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Opportunities for Collaborative Research at the Clinical Center (U01)

Special Instructions for Intramural Investigators

1. If you intend to serve as a co-Program Director/Principal Investigator (co-PD/PI) on this U01 application, or on an X02 pre-application, you will need to be registered as a PI in the eRA Commons.

Registration is required in order to be listed on the application as a co-PD/PI. While an intramural Investigator can hold the role of co-PD/PI, the intramural Investigator cannot submit the U01 application nor serve as the contact PI. If you are not already registered, your IC's Signing Official (SO) or Accounts Administrator (AO) can register you as a PI by creating an account with the PI authority role. When a Signing Official creates an account for a PI, the PI will receive an email to go to eRA Commons to verify the PI's profile information. If you already have a Commons Profile, the Signing Official or Accounts Administrator can affiliate that profile with your IC.

If you need assistance identifying your institute's Signing Official or Accounts Administrator, you may contact the eRA Commons Help desk by phone at 1-866-504-9552 (toll-free), or by email at

2. Your project will need to budget for study-related drug costs to the NIH Clinical Center.

You and your extramural partner should work together to identify costs associated with the Clinical Center and complete the Clinical Center Budget Template excel spreadsheet icon. The only NIH Clinical Center costs which may be included in the budget section of the application are the cost of drugs that are the subject of the study. It is recommended that, when possible, investigators work with pharmaceutical partners to minimize the cost of the study drugs. The Letter of Support from the NIH Clinical Center will indicate whether or not the CC is able to absorb the cost of any of the study drugs. Expensive treatments (i.e. protocols with drug costs expected to exceed $25,000/yr) will need to be paid for by the grant, by the IC, or through industry sponsorship. We suggest you submit the budget template as early as possible and no later than March 1st to

3. Your project will need to budget for the intramural investigator's institute-related costs (note: institute costs may include services that are provided by institutes and occur in the Clinical Center).

The intramural investigator will need to work with his or her institute to identify and document these costs.

4. Be sure to identify percent effort of all intramural key personnel on the Clinical Center and institute budget requests.

Even though award funds cannot be used to pay the salaries of intramural government employees, you should still list the name(s) and their time on the project and then indicate "0" dollars. This will enable reviewers determine whether sufficient effort is being devoted to the research project. If the intramural partner plans to hire temporary personnel on contract, the salary costs as well as level of effort for those individuals should be detailed in the budget.

5. Project Summary Statement Guidance

If you are an intramural collaborator and are unable to access the Summary Statement directly through your eRA Commons account, please request the project Summary Statement from your Extramural Collaborator, not the Program Officer of the grant. Each collaborator should fully understand and agree with contents of the Summary Statement.

6. Clinical Protocol IRB Authorization (Reliance) Agreements

Applicants should note that the NIH single IRB (sIRB) Policy applies to all NIH-funded domestic sites when research activities that require IRB oversight take place at more than one site. The U01 application will therefore need to identify a Reviewing IRB if the sIRB Policy is triggered. Applicants are advised to consult with their respective IRB offices in order to determine the IRB arrangements. Intramural investigators are required to consult with the NIH Office of IRB Operations by email ( or phone (301-402-3713). When an sIRB is required, letters confirming the intent to rely on the identified sIRB should accompany the U01 application from all institutions subject to the policy. Guidance on the NIH sIRB Policy and how it operates in the intramural context is available on the IRBO website at

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