MSU HRPP Newsletter

February 20, 2020

New Single IRB Requirement

Projects seeking funding from a federal department or agency that has adopted the Revised Common Rule for the protection of human subjects in research are now required to identify and use a single Institutional Review Board when certain criteria are met. Any institution located in the United States that is engaged in cooperative non-exempt research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States, with limited exceptions. At MSU, this requirement only applies to projects funded or supported by a federal department or agency that has adopted the Revised Common Rule for the protection of human subjects. A new HRPP Manual Section, 2-2-G, Revised Common Rule Single IRB Requirement, is now available and provides information about MSU’s requirements and process.

Selection of the Single IRB

The reviewing Single IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. When a cooperative research study may require a single IRB, the MSU Principal Investigator submits the HRP-562 – Template – Use of a Single IRB using the Click™ Research Compliance System to the MSU Human Research Protection Program to identify the Single IRB prior to submission of the grant proposal. The HRP-562 has been revised to include the new Single IRB requirements, in addition to the U.S. National Institutes of Health (NIH) Single IRB grant requirements.

The MSU HRPP must agree upon the selection of the single IRB prior to submission of the grant proposal. Please contact the MSU HRPP as early as possible for the Single IRB selection.

U.S. NIH Single IRB Requirement

The Revised Common Rule Single IRB requirement is in addition to the U.S. NIH grant policy requirement for single IRB review. If a study is conducted or supported by NIH, both the NIH Single IRB Policy for Multi-site Research and the Revised Common Rule Single IRB requirement for cooperative research would apply. A single IRB must be used if it was required under either the NIH Single IRB Policy for Multi-site Research or the Revised Common Rule Single IRB requirement.

Questions?

If you have any questions about the Single IRB requirement or reliance, please contact irbreliance@ora.msu.edu or visit the MSU HRPP website regarding Single IRBs.