Four questions to consider before waiving consent requirements in pragmatic cluster randomized trials

DESCRIPTION OF SESSION

Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in routine conditions to inform the decisions of patients, healthcare providers, and health systems managers. While most pragmatic trials use individually randomized designs, about 35% use cluster randomized designs. Cluster randomized trials (CRTs) involve randomly allocating groups (e.g., clinics or hospitals), as opposed to individuals (e.g., patients), to study interventions. However, the robust design and conduct of pragmatic CRTs may be in tension with the ethical requirement to obtain informed consent from research participants. As a result, researchers and research ethics committees tend to focus on whether an alteration or waiver of consent is appropriate for these trials. But pragmatic CRTs raise other important questions that have direct implications for determining when an alteration or waiver of consent is permissible. To assist those involved in the design and review of pragmatic CRTs, this presentation will outline four critical questions to consider: (1) What is the nature of the intervention being evaluated? (2) Is the choice to use cluster randomization justified? (3) Can the risk of recruitment bias be addressed? and (4) Is an alteration or waiver of consent appropriately justified? Two case studies will be used to illustrate how researchers and research ethics committees can undertake a stepwise ethical analysis of a planned pragmatic CRT.