News & Communications

The IRB provided an overview of the revised Common Rule and how to prepare for the regulatory changes in January 2019. Listen to the recording to learn more about the revisions that go into affect on January 21, 2019.

Vice President for Research Allen Levine has appointed Michelle Biros, M.D., to serve as deputy institutional official for biomedical studies for the University of Minnesota’s Institutional Review Board, effective May 1, 2018.

On April 20, 2018, OHRP proposed an additional delay to the Revised Common Rule. If finalized, the Revised Common Rule would require institutions to continue to comply with the requirements of the current Common Rule until January 21, 2019. This would be a six-month delay of the effective and compliance date of July 19, 2018.

See updates to the Toolkit for the month of March.

Protecting research participants is the responsibility of everyone within an organization and is not limited to the Institutional Review Board (IRB). The Human Research Protection Program (HRPP) committee has a mission to collaborate in the development, coordination, and evaluation of the University’s HRPP.

Based on feedback from the research community and recent regulatory changes, we have updated and enhanced several HRPP Toolkit documents. For more detail about the revisions and releases of new toolkit documents, visit Toolkit Changes.

On January 19, 2018, changes to regulations for protecting human research participants (also known as the revised “Common Rule”) were scheduled to take effect. We learned on January 17 that the revised Common Rule will be delayed for six months. The new compliance date is now July 19, 2018.

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.

The NIH sIRB policy is effective for NIH grant applications with due dates on or after January 25, 2018. For contracts, the policy applies to all solicitations issued on or after January 25, 2018. At this time, the University of Minnesota is not agreeing to serve as the sIRB, though this may change in the future.

Effective October 1, 2017, written reports of study monitors will require central filing with the Post Approval Review (PAR) program of the HRPP and no longer require mandatory submission to the IRB.