Suchergebnisse

Provisions for post-trial access (PTA) of the experimental intervention are required before the start of a clinical trial. Although there has been ample attention for PTA in the context of preventive vaccine research, discussions on PTA barely include maternal vaccine trials in which mother-infant pairs are exposed to the intervention. In maternal vaccination trials, specific PTA arrangements are required because pregnancy is transient and PTA may apply to the next pregnancy or the child. In this article, we examine the application and adherence to PTA in the context of maternal vaccine trials. We focused on differences between publications before and after 2000 when international ethical guidance documents formalized PTA requirements. Randomized maternal vaccine trials were included after a systematic search for clinical trials in phases II and III with a maternal vaccine as intervention. We used PTA as defined at the time of publication in the World Medical Association's Declaration of Helsinki (DoH) or in the ethical guidelines of the Council for International Organizations of Medical Sciences (CIOMS). In addition, we investigated whether PTA was included in the trial design. Therefore, we contacted principal investigators (PI's) of the publications found in the review to fill out a questionnaire regarding provisions for PTA. Before and after 2000, no trial articles examined in the systematic review described PTA in their trial publication (0/7, 0% and 0/17, 0%, respectively). In addition, more than half of the PI's of the trials found were not familiar with PTA recommendations in international ethical guidelines. Most cases of PTA included making knowledge available by publishing the results of the trial. The revision of the DoH in 2002 and the CIOMS ethical guidelines in 2002 has not resulted in increased PTA provisions for maternal vaccination trials. PTA is a shared responsibility of various stakeholders including sponsors, Institutional Review Boards, regulators, political entities, and researchers. Inclusion of PTA provisions in trial protocols and publications on maternal vaccination trials is essential to increase transparency on the form and content of these provisions.

AbstractWith innovations such as the six‐member jury, with efficient management of juror call‐ups and with persistent reminders to lawyers about possible abuse of the jury system, we can effectively modernize that antiest legal institution.

Includes index ; Bibliography: p. 341-342 ; Political or historical trials.--Religious trials.--Military trials.--Civil trials.--Criminal trials ; Mode of access: Internet.

The Japanese seeking to involve their citizens in the judicial system as well establishing a check on the power of the judiciary have enacted legislation to create jury trials. The type of jury trial enacted by this legislation, which takes effect in 2009, is a mixed-jury system where judges and citizens participate together in the jury deliberation. This article first explores the differences between mixed-juries and the American jury system. It then suggests why the Japanese opted for a mixed-jury system. From that point the article explores psychological theory surrounding collective judgment and how dominant individuals influence the group dynamics. With these theories in mind the article explores Japanese cultural attitudes and suggests that the objective of meaningful citizen participation might be impeded in the jury deliberation process. Finally the article proposes specific procedural devices to ensure meaningful citizen participation.