NIH


 What is my NIH grant number? Where can I find it?

After submission of your grant to the NIH, you will be assigned an application assignment number within two weeks.  This is commonly referred to as your grant number.  An example would be 1R01HL123456-01.  You can find your grant number by signing in to eRA Commons.  Once signed in, click on the Status tab in the blue heading on the eRA Commons home page.  Next click on the “List of Applications/Grants” link.  This will take you to a list of your successfully submitted applications, where you can search for your grant title.  The grant number will already have been assigned and associated with that title going forward.  The NIH has a tutorial for PIs that explains how to search for grants and other information available in the Status tab, viewable here.

 How can I view my NIH SF424 application before it is submitted to the sponsor? After it is submitted?

It is possible to view the eBridge-generated SF424 forms of your NIH application before the FP is submitted to the Grants and Contracts Office.  It is not possible to view the entire application with all attachments as a single continuous document before it is assembled in eRA Commons.  There are no systems outside of Commons that are able to replicate the way an SF424 is assembled in its entirety. 

If your NIH application is an eBridge-generated SF424, then you can view your application before it is submitted to the NIH by taking the following steps in eBridge:

  1. In the Funding Proposal Workspace, the PI, BS and PDA will have the activity “View SF424” under the My Activities list on the left-hand side of the screen.  Click this activity.
  2. After the SF424 pop-up window closes when it has finished generating, navigate to the SF424 Workspace.  In the Funding Proposal Workspace, in the middle of the screen under Submission to Sponsor, click on the link under Name that begins with “SF-424000…”.
  3. You will now be in the SF424 Workspace.  To view the SF424 forms, you can either click on View Grant Application on the left-hand side of the screen, or click on Print Version.  Using View Grant Application will allow you to see each SF424 form page separately; you can continue from SF424 page to page in order, or use the drop-down menu to jump to a different form.  If you select Print Version, you will be able to scroll through the entire SF424 to see the application in a single view.  In either version, you will be able to click on individual attachment links to open each as a PDF to review the various documents in your application.

After the Grants and Contracts Office submits your SF424 application to Grants.gov and it moves into eRA Commons, you will be able to (and need to) view your full application in that system.  The PI should log into eRA Commons, select the Status tab, then click on “Recent/Pending eSubmissions.” Here you will find your grant and be able to view the entire SF424 as the NIH reviewers will see it.

For the NIH instructions on viewing the application in eRA Commons, go here.

See the NIH FAQs on viewing an assembled application in eRA Commons here.

 How do I include biosketches for non-Key Personnel, Other Significant Contributors (OSC), and unpaid Consultants in a NIH application?

How do I include biosketches for non-Key Personnel, Other Significant Contributors (OSC), and unpaid Consultants in a NIH application?

 

Non Key Personnel: The NIH does not allow biosketches to be included in an application for non-Key Personnel.  Following instructions found on the top of the current NIH biosketch template will tell you that a biosketch is only needed when your intention is to:Provide the following information for the Senior/Key personnel and Other Significant Contributors.” Please only include biosketches in an NIH application for those individuals identified as Key on the project.


Other Significant Contributors (OSC): The biosketch for an OSC can be added to a NIH application in the same way that it is added for a Senior/Key Person.  OSCs should fall in order behind all Key Personnel. Please add all Senior/Key Persons first and then list the OSCs in alphabetical order.  Add an OSC (or a Senior/Key Person) to your NIH application key personnel list by including the individual on eBridge question B1.0 or B3.0. If the SF424 is not being generated by eBridge, add the biosketches to PHS 398 form “Research & Related Senior/Key Personnel Profile.”

 

Unpaid Consultants:  At MCW, the role of an Other Significant Contributor (OSC) is commonly referred to as an “Unpaid Consultant.” If you are participating in a NIH funded project in a scientific advisory capacity, meaning you have no measurable effort and will not require any salary support from the project, please consider the role of OSC instead of “Unpaid Consultant.” Please see the NIH guidance here for the definition of an Other Significant Contributor (OSC). If the NIH definition for OSC meets your need, please see the related FAQ answer above for how to add a biosketch to a NIH application for an OSC.

