Grant Administration

Upcoming Changes to the Biographical Sketch and Other Support Format Page

Updated biosketch format page, other support format pages and instructions are available for use in applications, Just-in-Time (JIT) Reports, and Research Performance Progress Reports (RPPRs) due on/after May 25, 2021. Full details are available in NOT-OD-21-073 and NOT-OD-21-110. Below are highlights of significant changes.

Effective Date

• NIH expects applicants and recipients to use the updated biosketch and other support format for applications, Just-in-Time (JIT) Reports, and Research Performance Progress Reports (RPPRs) as of May 25, 2021.
• During the transition to the new Biosketch format, NIH will not withdraw applications that include the previous Biosketch format. Beginning with applications submitted on or after January 25, 2022, failure to follow the appropriate Biosketch format may cause NIH to withdraw your application from consideration.
• As a normal matter of business, NIH will incorporate the changes into the NIH Application Form Instructions within the next forms update by FY 2022.

Changes to Other Support

• The format page has been re-organized to separate funded projects from in-kind contributions.
• Signature block added, for Program Director/Principal Investigator or Other Senior/Key Personnel to certify the accuracy of the information submitted. Each PD/PI or senior/key personnel must electronically sign their respective Other Support form as a PDF prior to submission.
• Supporting documentation, which includes copies of contracts, grants, or any other agreement specific to senior/key personnel foreign appointments and/or employment with a foreign institution for all foreign activities and resources that are reported in Other Support. If the contracts, grants, or other agreements are not in English, recipients must provide translated copies.
• Immediate notification of undisclosed Other Support.
  • When a recipient organization discovers that a PI or other Senior/Key personnel on an active NIH grant failed to disclose Other Support information outside of Just-in-Time or the RPPR, as applicable, the recipient must submit updated Other Support to the Grants Management Specialist named in the Notice of Award as soon as it becomes known.

Changes to Biosketch

(Specific changes are below, in bold italics)

Section A

Section A. Personal Statement updated to read:

Briefly describe why you are well-suited for your role(s) in this project. Relevant factors may include: aspects of your training; your previous experimental work on this specific topic or related topics; your technical expertise; your collaborators or scientific environment; and/or your past performance in this or related fields, including ongoing and completed research projects from the past three years that you want to draw attention to (previously known as research support).

Section B

Section B ‘Positions and Honors’ has been renamed ‘Positions, Scientific Appointments, and Honors’.

Section B. Positions, Scientific Appointments, and Honors updated to read:

List in reverse chronological order all positions and scientific appointments both domestic and foreign, including affiliations with foreign entities or governments. This includes titled academic, professional, or institutional appointments whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary). High school students and undergraduates may include any previous positions. For individuals who are not currently located at the applicant organization, include the expected position at the applicant organization and the expected start date.

Section D

• Section D is solely present on the fellowship version of the Biosketch, and no longer includes research support, only Scholastic Performance.
• For the non-Fellowship Biosketch, Section D. has been removed.
• For the Fellowship Biosketch, Section D has been updated to remove ‘Research Support.’

Resources

Updated Biosketch resources, including FAQs and sample Biosketch format pages can be found here.

Updated Other Support resources, including FAQs and sample Other Support format pages can be found here.

A member of the Grants team is here and ready to help both seasoned and new investigators with proposal review and submission. Early contact to a member of the Grants team is advised to ensure appropriate time to review the agency funding announcement and to ensure each proposal is in optimal position to be submitted by the deadline. At minimum, and in accordance with FIN – 049.0 - Research Agreements, Applications and Proposals for Extramural/Sponsored Project Funds, the financial and administrative portions of the application should be submitted to the Grants team at least five (5) working days prior to the submission deadline.

Investigators at CHLA are recommended to check the Research Funding Opportunities webpage, which is updated regularly to reflect:

• Intramural Funding Opportunities
• Private Funding Opportunities
• SC CTSI Pilot Research Funding
• USC Funding Opportunities
• USC Research Awards
• National Institutes of Health

Funding opportunities for all other federal sponsor agencies can be found here.

NIH Career Development ("K") Awards provide support for individuals who have demonstrated independent research accomplishments and need additional experience to establish or sustain an independent research program. Career Development Awards may be mentored or non-mentored. Individual mentored K awards (K01, K07-developmental, K08, K22, K23, K25, K99/R00) provide support for a sustained period of "protected time" (generally three, four, or five years) for intensive research career development under the guidance of an experienced mentor or sponsor in the biomedical, behavioral, or clinical sciences. Independent (non-mentored) K awards (K02, K05, K07-leadership, K24) provide protected time for scientists who demonstrate the need for a period of intensive research focus as a means of enhancing their research careers. Independent K awards are intended to foster the development of outstanding scientists and to enable them to expand their potential to make significant contributions to their field of research.

