This blog was co-authored by Dr. Michael Lauer, NIH's Deputy Director for Extramural Research and the Director of the Office of Extramural Research (OER). More information about OER can be found here.
Today, Dr. Michael Lauer and I coauthored an Open Mike blog announcing the release of the parent FOAs for Basic Experimental Studies Involving Humans (BESH). These FOAs will provide basic researchers who fell under the clinical trials policies a home for submitting their basic experimental research. Grant applications submitted under BESH will have additional flexibility for registration and reporting, and OBSSR and ClinicalTrials.gov continue to work together to make registration and reporting on this portal more amenable to basic human research. OBSSR also will initiate the development of Good Clinical Practice (GCP) training specifically tailored to basic experimental studies with humans.
We will continue to work with the basic science community to address concerns while ensuring transparency of the human interventional research that the NIH funds.