Pediatrics Pre-Award FAQ

Links: Stanford Research Guide, Pivot

Contacts: Peds ORD

Funding your research at Stanford can come from a variety of sources both internal and external. Internally, Seed Grants or Pilot Grants from institutes like MCHRI support faculty at critical early stages of their research. Externally, both federal sponsors and private foundations provide the bulk of support for Stanford research. Pivot is an excellent search tool to mine these external opportunities, and can even set up regular notifications of new funding announcements. However, no one tool can capture all opportunities, so we suggest visiting the Stanford Pediatrics Funding Page below to access the most current listings from RMG, Stanford, and other aggregating tools.

Doris Duke Charitable Foundation (DDCF)
Physician Scientist Fellowship https://www.ddcf.org/what-we-fund/medical-research/goals-and-strategies/encourage-and-develop-clinical-research-careers/physician-scientist-fellowship/

Summary: Grants of up to $220,000 over two years will be awarded to physician scientists in subspecialty fellowship training to support two years of clinical research that will strengthen their careers as biomedical investigators. The priority of the Physician Scientist Fellowship (PSF) award is to fund candidates with promise for strong research careers. DDCF does not have funding priorities based on disease area or research type.  

The Gerber foundation
https://www.gerberfoundation.org/how-to-apply/

Links: Grant Writing Academy, Route 2 Getting Grants, Tackling Your F32 Writing Club, K Writing Club, Grant Writing Club, OFDD

Contacts: Peds ORD

The Department of Pediatrics has a dedicated Office of Research Development that provides comprehensive support and training for all funding activities from individual fellowships to large program project grants. It is recommended to contact this office as soon as possible to leverage their support throughout your proposal process.

Links: NIH Grant Writing Handbook, 

Contacts: Peds ORD

Links: NIH RePORTER, Digital Dimensions

Contacts: Peds ORD, Chelsey Perry

NIH Reporter is the primary tool when looking for currently funded research. Search criteria are extensive, from keywords, investigators, institute, organization, etc.

Digital Dimensions is another search tool that includes NIH as well as other sponsors. Stanford has a subscription to this tool, which can give a more comprehensive view of the funded landscape from grants, publications, patents, etc. around a specific topic.

RMG Funding Email List is another resource offered by Stanford to alert you to new funding announcements. Please contact Chelsey Perry to be added to the email list.

Links: NIH, Stanford Grant Writing Academy

Contacts: Peds ORD

The NIH provides funding (referred as Diversity Supplements) to attract trainees and faculty from underrepresented groups to research careers. These diversity supplements:

•  
• Work within the scope of the original NIH-supported grant project. The Principal Investigator must hold NIH research grants (R01, P01, etc.) with remaining support, usually two years or more.
•  
• Support Graduate Student and Postdoctoral Scholars / Fellows as well as other career stages from underrepresented groups (see more information below and PA-20-222)
•  
• Receive administrative review instead of peer review
•  
• Provide salary support for named candidates that are citizens or non-citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence in the United States (i.e., in possession of a Permanent Resident Card, Form I-551

Find more detailed information visit:  NIH and the Stanford Grant Writing Academy.

Links: NIH Matchmaker, How to use Matchmaker, Role of the Program Officer, What to say and not to say to PO, When and how to contact a PO

Contacts: Peds ORD

The Program Officer (PO) is the NIH official who guides the programmatic and scientific aspects of grants and grant programs. This person is your point of contact before you submit an application and after your application is reviewed, including funding decisions. A PO has a portfolio of grantees, and has input on which applications ultimately receive funding. The PO is an applicant’s point of contact for questions about:

• appropriate topics for an application
• programmatic interest in funding specific research
• activity codes and mechanisms for funding
• your score and summary statement from an application that has undergone peer review

The PO cannot give feedback on the scientific merit or competitiveness of your proposal. 

