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Revised Common Rule

The Common Rule is a federal policy regarding Human Subjects Protection that applies to 17 Federal agencies and offices.  On January 21, 2019, all new federally funded human subjects research studies must comply with the revisions to the U.S. Department of Health and Human Services (DHHS) human subjects research regulations, the Revised Common Rule.  In addition, all research conducted in Maryland must follow the Revised Common Rule.

In preparation for implementation of the Revised Common Rule, the JHM IRB is using the following timeline for new applications not granted final IRB approval before January 21, 2019.

  • New applications submitted after 12/15/2018, but not reviewed by the IRB, will be returned to study teams after 01/21/2019 with any pre-review issues. Study teams will see some sections of the application have changed to be in compliance with the Revised Common Rule.  Study teams should address all pre-review issues, complete any new required questions and resubmit the application for review.
  • New applications reviewed by the IRB, but not approved prior to 01/21/2019, will be returned to study teams after 01/21/2019 and include the IRB review issues. Study teams will see some sections of the application have changed to be in compliance with the Revised Common Rule.  Study teams should address all IRB review issues, complete any new required questions and resubmit the application for review.

Guidelines & Policies

Forms, Tools, and Templates Related to the Revised Common Rule

IRB Office Hours:

The IRB will hold open office hours to help study teams with questions about new applications affected by the Revised Common Rule.  IRB staff will be available in Reed Hall conference room B102G to help answer your questions. In order to provide specific guidance, we will need the number for the application you are working on. Staff will be available at the following times:

Tuesday 1/22/2019 through Thursday 1/24/2019 – 12:00 – 3:00

Monday 1/28/2019* through Thursday 1/31/2019 – 1:00 – 3:00

If you are not able to attend on one of these days, you may request an appointment by emailing the eIRB help desk at jhmeirb@jhmi.edu.

*   This session will be held in Reed Hall conference room 102.