FDA Releases Small Entity Compliance Guide for Informed Consent Elements
The US Food and Drug Administration (FDA) released a guide to the informed consent process for sponsors, investigators and institutional review boards (IRBs) entitled Questions and Answers on Informed Consent Elements, 21 CFR §50.25(c) on 9 February 2012.
The document provides 27 questions and answers regarding FDA's informed consent regulations that govern how patients must be informed of clinical trial information being entered in to a databank maintained by the National Institutes of Health and the National Library of Medicine.
The document represents FDA's current thinking on the topic, but, as with all guidance documents, is non-binding.