Journal of Bioethical Inquiry

, Volume 15, Issue 1, pp 89–100 | Cite as

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

Original Research
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Abstract

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.

Keywords

Ethics committees Insurance Informed consent Human subjects research Research ethics China 

Notes

Compliance with Ethical Standards

Conflict of interest

The authors report no conflicts of interest in this work.

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Copyright information

© Journal of Bioethical Inquiry Pty Ltd. 2017

Authors and Affiliations

  1. 1.Office of Drug Clinical Trial InstitutionThe First Affiliated Hospital of Wenzhou Medical UniversityWenzhouPeople’s Republic of China
  2. 2.Office of Drug Clinical Trial Institution, The Frist Affiliated Hospital of Wenzhou Medical UniversityWenzhouPeople’s Republic of China

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