Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  

Funding Opportunity Title

Pediatric Critical Care and Trauma Scientist Development Program (K12 Clinical Trial Optional)  

Activity Code

K12 Physician Scientist Award (Program) (PSA)

Announcement Type

Reissue of RFA-HD-14-019

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HD-19-008  

Companion Funding Opportunity

None  

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.865   

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications to support a national program of mentored career development and training in research for junior faculty in pediatric critical care medicine and pediatric trauma surgery. Such a program is necessary to fuel the pipeline of well-trained investigators and advance research in these two clinically demanding fields.

This Funding Opportunity Announcement (FOA) allows appointment of Scholars (K12) proposing to serve as the lead investigator of an independent clinical trial; or proposing an ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development. Scholars may also propose fundamental research or human subjects research that is not a clinical trial.

Key Dates
Posted Date

July 30, 2018

Open Date (Earliest Submission Date)

September 1, 2018  

Letter of Intent Due Date(s)

September 1, 2018  

Application Due Date(s)

October 1, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November 2018  

Advisory Council Review

January 2019  

Earliest Start Date

April 2019  

Expiration Date

October 2, 2018 

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.


Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Purpose

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.  Physician scientist career development programs assist in the transition of clinical investigators to an independent research career. More information about career programs may be found at the NIH Extramural Training Mechanisms website.

The purpose of this funding opportunity announcement (FOA) is to invite applications for the program administration and direction of the Pediatric Critical Care and Trauma Scientist Development Program (PCCTSDP), a national program of research career development for physician-scientists specializing in pediatric critical care and trauma.

The goals of the PCCTSDP are to expand the pool of investigators trained to advance research in pediatric critical and trauma care. In doing so, the program aims to stimulate novel research and innovative investigation into the scientific basis of pediatric critical care and trauma practice and the consequences of critical illness and injury for families and children. Additionally, it is intended that this program will build upon and expand the community of investigators who network effectively to advance research in these related fields. The program will fund, up to a maximum of 5 years, the administration and infrastructure of one K12 Career Development Program.

Within the framework of the Pediatric Critical Care and Trauma Scientist Development Program's longstanding commitment to excellence, attention must be given to recruiting a diverse group of investigators to seek opportunities in these relatively young and clinically-laden fields, including K12 Scholars from racial or ethnic groups underrepresented in the biomedical, behavioral and clinical sciences, individuals with disabilities, individuals from disadvantaged backgrounds, and individuals working in Institutional Development Award (IDeA)-eligible states. 

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.


Background

Several convergent developments in critical care medicine, as well as in the larger medical, scientific, and national communities, were fundamental to the initial NICHD decision to develop and maintain support of pediatric critical care and trauma career development and research at the junior faculty level.  Although these nascent fields have exhibited substantial growth over the past decade and outcomes have improved, there are little evidence-based data to drive the field and treatments are still often founded on adult studies. Consequently, there is a vital need for research to best inform the care of critically ill and injured children.

To assure that such work will be pursued, a pipeline of well trained and prepared investigators is needed. However, given the intense clinical and physical demands of critical care and trauma training, the paucity of established research mentors in these fields, the ever-growing educational and administrative responsibilities of these practices, and the financial incentive of clinical practice in the wake of substantial debt, it is problematic to maintain a workforce of committed and well-prepared scientists in these fields.

Objectives and Scope

It is expected that the Scholars supported by this program will emphasize basic, clinical and/or translational research focused on acute, intermediate and longer-term outcomes for critically ill and/or injured children and their families.  Recent discoveries across a broad range of basic and clinical science research areas have expanded the potential diagnostic and therapeutic options for the critically ill and injured child.  For example, advances in the understanding of the molecular biology underlying organ system failure offer the possibility of manipulating otherwise poorly controlled processes, including inflammation, cell and organ injury, dysfunction and death, regeneration of tissues, and functional organ system capacity.

