RT Journal Article
SR Electronic
T1 Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial
JF Journal of Medical Ethics
JO J Med Ethics
FD BMJ Publishing Group Ltd and Institute of Medical Ethics
SP 560
OP 566
DO 10.1136/medethics-2017-104478
VO 44
IS 8
A1 Joseph E Andrews
A1 J Brian Moore
A1 Richard B Weinberg
A1 Mysha Sissine
A1 Sabina Gesell
A1 Jacquie Halladay
A1 Wayne Rosamond
A1 Cheryl Bushnell
A1 Sara Jones
A1 Paula Means
A1 Nancy M P King
A1 Diana Omoyeni
A1 Pamela W Duncan
A1 ,
YR 2018
UL http://jme.bmj.com/content/44/8/560.abstract
AB Cluster randomised clinical trials present unique challenges in meeting ethical obligations to those who are treated at a randomised site. Obtaining informed consent for research within the context of clinical care is one such challenge. In order to solve this problem it is important that an informed consent process be effective and efficient, and that it does not impede the research or the healthcare. The innovative approach to informed consent employed in the COMPASS study demonstrates the feasibility of upholding ethical standards without imposing undue burden on clinical workflows, staff members or patients who may participate in the research by virtue of their presence in a cluster randomised facility. The COMPASS study included 40 randomised sites and compared the effectiveness of a postacute stroke intervention with standard care. Each site provided either the comprehensive postacute stroke intervention or standard care according to the randomisation assignment. Working together, the study team, institutional review board and members of the community designed an ethically appropriate and operationally reasonable consent process which was carried out successfully at all randomised sites. This achievement is noteworthy because it demonstrates how to effectively conduct appropriate informed consent in cluster randomised trials, and because it provides a model that can easily be adapted for other pragmatic studies. With this innovative approach to informed consent, patients have access to the information they need about research occurring where they are seeking care, and medical researchers can conduct their studies without ethical concerns or unreasonable logistical impediments.Trial registration number NCT02588664, recruiting. This article covers the development of consent process that is currentlty being employed in the study.