Are you developing an NIH proposal that proposes human subject research, and not sure what to put in the Research Strategy vs supporting documentation? Below is guidance from NIH.
Effective January 2018, all NIH research proposals that involve human subjects research research must include a Human Subjects and Clinical Trials Information form in their application.
Applicants must use FORMS-H application packages for due dates on or after January 25, 2023. Applications submitted using an incorrect forms package for their intended due date will be withdrawn and removed from funding consideration.
Application guides for FORMS-H application packages will be posted to the How to Apply - Application Guide page no later than October 25, 2022.
FORMS-H application packages will be posted as follows:
High-level Grant Application Form Change Summary: FORMS-H
New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023
Below are templates and examples for all the attachments required for proposals that involve human subjects research. UCSF MyAccess required.
Not sure if your study is considered a clinical trial? Review the figure below. If you answer "yes" to all four questions, NIH considers your study a clinical trial, and you will need to include the following attachments in your Human Subjects and Clinical Trials Study Record in addition to the sections outlined above:
Are you preparing a proposal with multiple components (e.g., a P50 with multiple Cores and Projects) what will work together to execute a study or trial? If so, refer to the guidance below on how to prepare your application materials.