Special Instructions for Intramural Investigators

1. If you intend to serve as a principal investigator (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 one of the Multiple PIs. The Multiple PD/PI model is strongly encouraged but not required.  For those applicants opting not to use the Multiple PD/PI model, the intramural investigator can hold any role other than the PD/PI role. 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 commons@od.nih.gov

2. Your project will need to budget for project-related 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. New for this FOA, 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 (standard of care drugs will be free). It is recommended that, when possible, investigators work with pharmaceutical partners to minimize the cost of the study drugs. We suggest you submit the budget template as early as possible and no later than March 1, 2019, to ClinicalCtrPartner@mail.nih.gov.

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 not the PI of the grant, 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. If you are a primary investigator on the grant (MPI), then you may request the summary statement directly from the program officer.

6. Clinical Protocol IRB Authorization (Reliance) Agreements

If the extramural collaborator will be engaged in human subjects research, there must be oversight by an IRB (NIH or extramural institution). If the extramural collaborator will be engaged in human subjects research and the plan is to have that individual’s institution rely on the NIH for IRB oversight, the NIH intramural research collaborator must initiate the Reliance Agreement process. Please contact the Office of Human Research Protections (301-402-3444) and review the Standard Operating Procedure (SOP 20A) for further guidance.

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This page was last updated: 11/26/2018