Challenges of informed consent for pragmatic trials

Abstract The Innovative Medicines Initiative’s (IMI) GetReal consortium aims to develop strategies to incorporate real world evidence earlier into the drug life cycle to better inform health care decision-makers on the comparative risks and benefits of new drugs. Pragmatic trials are currently explored as a means to generate such evidence in routine care settings. The traditional informed consent model for randomized clinical trials has been argued to pose substantial hurdles to the practicability of pragmatic trials: it would lead to recruitment difficulties, reduced generalizability of the results and selection bias. The present paper analyzes these challenges and discusses four proposed alternative informed consent models: integrated consent, targeted consent, broadcast consent and a waiver of consent. These alternative consent models each aim at overcoming operational and methodological challenges, while still providing patients all the relevant information they need in order to make informed decisions. Each consent model, however, relies on different attitudes towards the principle of respect for persons and the related duty to inform patients, and represents different views on whether the common good demands moral duties from patients. Such normative consequences of modifying consent requirements should be at least acknowledged, and ought to be assessed in light of the validity of empirical claims.