Informed Consent Documents Used in Critical Care Trials Often Do Not Implement Recommendations.

Area of Science:

• Medical Ethics
• Clinical Research
• Patient Advocacy

Background:

• Informed consent is crucial but often challenging in critical care due to time pressure and patient capacity.
• Existing recommendations aim to improve critical care informed consent processes.
• Current practice regarding these recommendations is not well understood.

Purpose of the Study:

• To assess the implementation of critical care-specific informed consent recommendations in clinical trials.
• To evaluate general informed consent recommendations within critical care research documents.

Main Methods:

• Systematic literature search for critical care informed consent recommendations.
• Analysis of informed consent documents from registered critical care trials.
• Rating implementation of 18 critical care and 36 general recommendations using a four-point scale.

Main Results:

• A 34.1% response rate yielded 86 assessable informed consent documents.
• Implementation of critical care recommendations varied widely (2% to 96.5%).
• Overall rater agreement was high (90.6%).

Conclusions:

• Critical care research frequently omits recommended information for consent.
• These findings highlight areas for improving the informed consent process for critical care research participants and their families.