16. I submitted my study before January 21, 2019 but it has not been approved. Will the revised Common Rule apply and how will I know?

The revised Common Rule will only apply if your study is approved on or after January 21, 2019.  Applicability of the revised Common Rule is not based on the study submission date.  If our IRB reviewers believe your study is not likely to be approved prior to January 21, 2019, we will communicate via comments during the protocol review process and ask you to update your consent(s) to comply with the revised Common Rule.  In addition, if applicable, our staff will automatically re-assign the review category (Exempt --> Expedited or Expedited --> Exempt) under the provisions of the revised Common Rule.

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