Procedures for dealing with applications to and grants from US federal funding agencies, in particular the National Institutes of Health (NIH)

Background

This procedure replaces the previous procedure from 2010 (UFV 2010/1765).

Research funding from federal funding agencies in the US (e.g. National Institutes of Health [NIH]) is subject to a large common regulatory framework as well as authorityspecific rules. The university, in its capacity as a legal entity, submits applications and signs agreements with these funding agencies, which has led Uppsala University to establish a procedure for dealing with applications to and grants from US federal funding agencies. The purpose of this procedure is to ensure compliance with the relevant regulations and good quality and efficient procedures for the administrative work. There must be compliance with this procedure both when Uppsala University is the main applicant/recipient and the co-applicant/recipient (this also includes instances in which existing federal grant funding is to be transferred from another higher education institution to Uppsala University).

The procedure is established on the basis of the university’s largest federal funding agency, NIH. Other federal funding agencies are essentially subject to the same regulations, but there may be some differences.

Responsibility according to the Delegation of Authority at Uppsala University (UFV 2020/945)

Since the university’s largest federal funding agency, NIH, is most relevant to the Disciplinary Domain of Medicine and Pharmacy, responsibility for all university-wide registrations required by the federal funding agencies is delegated to the Vice-rector for the Disciplinary Domain of Medicine and Pharmacy. For example, the Vice-rector for the Disciplinary Domain of Medicine and Pharmacy is responsible for SAM registration (see the section entitled University-wide registrations and examinations), and thus is ultimately responsible for the information submitted and for ensuring that the university meets the registration requirements for compliance with applicable federal laws and regulations.

The Vice-rector of the three disciplinary research domains (not the heads of department) have the delegated authority to enter into contracts related to research projects, within their disciplinary research domain, funded by US federal funding agencies.

University-wide registrations and examinations

The university must maintain a registration in the System for Award Management (SAM) in order for its researchers to apply for and receive funding from US federal funding agencies. Annual updating of the registration is required in order to maintain its validity. The Research Support Unit at the Faculty Office of Medicine and Pharmacy carries out the annual update of the SAM registration. NIH requires organisations conducting human studies to have a Federalwide Assurance for the Protection of Human Subjects and an Internal Review Board (IRB) registered with the Office for

Human Research Protection at the US Department of Health and Human Services. The Research Support Unit at the Faculty Office of Medicine and Pharmacy is responsible for maintaining these registrations. Other federal funding agencies that fund human studies (as well as some private funding agencies) may also request this.

Under NIH regulations, non-US organisations must have a valid Animal Welfare

Assurance for Foreign Institutions in order to conduct animal studies. The Research Support Unit at the Faculty Office of Medicine and Pharmacy is responsible for maintaining this registration.

Furthermore, federal funding agencies require all organisations receiving grant funds to conduct an annual check on the possible occurrence of misconduct in research for researchers with projects funded by these funding agencies. The Research Support Unit at the Faculty Office of Medicine and Pharmacy shares responsibility with the Legal Department for conducting this examination.

Uppsala University must undergo a financial audit of federally funded projects if the university as a whole receives USD 750,000 (or more) per annum in federal funds. The contracted audit firm deals with this together with the responsible economist at the Financial Administration and Procurement Division.

Dealing with applications and grants awarded

1. Contact/information

In the application process, the applicant must contact the Research Support Unit at the office for the disciplinary domain to which the applicant belongs, as well as the Financial Administration and Procurement Division. The Research Support Unit is contacted as soon as the researcher has identified a call for applications for which they intend to apply, but no later than 20 working days before the application deadline. The Research Support Unit informs the researcher of the applicable regulations and the certificates which must be signed (see section 2). The economist at the Financial administration and Procurement Division who is responsible for federal grants must review the project budget before the application is submitted (see section 7 for information on indirect costs).

The researcher is responsible for informing the Head of Department at an early stage that they intend to submit an application to a federal funding agency. The Head of Department provides their written authorisation in certificate 2a below before submitting the application.

