Study on the rights and interests of subject in clinical trials

Abstract

Clinical trials are essential measures to determine the efficacy and safety of drugs. Clinical trials of new drugs and new medical devices have also received strong support at the national level. In the case of more and more clinical trial cases, how to better protect the rights of the subject becomes a problem that needs to be discussed in more depth. Based on the background of the development of clinical trials, this paper describes the lack of rights protection under the traditional support methods of clinical trial subject and then analyzes the problems of the subject’s right to life, body autonomy, informed consent, privacy and compensation. Problems with current subject rights protection and possible safeguards. The paper believes that the development and application of new life technologies make the clinical trial process more complicated and the results more uncertain. Therefore, the protection of traditional subject rights is not perfect, we need to expand legislative coverage, improve the rights dimension of subject rights protection and the structural dimension analysis of the ethics review committee which are effective measures to protect the rights of subject.

Keywords: clinical trial, subject rights, rights protection

DOI: 10.7176/PPAR/9-12-01

Publication date: December 31^st 2019