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Overview of IRB Regulation Changes

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.  

Interested in Learning More?

Contact IRB Office if you want us to come to your class or faculty meeting. 

So what's new?  

While there are a number of revisions that are included in the Revised Rule, the most notable are:

  1. Revised definition of "research," which deems certain activities not to be research
    (Note: Oral history will no longer be considered research)

  2. New definitions for "clinical trial," "written or in writing," and "public health authority"

  3. Revised definitions for "Legally Authorized Representative," and "Human Subject"  

  4. New and revised exempt categories
    (Note: The Exempt categories have been expanded to be more inclusive of standard research methodologies so much so that many research studies that are Expedited will qualify for Exempt status.) 

  5. No continuing review for expedited studies
    (Note: Full Reviews will still have annual continuing review)

  6. New informed consent requirements including  the addition of new "key elements" and a re-arrangement of content designed to facilitate understanding
    (Note: Luckily, we have already integrated the new consent elements into our current consent templates. So, if you are using a template from January 2018 or onward, you are already in compliance.) 

  7. New informed consent waivers

  8. Single IRB requirement for collaborative projects
    (Note: This is scheduled to be implemented in January 2020)

  9. Implementation of "broad consent" 

How will this affect your research? 

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 irb@csusm.edu. Please remember if you are making changes to an already approved project, you still must fill out and submit a "Minor Modification Form"