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National Institutes of Health (NIH)

5/2/24 – NIH Published Revised Grants Policy Statement (GPS) for FY 2024

The FY 2024 Grants Policy Statement (GPS), released May 2, 2024, applies to all NIH grants and cooperative agreements with budget periods beginning October 1, 2023 or after. Awards prior to this date will follow the previous version of the GPS. Please see the Summary of Significant Changes, as well as NOT-OD-24-115, and the NIH GPS for more information.


4/23/24 – Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels Effective for Fiscal Year 2024

NIH recently published NOT-OD-24-104, which outlines FY24 annual stipend levels that apply to all individuals receiving support through NRSA institutional training grants or institutional fellowships. The new rates are effective for all NRSA awards made on or after 10/1/23. Please see the NOT for more information.

For budgeting implications on upcoming applications, please reach out to your OSP Proposal Team. For impacts related to an existing award, please reach out to the CGA Awards group.


2/13/24 – NIH Guidance on Marking Changes in Resubmission Applications

Effective May 25,2024, the guidance of NOT-OD-24-061 replaces the previous guidance on how to mark changes in Resubmission applications. The use of markups throughout the application should no longer be used; changes should instead only be outlined within the Introduction attachment. Please see the NOT for more information.


1/29/24 – NIH Salary Cap Increase to $221,900

Per NIH notice NOT-OD-24-057, the Executive Level II salary rate has been increased to $221,900 effective January 1, 2024. The salary cap for AY is $166,425 and the summer salary cap is $55,475.


12/21/23 – Reminder on eRA Commons ID Requirement

Previously, NIH issued NOT-OD-21-109, requiring an eRA Commons ID for all personnel listed in the application on the Senior/Key Person Profile form. Since that time, applications that included key personnel without a Commons ID were given a warning at the time of submission. Per NOT-OD-24-042, beginning with NIH due dates on or after January 25, 2024, the warning will change to an error. A warning does not prevent an application from moving forward for processing; an error, however, prevents successful submission.

If you are working on a proposal with MSU key personnel* without a Commons ID, please reach out to your OSP Proposal Team for assistance. Non-MSU key personnel will need to work through their organization to receive a Commons ID.

Please reach out to your OSP Proposal Team if you have any questions.

*Includes Henry Ford researchers with MSU appointments.


9/1/23 – NIH Application Instruction Updates – Data Management and Sharing (DMS) Costs

NIH has updated their guidance regarding budgeting Data Management and Sharing (DMS) costs. For proposals due on or after October 5, 2023, NIH will no longer request DMS costs to be budgeted as a separate line item in the budget. They should be budgeted in the appropriate cost category, e.g., personnel, equipment, supplies and other expenses. The budget justification (for detailed budgets) or additional narrative justification (for modular budgets) should still include information on what costs are considered DMS costs.

Please see NOT-OD-23-161 for more information.

If you have questions regarding budgeting DMS costs, please reach out to your OSP Proposal Team.


7/31/23 – NIH RPPR Tips for Adminstrators Webpage

NIH requires that a Research Performance Progress Report (RPPR) be submitted periodically based on the terms of the award. CGA often receives questions related to NIH RPPR submissions from both MSU and NIH. The NIH RPRR Tips for Administrators Webpage is intended to address the most frequent inquiries and assist MSU PIs and Research Administrators in completing an RPPR with information that meets NIH's expectations and requirements.


1/25/23 – NIH Policy for Data Management and Sharing 

NIH’s new Policy for Data Management and Sharing requires researchers to prospectively plan for how scientific data will be preserved and shared through submission of a Data Management and Sharing Plan with most NIH applications and to implement the approved plan if a project is funded.  A cross-campus workgroup has developed the Data Management Plans – Resources for MSU and Data Management Plans – Sponsor Requirements webpages to support the new policy.

Proposal Guidance

Guidance on the requirements of your NIH proposal will be in the solicitation, and comprehensive instructions can be found in NIH’s General Application Guide. Note that FORMS-H is applicable for proposals due on or after January 25, 2023.

NIH’s Annotated Form Set is another good resource that provides tips and business rules for completing NIH application forms.

