Little evidence exists about the effectiveness of the Speak Up campaign (in the USA), which focused on helping patients to be involved in preventing medical error by being vigilant about their care, asking questions and raising concerns. Moreover, research has identified a general reluctance among patients to challenge or ask a question of staff about safety, particularly among less educated, male and unemployed patients. In fact, some have argued that an over-reliance on patients could also inadvertently lull healthcare professionals into a false sense of safety and the potential for increasing inequalities between those patients who do and those who do not actively play a role in their safety should not be ignored.