Answer： The use of human blood samples to develop or validate certain medical testing methods, such as clinical trials of in vitro diagnostic reagents, belongs to research conducted on human subjects. China's GCP stipulates that all research on human subjects must comply with the Helsinki Declaration of the World Medical Congress. Article 32 of the 2013 edition of the Helsinki Declaration states that "for medical research using identifiable human tissue materials or data, doctors must generally seek the consent of the subjects regarding the collection, analysis, storage, and/or reuse of human tissue materials or data." Based on this ethical principle, informed consent from the blood donor should be obtained in such cases. The use of residual specimens for laboratory internal accusation or calibration is not within the scope of medical research and is not subject to this ethical principle.