“Common Rule” Revisions

On January 18, 2017, revisions to the “Common Rule”, the federal regulations that guide IRB activities, were published. They occupy more than 500 pages in the Federal register, and are the result of 6+ years of drafting and public deliberation. As it stands, institutions (CSU included) have until January 2018 to modify institutional policies and procedures to come into compliance with the revised Common Rule. We are aware that the revisions to the Common Rule have been, and will continue to be much discussed. With respect to IRB activities at CSU, we draw your attention to the following:

  • At the moment, and until further notice, there are NO changes in IRB policy at CSU. The IRB will operate under existing policy until we have time to carefully review the policy implications of the revised Common Rule and revise the CSU policies and procedures accordingly. It is inescapable that this will take some time; the January 2018 “deadline” for compliance with the revised Common Rule is precisely because of the breadth and depth of the revisions.
  • We will provide ample lead time and regular communication to all investigators regarding all changes in IRB policy related to the revised Common Rule. There will be no surprises; our aim is to make this clear, timely, and as easy as possible for investigators.
  • We will move with all due diligence on revising IRB policies and procedures. While this work is underway, we remind all investigators that CSU continues to operate under existing IRB policies. The revised Common Rule should NOT be taken as placing any roadblocks for IRB review and approval.

We appreciate your patience as we work toward attending to the changes in the Common Rule.

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