Concurrent Salary Support For K Award Recipients

In accordance with the NIH Grants Policy Statement, mentored K awardees (K01, K07, K08, K22, K23, K25), as well as individuals mentored through institutional awards (K12, KL2) are required to devote a minimum commitment equivalent of nine (9) calendar person months (75% of their full-time appointment at the applicant institution) which is charged to the K award.

Mentored K awardees are not eligible to receive concurrent salary support from other research projects, except during the last two (2) years of a mentored K award. The awardee may be eligible to receive concurrent salary support from a concurrent research project once they have competed successfully for a peer-reviewed research award from NIH or any federal agency. As outlined in the NIH Grants Policy Statement (12.3.6.2 Concurrent Support), to be eligible for salary support from peer-reviewed research awards from any federal agency, all three (3) of the following requirements must be met:

• The K award recipient must be one of the named PIs on a competing NIH research grant application (R01, R03, R15, R21, R34, or equivalent application from another federal agency) or a sub-project director on a competing multi-component research or center grant or cooperative agreement application (P01, P50, U01, or an equivalent application from another federal agency)
• The K award must be active when the competing research grant application is submitted
• The K award must be in its final two years before the reduction in effort to six (6) person-months (50% full-time professional effort) is permitted

Non-mentored K (K02, K05, K07, K24) awardees are allowed to charge effort and salary to federally funded projects as defined by the NIH Grants Policy Statement, 12.3.6.3. Generally, a non-mentored awardee may receive additional salary support from other NIH/PHS grants for effort above that required for the K award and there are no limitations to receiving other salary support. However, K02 recipients may not receive salary from other NIH/PHS grants.

To ensure all appropriate salary reimbursements are captured, CHLA will review each K award on its own merits. It is CHLA's responsibility to verify charges to grants are allowable, allocable, and appropriate according the NIH Grants Policy Statement and federal regulations.

As with any agency guidelines, the awarding agency may grant exceptions to the policies and guidance provided by NIH. At the time of the just-in-time award, Grants team will work with the K awardee and their mentor to request any necessary changes to the NIH policy. This may include the need to request approval of effort and/or salary on federal peer-reviewed grant when the K awardee is not in the last two years of their project.

Gifts vs. Grants

Both sponsored and donor-funded activities are externally-supported projects, and the classification of funding as "gift" or "sponsored" will affect, among other things, the way CHLA accounts for the funds, assesses F&A (indirect) costs, and reports on the use of the funds to the sponsor or donor.

Foundation Grants

The CHLA Office of Foundation Relations (OFR) can work with PIs to develop and shepherd grants foundation organizations. Once the PI has decided to submit the grant, the CHLA OFR office should be notified. The division analyst will work directly with the OFR on proposal documents as per the agency’s guidelines/announcement. All applications submitted by the OFR must first be reviewed and approved by the Grants team.

Grants

Grants are sponsored projects that are typically awarded to CHLA in response to a detailed statement of work, usually supported by a project schedule and a line-item budget, both of which are essential to financial accountability. The purpose of a grant is to transfer money or anything of value to a recipient in order to accomplish a public purpose. Grants can support research, training and educational activities, travel, and conferences. Research Operations must review all sponsored projects grant applications and proposal submissions prior to submission to the agency.

Sponsored project grants typically include:

• a line-item budget including indirect costs
• a detailed scope of work or specific aims
• a specified period of performance
• a requirement to return any unexpended funds at the end of that period
• regular financial reporting and audit
• terms and conditions for the disposition of tangible properties, such as equipment, technical reports) or intangible properties, such as publication rights, inventions

Gifts

A gift is an in-kind contribution given to CHLA by a donor with no expectation of benefit other than the hospital expending the contribution for any mutually-agreed upon purposes.

A gift typically has the following characteristics:

• no contractual requirements
• no deliverables to the donor (though the funds may be restricted to a particular purpose)
• irrevocable
• no specified period of performance
• no formal fiscal accountability to the donor beyond periodic progress reports

Government funds are never treated as gifts. Funding from voluntary health organizations or associations are sponsored projects and not gifts. In remaining cases, when funding is being provided by corporations or foundations, the distinction between gifts and sponsored projects will be made based on the proposal, statement of work, and terms of the agreement, taking into consideration the intent of the donor or sponsor. Sometimes, donors may use the word "grant" and "gift" interchangeably.

Limited Submissions are funding opportunities that restrict the number of applications from qualified institutions. Research Operations will post opportunities on this page as they become available.

Current Limited Submission opportunities:

Any investigator interested in a limited submission proposal must submit a pre-application packet to the Grants team at TSRIPreAward@chla.usc.edu once they determine intent to submit an application. Pre-applications must include a short (2-3 page) project description and the PI’s CV or bio sketch. An internal committee comprised of research faculty and the Chief Scientific Officer will review the pre-applications and select the best qualified applicant(s). The committee will communicate results of the selection process to both the investigators and Research Operations. Selected investigators are then responsible for submitting a full proposal to the Grants team one week prior to the agency deadline for final review and submission.