Links: Find an SRO, Role of the SRO

Contacts: Peds ORD

The Scientific Review Officer (SRO) is the Designated Federal Official for peer review meetings at the NIH. The SRO identifies appropriate reviewers, creates the list of applications to discuss, and is in the room during discussion to provide a summary for your application. The SRO is the applicant’s point of contact from the time you submit your application until the time of the review meeting. You can address review-related questions or concerns to your SRO, including:

• completeness of your application and allowable post-submission materials
• roster of attendees for the meeting at which your application will be reviewed
• general questions about the review process and timeline

SRO's cannot address what specific scientific content should be in your application, what your summary score means, or whether you will get funded.

Links: Search Study Sections, Peer Review Video, Mock Study Section Video

Contacts: Peds ORD

At NIH, application reviews are organized by the Center for Scientific Review (CSR) which consists of Integrated Review Groups (IRGs). Each IRG represents a cluster of study sections around a general scientific area. Applications generally are assigned first to an IRG, and then to a specific study section within that IRG for evaluation of scientific merit.

Study sections primarily consist of an NIH staff Scientific Review Officer (SRO) and invited Reviewers. The SRO identifies appropriate reviewers, creates the list of applications to discuss, and summarizes the discussion of each application. Reviewers give preliminary scores for all applications that define those that will or won't be discussed. Only those that are discussed will potentially be funded. 

You can visit the CSR website below to look at study section rosters and use the Assisted Referral Tool to guide your application to the appropriate section.

Links: Download ESI Infographics, FAQ

Contacts: Peds ORD

NIH defines Early Stage Investigator (ESI, learn more) as a Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a substantial NIH independent research award.  Download ESI Infographics. FAQ. 

See list of NIH grants that a PD/PI can hold and still be considered an ESI. 

What is the benefit of having an ESI status? ESI applications with meritorious scores will be prioritized for funding by the institute or center receiving the application. Each NIH Institute/Center have slightly different policies. 

How can I check if I have an ESI status? Check the Education section of your eRA Commons profile. ESI status is determined automatically by functionality built into eRA Commons. The status is based on the investigator’s record of receiving NIH grants and the completion date of his/her terminal research degree or the completion of post-graduate clinical training entered into the eRA Commons personal profile.

How can I request an extension of my ESI eligibility? Investigators request an extension of their ESI eligibility directly through eRA Commons via an ESI Extension request button in the Education section of their personal profile. For step-by-step instructions, review the video tutorial ESI Status Extension Request on the eRA Videos page. 

Can ESI status be extended due to birth of child? Yes. NIH will approve an ESI extension of one year for childbirth within the ESI period (read NOT-OD-18-235). PDs/PIs must provide the child’s date of birth in the extension request justification on the NIH Extension portal. If an individual has multiple children during the 10 year ESI period, the automatic 12 month extension would be applied to each childbirth. See FAQ. 

Can ESI Status Be Extended Due to Disruptions From COVID-19? Yes. Be sure to describe the nature of the disruption to your research in your ESI extension request. We suggest you submit the request once you know how much research time was lost, unless your upcoming application deadline is imminent and an ESI extension is urgently needed. In this case you would be able to submit another extension once you know the full extent of the time lost.  ESI extension submission instructions may be found here.

Links: Peds PI Waiver & Eligibility, RMG PI Waiver, PI Waiver Toolkit

Contacts: Peds ORD, Division Manager

The School of Medicine has restrictions on the type of award you can receive based on your title and position. Refer to the links below for updated guidance on your PI Waiver Eligibility.

Note: The Department of Pediatrics requires that all PI Waivers are submitted at least 4 weeks in advance of the proposal deadline.

Links: SeRA, Introduction to SeRA

Contacts: Peds ORD, ORA

The Stanford Electronic Research Administration System (SeRA) supports research administration at Stanford. It tracks the stages of the research project lifecycle from initial proposal to award closeout enabling investigators and staff to effectively manage their projects.

Anyone with an active SUNet ID can access SeRA to initiate a Proposal Development Routing Form (PDRF), the School of Medicine Proposal Intake Form (PIF), and access records that they have previously initiated or been added to by another user.

More information and a user guide can be found here.

