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PAM and Revised Common Rule

Wednesday, June 20, 2018

Good afternoon.  Please see the following important announcements from the UNM Office of the IRB.

Post Approval Monitoring Activities

The OIRB is commencing a new season of post approval monitoring (PAM).  If your human research project is active, you may be selected to complete a self-assessment checklist. The self-assessment checklist is a tool that walks you through reviewing your study records and files to ensure your project is being conducted in compliance with the approved procedures and IRB regulations and policies.  For graduate student projects, both the faculty PI and the student investigator are required to participate in and sign the self-assessment.  If you receive a request to complete a self-assessment, this can be completed at a time that is convenient to you but must be returned to our office within 30 days via IRBNet. If you would like to take a look at the self-assessment tool, it is attached here and is also available on our website in the IRB library under the PAM tab at http://irb.unm.edu/irb-library-pam.

Delay in Revised Common Rule

The federal Office of Human Research Protections (OHRP) recently issued a notice that a Final Rule has delayed the general compliance date of the revised Common Rule for an additional 6-month period until January 21, 2019. The transition provision in the Final Rule is structured so that regulated entities cannot implement the revised Common Rule in its entirety, in lieu of compliance with the current version of the Common Rule, until the general compliance date of January 21, 2019. As a result of this, regulated entities will be required to continue to comply with the requirements of the pre-2018 version of the Common Rule until January 21, 2019.

What does this mean to us?  Policies and procedures that have been revised to comply with the Final Rule changes (mostly impacting federally funded research) will not go into effect until 1/21/19.  We will continue under our current policies and procedures until that time.

Thank you and have a great day!