Current issues in clinical research and the development of new pharmaceuticals

As a normal part of the drug development process, U.S. pharmaceutical companies conduct many thousands of clinical trials each year. Only after a reasonable assurance of safety is made can the drug be given to patients who have the underlying medical condition that the drug is designed to treat. Patient welfare is assured by adhering to the Food and Drug Administration's interpretation of the “common rule”; if the data will be used to support a licensing application. 21 CFR Part 50 sets forth the regulations along with the principles of informed consent and the use of institutional review boards (IRBs) that assure patients’ rights are protected. Any potential conflict of interest on the part of a clinical investigator must be reported to the FDA. Pharmaceutical companies extensively monitor ongoing clinical trials for compliance with appropriate regulations. The recent revision of the Declaration of Helsinki governing placebo‐controlled clinical trials may adversely impact drug development     

14 to 18 Year Olds as “Children” by Law?

SUMMARY

The European Union Council Framework Decision 2004/68/JI of 22.12.2003 “on combating the sexual exploitation of children and child pornography” defines as “child” any person below the age of 18. Under Austrian law there are no children between the ages of 7 and 18. The author criticizes that, up to now, the development of age limits in legal history has taken a clearly different way in the various fields of law of the Austrian legal order. The Austrian legislator's tendency, which has evolved in the course of legal history, to grant rights and permits to young people between 14 and 18 years earlier but, at the same time, to impose on them more and more obligations arising from private and public law, to give them the opportunity to grow into adult life with full powers and responsibilities step by step, totally contradicts the Council Framework Decision.

Today, adolescents live in a cultural environment characterized by globalized pop culture and world-wide communication technology. Access to “extreme ideas” is offered everywhere and anytime. It is highly difficult to grow up without any interference and develop one's own personality and sexual orientation according to one's inherent nature under such circumstances of a world society, and this process may be seriously disturbed or even prevented by inappropriate prohibitions imposed by criminal law. However, the aim of any education is to accompany adolescents while they are growing up so that they become self-assured, self-responsible citizens with an understanding of how to work for peace and common welfare who know “how to walk upright” and do so, and who are informed about their civil rights and are able to exercise the same decidedly. We do not need only consumers but also citizens of the world! Repatriarchalization and criminalization are the wrong answers to the urgent questions of world society. The question how to combat child pornography commerce is certainly one of the most important concerns because it is abused children and adolescents for whom it is most difficult to develop their personalities and become citizens of the world.

Legally useful answers can only be expected by those who address precise questions to the law. In this respect Europe failed. Given the fundamental right to respect for one's private life and the prohibition of discrimination on the grounds of age the creation of new offencesinvolving a definition of the child as a person up to the age of 18, which contradicts well established law and is unrealistic-shoots past the mark in the author's opinion. Such provisions miss the target group of potential offenders, and infantilize and criminalize society instead. With the proposed legal means it will not be possible to attain the actual aims, i.e., to finally destroy the market for child pornography, and to punish its organizers, “wire-pullers” and users as offenders, and to eliminate them once and for all. The legal status of adolescents is weakened or at least serious curtailment of their claims arising from the fact that they have fundamental rights depending on personality and age; and the Council Framework Decision contradicts the equality guarantees in primary law of the European Union that they must not be discriminated on the grounds of age.     

从伦理视角完善我国的代为同意制度

知情同意理论当下已经成为医法学者研究的热点。我国知情同意理论法律制度的不健全，特别是作为其重要组成部分的代为同意制度的不完善，严重地阻碍了医患关系的发展。以伦理视角为切入点，可以从下列几个方面完善该制度：一是确立紧急情形下强制诊治义务和责任限制原则；二是规范紧急情形下代为同意主体排序和程序；三是健全代为同意的社会责任保障制度。     

Participation of Mentally Disabled Persons in Experimental Research

Abstract

The need for persons adjudged incompetent is sometimes crucial to performing necessary research. However, this is a complicated proposition since the rights of mentally challenged persons must be protected. There is an acknowledged need to balance the objective requirements of scientific research with the rights and concerns of those who are the subjects of experimentation. This article discusses the role of social workers concerning the participation of mentally challenged persons in experimental research.     