The overall purpose and objectives of the program have not changed significantly since the last competitive funding opportunity announcement for this program, although the structure has evolved to enhance function, increase diversity and optimize opportunity for success. The overarching goal of the initiative is to stimulate pediatric critical care and trauma research in the basic, translational and clinical sciences that will improve outcomes in children who sustain critical illness and/or injury by enhancing research capacity and infrastructure in the field on a national level.

More specifically, the objectives of the program are to:

  • Develop guidelines for training, didactic interactions, career development, and the responsible conduct of research among junior faculty pediatric critical care and trauma clinicians.
  • Identify and develop a network of established faculty with a record of research support and productivity who can serve as potential mentors and secondary resources for Scholars.
  • Assure that primary consideration be given to candidates whose research interests will lead to expanded knowledge that ultimately will improve outcomes and quality of life for critically ill and/or injured children as well as for children with potential and present disability.
  • Coordinate with participating institutions and departments to ensure that Scholars receive the appropriate research support, non-clinical time protection, and opportunities for advancement.
  • Recruit, identify and select those individuals who would most benefit from participation in this program and are most likely to develop independent careers in research.
  • Provide special opportunities for research presentations, professional advancement, career counseling and networking.
  • Through recruitment efforts, encourage underrepresented minorities and persons with disabilities to seek opportunities to participate as Scholars, mentors, or in other resource positions.
  • Provide a framework for early research career awareness, preparation and choice for a diverse group of participants, including women and members of underrepresented racial and ethnic groups.
  • Provide periodic and systematic evaluations of the PCCTSDP as a whole.

A new goal for this cycle of the program is to encourage participation through recruitment of K12 Scholars working in Institutional Development Award (IDeA)-eligible states to further augment research capacity for critically ill and injured children on a national level. Given the relatively small and vastly heterogeneous critically ill and injured pediatric patient population, the ability to conduct research in all areas of the country is paramount to sustained success. The IDeA program builds research capacities in states that historically have had low levels of NIH funding by supporting basic, clinical, and translational research; faculty development; and infrastructure improvements. IDeA-eligible states include Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, and Wyoming as well as Puerto Rico. (https://www.nigms.nih.gov/Research/DRCB/IDeA/Pages/default.aspx).  

Note: In addition to basic, translational and clinical research, this Funding Opportunity Announcement (FOA) allows appointment of Scholars (K12) who will 1) serve as the lead investigator of an independent clinical trial; 2) propose an ancillary clinical trial; or 3) propose to gain research experience in a clinical trial led by another investigator.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s)

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

 NICHD intends to commit up to $650,000 in total costs in FY 2019 to fund one award and is contingent upon NIH appropriations.

Award Budget

Application budgets are limited to $600,000 in direct costs and must reflect the actual needs of the proposed project.   

Award Project Period

The maximum project period is five years. 

Other Award Budget Information
Personnel Costs

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.

The salaries of administrative and clerical staff should normally be treated as indirect (F&A) costs. Direct charging of these costs may be appropriate only if all of the following conditions are met: (1) administrative or clerical services are integral to a project or activity; (2) individuals involved can be specifically identified with the project or activity; (3) such costs are explicitly included in the budget or have the prior written approval of the Federal awarding agency; and (4) the costs are not also recovered as indirect costs. When specifically identified and justified, these expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.   

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), Training Director, and/or Recruiting Officer, as appropriate to the proposed program. The Cost limit applies to all faculty salaries combined.

Up to $25,000 per year may be requested for administrative, clerical, or other staff with responsibilities directly associated with the institutional career development program.  The cost limit applies to all staff salaries combined.

Items that may NOT be supported with K12 grant funds include:

  • Salaries and fringe benefits for program mentors;
  • Salary and support for central institutional administrative personnel (e.g. budget officers, grant assistants, and building maintenance personnel), which are usually paid from institutional overhead charges;
  • Salary and support for administrative activities such as institutional public relations or health and educational services.
Participant (Scholar) Costs  

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.

Candidates receive two to three years of intense career development training in a basic or clinical science discipline with an established investigator serving as mentor. The program is designed to support an average of four to five Scholars per year.

