ABSTRACT
This article describes the definition of precision medicine and the American and Chinese precision medicine initiatives.It then discussed ethical and regulatory challenges raised by precision medicine.These challenges include cost-effectiveness ratio evaluation for precision medicine initiatives,risk-benefit ratio in precision medicine,valid informed consent for research participants,independent ethical review of precise prevention and treatment protocols,protection of individual privacy data,mass data sharing and equitable access of research results.
ABSTRACT
The reasonable risk-benefit ratio is one of the most significant criteria in ethical review .However , there is not a well-organized standard for risk -benefit analysis and assessment .Also the commonly used Common Rule and Duty of Personal Care Approach have their own limitations , which revoked the Component Analysis Strate-gy, unfortunately, failed again.Alex John London, as a result, tried to construct a comprehensive approach , in which he clarified reasonable riskbased on the distinction of personal interest and basic interest , as well as brought in the concept of comparator activities .Compare to the theoretical contribution of London ,A seven-step framework for risk-benefit evaluationcreated by Annette Rid and David Wendler concerns more from the practi-cal aspect .