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HHS/FDA RIN: 0910-AH52 Publication ID: Spring 2019 
Title: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations 
Abstract:

This proposed regulation would permit an Institutional Review Board (IRB) to waive or alter the informed consent requirements under certain conditions for minimal risk clinical investigations. This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat disease and would harmonize with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies. This proposed 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, or address unmet medical needs.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 21 CFR 50    21 CFR 312    21 CFR 812   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 343    21 U.S.C. 346    21 U.S.C. 346a    21 U.S.C. 348    21 U.S.C. 350a    21 U.S.C. 350b    21 U.S.C. 352    21 U.S.C. 353    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 360c to 360f    21 U.S.C. 360h to 360j    21 U.S.C. 371    21 U.S.C. 379e    21 U.S.C. 381    42 U.S.C. 216    42 U.S.C. 241    42 U.S.C. 262    42 U.S.C. 263b to 263n   
Legal Deadline:  None
Timetable:
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  02/13/2019 
Final Rule  04/00/2020 
Regulatory Flexibility Analysis Required: Undetermined  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
Email: lauren.milner@fda.hhs.gov