Earlier this summer, NIH released a statement, defining a new subset of NIH-funded studies as Prospective basic science studies involving human participants and delineating a 1 year + grace period (until September 24, 2019)  for enforcing Clinical Trial requirements for this type of study.

• NIH has stated that, during the grace period, they will not administratively reject proposals submitted to an incorrect FOA based on study type designation.
• NIH is also delaying the requirements for investigators conducting this type of study to register and report research findings through ClinicalTrials.gov.
• NIH plans to issue Funding Opportunity Announcements (FOAs) specifically for Prospective basic science studies involving human participants (anticipated November 2018)
• The Human Subjects and Clinical Trial Information form is still required

REMINDERS: The NIH Definition of a Clinical Trial is separate and different from ASU’s institutional definitions of ‘Clinical Research’ vs. ‘Clinical Trial’.  Typically, when ASU engages in a clinical trial according to the institutional definition, ASU will have a clinical partner.  Principal Investigators (PIs) are responsible for making the determination if their NIH research meets the NIH-specific definition of a clinical trial.  Once a PI has made that decision, their RA can help ensure the correct FOA is used.

Links & Resources:

• NIH Definition of a Clinical Trial
• NIH All About Grants Podcast: Understanding the Definition of a Clinical Trial and What That Means for You
• NIH Policy Website – New Human Subjects and Clinical Trials Information Form