Salary and Fringe Benefits:

Individual Scholars are eligible for up to $75,000 per year in salary, plus fringe benefits, consistent with the institution's salary scale.  The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived.  The total salary requested must be based on a full-time, 12-month staff appointment and requires scholars to devote a minimum of 9 person-months (75% full-time professional effort) of full-time professional effort to conducting career development and health-related research, with the remaining effort being devoted to activities related to the development of a successful research career. 

Research and Career Development Support:

For each Scholar, up to $10,000 in additional funds may be budgeted each year to help defray the costs of materials, supplies, technical assistance, and miscellaneous expenses generated by the Scholar's research in the departments and laboratories of the established investigators who serve as mentors. In specific cases, grant funds may also be used for tuition, fees, and other educational materials related to career development. Up to $3,500 per Scholar in travel funds may be budgeted to attend annual PCCTSDP functions and other professional meetings. Total awards to individual Scholars need not be equal across these different budget categories. 

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.
Other Program Related Expenses

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.

Other Program-Related Expenses are limited to $25,000 per year, and may include:

  • Travel expenses for the PD/PI to attend the annual PCCTSDP meetings.
  • Travel expenses for members of the National Advisory Committee to attend the annual PCCTSDP meetings and any other meetings required for the management or evaluation of the K12 program.
  • Limited travel funds for featured speakers and former Scholars to attend annual PCCTSDP meetings for the purpose of providing career development guidance to those currently in the program.

Items that may NOT be supported with K12 funds include:

  • Direct support of the mentors' laboratories beyond those expenses directly attributable to the Scholar's project;
  • Travel of the PD/PI, mentors, or other investigators to scientific meetings beyond those associated with the administration of the PCCTSDP;
  • Patient care costs such as inpatient bed days or outpatient visits, except for clinical laboratory analyses essential for the Scholar's research
  • Alterations and renovations.
Indirect Costs

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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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

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 a strong and high-quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, and facilities on site to administer the program. As this is intended to be a national program, administered at the PD/PI's institution on behalf of the development of research training and career development for Scholars from across the United States, it is particularly important that the institution where the PD/PI is based be research-intensive.

Foreign Institutions

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.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

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.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – 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. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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.

Eligible Individuals (Program Director/Principal Investigator)

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 underrepresented racial and ethnic groups, individuals with disabilities as well as individuals working in Institutional Development Award (IDeA)-eligible states are always encouraged to apply for NIH support.

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 fields of pediatric critical care and/or pediatric trauma and capable of providing both administrative and scientific leadership to the development and implementation of the proposed 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 PCCTSDP and is responsible for appointing members of the National Advisory Committee (see below), using their recommendations to determine the appropriate allotment of funds for research and career development. The PD/PI must be a physician and senior faculty member who is knowledgeable about pediatric critical care and/or pediatric trauma research, has a record of success in laboratory and/or clinical investigation, and has demonstrated skill in mentoring and career development. The PD/PI, in consultation with the National Advisory Committee, shall define the application process, review candidates, make appointments to qualified individuals, and monitor progress.      

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility
Number of Applications

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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 NOT-OD-11-101).
Mentors

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 racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the award.

Mentors shall be tenured faculty (or their equivalent) who have an established record of research productivity and grant support in areas of basic, translational and clinical research relevant to pediatric critical care and/or trauma research.  Generally, they will be researchers and clinicians from pediatric critical care and allied fields, whose particular expertise is needed to support certain career research goals.  Linkages to other departments should be encouraged, as they enhance the power of this career development program and pediatric critical care and trauma care research, in general.

Mentors and their institutions are expected to make a strong commitment to the career development of PCCTDSP Scholars as they seek to establish themselves as independent investigators.  

Scholars

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 received, as of the beginning date of their support, an MD or DO degree, or its equivalent from an accredited domestic or foreign institution and be fully qualified in postgraduate training for pediatric critical illness or trauma practice.  PCCTSDP candidates should be physicians who have completed clinical training and are no more than five years beyond fellowship training when they enter the program. Scholars must hold junior faculty positions at institutions with academic and research-intensive programs in pediatric critical care and trauma.

