Rulemaking in the US

Our mandate was to “evaluate the implications for Europe of the development in United States of a risk-based ethical review system for medical research aimed at replacing the Common Rule“(the Common Rule is the popular phrase for The Federal Policy for the Protection of Human Subjects in research). We have solved this task by describing the new legislation and review system in the US and how this affects biobanking and research on health data. We have further looked at the American research ethical debate on the new Common Rule. Finally, we have discussed pros and cons of the American research regulation compared to the typical European one. The project was conducted in the period of April 2017 to June 2018.