NIH has extended flexibilities for registration and results reporting for studies submitted to basic experimental studies with humans (BESH) funding opportunities. This policy flexibility is now extended through September 24, 2024.
I Am Conducting a Basic Experimental Study Involving Humans (BESH). Do I Have Flexibilities for Registration and Results Reporting in ClinicalTrials.gov?
It depends. Only BESH studies that were awarded through a BESH-specific funding opportunity are eligible for registration and reporting flexibilities (as noted in NOT-OD-21-088).
Basic Experimental Studies Involving Humans (BESH) are studies that meet both the federal definition of basic research and the NIH definition of a clinical trial. Looking for more information about what studies fall within the BESH definition and what policies apply? Our latest NIH All About Grants podcast episode will answer these questions and more!
Working on a study that might meet both the definition of basic research and the NIH definition of a clinical trial? Check out our new webpage on Basic Experimental Studies involving Humans (BESH).
NIH has extended flexibilities for registration and results reporting for studies submitted to BESH funding opportunities. This policy flexibility, originally announced in NOT-OD-18-212 and NOT-OD-19-126, is now extended through September 24, 2023.
Continuing to Work with the Community on Registration and Results Reporting for Basic Experimental Studies involving Humans
Basic research involving humans that seeks to understand the fundamental aspects of phenomena also may meet the NIH-definition of a clinical trial. We refer to these studies as BESH – Basic Experimental Studies involving Humans (see our previous blog). Since this type of research meets the NIH definition However, some researchers have faced challenges in fitting these studies into the data fields for submission in ClinicalTrials.gov. The NIH has determined that more time is needed to address these challenges. Today, NIH published a Guide Notice (NOT-OD-19-126) announcing the extension of delayed enforcement of registering and results reporting of BESH on ClinicalTrials.gov through September 24, 2021.
For your convenience, here is a roundup of recently announced changes impacting grant application submission for due dates on or after January 25, 2019.
In November, NIH announced the publication of new funding opportunities specifically for Basic Experimental Studies Involving Humans (BESH). Need help determining if your research fits within the scope of a BESH funding opportunity announcement (FOA)? Check out these new resources.