首页> 外文期刊>AJOB empirical bioethics. >Clinicians or researchers, patients or participants: Exploring human subject protection when clinical research is conducted in non-academic settings
【24h】

Clinicians or researchers, patients or participants: Exploring human subject protection when clinical research is conducted in non-academic settings

机译:临床医生或研究人员,患者或参与者:在非学术环境中进行临床研究时,探索对人类受试者的保护

获取原文
获取原文并翻译 | 示例
获取外文期刊封面目录资料

摘要

Background: Clinical research is increasingly conducted in private physicians' offices, clinics, community hospitals, local institutes, and independent research centers. The migration of research into this non-academic environment has brought new cadres of researchers into the clinical research enterprise and broadened the pool of potential research participants. This study was designed to explore how clinical investigators and research coordinators protect human subjects and ensure research integrity when conducting clinical research in non-academic settings. Methods: We employed a qualitative research design employing semistructured interviews that took place between October 2010 and September 2012. The sample of 80 participants from across the United States included 38 clinicians and 42 research coordinators, most of whom had been involved in clinical research for more than 5 years and nearly all of whom reported their patient base included a sizable rural population. With the aid of a research management tool, Atlas-Ti, the data were coded and organized into themes that could be compared and contrasted. Results: Findings suggest that clinicians conduct clinical research because such research is perceived as beneficial for both the patient and the practice. Findings also suggest that clinicians do not perceive firm distinctions between the roles of clinician and researcher, nor do they perceive firm distinctions between the goals of research and the goals of clinical care. Rather, most of the clinicians and coordinators in this study viewed trial participation as a means of providing optimal care for the individual patient. Conclusions: Findings suggest that the current processes and protocols employed in non-academic research settings may not achieve optimal protection of human subjects. More research is needed in order to more fully understand how a combination of factors, including the financing of research, recruitment practices, and the blurred distinctions between research and treatment, may undermine the optimal protection of human subjects.
机译:背景:临床研究越来越多地在私人医师办公室,诊所,社区医院,当地机构和独立研究中心进行。研究向这种非学术环境的迁移将新的研究人员带入了临床研究企业,并扩大了潜在研究参与者的范围。本研究旨在探讨临床研究人员和研究协调员如何在非学术环境中进行临床研究时保护人类受试者并确保研究完整性。方法:我们采用了定性研究设计,该研究采用了2010年10月至2012年9月之间的半结构化访谈。来自美国各地的80名参与者的样本包括38名临床医生和42名研究协调员,其中大多数人参与了更多的临床研究。不到5年,几乎所有报告其患者基础的人都包括相当多的农村人口。借助研究管理工具Atlas-Ti,数据被编码并组织成可以比较和对比的主题。结果:研究结果表明临床医生进行临床研究,因为这样的研究被认为对患者和实践都是有益的。研究结果还表明,临床医生不会在临床医生和研究人员的角色之间感觉到明显的区别,也不会在研究目标与临床护理目标之间感觉到明显的区别。相反,该研究中的大多数临床医生和协调员都将参加试验视为为单个患者提供最佳护理的一种手段。结论:研究结果表明,当前在非学术研究环境中采用的程序和协议可能无法实现对人类受试者的最佳保护。为了更全面地了解包括研究经费筹集,招聘实践以及研究与治疗之间的模糊区分在内的多种因素如何可能破坏对人类受试者的最佳保护,需要进行更多的研究。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱:kefu@zhangqiaokeyan.com

京公网安备:11010802029741号 ICP备案号:京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有
  • 客服微信

  • 服务号