2. Certification

The Research Support Unit at the faculty office for the relevant disciplinary domain is responsible for obtaining and registering the following signed certificates:

a) Head of Department’s approval prior to submission of the application

Researchers who intend to apply for US federal research funding must notify the relevant Head of Department. The costs that are defined as indirect costs according to SUHF’s accounting model are not eligible for grants according to the rules of NIH and other federal funding agencies, which is why the Head of Department must certify before the application process begins that the institution can receive an approved grant. All relevant heads of department must make this certification if more than one department at Uppsala University is involved in the application.

The certification is made in the e-form on this website:

Approval from Head of Department of application to federal American funding agencies | admin (uu.se)

b) Assurance by the principal investigator prior to submission of the application and during the ongoing project

The principal investigator at Uppsala University must sign an assurance indicating the authenticity of the submitted information in connection with all grant applications to US federal funding agencies. This is known as the Principal Investigator Assurance (PIA). This is applicable regardless of whether Uppsala University is the main applicant or a co-applicant. In cases where Uppsala University is the main recipient of grant funds from NIH, the principal investigator must also sign this assurance in connection with the annual scientific report and for any requests for prior approval (requests for major changes in the project that require approval from NIH). The assurance is made in the e-form on this website: Principal Investigator Assurance | admin (uu.se)

c) Disclosure of significant financial interests prior to submission of the application and during the ongoing project

Uppsala University has a guideline for reporting significant financial interests and managing potential conflicts of interest (UFV 2021/1302) in research projects linked to US federal funding agencies. This guideline is designed to comply with NIH regulations regarding objectivity in research. According to this guideline, all researchers at Uppsala University who are involved in a grant application or an approved project linked to a federal funding agency, regardless of whether they are main applicants or co-applicants, must declare their financial interests by completing and signing a Disclosure of Significant Financial Interests form. This must be done prior to submission of the application, and annually if a grant is approved, or immediately when an interest has been identified or acquired. The report is assessed by the legal department. The report is submitted in the e-form on the following website: Federal American Funding Agencies: Disclosure of Significant Financial Interests | admin (uu.se)

d) Declaration of participation in the project by external coapplicants when submitting the application

If there are external co-applicants for an application where Uppsala University is the main applicant, these co-applicants must sign a declaration known as a subrecipient commitment before submitting the application. This declaration is important to ensure that external co-applicants are prepared to enter into an agreement with Uppsala

University if the application is approved, and that they comply with

NIH regulations regarding financial conflicts of interest. The Research Support Units at the three faculty offices provide this form and check that it is signed correctly by any co-applicants before submitting the application. A similar declaration may be required from the main applicant organisation when Uppsala University is a co-applicant.

e) Approval from the Vice-rector for the relevant disciplinary domain before submitting the application, when Uppsala University is the principal applicant

When a grant application is submitted, the main applicant organisation makes a number of certifications in the electronic application system, which is why the Vice-rector of the disciplinary domain in question must approve in writing all grant applications submitted with researchers from Uppsala University as the main applicant. The Research Support Units at the three faculty offices deal with these cases.

f) Approval of the Notice of Award from the Vice-rector for the relevant disciplinary domain if a project is approved

The Notice of Award constitutes the contract between the main recipient organisation and the funding agency. A Notice of Award is sent from NIH to the main recipient organisation prior to the start of the approved project, and annually during the lifetime of the approved project. The contracts are not signed, but are authorised the first time funds are requested. If Uppsala University is the main recipient of funds from NIH, the Vice-rector of the relevant disciplinary domain must approve the Notice of Award received prior to the start of the project, before funds can be requested. The Research Support Units at the three faculty offices deal with these cases.

3. Examination and submission of the application

The main applicant higher education institution usually submits the application via the electronic system eRA Commons (in the case of NIH) or Grants.gov. The researcher cannot submit the application personally as a number of certifications on behalf of the organisation are made when the application is submitted. Submission must be done at the central level of the university administration by administrators holding the role of Signing Official in eRA Commons or

Authorized Organization Representative in Grants.gov. The Research Support Units of the three faculty offices have designated individuals to hold these roles. These individuals handle the submission of applications after approval by the Vice-rector of the relevant disciplinary domain (see section 2e above).