For additional limited submission opportunities, please visit the USC Limited Opportunities website.

The Grant Identifications Number is also commonly referred to as Assignment Number, Application Number, or the Award Identification Number, depending on its processing status. The identification number consists of several parts, each having a distinct meaning. The following example highlights each part of the award identification number.

For a complete description of Activity Codes, Organizational Codes, and definitions used in extramural programs, see the NIH website.

Example: 3 R01 CA12345-02S1A1

 NIH Grants ID Numbers System

Application Type     3

Activity Code           R01

Awarding Office       CA

Serial Number          12345

Grant Year               -02

Other                       S1A1

 Other helpful NIH information available at https://grants.nih.gov/grants/oer.htm

Personnel definitions

Principal Investigator (PI, also referred to as Program Director or Project Director) - The one individual designated by the applicant organization to direct the project or program to be supported by the grant. The PI is responsible and accountable to the applicant organization officials for the proper conduct of the project or program.

Co-Investigator (Collaborator) - An individual involved with the principal investigator in the scientific development or execution of the project. These individuals typically devote a specific percent of effort to the project and are identified as key personnel. The individual(s) may be employed by, or affiliated with, the grantee organization or an organization participating in the project under a consortium or contractual agreement.

Consultant - An individual who provides professional or highly technical advice or assistance to the hospital, over which the hospital controls the results but not the manner in which the service is performed. A consultant has measurable effort and is not normally an employee of the organization receiving the services. A consultant may also be a firm or an individual who is an established consultant and the services are provided on the basis of a written agreement for a fee.

Key Personnel - In addition to the principal investigator, Key Personnel are defined as individuals who contribute in a substantive, measurable way to the scientific development or execution of the project, whether or not salaries are requested. Typically, these individuals have doctoral or other professional degrees.

Other Significant Contributors - This category identifies individuals who have committed to contribute to the scientific development or execution of the project, but are not committing any specified measurable effort to the project. These individuals are typically presented at zero percent effort or as needed. A biosketch, including research support information, will be required for these individuals as this highlights their accomplishments as scientists. However, if an award is to be made, other support information will not be required or accepted for other significant contributors since considerations of overlap do not apply to these individuals. Should the level of involvement change for an individual listed in this category, they should be re-designated as Key Personnel.

Subrecipient vs. Vendor

U.S. Office of Management and Budget (OMB) Circular A-133 and Circular A-81 require awarding entities to determine whether an arrangement resulting from a particular award the awarding entity makes to another organization creates a subrecipient or vendor relationship between the awarding entity and that organization. The OMB defines the terms “vendor” and “subrecipient” and provides guidance for distinguishing between the two relationships. Please refer to the “Subrecipient vs. Vendor” section for detailed information.

Subrecipient/Subcontractor

An entity that expends awards received from a pass-through entity to carry out a project. According to A-133 and A-81, a subrecipient relationship exists when funding from a pass-through entity is provided to perform a portion of the scope of work or objectives of the pass-through entity’s award agreement with the awarding agency. A pass-through entity is an entity that provides an award to a subrecipient to carry out a project.

Subrecipients/subcontractors generally:

• Determine who is eligible to receive financial assistance, and which specific type of federal assistance is to be distributed.
• Have its performance measured against whether it meets the objectives of the project.
• Have responsibility for programmatic decision making.
• Have responsibility for adherence to applicable program requirements.
• Subrecipients use funds to carry out a project of the organization as compared to providing goods or services for a project of the awarding entity.

Vendor

A vendor is generally a dealer, distributor or other seller that provides, for example, supplies, expendable materials, or data processing services in support of the project activities. A vendor provides generally acquired goods or services related to the support of the prime award.

Vendors generally:

• Provide goods and services within normal business operations.
• Provide similar goods or services to many different entities.
• Operate in a competitive environment.
• Provide goods and services that are ancillary to the operation of the project.
• A Vendor is not subject to compliance requirements of the project.

Please also refer to this checklist, developed by the Federal Demonstration Partnership Subcontracts Committee, to help determine when an entity is a subrecipient or a vendor.

As a component of the reporting process to the sponsoring agency, progress reports are typically required for all awards. The reporting requirements for an agency are generally listed in the program announcement, the agency’s polices and guidelines, notice of grant award, or sponsored research agreement. The Grants team must review and approve all progress reports prior to submitting to the agency.

