National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
K12 Physician Scientist Award Program (PSA)
NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
See Section III. 3. Additional Information on Eligibility.
This funding opportunity announcement (FOA) invites applications for the pediatric scientist development program (PSDP). This program constitutes a national network of mentors and scholars, in contrast to K12 programs where the training and mentoring is based solely at a single applicant institution.The PSDP was initiated in response to the need for greater numbers of physician-scientists in pediatric research. The PSDP supports research career development for pediatricians who are in their final stages of subspecialty training and will match them with established senior investigator mentors with strong records of research productivity. The program will develop guidelines for mentoring and career development in order to promote the successful transition to independent research careers in academic settings.
Not Applicable
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| Not Applicable | September 12, 2022 | Not Applicable | November 2022 | January 2023 | April 2023 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Purpose and Background Information
The overall goal of the NIH Research Career Development programs is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation’s biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.
This FOA encourages applications from organizations that propose creative and innovative institutional research career development programs in the mission area(s) of the NIH.
The proposed institutional research career development program may complement other, ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving Federal support.
This Funding Opportunity Announcement (FOA) does not allow appointed Trainees to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor. NIH strongly supports training towards a career in clinically relevant research and so gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged.
This funding opportunity announcement (FOA) invites applications from organizations that propose a creative and innovative research career development program (K12) for pediatric physician scientists. The PSDP constitutes a national network of mentors and scholars, in contrast to K12 programs where the training and mentoring is based solely at a single applicant institution. The program will be responsible for identifying pediatricians in their final stages of subspecialty training and who have promising research potential and matching them with established mentors with a strong record of research productivity and substantial record of successfully training early career investigators. The program will develop guidelines for mentoring and career development in order to promote the successful transition to independent research careers in academic settings. The program will:
- Choose talented scholars with a strong interest in a research-focused career from a diverse pool of pediatric residents and fellows.
- Provide individualized mentored research experiences guided by established mentors from a wide range of subspecialties related to child health.
- Support educational opportunities to enhance the Scholars' expertise in scientific research methodology.
- Facilitate rigorous projects that incorporate the most up-to-date scientific techniques and procedures.
- Offer experience and guidance in grantsmanship and oral and written presentation of research findings.
- Support academic career-development activities that focus on a variety of topics relevant to pediatrician scientist professional development.
Scope of Program
The PSDP program targets clinical fellows and junior faculty in pediatrics, who will be referred to as "Scholars" in the remainder of the FOA. The Scholars supported by the NICHD will train in laboratories and other settings located at research institutions across the country. Scholars will be chosen, after careful consideration of all interested applicants, for entry into the program. The PI will develop procedures to review scholar applications which will include the final approval by a Selection Committee comprised of leaders in academic pediatrics.
Biomedical research and resulting scope of scientific knowledge are increasingly complex and multidisciplinary in nature. Career development activities of the PSDP can be lab-based biomedical, translational, or from a wide spectrum of clinical sciences. The mentors will develop an individualized plan to provide an intensive research experience and complementary educational and career development activities for participating scholars. The duration of training and the transition to the next career stage are important considerations when identifying scholars for potential funding.
Within the framework of the NICHD's longstanding commitment to excellence and the projected need for well-trained pediatric scientists across the country, attention must be given to recruiting prospective scholar candidates from diverse backgrounds, including from groups that have been shown to be nationally underrepresented in academic pediatrics.
This FOA does not allow appointed Scholars to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial led by a mentor.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Renewal
Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
Note: Appointed Trainees are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.
The NICHD intends to fund one award, corresponding to a total of $1.5 million, for fiscal year 2023. Future year amounts will depend on annual appropriations.
Applicants may request direct cost budgets of up to $1.40M per year.
The maximum project period is 5 years.
Other Award Budget Information
Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds.
Salary support for individuals involved in program administration and management must be substantially justified. Salary support for ancillary personnel (e.g. administrative assistance or secretarial support) on CDAs is not allowable.
Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. These expenses must be itemized in the proposed budget.
The PSDP program will provide support for Scholars for periods of up to three years consisting of consecutive 12-month appointments. The number of PSDP Scholars supported by funds from the NICHD shall be no more than 10.
The NICHD will provide total support for each Scholar position of up to $125,000 in direct costs per year. This amount includes salary, fringe benefits, and research and career development expenses as itemized below.
Salary and Fringe Benefits
Scholars may receive up to $100,000 per year for salary and fringe benefits, consistent with the institution's salary scale. Scholars must devote 9 person-months (equivalent to 75 percent) of full-time professional effort toward approved scholar projects or career development activities, with the remaining 25% effort to be determined by the mentor, scholar, and the local subspecialty program director.
