Prior NIH Approval of Human Subjects Research in Active Awards Initially
Submitted without Definitive Plans for Human Subjects Involvement
(Delayed Onset Awards)


Important Points: Research applications may be submitted with the
knowledge that human subjects will be involved during the period of
support, but definite plans for this involvement cannot be described in
the application. This situation is referred to as “delayed onset human
subjects research.”

Delayed Onset awards generally fall into one of three broad categories:

* Single project awards (research grants, career development
awards or fellowships) in which results from initial pre-clinical
research are needed before the human subjects research can be fully
* Clinical research networks or consortia often funded as
cooperative agreements or multi-project awards, that plan to add new
protocols over the course of the award.
* Award mechanisms that include funds for small projects that will
be selected and funded by the awardee. These are often referred to as
pilot project programs and may be used to support new or junior faculty
or to stimulate new research areas at the awardee institution and its

Process for Submitting Prior Approval Requests: After award and prior to
the involvement of human subjects, the grantee must submit to the NIH
awarding Institute/Center (IC) for approval, a detailed human subjects
section. Please refer to the Notice for the guidelines associated with
this section.

Should you have any questions regarding this Notice, please contact your
Contract and Grant Officer .

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