NIH guide notice on basic science studies involving human participants
The purpose of this notice is to describe interim policy flexibilities for a subset of NIH-funded studies whose primary purpose is the pursuit of basic science. These are studies that meet the NIH definition of a “clinical trial” and that also meet the Federal definition of basic science. These studies will heretofore be referred to as “prospective basic science studies involving human participants.” These studies do not include those for which there are specific applications towards products or processes in mind, such as phase 0 or phase 1 studies of candidate interventions.
This initial implementation phase will last through September 24, 2019. During this time NIH will assess its approach to registration and results reporting for prospective basic science studies involving human participants, while delaying enforcement. In addition, it will provide leniency regarding submission to the correct funding opportunity announcement (FOA) based on the study type designation.
Read the notice in its entirety here.