UCSF Research Development Office (RDO): Grant Templates and Guides

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.

To learn more about this form, please read this summary document prepared by the UCSF Research Development Office. Copies of the form (main form and study record) are provided below:

Human Subjects

Below are templates and examples for all the attachments required for proposals that involve human subjects research. UCSF MyAccess required.

• Inclusion of Women, Minorities, and Children
• Recruitment and Retention Plan
• Study Timeline
• Protection of Human Subjects
• Single IRB Plan
• Justification for Delayed Onset Study (example)

Clinical Trials

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:

• Data Safety Monitoring Plan
• Overall Structure of Study Team
• Statistical Design and Power
• Dissemination Plan

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.