FDA Proposes Rule To Waive Informed Consent In Minimal Risk Trials

FDA on Tuesday (Nov. 13) moved toward fulfilling provisions in the 21st Century Cures Act that allow FDA to waive or alter informed consent regulations for minimal risk clinical investigations as long as there are appropriate human subject protections in place. The agency’s proposed rule would replace a 2017 guidance that outlines a similar policy shift. Section 3024 of Cures gives FDA the authority to waive or alter informed consent for clinical testing that poses no more than a minimal...