Managing a National Institutes of Health award

When you accept a grant award from the United States National Institutes of Health (NIH), you agree to be bound by its terms and conditions, which take effect as soon as you receive grant funds. This guidance is for principal investigators responsible for managing NIH awards (either awards made directly to Oxford, or via subcontracts with US universities), University staff employed on the awards, and departmental support staff.

These points are a summary of the key terms and conditions applicable to Oxford holders of NIH awards, the full NIH Grants Policy statement is available on the NIH website.

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 You are likely to receive a notice of award for every budget period (usually one year) unless you have a multi-year grant, in which case you will receive just one. Read this: it contains a lot of helpful information. It tells you the funds you will receive for current and future years, start and end dates, terms and conditions of award, and the name of your NIH programme officer and grants management specialist.

  • The NIH publishes policy updates in the NIH guide for grants and contracts. Individuals may subscribe for weekly email updates.
  • The cost considerations section of the NIH grants policy statement requires that researchers who are not 100% dedicated to the NIH funded project (including principal investigators) should keep a record of the time they spend on the project, so that salary payments allocated to the NIH grant are based on a reasonable estimate of the actual time spent on the research funded.
  • The cost transfers section states that transfers or journals of costs that represent corrections of errors should be accomplished within 90 days of when the error was discovered and systems are required to be in place to detect such errors within a reasonable timeframe. Any transfers must be supported by documentation that fully explains how the error occurred and a certification of the correctness of the new charge by a responsible authoriser. 

If your research involves human participants:

  • Have you obtained IRB (ethics committee) approval of your research plan, which needs to be reapproved every year? Approval of Oxford research plans funded by NIH grants will either need to be sought through NRES ethical review procedures (for projects which require scrutiny by the NHS) or OxTREC (for all other NIH-funded research involving human participants).
  • Note that the University of Oxford's 'Federalwide Assurance Number' (FWA) as registered with the US Office for Human Research Protections is FWA0003276. OXTREC's IRB number, as registered with the US Office for Human Research Protections, is IRB00002797. You are likely to be asked to supply these numbers when applying for a renewal/continuation of funding.
  • If your research requires approval from an NHS (NRES) ethics committee, you will need to supply its IRB number, and the committee will need to be linked to the University's FWA. Before submitting an application to NRES, check that the committee is already registered with the US Office for Human Research Protections.
  • All key personnel involved in the study must receive training in the protection of human subjects (and provide proof to the NIH that they have completed such training) and this training must be undertaken every three years.
  • Note that 'key personnel' includes principal investigators on NIH awards that include research involving human subjects, all individuals responsible for the design or conduct of the study, and those individuals identified as key personnel of consortium participants or alternate performance sites if they are participating in research that involves human subjects. Further information about this requirement is available from the NIH's frequently asked questions for the requirement for education on the protection of human subjects.
  • The NIH offers a free online tutorial on protecting human research participants which may be used to meet this training requirement (upon completion of this short course, you can print out a certificate of completion that may be provided as documentation of compliance with the requirement).

If your research involves vertebrate animals:

  • Do you have institutional animal care and use committee (IACUC) approval (this needs to be reapproved every three years)? Information about related requirements is available on the NIH website
  • Note that the University of Oxford's Animal Welfare Assurance Number, as issued by the US Office of Laboratory Animal Welfare (OLAW) is # A5061-01. Remember to use this assurance number when corresponding with OLAW or when applying for a renewal/continuation of funding.

Changes in the scope of the research significantly alter your peer-reviewed and NIH-approved project. You need to obtain approval from your grants management specialist before making this type of change. For a list of all actions that constitute a change in scope, see NIH grants policy statement on prior approval requirements. All requests that require prior NIH approval must be made in writing to the NIH grants management specialist at least 30 days before the proposed change.

The NIH expects you to have 'reasonable monthly expenditures' and when reviewing your quarterly reports, takes your expenditure into account when considering whether to continue funding your project. For more information, see NIH cost considerations.

