Alterations to the Consent Process in Five Pragmatic Randomized Trials of Routine Hemodialysis Care

Large, pragmatic, randomized trials are needed to identify which components of routine hemodialysis care improve outcomes, but conventional processes, including individual written consent for every eligible patient, can make some trials infeasible. Alterations to the consent process refer to departures from the usual written informed consent requirements: consent may be waived for a specific trial element; the process may be modified through notification with an opt-out; preferences may be documented in usual clinical records; or separate consent may be used for selected data collection. These alterations may be ethically acceptable when the research poses no more than minimal incremental risk beyond usual care, usual written consent is impracticable or would compromise the validity of the trial, participant welfare is maintained, and communication with participants remains appropriate. We describe our experience with five pragmatic randomized trials of hemodialysis care interventions, including trials of dialysate temperature, magnesium, bicarbonate, expanded solute removal, and transplant access. These trials used different approaches to consent for trial participation, receipt of the allocated intervention, and use of routinely collected data. When designed with patient notification, opt-out opportunities, independent oversight, attention to vulnerability and inclusivity, and acceptable intervention delivery, alterations to the consent process can remain respectful, transparent, and attentive to patients' interests, while enabling rigorous trials that might otherwise not be done.