Evaluation of Informed Consent Documents used in Critical Care Trials

Abstract

The literature suggests that informed consent documents (ICDs) are not well understood by research participants. The patient decision aid model may suggest improvements for the informed consent process, particularly in the critical care setting (ICU) because of patient capacity issues. Our goal was to evaluate the extent to which existing ICDs used in ICU research adhere to standards and recommendations for high quality informed consent. Eighteen items from recommendations specific to ICU trials were added to a previously developed ICD evaluation tool. A sample of ICU trials was identified from clinicaltrials.gov database and the investigators contacted for their trial ICD. Conformity to the recommendations was variable. Some information are found routinely in consent documents for critical care research and some are not. Efforts should aim to establish tools for measuring decision quality in the ICU with the goal of facilitating and helping patients and surrogates work through trial participation decisions.