A Systematic Review of Federal Drug Administration Docket for Community Consultation and Public Disclosure in Exception from Informed Consent Trials

摘要

BackgroundException from informed consent imposes community consultation and public disclosure requirements on clinical investigation in critically ill and injured patients. In 2011, the Food and Drug Administration (FDA) instructed sponsors to submit publically disclosed information to the FDA Docket, but to date there has been no comprehensive analysis of available data. We summarized the community consultation and public disclosure practices of exception from informed consent trials published on the FDA docket in order to better understand the breadth of common practices that exists among acute care clinical research.