On January 17, 2018, changes to the common rule that were scheduled to be effective on January 19, 2018, were delayed 6 months.  The new effective and compliance date is July 19, 2018.  This will allow time for the regulatory agencies to develop more guidance around the 2018 Common Rule, and they will also work with stakeholders to determine when 2018 Common Rule should ultimately go into effect. eIRB changes related to the revised Rule were implemented, but will be “turned off” until the Rule becomes effective.  For more information about this delay and the official announcement from OHRP, please go to our website.

The NIH policy changes imposing new clinical trial requirements, and the requirement for single IRB review of multisite studies are still in place and went into effect on January 25, 2018.  Per the NIH: “This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.  It does not apply to career development, research training or fellowship awards.”  Please see our website for templates of what to provide in your NIH grant applications, when to budget for single IRB review, and for helpful templates and tools.