On January 21 2019, CSUSM IRB office along with other IRBs across the county implemented the revised federal regulations (also referred to as "Revised Rule" and "Revised Common Rule"). Our federal regulators have put together a video that provides an overview of the changes in the Revised Rule. Watch here: What's New in IRB Review Under the Revised Common Rule. For more information, visit Office of Human Research Protections (OHRP) website. Also, please review New and Revised Definitions document from the CITI program to get yourself familiar with changes to terms and how they are defined and used.
Contact IRB Office if you want us to come to your class or faculty meeting.
While there are a number of revisions that are included in the Revised Rule, the most notable are:
We do not foresee these changes having a negative impact on your research. CSUSM IRB Office has already implemented the three burden reducing provisions including the elimination of continuing review for the expedited review studies as of July, 2018. If your existing expedited review is up for continuation review after July, 2018 and you need an updated consent form with no expiration date, please contact the IRB office at firstname.lastname@example.org. Please remember if you are making changes to an already approved project, you still must fill out and submit a "Minor Modification Form"