results

These assaults were both infrequent (53 per 100,000 inmates annually) and progressively more infrequent as the severity increased (hospitalization for non-life threatening injury or required reconstructive surgery = 2.2 per 100,000 inmates annually; hospitalization for life-threatening injury = 0.5 per 100,000 inmates annually). Among staff victims, Black and female correctional officers were underrepresented. Inmate perpetrators who were younger, Black, prison gang members, and/or serving sentences for violent offenses were disproportionately represented among assailants.

Conclusions

The low overall rate of serious staff assaults attests to the level of professionalism and training in modern corrections departments. Nonetheless, situational factors uncovered in the current analysis suggest that particular circumstances increase the likelihood of staff assaults, hence the need for continued training and vigilance on the part of correctional staff that come in direct contact with inmates.     

On the beginnings of foundational legal research into legal discourse

Conclusion The beginnings of foundational legal research require reflective access to the cultural dynamics which drive the social construction of legal reality. Such access is blocked by our naive immersion within commonsensical and policy-orientated attunements towards our experience of law.Since this very blockage is veiled by its own operation, a suspension of these standpoints is required. This allows us to begin to comprehend the way common sense institutes an ungrounded and superficial obviousness through a self-concealing and naively realistic interpretative schema. From here the positive character of foundational legal studies can itself emerge as the systematic interrogation of legal experience in relation to its what, how and forwhom structure. Foundational theorising is then redirected towards a more respectful and less exploitative relationship with the linguistic roots of our consciousness of law.I would like to thank Peter Goodrich for the useful comments made on the first draft of this article.     

The legal ethics of pediatric research

Since the mid- to late 1990s, the scientific and medical research community has sought to increase its access to healthy children for research protocols that involve harm or a risk of harm. This move reverses longstanding policy within that community generally to exclude healthy children from such protocols on the grounds that the research as to them is non-therapeutic, that they are particularly vulnerable to research-related abuses, and that they are unable themselves to give informed consent to their participation. The research community's new posture has been supported by prominent pediatric bioethicists who have argued that unless healthy children are included as research subjects in harmful or risky research, the pediatric population will continue to suffer relative to the adult population in the extent to which it benefits from modern advances in science and medicine. In their view, it is possible for the research community to self-administer a rule that strikes a balance between protecting healthy children from research-related abuses and allowing their inclusion in cutting-edge pediatric research. In this scheme, parental consent is central to the research community's claims about child protection. This Article explores the flaws inherent in this ethics of pediatric research. Specifically, it challenges the view from ethics that the law permits parents to consent to their children's inclusion in harmful or risky research to the extent that related invasions would meet legal maltreatment standards. More broadly, it challenges the movement to increase access to healthy children for harmful and risky research on the ground that it risks two important regressions: First, in its willingness to risk harm to individual children in the interests of the group, it threatens the progress the law has made in its development of the concept of the child as an individual worthy of respect in his or her own right, a concept that imagines parents as fiduciaries and that includes strong protections against invasions of bodily integrity. Second, in its failure to assure that the burdens of non-therapeutic research are not placed disproportionately on children of lower socioeconomic and minority status, it violates the antidiscrimination principle, which has only begun to make good on its promise of equal treatment for all children. Ultimately, this Article argues that harmonization of the rules governing pediatric research with the law of child protection and parents' consent authority is the best way to assure that children are protected in the research setting in these respects and to the same extent they are otherwise in the society.     

Pharmacy practice developments: the potential impact on pharmacists' legal liability

The practice of pharmacy has changed over recent years with a greater emphasis on the patient and the provision of patient care services. This expanded role of pharmacists as medication managers has resulted in changes to their professional responsibility and potential legal liability. Recent international case law demonstrates an increased legal liability of pharmacists in certain instances. However, pharmacists' liability in this new context in Australia is yet to be clarified.