NIH's Submission Policies webpage provides links to common submission questions, such as: what happens with late applications, continuous submission rules, resubmission rules, deadlines on holidays/weekends, etc.

OSP has created a checklist for FORMS-H NIH research proposals (e.g. R01, R21, R03) with guidance on what attachments are mandatory versus optional, as well as specifics on how to complete the proposal in Kuali Research (MSU’s proposal submission system). 

Proposal Tips

Following is a list of some NIH proposal requirements (note, this is not a comprehensive list):

  • Every MSU PD/PI must have an eRA Commons ID associated with MSU. If a PD/PI does not have an eRA Commons ID, or if their ID is not associated with MSU, please contact your OSP Proposal Team. NIH has a Multiple PI option that allows more than one PI to be included on an application.  If this option is being pursued, a Multiple PI Leadership Plan must be attached to the proposal.
  • Other Significant Contributors (OSCs) are defined by NIH as individuals who contribute to the scientific development of a project without any specific measurable effort. Consultants paid on a project would not meet this definition because their effort is measurable (i.e., paid hourly or daily for an estimated number of hours or days).
  • The PHS Human Subjects and Clinical Trials Form is required and can be challenging to complete.  Please reference the FORMS-G PHS Human Subjects and Clinical Trial Information Guide for assistance with completing this form. NIH’s Annotated Forms can also help.
  • Single IRB – If the proposal includes subrecipients and human subjects will be involved at multiple-sites, a Single IRB plan will need to be included at Just-in-Time stage.  To allow proper time, it is recommended to contact MSU HRPP at proposal stage for assistance with completing the plan, IRBReliance@ora.msu.edu.  More information is provided in the Compliance section of this webpage.
  • Prior approval is required from an NIH Program Officer if any budget period in a proposal includes $500,000 or more in direct costs, excluding consortium F&A.   The approval must be indicated in a cover letter that is attached to the application. Please NOTE if a proposal is submitted with $499,999.50 in any of the budget years, NIH will round to $500,000 and will need Program Officer approval. Please make sure to submit budgets that are at least $1 less than the cost cap. 
  • Biosketches are typically required for all Key Personnel and should follow NIH’s format.  They are limited to five pages per person.  The Personal Statement should only include up to four publications, and the Contributions to Science section should only include up to five contributions. The use of URLs outside of works cited, such as to include a full list of published work, is limited to Federal Government websites only; NIH suggests My Bibliography.
  • Other Support forms are required at the Just-in-Time stage.  For additional information on completing Other Support forms, see the Current and Pending/Other Support Requirements by Sponsor webpage.
  • Annual and Project Based Conflict of Interest forms must be completed for all Key Personnel prior to proposal submission.  For more information, see the Compliance section.
  • Many proposal submissions follow NIH Standard Due Dates.  Some investigators who participate in NIH review committees may have continuous submission eligibility, which allows them some flexibility with submission deadlines.
  • The Assignment Request Form should be included with the proposal if the PI would like to recommend a particular institute or center that they would like their proposal to be reviewed by. This form is included as a User Attached Form in the KR Proposal Development Document. The “Equipment” attachment is a required form for most research proposals.  It should list the major items of equipment already available for the project with the pertinent capabilities.
  • Exercise caution when using URLs/hyperlinks in applications:
    • URLs/hyperlinks are not generally allowed. Check application instructions or the funding opportunity announcement to ensure they are allowed in the section of the proposal where they’re being added.
    • URLs/hyperlinks to videos are not allowed.

Submission System

Most NIH proposals are submitted using the System-to-System (S2S) feature in Kuali Research (KR). For assistance with completing NIH S2S research proposals, use the NIH FORMS-H checklist.

There are some NIH proposals that currently cannot be submitted using KR.  They are:

  • Proposals with multiple projects/cores
  • Training Grants
  • Proposals with budgeting requirements that cannot be accomplished in the KR Budget Module (this scenario requires OSP’s approval to proceed with another submission system)

If the proposal cannot be submitted in KR using S2S, it can be submitted in ASSIST, which is NIH’s submission system, or Grants.gov’s Workspace.  Check with your Proposal Team prior to using ASSIST or Workspace.   

