Managing an NIH award
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. The following is intended as guidance for Principal Investigators responsible for managing NIH awards (either awards made directly to Oxford, or via sub-contracts with US universities), University staff employed on the awards, and departmental support staff.
The points below are intended as a summary of the key terms and conditions applicable to Oxford holders of NIH awards, the full NIH Grants Policy statement is available from http://grants.nih.gov/grants/policy/nihgps/index.htm.
- Notice of Award
- Ongoing Obligations
- Human Participants
- Animal Welfare
- NIH Financial Conflict of Interest
- Change in Scope
- Regularity of Expenditure
- Eligibility of Expenditure
- Academic Reporting Requirements
- Financial Reporting Requirements
- Public Access
- Record Retention and Access
Notice of Award
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.
To see general terms and conditions for all grants, visit NIH's Award Conditions and Information for NIH Grants.
The NIH Foreign Grants Information provides useful information specifically for foreign grantees.
The NIH publishes policy updates in the NIH Guide for Grants and Contracts. Individuals may subscribe for weekly e-mail 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.
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 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).
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 at http://grants.nih.gov/grants/olaw/faqs.htm
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.
NIH Financial Conflict of Interest
The US Department of Health and Human Services has revised the regulations on disclosing and reporting conflicts of interest for researchers funded via its Public Health Service (which includes the NIH) available at http://grants.nih.gov/grants/policy/coi/fcoi_final_rule.pdf.
The new regulations (which took effect on 24 August 2012) make some significant changes to the previous framework for disclosing, managing and reporting conflicts of interest.
In particular, the new regulations:
- Require investigators to complete training related to the regulations and their institution’s financial conflict of interest policy.
- Require investigators to disclose to their institutions annually all of their significant financial interests (SFIs) related to their institutional responsibilities. Please note that SFIs include (but are not limited to) consultancy payments, honoraria, paid authorship, equity interests (including any stock, stock option, or other ownership interest) and reimbursed travel. Institutional responsibilities are defined as teaching/education, research, outreach, clinical service, training and University and public service, on behalf of their institution and directly related to those credentials, expertise and achievements upon which the Investigator’s institution position is based
- Lower the threshold at which significant financial interests require disclosure, generally from $10,000 to $5,000.
- Require institutions to report to the NIH additional information on identified financial conflicts of interest and how they are being managed.
- Require institutions to make certain information accessible to the public concerning identified financial conflicts of interest held by senior/key personnel.
Frequently Asked Questions (FAQs) about the new regulations are available at http://grants.nih.gov/grants/policy/coi/coi_faqs.htm
Oxford researchers are asked to note the following:
- The regulations apply to all Investigators funded by the NIH (or via a sub-contract with a University, where the research in question is funded by the NIH). The regulations define an 'Investigator’ as project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding, which may include, for example, collaborators or consultants.
- A Significant Financial Interest need not necessarily represent a Financial Conflict of Interest, but must be disclosed by the Investigator to the relevant Head of Department or Faculty to determine whether this presents any possible conflict of interest which needs to be reported to the NIH.
- There is no requirement to make a 'nil return’ if an Investigator does not hold any Significant Financial Interests.
- Each Investigator must complete training in the regulations (prior to engaging in research related to any NIH-funded grant or contract and at least every four years). To satisfy this requirement, an online training module is available to complete at http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm. As part of this training requirement, NIH-funded Investigators are also required to familiarise themselves with their own University’s Policy on Conflict of Interest.
- The procedure at Oxford for making a declaration internally is set out in this Flow Diagram (25kb). In summary, a declaration of a 'Significant Financial Interest’ should be made initially to the researcher’s Head of Department or Faculty (or in the case of a Head of Department or Faculty, to the Head of Division) via the Annual Declaration of Significant Financial Interests form (39kb).
If, in the view of the Head of Department or Faculty (or Division), this could present a Financial Conflict of Interest, this should then be submitted to the Secretary of the University’s Committee on Conflict of Interest (email@example.com) together with a plan for how the conflict can be reduced, eliminated or managed. The Secretary of the University’s Committee on Conflict of Interest will then liaise with Research Services who will submit the plan to the NIH via their electronic Research Administration (eRA) Commons Financial Conflicts of Interest module.The Investigator is required to produce annual updates on how the conflict is being managed.
- Significant Financial Interests do not include (1) payments made by the University (salary, royalties, honoraria, expense reimbursement or any other remuneration) or (2) income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical centre, or a research institute that is affiliated with an Institution of higher education or (3) an investment by a mutual fund, pension fund or other investment fund over which the investigator or his/her immediate family member does not exercise management of fund investment.
Change in Scope
- 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.
Regularity of Expenditure
- 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.
Eligibility of Expenditure
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?) For more information, see Allowability of Costs/Activities-Selected Items of Cost-Pre-Award (Pre-Agreement) Costs. Note that 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 'US flag air carriers wherever possible', even if this might run counter to the University's normal requirement to achieve value for money? See the Travel sections under the Grants Policy Statement - selected items of cost.
Academic Reporting Requirements
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 Isis Innovation, Isis can advise on how to report this as appropriate (for details, contact Steven Bayliss, Patent & Licence Administration Manager - firstname.lastname@example.org)
- Final invention statement. At the end of your project, you are required to submit a final invention statement and certification, HHS 568 (PDF, 47KB). 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.
Financial Reporting Requirements
As with all financial claims to research funders, financial reports to the NIH should be submitted by Research Accounts in the Finance Division.
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 in the Finance Division. 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 sub-contracts 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.
Record Retention and Access
NIH grantees, generally, need to retain research and financial records relating to the grant for a period of 3 years from the date the annual Financial Status Report was submitted.