You can also submit a help ticket within SeRA for further assistance.

Links: PIF Toolkit

Contacts: Peds ORD

The Proposal Intake Form (PIF) is part of SeRA, a system used to track research projects at Stanford. A PIF is an electronic form used to communicate upcoming grant submission to RMG so that all elements of the application can be completed and submitted on time. 

Note: RMG requires submitting a PIF at least 30 days prior to proposal due date.

Do I need a PIF?

Are you submitting a non-fellowship award (NIH K, R, etc.)? Yes. Complete the Proposal Intake Form (PIF) using the required information outlined here.

Are you submitting a fellowship award (NIH F32 or Foundational fellowship)? No. Complete the SOM Post-Doc Fellowship instead.

Are you submitting an industry-sponsored clinical trial? No. Complete the Study Activation Form instead.

Links: SoM Fellowship Guide, Fellowship Checklist, SeRA

Contacts: 

Angela Au, Assistant Director, Fellowships  

Jonathan Gagante, Fellowship Research Process Manager associate 

Yes if you are a postdoc or subspecialty clinical fellow applying for fellowship. 

PDRF is done via Stanford’s Electronic Research Administration (SeRA). The PDRF documents the approvals required (department, Mentor, Institutional Official, etc.) for proposal review and endorsement by Stanford. 

How do I submit a PDRF? Follow the SoM Fellowship Guide and the Fellowship Checklist. 

When to submit a PDRF? A PDRF should be completed at least 5 business days prior to the proposal deadline to the Research Management Group (RMG). 

In order to ensure both institutional and sponsor compliance, Research Management Group (RMG) has internal deadlines for all grants, contracts, subcontracts, and fellowships. It is important to adhere to these requirements so that the complex budget and formatting requirements are met  as well as all institution-required documents. It is recommended to talk with your RPM a couple of weeks prior to discuss their schedules and determine the final day to receive all sections of the application.

At 30 days from Sponsor Deadline:

• Submit Proposal Intake Form (PIF) to RMG through SeRA.

At 5 Business Days from Sponsor Deadline, your RPM should be able to review:

• Administrative sections of the application (with the exception of the research plan)
• Approved internal budget and budget justification
• Applicable waiver approvals
• Subaward budget(s) and budget justification(s)

At 3 Business Days from Sponsor Deadline, your RPM should be able to review:

• Proposal Development Routing Form (PDRF) approved by all participating faculty
• PDRF approved by department Manager or designee (if cost-sharing &/or space approval required)
• Application Research Plan

The Office of Research Administration provides useful templates and resources for building successful budgets and budget justifications. 

The Research Management Group (RMG) also provides templates and resources for budget and budget justifications.

Stanford Institutional Facts have to be entered into your application. The Office of Research Administration (ORA) for Stanford has collected a detailed list of these for convenience. 

Links: Stanford Research and Development Office (SRDO), Stanford Core Facilities, Spectrum, Stanford Cancer Institute, Stanford Pediatrics Facilities & Resources  (Coming Soon)

Contacts: Peds ORD

Stanford's facilities and resources are expansive and change from year to year. Adapting previous drafts of these documents to your current proposal requires checking that the statements are accurate and up-to-date.

If starting from scratch, we recommend going first to the NIH websites (NIAID and SF424) to understand the specific requirements of these documents.

To populate this section with your application's relevant resources, above are several helpful collections of Stanford Facilities and Resources which can be tailored to your application:

If you are unsure what facilities and resources are available to you, contact your division chief.

Links: Cardinal Curriculum

Contacts: Peds ORD

Yes, Stanford has two certificate programs for research administrators. Cardinal Curriculum Level 1 provides a foundation in research administration and Cardinal Curriculum Level 2 delves into specific details of managing the financial aspects of research and research administration. The Office of Research Administration also has a ”how to” webinar series focused for research administrators.

Links: Peds PI Waiver & Eligibility, RMG PI Waiver, PI Waiver Toolkit

Contacts: Peds ORD, Division Manager

The School of Medicine has restrictions on the type of award you can receive based on your title and position. Refer to the links below for updated guidance on your PI Waiver Eligibility.

