The Revised Common Rule - An Overview

On January 21, 2019, most provisions of the Revised Common Rule became fully effective.

• Informed Consent Requirements were updated
• Continuing Review was eliminated for some research
• Exemption categories were modified
• Human subjects definition was updated to include identifiable biospecimens
• Activities not deemed to be research were updated
• Single IRB for multi-site research will be required in January 2020

Major Takeaways:

• The new requirements do not impact studies approved prior to the proposed implementation date of January 21, 2019. 
• Most of the changes are addressed by updates to the application in eResearch and IRB processes.
• eResearch continues to guide the researcher through the IRB application for submitting the information required for the IRB to review.
• The primary impact to Study Teams involves meeting new requirements for "key information" in the updated Informed Consent Template and the requirement to post Clinical Trial Consent Forms on a publicly available Federal Web site.
  • NOTE: It is a study team obligation to post a consent form online for federally sponsored clinical trials approved on or after January 21, 2019. IRBMED is not involved in the process and therefore is not capable of providing reminders or assistance.

What Has Not Changed:

• Only the Common Rule (45 CFR 46 Subpart A) have been revised.
• There has been no updates to:
  • 45 CFR 46 Subpart B - Additional Protections for Pregnant Women, Human Fetuses, and Neonates
  • 45 CFR 46 Subpart C - Additional Protections for Prisoners
  • 45 CFR 46 Subpart D - Additional Protections for Children
• HIPAA Regulations governing the use of Protected Health Information (PHI) in research has not changed.
• The FDA has not yet harmonized with the Revised Common Rule.

An IRBMED Transition to Revised Common Rule Grid has been developed to aid study teams in identifying the application of the revised Common Rule to research initially approved before January 21, 2019, and to research initially approved on or after January 21, 2019 - depending on funding source(s). The grid was updated on January 18, 2019. View the grid.

For more information about the Revised Common Rule and Other Recent Changes, visit the Research Ethics & Compliance webpage.