The National Institutes of Health (NIH)
The National Institutes of Health (NIH) is the largest funder of biomedical research in the world and one of eleven divisions that fall under the US Department of Health and Human Services. It is the US medical research agency and makes important discoveries that improve heath and saves lives. The NIH is made up of 27 different components called Institutes and Centers. Each has its own specific research agenda, focusing on particular diseases or body systems. All but three of these components receive their funding directly from Congress and administrate their own budgets. NIH organisational chart can be found here.
The NIH is Imperials most commonly applied to US Federal Funding agency and we hold many awards both as Lead (Pass-Through Entity), and as a Partner (Subrecipient). The submission process has many unique features which will be explained below in this step-by-step guide.
HOW TO APPLY FOR NIH FUNDING
- Request an eRA Commons account
- Creating an application
- Finalise and prepare application
- Accepting an awarded proposal
- Managing NIH Grants at Imperial
Applicants will first require an eRA commons user account to submit an application for NIH funding to Grants.gov using this submission platform. These details are mandatory to access the ASSIST portal. The Application Submission System & Interface for Submission Tracking (ASSIST) system on the eRA Commons platform is used to prepare and submit NIH applications (and those for other Public Health Service agencies) electronically to Grants.gov.
All investigators applying for NIH funding must have an eRA Commons account regardless of whether Imperial is the lead institution. Account set-up's can be requested via email from the Research Office. Once an account has been requested, the RO systems team will create the account and the applicant will receive automated emails with username and password details.
Imperial’s preferred submission route is via eRA commons as this method supports both single and multi-project grant applications as well as allowing control over application access for support staff. If an applicant intends to submit their application by creating and submitting a Workspace document directly on Grants.gov (and will therefore not submit via the eRA Commons platform), then they will need to register for a Grants.gov account and follow the guidance here. NOTE; NIH has no visibility and cannot help with issues encountered in Workspace
The NIH have a useful webpage which highlights the options and key features of submitting either by ASSIST/eRA Commons route or Grants.gov/Workspace here
Prior to creating an application using ASSIST, applicants must identify a Funding Opportunity Announcement (FOA) to which they would like to apply. FOAs are posted in the NIH Guide for Grants & Contracts and in Grants.gov Find Grant Opportunities link, each of which has robust search capabilities. The FOA text indicates whether ASSIST can be used to apply to that opportunity. The opportunity number (e.g., PA-12-987) is required to initiate an application.
Log into ASSIST using eRA commons credentials. From the ‘Welcome page’, enter the opportunity number in the field of the same name. Click ‘Go; and fill in the required fields. Ensure the correct Organisation is selected from the drop-down menu ‘Lead Applicant Organization Name’ so the application is routed correctly. Imperial Institutional registration numbers will be required at this stage which can be found here. US Applications Registration Numbers [PDF].
Further guidance on application creation can be found on the ASSIST Online Help pages here.
For Pre- award management of NIH grants, please see the US Federal Funding Golden Rules page.
Once the application is finalised, applicants can use the ‘Preview application’ action to generate a draft copy. Further information on validating and checking the submission against NIH criteria can be found here ASSIST-ValidateApplication (youtube.com)
Applicants will ned to use the ‘Update submission’ action to change the workflow from Work in Progress, to Ready for Submission status.
NOTE: Only active users logged into ASSIST with an eRA Commons account with the Authorised Organisational Representative role can provide final validation and submission. This will be a member of RS/JRO. If you are uncertain who this is in your Department, Please contact the Research who will advise further..
Detailed submission for NIH can be found here including preparing to apply, writing an application and how to submit/track/view.
An informative video is available on the NIH Grants YouTube channel ASSIST-SubmitApplication (youtube.com)
A Notice of Award (NoA) will be issued to notify the Grantee that the award is successful. This NoA will detail the initial budget period and reference any further budget periods along with all relevant Terms and Conditions of the award. NoAs are sent to the specified email address entered in the NoA email field by the applicant when completing the eRA Commons registration process.
The NoA will be available to authorised users in eRA Commons. Step-by-step instructions on how to view a notice of award can be found here.
Accepting the Award
The Grantee can accept an NIH award by drawing down or requesting funds from the Payment Management System , or upon the endorsement of a check from the US Treasury for foreign awardees.
