Community Consultation and Public Disclosure for the Randomized Trial of Sedative Choice for Intubation.

ABSTRACT:

Background

Randomized trials evaluating emergency treatments may be conducted with Exception from Informed Consent (EFIC) when prospective informed consent is infeasible. In EFIC trials, a period of community consultation and public disclosure precedes initiation of enrollment. The Randomized Trial of Sedative Choice for Intubation (RSI) is a 2,364-patient randomized trial being conducted with EFIC in 14 emergency departments and intensive care units across the United States. This manuscript reports the approach to community consultation and public disclosure in the RSI trial.

Methods

Community consultation and public disclosure were conducted locally in each of the 5 regions of enrolling sites. The coordinating center provided sites with templates and access to an engagemen

SUBMITTER: Lewis AA 

PROVIDER: S-EPMC12622125 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature