医疗技术人体试验中受试者的知情同意权

自纽伦堡大审判以来,医疗技术人体试验中取得受试者的知情同意已经成为人体试验的首要原则.受试者知情同意权包括知情权和同意权.对缺陷告知而实质上影响到受试者的选择权或未经受试者同意实施的试验行为,不管在人体试验中试验者是否尽到注意义务,由此试验行为造成的损害均由试验者承担.     

Research involving human subjects

This paper will discuss the history of human subjects in research and the subsequent regulations and requirements that now govern human subject research. Also presented are the requirements and definitions of the oversight bodies which govern human use research in the United States.     

人体试验管制的主要国际规范简介

纽伦堡大审判之后,国际上关于生物医学人体试验的管理规范被系统地提出。在比较研究的基础上对国际以及国际组织的相关人体试验伦理、法规作一简要介绍。     

A review committee's guide for evaluating qualitative proposals

Although they complain that qualitative proposals are not reviewed fairly when funding agencies use quantitative criteria, qualitative researchers have failed the system by not developing alternative criteria for the evaluation of qualitative proposals. In this article, the author corrects this deficit by presenting criteria to assess the relevance, rigor, and feasibility of qualitative research. These criteria are not a checklist but rather a series of questions that can aid a reviewer, adept in qualitative methods, to comprehensively evaluate and defend qualitative research.     

上海市部分公立医院涉及人体医学研究项目知情同意书的评价

随机抽取上海市8所公立医院145份涉及人体的医学科研项目知情同意书,对其内容、语言和签字状况进行了审核。研究显示,知情同意书总体符合研究伦理要求,但仍存在不足。为此,建议规范知情同意书的的内容。     

Development of human resources for medical research

Acknowledges that progress in health care depends on achievements in biomedical research. Discusses the continuing professional development of research workers and the role of international organizations such as the WHO and UNESCO. Argues that a creative approach is necessary to ensure stability in health development.     

A random walk model for evaluating clinical trials involving serial observations

For clinical trials where the variable of interest is ordered and categorical (for example, disease severity, symptom scale), and where measurements are taken at intervals, it might be possible to achieve a greater discrimination between the efficacy of treatments by modelling each patient's progress as a stochastic process. The random walk is a simple, easily interpreted model that can be fitted by maximum likelihood using a maximization routine with inference based on standard likelihood theory. In general the model can allow for randomly censored data, incorporates measured prognostic factors, and inference is conditional on the (possibly non-random) allocation of patients. Tests of fit and of model assumptions are proposed, and application to two therapeutic trials of gastroenterological disorders are presented. The model gave measures of the rate of, and variability in, improvement for patients under different treatments. A small simulation study suggested that the model is more powerful than considering the difference between initial and final scores, even when applied to data generated by a mechanism other than the random walk model assumed in the analysis. It thus provides a useful additional statistical method for evaluating clinical trials.     

上海市部分公立医院涉及人体的医学研究项目知情同意的效果评价

对上海市40名曾参加过药物临床试验的高校学生进行了有关知情同意方面的问卷调查.结果显示,研究项目知情同意的状况基本被学生受试者接受,但作者建议今后应更好地保护学生受试者.     

上海市部分公立医院涉及人体医学研究项目知情同意过程分析

建议进一步加强医院伦理委员会的作用,规范知情同意的操作,加强公众宣传、改善医患关系,以改善公立医院涉及人体研究项目的知情同意工作。     

上海市部分公立医院涉及人体的医学研究项目知情同意的效果评价

对上海市40名曾参加过药物临床试验的高校学生进行了有关知情同意方面的问卷调查。结果显示，研究项目知情同意的状况基本被学生受试者接受，但作者建议今后应更好地保护学生受试者。     

A warm welcome for refugees

The Catholic Collaborative Refugee Network (CCRN) was established more than four years ago as a result of discussions among CHA, Catholic Charities USA, and the U.S. Conference of Catholic Bishops' office of Migration and Refugee Services. The dozen CCRN sites each provide an organized response to the social, economic, and health problems often faced by refugees. Although the sites differ in their services, they typically help refugees prepare for and find work, preferably work with health insurance coverage. Serving both immediate and long-term needs of refugees by consolidating services and forging partnerships with local groups, the CCRN helps refugees to become self-supporting. This article introduces the work of CCRN by highlighting recent success stories from Baton Rouge, LA, and from Joliet, IL. The CCRN site coordinator for Amityville, NY, provides guidance in identifying victims of trafficking.