If you do not agree that the individual for which you are seeking this information should be considered an OSC by NIH definition, please contact the Grants and Contracts Office analyst who reviews and processes NIH applications for your department to discuss and identify the correct role for the person(s) in question.

 How does the NIH determine if I am an Early Stage Investigator (ESI)? Where do I indicate this in my NIH application?

An Early Stage Investigator (ESI) is defined as an individual who is classified as a New Investigator and is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residence (or the equivalent).  An individual will be classified as a New Investigator if s/he has not previously competed successfully as a PD/PI for a substantial independent research award.  For example, a PD/PI who has previously received a competing NIH R01 is no longer considered a New Investigator but a PD/PI who has received a Small Grant (R03) or an Exploratory/Developmental Grant (R21) retains his or her status as a New Investigator.  For a complete list of NIH grants that do not disqualify a PD/PI from being considered a New Investigator, click here.

The NIH determines your status as an ESI by relying on the data entered by you in your eRA Commons profile.  Please ensure to verify the accuracy of your eRA Commons profile, specifically the terminal research degree and end date of residency data fields.  If you are eligible for ESI status, this status and the end of your eligibility date will appear in your eRA Commons profile.  Thus, you do not need to indicate this status in your NIH application.  NIH does not determine an investigator’s eligibility by information provided in the SF424 application package.

For a complete rundown of NIH policies concerning New and Early Stage Investigators, please click here.

 What is the suggested formatting for my PDF attachment in my NIH application?

NIH only accepts attachments in PDF format. Do not submit attachments in other formats such as Microsoft Word, Word Perfect, etc. Other formats may be allowed through Grants.gov but are not accepted by NIH.
 

Note that all PDF attachments must be submitted as individual files. Although some software packages allow bundling of multiple PDFs into a single file, eRA systems cannot support “Bundling” or “Portfolio” features at this time. Use of these features may result in delays in the review of an application or an application not being accepted by Grants.gov or eRA Commons.

It is recommended that applicants avoid scanning text documents to produce the required PDFs whenever possible. Instead, NIH recommends producing the documents electronically using text or word-processing software and then converting documents to PDF. Scanning paper documents, without the proper Optical Character Recognition (OCR) process, will hamper automated processing of your application for NIH analysis and reporting. For additional information on PDF conversion software, visit the Grants.gov website: http://www.grants.gov/web/grants/support/technical-support/software/pdf-conversion-software.html.

 Can I submit my NIH RPPR (Research Performance Progress Report) if I have a non-compliant publication? What are the consequences?

Yes, you can submit your RPPR if you have publications that are out of compliance with the NIH Public Access Policy.  However, the consequence of submitting with non-compliant publications listed is that the NIH will delay the next Continuation award until all publications have been brought into compliance.  NIH will not issue the award for the next budget period until all non-compliant publication issues have been resolved.  This means your award could be held for days, weeks or months past the next expected start date until every publication listed has a “Compliant” or “In Process” status.

For specific instructions on how to report publications in the RPPR, refer to the RPPR Instruction Guide.

For information on the NIH Public Access Policy, go to the NIH Public Access Homepage.

For assistance in using the My NCBI system or compliance information for individual MCW authors or departments, please contact the MCW Libraries staff at mailto:asklib@mcw.edu or 414-955-8302.

 Do I need to submit a NIH progress report (RPPR) in a No Cost Extension year?

No. A No Cost Extension (NCE) is an extension of the period of performance beyond the expiration end date of the award.  Progress does not have to be reported until the end of the performance period. At the end of the NCE year, the PI should either be working on a NIH renewal application for the current project or the final progress report.  Final Progress Reports are not submitted via the RPPR module in Commons.

 When is my NIH grant due to the sponsor? What happens if the due date falls on a weekend or holiday?