An individual who has previously served as PD/PI of an NIH research grant (e.g., R01, R03, R21, P01), mentored career development award (e.g., K08, K23, K25, K99), subproject of program project (P01), contract (N01), or other equivalent research awards may not be considered for career development training in this program.

During the period of their appointment, Scholars may not accept or hold any other PHS award that duplicates the provisions of this career award.  However, Scholars may remain eligible for other individual mentored career development awards (e.g., K08, K23, K99) at the conclusion of the K12 appointment if additional training is needed to establish research independence.  Combined support through the K12 and other mentored career development award programs must not exceed six years.

As part of its recruitment efforts, the PCCTSDP should broadly advertise career development opportunities and provide information on prospective mentors.  In addition, the PCCTSDP is expected to encourage individuals from underrepresented groups to seek out available opportunities to participate in the program, including women, individuals from underrepresented racial and ethnic groups, and persons with disabilities.

Prospective Scholars should be encouraged to contact potential mentors prior to formally applying to the PCCTSDP.  Although remaining at the institution of their fellowship is a possibility for Scholars under this award, academic diversity through research career development and clinical practice at a different institution should be strongly encouraged.

Scholars selected for the program receive two to three years of intense career development training in a basic or clinical science discipline with an established mentor. Wherever and however possible, the program should support career development in those areas of research that would have the greatest potential for a positive effect on the emerging field of pediatric critical care and/or trauma medicine and benefit the growing population of children surviving critical illness and injury. In conjunction with the mentor, the candidate develops a research and career development plan, which will be reviewed annually by the PD/PI and the National Advisory Committee.  At least 9 person-months (75 percent of the Scholar's professional effort) must be devoted to research activities supported by the PCCTSDP. In the beginning of the second year, Scholars should start seeking outside grant support as they transition to independent researcher positions in their sponsoring pediatric critical care medicine or trauma surgery departments and institutions.  It is expected that the departments associated with the PCCTSDP will make a strong commitment to supporting individuals as they develop their independent research careers.

Scholars may engage in brief research activities at another institution if the experience is directly related to the purpose of the award. 

Periods of leave from the program for greater than two months, whether for professional or personal reasons, require prior written approval from NIH.

Section IV. Application and Submission Information
1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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:

Robert Tamburro, MD, MSc
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-480-2619
Email: tamburrorf@mail.nih.gov

Page Limitations

All page limitations described in the SF424 (R&R) 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

Follow all instructions provided in the SF424 (R&R) Application Guide. 

SF424(R&R) Project/Performance Site Locations

Follow all instructions provided in the SF424 (R&R) Application.

SF424 (R&R) Other Project Information

Follow all instructions provided in the SF424 (R&R) Application, with the following additional modifications:

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 research career development program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of scholars including their levels (i.e., , ,  junior faculty), and intended scholar outcomes.

Other Attachments. A plan must be provided for the appointment of a National Advisory Committee to monitor progress of the career development program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the National Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, efforts to sustain the interest of participants, and the evaluation of the overall effectiveness of the program. A plan for National Advisory Committee approval and selection of Scholars should also be included. The proposed National Advisory Committee members should not be named in new applications, particularly if they include individuals from outside the institution. However, renewal applications with National Advisory Committees should include names of existing external advisors. Please name your file "National Advisory_Committee.pdf".

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, with the following additional modifications:

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 or if the FOA specifically instructs applicants to do so.

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

Substitute all references to "trainees" in the SF424 (R&R) Application Guide with "Scholars" and all references to "training" in the SF424 (R&R) Application Guide with "career development".

Program Plan

Program Administration

Describe the strengths, leadership and administrative skills, and scientific expertise of the Training PD/PI. Include the planned strategy and administrative structure to be used to oversee and monitor the program. For applications with multiple PD(s)/PI(s), address the Leadership Plan and how the combined knowledge, skills and experience of the individual PD(s)/PI(s) will enhance the likelihood of success of the program. 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.

