Human subject protection in clinical cancer trials : Action research

4年来行动研究的成果总结如下：a.参与癌症临床试验的研究护士联网肿瘤研究护士需要联网机会来讨论和解决病人的问题。我们最初开始了学习会议，然后联系了日本癌症护理学会，组织了专门的兴趣小组来回应成员的要求。2006年，全体会议批准了14个特殊利益小组，临床试验护士是其中之一。网络是这项行动研究最重要的成果。B.临床癌症试验中人类保护的同步概念分析我们在3个阶段进行了同步概念分析：1)日本的现状；2)其他国家的现状；3)整合日本和其他国家的情况。然后我们组成了一个共识小组。分析和独立澄清的概念包括“知情同意”、“风险/效益评估”、“倡导…More Cy”和“协作”。图中详细描述了每个概念的关键属性、前提条件、推动因素和结果。此外，提取了与每个概念相关的公共因素，并细化了临床癌症试验中人类主体保护的定义。共同的因素，即前置因素和促成因素、关于人类研究的规定、“豁免”和“信息”表明，在临床癌症试验中，人类的主体保护是可以控制的。C.护理专家的定性分析与文本数据分析软件的比较从《朝日新闻》和《读卖新闻》的文章中分析了来自临床癌症试验的高风险信息，因为这些报纸有数据系统，允许对已发表的文章进行计算机搜索。文本数据分析软件WordMiner[0！R]从标题和文章中单词的含义中选择关键词，而护理专家则通过在上下文中解释单词来选择关键词。这些发现表明，收集的数据的可信度需要在双方同意的情况下比较专家的解释。因此，WordMiner[0！r]选择了专家在阅读时可能会忽略的有价值的信息(单词)，因为不同的字符是通过概率测试提取的。较少

Outcomes of action research over 4 years are summarized as follows:A. Networking for research nurses involved in clinical trials of cancerOncology research nurses required networking opportunities to discuss and resolve patients' issues. We initially started study meetings and then approached the Japanese Society of Cancer Nursing to organize special interest groups to respond to members' requests. The plenary session approved 14 Special Interest Groups in 2006 and Clinical Trial Nurses comprised one of them. Networking was the most important outcome of this action research.B. Simultaneous concept analysis of human protection in clinical cancer trialsWe conducted simultaneous concept analyses in 3 phases: 1) the current situation in Japan; 2) the current situation in other countries; 3) integrating situations in Japan and other countries. We then formed a consensus group. Concepts for analysis and independent clarification included "informed consent", "risk/benefit assessment", "advoca … More cy", and "collaboration". Critical attributes, antecedents, enablers, and outcomes of each concept are described in detail in a figure. Furthermore, extracted common factors associated with each concept and the definition of human subject protection in clinical cancer trials was refined. The common factors, namely antecedents and enablers, "regulation of research on humans", "waivers" and "information" suggested that human subject protection can be controlled in clinical cancer trials.C. Comparison between qualitative analysis by nursing experts and software for text data analysisRisk information from clinical cancer trials was analyzed from articles in the Asahi Shinbun and Yomiuri Shinbun because these newspapers have data systems that allow computer-based searching of published articles. The software for text data analysis, WordMiner【○!R】, selected keywords from the meanings of words in headings and articles, whereas nursing experts selected them from interpreting the words in context. These findings suggest that trustworthiness of the collected data requires comparing expert interpretations by mutual consent. Thus WordMiner【○!R】 selects valuable information (words) that experts might overlook while reading because distinctive characters are extracted by probability tests. Less