and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|
Funding Opportunity Title |
Postdoctoral Training Program in Obstetric and Pediatric Pharmacoepidemiology (T32) |
Activity Code |
T32 Institutional National Research Service Award (NRSA) |
Announcement Type |
Reissue of PAR-10-194 |
Related Notices
|
|
Funding Opportunity Announcement (FOA) Number |
PAR-13-112 |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.865 |
Funding Opportunity Purpose |
This funding opportunity announcement (FOA) encourages applications from organizations that propose creative and innovative institutional research training programs in the mission area(s) of the NICHD. The purpose of the training program 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. The goals of this training program are: (1) to encourage and support training in pediatric and/or obstetric pharmacoepidemiology; and (2) to produce a well-qualified cadre of academic investigators who are capable of conducting pharmacoepidemiologic research in children and/or pregnant women. |
Posted Date |
February 11, 2013 |
Open Date (Earliest Submission Date) |
April 25, 2013 |
Letter of Intent Due Date(s) |
30 days before application due date(s) |
Application Due Date(s) |
May 25, 2013, (Extended to May 29, 2014 per NOT-OD-14-070) , Originally May 25, 2014, May 25, 2015, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
October/November 2013, October/November 2014, October/November 2015 |
Advisory Council Review |
January 2014, January 2015, January 2016 |
Earliest Start Date |
April 2014 |
Expiration Date |
May 26, 2015 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, 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.
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
The overall goal of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) program 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 NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.
This funding opportunity announcement (FOA) encourages applications from organizations that propose creative and innovative institutional research training programs in the mission area(s) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The purpose of the training program 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. The goals of this training program are: (1) to encourage and support training in pediatric and/or obstetric pharmacoepidemiology; and (2) to produce a well-qualified cadre of academic investigators who are capable of conducting pharmacoepidemiologic research in children and/or pregnant women.
Currently, there is a dearth of NIH-sponsored graduate level training opportunities in obstetric and pediatric pharmacoepidemiology research despite the increasing demands for investigators with these skills. Targeted training grants in these disciplines are needed. Barriers to recruiting and training students include lack of stipends, external funding, dedicated faculty, protected research time, and administrative support.
Pharmacoepidemiology is the study of the use of drugs, their beneficial or adverse effects, and outcomes of drug therapy in large populations. It is a swiftly growing discipline that applies epidemiological methods to pharmacological treatment of conditions to better understand the safety and effectiveness of the drug therapy. With the increasing availability of electronic medical records and other large electronic health-related databases, pharmacoepidemiologic study will be an important research approach/tool when evaluating drug safety and other outcomes associated with treatments from these databases. Many health data contain genetic and biomarker information that could help pharmacoepidemiologic studies and explain previously unknown causes of ineffective treatment. Knowledge gained from pharmacoepidemilogical studies will provide opportunities for further research and guidance to improve patient care. There are very few investigators with an appropriate expertise to conduct pharmacoepidemiologic research in pediatric and obstetric populations in the U.S. There is a need to train the next generation of researchers in pediatric and/or obstetric pharmacoepidemiology.
The NICHD will award Institutional NRSA Training Grants (T32) to eligible institutions to develop or enhance research training opportunities for individuals, selected by the institution, who are training for careers in obstetric and/or pediatric pharmacoepidemiology research.
The training grants described in this announcement provide support for postdoctoral research training programs at domestic institutions of higher education. The institutional NRSA training grants are designed to allow the Training Program Director/Principal Investigator (PD/PI) to select the trainees and to develop a curriculum of study and research experiences necessary to provide high quality research training. The NRSA program will provide each trainee three years of postdoctoral support.
Postdoctoral research training must provide coursework, mentoring, and guided research as needed to assure knowledge and competence in pharmacoepidemiology, as well as opportunities to acquire substantive knowledge of obstetric and/or pediatric health issues. Trainees are expected to be participants in a formal curriculum in pharmacoepidemiology. The anticipated curriculum should include courses in pharmacoepidemiologic methods, biostatistics, epidemiology, clinical pharmacology, pharmacogenomics, obstetric and/or pediatric pharmacoepidemiology, research ethics, and related areas.
