The Common Rule (45 CFR 46)

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.

Summary of changes to the revised Common Rule

Revised Sections of the Common Rule Summary of Changes Notes
Applicability
45 CFR 46.101
46.101(f) – When applicable, American Indian and Alaska Native Tribal Laws will be applied
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

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. Administrative Review of grant applications will continue to be conducted by IRB administrators.
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
IRB Review of Research

45 CFR 46.109

 

46.109(a) – Exempt Research that require *limited IRB review as a condition of exemption.

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).

*Limited IRB review is performed through the same mechanism as Expedited Review by members of the IRB committee to determine there are adequate provisions to protect the privacy of participants and maintain the confidentiality of data as well as confirm consent procedures are adequate.

PI must provide annual certification that study procedures and design have not changed will be required for all research eligible for expedited review.  PIs will do so by completing an ER Annual Certification form and submitting to the IRB Office.

 

Research limited to data analysis will require PIs to annually confirm that data analysis is ongoing.

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.

46.11(a)(8)  Approval criteria for a limited IRB review

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 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
UTD template consent forms have been updated in accordance with the revised Common Rule and are available on the IRB Office’s website.
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

UTD Transition Plan

When was initial IRB Approval issued for the Research? Is transition to 2018 Common Rule required?
Prior to July 19, 2018 NO – research will continue to follow the Pre-2018 Common Rule.

EXCEPTION: Research must transition to the 2018 Common Rule IF a protocol is or will be associated with new or renewal federal funding* awarded on or after January 21, 2019. In this scenario, the Principal Investigator (PI) or Faculty Sponsor (FS) may opt to submit either a Request for Revision (MOD) or a new IRB application.

July 19, 2018 – January 20, 2019 NO – research will continue to follow the Pre-2018 Common Rule.  This research will not be required to transition to the 2018 Common Rule; however, Investigators may opt to transition to the 2018 Common Rule by either submitting a MOD or a new IRB application.
EXCEPTION: Research must transition to the 2018 Common Rule if a protocol is or will be associated with new or renewal federal funding* awarded on or after January 21, 2019.  In this scenario, the PI / FS may opt to submit either a MOD or a new IRB application.
On or after January 21, 2019 YES, all research (regardless of funding/support) must follow the 2018 Common Rule.

*New federal funding means an award of funds (i.e., grant, contract, cooperative agreement or other funding mechanism) to support a project not previously funded by the U.S. government.  Renewal federal funding means an award of funds to support the next competitive segment of a project previously funded by the U.S. government.