SUBJECT:

Update – NIH Changes to Clinical Trials Definitions and Regulations

All current and future funded NIH researchers must be aware that, on September 5, 2017 NIH distributed a notice that will have a significant impact on projects involving human research (http://adminrecords.ucsd.edu/Notices/2017/2017-9-5-5.html). NIH has established new definitions for clinical trials that will now include studies involving human participants prospectively assigned to interventions where health-related biomedical or behavioral outcomes are measured. This change significantly broadens the existing clinical trial definitions and will require that studies meeting the new definition respond to specific funding opportunity announcements. These changes are effective January 1, 2018.

We want to emphasize the importance of this change to researcher submitting applications for NIH funded opportunities. We urge that they read the funding opportunity announcements (FOA) very carefully to determine if the proposed application meets the conditions of the published FOA. NIH recently published a list of new funding opportunities due after January 1, 2018 conforming to the new definitions (https://grants.nih.gov/grants/guide/WeeklyIndex.cfm?WeekEnding=11-03-2017).

Applications meeting the definition of a clinical trial will only be accepted through a FOA which explicitly states it will accept clinical trials. If an application is submitted to an opportunity that does not specially allow clinical trials as defined by NIH, it will be rejected and not considered for review. The chance that this may occur would be devastating to any researcher and could impact UC San Diego’s success of receiving future funding. Thus, it is critical that researchers carefully review the information published in the FOA and complete the new forms package and additional information requirements if studies fall into the new NIH definition of a clinical trial.

Please refer to the following web page for links to NIH published information on this and other important requirements affecting NIH funded human research (http://go.ucsd.edu/2jbEg7N). NIH has advised that specific questions or clarifications should be raised with the applicable Program Officer.

Sandra A. Brown Vice Chancellor for Research David A. Brenner Dean, School of Medicine Vice Chancellor for Health Sciences