If the due date falls on a weekend or federal holiday, the deadline automatically moves to 5:00pm CST the next business day.

NIH standard due dates can be found on the NIH Grants & Funding website. Please refer to your funding opportunity announcement to verify your due date.

 What information do I need to collect from a consortium site if I plan to include a subcontract to that site on my NIH application?

MCW internal policy requires that a Letter of Intent (LOI) be collected from every consortium site before they can be included on an application.  The Letter of Intent for each subcontract site can either be included in the NIH SF424 application package by attaching the document within Q3.0 as part of the Consortium Contractual Agreement, or needs to be attached elsewhere in the FP or paper application file (R10.0 is the preferred location if the LOI will not be included in the application.).


Other application documents to request from a consortium site could include:

  • A biosketch for all individuals that will be included as Senior/Key personnel on the MCW grant application.
  • A detailed budget that includes Key Personnel effort. (Note: A least one Key person with measurable effort is required on every individual subcontract budget.)
  • A budget justification.
  • The site’s federally negotiated rate agreement.
  • A statement of work to be done at the consortium site.
  • The site’s DUNS number and Congressional district.
  • Letters of Support from the PI or others interested in supporting the application.



Though some departments and other institutions require information to be submitted on specific forms or formatted a specific way, there is no NIH or MCW policy requiring the collection of this information. The collection of this information is for application preparation only and in most cases, the documents submitted to MCW will need to be reformatted before being added to the NIH application to make sure they are in accepted PDF formatting.
 

Lastly, the documents listed above should be considered standard and representative of requirements for the customary NIH parent mechanisms. Always defer to your application instructions to confirm what information is required for MCW and consortium partners in order to comply with sponsor requirements.

 The Just-in-Time (JIT) link has appeared in eRA Commons for my NIH grant application. Should I submit my JIT documentation now?

No.  The JIT link appears for all grant applications within 24 hours after the impact score is released to ensure its availability should the NIH formally request JIT information.  This does not mean JIT will be requested and submitted for the grant.  A formal request for JIT submission from the NIH will come in one of two ways:  (1) An eRA Commons system-generated email for those applications that receive an impact score of 40 or less.  The expectation is that only those applicants with a score within the specific NIH Institute or Center payline will submit JIT when the JIT request comes via an automated email from eRA Commons; or (2) A specific email from the NIH Grants Management Specialist (GMS) assigned to your grant requesting that you submit JIT. 

Should you receive either an eRA Commons system-generated JIT email request and have achieved a fundable score, or have received a direct JIT submission request from your NIH GMS, the Grants and Contracts Analyst assigned to your department for NIH application support will contact you to provide instructions on how and when to compile and submit your JIT materials.  For further instructions on how to submit JIT to the Grants and Contracts Office for review and institutional approval, please review the MCW Grants and Contract JIT Procedure Guide.

 I have been formally requested by NIH to submit Just-in-Time (JIT) for my NIH grant application. What should I include in my JIT submission?

Unless otherwise indicated in a specific request from the NIH Grants Managements Specialist (GMS) assigned to your grant, the following is expected to be included within your JIT submission:

  • Current Other Support: Provide funding support information for all individuals designated in your grant application as Senior/Key Personnel that are providing measurable effort to the project.
  • IACUC Approval Date:  If your grant application proposes to use live vertebrate animals, provide the date your IACUC protocol was approved.   If your IACUC protocol uses Rats, Mice or Zebrafish, provide the approval date of the most recent 3 year de novo review approval.  If your IACUC protocol uses an animal other than Rats, Mice or Zebrafish, provide the approval date of the most recent annual review approval.  If you have more than 1 IACUC protocol for your grant, provide the approval date of your most recently approved IACUC protocol.
  • IRB Approval Date: If your grant application proposes to use human subjects research, provide the date your IRB protocol was approved.  If you have more than 1 IRB protocol for your grant, provide the approval date of your most recently approved IRB protocol. 
  • Human Subjects Education:  If your grant application proposes to use human subjects research that has not been designated by the IRB of record as exempt, provide certification letters for each individual that will be involved in the human subjects research on your grant that s/he has completed an education program in the protection of human subjects (e.g. CITI training certificate).

