A Qualitative Study on the Issues of Informed Consent Among Research Participants

Informed consent, as the core mechanism for safeguarding the rights and interests of research participants in drug clinical trials, still faces many challenges in its actual implementation process. Semi-structured interviews with 71 participants in a drug clinical trial study in a tertiary hospital revealed that poor readability of informed consent forms, participants' preference for verbal explanations over reading, limited diversity in modes of information disclosure, and excessive reliance on the credibility of institutions all affected participants' understanding and evaluation of informed information to varying degrees, thereby weakening the effective exercise of their right to know. Some research participants who frequently participated in the trials questioned the necessity of informed consent forms. Based on these problems, improvements are needed in the design of consent documents, better integration of verbal and written communication, diversification of information delivery methods, and enhanced education for participants. These measures aim to better guarantee participants' right to know and the right to make independent decisions, and improve the ethical compliance and effectiveness of clinical drug trials.