Common Rule for Human Participant Research Changing January 19

The “Common Rule” is the common ethical standard for human participant research in the United States issued by the US Department of Health and Human Services (HHS). A significant revision to the Common Rule, also known as the Federal Policy for the Protection of Human Subjects, will go into effect on January 19, 2018.

Many of the Common Rule changes relate to the management and function of the Institutional Review Board (IRB), but researchers will see changes to their work as well:

  • Continuing review, an annual IRB requirement for many active studies, will no longer be required for some minimal-risk research. At the University of Minnesota, researchers will be notified upon initial IRB approval about any post-approval review requirements.
  • The categories of research that are exempt from IRB review has been expanded. Some exemptions may require "limited IRB review," similar to an expedited review process, while others may qualify for "self-determination." (Researchers will still be required to submit all human participant research to the IRB for an exemption determination.)
  • The informed consent section of the Common Rule has been revised to include a new "Key Elements" section and rearranged content, and a new option for broad consent may be available in the future for UMN studies. University administrators are awaiting further guidance about implementing the option from regulators and advisory groups, including the Office for Human Research Protections and its Secretary’s Advisory Committee on Human Research Protections.
  • Starting January 20, 2020, research projects (commercial, academic, or hospital-based) located in the US will be required to use a single IRB-of-Record (sIRB). 

IRB will notify some affected researchers with more information in the coming week. Other researchers will be notified as part of their projects’ continuing review.