Cluster randomized controlled trials (cRCTs) are increasingly popular in health services research. Our project is looking at the research ethics of these trials.
What is a cRCT?
For example, a new handwashing protocol may be assigned to half the hospital wards while the other wards continue to do their old handwashing protocol. The study mainly collects data about health care providers’ handwashing behaviour, but also looks at whether infection rates in hospital units that use the new protocol differ from the ones that are not using this new protocol.
How are we studying cRCTs?
We’re asking: who should be required to provide consent for these different trials? Clinic or hospital administrators? Doctors and other care team members involved? Patients?
To investigate these questions, we conducted a systematic review and qualitative interviews to explore patients’, cRCT researchers’, and research ethics boards’ perspectives on ethical consent processes for different types of cRCTs.
Based on our findings, we are developing a framework and online module to guide researchers and research ethics boards on ethical design of cRCTs, with emphasis on issues of consent.
Our preliminary findings suggest that these questions are challenging to navigate.
Our data analysis is ongoing. We are currently in the process of producing video and educational modules on our findings and on questions around ethical cluster trials more generally.
We will be presenting these preliminary findings to a virtual patient feedback group later this month. For more information, please email Dr. Anita Ho (firstname.lastname@example.org) by March 18, 2022.