Informed Consent Elements (US Food and Drug Administration Regulation) (FDA) (2018 Edition)

Informed Consent Elements (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Informed Consent Elements (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients. This book contains: - The complete text of the Informed Consent Elements (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section