New NIH regulations say most basic brain research is a clinical trial

Neuron 96 (2017) pp. 14-16 Author: Adina Roskies

New NIH definitions classify virtually all human brain and behavioral research as clinical trials. The new definitions will change regulatory, reporting, and funding schemes for noninvasive studies such as neuroimaging. Resulting burdens threaten the viability of basic biobehavioral science research.
There are two primary categories of biological research in humans: basic science research, or research aimed at understanding the mechanisms, causal structure, and functioning of the human body (including brain/mind), and clinical research, which primarily aims to apply and expand upon that knowledge for medical purposes. Although the public most obviously reaps the benefits of scientific knowledge when that knowledge is used to improve health outcomes, it is also indisputable that our medical advances have only been made possible by building on a foundation of discoveries in basic science and that the success of the medical technology sector is due in large part to prior investments made in basic research. Both types of research are valuable in their own right, and each type has a distinct kind of scientific structure and dynamic. Until now, each has been recognized as distinct by the public and by our governmental agencies, and each has enjoyed distinct regulatory and funding schemes suited to their differences in modes of discovery, timescales, scope, costs, and risks of research.

For the full article in Neuron.