Continuing to Work with the Community on Registration and Results Reporting for Basic Experimental Studies involving Humans
William Riley, Ph.D., Associate Director for Behavioral and Social Sciences Research, NIH
Carrie Wolinetz, Ph.D.,
Associate Director for Science Policy, NIH
The research that NIH funds doesn’t always fall neatly into a single category. 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 of a clinical trial, these trials must register and report summary results information for transparency and other purposes outlined in the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. However, some researchers have faced challenges in fitting these studies into the data fields for submission in ClinicalTrials.gov.
In
response to concerns from the basic science communities, the NIH issued a
Request for Information (RFI; NOT-OD-18-217) seeking additional input
from stakeholders on how best to implement the NIH clinical trials policies. NIH asked for examples of BESH that pose
challenges for registration and results reporting on ClinicalTrials.gov, asked
for potential modifications to ClinicalTrials.gov that would better meet the
needs of BESH, and asked about the strengths and weaknesses of potential
alternative platforms.
Thanks
to the outreach efforts of the basic science com...
Source: NIH Extramural Nexus - Category: Research Authors: Carrie Wolinetz, Michael Lauer, and William Riley Tags: blog Open Mike basic science BESH Clinical Trials Clinicaltrials.gov Source Type: funding
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