  • Ensure that you are familiar with the particular terms and conditions of the award, or sub-award, in addition to the NIH's requirements. Some US awardee organisations passing sub-awards on to Oxford may have additional requirements to those imposed by the NIH, including additional reporting requirements.
  • Are you aware of those costs that are allowable (and those that are not?) All grant funds issued on or after 26 December 2014  are subject to the NIH Interim General Grant Conditions (NOT-OD-15-065) and the refreshed NIH Grant Policy Statement (GPS). One major change is that VAT is now an eligible cost for NIH projects. This is included in 45 CFR 75.470/ NIH Grants Policy Statement (Chapter 7.9.1 - Selected Items of Cost): this table has been updated to be consistent with the federal ordinances. Please also see the grants and funding FAQs
  • Please note that for all grant funds issued before 26 December 2014, VAT is not an allowable expense and so should not be charged to the project. For advice on VAT coding of inputs, you should consult the University's VAT team.
  • Regarding travel costs, are you aware of the NIH's requirement to use airlines within the Open Skies agreements? See the travel sections under the Grants Policy Statement – selected items of cost.
  • The NIH operates a salary cap which is a legislatively mandated provision that limits the salary that can be charged to an NIH grant for a person working on the grant. This is regularly updated.
  • Alcohol cannot be charged to an NIH grant if it was part of a meal or other entertainment expenses.

The NIH require that grantees periodically submit reports. It is important that all reports are accurate, complete, and submitted on time.

  • Progress reports are usually required annually as part of the non-competing continuation award process.
  • eSNAP (the NIH's Electronic Streamlined Non-competing Award Process) is enabled for Oxford. Using eSNAP, you may file an electronic progress report 45 days before the grant anniversary date. The submission of progress reports via eSNAP is mandatory for all eligible non-competing continuation awards (NOT-OD-10-093). Note that all progress reports filed via eSNAP will need to be submitted by Research Services.
  • Invention reporting requirements
    You are required to disclose all inventions arising from NIH-funded research to the awarding agency as well as include an acknowledgement of federal support in any patents. Grantees are expected to use NIH's iEdison to comply with these reporting requirements. If your NIH-funded invention is to be commercialised through Oxford University Innovation, OUI can advise on how to report this as appropriate.
  • Final invention statement
    At the end of your project, you are required to submit a final invention statement and certification, HHS 568. This can be submitted, together with other closeout documents, through the eRA Commons and will require signature by Research Services on behalf of the University.

Note that the NIH can put a restriction on your grant at any time if you fall behind in reporting requirements.

 As with all financial claims to research funders, financial reports to the NIH should be submitted by Research Accounts.

  • Financial status report
    The NIH usually requires a financial status report (FSR) at the end of your grant's final year and on an annual basis. FSRs are submitted and authorised by Research Accounts. The FSR must be submitted within 90 days of the end of each 12-month budget period and at the end of the project period, and you should liaise with your department's Research Accounts Adviser in good time to agree the figures. Research Accounts submit the FSRs electronically through eRA Commons.

Other financial reports may be required by the NIH, such as quarterly cash transaction reports. In the case of subcontracts with US universities, the US university which is the main NIH grant holder may have its own additional financial reporting requirements.

After the completion of the University of Oxford's financial year, all NIH projects are subject to audit. The auditors will pick a sample of projects from across the university which will include Oxford as well as subrecipient (collaborator) costs.

If a project has got subrecipient costs, subrecipient monitoring will have to be carried out:

  • The department will be provided with a subrecipient monitoring form which the subrecipient will have to complete. The auditors will also be looking for a copy of the subrecipient's accounts. 
  • The auditors will be asking for evidence of financial monitoring, e.g. regular provision of UO Project Status and Activity reports or meetings between the project team and subrecipient to discuss the financial situation of the grant.
  • The auditors will be looking for documentation of the project team having been in contact with the subrecipient, e.g. agendas for meetings, notes from meetings/tele conferences or email exchanges.

You are required to cite PubMed Central identification numbers when citing a paper you author or co-author that resulted from an NIH-funded award. You must also submit to PubMed Central an electronic version of any final peer-reviewed manuscript accepted for publication that resulted from NIH-funded research and quote your NIH grant number in your acknowledgements on your publication.

NIH grantees, generally, need to retain research and financial records relating to the grant for a period of three years from the date the annual financial status report was submitted.