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the end of January, FABBS started receiving emails from worried researchers saying their proposals to NIH had been withdrawn before review because they were not classified as clinical trials, and perception was that they should have been.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

National Institute on Aging Advancing New Research Initiatives on Alzheimer’s

At the recent National Advisory Council on Aging meeting, 26 new concept proposals focused on Alzheimer’s and related dementia’s were approved by Council. According to NIA Director Richard Hodes, the concept proposals will be developed into a “record number” of new Funding Opportunity Announcements in the next few months. NIA has benefited from increased federal funding for Alzheimer’s research over the last few years and is expected to receive additional increases this fiscal year,