Challenges and Countermeasures for Protecting Research Participants' Rights after the Completion of Research

The protection of research participants' rights following the completion of clinical trials has long been a focus of the Declaration of Helsinki. Currently, however, medical ethics and domestic and international regulations primarily concentrate on the research process itself; while there are limited regulations available to guide the protection of participants' rights in cases where they suffer harm as a result of their participation after the study has concluded. In China, research participants primarily face issues such as post-study information disclosure, identification of rights violations and research-related harm, as well as compensation and indemnification. By reviewing international and domestic regulations, guidelines, and relevant international experiences, this paper proposes strategies across four dimensions: improving national regulatory improvements, clarifying the responsibilities of sponsors through institutional agreements, strengthening ethics committee review safeguards, and standardizing implementation by researchers. It aims to provide regulatory authorities and practitioners with approaches to better protect the post-study rights of research participants.