 After submission, the proposal may be reviewed in eRA Commons. The PD/PI is encouraged to log in to eRA Commons to ensure the final proposal is accurate and correct. If there are any issues that need to be addressed or any attachments that need to be updated, please work with your proposal team to submit a changed/corrected proposal within two business days of original submission and prior to the proposal deadline.

 Supplement applications may be submitted via KR, ASSIST, or eRA Commons. If the supplement can be submitted in eRA Commons, refer to the eRA Commons Administrative Supplement Module User Guide. Please work with your proposal team to determine the best method for submission.

Just in Time

NIH sends automated JIT emails to the PD/PI(s) for any proposal receiving an impact score of 30 or less, regardless of the Institute/Center’s payline. The automated JIT email includes requests for updated Other Support and certifications such as IRB approval. You do not need to respond to this automated request. You may wish to provide JIT materials at this time if your application scored within the Institute/Center’s payline and you wish to provide materials to help speed NIH review; additional materials may be requested later.

After the automated JIT request, the PD/PI may receive a personalized JIT email from a NIH Grants Management Specialist (GMS) that may include requests for updated Other Support, confirmation of MSU’s current F&A rate agreement, and other materials specific to the application such as IACUC approval, IRB approval, human subjects education certificates or a Single IRB plan. The GMS will typically provide a deadline for JIT submission, and unless otherwise noted, these materials should be submitted using the JIT module in eRA Commons. You must respond to this request to be considered for funding.

Please work with your proposal team to coordinate JIT submission.

Budget Guidelines

The guidelines listed here are generally applicable to this sponsor. Please refer to the solicitation for any deviation to standard guidelines or specific requirements for a program.

Personnel

Salary
Salaries should be based on KR values unless a known increase/decrease is expected, for example due to a change in title/rank; the salary cap may be used when using a module budget or if there is a budget ceiling, otherwise NIH advises that the full salary be used; FY24 salary cap is $221,900 (AN)/ $166,425 (AY) / $55,475 (Summer); salaries are usually escalated in the out years using 2-3% inflation
Fringe
Fringe should be based on KR values; the fringe rate at the level of the salary cap may be used.
Research Associate (Post Doc) Salary
Salaries should be based on KR values if a current employee; the current (2023) NIH minimum salary for a Post Doc is $56,484(AN).
Research Associate (Post Doc) Fringe
Fringe should be based on KR values; Post Docs are eligible for retirement in the 4th year of employment or if they participated in a retirement plan at a previous employer that made employer contributions. Please contact HR for more information.
Graduate Student Stipend
Stipend amounts should be based on standard/published college/department levels or HR levels
Graduate Student Fringe
Appropriate health benefits should be applied based on the current Grad Fringe Chart; 7.65% for summer hourly work
Undergraduate Labor
Usually based on hourly rates; see HR standard rates
Undergraduate Fringe
Fringe of 7.65% applied during the summer; fringe only applied during AY if student is not expected to be enrolled full time
Administrative Staff
Allowable per UG if justified and integral to the project; salaries and fringes should be based on KR values

Equipment

Allowable items ordinarily will be limited to research equipment not already available for the conduct of the work; quotes must be provided to the sponsor for equipment proposals

Participant Support Costs

Only allowable when specifically identified in the Notice Of Funding Opportunity (NOFO)

Patient Care Costs

Routine services provided by hospitals to research participants are allowable; OSP recommends the PI/research administrator contact CTSI to develop a billing grid; rebudgeting to or from patient care costs may be considered a change in scope and requires prior approval

Travel

Domestic
Includes U.S, Canada, Mexico, and U.S. possessions; justification should include the purpose of travel, destination, dates of travel (if known) or estimated number of days, and the number of individuals for each trip
International
Includes any destination not considered domestic; justification should include the purpose of travel, destination, dates of travel (if known) or estimated number of days, and the number of individuals for each trip

