U.S. funding - after a grant is awarded
When you have been awarded an American research grant and are about to start your project, there are a number of things that you need to think about.
Contracts need to be drawn up, research funds must be requisitioned and properly accounted for, and both the scientific and financial results must eventually be reported to the funder.
Contract
When an award is granted, the main applicant receives the decision in the form of a so-called Notice of Award (NoA). This document constitutes the contract that the University enters into with the NIH. The Legal Affairs Division will help you by reviewing the legal aspects of the contract before it can be approved and signed by the Vice-rector of the relevant disciplinary domain. After this approval you can start to requisition funds.
Contact Research Support as soon as you have received a NoA.
If you are a co-applicant in an NIH-application, the University must enter into a so-called subaward contract with the main applicant organization. The main applicant organization initiates the subaward contract. Observe that the Head of Department cannot sign these contracts. It must be done by the Vice-rector of the relevant disciplinary domain. Before the Vice-rector signs the contract, it must be reviewed by the Legal Department.
Contact Research Support as soon as possible if you discover that an application in which you are a co-applicant has been approved.
During the ongoing project, the main applicant annually receives a new NoA from the NIH, and new subcontracts thus need to be created. These must also be approved and signed by the Vice-Rector.
NIH requires that foreign co-applicants annually make available copies of all documentation (including lab books and data) supporting the research results to the main recipient. This requirement will be regulated in the contract. The requirement means a risk that a lot of data may have to be disclosed, which may not be possible based on Swedish and European law. It is therefore important to discuss with your counterpart in the US exactly which documentation will need to be shared. Research Support and the Legal Department support you in developing a wording for the contract that works for your project.
Requisition, accounts and accounting
In NIH-funded projects, the department requisitions costs afterwards. The NoA or subcontract states the intervals at which the requisitions can be made. Subcontracts also often contain a template for which information the main recipient wants the invoices to contain.
Direct funds are paid directly to the department. Indirect funds, so-called F&A, may not be used as ordinary OH and must therefore be posted in a common university account. This applies both when the University is the main recipient and the co-recipient. Contact the Financial Administration and Procurement Division for more information.
Human subject studies
Note that Swedish and American legislation defines human studies in different ways. You can read more about the Swedish definition at the Swedish Ethics Review Authority (Etikprövningsmyndigheten). Potentially, a study that does not meet the requirements for a human study according to American legislation can still do so according to Swedish legislation, and thus require permission from the Swedish Ethics Review Authority.
Use NIH's tools to determine if your research is defined as "Human Subject Research" under U.S. law.
If your project involves human studies according to the American definition, approval from the University's Internal Review Board (IRB) is required, in addition to approval by the Swedish Ethics Review Authority. The IRB is specially set up at the University to meet NIH’s requirements for review of human studies. Approval from the IRB is required both before the start of the project and annually during the project period. The Research Support will help you with this. Therefore, be sure to inform Research Support if your project involves human studies already when submitting the application.
If your project involves human studies, you also need to take a mandatory online course in human ethics before the start of the project. Contact Research Support to get access to the course.
If you handle personal data in the project, it is important that you are aware that such data must not be transferred from Sweden to the USA without further protection measures. Contact Jacob Håkansson at the Legal Affairs Division for more information.
Reporting
As a researcher, you are often not allowed to submit reports to the NIH, but this needs to be done by an official representative of the University (for example, someone at Research Support or an economist at the Financial administration and procurement division). You therefore need to contact Research Support well in advance of the report due date.
Time reports
Time reports are required for all personnel whose salaries are paid in full or in part by NIH funds. Contact the economist at your department or the Financial Administration and Procurement Division to get a template for time reports.
Financial reports
The main recipient of NIH funds must submit a financial report (called the Federal Financial Report, FFR) to the NIH either annually or after the project is completed. If the NoA indicates that the project runs under the Streamlined Non-competing Award Process (SNAP), reporting is required only after the project has been completed. Otherwise, an annual financial report is required. The Financial Administration and Procurement Division is authorized to submit the financial report in NIH's financial system. The departmental economist together with the researcher provides the Financial administration and procurement division with information for this report.
Scientific reports
The main recipient of NIH funding must submit an annual scientific report (called Research Performance Progress Report, RPPR) via the NIH's web system (eRA Commons). While it is you as a researcher who completes the report, it is Research Support that submits it. Contact Research Support as soon as possible when it is time for this report.
NIH requires that foreign subapplicants, prior to the annual scientific report, provide access to all documentation (data, lab books, etc.) that support the research results. Digital access to material is approved.
Invention reports
In connection with the annual scientific report, any patents produced in the project must also be reported in the iEdison system. After the project is completed, a final report on all patents must be submitted. Please note that this final report must be submitted even if you have not produced any patents within the project.
Mandatory annual certifications
You as a researcher need to annually submit two signed certifications to Research Support during the entire project period.
1. Principal Investigator Assurance Form (PIA; e-form). If Uppsala University is the main applicant organization, the funder requires the principal investigator to submit a PIA in connection with the annual scientific report, as well as in connection to any "requests for prior approval". In the PIA, the researcher certifies, among other things, that the information submitted is correct and truthful and that she/he takes responsibility for the scientific execution of the project.
2. Reporting significant financial interests (e-form). NIH requires that each researcher responsible for the project annually reports any financial interests that are related to her/his institutional responsibilities (that is, research, teaching, administration), and that the organization must assess whether a conflict of interest exists. Please note that you must submit the report even if you have no financial interests. In connection with filling in this form, you must also certify that you have attended a short, mandatory training in NIH's regulations for handling financial conflicts of interest (the link to the course is found in the e-form).
Review of good research practice
The University must follow American guidelines and regulations regarding good research practice. That means, among other things:
- that the University submits an annual report on possible misconduct in research funded by federal U.S. grants to the Office of Research Integrity (ORI)
- that the University cooperate with ORI if misconduct in research is identified
- that the University must report to ORI how identified misconduct has been handled.
ORI compiles the cases where researchers have not followed good research practice on their website, where they also publish names. You as a researcher do not need to do anything in this review. It is managed by Research Support and the Legal Affairs Division.
Post award help and support
Research Support provides support to researchers who have received a federal grant, for example with reporting and questions that arise.
The Legal Affairs Division and Research Support will help you review any contracts and get them signed by the Vice-Rector. The Financial Administration and Procurement Division can provide support to the departmental economist in producing the material for the financial report to the NIH. It is also this Division that is responsible for submitting the report to the NIH.
When it's time for the annual scientific report, Research Support will help you submit it in NIH’s web system (eRA Commons). If you conduct human studies, Research Support will also help you with the preparation of the case to the university's Internal Review Board, to get the mandatory approval before the start of the project and annually during ongoing projects.
A grant application to a federal american funder differs from Swedish applications - it is generally more extensive and complex.
Learn more about how you apply for American funding at Uppsala University
Contact
Swedish Ethics Review Authority (Etikprövningsmyndigheten)
Financial Administration and Procurement Division
Information on transferring personal data from Sweden: Jacob Håkansson