Acceptance of National Institutes of Health (NIH) funding is an agreement to be bound by the terms and conditions of the grant.
This guidance is for Researchers in receipt of NIH funding either as the Lead (Pass-Through-entity) or as a Partner (Subrecipient). This information is also relevant for those managing NIH awards, DI staff employed on the awards, and departmental support staff.
- Award Notices: Grantees will receive a notice of award for each budget period and all relevant details will be contained here such as a breakdown of budget, start/end dates, the name of your NIH programme officer and grants management specialist and full terms and conditions of the award.
- Animal Welfare; Research involving vertebrate animals requires Institutions to obtain Animal Welfare Assurance. Imperial submit an Annual report to maintain compliance and are registered with the US Office of Laboratory Animal Welfare (OLAW) Foreign Assurance Programme. Imperial's foreign assurance number is #F16-00140 (A5634-01). Please quote this assurance number when applying for any extensions/renewal of funding.
- Human Participation: Imperial requires Federal Wide Human subjects’ assurance via United States Department of Health and Human Services (DHHS). Current assurance number is #FWA00003281. Registration is renewed periodically by the Research Office’s Research Governance and Integrity Team (RGIT). All key personnel involved in the study must receive training in the protection of human subjects which must be undertaken every three years. A free online tutorial is provided by NIH which can be used to meet this requirement. Upon completion of the online protecting human research participants a certificate will be issued as confirmation of compliance.
- Project Changes; Any significant project changes will require approval by the designated Programme Manager at least 30 days in advance in writing. For details of changes requiring approval, see NIH grants policy statement on prior approval requirements.
These points are a summary of the key terms and conditions applicable to holders of NIH awards, the full NIH Grants Policy statement is available on the NIH website.
For general terms and conditions for NIH grants, visit NIH's award conditions and information for NIH grants
For further details on Post award management of Imperial NIH grants, please see the US Federal Funding Golden Rules page.
NIH Policy Specifics
- Conflicts of Interest
- NIH Subrecipient Monitoring
- Office of Research Integrity Return
- Record retention and Public access
- Research Performance Progress Reports
- Timesheets
- US Federal Single Audit
Guidance for NIH requirements regarding Institutional conflicts of interest can be found at Imperial’s NIH financial conflict of interest policy and guidance page.
For further information see the NIH Conflict of Interest section.
Subrecipient monitoring is required on all NIH awards, as dictated by the Code of Federal Regulations. The objective is to assess and address both risk and performance. Imperial, whether as the Lead Institution or as a Subawardee, has a responsibility to support this activity at both pre and post award stage. Key monitoring processes are outlined in the table below.
Pre-Award
|
Imperial Role |
Process |
Responsible Persons |
Further Information |
Activity & Objective (Summary) |
|
Lead |
Research Third Parties Framework for Managing Due Diligence |
Principal Investigator, Academic Department, Research Office |
Identifying Partners | Research and Innovation | Imperial College London |
Consideration of the ethical implications of any relationships formed, ensuring that the relationship does not:
Consideration of financial risk. |
|
Lead |
Contract Negotiation |
Faculty Contracts Team |
Contract negotiation process | Research and Innovation | Imperial College London |
Review the Research Office’s risk assessment recommendations and incorporate non-standard terms and conditions and additional clauses into the subcontract agreement during the negotiation process to mitigate any identified risks.
Ensure the inclusion of a clause requiring all foreign subrecipients to provide access to copies of all records/data that support the research outcomes as described in the Research Performance Progress Report (RPPR). See webpage guidance here. |
|
Partner |
Lead Institution Pre-Award Monitoring (usually form-based) |
Faculty Research Services Team |
N/A |
Provide Lead Institutions with information that allows them to assess Imperial. Pre-award monitoring forms will usually require project-specific information, and details about Imperial-wide policies, processes, and its registrations with relevant US bodies. A list of Imperial’s registrations is available here US Applications Registration Numbers [PDF].
