The European Union is beefing up protections for volunteers in phase I clinical trials in the wake of a disastrous clinical study in Rennes, France, that resulted in the death of one volunteer and the hospitalization of five others.

On 21 July, the European Medicines Agency (EMA) in London announced in a “concept paper” that it wants to improve strategies to identify and reduce risks in “first-in-human” (FIH) studies on healthy volunteers. EMA is asking for input from stakeholders.