Interactive Media-Based Approach for an Exception From Informed Consent Trial Involving Patients With Trauma.

ABSTRACT:

Importance

Exception From Informed Consent (EFIC) research requires community consultation (CC) and public disclosure (PD). Traditional methods of conducting CC and PD are slow, expensive, and labor intensive.

Objective

To describe the feasibility and reach of a novel interactive, media-based approach to CC and PD and to identify the similarities and differences between trial sites in website views, survey responses, online community forum attendance, and opt-out requests.

Design, setting, and participants

This survey study analyzed the CC and PD campaigns conducted for the TAP trial (Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival), an EFIC trial of the early administration of prothrombin complex concentrate in pati

SUBMITTER: Stephens SW 

PROVIDER: S-EPMC11223059 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature