摘要
目前国内越来越多的采供血机构陆续开展涉及人的生命科学与医学研究,这就要求机构设立医学伦理委员会对其进行伦理审查,以确保医学研究试验的设计和实施合乎道德和法律,同时保护受试者的安全、健康、隐私等权益。本研究结合采供血机构的性质与特点,以南京红十字血液中心伦理委员会为例,探索采供血机构医学伦理委员会规范化建设中的经验与不足,并针对采供血机构以献血者血液样本及相关信息开展医学研究和采供血机构医疗器械临床试验的伦理审查提出思考,从而更好地保护受试者权益,促进采供血机构输血医学研究健康平稳发展。
To date,the proliferation of life science and medical research involving human participants in Chinese blood collection and supply institutions necessitates the eatablishemnt of medical ethics committees,which conduct ethical reviews to ensure that medical research trials adhere to ethical and legal standards,safeguarding the safety,health,privacy and other rights of study subjects.Taking the Ethics Committee of Nanjing Red Cross Blood Center as a case study,we aimed to explore the standardization process of medical ethics committees within blood collection and supply institutions by evaluating their accomplishments and shortcomings,and we sought to offer insights into the ethical considerations regarding medical device clinical trials using blood samples and donor information from these institutions,thus better protecting the rights and interests of research participants,and fostering the healthy and sustainable growth of blood transfusion medical research within the sector.
作者
刘紫娟
王婷
张立波
傅强
何成涛
张春
LIU Zijuan;WANG Ting;ZHANG Libo;FU Qiang;HE Chengtao;ZHANG Chun(Nanjing Red Cross Blood Center,Nanjing,Jiangsu,210003)
出处
《临床输血与检验》
CAS
2024年第5期702-708,共7页
Journal of Clinical Transfusion and Laboratory Medicine
关键词
采供血机构
医学伦理委员会
伦理审查
医疗器械临床试验
Blood collection and supply institutions
Medical ethics committee
Ethical review
Clinical trials of medical devices