The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale from non-federal sources; however, supplementation may not be from federal funds unless specifically authorized by the federal program from which such funds are derived. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the Program.
For effort not directly committed to the K award (e.g., 25%), K recipients may devote effort, with compensation, on Federal or non-Federal sources as PD/PI or in another role, as long the specific aims differ from those of the K award.
Research and Career Development Support
Within each scholar's $125,000 direct cost award, up to $25,000 per year may be allocated for research and career development costs. Allowable research expenses may include 1) research expenses such as supplies, equipment and technical personnel, including expenses generated in the laboratories of the established investigators who serve as mentors; 2) travel to attend the annual PSDP scholar's meeting which may be held at an appropriate professional meeting or at a site chosen by the grantee; 3) travel to receive training or attend scientific meetings; 4) tuition, fees, or books; 5) technical support for data analysis and statistical or computer services. These research and development costs must be related to the Scholar's research activities. They cannot be pooled and used for other programs unrelated or indirectly related to the research activities of individual Scholars.
Items that may NOT be supported with each Scholar's Research and Career Development Support category include:
- Direct support of the laboratories, travel, and research projects of the investigators serving as mentors beyond those expenses directly attributable to the scholar's project
Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.
- Up to $25,000 may be requested for all faculty who are involved in designing, directing, and administering the K12 program. This may include the PD(s)/PI(s) or training director as appropriate to the proposed program. The cost limit applies to all faculty salaries combined.
- Up to $100,000 per year may be requested for administrative, clerical, or other support staff or coordinator with responsibilities directly associated with the institutional career development program. Program expenses may include the support of an administrator focused on new scholar recruitment, application review, and selection. The cost limit applies to all staff salaries combined.
-
Items that may NOT be supported with K12 funds include:
- Travel of the PD(s)/PI(s), or program mentors to scientific meetings other than the annual K12 Scholar's meeting;
- Patient care costs such as inpatient bed days or outpatient visits, except for clinical laboratory analyses essential for the Scholars research;
- Alterations and renovations.
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated rate agreement.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- U.S. Territory or Possession
Other
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
Federal Governments
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.
The applicant institution must have the requisite faculty, staff, and facilities on site to coordinate and direct the proposed national K-12 program.
The applicant institution must have a strong and high quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- Unique Entity Identifier (UEI) A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
- eRA Commons Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day-to-day administration of the program and is responsible for appointing members of the Advisory Committee (when applicable), using their recommendations to determine the appropriate allotment of funds.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
3. Additional Information on Eligibility
Applicant organizations may submit more than one application, provided that each application is programmatically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission. This means that the NIH will not accept:
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, persons with disabilities, and women are encouraged to participate as mentors.
Scholars
Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award.
Scholars must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship requirements are available in the NIH Grants Policy Statement.
Scholars must have an M.D. degree and must have completed a pediatric residency and intend to complete training in one of the pediatric specialties. PSDP Scholars may also have a Ph.D. or other doctoral degree in addition to an M.D.
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
The letter of intent should be sent to:
Karen K. Winer, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6877
Email: winerk@mail.nih.gov
Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424 (R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Substitute the term scholars for all references to trainees in the SF424 (R&R) Application Guide, and substitute the term career development for all references to training in the SF424 (R&R) Application Guide.
Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the career development program, as well as key activities in the training plan. Indicate the plannedduration of appointments, the projected number of scholars including their levels (i.e., predoctoral , postdoctoral , short-term faculty ), and intended trainee/scholar outcomes
The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.
SF424(R&R) Senior/Key Person Profile Expanded
Follow all instructions provided in the SF424 (R&R) Application.
PHS 398 Cover Page Supplement
Follow all instructions provided in the SF424 (R&R) Application.
PHS 398 Training Subaward Budget Attachment(s)
Follow all instructions provided in the SF424 (R&R) Application Guide.
Research and Related (R&R) Budget
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
- Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars.
- Do not complete the section on Participant/Trainee Support Costs.
PHS 398 Research Training Program Plan
The PHS 398 Research Training Program Plan Form is comprised of the following sections:
- Training Program
- Faculty, Trainees, and Training Record
- Other Training Program Sections
- Appendix- Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials.
Follow all instructions provided in the SF424 (R&R) Application Guide.
Applicants should summarize, in the body of the application the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program.
For this FOA, applicants should use the following Data Tables only (data for Scholars should be entered into the Postdoctoral sections of the Data Tables):
Table 5B (Renewal applications only); Table 7 (Renewal applications only); Table 8C, Part I only (Renewal applications only)
Training Program:
Applicants must explain how this program fills a gap in the array of training and mentoring opportunities already available to nascent pediatrician scientists. Describe the pool of faculty, potential scholars, and how you intend to enhance this pool of resources in the future.
