NIH program grants (P series) are intended to support multi-project research programs. NIH cooperative agreements (U series) involve high-priority research areas that require substantial involvement from the NIH program or scientific staff.
When applying for a P or U series grant, follow the most current NIH SF424 guidance, as well as any specific instructions in the funding opportunity announcement (FOA).
Also review additional NIH proposal guidance:
- Page limits for common sections
- Formatting guidelines
- Rules for text fields
- NIH Grants Policy Statement (to better understand the NIH, its grants process, and terms and conditions if the proposal is awarded)
Note: The FOA instructions always supersede the SF424 or standard page limitation guidance.
Support for NIH proposal development
Included below are grant writing toolkits developed by the SoM Office of Research Development and the Office of Campus Research Development (OCRD).
- Campus Schools/Provost Area - the Office of Campus Research Development (OCRD) provides additional proposal development support for NIH grant proposals to Duke campus-side faculty upon request.
- School of Medicine - explore how the SoM Office of Research Development supports NIH proposals.
Templates and examples
NIH complex grant toolkit
- NIH complex grant application tracking sheet and user guide
- NIH complex grant proposal development calendar template and user guide
- NIH P/U award writing tips
- Authentication of Key Biological and Chemical Resources
- Biosketch (includes new form and guidance for proposals due on or after 1/25/2022)
- Budget Justification (Detailed)
- Consortium/Contractual Arrangements
- Data Management and Sharing Plan
- Facilities and Other Resources: Overall
- Facilities and Other Resources: Admin Core
- Facilities and Other Resources: Core
- Facilities and Other Resources: Project
- Multiple PI Leadership Plan
- SoN Multiple PI Leadership Plan (access only available to individuals in the School of Nursing)
- Project Narrative
- Research Strategy: Overall
- Research Strategy: Admin Core
- Research Strategy: Core
- Research Strategy: Project - no clinical trial
- Research Strategy: Project - with clinical trial
- Resource Sharing Plan
- Select Agent Research
- Specific Aims
- Vertebrate Animals
NIH P/U grants Human Subjects and Clinical Trials attachments
- Human Subjects Study fillable form (download to view); annotated fillable form (see p. 9)
- Study Record: Human Subjects and Clinical Trials Information fillable form (download to view); annotated fillable form (see p. 10-15)
- Availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) Status
- Data and Safety Monitoring Plan
- Delayed Onset Justification
- Dissemination Plan
- Human Specimens and/or Data Not Considered Human Subjects Research
- Inclusion of Individuals across the Lifespan
- Inclusion of Women and Minorities
- Other Requested Information
- Overall Structure of the Study Team
- Protection of Human Subjects
- Recruitment and Retention Plan
- Recruitment and Retention Plan, if using existing dataset/resource
- Single IRB Plan
- Statistical Design and Power
- Study Timeline
NIH P20 Climate Change
(RFA-ES-23-007) The P20 planning grant for a multi-component Climate Change and Health Research Centers (CCHRCs) will support the development of a transdisciplinary research environment to sustain a program of fundamental and applied research to examine the impacts of climate change on health and to develop action-oriented solutions to protect the health of individuals, communities, and nations from the hazards posed by climate change.