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.

Since clinical trials are optional, provide documentation of the PD/PI's expertise, experience, and ability to oversee the program organization with regard to the appointment of faculty mentors able to oversee the management and implementation of the clinical trial, feasibility or ancillary study, proposed by Scholar(s).

Program Faculty

Describe in general terms the complementary expertise and experiences of the proposed mentors. Provide an overview of their active research and other scholarly activities, as well as track records of mentoring and training.

The application should describe past research career development activities/experiences of the PD(s)/PI(s) and mentors, documenting the success of former trainees and Scholars in establishing independent productive scientific careers. Do not duplicate information already provided in biosketches.

If a mentor will supervise a Scholar (K12) 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.

Proposed Training

Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including activities that will be used to ensure that the objectives of the program are met. Include information about planned courses, curricula, seminars, workshops, or tutorials that will be incorporated into the career development program and mentored research experiences and activities. The description should include planned strategies to be used to ensure that the objectives are met.

The PD/PI should describe program activities intended to develop the working knowledge needed for Scholars to select among and prepare for the next step in varied research career options available in the biomedical workforce. For example, programs should provide all Scholars with instruction and training in oral and written presentation and in skills needed to apply for individual grant support. All Scholars should also be provided with instruction in project management.

Given that a K12 Scholar may propose to either lead a clinical trial, or gain research experience in a clinical trial as part of this program, provide documentation that available mentors will have the 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. 

Program Evaluation

Describe an evaluation plan to review and determine the effectiveness of the program. This should include plans to obtain feedback from current and former Scholars to help identify weaknesses and to provide suggestions for program improvements, as well as plans for assessing Scholars' career development and progression, including metrics such as degree completion (if applicable), publications, research funding secured, and subsequent academic and professional positions. Specified evaluation metrics should be tied to the goals of the program. Evaluation results should be included in future renewal applications and in the Final Progress Report. 

For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and to evaluation of the training program. 

Scholar Candidates

Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training and the expected career level required for the program. Do not name prospective Scholars. Describe plans to recruit candidates and explain how these plans will be implemented (see also section on Recruitment Plan to Enhance Diversity). Describe the evaluation criteria to be used in the selection of Scholars. Provide brief summaries of career development plans that the program will employ. The application should contain a description of how career development plans will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences.

If clinical trial is proposed, discuss the potential of prospective Scholars (K12) to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study. 

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 PD(s)/PI(s) 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.         

The application must include a statement from the applicant institution describing the commitment to the planned program. The institution must assure that essential time will be allowed for the PD(s)/PI(s), other faculty and mentors, and the required protected time for Scholars (9-person months, equivalent to 75% effort) selected for the program. It is expected that the individual institutions of Scholars ultimately selected for the program will provide similar assurances for the Scholars protected time.

Data Tables

Particular attention must be given to the required Training Data Tables. 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 2 (New and Renewal applications)

Table 3 (New and Renewal applications)

Table 4 (New and Renewal applications)

Table 5B (Renewal applications only)

Table 7 (Renewal applications only)

Table 8C, Part I only (Renewal applications only)

Applicants should follow all instructions provided in the SF424 (R&R) Application Guide, as well as the specific instructions for the Training Data Tables.  Information presented in the Data Tables should be summarized in the Research Training Program Plan as described in the Instructions and Sample Data Tables Files.

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. 

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. Do not use the Appendix to circumvent page limits.

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

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.

If you check the "Anticipated Clinical Trial" box within your Delayed Onset Study, then the Justification attachment must acknowledge that additional clinical trial information will be provided to the awarding component before any Scholar begins independent clinical trial research. 

In the event that a Scholar planning to pursue a clinical trial as the lead investigator is appointed to the program, the PD/PI will assure that all required and requested clinical trial information is provided to the funding institution prior to the start of the Scholar's proposed trial.

