The National Institute of Health (NIH) grant award is basically a formalization of a partnership between the NIH and the grant recipient to ensure abidance by laws, regulations, and policies. It protects the integrity as well as official and authorized acceptance of the overall endeavor.
The NIH is the major federal funding agency that invests more than $30 billion in research annually (Hendriks and Viergevercorresponding, 2016). The NIH Institute or Center (IC) determines the eligibility for the award, special conditions criteria, and funds appropriation following the review of all applicable information.
This article guides you through the intricacies of the pre-award and post-award process by means of an in-depth description of every stage with step by step regulation.
Terms & Conditions
The National Institutes of Health Grants Policy Statement (NIHGPS), as a term and condition for all awards, contains the legal requirements for grant recipients. There are two sections (III & IV) mentioned in Notice of Award (NoA) where terms of the award are described.
- Section III of awards consists of standard terms
- Section IV, however, of awards comprises of Special Terms and Conditions specific to the NIH Institute/Center and/or to the particular grant.
It is important that you read terms and conditions with due deliberation in order to prevent unintentional violation of specific regulations of the award. In case of a rule violation, the NIH immediately restricts the award and constitutes a special monitoring body, which more often than not, results in the termination of an award. In some instances, institutes require an accurate funding track record for faculty engagements. (Schimanski and Alperin, 2018)
Designations and Duties
The efficient communication timeframe between the grant recipient and the NIH staff is crucial during the entire course of award processes.
At this point, the following members of NIH staff and grantee organization work closely together:
· Grants Management Officer (GMO)
The GMO is the NIH official responsible for the management of business/non-programmatic aspects of the award. The GMOs, along with signing the Notice of Award (NoA), ensure the fulfillment of laws and administrative policies by the NIH and grantee staff.
· Grants Management Specialist (GMS)
The GMS and GMO work together in an organized routinely management of the grant. The contact information of the assigned GMS to a specific grant award is present on the NoA.
· Program Official (PO)
The PO’s responsibilities include devising research incentives and training programs in accordance with the mission of the Institute/Center (IC) in synchronization with the Center for Scientific Review and IC Scientific Review Officers. The PO is responsible for the scientific and technical aspects of assigned applications and grant-to-grant management on post-award supervision, progress reports reviews, and site visits.
· Authorized Organizational Representative (AOR)
The AOR, or Signing Official (SO) known in the eRA Commons, is the official assigned by the grantee organization to manage its NIH grants administration award. Initially, when the grant application is signed, this individual official verifies that the applicant organization will comply with all the authorizations referenced in the application. The AOR signature further certifies that the grantee organization will be liable for the utilization of awarded funds and for the statics of the grant-financed project.
· Project Director (PD) & Principal Investigator (PI)
The PD/PIs are the official(s) designated by the applicant organization to direct the award-supported program with appropriate authority and responsibility. The applicant organization is allowed to assign multiple individuals as PIs to lead the project with due logistics and intellect. Each PI is accountable to the applicant organization for project conduction, comprising the submission of all required documents reports.
The PD/PIs are key members of the grantee team who ensure compliance with the financial and administrative regulations of the award. These officials work closely with the grantee organization and the NIH PO/GMO concerning scientific, business, and administrative aspects to develop and maintain necessary documentation official procedure.
Pre-Award Process - Competing Applications & Non-Competing Awards
The NIH employs the project period mechanism of funding for most grants. Projects go through peer review and henceforward to programmatic approval for support funds for generally 5 years but are financed in annual charters called budget periods. The subsequent budget years of the preliminary budget period are measured as non-competing, whereas the year all applications go through peer review are considered as competing.
For non-competing extensions of awards, the pre-award process is an updated version of the competing awards process. Grant recipients are required to submit annual progress reports to be assessed and reviewed by the NIH program staff for grants management before the next non-competing budget period award. If the grantees fail to provide statistics requested by management staff for project evaluation in order to sanction further funds, the NIH program officials can delay or in some cases withdraw continued support funds.
Competing Award Negotiations
Communication between the NIH and the applicant organization is important in the pre-award process to negotiate the adjustments required prior to award.
Five most common points the NIH staff regularly reflects during award negotiations are listed below:
- Overlap:The other support information is reviewed by the program and grants management staff to prevent any overlap with previously funded projects and/or scientific, financial, or commitment obligations.
- Peer Review References:On certain occasions, peer reviewers recommend alterations to the requested budget in the summary report. In such a situation, the NIH staff includes these references in consideration of a possible award.
- Facilities and Administrative (F&A) Costs:For each grant, the grants management staff will apply the negotiated indirect costs (also known as F&A costs).
- Budget Modification:The NIH reserves the authority to reduce the project’s budget upon the unavailability of sufficient funds required to support the application.
- Level of Effort: To support the approved project, grants management, and program staff ensure the commitment of adequate effort.
NIH Institute or Center (IC) Initial Review
Applications that score high in the peer review stage and are considered plausible for award funding are reviewed again by the NIH Institute or Center (IC) for different sets of deliberations. It includes absolute compliance with funding principles of the NIH project budget assessment, grantee eligibility evaluation, and abidance with public policy requirements. (Chung, Giladi & Hume, 2015).
Just In Time (JIT) Information Procedures
The NIH uses Just-in-Time procedures for most proposals which allow certain features of an application to be submitted later in the process when it is established that the proposal has the potential of being funded.
These features include:
- Other support information (active and pending) for key personnel
- Certification of International review board (IRB) approval of the project’s proposed use of human subjects
- Verification of Institutional Animal Care and Use Committee (IACUC)
- Evidence of compliance with the protection of human research members obligation
Applicants are notified chiefly by e-mail when Just-in-Time information is needed. This notification is NOT a Notice of Award nor should it be mistaken as a pointer of possible funding. Applicants should only submit this information when requested.
When you receive a JIT request, you have a window of about one month to submit the documents described above.
Post Award Process
If you are the recipient of a grant from the NIH, there is a great deal of information that your organization will need in order to be the successful attendant of federal funds.
After a successful submission to NIH for a federal sponsor, the grant application is generally directed to the Scientific Review Group (SRG) requested in the application cover letter.
Four months after submission, the Scientific Review for most NIH applications takes place. Applicants are informed through e-mail that the application has been received along with the information about assigned SRG. The introductory information about Scientific Review Officer (SRO) administratively responsible for the SRG, is also present in the notification email.
Notice of Grant Award
The Notice of Grant Award provides summarized terms and conditions of the award, as well as categorizing project and budget period dates and award fund amounts. Principal investigators are not required to take any action on the receiving of the NoA other than contacting the OFR to understand awarded funds allocation. The NoA also contains contact information for the NIH specialist program officer and grant management specialist for the award.
The NIH awarding bureaus actively monitor grants to identify possible complications and technical hitches necessitating assistance. Monitoring is done through the review reports, the grant recipient’s correspondence, audit reports, and the site visits information available to the NIH. The keen grant recipients are responsible for managing routinely operations of their grant.
Grant payments are likely to be made by one or the other advance payment methods. To name a few of the several preferred methods:
- SMARTLINK II/ACH
- CASHLINE/ACH, or cash request, as stated in the NoA
The NIH monitors expenditure of grant recipient organization under both the individual grants within each budget period and the overall project period. Applicant organizations are also required to set up monetary systems that could monitor their grant outgoings. The NIH allows flexibility to grantees with regards to re-budgeting but expects consistency of rates and expenditures with approved project and budget and holds the authority to question/restrict expenditures that become inconsistent.
Grantees are required by NIH to submit annual Research Performance Progress Reports (RPPR) through the eRA Commons as part of the non-competing extension of the award process.
For non-competing fund, each budget period in an approved period project and the progress report (RPPR) must be approved by NIH.
Grantee organizations are obligated by the rules to report all of the inventions to award institutions (see NIH Grants Policy Statement), along with an acknowledgment of federal support funds in all official documents and copyrights.
NIH grant recipients or sub-recipients that lay out $750,000 in federal awards through the fiscal year are liable for an annual audit requirement. Organizations expanding less than $750,000 for the duration of the fiscal year are not required to have an annual audit but are expected to keep their grant records available to NIH for a review or audit.
If the grant is not to be extended or if sustained funding is not provided, NIH closes out a grant after the project period end date. Closeout comprises of readily available reports and alterations for amounts due to the grant recipient or NIH. Grant closeout does not revoke any requirement for property/financial accountability and record retention. If anything, the grantee remains obliged to return due funds. Based on the audit results of the period of grant support, the federal government may possibly recover amounts.
- Hendriks, T.C., & Viergevercorresponding, R.F. (2016, February 18). The 10 largest public and philanthropic funders of health research in the world: what they fund and how they distribute their funds. Health Res Policy Syst, 14, 12. http://dx.doi.org/10.1186/s12961-015-0074-z
- Alperin, J.P., & Schimanski, L.A. (2018, October 5). The Evaluation Of Scholarship In Academic Promotion And Tenure Processes: Past, Present, And Future. Version 1. F1000Res, 7,1605. http://dx.doi.org/10.12688/f1000research.16493.1
- Chung, K.C., Giladi, A.M., & Hume, K.M. (2015, February 1). Factors Impacting Successfully Competing for Research Funding: An Analysis of Applications Submitted to The Plastic Surgery Foundation. Plast Reconstr Surg, 135(2), 429e–435e. http://dx.doi.org/10.1097/PRS.0000000000000904