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HHS/FDA RIN: 0910-AH52 Publication ID: Fall 2017 
Title: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations 
Abstract:

This regulation will permit an Institutional Review Board (IRB) to waive informed consent under certain conditions for minimal risk clinical investigations. This will facilitate certain minimal risk clinical investigations that may support the development of new products to diagnose or treat diseases or conditions and will harmonize 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 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: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 50    21 CFR 56   
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
Direct Final Rule  06/00/2018 
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:
Janet Norden
Senior Regulatory Policy Advisor
Department of Health and Human Services
Food and Drug Administration
Office of Good Clinical Practice, WO 32, Room 5108, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-1127
Email: janet.norden@fda.hhs.gov