Specific skills and research areas to be developed include, but are not limited to: prenatal and childhood exposures of drugs, determinants of pregnancy outcomes, neonatal treatment, issues regarding conduct of clinical trials in pregnant women and children, as well as investigation of specific health care questions in pediatric or obstetric diseases/conditions such as asthma, diabetes, obesity, hypertension, and management of pediatric psychiatric conditions.
The proposed institutional research training program may complement other
ongoing research training and career development programs at the applicant
institution, but the proposed research training experiences must be distinct
from those research training programs currently receiving Federal support.
Within the framework of the NRSA program’s longstanding commitment to
excellence and projected need for investigators in particular areas of
research, attention must be given to recruiting trainees from racial or ethnic
groups underrepresented in the biomedical, behavioral and clinical sciences,
individuals with disabilities, and individuals from disadvantaged backgrounds.
The Training PD/PI should limit appointments to individuals
who are committed to a career in research and who plan to remain on the
training grant or in a non-NRSA research experience for a cumulative minimum of
2 years. The Training PD/PI should also encourage and provide training in the
skills necessary for trainees to apply for subsequent support through a mentored
career development award (K) program, or independent research project grant.
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 The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. |
Award Budget |
Application budgets are not limited but need to reflect actual needs of the proposed project. Grantees are expected to be familiar with and comply with applicable cost policies and the NRSA Guidelines (NIH Grants Policy Statement - Institutional Research Training Grants). Funds may be used only for those expenses that are directly related to and necessary for the research training and must be expended in conformance with OMB Cost Principles, the NIH Grants Policy Statement, and the NRSA regulations, policies, guidelines, and conditions set forth in this document. |
Award Project Period |
The scope of the proposed project should determine the project period. The total project period may not exceed five years. |
Stipends, Tuition, and Fees
|
Kirschstein-NRSA awards provide stipends as a subsistence
allowance to help defray living expenses during the research training
experience. |
Trainee Travel |
Trainee travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable trainee expense. |
Training Related Expenses |
NICHD will provide funds to help defray other research training expenses, such as health insurance, staff salaries, consultant costs, equipment, research supplies, and faculty/staff travel directly related to the research training program. The most recent levels of training related expenses are described on the Ruth L. Kirschstein National Research Service Award (NRSA) site. Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information. |
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 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 in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Governments
Other
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 and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing research training programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating trainees may gain relevant experiences consistent with their research interests and goals. 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 trainees, and resources are robust enough to support additional programs.
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.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Directors/Principal Investigators (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF424 (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 expected to monitor and assess the program and submit
all documents and reports as required.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is programmatically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
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.
Details on citizenship, training period, and aggregate duration of support are available in the NIH Grants Policy Statement.
Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a PhD, MD, DDS, or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: DMD, DC, DO, DVM, OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, ND (Doctor of Naturopathy), DSW, PsyD, as well as a doctoral degree in nursing research. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable.
A Kirschstein-NRSA institutional research training grant must be used to support a program of full-time research training. Within the full-time training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. The program may not be used to support studies leading to the MD, DDS, or other clinical, health-professional training except when those studies are part of a formal, combined research degree program, such as the MD/PhD Similarly, trainees may not accept NRSA support for clinical training that is part of residency training leading to clinical certification in a medical or dental specialty or subspecialty. It is permissible and encouraged, however, for clinicians to engage in NRSA-supported, full-time postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the 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:
The letter of intent should be sent to:
Zhaoxia Ren, MD, PhD
Medical Officer
Obstetric and Pediatric Pharmacology and Therapeutics
Branch
Eunice Kennedy Shriver National Institute of Child
Health and Human Development, NIH
6100 Executive Blvd Room 4A01D MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service;
non-USPS service)
Email: [email protected]
Telephone: 301-402-9340
Fax: 301-480-2897
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA), with the following modifications:
Other Attachments
Project Summary /Abstract
Provide an abstract of the entire application, including the long-term goals and objectives of the program. Include the rationale and design of the program, the planned duration of the program and the projected number of scholars, including their levels (i.e., predoctoral, postdoctoral. l
Advisory Committee (Uploaded via the Other Attachments section)
A plan must be provided for the appointment of an Advisory Committee to monitor progress. Composition, responsibilities, frequency of meetings, and other relevant information should be included. Describe the composition of the Advisory Committee, identifying the role and the desired expertise of members. A plan for Advisory Committee approval and selection of participants should be included. Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, and the evaluation of the overall effectiveness of the program. Note that proposed Advisory Committee members should not be named in the application, particularly if they include individuals from outside the institution. However, renewal applications with Advisory Committees should include names of existing external advisors. Please name your file 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.
Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:
All Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application must be followed, with the additional instructions described below:
Program Administration (Component of Program Plan)
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 PDs/PIs, address the Leadership Plan and how the combined knowledge, skills and experience of the individual PDs/PIs will enhance the likelihood of success of the program.
Program Faculty (Component of Program Plan)
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.
Proposed Training (Component of Program Plan)
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 training program and mentored research experiences and activities. Institutions with existing training or career development programs must explain what distinguishes this program from the others, how the programs will synergize, if applicable, and justify that the faculty, pool of potential trainees, and resources are robust enough to support additional programs. The description should include planned strategies to be used to ensure that the objectives are met. The PD/PI should also describe past research career development activities/experiences including those of mentors, documenting the success of former trainees in establishing independent productive scientific careers. Programs should provide all trainees with additional professional development skills and career guidance including instruction and training in grant writing in order to apply successfully for future fellowships as eligible and career development and independent research support. All postdoctoral trainees should also be provided with instruction in laboratory and project management.
Program Evaluation (Component of Program Plan)
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 trainees career development and progression, including metrics such as degree completion (if applicable), publications, and subsequent 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.
Trainee Candidates (Component of Program Plan)
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 trainees. Describe plans to recruit candidates and explain how these plans will be implemented (see also section on Recruitment and Retention Plan to Enhance Diversity). Describe the evaluation criteria to be used in the selection of trainees. Provide brief summaries of training plans that the program will employ. The application should contain a description of how training plans will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences.
Institutional Environment and Commitment to the Program (Component of Program Plan)
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.
Recruitment and Retention Plan to Enhance Diversity
Individuals are required to comply with the instructions for Recruitment and Retention Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide.
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 Chapter 8 of the SF424 (R&R) Application Guide.
Appendix
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the deadline to ensure they have time to make any application corrections
that might be necessary for successful submission.
Organizations must submit applications via 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.
Applicants are
responsible for viewing their application before the deadline 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.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH
Grants Policy Statement. The National
Research Service Award (NRSA) policies apply to this program. An NRSA
appointment may not be held concurrently with another Federally-sponsored
fellowship, traineeship, or similar Federal award that provides a stipend or
otherwise duplicates provisions of the NRSA.
Pre-award costs are allowable only as described in the NIH
Grants Policy Statement. Note, however, that pre-award costs are not
allowable charges for stipends or tuition/fees on institutional training grants
because these costs may not be charged to the grant until a trainee has
actually been appointed and the appropriate paperwork submitted to the NIH
awarding component.
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.
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 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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. Applicants are advised to refer to Agency Contacts for exceptions.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the program to exert a sustained, powerful 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 scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Training Program and Environment
Are the research facilities and research environment conducive to preparing trainees for successful careers as biomedical scientists? Do the objectives, design and direction of the proposed research program ensure effective training? Is the proposed program of training likely to ensure that trainees will be prepared for successful and productive scientific careers? Do the courses, where relevant, and research training experiences address state-of-the-art science relevant to the aims of the program? Does the program provide training in inter- or multi-disciplinary research and/or provide training in state-of-the-art or novel methodologies and techniques? Is a significant level of institutional commitment to the program evident?
Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
Does the Training PD/PI have the scientific background, expertise, and experience to provide strong leadership, direction, management, and administration of the proposed research training program? Does the Training PD/PI plan to commit sufficient time to the program to ensure its success? Is sufficient administrative and research training support provided for the program?
For applications designating multiple PD/PIs: Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees? 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 training program and with the complementary expertise of each of the PDs/PIs?
Preceptors/Mentors
Are sufficient numbers of experienced preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees proposed in the application? Do the preceptors/mentors have strong records as researchers, including successful competition for research support in areas directly related to the proposed research training program? Do the preceptors/mentors have strong records of training pre- and/or postdoctorates?
