The Ottawa Statement implementation guidance document for cluster randomized trials in the hemodialysis setting

Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants.

Source: Kidney International - April 18, 2024 Category: Urology & Nephrology Authors: Cory E. Goldstein, Monica Taljaard, Stuart G. Nicholls, Mary Beaucage, Jamie Brehaut, Charles L. Cook, Brenden B. Cote, Jonathan C. Craig, Stephanie N. Dixon, Jessica Du Toit, Catherine C.S. Du Val, Amit X. Garg, Jeremy M. Grimshaw, Shasikara Kalatharan, Tags: Editorial: Special Report Source Type: research