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美国人类受试者使用的历史   总被引:7,自引:0,他引:7  
所有关于研究伦理的国际法典及实际中的关于人体受试者研究领域的各国立法及规则都表明了保护主义的姿态,他们的主旨是保护个人不受伤害和剥削。这种保护主义姿态有其重要的历史原因,起草这些文件具有这样的目的;保证像被纳粹医生-研究者犯下的罪行,试验药物Thalidomide引发的灾难及Tuskegee梅毒研究对伦理道德的亵渎永远不会重演,近些年来社会对临床研究的理解已发生了戏剧性转变,如经AIDS积极分子努力的结果,人们已以宽容和有益的心态广泛接受临床试验。虽然这种姿态的转变已产生了在指导进行临床研究方面的政策及实践某些重要的改善,但人们必须认识到,这种新的接受正像先前的过度保护主义一样的错误,其应该维护一个平衡的比例。我们的政策应反映出鼓励符合伦理学的研究的要求,同时要保持必要的防范以保护受试者的权益。  相似文献   
54.
美国人体研究的监督:科学发展中的伦理与规定   总被引:7,自引:0,他引:7  
美国保护人体受试者的制度建立在伦理学基础之上,并正式通过相关法律。对人体研究的监督是保护受试者个人的健康和权益,确保研究的有效性,整体性,以及科学与社会更大范围的利益,监督审查机构是联邦卫生部下属的两个机构-食品与药品管理局(FDA)和人体研究保护办公室(OHRP),大部分人体研究受两机构监督。美国人体受试者保护系统的基础部分是伦理审查委员会(IRB)及知情同意,IRBU电在提供一种机制,以进行客观的审查,同意和研究过程听持续监督;知情同意意在保证个人在了解与实验相关的风险,不适,收益后能自由做出参加与否的决定,美国人体研究保护制度正面临着挑战。美国也为促进人体受试者保护在进行新的努力。  相似文献   
55.
The present study investigated the effect of threat of physical harm on the aggressive behavior of intoxicated and nonintoxicated subjects. Forty male undergraduates competed in a reaction time task in which they could deliver shock to an increasingly provocative opponent. In the threat condition, subjects could be hurt by the opponent (they wore a shock electrode), while in the no-threat condition, they could not be hurt by the opponent (the electrode was removed prior to the competition). The results indicated that under conditions of low provocation, the intoxicated subjects behaved more aggressively than the nonintoxicated subjects in both the threatening and nonthreatening condition. However, under conditions of increasing provocation, only the intoxicated subjects in the threatening condition increased their shock settings.  相似文献   
56.
Resurgence experiments sometimes include an operandum on which a history of reinforcement has not been experimentally established. The purpose of this control operandum is to rule out a generalized increase in responding when the alternative response is extinguished as being the cause of the resurgent target response. A review of the results of experiments conducted with both nonhumans and humans in which a control operandum was included shows that control- operandum responding is more common in the latter and almost nonexistent in the former. Both the presence and absence of responding on the control operandum, however, are subject to multiple interpretations thereby rendering it a compromised tool. Alternatives to using a control operandum to rule out extinction induction as the basis for resurgence include a preresurgence test control procedure and a differential resurgence procedure.  相似文献   
57.
Our aims are to (1) set forth a multiprinciple system for selecting among clinical trials competing for limited space in an immunotherapy production facility that supplies products under investigation by scientific investigators; (2) defend this system by appealing to justice principles; and (3) illustrate our proposal by showing how it might be implemented. Our overarching aim is to assist manufacturers of immunotherapeutic products and other potentially breakthrough experimental therapies with the ethical task of prioritizing requests from scientific investigators when production capacity is limited.  相似文献   
58.
生物医学人体受试者研究未来面临的挑战   总被引:8,自引:0,他引:8  
人体受试者研究的伦理问题在今后将会愈益引起关注,如何看待知情同意的代理权?如何处理不同文化背景下的知情同意原则?在商业利益诱惑下背离本人健康利益和知情同意是否有效?受试者的利益回报,以及体试验研究要求的双盲,随机、对照等原则可能面临的新问是,都是人体受试者研究未来面临的挑战。  相似文献   
59.
This review summarizes the 6 studies with nonhuman animal subjects that have appeared in the Journal of Applied Behavior Analysis and offers suggestions for future research in this area. Two of the reviewed articles described translational research in which pigeons were used to illustrate and examine behavioral phenomena of applied significance (say-do correspondence and fluency), 3 described interventions that changed animals' behavior (self-injury by a baboon, feces throwing and spitting by a chimpanzee, and unsafe trailer entry by horses) in ways that benefited the animals and the people in charge of them, and 1 described the use of trained rats that performed a service to humans (land-mine detection). We suggest that each of these general research areas merits further attention and that the Journal of Applied Behavior Analysis is an appropriate outlet for some of these publications.  相似文献   
60.
Psychologists have long been concerned with the welfare and competent treatment of underserved populations. However, terminology used in psychological research is not always conducive to cultural sensitivity. This article discusses why the term “non-white” may be less sensitive to diverse populations and provides practical alternatives to this nomenclature. In addition, the authors examine the literature from 2008 to 2012 to establish whether the term “non-white” is still used to describe populations in psychological research. The article concludes with several recommendations for how researchers could choose to proceed in regards to identifying populations using culturally sensitive and relevant language.  相似文献   
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