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