Continuing to Work with the Community on Registration and Results Reporting for Basic Experimental Studies involving Humans

July 24, 2019

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 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 through September 24, 2021.

New Funding Opportunities for Basic Experimental Studies Involving Humans

November 28, 2018

Over the past year, since we published an essay in Nature Human Behaviour on “NIH policies on experimental studies with humans,” NIH has engaged in a discussion with the basic science community to find ways to meet our shared obligations to study participants and taxpayers, while respecting the unique goals and outcomes of basic science.  While we are still in the midst of that conversation, we are pleased to announce real progress in the form of new funding opportunity announcements for Basic Experimental Studies involving Humans. 

NIH’s Commitment to Basic Science

March 25, 2016

Several years ago, my colleagues and I analyzed the diversity of disease research supported by NIH’s National Heart, Lung, and Blood Institute, and wrote about the importance of maintaining a diverse scientific portfolio. In times of scarce resources, it is tempting to prioritize investments that seem to offer a better promise of direct returns. In my current position as NIH’s deputy director for extramural research, I still feel strongly that maintaining a strong commitment to long-term goals and maintaining a diverse science portfolio ultimately balances risk and long- versus short-time pay-offs. Basic science is an essential component of this diverse portfolio. ….