Introduction and practice of broad consent in China / 中华医院管理杂志

ABSTRACT

In recent years, foreign countries are gradually implementing broad consent to improve the utilization of medical data and biological samples, but broad consent may face ethical issues such as imperfect notification and affecting the rights of subjects. There are already relevant regulations and practices on broad consent in foreign countries. The concept of broad consent is not clearly defined in China′s laws. At present, the treatment of biological samples can be roughly divided into four categories in practice, and there is potential application space for broad consent. The specific scope of broad consent should be clarified, distinguished from donation behavior, and the implementation of broad consent should be explored on the basis of protecting the rights of subjects.