NIH issued notice NOT-OD-15-128 to provide detailed guidance on the types of changes in human subjects research awards that will require prior NIH approval and provides information on the process for submission of such requests. This is a revision of a prior notice and is almost identical to the previous notice (NOT-OD-12-129) with a few edits/additions to the language to further clarify expectations regarding NIH policies for the inclusion of women, minorities, and children.