The below message was sent on behalf of Dr. Robert Nobles, Vice President for Research Administration:
March 12, 2021
Dear Colleagues,
I am writing to share the outcome of an extensive review of our clinical trial definition and Facilities and Administrative Rate (F&A) rate. Over several months, we organized a working group that included faculty, CBOs, and senior leadership to review and ensure Emory University’s F&A rate applied to industry sponsored clinical trials was competitive.
As a result of the review, Emory University is instituting new guidance to mandate a minimum F&A rate of 32% on all industry funded clinical trials effective on 4/1/2021. Any agreement that is negotiated or proposal development occurs after 4/1/2021 is subject to the new minimum rate of 32%. Agreements in negotiation or proposal development prior to 4/1/2021 will be under the previous guidance of a 30% minimum F&A rate.
In the future, the industry funded clinical trial rate will be evaluated and adjusted on the same four-year cycle as the Emory federally negotiated F&A rates. Federally funded clinic trials will utilize the federally negotiated Other Sponsored Activities (OSA) rate.
Emory University utilizes the NIH definition of “clinical trial” which defines clinical trials as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. A decision tree has been developed to help research administrative staff ensure the correct F&A rate is assigned to awards deemed clinical trials.
Thank you in advance for your support of this policy change. You may contact me directly with any questions.
Thank you again,
Robert
Robert Nobles, DrPH, MPH, CIP
Vice President for Research Administration