Revised Rule on the Federal Policy for the Protection of Human Subjects

August 21, 2019

Revised Rule on the Federal Policy for the Protection of Human Subjects

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

Significant changes include:

• Removes the requirement to conduct annual IRB renewal review for new 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
• Establishes new exempt categories; under some of the new categories, exempt research would be required to undergo limited IRB review
• Creates a requirement 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 (implements January 2020)

As part of the Michigan State University Human Research Protection Program (HRPP) implementation, many HRPP documents have been updated, including forms, HRPP Manual sections, and informed consent templates. The updated documents are available on various HRPP webpages, such as the Templates and Informed Consent Templates webpages: http://hrpp.msu.edu/templates/index.html and http://hrpp.msu.edu/templates/consent.html

More information about the Revised Common Rule can be found at: http://hrpp.msu.edu/help/revisedrule/index.html