Revised Common Rule

The U.S. Department of Health and Human Services (HHS) and other Common Rule federal departments and agencies are implementing a revised rule on Federal Policy for the Protection of Human Subjects (also known as the Common Rule) that became effective January 21, 2019. 

Please note that the U.S. Department of Justice and the U.S. Food and Drug Administration have not adopted the revised regulation.

Overview of Significant Changes

Significant changes include:

  • Removes the requirement to conduct annual renewal review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care (modifications are still required)
  • New requirements regarding information that must be given to prospective research subjects as part of the informed consent process
  • Allows the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens
  • Establishes new exempt categories; under some of the new categories, exempt research would be required to undergo limited IRB review
  • Creates a requirements for U.S. based institutions engaged in cooperative research to use a single IRB for that portion of research that takes place within the U.S., with certain exceptions

The revised regulation is available at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/revised-common-rule-regulatory-text/index.html 

Training

In January 2019, the webinar, "Upcoming Changes to Human Research Protection Regulations: How Do the Changes Impact Researchers?" will be offered. 

The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies are implementing a revised rule on Federal Policy for the Protection of Human Subjects (also known as the Common Rule) that is anticipated to become effective January 21, 2019. This webinar provides an overview of the changes and how it impacts MSU researchers.

Learning objectives: After the webinar, participants should be able to:

  • Explain upcoming changes to the human research protection regulations that impact researchers
  • Determine the impact of the changes on new and ongoing projects
  • Identify and locate resources available to assist researchers with the changes

Visit the Events page for dates and times.

Resources

Additional information is available on the webpages developed for specific topics (e.g. exemptions, informed consent), as well as the Additional Resources webpage. 

Revised Common Rule