2018 Common Rule

The New Common Rule, called the “2018 Common Rule”
goes into effect on:
January 21, 2019

What does this mean for your human subjects research?

To find out more about each of these areas – click the link….

New Projects First Approved ON or AFTER January 21, 2019

Studies that were First Approved BEFORE January 21, 2019, and are ONGOING

Transitioning Studies First Approved BEFORE January 21, 2019, and are ONGOING

Key Changes in the 2018 Common Rule Impacting Your Research

To find out more about each of these areas – click the link….

Exempt Research
New and Revised Categories of Research

Continuing Review
     Removed in Some Research – See if your study will qualify

Informed Consent
     New Key Information section and new wording required

Clinical Trials
     New requirement to post consent document to public federal website

IRB Grant Review
     Changes to who is responsible for certification process

Single IRB (sIRB)
     Single IRB model for cooperative research

Reliance Agreement
     New requirements for agreements and responsibilities