View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AH52 Publication ID: Fall 2023 
Title: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations 

This regulation would permit an Institutional Review Board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent under limited conditions, for certain minimal risk clinical investigations. This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat diseases or conditions and would harmonize, to the extent practicable and consistent with statutory provisions, with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies. This regulation is intended to aid patient access to new products by facilitating investigators’ ability to conduct studies that may contribute substantially to the development of products to diagnose or treat diseases or conditions, including products that may address unmet medical needs.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 50    21 CFR 312    21 CFR 812   
Legal Authority: 21 U.S.C. 355(i)(4)    21 U.S.C. 360j(g)(3)    21 U.S.C. 371(a)   
Legal Deadline:  None
Action Date FR Cite
NPRM  11/15/2018  83 FR 57378   
NPRM Comment Period Extended  12/20/2018  83 FR 65322   
NPRM Comment Period End  01/14/2019 
NPRM Comment Period Extended End  02/13/2019 
NPRM Comment Period Reopened  02/25/2019  84 FR 5968   
NPRM Comment Period Reopened End  03/07/2019 
Final Rule  11/00/2023 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Lauren Milner
Regulatory Policy Advisor
Department of Health and Human Services
Food and Drug Administration
Office of Clinical Policy, 10903 New Hampshire Avenue, WO 32, Room 5103,
Silver Spring, MD 20993-0002
Phone:301 796-5114