Introduction
Overview
The pre-application process is required. NIH uses this review to determine whether the proposed project:
- Aligns with the research mission of the selected NIH IC.
- Can be supported by NIH IRP resources.
- Can be supported by NIH Clinical Center space and resources, when applicable.
- Has a workable plan for covering NIH Clinical Center and intramural investigator costs.
OCRECO will notify the applicant and collaborators of the review decision. If the project can be supported, the notice will include the required LOSs and authorization to submit the full U01 application.
If an NIH Clinical Center LOS is required, it will explain whether the NIH Clinical Center can cover the study drug costs or whether those costs must be paid by the grant, the supporting IC, or an industry partner.
Questions about whether an NIH Clinical Center LOS is required should be sent to [email protected].
How to Request LOSs
As described in PAR-28-045, applicants must obtain an LOS from a participating NIH IC and, when applicable, an LOS from the NIH Clinical Center.
Send requests between December 14 and January 16. Early submission is strongly encouraged.
Send requests to:
Opportunities for Collaborative Research with the NIH Intramural Research Program (U01)
NIH Office of Clinical Research Education and Collaboration Outreach
Email: [email protected]
Telephone: 301-496-4121
What NIH Will Review
- Program fit: Does the project align with the mission of the selected NIH IC?
- NIH Clinical Center resources: Does the NIH Clinical Center have the needed space, staff, and resources?
- Cost coverage: Can the participating NIH IC cover the NIH Clinical Center and intramural investigator costs if the project is funded?
The multiple PD/PI model is allowed but is not required.
What to include in the LOS Request
1. Project title
2. Collaborators
List the names, institutions, and contact information for all intramural co-PD/PIs, extramural PIs, and, when possible, all co-investigators.
At least one NIH intramural investigator must be included.
At least one lead NIH intramural investigator must serve as a co-PD/PI.
3. Collaboration overview
Describe the partnership between the extramural applicant and the NIH intramural investigator.
Briefly explain the research the team will conduct.
State the time and effort each investigator will devote to the project.
Describe each investigator's responsibilities.
4. Research to be conducted with the NIH IRP
Describe the special NIH IRP resources the project will use, such as technology, specimens, or other research capabilities.
For projects involving patients, include the research population; inpatient, outpatient, or both; estimated number of patients; expected visit or stay length; and special procedures or tests, including the estimated number of patients who will receive them.
5. Collaboration plan
Organizational structure.
Management plan, including how NIH IRP resources will be used.
Roles and responsibilities of key personnel.
How the research teams will communicate, such as by video or web meetings.
What resources are available and how they will be shared.
6. Research strategy (six-page limit)
Describe the size and scope of the project and the specific resources needed.
Include any tables, graphs, figures, diagrams, or charts needed to explain the project.
Explain how the project supports the goals of the U01 Program.
Identify at least one NIH intramural scientist as a co-PD/PI.
Describe each investigator's level of effort and responsibilities.
Describe the work that will be conducted with the NIH IRP.
7. Study drug costs
Do not submit a full budget at the LOS stage. If the project involves study drugs, however, describe the expected cost and how the cost may be covered.
The only NIH Clinical Center costs that may be included in the U01 budget are costs for drugs being studied in the project.
When possible, work with pharmaceutical partners to reduce study drug costs.
The NIH Clinical Center LOS will state whether the Clinical Center can cover any study drug costs.
Study drug costs expected to exceed $25,000 per year must be covered by the grant, the supporting IC, or an industry partner.
Information Not Required for the LOS Request
The following items are not required at the LOS stage, but may be required for the full U01 application:
A full budget.
Appendix materials.
For a clinical trial: the clinical protocol, statistical analysis plan, data and safety monitoring plan, informed consent forms, and similar attachments.