 

Should you receive a specific JIT submission request from the NIH GMS assigned to your grant, please provide the materials requested in that correspondence for JIT submission.  The revised NIH policy on JIT submission, which details the above JIT requirements, can be found on the NIH JIT Guidance website page.

 How do I submit Just-in-Time (JIT) a second time for my NIH grant application if I have additional or updated JIT information?

JIT can be submitted more than once for an application in eRA Commons.  Should you encounter any substantive changes to previously submitted JIT information, such as changes to Other Support or changes in the use or approval of vertebrate animals or human subjects pertaining to your grant application, you are responsible for notifying the NIH of such changes via an additional JIT submission.  Following the same internal processing that occurred during the first JIT submission for your grant, the updated or additional JIT information must be routed through your Funding Proposal in eBridge for review and MCW institutional approval by the Grants and Contracts Analyst assigned to your department for NIH application support.  Once you have identified that you wish to submit updated or additional JIT information, please contact the Grants and Contracts Analyst assigned to your department for NIH application support to discuss a second JIT submission and s/he will provide further instructions on processing your updated or additional JIT information for official submission.  For further instructions on how to submit JIT to the Grants and Contracts Office for review and institutional approval, please review the MCW Grants and Contract JIT Procedure Guide.

 What do I do if there is going to be more than one PI on my NIH application? What role should each PI be assigned? What if one of the other PIs is at another institution?

If there will be more than one person with the PI role on your NIH application, you will need to submit the application as a Multi-PI grant.  One person will need to be designated as the Contact PI (who will have the “PD/PI” role); this is the individual whose name will appear on the SF424 application cover pages, whose institution will submit the grant, and who will be the contact PI for communications from the NIH.  Each other individual who is going to be a PI needs to be assigned the role “PD/PI” in the SF424 Senior/Key Personnel form and, if applicable, the R&R detail budget.  Each PD/PI will need to have an eRA 13. Commons account with the PI role, and will need to provide his or her Commons username in the application.

In eBridge, this means you will create and submit the Funding Proposal (FP) under the name of the Contact PI for the application.   You will then need to assign the “PD/PI” role to every applicable individual listed on page B, question 1.0 in the FP, and enter the same role for them on page W in the budget.  Do not assign the role “Co-PI” to these individuals, the NIH does not recognize that role (see the related FAQ on this list for more information). 

A multiple-PI can be a faculty member from another institution; he or she would also be assigned the “PD/PI” role in the application (on page B question B3.0 in eBridge, and the same role assigned in the subcontract budget page W).  A subcontract would need to be proposed in the application to cover this individual’s effort and any other costs at the consortium institution.

In your NIH application, you will need to include a Multiple PD/PI Leadership Plan attachment, which explains the rationale for submitting with multiple PIs and describes the organizational structure of the leadership team.  Refer to the specific instructions for this attachment in the SF424 R&R Application Guide, PHS398 Research Plan Form section.  In eBridge, attach the Leadership Plan in Q3.3 if it is a system-generated SF424 application.

For more detailed information on Multi-PI applications, refer to the MCW GCO Procedure Guide.  For further NIH guidance and instructions, see the NIH guidance on Multiple Principal Investigators and the NIH FAQs related to Multiple Principal Investigators.

 Why can’t I assign the role “Co-PI” to someone on my NIH application?

The NIH does not recognize or use the role “Co-PI.”  Instead, an application can have multiple PD/PIs, each of whom must have the “PD/PI” role assigned to them in the application.  “Co-PI” is an available option on the Project Role drop-down menu of the SF424 Senior/Key Personnel form because this form is used by other non-NIH federal agencies that do recognize the term “Co-PI.”

 How do I add a sponsor to the pick list on page I of the eBridge Funding Proposal module? What about subcontractors on page T?

