Reconceptualizing the informed consent process at eight innovative hospitals.

BACKGROUND Hospitals struggle to make informed consent processes understandable for patients. Amid "promising practices" for patient-centered communication, there is debate over how to handle consent processes for patients with limited literacy, health literacy, or English proficiency. METHODS In 2005, the American Medical Association's Ethical Force Program and the American Hospital Association's Health Research and Educational Trust conducted eight site visits to determine how hospitals use patient-centered communication to improve health care. FINDINGS Each of the eight hospitals noted a number of problems in the traditional informed consent process, sparking a broad set of efforts to improve. Disagreements about how to do so often focused on whether to attempt simplification and translation of informed consent documents. Specifically, hospital leaders held widely divergent views on legal and accreditation requirements for these forms. However, several other promising practices met with widespread approval. DISCUSSION Overall, informed consent in the eight hospitals was becoming more patient centered and integrated. The significant variation across states makes it difficult to provide overarching policy guidance on the informed consent process. Greater regulatory clarity is needed so that policies and practices can be more closely aligned with the ethical foundations of informed consent.