1. Register in eRA Commons
An NIH intramural investigator who will serve as a co-PD/PI must be registered as a PI in eRA Commons. An intramural investigator may serve as a co-PD/PI but cannot submit the application or serve as the contact PI.
If you do not have the required account or role, your IC's Signing Official or Accounts Administrator can create or update your account. If you need help identifying the appropriate official, contact the eRA Commons Help Desk at 1-866-504-9552 or [email protected].
2. Plan for study drug costs
Work with your extramural partner to identify study drug costs. The only NIH Clinical Center costs that may be included in the application budget are costs for drugs being studied in the project.
- When possible, work with pharmaceutical partners to reduce these costs.
- The NIH Clinical Center LOS, if required, will state whether the Clinical Center can cover any study drug costs.
- Costs expected to exceed $25,000 per year must be covered by the grant, the supporting IC, or an industry partner.
- Include this information in the pre-application request.
3. Identify intramural institute costs
Work with your IC to identify and document all project-specific intramural costs. These may include IC services that take place in the NIH Clinical Center.
4. Report the effort of intramural personnel
List the name and percent effort of every intramural key staff member in the Clinical Center and IC budget requests. Federal award funds cannot pay the salaries of federal employees, so enter $0 for salary while still reporting their time on the project. If temporary contract staff will be hired, include their salary costs and level of effort in the budget.
5. Obtain the project Summary Statement
If you cannot access the Summary Statement through eRA Commons, request it from your extramural collaborator, not from the grant Program Officer. All collaborators should review and understand the Summary Statement.
6. Plan for single IRB requirements
The NIH single IRB policy applies to NIH-funded domestic studies when human subjects research that requires IRB review will take place at more than one site. If the policy applies, the U01 application must identify the reviewing IRB.
Consult your local IRB office to determine the required arrangements. NIH intramural investigators must also consult the NIH Office of IRB Operations at [email protected] or 301-402-3713. When a single IRB is required, include letters from the participating institutions confirming their intent to rely on the selected reviewing IRB.
More information: https://irbo.nih.gov/multi-site-research/