Note: The Department of Pediatrics requires that all PI Waivers are submitted at least 4 weeks in advance of the proposal deadline.

Links: SeRA, Introduction to SeRA

Contacts: Peds ORD, ORA

The Stanford Electronic Research Administration System (SeRA) supports research administration at Stanford. It tracks the stages of the research project lifecycle from initial proposal to award closeout enabling investigators and staff to effectively manage their projects.

Anyone with an active SUNet ID can access SeRA to initiate a Proposal Development Routing Form (PDRF), the School of Medicine Proposal Intake Form (PIF), and access records that they have previously initiated or been added to by another user.

More information and a user guide can be found here.

You can also submit a help ticket within SeRA for further assistance.

Links: PIF Toolkit

Contacts: Peds ORD

The Proposal Intake Form (PIF) is part of SeRA, a system used to track research projects at Stanford. A PIF is an electronic form used to communicate upcoming grant submission to RMG so that all elements of the application can be completed and submitted on time. 

Note: RMG requires submitting a PIF at least 30 days prior to proposal due date.

Do I need a PIF?

Are you submitting a non-fellowship award (NIH K, R, etc.)? Yes. Complete the Proposal Intake Form (PIF) using the required information outlined here.

Are you submitting a fellowship award (NIH F32 or Foundational fellowship)? No. Complete the SOM Post-Doc Fellowship instead.

Are you submitting an industry-sponsored clinical trial? No. Complete the Study Activation Form instead.

Links: SoM Fellowship Guide, Fellowship Checklist, SeRA

Contacts: 

Angela Au, Assistant Director, Fellowships  

Jonathan Gagante, Fellowship Research Process Manager associate 

Yes if you are a postdoc or subspecialty clinical fellow applying for fellowship. 

PDRF is done via Stanford’s Electronic Research Administration (SeRA). The PDRF documents the approvals required (department, Mentor, Institutional Official, etc.) for proposal review and endorsement by Stanford. 

How do I submit a PDRF? Follow the SoM Fellowship Guide and the Fellowship Checklist. 

When to submit a PDRF? A PDRF should be completed  at least 5 business days prior to the proposal deadline to the Research Management Group (RMG). 

Links: RMG Best Practices

Contacts: Peds ORD

In order to ensure both institutional and sponsor compliance, Research Management Group (RMG) has internal deadlines for all grants, contracts, subcontracts, and fellowships. It is important to adhere to these requirements so that the complex budget and formatting requirements are met  as well as all institution-required documents. It is recommended to talk with your RPM a couple of weeks prior to discuss their schedules and determine the final day to receive all sections of the application.

At 30 days from Sponsor Deadline:

• Submit Proposal Intake Form (PIF) to RMG through SeRA.

At 5 Business Days from Sponsor Deadline, your RPM should be able to review:

• Administrative sections of the application (with the exception of the research plan)
• Approved internal budget and budget justification
• Applicable waiver approvals
• Subaward budget(s) and budget justification(s)

At 3 Business Days from Sponsor Deadline, your RPM should be able to review:

• Proposal Development Routing Form (PDRF) approved by all participating faculty
• PDRF approved by department Manager or designee (if cost-sharing &/or space approval required)
• Application Research Plan

Links: ORA, RMG

Contacts: Peds ORD

Are you a Postdoctoral or Subspecialty Fellow?

Yes. Contact Allison Guerin in the Office of Pediatric Education

No. Contact your Finance Department within your Division.

The Office of Research Administration provides useful templates and resources for building successful budgets and budget justifications. 

The Research Management Group (RMG) also provides templates and resources for budget and budget justifications.

Links: Stanford Institutional Facts

Contacts: Peds ORD

Stanford Institutional Facts have to be entered into your application. The Office of Research Administration (ORA) for Stanford has collected a detailed list of these for convenience.

