揭开人类研究伦理委员会申请的神秘面纱。
Demystifying human research ethics committee applications.
机构信息
MBBS, FRACGP, PhD, MPH, Associate Professor and Chair of Phase 3, Graduate School of Medicine, University of Wollongong, Wollongong, NSW.
FRACGP, BSc(Med), MBBS, MIPH, PhD,@Associate Professor in Primary Care and Academic Lead in General Practice, Griffith University, Nathan, Qld.
出版信息
Aust J Gen Pract. 2023 Oct;52(10):721-727. doi: 10.31128/AJGP-02-23-6733.
BACKGROUND
The National Health and Medical Research Council's National Statement on Ethical Conduct in Human Research and updated Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research provide guidance for primary care researchers.
OBJECTIVE
This paper describes a step-by-step approach to ethics applications for research projects in primary care for new or inexperienced researchers, or those new to primary care research.
DISCUSSION
Domains that may enhance ethics applications include increased consumer involvement; comprehensive literature reviews; evidence of researcher training in ethical research and clinical trials; the use of online platforms for participant information, consent processes and surveys; and consideration of the risks of genomic research or research in subpopulations. This paper discusses steps required when preparing ethics applications to ensure the community, clinicians and researchers are protected.
背景
国家卫生和医学研究委员会的《人类研究伦理行为国家声明》和更新的《原住民和托雷斯海峡岛民健康研究伦理行为指南》为初级保健研究人员提供了指导。
目的
本文为初级保健研究领域的新项目或缺乏经验的研究人员，或刚接触初级保健研究的人员，描述了一种伦理学应用的逐步方法。
讨论
可能增强伦理学应用的领域包括增加消费者的参与度；全面的文献综述；证明研究人员在伦理研究和临床试验方面的培训；使用在线平台提供参与者信息、同意程序和调查；以及考虑基因组研究或亚人群研究的风险。本文讨论了在准备伦理学申请时需要采取的步骤，以确保社区、临床医生和研究人员得到保护。
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