If the name of your sponsor does not appear in the pick list in question 1.0 or 2.0 on page I of the eBridge Funding Proposal, you will need to request that your sponsor be added in Oracle.  New sponsor information is validated by the Controller’s Office, set up in Oracle, and will then be made available for you to select within eBridge.  To request a new sponsor, go to http://www.mcw.edu/eBridge/addnewsponsor.htm, complete the online form and click ‘submit.’  You will need the following pieces of information to complete the form:  legal name of sponsor, tax ID, mailing address, and sponsor financial contact name, telephone number and email address.

If you are completing page T, question 6.1 of the eBridge Budget and your subcontractor does not appear in the pick list, you will need to request that your subcontractor be added as a supplier in Oracle.  New suppliers/subcontractors are validated by Accounts Payable, set up within Oracle, and are then made available for you to select within eBridge.  To request a new subcontractor, go to http://www.mcw.edu/eBridge/addnewsupplier.htm, complete the online form and click ‘submit.’ You will need the following pieces of information to complete the form:  legal name of subcontractor, general description of what they will be providing, tax ID, mailing address, and subcontractor financial contact name, telephone number and email address.

 What is a Letter of Intent (LOI)? What does it contain?

A LOI is a document provided by an institution acknowledging their participation on a project.  A LOI is used when an institution is submitting an application to a sponsor, and the investigator intends to collaborate with another institution on a portion of the project (the consortium/subcontracting site).

The LOI is signed by an appropriate institutional or administrative official of the subcontracting site, and contains details such as the name of the PI, proposed project dates, budget amount, applicable F&A rate, and a statement to the effect that: "The appropriate programmatic and administrative personnel of each organization involved in this grant application are aware of the consortium agreement policy and are prepared to establish the necessary inter-organizational agreement(s) consistent with that policy." The institutional signature on the LOI signifies that the proposed consortium participant(s) understand and agree with this statement. It is not sufficient for the PI at the consortium institution to sign the LOI, as only an administrative official has the authority to commit the institutional resources to the proposed collaboration. The NIH does not mandate a LOI be attached in applications; however, you must include a LOI for each consortium / subcontract sites on an MCW application. Please review the LOI Procedure Guide for additional instructions on how to submit a LOI with a paper application versus an eBridge Funding Proposal, which can be located on the Grants and Contracts website at Procedures Guides / NIH Federal Procedure Guides / Process.

 Who is responsible for drafting the Letter of Intent (LOI) if a PI wants to collaborate on a grant that another institution is applying for? How do I get a LOI for my collaboration with a PI at another institution?

Your Grants and Contracts (GCO) contact person will draft the LOI for applications where MCW is the subrecipient. You have to submit a Funding Proposal (FP) for a new Federal Pass-through application in eBridge, and then complete the following steps in order to request a LOI:

  1. Follow the instructions in the eBridge Procedure Guide for Federal Pass-Through applications to complete the FP, available on the GCO website at: Procedure Guides / Non-NIH Federal Procedure Guides / Federal Pass-Through.
  2.  After the PDO approves the FP and the application moves into state  Grants and Contracts Review, the “Request Letter of Intent” activity will become available for the PI, BS and PDA. One of these individuals needs to go into the FP Workspace and select “Request Letter of Intent” from the “My Activities” list on the left-hand side of the screen.
  3. Complete the requested information in the “Request Letter of Intent” activity and click Submit. The necessary information needed is as follows:
    1. Name of Principal Investigator at the Primary Sponsor/collaborating organization site who is serving as PI on the application (include degree info, MD or PhD, as applicable)
    2. Legal name of the institution submitting the application to NIH or other agency (Primary Sponsor in eBridge)
    3. Name of the administrative official at the collaborating institution to whom the LOI should be addressed
    4. Department of the administrative official
    5. Address of the administrative official
    6. Telephone, fax and email address for administrative official at the Primary Sponsor site

After the information is completed, click Submit. An email notification that the LOI has been requested will go to the GCO Owner.

