Summary of Changes to The Common Rule

Revised Sections of The Common Rule                   Summary of Changes Timeline of Implementation

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(I)-Examples of what are not considered human subjects research.

46.102(m)-Defines written (or, in writing) as paper or electronic format.

January 21, 2019

Assurance

45 CRF 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 46.014

Exempt categories 1-2 and 5 are further defined, and 6 remains unchanged

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,

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.

5:New section for research conducted by federal employees. New categories are 3-4 and 7-8.

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

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 beginning 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 20, 2020
Documentation of Informed Consent

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