Faculty Research Services Teams can refer to the bank of completed forms and the Subrecipient Monitoring Form guidance document on Research Office SharePoint, which provides answers to most questions about internal processes: Federal Financial Audit and Subrecipient Monitoring Forms.pdf (sharepoint.com) Contact the Research Office if there are any novel questions or if unsure about any answers: ro.audit@imperial.ac.uk
|
Post-Award
|
Imperial Role |
Process |
Responsible Persons |
Further Information |
Activity & Objective (Summary)
|
|
Lead |
Post-Award Subrecipient Monitoring |
Research Office |
N/A |
This two-stage process assesses financial risk and performance.
The Principal Investigator will be asked to provide a risk rating and confirm:
The partner will be contacted and asked to complete a form with information about the institution and provide documents include audit reports. |
|
Lead |
Post-Award Due Diligence Monitoring |
Principal Investigator, Academic Department, Faculty Research Services Team |
N/A
|
Enact the Research Office’s risk assessment recommendations made at pre-award Due Diligence Review to mitigate any identified risk. |
|
Partner |
Lead Institution Post-Award Monitoring |
Research Office |
N/A |
Post-Award Subrecipient monitoring forms should be sent to the Research Office to complete: ro.audit@imperial.ac.uk These forms often request details of US Federal Single Audit results, a process which is managed by the Research Office.
|
NIH-funded Principal and Co-Investigators should be aware that they are subject to Imperial’s annual Office of Research Integrity (ORI) return, which is coordinated by the Research Office. This return requires Imperial to indicate whether it has received allegations of, or conducted inquiries or investigations into, possible research misconduct involving US Federal Public Health Service-supported research (including the NIH). This activity is mandated by the US Public Health Service regulation, Policies on Research Misconduct 42 C.F.R. Part 93.301.
Imperial are required to retain research and financial records relating to an NIH funded grant for a period of three years from the date the annual financial status report was submitted.
As part of the Terms and Conditions of an NIH grant, Researchers are required to cite PubMed Central ID numbers when citing authored or co-authored papers resulting from NIH funded grants Researchers must also submit an electronic version of final peer-reviewed papers/articles/manuscripts to PubMed Central, quoting NIG grant number in the acknowledgements section.
NIH requires funding recipients to submit Research Performance Progress (RPPR) reports to NIH on their grant awards.
There are three types of RPPRs:
- Annual RPPR – Use to describe a grant’s scientific progress, identify significant changes, report on personnel, and describe plans for the subsequent budget period or year.
- Final RPPR – Use as part of the grant closeout process to submit project outcomes in addition to the information submitted on the annual RPPR, except budget and plans for the upcoming year.
- Interim RPPR – Use when submitting a renewal (Type 2) application. If the Type 2 is not funded, the Interim RPPR will serve as the Final RPPR for the project. If the Type 2 is funded, the Interim RPPR will serve as the annual RPPR for the final year of the previous competitive segment. The data elements collected on the Interim RPPR are the same as for the Final RPPR, including project outcome
Instructions on how to submit RPPR’s can be found here; NIH and Other PHS Agency Research Performance Progress Report (RPPR) Instruction Guide. NIH provide a general overview and resources to help understand how to submit a progress report here.
All Directly Incurred staff working less than 100% of their time on one Federal Agency award must complete a comprehensive timesheet.
We would recommend that all staff charged to a Federal Agency award complete a comprehensive timesheet for audit purposes.
More information and links to Imperial timesheet templates can be found here.
The US Federal Single Audit occurs annually and is coordinated by the Research Office. In line with the guidelines set out in 2 CFR Part 200 (Code of Federal Regulations) Federal Register :: Uniform Administrative Requirements, Cost Principles, and Audit Requirements, it is mandatory for any organisation that expends more than $1,000,000 in US Federal funding during the financial year. It promotes accountability, transparency, and the responsible use of public funds. Expenditure charged to any US Federal award from 1st of August 2024 is within scope. Before this date, the audit only applied to awards from select US Department of Health and Human Services (DHHS) Agencies - primarily the National Institutes of Health (NIH) – and the United States Agency for International Development (USAID).
The Single Audit involves a comprehensive examination of a sample of US Federal awards, evaluating financial statements and supporting documents (including timesheets, if applicable) to assess internal controls and compliance with regulations and conditions of awards. For more information about audit requirements for foreign entities, recipients should review the Standard Terms and Conditions of the Notice of Award