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Revised Common Rule Changes Now in Effect

January 21, 2019

*This notice affects all researchers conducting human subjects research.

 

The Department of Health and Human Services (DHHS) has incorporated changes to the Federal Policy for the Protection of Human Subjects (a.k.a. the “Common Rule”), effective January 21, 2019.

 

The new regulations do not impact Institutional Review Board (IRB) studies approved prior to January 21, 2019.

 

For IRB studies approved after January 20, 2019, notable regulation changes include:

  • Expanded exempt categories of review. Some studies that previously required expedited review may be eligible for exempt review under the new regulations.
  • Relaxation of continuing review requirement. Certain expedited studies approved under the new regulations will no longer require annual continuing review.
  • Informed consent changes. A new “Key Elements” section and a rearrangement of content is required for non-exempt studies.
  • Single IRB-of-Record requirement. With the exception of NIH-funded studies, federally-funded collaborative research projects located in the U.S. will be required to use a single IRB beginning January 20, 2020. The NIH incorporated a variation of this policy effective January 25, 2018.

 

Please see the following website for further guidance on these issues: http://www.gvsu.edu/irb/changes-to-common-rule-75.htm

 

If you have any questions, please contact the ORCI at rci@gvsu.edu or 616-331-3197.

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Page last modified January 21, 2019