An Exploration of the Protective Effects of Investigators' Ethical Awareness upon Subjects of Drug Clinical Trials in China

作者：Zhang, L.; Huang, X. X.; Chen, H. F.^*

来源：Journal of Bioethical Inquiry, 2018, 15(1): 89-100.

DOI：10.1007/s11673-017-9826-5

• Ethics committees
• Insurance
• Informed consent
• Human subjects research
• Research ethics
• China

Up till now, China has not enacted any legal mechanisms governing certification or supervision for ethics committees. This article analyses deficiencies in the protection of subjects in clinical drug trials under China's current laws and regulations; it emphasizes that investigators, as practitioners who have direct contact with subjects, play significant roles in protecting and safeguarding subjects' rights and interests. The paper compares the status quo in China in this area to that of other countries and discusses ways China might enhance the protection of rights and interests of trial subjects, such as enhancing the ethical awareness of investigators through training, improving laws and regulations, and strengthening the communication between investigators and ethics committees.

• 出版日期2018-3
• 单位温州医科大学