In Europe and the US, an efficient scheme called “trial-ready cohort” has been introduced mainly for Alzheimer’s disease prevention, aiming to recruit participants from observational studies for clinical trials. Similar mechanism, in which participants in observational studies receive preventive intervention based on risk assessment, is strongly required in Japan, following a great improvement in disease risk prediction by using genomic analysis. Some attempts to use the mechanism have already been made in ongoing cohort studies or population biobanks. In this study, we will conduct research on the significance, impact on societies, and ELSI/RRI of such mechanism where healthy individuals in observational studies receive intervention based on risk assessment. Focusing on the relationship between observational studies and intervention studies, we will examine what are the conditions for intervention in observational studies; conflict of interest issues between research organizations/researchers and private companies; and reactions and viewpoints of the public who participate in research studies.

・R&D Period： October 2024 - March 2027
・Grant Number： JPMJRS24J1