Further Discussion on Legal Points in Ethical Review of Research Participants’ Informed Consent / 中国医学伦理学

ABSTRACT

The protection of research participants’ rights and interests is mainly guaranteed through the informed consent system and the ethical review of the Ethics Committee. In practice, some sponsors or researchers misused or mixed legal terms when writing the informed consent forms. More importantly, during the implementation of informed consent by researchers, the phenomenon that insufficient and incomplete notification, and derogation of research participants’ specific rights and interests occurred. This not only affected the scientific nature of the research, but also violated the original intention of clinical trials or medical researchers, and did not fully respect the human dignity and value of research participants. It was urgent for the ethics committee to correct it during the ethical review, and urge the researchers or sponsors to correct and improve it in a timely manner.