Variation within households in consent to link survey data to administrative records: evidence from the UK Millennium Cohort Study

This study expands our knowledge of consent in linking survey and administrative data by studying respondents’ behaviour when consenting to link their own records and when consenting to link those of their children. It develops and tests a number of hypothesised mechanisms of consent, some of which were not explored in the past. The hypotheses cover: parental pride, privacy concerns, loyalty to the survey, pre-existing relations with the agency holding the data, and interviewer effects. The study uses data from the longitudinal Millennium Cohort Study to analyse the correlates of consent in multiple domains (i.e. linkage of education, health and economic records). The findings show that respondent’s behaviour vary depending on the consent domain and on the person within the household for whom consent is sought. In particular, the cohort member’s cognitive skills and the main respondent’s privacy concerns have differential effects on consent. On the other hand, loyalty to the survey proxied by the longitudinal response history has a significant and strong impact on consent irrespective of the outcome. The findings also show that interviewers account for a large proportion of variations in consent even after controlling for the characteristics of the interviewer’s assignment area. In total, it is possible to conclude that the significant impact of some of the correlates will lead to sample bias which needs to be accounted for when working with linked survey and administrative data.     

Baby K's unlawful removal: practice issues in the emergency protection of children

This paper addresses the legal and practice issues raised by a particular case in the UK. In January 2008, less than three hours after his birth, Baby K was removed from his mother's care by hospital staff and placed in a separate ward. At a High Court hearing later that morning, it was ruled that the removal of Baby K was unlawful. Important practice issues are raised by this ruling. After setting out the circumstances under which Baby K was removed from his mother, this paper considers a number of issues raised by the case: (i) what constitutes lawful removal under domestic law; (ii) European jurisprudence and domestic law in relation to emergency removal at birth; (iii) parental consent to removal; (iv) professionals' liability for breaches of human rights; and (v) the role of child protection plans in safeguarding children. Copyright © 2010 John Wiley & Sons, Ltd.     

Ableism,ambiguity, and the Anna Stubblefield case*

This article discusses the ongoing case of Anna Stubblefield, a former Rutgers University philosophy professor who was convicted of the sexual assault of an African American man with cerebral palsy. On appeal, the conviction was reversed, and as of this submission Stubblefield is awaiting news from the state of New Jersey Supreme Court as to whether there will be a retrial. This piece engages with Sherry’s article in this journal, and dissects the many layers of ableism at play in this case, arguing that justice will not be served until the alleged victim gets to be heard.     

论受害人同意

受害人同意是侵权法上的重要抗辩事由之一,具有使侵害人实施加害行为而不承担侵权责任或者减轻其责任的法律效力.受害人同意发生法律效力应当具备四个要件.受害人同意法律效力的基础有正当理由说、权利抛弃说、受害人过错说.受害人同意是一种正当的抗辩事由,而非免责事由,其基础应当考虑行为自由、权利滥用、利益量衡、法律价值趋向等方面.     

推进避孕节育知情选择的探索与认识

作为联合国人口基金生殖健康 /计划生育项目试点县 ,英山县在推行避孕节育知情选择工作中做了一些有益的探索。通过对实践的总结、分析、思考 ,认识到 :推进避孕节育知情选择 ,需要对该项工作有全面、正确的理解 ;对工作中的风险应有准确的认识和防范能力 ,该项工作的深入开展还须与目标考核改革相配套     

冲突与共识：《泥泞时节的两个流浪汉》的应用伦理学解读

罗伯特·弗罗斯特诗作《泥泞时节的两个流浪汉》以直面现实的态度忠实记录了发生在大萧条时期的一场富于伦理意味的冲突。传统伦理批评强调对是非善恶做出判断和选择，在面对此类道德悖论时往往陷入两难僵局。应用伦理学倡导直面冲突、依靠商谈程序、寻求道德共识和容错纠错，恰好为这首诗的解读提供了钥匙。