Other Direct Costs

Communications
Allowable if not otherwise treated as F&A costs; should be allocable to the project
Computer Services/ADP
MSU services should be based on the established computer service rates (Financial Analysis approved rates); quotes or other justification for how rate was determined are helpful
Conferences
Allowable under R13 and U13 activity codes for most Institutes and Centers (IC’s); budget guidelines vary by IC; prior approval is required before submission of an application for conference support; for generally allowable/unallowable costs see NIH Grants Policy Statement, Section 14.10
Consultant Services
Justification should include: services performed, total number of days, travel costs, total estimated costs, names and organizational affiliations other than those involved in a consortium agreement, consulting physicians in connection with patient care, persons to serve on external monitoring boards or advisory committees
Equipment/Facility Rental
Allowable to the extent rates are reasonable
Event Registration Fees
Allowable for symposiums/seminars if necessary to accomplish project objectives
Genomic Arrays
Allowable; genomic array costs in excess of $50,000 in a budget period should be excluded from the MTDC base for determining F&A; see NIH Grants Policy Statement, Section 7.4
Graduate Student Tuition & Fees
Should match the graduate student tuition chart unless applying to a fellowship solicitation; tuition should be prorated based on project dates; KR will apply appropriate inflation
Honoraria
Unallowable; speaker's fees or other payments for services are allowable
Human Fetal Tissue
If the project includes the use of Human Fetal Tissue, choose the Object Code Name “Human Fetal Tissue Costs” under Other Direct
Incentives
Allowable; incentive should not be so great as to coerce or unduly influence participation in the project
IRB/IACUC Fees
Effective January 25, 2018, costs associated with Single IRB (sIRB) review may be charged as direct costs, provided costs are well-justified and consistently treated (details and scenarios).  Please contact MSU HRPP for more guidance on the sIRB policy. Non-sIRB and IACUC fees are not allowable as direct costs. 
Materials & Supplies
Justification should include general categories including an amount for each category; categories with amounts less than $1,000 are not required to be itemized. If animal purchase and care is budgeted, the price per animal, number/type of animals, and per diem rates should be included in the justification. For Modular Budgets, OSP may request additional justification if this line item is 25% or more of TDC.
Meals/Refreshments
Allowable for subjects or patients in study where specifically approved as part of the project activity; alcohol is unallowable unless within the scope of an approved research project; meals for conferences/meetings for which the primary purpose is technical dissemination are not allowable
Publication/Dissemination
Allowable
Service Charges/CORE Services
Must be based on Financial Analysis approved rates; quotes or other justification for how service rate was determined are helpful
Subaward
Subaward budget, justification, scope of work, and commitment form must be on file internally; foreign subawards are restricted to 8% F&A; consortium justification will need to be submitted with proposal, whether detailed or modular
Visa Fees
Generally allowable as a recruiting cost on an NIH grant

Contingency
/Misc.

Unallowable

F&A

NICRA rates should be used based on project nature unless otherwise limited by the solicitation

Cost Share

Only include cost share if required in the solicitation. Voluntary committed cost share should be documented in the Supplemental Information option in KR.

NIH Modular Budget

Establishes $25,000 increments in which direct costs must be requested up to a maximum of $250,000 direct costs per year (excluding any consortium F&A costs). Modular budgets are required for new, renewal, and resubmission applications for the following types of applications:

  • Research Project Grants Program (R01/U01)
  • Small Grant Program (R03)
  • Exploratory/Development Research Grant Award (R21/UH2)
  • Clinical Trial Planning Grant Program (R34/U34)
  • Academic Research Enhancement Awards (R15/UA5)

If the direct costs (excluding consortium F&A costs) exceed $250,000 in any given year, a detailed budget must be submitted.  For instructions on how to create a modular budget in the KR Budget Module, see the Creating a Modular Budget job aid.

Additional Budget Resources

Compliance

Conflicts of Interest (COI)

Annual and project-based disclosures are required for any key person prior to submission of an NIH application. This includes the PD/PI(s), Co-Investigator(s), key person(s), and any consultant named on the Senior/Key Person Profile form. MSU employees should complete their disclosures in KR. Anyone listed with the Other Significant Contributor role typically does not need to complete a COI disclosure.

Key Persons under a subaward may be covered by their institutions PHS-compliant COI policy. This will be noted on the subrecipient commitment form. If the subrecipient does not have a compliant policy and agrees to follow MSU’s policy, each key person will need to complete a Conflict of Interest Disclosure Form prior to submission.