NIH Awards

Progress reports usually are required annually as part of the non-competing continuation award process.  NIH may require these reports more frequently. Refer to the notice of award (NOGA or NOA) for reporting requirements. The “Non-Competing Continuation Progress Report” (PHS 2590) or equivalent documentation (e.g., Research Performance Progress Report [RPPR]) must be submitted to, and approved by, NIH to non-competitively fund each additional budget period within a previously approved project period (competitive segment). Except for awards subject to Streamlined Non-Competing Award Process (SNAP), the progress report includes an updated budget in addition to other required information.

The RPPR is a federal wide format for the submission of required annual or other interim performance reporting on grant and cooperative agreement awards. NIH now requires use of the RPPR module in eRA Commons to submit all annual progress reports. NIH continues development of the RPPR for final progress reports and for administrative extensions (Type 4s; e.g., SBIR/STTR Fast-Track Phase II application) and will update the community as progress is made.

NIH Progress Report Deadline

Streamlined Non-Competing Award Process (SNAP) RPPRs are due approximately 45 days before the next grant year budget period start date. Non-SNAP RPPRs are due approximately 60 days before the next grant year budget period start date. Multi-year funded (MYF) RPPRs are due annually on or before the anniversary of the budget/project period start date of the award. The exact start date for a specific award may be found in grants status in eRA Commons.

A report of all progress reports due for an organization is available at here (CHLA’s IPF Number is 1520001).

NIH RPPR Progress Reports

Route the completed RPPR to the Grants analyst by selecting an Authorized Signing Official. Use the validation button in the RPPR application to ensure there are no errors in the application prior to submitting it to Grants.

Almost without exception, a change in scope of work requires a prior approval from the sponsoring agency.

In general, the Principal Director (PD)/Principal Investigator (PI) may make changes in the methodology, approach, or other aspects of the project objectives. However, a change in scope almost always requires sponsor approval unless special permission is given within the award agreement. A change in scope is a change in the direction, aims, objectives, purposes, or type of research training, identified in the approved project.

Actions likely to be considered a change in scope or objectives include, but are not limited to, the following:

• Change in the specific aims of the project and approved at the time of award
• Substitution of one animal model for another
• Any change from the approved use of animals or human subjects
• Shifting the emphasis of the research from one disease area to another
• Applying a new technology, or changing assays from those approved to use of a different type of assay
• Transferring the performance of substantive programmatic work to a third party by contract or any other means
• Change in key personnel whose expertise is critical to the approved project
• Significant re-budgeting whether or not it requires approval under rules governing budget changes. Significant re-budgeting occurs when the cumulative amount of transfers among direct cost categories for the current budget period exceeds either 25 percent of the total amount awarded or $250,000, whichever is less
• Incurrence of patient care costs not previously approved and/or when a grantee desires to re-budget funds out of the patient care category
• All requests for prior approval must be in writing, well-justified, and accompanied by supporting documentation to ensure that changes are reasonable and appropriate. The written requests have to be submitted to Grants to be reviewed and submitted.

To obtain sponsor approval, the PI must draft a justification letter on institutional letterhead. The letter must be signed by the division head and forwarded to the assigned Grants analyst.

Occasionally, it is necessary to change the Principal Investigator (PI)/Project Director (PD) or key personnel of an awarded grant or contract. This may be the result of a PI withdrawing completely from a project or taking a leave or sabbatical for a continuous period of three (3) months or more.

Most federal sponsors require the grantee to notify them prior to any changes with the PI or other key personnel named in the notice of award, as well as approval of any alternate arrangement to the PI or other key personnel proposed by the grantee before such changes can be implemented. Divisions should refer to the terms and conditions of the award to determine if the sponsor will allow the award to be retained in the absence of the original PI. Generally, sponsors reserve the right to terminate a grant if approval for a leave of absence has not been sought or if the replacement PD/PI or key personnel is not acceptable.

When the sponsor requires prior approval, such requests should be sent in writing to the Grants team for review and approval before they are submitted to the sponsor. Contact your Grants analyst for assistance.

Change in Principal Investigator

To request a change in PI/PD, the current PI or division must initiate the request and route it to the Grants team.

A request to a sponsoring agency for designation of a new PI/PD will typically state the reason(s) for such change. The letter should also include a clear outline of the new PI's qualifications to lead the program and accomplish the objectives as outlined in the original proposal. For NIH grants, a strong scientific justification related to the scientific project, including any proposed changes in scope and any budget changes resulting from the proposed change should be included in the letter. Additionally, these items may be required for submission to the sponsor in support of the proposed PI:

Curriculum vitae (CV)

Current and pending support

Letter signed by the department chair justifying the change. Also include a signature block for a CHLA authorized signing official

Submit this letter, plus a Research Conflict of Interest Certification form for the new PI, to the Grants team. Upon receipt of the letter, Grants will submit the request to the sponsor in accordance with their guidelines. Upon sponsor approval for change of PI, Grants will notify all of the appropriate business officials of the change and make necessary updates to all data systems and files.