FDA extends comment period for proposed rule on informed consent for minimal risk clinical investigations

The Food and Drug Administration (FDA) is extending the comment period for the proposed rule entitled “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations” that appeared in the Federal Register of November 15, 2018.  FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.  The proposed rule can be accessed at

Comments on the proposed rule may be submitted at (Docket No. FDA-2018-N-2727) and are now due by February 13, 2019.