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Common Rule Changes

The “Common Rule,” also known as the Federal Policy for the Protection of Human Subjects, is the common ethical standard for publicly funded research in the United States. Changes to the Common Rule were issued by the Department of Health and Human Services (HHS) in January 2017. Most changes will go into effect on January 21, 2019.

Revised Common Rule Delayed

On January 19, 2018, changes to regulations for protecting human research participants (also known as the revised “Common Rule”) were scheduled to take effect. However, the revised Common Rule has been delayed. We learned on June 19 that the revised Common Rule will be delayed for an additional six months. The new compliance date is now January 21, 2019. Institutions do have the option to implement three provisions during this delay to exclude IRB review for certain activities, eliminate continuing review for most minimal risk research, and eliminate the IRB’s review of grant applications. The University of Minnesota will not implement these provisions prior to the compliance date.

New regulations do not impact studies approved prior to January 21, 2019.

For new studies, approved after January 21, 2019, expect to see:

  • Changes in ETHOS
  • Revisions to Informed Consent Template (Posted January 2018)
  • HRPP Toolkit updates (manuals, SOPs, worksheets, checklists) 
  • The University of Minnesota position regarding sIRB

 

Major Regulatory Changes

Many Common Rule changes relate to IRB management and function, but researchers may also be affected.

Watch OHRP Video: What's New in IRB Review Under the Revised Common Rule (8:22)

Major changes include:

Continuing Review

Continuing review is no longer required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data. In most cases, minimal risk studies will no longer require continuing review. The IRB will notify researchers upon initial approval about any post-approval review requirements.

Exemptions

The categories of research that are exempt from IRB review have been expanded and some existing categories have been clarified. Some exemptions may require "limited IRB review" (similar to an expedited review process), while others may qualify for "self-determination." Under the revised rule, researchers will still submit all human participant research to the IRB to determine any exemptions.

Watch OHRP Video: When Does the Common Rule Apply? Review of the Basics Under the Revised Rule (18:14)

Watch OHRP Video: Overview of Changes to Exemptions in the Revised Common Rule (Focusing on Exemptions 1, 2, 3, and 5) (26:06)

Informed Consent

A new "Key Elements" section and rearranged content aims to facilitate a potential research subject's decision to participate or not. A new option for broad consent may be available in the future for University of Minnesota studies, but the University will not offer this option to researchers until it receives further guidance about implementing the option from regulators and advisory groups: Office for Human Research Protections (OHRP); Secretary's Advisory Committee on Human Research Protections (SACHRP).

Watch OHRP Video: What's New in Informed Consent: Revisions to the Common Rule (26:50)

Single IRB-of-Record (sIRB)

Most federally funded collaborative research projects located in the US that require IRB oversight will be required to use a single IRB (commercial, academic, or hospital-based) starting January 2020. See the NIH Regulatory Changes.

 

Implementation Decisions

  • The University of Minnesota will continue the requirement that all human research undergo review by a U of M-designated IRB. Common Rule and/or FDA rules will apply to all human research at the University of Minnesota.
  • The University of Minnesota will not adopt the option for broad consent until further guidance about implementing the option is available from OHRP/SACHRP. This applies to the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens.
  • The University of Minnesota IRB will maintain two toolkits, one reflecting pre-January 21, 2019 regulatory requirements (will be referred to as “pre-2018 rule”) and one reflecting post-January 21 requirements (will be referred to as “revised rule”).
  • The UMN IRB will apply the revised rule to all new applications approved on or after January 21, 2019. IRB applications submitted in the weeks prior to January 21 may not be reviewed by the IRB in time for the “pre-2018” rule to apply. Please check the IRB metrics page prior to submission to help you predict under which rule your study is likely to be reviewed.
  • After the implementation date (January 21, 2019), studies that were approved under the pre-2018rule will continue to be evaluated against those regulations. The decision to transition a study from pre-2108 to the revised rule will be at the discretion of the reviewing IRB.
  • The IRB released new consent templates that meet revised rule requirements well in advance of the revised rule compliance date. These templates can be used at any time and do not conflict with either set of rule requirements.

 

What Researchers Can Do