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

ABSTRACT: 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

SUBMITTER: Andrews JE 

PROVIDER: S-EPMC6073919 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature