National Institutes of Health Toolkit: Proposals At a Glance

 

Introduction

Proposals and the budgets for projects being submitted to the National Institutes of Health (NIH) should be developed by principal investigators (PIs) with the assistance of their department and/or Research Business Manager Liaisons (RBML). Proposals must be submitted to OGCA following the 5 day proposal submission procedure. Following the 5 day proposal submission procedure, the proposals may include draft technical sections (Research Strategy, Specific Aims, Project Summary/Abstract, and Bibliography/References Cited documents) but complete in all other respects. Final versions of the Research Strategy, Specific Aims, Project Summary/Abstract, and Bibliography/References Cited documents should be provided to OGCA no later 48 hours before the NIH deadline. Please review the 5 day proposal submission procedure here for full details. Proposals and IPFs are routed to relevant signatories and finally to the Office of Grant and Contract Administration (OGCA) for review prior to the official submission to the NIH. 

OGCA reviews each NIH proposal for compliance with both sponsor and University policies. OGCA also reviews the proposal to verify that only allowable costs have been requested and only approved University and/or other vetted personnel such as subcontractors, consultant, fee for services providers are included in the proposal. For a review of allowable costs on Federally-funded projects please click here.

PIs seeking assistance with how to prepare an NIH proposal should contact their department or the RBML network. However, PIs should feel free to contact Jim Ayres at jayres@research.umass.edu during any point of this process for clarification, guidance, or consultation.

NIH Proposal Submission

Prior to official submission to the NIH, proposals must be submitted to OGCA for review and institutional approval. Currently, NIH proposals may be submitted to the sponsor via two mechanisms:

1.    Through Fastgrant (SmartGrant), our own system to system interface with grants.gov built into SmartGrant (the UMass Amherst system that assists with building and routing proposals to OGCA).

2.    Through grants.gov using a PDF application package (this avenue is discouraged, see more below).


NIH eRA Commons

When submitting a proposal to NIH, NIH requires the Principal Investigator to have an NIH eRA Commons account.  The NIH eRA Commons account allows the PI to submit an application via OGCA and review and administer certain aspects of their own NIH submissions. To register, contact jayres@research.umass.edu.You will need to provide the following information:

First Name:
Last Name:
UMass Amherst Email:
Type of account needed (i.e., PI, Postdoc, Graduate Student, Assist):

After your account is created, you will receive an automated “Account Created” notification email from NIH containing the username and a randomly generated password. Please activate your account and populate your profile as soon as possible.

When submitting a Progress Report to NIH, NIH requires associated undergraduate and graduate students on NIH-funded projects for at least one person month or more to have an NIH eRA Commons account. Follow the same instructions above to request the creation of an account for undergraduate and graduate students who participate in NIH-funded projects.


Changes to NIH Policy and Procedures

To stay up to date with important changes in NIH policy and procedures, PIs and Business Managers may want to subscribe to the NIH Guide for Grants and Contracts or visit OGCA’s website.


Consultant, Subcontract, Fee for Service or Other Significant Contributor?

At times it can be difficult to tease out a participant’s role in your proposed project.  It is important that the correct agreement determination is made early in the process of preparing a grant application, as indirect costs and monitoring requirements for these types of agreements vary and will impact the grant budget and, in some cases, the grant narrative.  

Before entering into a relationship with another organization in relation to NIH-funded research in which the other organization will provide services or programmatic work to UMass Amherst as the prime recipient of funding, a determination must be made as to the nature of the legal relationship of UMass Amherst and other organization. The determination will drive the type of legal agreement required to formally establish the relationship.  This is a significant decision because it determines the allocation of responsibilities and the appropriate application of indirect cost rates. In the case of a subcontract, it is incumbent upon our University to ensure that subcontractors conduct their portions of research projects in compliance with all applicable terms and conditions of awards and that project costs incurred by subcontractors are reasonable and allowable. Agreements with vendors for the purchase of services (“fee for service”), however, typically do not bind vendors to the full set of NIH terms and conditions.

Some of the terminology that you may be using in certain contexts may have very specific definitions for NIH and the University. For example, while the NIH defines a consultant as an individual who provides professional advice or services for a fee, a consultant is not directly responsible for the completion of the project’s “aims” and does not conduct research but rather acts in an advisory role lending only their expertise.  For more information, see “Proposal Preparation Guide: Consultant”.  If in doubt, contact Jim Ayres at jayres@research.umass.edu.

A subcontract is a formal legal agreement between our University and another organization. This agreement is used when a substantive portion of the work outlined in a proposal is conducted at another organization. Commonly, the other organization is another educational or research institution, but can be any organization outside the University. Click here for a list of the documentation needed to initiate a subcontract.

If the individual or company in question provides a service for which an established published flat fee is routinely charged for the work to be done and they are not involved in the research effort per se but simply provide a fee for service, this transaction is classified as a standard procurement rather than a subcontract. As such, no statement of work, budget, or letter of intent is needed. Provide OGCA with a copy of the published rate sheet for these services.

Lastly, NIH defines individuals who commit to contribute to the scientific development or execution of the project, but do not commit any specified measurable effort to the project as Other Significant Contributors (OSC), these individuals may even be UMass Amherst faculty or staff. OSCs are typically presented at effort of “zero person months” in the Personnel Justification if modular, or the Budget Justification if non-modular.  OSCs are usually respected, established faculty (external or internal) who may provide the PI or other key personnel guidance on an as needed basis.

If you have any doubt as to participant roles in your proposed sponsored project please do not hesitate to consult an OGCA representative to flesh out the specifics and make a determination as to appropriate roles.


Budgets

Know your limits. Carefully read the Funding Opportunity Announcement for budget criteria. You should look for limits on the types of expenses (e.g. no construction allowed), spending caps on certain expenses (e.g. travel limited to $10,000), and overall funding limits (e.g. total costs cannot exceed $300,000 per year, etc.).

NIH uses two different formats for budget submission depending on the total direct costs requested and the activity code used. The SF424 (R&R) Application Guide includes two optional budget components—(1) R&R Budget Component requesting detailed budget information; and, (2) the “simplified” PHS398 Modular Budget Component. Note: NIH applications will include either the R&R Budget Component or the PHS398 Modular Budget Component, but not both. NIH provides the following useful flowchart to determine what budget type to use:

For more information on other considerations to take into account when developing NIH budgets please click here.


NIH Salary Cap

The NIH has historically restricted the amount of direct salary an individual may charge an NIH grant or contract. Commonly referred as the “NIH salary cap, ” it has, for a number of years, been  linked to the Executive Level II salaries of the federal executive pay scale and adjusted whenever federal salaries were increased. The Consolidated and Further Continuing Appropriations Act, 2015 (Public Law 113-235), signed into law on December 16, 2014, continues to restrict the amount of direct salary to Executive Level II of the Federal Executive pay scale. As of January 11, 2015, the Executive Level II salary is currently set at $183,300. See Notice Number NOT-OD-15-0439. 

NIH Salary Cap Example:

Assume PI Smith earns $162,000 for a nine-month academic appointment. Smith’s monthly salary is $18,000 ($162,000/9 months) and annualized salary is $216,000 ($18,000 x 12) which is above the NIH annual salary cap of $183,300 and must be cost shared by the University.

Furthermore, assume Smith is committing one month of budgeted effort to an NIH grant. The effective NIH salary monthly cap rate is $15,275 ($183,300/12) and the difference between the capped rate ($15,275) and the UMass appointed rate ($18,000) equals $2,725. This amount above the cap must be funded by non-federal sources and shown as cost-share on the effort report.


Graduate Student Compensation on NIH Grants

Compensation for graduate students on NIH grants includes salary/wages and fringe benefits. NIH has established the zero-level postdoctoral NRSA stipend as the benchmark for an award amount that approximates a reasonable rate of compensation for graduate students. The maximum compensation (salary & fringe) for graduate students should not exceed the zero-level National Research Service Award (NRSA) stipend in effect at the time of the award.

Currently, NIH’s zero-level postdoctoral NRSA stipend is $42,000. Under no circumstances should a graduate student appointed to an NIH grant be compensated in an amount that exceeds $42,000 inclusive of fringe benefits.

For the NIH policy, see NIH Graduate Student Compensation (Notice NOT-OD-02-017). For the latest NRSA stipend levels, see NIH Ruth L. Kirschstein National Research Service Award (NRSA).

Sample:

The current campus minimum hourly rate is $22.76, a graduate student working 20 hours per week for the entire year (38 academic weeks and 14 summer weeks) would result in graduate student compensation well below the NIH zero-level postdoctoral NRSA stipend (see table below, please note a 5% cost of living adjustment for succeeding years):


NIH Proposals Submitted with FastGrant (nested within SmartGrant)

FastGrant is a system-2-system (S2S) software interface at UMass between SmartGrant and Grants.gov that allows for the submission of all research proposals to NIH utilizing robust tools that help streamline the process.  FastGrant (and SmartGrant) has smart budget capabilities, certain salary data is automatically pulled from Human Resources, it pre-populates certain data into forms, and is more stable than a PDF package.

Please review the Critical Information page to ensure that you’re broadly aware of the proposal submission process. It is vitally important to take into account the Five Day Proposal Submission Procedure when planning to submit a proposal. After preparing the NIH proposal, the proposal should be routed to OGCA through SmartGrant alongside an Internal Processing Form (IPF) with approval signatures (for more information click IPF here). See SmartGrant Help for specific instructions and guidance for logging on and navigating through SmartGrant.

NIH Proposals Submitted via grants.gov website

As previosuly mentioned, submitting through the grants.gov website itself is discouraged. However, if for some compelling reason this mode of submission is needed, the proposal should be routed through SmartGrant following the Five Day Proposal Submission Procedure, alongside an IPF with a copy of the PDF package attached in the SmartGrant Proposal Related Documents section. However, submitting to NIH using an application package is discouraged.  PDF packages may be vulnerable to corruption and viruses. Additionally, the FastGrant system conveniently offers some automation and pre-populated data which makes the process much more efficient and stable.


Research Performance Progress Report (RPPR)

When NIH funds your proposal, NIH will require an annual Progress Report to document your accomplishments and compliance with the terms of award. NIH requires that Progress Reports be submitted by an Authorized Organization Representative therefore, the Progress Report has to be submitted through OGCA by the “Signing Official.”

The Research Performance Progress Report (RPPR) is required for all awards issued under the Streamlined Non-competing Award Process (SNAP), and all F awards, with budget start dates on or after July 1, 2013. NIH continues development of the RPPR for non-SNAP awards, including complex and training awards, and will update the community as progress is made in that regard (see the table below to determine if your award requires RPPR submission).

TYPE OF PROGRESS REPORT

PROGRESS REPORT FORMAT

Streamlined Non-Competing Award Process (SNAP)

RPPR – required

Fellowship

RPPR – required

Non-SNAP

RPPR – required

Multi-Year-Funded (MYF)

RPPR – required

Phase I Final Year
(Phase II Type 4 Application)

PHS 398 or PHS 2590 - defined by terms of award

RPPR and the NIH Public Access Policy

The NIH public access policy applies to any manuscript thatis: (1) peer-reviewed, (2) accepted for publication in a journal on or after April 7, 2008, and, (3) arises from any direct funding from an NIH grant or cooperative agreement active in Fiscal Year 2008 or beyond. This policy requires that manuscripts resulting from NIH funding be linked with the PubMed Central archive. PIs will need to use the bibliography tool My NCBI to link papers to their Progress Reports. The RPPR process allows the NIH to screen for compliance with the NIH public access policy. Publications and manuscripts listed and subject to NIH Public Access policy must include the PubMed Central reference number. NIH will not award non-competing continuation awards when the RPPR publications are not in compliance with the Public Access Policy.

Please note that NIH is increasingly focusing on the Public Access policy at the time of submission of grant proposals as well.  When preparing your submission documents ensure that the Selected Peer-Reviewed Publications section of your NIH biosketch is also compliant with the Public Access policy.


Effort Reporting

As previously mentioned, NIH requires progress reports to be submitted via an Authorized Organization Representative (OGCA); therefore, the University must make a reasonable attempt to vet the information contained in the progress report. One of the trickiest aspects of the progress report process is effort reporting. University faculty and staff are expected to charge their time to sponsored awards commensurate with the committed effort expended on all activities they perform. Payroll charges to sponsored awards, serve as the initial data points for the University’s effort reporting system. OMB A-21 states, “In the use of any methods for apportioning salaries, it is recognized that, in an academic setting, teaching, research, service, and administration are often inextricably intermingled. A precise assessment of factors that contribute to costs is not always feasible, nor is it expected. Reliance, therefore, is placed on estimates in which a degree of tolerance is appropriate.” The effort certification should be a reasonable estimate of how time was expended but there must be correspondence between the effort expected by the NIH as submitted in the proposal and the amount charged to the grant. Simply put, effort reported must equal effort charged to the grant. It is the policy of the University to assume a cost-sharing commitment only when required by the sponsor or by the competitive nature of the award, and then to cost share only to the extent necessary to meet the specific requirements (Please review the cost-sharing approval process, in particular, item #6).

At the time of preparing the progress report, it is important to be in contact with the necessary administrative support who can help you verify the official effort that has been devoted to the sponsored project in question.


NIH Financial Conflict of Interest Requirements

The U.S. Public Health Service (PHS) amended its Financial Conflict of Interest (FCOI) Regulations effective August 24, 2012. These regulations have unique reporting and conflict management requirements and require an initial disclosure of all financial interest related to the institutional responsibilities of the investigator to the UMass Amherst Office of Research Compliance.

Faculty investigators who are supported by U.S. Public Health Service (PHS) funding, including, but not limited to, NIH, CDC, HRSA, SAMHSA, FDA, and AHRQ, are required to submit a PHS Conflict of Interest Disclosure Form to the UMass Office of Research Compliance at the point of each proposal submission and receive training on the regulations.


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