Recommendations for informed consent forms for critical care clinical trials*

Abstract

Many subjects enrolled in research studies have a limited understanding of the research to which they consented. To develop recommendations to enhance comprehensiveness and understanding of informed consent forms used in critical care clinical trials. Consensus process. We provide recommendations regarding the U.S. federally required basic and additional elements of informed consent as applied to critical care clinical trials. We also identify issues that investigators need to address, if relevant, in the informed consent forms of critical care clinical trials. These include the description, in understandable language, of complex and detailed experimental protocols that are the focus of the clinical trial, disclosure of death as a risk factor if mortality is an outcome variable, and the identification of who can legally serve as the prospective subject's surrogate. We also offer suggestions to enhance subjects' understanding of informed consent forms. The literature on informed consent forms suggest that shorter informed consent forms written at a lower reading level, when read carefully, might provide better subject understanding. Prospective evaluation is needed to determine whether our recommendations enhance the informed consent process.