Randomization to Standard and Concise Informed Consent Forms: Development of Evidence-Based Consent Practices

摘要

BackgroundConsent to participate in research is an important component of the conduct of ethical clinical trials. Current consent practices are largely policy-driven. This study was conducted to assess comprehension of study information and satisfaction with the consent form between subjects randomized to concise or to standard informed consent forms as one approach to developing evidence-based consent practices.