The Failure to Disclose Unexpected Benefits in Consent for Clinical Trials

A major legal and ethical requirement for research consent is that a person be given appropriate information about the possible benefits of participation. All too commonly, however, consent forms provide a generic statement that “you may or may not benefit from participating in this study.”

A new drug for treating common forms of metastatic breast cancer, when it was announced in 2022 at a major medical meeting, led to a standing ovation – the first one in decades at such a meeting – because the improved survival – six months – was so unheard-of. Looking at online versions of consent forms for this type of research shows that it is rare for them to include any of this crucial information: that even if the trial is successful, the benefit is likely to be at best a few extra weeks of life.