If you check the "Anticipated Clinical Trial" box within your Delayed Onset Study, then the Justification attachment must acknowledge that additional clinical trial information will be provided to the NICHD before any appointed Scholar begins independent clinical trial research. In the event that a Scholar proposing an ancillary clinical trial to an existing trial or proposing to gain research experience in a clinical trial led by another investigator is appointed to the program, the scholar and mentor will assure that all required clinical trial information is provided to the PD/PI of the K12 program.  The PD/PI will confirm that NIH clinical trials requirements will be met and submit required information to the Project Officer at NICHD for approval prior to the start of the Scholar's proposed trial.  If a clinical trial will be conducted, a milestone plan will also be established at that time.

 
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.  Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization's profile in the eRA Commons and for the System for Award Management (SAM). 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.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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).

Scored Review Criteria

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 in pediatric critical care or pediatric trauma research?
  • 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?
  • 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?
  • Is there adequate documentation describing the responsibilities of the National Advisory Committee with regard to the provision of input, guidance and oversight of the program?
  • Will the proposed PCCTSDP contribute to the development of well-qualified pediatric critical care medicine and/or trauma medicine investigators, the advancement of pediatric critical care and trauma research, and the application of current and emerging research developments to significant clinical problems?
  • If a clinical trial is proposed by a Scholar, are there plans in place to assure that the administrative, data coordinating, enrollment and laboratory/testing centers, are appropriate for the trial proposed? In particular, does the application adequately address the capability of the PD/PI and the proposed program to evaluate the Scholar's ability to conduct any proposed clinical trial, feasibility or ancillary study at the proposed site(s) or centers? Will the program be able to ensure that Scholars have the ability and support to meet the demands of clinical trials including but not limited to: (1) enrolling the proposed number of patients; (2) adhering to the protocol; (3) collecting and transmitting data in an accurate, secure and timely fashion; and, (4) operating within the proposed organizational structure?

 Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

  • 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 pediatric critical care and / or pediatric trauma?
  • If a clinical trial is proposed by a Scholar, do the PD(s)/PI(s) have the expertise, experience, and ability to assure that the organization, management and implementation of the proposed trial are appropriate?

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 PD(s)/PI(s)?

Mentors

  • 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 mentors at remote sites 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?
  • Does the program include a broadly based and productive network of established investigators who are involved in research areas relevant to pediatric critical care and pediatric trauma medicine?
  • Do the mentors who will supervise the Scholar(s) have the expertise, experience, and ability to provide guidance in the organization, management and implementation of a clinical trial, ancillary, or feasibility study and help him/her to meet timelines?

Scholars

  • Is a recruitment plan proposed with strategies likely to attract high quality scholars with a commitment to research relevant to the objectives of the FOA and the potential to develop as independent researchers?
  • 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?
  • Do prospective Scholars have the potential to organize, manage, and implement any proposed clinical trial, feasibility or ancillary study? 
  • Are there plans to provide instruction in data management and statistics including those relevant to clinical trials to the prospective Scholars?

Training Record

  • Is there evidence of a successful past training and career development 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 career development and training?
Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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 Children 

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.

Resubmissions

Not Applicable 

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

Additional Review Considerations

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 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 training program, the level of scholars' experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR training 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 training 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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the 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:

  • 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.
  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted 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 (NACHHD). The following will be considered in making funding decisions:

  • 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.
3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information
1. Award Notices

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 grantee's business official.

Awardees must comply with any funding restrictions described in Section IV.5. 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. 

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/.   

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. 

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 "Federal awarding agency review of risk posed by applicants."  This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees 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 grantee 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. 

Other Reporting Requirements
  • The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant for 8 weeks or more. Grantees 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.
  • A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.
  • 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 trainee appointed for eight weeks or more. Trainees 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 accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

4. Evaluation

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.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Robert Tamburro, MD, MSc
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-480-2619
Email: tamburrorf@mail.nih.gov  

Peer Review Contact(s)

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov 

Financial/Grants Management Contact(s)

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov 

Section VIII. Other Information

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.

Authority and Regulations

Awards are made under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.

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.

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