Links: Stanford Research and Development Office (SRDO), Stanford Core Facilities, Spectrum, Stanford Cancer Institute, Stanford Pediatrics Facilities & Resources 

Contacts: Peds ORD

Stanford's facilities and resources are expansive and change from year to year. Adapting previous drafts of these documents to your current proposal requires checking that the statements are accurate and up-to-date.

If starting from scratch, we recommend going first to the NIH websites (NIAID and SF424) to understand the specific requirements of these documents.

To populate this section with your application's relevant resources, above are several helpful collections of Stanford Facilities and Resources which can be tailored to your application:

If you are unsure what facilities and resources are available to you, contact your division chief.

A Material Transfer Agreement (MTA, learn more) is used to effect the transfer of research materials from one entity to another.  The materials may range from biological materials to chemical compounds to equipment. An MTA is used in two instances:

1. When you are receiving material at Stanford from another entity.  Typically, the entity sending out the material will prefer to use its own MTA. Incoming MTAs process & intake forms.

2. When you are transferring material from Stanford to another entity.  Outgoing MTAs process & intake forms. 

MTAs are not always necessary. The University encourages researchers to share biomedical and other laboratory research materials without agreements, when possible.  A number of other research institutions have agreed to share research materials either without an agreement or using a standard MTA whenever possible. Please see the memo from Stanford's Vice Provost and Dean of Research.

Please note that MTAs are required when:

- Sending or receiving human tissues for research purposes.

- Sending or receiving material created under funding from the California Institute of Regenerative Medicine (CIRM).

- Sending or receiving materials other times when an MTA is legally required, for example, sending out materials received under an MTA.

Once the MTA Intake Form  is submitted the Industrial Contracts Office will be in touch.

A Data Use Agreement (DUA, learn more) is a contract that governs the exchange of specific data between two parties. DUA’s establish who is permitted to use and receive a unique data set, along with the allowable uses and disclosures of the data by the recipient.  A DUA also assigns appropriate responsibility to the researcher and recipient for using the data.

Common terms of a DUA provide that the recipient will:

- not use, disclose, or destroy the data set other than as permitted by the DUA, or as required by law;

- use appropriate administrative, technical, and physical safeguards to prevent unauthorized uses or disclosures of the data set, including specific data transfer/access/disposition instructions;

- report to the provider any uses or disclosures of the data set that are in violation of a DUA;

- ensure that anyone to whom it provides the data set agree to the same requirements that apply to the recipient for receiving or accessing the data; and

- not re-identify or contact the data subjects (for data related to a human subject).

Use the Data Use Agreement decision tree!

- DUA with government or non-profit entities are handled by the Office of Sponsored Research (OSR) Pre-Award Team. Submit a request by emailing osr_intake@stanford.edu the OSR Data Use Agreement Request form. Agreements for data associated with a sponsored project are handled by your OSR Contract & Grant Officer (In Dept of Pediatrics contact Allison Ramos and Sarah Makarchuk). Agreements not associated with a specific sponsored project are handled by your OSR Business Contract Officer (In Dept of Pediatrics contact Neil Morimoto).

- DUA with industry should be sent to the Industrial Contracts Office.

- DUA to purchase or store data are handled by the Procurement Office.

Additional guidance for Faculty on Data Agreements: Memo from Ann Arvin dated February 5, 2015.

NIH requests pre-award materials at Just-in-Time (JIT). This is typically time sensitive information that was not submitted as part of the application. Often there is little time to respond to these requests completely; for example, human subjects or vertebrate animal protocol approval can take a substantial amount of time. If there is not enough time to provide all JIT information by the deadline provided, NIH may issue awards with restrictions. This practice has become more and more common. RMG must hold these awards until the restriction is removed and causing delays in the release of funding. Other sponsors will simply hold the award until they have received all protocols and required approvals. For NIH JIT requests, the sponsor requires submission of documents only following an email request from the appropriate Grants Management Specialist (GMS). NIH advises recipients: do not to respond to automated messages sent by eRA Commons or to JIT hyperlinks that appear automatically in eRA Commons without receiving an e-mail from the GMS.

