Consideration on choices of informed consent and data protection in Real-World Studies

Real-world study (RWS) plays an increasingly important role in medical regulation and medical decision-making. However, due to the implementation of RWS in real diagnosis and treatment environment and diverse study designs, the traditional informed consent method may lead to recruitment difficulties or selection bias in some RWS, thus reducing the universality of the study results. At present, many scholars have discussed the choice of RWS informed consent based on the risk, but the authors believe that it should adapt to the actual characteristics of RWS. In informed consent, appropriate informed consent methods can be selected according to the time of study design. For example, researchers in prospective studies are obliged to obtain the informed consent of patients. Oral, electronic and written informed consent can be selected according to the actual enforceability, but the content should be consistent and fully informed; Based on the content and regulations, the ethics committee of the retrospective study reviews whether informed consent can be exempted. However, it is recommended that medical institutions should establish and implement pan-informed consent from now on, so as to provide evidence for future studies using health data and biological samples.