HRPP Newsletter

February 18, 2021

Non-Exempt Studies with No Expiration Date

One of the major changes to the revised regulations for human research protection was removal of the requirement to conduct annual review (no expiration date) for some non-exempt studies. While annual review is not required for these studies, there are still continuing IRB responsibilities such as submission of modifications, reportable events, and closure of the study once it is complete. Once a year, principal investigators will receive an email reminder of these responsibilities for non-exempt studies approved by the MSU IRB with no expiration.

To learn more, visit the MSU HRPP Non-Exempt Studies with No Expiration Date webpage.

MSU Process for Use of External (Non-MSU) IRBs

Employees of MSU (faculty and staff), students of MSU, and agents of MSU (i.e. individuals engaged by MSU to conduct human subject research on behalf of MSU) conducting human subject research activities are required to obtain MSU IRB review and approval, an MSU IRB exempt determination, or to submit an application to the MSU HRPP to request reliance upon an external (non-MSU) IRB.

For employees, students or agents of MSU who will be collaborating with external (non-MSU) investigators who wish to obtain IRB approval from an external (non-MSU) IRB, an external IRB request must first be submitted in the Click™ Research Compliance System (Click) to the MSU HRPP. The MSU HRPP cannot make a determination about reliance on an external IRB prior to receipt and review of an external IRB request. 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.

MSU does not enter into reliance agreements for exempt research. For employees, students or agents of MSU who will be collaborating in exempt research with external (non-MSU) investigators, MSU will need to make its own exempt determination. A new study submission will need to be created in Click for review and determination.

To learn more, visit the MSU HRPP Reliance FAQs webpage.

SAVE THE DATE: Clinical Research Education Series and Training (CREST) Meeting

The Human Research Protection Program (HRPP) would like to invite you to the Clinical Research Education Series and Training (CREST) meeting on April 13th, 2021 from 12:00pm-1:00pm. This will be a virtual event and the Zoom link will be sent along with an agenda closer to the meeting date.

This meeting is designed to be an opportunity for study coordinators, clinical research administrators and all people who provide clinical research support to share questions/concerns and obtain information from the HRPP.

If you have any questions regarding this training session, please contact the MSU HRPP at hrpp@ora.msu.edu

Restart of In-Person Interactions with Participants

Reminder if your research involves any in-person interactions with research participants you must submit a Human Research Plan for a Safe Return.

More information can be found on our website.

For more information, visit the MSU HRPP COVID-19 webpage.