These FAQs explain how to establish a partnership with NIH intramural investigators and how to request access to NIH IRP resources. They also provide general guidance on application steps and the practical details of starting a collaboration. The information is general and may not apply in the same way to every project. Each collaboration is governed by its final written agreement.
To discuss a specific project, contact [email protected].
Eligibility to Apply for the U01 Funding Opportunity
The eligibility criteria include for-profit organizations, which would include small businesses. This is not a Small Business Innovation Research (SBIR) solicitation. The standard conditions of a U01 application apply to all applicants. Detailed information may be found in the NIH Grants Policy Statement: (http://grants.nih.gov/grants/policy/nihgps/HTML5/introduction.htm).
As described in the Notice of Funding Opportunity (NOFO) "eligible agencies of the federal government" may apply.
According to NOT-HD-20-029, which clarifies the language used to better align with NIH Grants policy, at least one intramural investigator must be listed as a co-PD/PI on the U01 grant application. This change in terminology does not change the overarching goals of the announcement, nor does it change the role of the lead intramural investigator(s). An extramural investigator will be responsible for submitting the application and will be the contact PI.
Certainly. The specific announcement (PAR-26-116) allows Multi-PI applications. The application comes from the applicant institution, and that organization submits the application on behalf of the PI(s). The extramural PIs would have to meet the requirements of their respective institution(s).
There is no limit to the number of PIs, but the more PIs the more complex your plan becomes. There can be more than one intramural co-PD/PI as well.
Yes, foreign institutions and components are eligible to apply. Please refer to: NOT-LM-14-004
Each IC determines which project(s) they will support based on their respective institute priorities. Some participating ICs may require that the intramural investigator, who is listed as either the co-PD/PI or as a collaborator on the application, be employed by that IC. Intramural investigators who have projects that may better align with another participating IC's scientific mission should contact the grants management staff listed in Section VII. Agency Contacts of the funding opportunity announcement to inquire about the IC's requirement on supporting intramural investigators not employed by that IC.
As long as the project has the required collaboration "one intramural investigator and one extramural investigator," then yes, a sub-contract would be allowed.
Building a Budget for the U01 Funding Opportunity
General budget instructions can be found in the Funding Opportunity Announcement in Section IV. Application and Submission Information. The project budget should not exceed $500,000 a year in direct costs, for a period of no more than four years. Applicants may request a fifth year if the first year is for planning and regulatory approvals. The budget should reflect this reduced activity for year 1. Funds should support the project costs of the extramural principal investigator, the intramural principal investigator / co-investigator, and the Clinical Center.
The Clinical Center and the intramural investigator costs associated with the research project will not be paid to the grantee but instead will be provided directly by the awarding NIH Institute/Center to the Clinical Center and the intramural investigator, respectively.
| How to determine the costs | Materials to submit in the grant application, and where | |
|---|---|---|
| Clinical Center | 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. 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. It is recommended that, when possible, investigators work with pharmaceutical partners to minimize the cost of the study drugs. | Enter the Clinical Center costs as a "subaward" budget in the budget section of the application, using "NIH Clinical Center Costs" as the descriptor and attach appropriate justification (including the final Budget Template) and documentation including any spreadsheets as appropriate Be sure to list the key personnel and their percent-effort (or "calendar months") on the project. 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. 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. Please see Section 4.8 of the SF424 application instructions. |
| Intramural Investigator | The intramural investigator is responsible for his or her intramural budget. IC Scientific and Financial Contacts should be consulted to determine IC-specific policies on intramural budgets. In general where allowed, the budget request will be limited to the incremental costs required for carrying out the proposed work if those costs can be specifically identified with the project. These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Restrictions: Budget requests from federal agencies, including the NIH intramural program, may not include any salary and related fringe benefits for career, career conditional or other federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative costs). | Enter the Intramural Investigator costs as a "subaward" budget section of the application and attach appropriate justification as appropriate. Be sure to list the key personnel and their percent-effort (or "calendar months") on the project. 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. If temporary personnel are to be hired on contract, the salary costs as well as level of effort for those individuals should be detailed in the budget. Please see Section 4.8 of the SF424 application instructions. |
The extramural institution is provided indirect costs in accordance with their indirect cost (F&A) rate at time of award. For the NIH portion of the project, there's no allocation of indirect costs.
Patient travel costs may be included in either the extramural or intramural budgets. Patient travel should not be included in the Clinical Center budget.
Any contract nurse hired specifically to work on the project should be included in the intramural investigator's budget.
No, the Clinical Center will not typically provide a signed consortium agreement. However, if your institution requires an agreement to document the partnership, we can accommodate such a request.
