Nurses: Research Integrity in Clinical Trials

护士：临床试验中的研究诚信

基本信息

批准号：
6616801
负责人：
JOAN LIASCHENKO
金额：
$ 13.05万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2002
资助国家：
美国
起止时间：
2002-08-01 至 2005-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6616801
关键词：
Parkinson's disease behavioral /social science research tag breast neoplasms cardiovascular disorder clinical research clinical trials decision making drug addiction ethics focus groups health care policy human subject mental disorders nursing research

项目摘要

DESCRIPTION (provided by the applicant): Research integrity is, appropriately, a national priority. However in discussions of clinical trials, research ethics focuses nearly exclusively on the perspective of Principal Investigators. Yet nurses are key in implementing clinical trials, that is, they perform much of the day-to-day work. While the ethical issues pertaining to physician-researchers are well documented, there is virtually no research on the ethical concerns and challenges confronting nurses working in clinical trials. There is some evidence indicating that their perspective differs from that of physician-researchers at least in certain circumstances. Also, the complexity of clinical trials suggests that the ethical concerns encountered by nurses might vary by disease being studied, type of trial, site of trial, source of funding, and other variables. In order to move towards a more complete knowledge of the ethical issues arising in research, it is crucial that we know more about the ethical concerns and challenges of nurses who implement Clinical trials and the institutional and other factors influencing these concerns and challenges. Assurance of research integrity requires that policies and guidelines be based on such an adequate understanding of the concerns and challenges faced in the work of Clinical trials. The specific aims of this research are to: 1) identify and describe the ethical and professional concerns encountered by nurses during their work in Clinical trials; 2) identify and compare the institutional and other conditions that influence the nurses' ethical/professional concerns; 3) describe the process nurses use in making ethical decisions within clinical trials; 4) identify sources of guidance/resolution for difficulties that clinical trials nurses have used to promote research integrity. Eight focus groups of nurses working in four disease-related Clinical trials will be conducted in two regions of the country. The four diseases are addictions/mental health, breast cancer, Parkinson's Disease, and cardiovascular disease. This study hypothesizes that Clinical trials investigating these four diseases will be associated with different ethical challenges and institutional factors. The sample will consist of 8 to 10 nurses per focus group with two focus groups for each disease. Demographic data including education level, specific training in ethics, and previous experience in Clinical trials work will be collected. Consensual qualitative analysis will be the primary method used for analyzing focus group data. This data will serve as a basis for future research, with two long-term goals for the research program. The first will be to evaluate the adequacy of existing policy and guidance for the research involving human participants, which has been developed without an understanding of the concerns confronting nurses in their work in Clinical trials. The second will be to reconsider the dominant understanding of the ethics of research, which conceives of moral decision-making as the application of abstract, impartial moral rules and tends to ignore the moral importance of context, such as the institutional and other factors we propose to investigate.

描述（由申请人提供）：研究完整性是适当的国家优先事项。然而，在对临床试验的讨论中，研究伦理几乎完全关注主要研究者的观点。然而，护士是实施临床试验的关键，也就是说，他们的日常工作大部分工作。虽然与医师研究人员有关的道德问题已经有充分的文献记录，但几乎没有关于在临床试验中面临的护士面临的道德问题和挑战的研究。有一些证据表明，至少在某些情况下，它们的观点与医师研究者的观点不同。此外，临床试验的复杂性表明，护士遇到的道德问题可能因研究，试验类型，试验地点，资金来源和其他变量而有所不同。为了更完整地了解研究中引起的道德问题，至关重要的是，我们对实施临床试验以及影响这些关注和挑战的机构和其他因素的护士的道德问题和挑战了解至关重要。研究完整性的保证要求政策和准则基于对临床试验工作中所面临的关注和挑战的充分理解。这项研究的具体目的是：1）识别和描述护士在临床试验中遇到的道德和专业问题； 2）确定并比较影响护士的道德/专业问题的制度和其他条件； 3）描述护士在临床试验中做出道德决策的过程； 4）确定指导/解决方案的来源，以解决护士用来促进研究完整性的困难。在该国的两个地区将进行四项与疾病相关临床试验的护士组成的焦点小组。这四种疾病是成瘾/心理健康，乳腺癌，帕金森氏病和心血管疾病。这项研究假设研究这四种疾病的临床试验将与不同的道德挑战和制度因素有关。样本将由每个焦点组的8至10个护士组成，每个疾病都有两个焦点组。人口统计数据将收集包括教育水平，特定的道德培训以及以前的临床试验工作经验。一定的定性分析将是用于分析焦点组数据的主要方法。该数据将作为未来研究的基础，并具有两个长期目标的研究计划。第一个是评估涉及人类参与者的研究现有政策和指导的充分性，该研究已经开发出来，而没有了解临床试验中护士面临的担忧。第二个将是重新考虑对研究伦理的主要理解，这种理解将道德决策视为抽象，公正的道德规则的应用，并倾向于忽略情境的道德意义，例如我们提出的制度和其他因素。