This post was written by Erin A. Janssen.
FDA has issued guidance in the form of a Small Entity Compliance Guide entitled “Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c).” This guidance is intended to help sponsors, investigators and Institutional Review Boards better understand new informed consent requirements. In the Federal Register of January 4, 2012 (76 Fed. Reg. 256), FDA published a final regulation 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 new guidance document provides detailed questions and answers related to the new requirements.