NIH recently introduced a new funding opportunity announcement (FOA) designation for prospective basic science studies involving human participants, to be called Basic Experimental Studies with Humans (BESH).
FOAs can now have any of the following clinical trial (CT) classifications:
- CT Not Allowed
- CT Optional
- Mechanistic CT Only
- BESH Required
- CT Required
When you’re ready to submit your next application, you must select a FOA that accepts the type of research you wish to propose.
Defining Prospective Basic Science
To determine whether your study is a clinical trial, use the decision tool available at Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial?
To assess whether a study is basic research, apply the Federal Code’s definition of basic research: “the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena or of observable facts without specific applications towards processes or products in mind.”
BESH studies must meet both definitions. The classification is largely aimed at behavioral and psychological studies, e.g., measuring brain activity when participants are shown image prompts.
NIAID Not Participating
NIAID is not participating in the Research Project Grant (Parent R01, Basic Experimental Studies with Humans Required) FOA and related BESH parent FOAs. Our view is that NIAID can best serve as a steward of CT research by leveraging our existing Networks and Investigator-Initiated Clinical Trial (IICT) Resources.
This does not mean that NIAID does not support fundamental basic science experimental research. We recognize that applications may include not only a clinical or mechanistic trial, but also fundamental basic science experimental research aims. NIAID will continue to accept such hybrid applications as well as applications solely proposing clinical trials or basic experimental studies with humans in response to our IICT suite of FOAs listed at How To Apply for Funding.
As always, we strongly advise applicants to contact NIAID staff to determine the appropriate NIAID-specific clinical trial FOA.
To learn more about BESH, read the October 26, 2018 Guide notice.