Research on issues in the protection of clinical trial human subjects in China: a Delphi study

Abstract Background This study aims to identify current deficiencies in the protection of human subjects participating in clinical trials in China and propose strategies for safeguarding their rights. Methods We conducted a comprehensive literature review on the protection of human subjects in clinical trials and gathered insights from experts and scholars among stakeholders. The Delphi expert consultation method was used to analyze and summarize the shortcomings in China’s regulatory framework for human subject protection and to develop strategies for improvement. Two rounds of surveys were conducted with experts from research institutions, ethics committees, regulatory agencies, sponsors, and Site Management Organizations (SMOs). The top three issues and proposed solutions were discussed and addressed based on expert consensus. Results A total of 30 articles were reviewed, leading to the identification of 46 distinct issues, which were categorized into three groups: compensation, privacy, and informed consent. Sixteen respondents completed both rounds of the survey, which included 56 questions (10 new questions were proposed in the first round). Compensation-related issues included the absence of a comprehensive “mandatory insurance system,” incomplete insurance systems and compensation procedures, and the lack of clear differentiation between liability for clinical trial infringements and medical harm. Privacy concerns involved inadequate regulations, privacy risks associated with third-party recruitment, and data entry by clinical research coordinators. Problems related to informed consent were primarily due to inadequate awareness and capacity among investigators, a lack of oversight by ethics committees, and the absence of legal standards for broad informed consent. Conclusions By improving the details of compensation rights, privacy protection, and informed consent in regulations, all parties involved in clinical trials can be encouraged to more effectively protect the rights and interests of subjects.