2 Comments
“Delayed Onset” generally means that human subjects research is anticipated within the period of award but definite plans for this involvement cannot be described in the application. It does not apply to a study that can be described but will not start immediately.
Have other questions about clinical trials? Visit the clinical trials policy pages on grants.nih.gov for additional resources, and other frequently asked questions and their answers.
Applications to a network U mechanism, generally do not provide any specific study, however, when the entire network is created, specific studies are developed. is this a delayed onset or delayed start study?
Generally if study details are not known at the time of application, as is often the case for large networks and cooperative agreements, an applicant would classify their studies as “delayed onset”. For a reference, the definition of “delayed onset” can be found in the NIH glossary: https://grants.nih.gov/grants/glossary.htm#DelayedOnsetHumanSubjectStudy
When in doubt, we recommend contacting the Program Official listed in Section VII of the FOA for guidance.