February Proves a Busy Month for NIH Advisory Councils

The National Institute of Child Health and Human Development (NICHD) Advisory Council met on February 2, 2021(Videocast). Director Diana W. Bianchi, M.D, began with the customary “directors report” providing a funding update, NICHD will receive $1.59 billion for fiscal year (FY) 21, a $66 million increase from the previous year. Of this money, $12.6 million is allocated for the Gabriella Miller Kids First Research Act and another $65 million for INCLUDE (INvestigation of Co-occurring

Clinical Trial Definition Continues to Cause Confusion

February 12, 2020

Towards the end of January, FABBS started receiving emails from worried researchers saying their proposals to NIH had been withdrawn before review because they were not classified as clinical trials, and perception was that they should have been. As readers may recall, in October 2014, NIH expanded their definition of clinical trials to include Basic Experimental Studies involving Humans (BESH). While the enforcement of registration in grants.gov for BESH had been

Struggles with NIH Clinical Trial Policies Continue For Basic Scientists

January 9, 2018

For at least six months now, NIH and segments of the basic science community have been engaged in a dialogue around the agency’s operationalization of the clinical trials definition to include much basic science involving humans. Through petitions, open letters (see NIH Director Awardee letter and Study Section Chairs letter), emails, responses to NIH blog posts, Advisory Council discussions, and more, the back-and-forth has led to some improvements in the process (e.g.,

21st Century Cures Becomes Law- Provide New Funds for NIH and Opioid Crisis

On December 13, President Obama signed into law H.R. 34, the 21st Century Cures Act, a bipartisan piece of legislation Congress had been negotiating since the original bill passed the U.S. House of Representatives in July 2015. The bill affects primarily the Food and Drug Administration and the National Institutes of Health (NIH) and includes provisions intended to improve mental health, building on recommendations from the President’s Mental Health and Substance Use Disorder Parity Task