Non-MSU consultants named as key persons will also need to complete a Conflict of Interest Disclosure Form prior to submission.

If awarded, all key personnel must maintain updated annual COI disclosures, and they must have up-to-date Conflict of Interest training (this includes non-MSU key personnel who are following MSU’s COI policy).

Human Subjects / IRB

Below are resources to assist faculty with making NIH Human Subjects determinations.

Single IRB - Proposals submitted after 1/25/2018, fall under NIH’s Single IRB Policy.  This requires additional steps to be taken at the proposal stage.  Below is specific information related to the new policy.

  • Which proposals will be impacted?  According to the NIH FAQ’s, “The NIH single IRB policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.”
  • If my proposal is subject to the NIH Single IRB policy, what do I need to do prior to proposal submission?  Contact the IRB office, IRBReliance@ora.msu.edu, for assistance with completing the IRB plan.  The plan describes the use of a single IRB that would be selected to serve as the IRB of record for all study sites.  This plan is submitted at Just-in-Time stage but contacting IRB at proposal stage gives time for them to assist with this plan.
  • Where Can I Find More Information?  To learn more, please visit the MSU HRPP website at https://hrpp.msu.edu/help/reliance/nih-sirb.html and the NIH Single IRB website at https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm.

IRB approval is not required at the proposal stage, but will be requested at the Just-in-Time stage.  A delay in IRB approval could delay the award being received or account setup.

Animal Subjects / (IACUC)

If animal subjects are being used, IACUC approval is not required at the proposal stage, but will be requested at the JIT stage. A delay in IACUC approval could delay the award being received or account setup.

NIH Policies on Harassment

NIH requires institutions to report changes in a principal investigator or other senior key person's status during an investigation of alleged sexual misconduct.  For additional information, visit the NIH section of the Resources Related to Harassment Notification Requirements webpage.

Responsible Conduct of Research

Please see Responsible Conduct of Research – Training Requirements by Agency for information on NIH compliance requirements. 

Award Guidance

NIH is a signatory to the FDP Phase VI Agreement, therefore, their award terms are usually standard. The Uniform Guide regulations at 2 CFR 200 govern funding. The solicitation is typically referenced in the Notice of Award and the terms of the solicitation also apply. Projects are incrementally funded, and future funding is subject to the availability of funds and satisfactory progress of the project. The NIH award will usually include an estimated amount to be awarded in future years. There can be spending restrictions that must be removed prior to initiation of research and typically an unobligated balance may be carried over into the next budget period without prior approval.

Subawards

Required Documents

At the time of proposal submission, the detailed budget, justification, scope of work, and signed subrecipient commitment form are required.

Drafting Subawards

NIH participates in the Federal Demonstration Partnership (FDP). Subawards issued under a Prime agreement from an FDP-participating Federal Agency are drafted by Contract and Grant Administration (CGA), unless the subrecipient is a for-profit entity or a national lab, in which case the subaward is drafted by the Office of Sponsored Programs (OSP).

Prior Approvals

Required Prior Approvals

NIH requires prior approvals for several actions, including no cost extensions, changes in scope, administrative/clerical staff not budgeted, reduction of PI effort by 25% or more, adding a foreign component, and pre-award costs more than 90 days before the effective date of the initial budget period. A full list of required prior approvals can be found in the NIH Grants Policy Statement.

Submission System

The following prior approvals can be submitted in eRA Commons:

  1. No Cost Extension (NCE): Contact CGA Awards Group
  2. Carryover Request: Contact CGA Awards Group
  3. Change of PD/PI Request: Contact CGA Awards Group for already established awards, Contact OSP Proposal Team for pending applications

Prior approvals submitted in eRA Commons need to be initiated by the Signing Officer (CGA) for submission. Please refer to the eRA Commons User Guide for directions for submitting each type of prior approval.

For all other prior approvals, please contact the CGA Awards Group at awards@cga.msu.edu.

