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

Going forward, whether or not your research is FDA regulated will be very important in determining which regulations the IRB will apply to your research. This is because the FDA has not yet harmonized their regulations with the 2018 Common Rule.

Terminology: Pre-2018 Common Rule Federal Human Subjects Regulations in effect prior to January 21, 2019
2018 Common Rule Federal Human Subjects Regulations in effect on or after January 21, 2019

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  • Studies may only be transitioned to the 2018 Common Rule at the time of Continuing Review
    • The IRB must conduct a complete expedited or full board review of your study under the 2018 Common Rule in order for it to transition.
      • The IRB only has sufficient information at the time of Continuing Review to conduct this complete review.
      • For those studies eligible to transition, a new question will appear as the first question on your Continuing Review application to ask if you want to transition.
        • If you say YES to transitioning to the 2018 Common Rule, this is a permanent decision and the entire 2018 Common Rule applies to your study going forward until it closes.
        • If you say NO to transitioning to the 2018 Common Rule, you will continue to be asked at each subsequent Continuing Review whether you want to transition at that time.
        • You do NOT have to transition your study to the 2018 Common Rule. You may leave your study under the Pre-2018 Common Rule for the remaining life of the study.
        • See Key Changes in the 2018 Common Rule Impacting Your Research for additional information on what new regulations apply if you choose to transition your study to the 2018 Common Rule.
  • Key reasons you might want to transition your study