When you accept a grant award from the 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.
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 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.
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 via www.hhs.gov/ohrp 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).
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.
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.
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.
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.