FDA Reopens the Comment Period for the Proposed Rule Regarding IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

The Food and Drug Administration (FDA) is reopening 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 due to technical difficulties at the Federal eRulemaking portal.  The proposed rule can be accessed athttps://www.gpo.gov/fdsys/pkg/FR-2018-11-15/pdf/2018-24822.pdf.  Comments on the proposed rule may be submitted at  https://www.regulations.gov (Docket No. FDA-2018-N-2727) and are now due by March 7, 2019.