학술논문
数字医疗临床研究的伦理审查问题研究 / Ethical Review of Digital Healthcare in Clinical Research
Document Type
Academic Journal
Author
Source
医学与哲学 / Medicine & Philosophy. 44(20):1-21
Subject
Language
Chinese
ISSN
1002-0772
Abstract
数字医疗作为一项新兴的医疗技术手段,其临床研究面临着多重伦理考量.首先需要明确研究类型及监管方式,确保研究符合相关政策要求;伦理审查应重点关注软件的设计是否有充分的科学性、软件的技术应当符合国家药品监督管理局相应规定,同时需要慎重考虑临床试验中的试验设计、对照组的选择、如何进行盲法、依从性监测、软件安全性风险、隐私数据保护等问题;知情同意告知内容应具有针对性,并充分考虑到数字医疗的产品可及性和研究者资格等方面的伦理问题,以更好地保障受试者的权益,促进我国数字医疗事业的健康发展.
As an emerging medical technology,digital healthcare faces multiple ethical considerations in clinical research.First,it is crucial to clarify the research types and regulatory methods to ensure compliance with relevant policies.Ethical review should focus on whether the design of the software is scientifically sound and whether the technology of the software complies with the corresponding regulations of National Medical Products Administration.Additionally,careful consideration is needed for trial design,selection of the control groups,implementation of blinding,compliance monitoring,software security risks,privacy data protection in clinical trials.Informed consent should be tailored to address ethical issues related to the accessibility of digital healthcare products,qualifications of researchers and other ethical issues,in order to better protect the rights and interests of subjects and promote the healthy development of digital healthcare in China.
As an emerging medical technology,digital healthcare faces multiple ethical considerations in clinical research.First,it is crucial to clarify the research types and regulatory methods to ensure compliance with relevant policies.Ethical review should focus on whether the design of the software is scientifically sound and whether the technology of the software complies with the corresponding regulations of National Medical Products Administration.Additionally,careful consideration is needed for trial design,selection of the control groups,implementation of blinding,compliance monitoring,software security risks,privacy data protection in clinical trials.Informed consent should be tailored to address ethical issues related to the accessibility of digital healthcare products,qualifications of researchers and other ethical issues,in order to better protect the rights and interests of subjects and promote the healthy development of digital healthcare in China.