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

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 Applications submitted using an incorrect forms package for their intended due date will be withdrawn and removed from funding consideration.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

FORMS-H application packages will be posted as follows:

• New FOAs posted before October 25, 2022 with initial due dates on or after January 25, 2023 will be posted without application forms until updated forms are available. Application packages will be added to these FOAs by November 25, 2022.
• All active Parent and IC-issued FOAs with due dates on or after January 25, 2023 will be updated to add FORMS-H application packages between October 25, 2022 and November 25, 2022 with all application forms packages posted 30 calendar days or more prior to receipt dates.

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

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 (updated Feb 2023)
• 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.