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2018 Common Rule Requirements

Announcements

On January 19, 2017, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991.

The Final Rule reflecting the 2018 Common Rule Requirements will be effective January 21, 2019, with the exception of cooperative research (single IRB review) which will not be effective until January 20, 2020.

The Department of Justice (DOJ) and the Food and Drug Administration (FDA) have not yet adopted the revised Common Rule. As such, research that is supported or regulated by these entities are not eligible for the new requirements and must adhere to the Pre-2018 Common Rule Requirements until which time they adopt the 2018 Common Rule Requirements.  

Revised Sections of the Common Rule

Summary of Changes

Timeline of Implementation at UCI

Applicability

45 CFR 46.101

  • 46.101(f) - When applicable, American Indian and Alaska Native Tribal Laws will be applied
January 21, 2019

Definitions 

45 CFR 46.102

  • 46.102(e) - Definition of Human Subjects includes identifiable biospecimens
  • 46.102(l) - Examples of what are not considered human subject research
  • 46.102(m) - Defines Written (or, in writing) as paper or electronic format
January 21, 2019

Assurance 

45 CFR 46.103

The elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.

July 19, 2018

Exempt Research

45 CFR 46.104

  • Exempt categories 1-2 and 5 are further defined, and 6 remains the same
    • 1: Normal educational practices not likely to adversely impact students’ opportunity to learn
    • 2: Criteria iii specifies that an IRB can conduct a limited review for studies in which identifiable information is obtained/recorded
    • 5: New section for research conducted by Federal employees
  • New categories are 3-4, and 7-8
    • 3: Research involving benign behavioral interventions with adult subjects, in conjunction with the collection (verbal, written, data entry, audio/visual recording) of information is permitted with prospective consent and at least one of three additional criteria are met
    • 4: Secondary research for which consent is not required is permitted if at least one of three additional criteria are met
    • 7: Store/maintain identifiable private information/specimens for potential secondary research permitted by a limited IRB review
    • 8: Research involving the use of identifiable private information/specimen for secondary research use for which broad consent is required, is permitted when 3 additional criteria are met
January 21, 2019

IRB Review of Research

45 CFR 46.109

  • 46.109(a) - Exempt Research that require limited IRB review as a condition of exemption.  Limited IRB Review is performed at an IRB Expedited Subcommittee meeting by an IRB Chair or an IRB Chair-designee.
  • 46.109(f) - Continuing review is not required when:
    • Research eligible for expedited review
    • Research reviewed by the Limited IRB review process
    • Research limited to only: data analysis, or accessing follow-up clinical data (performed as part of clinical care).  
January 21, 2019

Criteria for IRB Approval 

45 CFR 46.111

  • 46.111(a)(3) & 46.111(b) - Vulnerable populations: 
    • Pregnant women and handicapped/mentally disabled populations are no longer considered vulnerable.
    • Individuals with impaired decision-making capacity and economically/educational disadvantaged are considered vulnerable population.
  • 46.111(a)(7)(i) - Include adequate provisions to protect privacy of subjects / maintain confidentiality of data. DHHS guidance forthcoming.
  • 46.11(a)(8)  Approval criteria for a limited IRB review 
January 21, 2019

Cooperative Research (sIRB)

45 CFR 46.114

The final rule mandates the use of a single IRB for multisite studies. Federal departments or agencies supporting or conducting the research can determine that the use of a single IRB is not appropriate for particular types of studies. January 20, 2020

Informed Consent

45 CFR 46.116

This entire section has been revised.  A brief summary is outlined below:

  • 46.116(a) - New requirement of Key Information at the beinning of the consent form 
  • 46.116(b) - One (1) new Basic element of informed consent 
  • 46.116(c) - Three (3) new Additional elements of informed consent
  • 46.116(d) - Seven (7) elements of a Broad consent form
  • 46.116(f) - Revised criteria for a General Waiver or Alteration of Consent
  • 46.116(g) - New exception to Informed Consent: Screening, recruiting, determining eligibility is permitted under specific circumstances
  • 46.116(h) - A copy of the template consent form must be posted on a federal website after the clinical trial (sponsored by a federal department or agency) is closed to recruitment and no later than 60 days after the last study visit by any subject. DHHS guidance is forthcoming.
January 21, 2019

Documentation of Informed Consent 

45 CFR 46.117

  • 46.117(a) - Includes electronic format 
  • 46.117(b) - Ensures that Key Information was presented first to the subject
  • 46.117(c) - New criteria for a waiver of documentation (signed) of informed consent
January 21, 2019

RESOURCES

To be published here soon:  HRP EQUIP Summary of UCI's Implementation of the revised 2018 Common Rule

HRP EQUIP Summary of 2018 Common Rule Requirements

HRP EQUIP Highlighted Preamble of the revised 2018 Common Rule

HRP EQUIP Exempt Research Determination Guide

News & Announcements about the 2018 Common Rule Requirements

News & Announcements

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