  1. The GCO Owner (the staff member who supports the PI’s department) will draft the LOI using information from the activity, FP and budget, and will obtain institutional signature. After the FP receives AOR Approval, the GCO Owner will upload the signed LOI using the “Log Comment and Attach Documents” activity, and the signed LOI will be available to the PI, PT, BS and PDA in the History Log of the FP. Once the FP is moved to state Pending Sponsor Decision, the signed LOI can be sent with other application materials to the Primary Sponsor (the collaborating institution that is submitting the application to the NIH).
 Who needs to sign a Letter of Intent (LOI) from another institution?

An Authorized institutional or administrative official from the subcontracting site must sign the LOI. It is not sufficient for the PI at the consortium institution to sign the LOI, as only an administrative official has the authority to commit the institutional resources to the proposed collaboration.

 

 Another institution is applying for or has an NIH grant, and I am/MCW is participating as a subcontract site. The institution sent a Subrecipient Information form that needs to be completed and signed by an institutional official(AOR). Who completes and signs the form?

The GCO staff member who reviews the new federal pass-through Funding Proposal (FP) will complete the Subrecipient Information form and route for AOR signature after the FP has been reviewed and approved.  Attach the form, and any other documents needing AOR signature, in the “Request Letter of Intent” activity in the FP.  The activity becomes available to the PI, BS and PDA after the FP has been submitted to the GCO and is in state “Grants and Contracts Review.”

 What are indirect costs / what is F&A? How do I determine the correct F&A rate for my application?

Indirect Costs, also called F&A (Facilities and Administration) costs, are allowable costs that are incurred for common or joint objectives, and cannot be readily and specifically identified with an individual sponsored research project or award.  Common examples of indirect costs include building and equipment depreciation, institutional administration costs, departmental administration, and library services. 

Institutional F&A rates are set in MCW’s federally negotiated indirect cost College and Universities Rate Agreement, which is negotiated by the MCW Controller’s Office and the federal Department of Health and Human Services on a periodic basis.  MCW has separate indirect cost rates for on-campus, off-campus, Froedtert, and CRI locations.

The F&A rate for an application is determined by two factors: 1. Whether a sponsor will allow F&A to be charged on a project, which needs to be determined in writing before an application is submitted, and 2. If F&A is allowed, either the applicable federally negotiated rate will apply per our institution’s Rate Agreement, or the sponsor will set a predetermined rate in the application instructions.

If an F&A rate from our negotiated Rate Agreement applies, then the rate is determined by where the majority of the research is taking place by MCW personnel.   The PI and department need to evaluate where the research is taking place, whether in the PI’s lab or office, in a clinic location, or elsewhere on- or off-campus.

If you have questions on whether F&A applies in an application or which F&A rate would apply for a project, contact the GCO staff member who supports your department for that sponsor type.  For additional information regarding F&A costs on grants from Non-Profit sponsors, refer to the GCO FAQ page, Non-Profit FAQs heading, Budget Preparation section.

 I have an NIH progress report (RPPR) due. Whose effort do I report in the RPPR?

All personnel who participated on the grant for one (1.0) person month or more during the budget period being reported on need to have their effort listed in the RPPR, section D. Participants, question D.1.  Person months are the same as calendar months, which is how MCW calculates effort for individuals.  Unless they are a PI whose effort level always needs to be reported, a person who participated for less than 1.0 calendar month does not need to be listed in the RPPR. 

The term “all personnel” includes PIs, Senior/Key Personnel, non-Key Personnel, and all individuals on any subcontract sites that provided at least the minimum 1.0 calendar month of effort.

Effort for an individual does not have to be paid from the grant in order to be counted; in the rare circumstances where someone’s effort is being cost-shared on an NIH award, if their level of effort is at or over 1.0 calendar month they should be included in the report.

Upcoming Event - CANCELLED!

GCO Information Session - You Ask, We Answer

Topic: Common Reasons Why FPs are Returned for Changes

Tuesday, December 16, 2014
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MFRC 3074

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