These can include:

- IACUC Protocol Approval for Animal Research

- IRB Protocol Approval for Human Subjects Research

- Scientific Review Committee (SRC) Protocol Approval for Cancer Center Research

- Stem Cell Research Oversight (SCRO) Protocol Approval

- Current & Pending Support (Other Support)

- Revised Budget

Please visit the RMG JIT website for specific actions on these JIT documents.

The distinction between a subaward or subrecipient and a subcontract is grant terminology that every applicant should be familiar with.  Please visit the Definitions and Classifications website at OSR for further clarification. In general,

A subaward, by the federal government’s guidance:

- must comply with award requirements;

- must use funds to carry out program activities for the PI; and

- makes programmatic decisions.

A subcontract, on the other hand:

- provides goods and services “that are ancillary” to program operations;

- is not subject to compliance requirements of the grant; and

- represents a distant, or vendor-like relationship to the research program.

Links: Subaward Toolkit

Contact: 

Inclusion of a Subaward in a proposal is a significant undertaking and should be commmunicated in the PIF to RMG at least 30 days prior to the sponsor's due date. Both NIH and RMG require detailed information about any collaboration with investigators at other institutions. These documents take time to gather, especially from institutions outside of the US, so it is best to start these early and discuss with your RPM. 

The following is a typical list of these documents:

- Letter(s) of Support from all key subaward personnel

- NIH-formatted Biosketches from all key subaward personnel

- A Statement of Work from the subaward institution

- A Budget Justification for subaward funds

- Subaward Facilities & Other Resources

- Subaward Equipment

- Subrecipient Committment Form (OSR Form 33)

After Stanford University accepts an award and establishes a financial account (PTA), the PI or his/her authorized administrator may submit a requisition to issue a Subaward.  Stanford Principal Investigators or designees may not authorize a Subrecipient to begin working until OSR fully executes the Subaward agreement.

Complete the following steps for review by OSR:

1. Submit a request to issue a Subaward by processing a requisition through Oracle iProcurement

2. Attaches required Subaward documents to the requisition including the statement of work, budget, budget justification, and Subrecipient Commitment Form (OSR Form 33)

During the Closeout process the awarding agency determines whether all applicable administrative actions and all work required as a condition of the award have been completed by the award recipient.

For most grants and contracts, the final technical and financial reports must be submitted within a 90-day period following the grant or contract end date. NIH and NSF allow 120 days. For non-federal awards (i.e. state, industry, non-profits), the closeout procedures vary, depending on the policies of the sponsor. The sponsor will clarify terms and conditions (T/C) for Closeout in the award or agreement.  In addition to the technical and financial reports, sponsors may have other requirements, e.g., NIH requires a Final Invention Statement.

If you are nearing the end date/Closeout period of the grant or contract and need more time to complete your research, submit a no-cost extension request to your Research Process Manager (RPM) well in advance of the end date.

A detailed How-to and other resources can be found at the RMG Closeout website.

A no-cost extension (NCX, learn more) extends the project period beyond the project end date, at no cost to the sponsor, to give the PI some additional time to complete project work. There is no additional funding, as the phrase "no cost" suggests. A no-cost extension should be requested from the sponsor at least 60 days before the award end date, when all four of the following conditions are met:

- No term of the award specifically prohibits the extension

- Funds are left in the project budget

- There is a programmatic need

- The project's originally approved scope will not change

Some federal sponsors, like the National Institutes of Health, have given authority to Stanford to approve a one-time no-cost extension of grants. These internal requests must be made at least 30 days in advance of the project end date. These extensions, although approved by Stanford University, must still be requested by the PI and the sponsor must be notified. They do not happen automatically! In fact, some agencies are now looking at reducing or even eliminating the approvals of no-cost extensions.

Request a No Cost Extension by submitting a Central Office Request in SeRA

Request a No Cost Extension for projects hindered by COVID-19

Once the No Cost Extension is submitted a Research Process Manager in the Research Management Group will be in touch.