HRPP Newsletter

April 18, 2019

Revised Common Rule: FAQs and Resources

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. Several resources are now available.

FAQs: The FAQ that we have received the most has been, “How does the Revised Common Rule impact studies ongoing before January 21, 2019?” Learn the answer to this FAQ and more, now available on the HRPP website: Revised Rule FAQs

Webinar Slides: In January 2019, webinars were offered on the Revised Common Rule. The PowerPoint slides from the webinars are available on the Revised Common Rule resources webpage.

More information: https://hrpp.msu.edu/help/revisedrule/2018-additional-resources.html

Western IRB (WIRB) Training

Michigan State University’s Human Research Protection Program (HRPP) is pleased to announce that Christopher Gennai from WIRB will be conducting an on-site training with a question/answer period on Tuesday, May 14 from 12:00 P.M. – 1:30 P.M. at 4000 Collins Road, Lansing, MI 48910. The session will also be available as a webinar through Zoom. WIRB is an external independent (commercial) IRB; MSU can rely upon WIRB for IRB review for certain studies, such as for multi-site research or studies that must comply with NIH Single IRB requirements.

Registration is required and is available through the Ability Learning Management System. To register, and for more information, please visit the "News & Events" webpage. https://hrpp.msu.edu/news-events/webinars.html

NIH Single IRB

The Final NIH Policy on Use of a Single IRB for Multi-Site Research establishes the expectation that all domestic sites participating in multi-site studies involving non-exempt human subjects research funded by NIH will use a single Institutional Review Board (sIRB). If you have a NIH proposal that may require use of a Single IRB, we highly recommend that you contact the HRPP early and as soon as possible, as the decision of which IRB should serve as IRB of record may require discussions between the institutions' IRBs.

Learn more about NIH Single IRB at: https://hrpp.msu.edu/help/reliance/nih-sirb.html

Change in IRB Assignment Process

The MSU IRB office has recently changed its process for assigning incoming application requests. In the past, applications were assigned to an IRB Coordinator based on the PI’s department. New initial exempt and expedited requests will now be assigned to IRB Coordinators on a rotating basis. This change aims to promote efficiency during the review process.