Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial

Area of Science:

• Clinical Trials
• Bioethics
• Health Services Research

Background:

• Cluster randomized trials pose ethical challenges, particularly in obtaining informed consent within clinical care settings.
• Ensuring an effective and efficient informed consent process is crucial to avoid impeding research or healthcare delivery.

Purpose of the Study:

• To demonstrate a feasible and ethically sound approach to informed consent in cluster randomized trials.
• To present the innovative informed consent process developed for the COMPASS study as a model for other pragmatic research.

Main Methods:

• The COMPASS study utilized a collaborative design involving the study team, institutional review board, and community members.
• A novel informed consent process was developed and implemented across 40 randomized sites comparing a postacute stroke intervention with standard care.

Main Results:

• The implemented informed consent process was ethically appropriate and operationally reasonable.
• The process was successfully carried out at all randomized sites without undue burden on staff or patients.

Conclusions:

• The COMPASS study's informed consent model effectively upholds ethical standards in cluster randomized trials.
• This approach provides a transferable model for conducting pragmatic studies with robust ethical considerations and minimal logistical impediments.