Variation in the extent to which patient information leaflets describe potential benefits and harms of trial interventions: a commentary.

Clinical trial participants must understand the possible risks and benefits of trial interventions before providing their informed consent to participate. The aim of this commentary is twofold: to summarize the discrepancies in the extent to which patient information leaflets (PILs) list potential benefits and harms of trial interventions; and to highlight subsequent ethical issues that may result from failure to disclose potential benefits or harms . A review of 247 patient information leaflets (PILs) found that the extent to which potential benefits and harms are described varies, with 28 (11%) not describing potential benefits and 23 (9%) not describing potential harms. We argue that there is no principled difference between potential benefits and potential harms (what is helpful for one person could harm another), and the need to disclose potential benefits may be less accepted than the need to disclose all potential harms. Additionally, while it is recognized that failure to mention potential harms may violate the ethical principle of autonomy, it is less well-established that other ethical principles, (the need to avoid harm (non-maleficence) , to help patients (beneficence), and to promote justice) may also be at risk when all potential harms and benefits are not  disclosed within PILs. We suggest that the way potential benefits and harms are described within PILs be harmonized according to recently established principles.