Administrative measures for clinical research of stem cells (for Trial Implementation)
Measures for the administration of stem cell clinical research (for Trial Implementation) issued by the national health and Family Planning Commission and the State Food and Drug Administration recently jointly issued the measures for the administration of stem cell clinical research (for Trial Implementation) (hereinafter referred to as the administrative measures). This is the first regulatory document for stem cell clinical research management in China. It aims to regulate stem cell clinical research behavior, protect the rights and interests of subjects, and promote the healthy development of stem cell research. According to the management measures, the medical institutions engaged in stem cell clinical research must have the qualification of class III class A hospitals, drug clinical trial institutions and relevant conditions for stem cell clinical research. The medical institutions shall not charge the subjects for stem cell clinical research related fees, and shall not publish or disguise stem cell clinical research advertisements.
According to the administrative measures, medical institutions are responsible for stem cell preparations and clinical research. Institutions shall establish academic and ethical committees to conduct project approval review and process supervision on stem cell clinical research projects, and conduct quality management and risk control on the whole process of stem cell preparation and clinical research to ensure quality and safety. In clinical research of stem cells, a record management system should be implemented to strengthen supervision during and after the event, establish an information disclosure system and accept social supervision.
In view of the protection of the rights and interests of the subjects, the management measures proposed that clinical research should follow the principles of science, standardization, openness and ethics. Clinical researchers must do their duty to inform, and the subjects sign the informed consent. For high-risk projects, research institutions should take effective measures to focus on supervision, and through the purchase of third-party insurance to compensate for research related damage. After the clinical study of stem cells, the subjects should be followed up for a long time to evaluate the long-term safety and effectiveness of the clinical study of stem cells.
According to the management measures, the health and family planning and food and drug regulatory authorities are responsible for the supervision and management of stem cell clinical research, and those who violate the laws and regulations shall be investigated and punished in accordance with the laws and regulations.
The administrative measures are not applicable to the hematopoietic stem cell transplantation with mature technical specifications and the clinical trials of stem cells declared according to the drugs.
June 3, 2014