Applying for the U01 Funding Opportunity
All applications submitted in response to the announcement must include a Collaboration Plan. A Leadership Plan is required for any application submitted using the Multiple PD/PI option. Although there will likely be some overlap or redundancy, both plans are required if the Multiple PD/PI option is used.
| Collaboration Plan | Multiple PD/PI Leadership Plan |
|---|---|
The required Collaboration Plan should describe how the proposed collaboration will be maintained throughout the duration of the award. The Collaboration Plan should focus on how the science will move forward; it should be prepared to align with the review criterion of Approach, which includes the following questions:
The following areas should be addressed in the Collaboration Plan:
The Collaboration Plan should be included as an attachment to the SF424 (R&R) Research and Related Other Project Information component under "Other Attachments". The filename "Collaboration Plan.pdf" should be used and will be reflected in the final image bookmarking for easy access by reviewers. The Collaboration Plan is NOT included in the page limit of the Research Strategy. | The Multiple PD/PI Leadership Plan should address the following administrative processes and PI responsibilities:
The Multiple PD/PI Leadership Plan should be included as an attachment to the SF424 (R&R) Research and Related Other Project Information component under "Other Research Plan Sections". Examples of leadership plans are available on the Multiple PI website at http://grants.nih.gov/grants/multi_pi/inde |
Yes. You should include "other attachments" with your application as applicable. Please refer to the Application section of the NOFO for specific details regarding "other attachments." https://www.grants.gov/search-results-detail/359659
Yes, if you are serving as a PI on a Multiple PD/PI application that is selected for an award, you will lose your New Investigator (NI) status. However, if you apply as a co-investigator, your NIH status would be preserved (see: http://grants.nih.gov/grants/multi_pi/faq.htm). Additional information about New Investigators and Early Stage Investigators may be found at http://grants.nih.gov/grants/new_investigators/.
The continuous submission policies do not apply to this NOFO (PAR-26-116). Continuous submission is limited to NIH R01, R21, and R34 applications (including those that are AIDS-related) that would normally be received on standard submission dates (http://grants1.nih.gov/grants/funding/submissionschedule.htm). Continuous submission is not available for applications submitted for special dates (RFAs, some PARs) or other activity codes.
The late application policies would apply to this NOFO. There is a two-week window of consideration after the application due date, during which time NIH might consider accepting a late application. Permission is not given in advance for late submission, but instead acceptance of late applications will be made on a case-by-case basis, dependent upon the explanation provided in a cover letter submitted with the application. Detailed guidance about the late application policy, which applications are eligible for the two-week window of consideration, and examples of circumstances that would or would not qualify for consideration are provided in NOT-OD-15-039, at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-039.html.
Yes, one of the requirements is that some work be done at the Clinical Center, but work is not limited to patient treatment at the Clinical Center. The project you described is not excluded from consideration, provided there is collaboration. Along with some work at the Clinical Center, key components will be collaborations and novel work to meet this NOFO's intent. However, projects that take only minimal advantage of Clinical Center resources, such as projects only utilizing banked samples or data, will not be considered for funding.
The scientific/research contact information at the relevant institutes is listed in the NOFO. These individuals would be your first point of contact. They can discuss the institute's research interests and help shepherd your request, identifying other contacts as needed.
No.
IRB approval is one of the "just-in-time" requirements. IRB approval is not needed to submit an application but would be needed in order to receive an award. Depending on where the clinical study was done "at the extramural institution and/or at the Clinical Center," there may potentially need to be more than one IRB review.
Renewals and Resubmissions
If your previous U01 application was a new application (-01), then the next U01 can be a resubmission (-01A1) and you will be able to include a 1-page introduction to summarize any changes made in response to the previous review. Alternatively, you may submit your next application as a new (-01) application, but then you would not be able to include the 1-page introduction. A resubmission must arrive within the 37-month window after the initial submission that it follows; after that, the only option is a new application. Both new and resubmission applications would be due on the same Application Due Date.
If your previous U01 application was a resubmission (-01A1), then your next U01 application would have to be a new application because second resubmissions ("A2s") are not allowed. Under the new resubmission policy, the subsequent "new" application need not demonstrate substantial changes in scientific direction compared to previously reviewed submissions. Any subsequent application submitted as new must not contain elements of a resubmission, including an Introduction or responses to the previous review. See NOT-DO-14-074 for more details.
If you wish to seek continued U01 support for your research, you may submit either a renewal or a new application. A renewal application would be appropriate if you have made progress and accomplished most or all of your Specific Aims, and if you plan a logical continuation of your research project. A new application would be more appropriate if you plan to go in a new direction or expand the scope of the research. Both new and renewal applications would be due on the same application due date.
When deciding whether to submit a new or renewal application, it's a good idea to contact your program officer for advice.
There are two policies that address submission after the application due date:
Continuous Submission procedures were initiated to recognize outstanding review and advisory service by members of the scientific community, and to minimize disincentives to such service. This alternative submission and review process is limited to NIH R01, R21, and R34 applications (including those that are AIDS-related) that would normally be received on standard submission dates. Continuous submission is NOT available for applications submitted for special dates (RFAs, some PARs) or other activity codes. Therefore, continuous submission is not an option for U01 applications submitted in response to PAR-26-116, which has special application due dates. See NOT-OD-11-093 for more details.
Consideration after the application due date may be permissible in certain extenuating circumstances. There is a two-week window of consideration after the due date, during which time NIH might consider accepting a late application. Request are considered on a case-by-case basis. Permission for late application submission is not granted in advance. Any reasons for late submission must be in relation to the individual(s) with the PD/PI role on the application. For multiple PD/PI (MPI) applications, the reasons may apply to any or all of the PDs/PIs. See NOT-OD-15-039 for more details.
In addition to any special requirements described in the NOFO, there are a number of general requirements expected for all submissions regarding such things as page limits, biosketches, and inclusion of inappropriate information in an application. General compliance guidance may be found at NOT-OD-15-095. NIH has also published guidance regarding what kind of information should be included in the 1-page introduction for resubmission applications in NOT-OD-15-030.