Trainees
Is a recruitment plan proposed with strategies to attract high quality trainees? Are there well-defined and justified selection criteria and retention strategies? Is a competitive applicant pool in sufficient numbers to warrant the proposed size and levels (predoctoral, postdoctoral and/or short-term) of the training program in evidence?
Training Record
How successful are the trainees (or for new applications,
other past students/fellows in similar training) in completing the program? How
productive are trainees (or for new applications, other past students/fellows)
in terms of research accomplishments and publications? How successful are
trainees (or other past students/fellows) in obtaining further training
appointments, fellowships, and career development awards? How successful are
the trainees in achieving productive scientific careers, as evidenced by
successful competition for research grants, receipt of honors or awards,
high-impact publications, receipt of patents, promotion to scientific
leadership positions, and/or other such measures of success? Does the program
have a rigorous evaluation plan to assess the quality and effectiveness of the
training? Are effective mechanisms in place for obtaining feedback from current
and former trainees and monitoring trainees subsequent career development?
For programs that provide research training to health-professional doctorates: Is there a record of retaining health professionals in research training or
other research activities for at least two years?
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
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 and the success of the program in attracting and retaining individuals from diverse populations, including populations underrepresented in biomedical and behavioral science. Does the application describe the program’s accomplishments over the past funding period(s)? Are changes proposed that would improve or strengthen the training experience?
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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 & Retention Plan to Enhance Diversity
Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement. Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.
Training in the Responsible Conduct of Research
Taking into account the specific characteristics of the training program, level of trainee experience, and the particular circumstances of the trainees, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, and laboratory safety? Do the plans adequately describe how faculty will participate in the instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years or at each stage of training? If this is a renewal, is there a report describing past instruction in the five components described above? 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 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:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council. The following will be considered in making funding decisions:
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.
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 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 the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Institutional NRSA training grants must be administered in accordance with the current NRSA section of the NIH Grants Policy Statement - Institutional Research Training Grants.
The taxability of stipends is described in the NIH Grants Policy Statement. Policies regarding the Ruth L. Kirschstein-NRSA payback obligation are explained in the NIH Grants Policy Statement.
As specified in the NIH Revitalization Act of 1993,
Kirschstein-NRSA recipients incur a service payback obligation for the first 12
months of postdoctoral support. Policies regarding the Ruth L. Kirschstein-NRSA
payback obligation are explained in the NIH Grants
Policy Statement; and more details are in the Frequently
Asked Questions. Officials at the grantee institution have the
responsibility of explaining the terms of the payback requirements to all
prospective trainees before appointment to the training grant. Additionally,
all trainees recruited into the training program should be provided with
information related to the career options that might be available when they
complete the program. The suitability of such career options as methods to satisfy
the NRSA service payback obligation should be discussed.
In general, trainees may receive stipends during the normal
periods of vacation and holidays observed by individuals in comparable training
positions at the sponsoring institution. For the purpose of these awards,
however, the period between the spring and fall semesters is considered to be
an active time of research and research training and is not considered to be a
vacation or holiday. Trainees may receive stipends for up to 15 calendar days
of sick leave per year. Sick leave may be used for the medical conditions
related to pregnancy and childbirth. Trainees may also receive stipends for
parental leave as described in NOT-OD-08-064.
A period of terminal leave is not permitted, and payment may not be made from
traineeship funds for leave not taken. Trainees requiring periods of time away
from their research training experience longer than specified here must seek
approval from the NIH awarding component for an unpaid leave of absence. Trainees
supported by academic institutions should refer to the NIH Institutional NRSA
training grant guidelines in the NIH
Grants Policy Statement for further guidance regarding vacations
and requested leave.
Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.
Not Applicable
The Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) and financial statements as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted. Chapter 8 of the SF424 (R&R) Application Guide, Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards, must be followed.
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.
A final Progress Report 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 Progress Report.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Commons Help Desk (Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Zhaoxia Ren, MD, PhD
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
Phone: 301-402-9340
Email: [email protected]
Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-3415
Email: [email protected]
Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]
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 Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.
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NIH Funding Opportunities and Notices
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