Reporting

* All final reports are due 120 days after the award end date and are submitted through eRA Commons

Progress/
Technical Report

  • Submitted in eRA Commons
  • Also called a non-competing continuation application
  • Initiates additional year of funding to be received
  • Contains scientific and administrative information
  • SNAP Research Performance Progress Reports (RPPRs) are due annually 45 days prior to current budget period end date
  • Non-SNAP RPPRs are due approximately 60 days before the next budget period start date.
  • Final/Interim Progress Report
    • Located in Requires Closeout Section of eRA Commons (not RPPR tab)
    • Similar to annual/interim report, but requires section I, Outcomes, to be completed.

Financial Reports

  • Submitted in eRA Commons
  • Final Financial Report

Other Reports

Effort Reporting / Cost Share

Effort is set up for PI/Co- PI and key personnel listed in the NoA. The Salary Cap for 2023 is $212,100 for AN Faculty and $159,075 for AY Faculty.

See the following for current and prior year salary cap amounts: Salary Cap

Effort Reporting

MSU effort reporting overview and FAQ’s can be found on the Sponsored Program Administration website at the following link:
https://www.cga.msu.edu/PL/Effort/EffortReportingTools.aspx

Effort reporting instructions can also be located on the Sponsored Program Administration website: 
https://www.cga.msu.edu/PL/Portal/231/EffortReportingInstructionsEffortAdministrators

For additional questions and information, please contact the CGA Effort Reporting inbox at, effortreporting@cga.msu.edu

Cost Share

Information on cost share can be found on the Sponsored Program Administration website at the following link:
https://www.cga.msu.edu/PL/Portal/249/CostSharePolicy

In cases where salaried cost share has been committed, MSU uses the effort reporting system for tracking and documentation. Non-salary cost share is documented through PI certified operating statements.

Record Retention

Record retention is three years from submission of the final financial report.

Sponsor Resources

Forms and Templates

 

Henry Ford Health + Michigan State University Health Sciences

A new organization was created under MSU to report research activity for Henry Ford Health and MSU’s College of Human Medicine, College of Osteopathic Medicine and Nursing.  The name of the new organization is Henry Ford Health + Michigan State University Health Sciences (HFH+MSU HS).  The new organization is phasing in its research activity starting with proposal submissions to NIH with deadlines after November 1, 2022. 

Proposal Guidance

  • HFH+MSU HS has its own Unique Entity Identifier, which is: NH77YPDEGG84.
  • A new Institution was setup in eRA Commons for HFH+MSU HS.  Faculty at HFH and MSU will need to be affiliated with the new institution before submitting a proposal under HFH+MSU HS. Any faculty that needs an affiliation to HFH+MSU HS should contact their OSP Proposal Team.
  • Faculty can have an affiliation with MSU/HFH and HFH+MSU HS and will need to switch between the different organizations in eRA Commons to see the activity that was submitted under the applicable institution.  For instructions on how to change the displayed institution, see NIH’s instructions: Changing the Displayed Affiliated Institution.
    • HFH faculty example: if I am a Henry Ford faculty member and I have an award that was issued to Henry Ford Health, I would need to display the Henry Ford Health institution in order to view the award.  Conversely, if I am a Henry Ford faculty and I submitted a proposal under HFH+MSU HS, I would need to display the HFH+MSU HS institution.
    • MSU faculty example: if I am a MSU faculty member and I have an award that was issued to MSU, I would look under MSU to see the award.  Conversely, if I am a MSU faculty member and I submitted a proposal under HFH+MSU HS, I would need to display HFH+MSU HS in order to see the proposal.
  • HFH+MSU HS proposals to NIH will be submitted as System-to-System (S2S) proposals in Kuali Research (KR).  To change the Applicant in KR to HFH+MSU HS, see the Selecting HFH+MSU HS as an Applicant Organization article in Issue 73 of the System Implementation Update.
  • For additional information on the collaboration, see the HFH+MSU Health Sciences Frequently Asked Questions.
  • HFH+MSU HS Subrecipient Commitment Form – Used by a subrecipient when HFH+MSU HS is the direct sponsor.
  • HFH+MSU HS Commitment Form - Used by HFH+MSU HS when we are the subrecipient.
  • HFH+MSU HS Letter of Intent Template - Used only by subrecipients who are part of the FDP Expanded Clearinghouse when HFH+MSU HS is the direct recipient of federal funds.

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