Faculty:
Describe the PI’s contributions to science and experience in leading pediatric training/mentoring programs. When a program administrator position is planned, include a description of the expertise, leadership, and administrative capabilities essential to coordinate the PSDP program.
Applicants must describe a plan for identifying appropriate mentors, linking candidates with those mentors, and ensuring that mentors will commit to candidate training and career development support. The K12 applicant need not provide a list of potential mentors. Providing an advanced listing of prospective mentors and collaborators at other institutions may compromise the review process by creating unnecessary institutional conflicts for the recruitment of peer reviewers.
The mentors should hold faculty positions, be supported by NIH or other competitively awarded grants, and be acknowledged experts in new advances in basic science, translational, or clinical research. Mentors with a track record for supporting and advancing the careers of junior pediatrician scientists are particularly valued. Established, funded investigators, as mentors, will make available their expertise, guidance, and laboratory facilities to be utilized by Scholars for research projects and to enhance their knowledge and skills. Mentors must have track records in mentoring and are expected to interact directly with the Scholar in order to develop an individualized career development plan. Assigned mentors will provide guidance for the development of each Scholar appointed to the PSDP.
Scholar Candidates:
Describe in general terms the pool of potential scholar candidates including information about the types of prior training and career level required for the program. Do not name prospective Scholars. Describe the scholar recruitment and application process. Specify intended strategies to promote and disseminate the PSDP mission to pediatric trainees and to the network of current and potential mentors. Describe plans to recruit prospective scholar candidates who have no prior formal research training, who have disabilities, or are from racial or ethnic groups that are currently underrepresented in the biomedical sciences, and explain how the plans will be implemented. List review criteria and methods for selecting talented scholar candidates who will benefit from the PSDP program. The application should contain a description of how the career development plan will be tailored to the needs of the prospective candidates, taking into account their past experiences and competencies.
Recruitment Plan to Enhance Diversity:
The applicant must provide a recruitment plan to enhance diversity. Include outreach strategies and activities designed to recruit prospective scholars from diverse backgrounds, e.g. those from groups described in the Notice of NIH's Interest in Diversity. Describe the specific efforts to be undertaken by the program and how these might coordinate with scholar recruitment efforts of the medical school(s), graduate school(s), and/or the institution(s).
For Renewal applications: Include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period, including successful and unsuccessful recruitment strategies. Information should be included on how the proposed plan reflects the program’s past experiences in recruiting individuals from underrepresented groups.
Career Development and Mentoring Program:
The PD/PI should describe program activities intended to develop the working knowledge needed for trainees to prepare for the next step in their research career. For example, programs should provide all trainees with instruction and training in oral and written presentation and in skills needed to apply for individual grant support.
Progress Report:
For renewal applications, follow instructions in the Application Guide. Highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge or educational practices.
Training Program
Program Plan
Program Administration.
Institutions with existing programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs. When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.
Program Administration.
In the event that a clinical trial may be proposed, provide documentation of the PD/PI(s) expertise, experience, and ability to oversee the organization, management and implementation of the clinical trial, including any feasibility or ancillary study, proposed by Scholar(s).
Proposed Training.
In the event that a clinical trial may be proposed, provide documentation of the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the clinical trial, including any feasibility or ancillary study, proposed Scholar(s).
Institutional Environment and Commitment to the Program
The sponsoring institution must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program, and that there will be protected time for scholars (9 person months, equivalent to 75%) selected for the program.
?????Plan for Instruction in the Responsible Conduct of Research
Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide.
This Funding Opportunity Announcement (FOA) does not allow appointed Scholars to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial led by a mentor.
Program Faculty.
If any mentors will supervise a Scholar proposing to either lead a clinical trial, or gain research experience in a clinical trial, provide documentation of his/her expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet the study timelines.
Trainee Candidates.
If the event that a clinical trial may be proposed, discuss the potential of prospective Scholars to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study.
Appendix:
Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to theSF424 (R&R) Application Guide instructions.
PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional modifications:
Study Record: PHS Human Subjects and Clinical Trials Information
DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must complete a Delayed Onset Study.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
4. Submission Dates and Times
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
6. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy . Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process.
Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
Reviewers should evaluate the potential for developing a national K12 program that will make important contributions to the field, taking into consideration the value of the proposed research career development program as a vehicle for developing successful, independent pediatrician scientists.
Overall Impact
Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed.
Reviewers will consider each of the review criteria below in the determination of the merit of the training program and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Career Development Program and Environment
- Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as biomedical or clinical researchers?
- Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support?
- Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate? Do the program activities foster the development of skill and expertise in transparent, rigorous, and reproducible research methodologies, including relevant areas of data science?
- Are appropriate timelines indicated for career progression and transition to independence?
- Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success?
- Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?
- Is the institutional commitment to the proposed program appropriate?
- If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided?
- Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the research training, career development, and related activities?
- When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program?
- Will the proposed national K12 program make important contributions to the field, taking into consideration the value of the research career development program as a vehicle for developing successful, independent pediatrician scientists?
Is there adequate documentation describing the process of appointing members of the Steering and Selection Committees with term limits for participation? Do appointment procedures seek to include current and prospective mentors from a wide array of pediatric subspecialties?
- Do the PD/PI and Research Administrator (if applicable) have the experience to develop, direct and administer the proposed program?
- Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?
- Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program?
- Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?
- For applications designating multiple PDs/PIs:
- Is a strong justification provided that the multiple PD/PI leadership approach will benefit the career development program and the scholars?
- Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs?
- is there an effective plan for identifying qualified mentors and linking them to scholar candidates?
Mentors
- Do the mentors have appropriate expertise and experience, as well as track records of past mentoring and training?
- Are the quality and extent of the mentors roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research?
- If the program will support clinical trial research experience for the Trainees, do the mentor(s) who will supervise the Trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance and help the Trainee(s) to meet the timelines?
This Funding Opportunity Announcement (FOA) does not allow appointed Scholars to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor.
- For this national K12 program, is there an effective plan for identifying highly-qualified mentors and linking them to potential candidates, and ensuring that those mentors commit to candidate support?
- Will the mentoring plans be individualized to the scholars goals, skills and past experience?
- Will mentors be effectively integrated into the national network of the proposed K12 program in terms of providing guidance and scientific advice to the scholars and supporting their transition to independent status?
Scholars
- Is a recruitment plan proposed with strategies likely to attract high quality scholars?
- Are there well-defined and well justified recruitment and selection strategies?
- Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of the career development program?
- Are the content, phasing, and proposed duration of the career development plan appropriate for achieving scientific independence of the scholars?
- What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars?
- Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?
Does the scholar recruitment plan:
- seek to include the entirety of pediatric residents or fellows who may be interested in pursuing a research-intensive career in pediatrics?
- include adequate administrative personnel to maximize new candidate interest in the PSDP and to review applications?
- describe effective methods of application review and scholar selection?
- describe effective strategies to recruit prospective scholar candidates from diverse backgrounds, including groups that have been shown to be nationally underrepresented in academic pediatrics?
Training Record
- Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?
Protections for Human Subjects
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Vertebrate Animals
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Biohazards
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Career Development in Methods for Enhancing Reproducibility
Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide career development in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the scholars?
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment Plan to Enhance Diversity, and Training in the Responsible Conduct of Research. Does the application describe the program’s accomplishments over the past funding period(s)? Are changes proposed that would improve or strengthen the career development experience? Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific research careers?
Revisions
Not applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Recruitment Plan to Enhance Diversity
Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.
Training in the Responsible Conduct of Research
All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the career development program, the level of scholar experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR career development in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all career development faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?
For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?
Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NICHD in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals for initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development Council.
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
- For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.
Not Applicable.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.
Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed or reappointed to the training grant for 8 weeks or more. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
- Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each scholar appointed for eight weeks or more. Scholars with service payback requirements must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS Form 6031-1) until the payback service obligation is satisfied.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement. Evaluation results should be included as part of the final RPPR.
In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.
Within ten years of making awards under this program, NIH will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.
The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:
For programs involving undergraduate students:
- Successful completion of an undergraduate degree in a STEM field
- Pending application for and/or enrollment in an advanced degree program in a STEM field
- Subsequent participation in a formal research training or career development program in a STEM field
- Subsequent participation in research or employment in a STEM field
- Authorship of scientific publications in a STEM field
For programs involving graduate students:
- Successful completion of a STEM graduate program
- Subsequent participation in a formal research training or career development program in a STEM field
- Subsequent participation in research or employment in a STEM field
- Authorship of scientific publications in a STEM field
- Subsequent independent research grant support from NIH or another source
For programs involving postdoctorates and early career investigators:
- Subsequent participation in a formal research training or career development program in a STEM field
- Subsequent participation in research or employment in a STEM field
- Authorship of scientific publications in a STEM field
- Subsequent independent research grant support from NIH or another source
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Karen K. Winer, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6877
Email: winerk@mail.nih.gov
Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email:duperes@mail.nih.gov
Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email:margaret.young@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.
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