Docket No. FDA–2018–N–2727 – FDA Proposed Rule on Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (21 CFR Parts 50, 312, and 812)

As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2019 about Docket No. FDA–2018–N–2727 – FDA Proposed Rule on Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (21 CFR Parts 50, 312, and 812) can be found below.