Electronic validation in eRA Commons, Grants.gov and the receiving authority may take several days. Any errors in the application must be rectified and a corrected version of the application submitted before the application deadline. Therefore, a full application must be entered in the relevant application portal by the researcher no later than 8 working days before the application deadline.

4. Decision/contract

The decision to award funding is sent from the funding agency to the main recipient organisation in the form of a Notice of Award. The Notice of Award contains all the terms and conditions of the grant and thus also constitutes the contract between the main recipient organisation and the funding agency. The contract is not signed, but is authorised the first time funds are requested. Therefore, the Vice-rector of the relevant disciplinary domain must give written approval for the Notice of Award, after review by the Legal Department, before funds can be requested (see section 2f above).

Under NIH regulations, the main applicant and any co-applicant organisations must enter into a written agreement with one another in order for funds to be transferred to the co-applicant organisation. At Uppsala University, these contracts must be signed by the Vice-rector of the relevant disciplinary domain (see the Vice-Chancellor’s delegation of authority, UFV 2020/945).

5. Special provisions for human studies

NIH requires organisations conducting human studies (which includes studies of identifiable biological samples) to have a registered Federalwide Assurance for the Protection of Human Subjects and a registered Internal Review Board (see the section entitled University-wide registrations and examinations).

Besides holding all applicable Swedish permits, clinical trials and other human studies funded by NIH must be approved by the Uppsala University IRB prior to the start of the project, and annually during the lifetime of the approved project.

At Uppsala University, this IRB consists of the Board for Investigation of

Misconduct in Research and the Adviser to the Vice-Chancellor on Good Research Practice. The Research Support Units of the faculty offices deal with these cases and are responsible for registering the decision of the IRB. NIH regulations also require certification indicating that all researchers working on projects involving human subjects have been trained in Protection of Human Subjects. Uppsala University offers a course through Studium that fulfils this requirement. This course is provided by the Research Support Units of the faculty offices in question. Clinical trials must also be registered in

ClinicalTrials.gov before the project commences. The Uppsala Clinical Research Center (UCR) is the point of contact for this registration.

6. Special provisions for animal studies

Under NIH regulations, non-US organisations must have a valid Animal

Welfare Assurance for Foreign Institutions in order to conduct animal studies (see the section entitled University-wide registrations and examinations). This certificate lists the Swedish and European laws and regulations that the university follows.

7. Management of grant funds received

Grant funds for direct costs are paid to the department concerned. Indirect costs are known as Facilities and Administrative Costs (F&A) in federal terminology. For NIH, only 8% F&A is allowed for non-US organisations unless specified otherwise in the contract. These funds may only be used to cover expenses incurred when the university fulfils its obligations to NIH, and to comply with NIH regulations. No other indirect costs for non-US organisations are eligible for funding. F&A must be placed against a university-wide project number in the Financial Administration and Procurement Division. This applies both when Uppsala University is the main applicant and co-applicant. Different rules may apply to other federal funding agencies, so this needs to be checked.

8. Reporting

The main recipient higher education institution must submit a scientific report to NIH each year. The Signing Official at the Research Support Unit for the faculty office in question must approve the submission of the report after the principal investigator for the project has finalised the scientific report in the NIH web system (eRA Commons). If Uppsala University is the main recipient, a signed PIA (see certificate 2b) must be submitted when this report is submitted.

Financial reporting to NIH takes place either annually, or only at the end of the project if the project comes under the Streamlined Non-Competing Award Process (SNAP). The Notice of Award indicates whether or not the project comes under SNAP. Financial reporting must be authorised and submitted to the NIH by the responsible economist at the Financial Administration and Procurement Division. The responsible administrator at the department must contact the Financial Administration and Procurement Division no later than 20 working days before the end of the reporting period in order to review the financial reporting for the period.