Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

Funding Opportunity Title

NHLBI Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral MD/PhD Fellows (F30)

Activity Code

F30 Individual Predoctoral NRSA for M.D./Ph.D. Fellowships

Announcement Type

Reissue of  PA-09-232

Related Notices

  • December 14, 2011 - See Notice NOT-OD-12-022 Ruth L. Kirschstein National Research Service Awards (NRSA) and Other Fellowship Applications: New Policy on Post-Submission Information on Sponsor’s Research Funding .

Funding Opportunity Announcement (FOA) Number

PA-11-125

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.837, 93.838, 93.839, 93.233

FOA Purpose

The National Heart, Lung, and Blood Institute (NHLBI) is interested in supporting individual predoctoral fellowships for combined MD/PhD training in research areas relevant to the mission of the NHLBI.

Applications to this FOA are accepted from (a) students currently enrolled in a combined MD/PhD program and (b) current medical or graduate students seeking admission to a combined degree program. Awards to those applicants are contingent on subsequently being enrolled in a combined MD/PhD program.

The NHLBI supports research training and career development of researchers in fundamental sciences and clinical disciplines related to heart, vascular, lung, and blood diseases; sleep disorders; and blood resources. Among the areas of emphasis, but not limited to, in research training are Computational Biology, Bioinformatics, Systems Biology or Network Biology, and Interdisciplinary Research.

Other potential overlapping areas of interest shared by the NHLBI and other Institutes/Centers of the NIH include myeloproliferative and myelodysplastic disorders, hematological malignancies resulting from disruptions in hematopoiesis, and the use of hematopoietic stem cell transplantation and other cellular therapies.

 The NHLBI does not support fellowship projects primarily focused on malignancy-related research, vaccine development, or pathogens per se. Therefore, applicants are strongly encouraged to contact the NHLBI before submitting an application to determine its appropriateness for this FOA and the mission of the NHLBI.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

March 8, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard dates apply by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Not applicable for Fellowships

Earliest Start Date(s)

Standard dates apply

Expiration Date

January 8, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Individual Fellowship 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

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.

The NRSA legislation requires that the Nation's overall need for biomedical research personnel be taken into account by giving special consideration to training physicians who propose to become active biomedical researchers. The NHLBI recognizes the critical importance of training physicians and scientists to become physician-scientists including those conducting translational research and patient-oriented research. To that end, the NHLBI supports Ruth L. Kirschstein National Research Service Awards (Kirschstein-NRSA) to individuals for combined MD/PhD fellowship training. The NHLBI awards Kirschstein-NRSA individual fellowship (F30) to promising applicants with the potential to become productive, independent, highly trained physician-scientists, including patient-oriented physician-scientists in its scientific mission area. The Institute plans, conducts, fosters, and supports an integrated and coordinated program of basic research, clinical investigations and trials, observational studies, and demonstration and education projects. Research is related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The NHLBI plans and directs research in development and evaluation of interventions and devices related to prevention, treatment, and rehabilitation of patients suffering from such diseases and disorders. It also supports research on clinical use of blood and all aspects of the management of blood resources (http://www.nhlbi.nih.gov/about/org/mission.htm).

NHLBI Programmatic Need

There is a critical need in the cardiovascular, pulmonary, and hematological disorders and sleep research arenas for physician-scientists. Graduates of MD/PhD programs differ from most other clinicians in having had intensive research training in basic, clinical, translational, epidemiologic, prevention, and health services investigations.

The enormous complexity of biomedical and behavioral science today along with the demands of modern medical practice means that clinical studies leading to an MD degree do not provide the training and experience necessary to develop clinician researchers. Integrated curricula that combine clinical training with extensive research experience leading to a combined MD/PhD degree are developed because scientists who are both medical doctors and trained researchers play a vital role in helping to bring the highest scientific standards to basic, clinical, translational, epidemiologic, prevention, and health services research settings.

Research Training Objectives

Special Note: Because of the differences in individual NIH Institute and Center program requirements for the F30 program, prospective applicants are strongly encouraged to consult the Specific Information, Requirements (below) and Scientific/Research Contact (Section VII. Agency Contacts) before submitting an application to determine its appropriateness for this FOA and the mission of the NHLBI.

This funding opportunity supports individual predoctoral F30 fellowships with the expectation that these training opportunities will increase the number of future investigators in basic, translational and clinical research who are physician scientists. The research training experience must provide:

The applicant's experience should be guided and supervised by a committed sponsor who is an active and established investigator in the area of the applicant's proposed research. The research training should occur in a research-intensive environment that has appropriate human and technical resources and one that is demonstrably committed to research training in the particular program proposed by the applicant.

Training under this award is designed to provide a foundation for a career as a physician-scientist in the areas of interest to the NHLBI. Recent developments in many different areas have made it possible to increase our understanding of the etiologic and pathophysiologic mechanisms underlying cardiovascular, lung, blood-related and sleep disorders. For example, the application of systems biology based techniques and studies in dissecting aberrant cellular and intracellular regulatory networks is resulting in better understanding of chronic disease pathogenesis. The ability to regulate the temporal expression of individual genes in specific cells of transgenic animals allows dissection of their role in normal and pathological function. Proteomic and genomic analysis are increasingly able to identify changes in gene expression in single cells. Clinical and epidemiologic research now involves genome-wide association studies to determine the role of genetic polymorphisms in the etiology of human disease. Advances in imaging techniques are increasingly applied to investigate protein-protein interactions and signaling in living organisms.

The NHLBI does not support F30 projects primarily focused on malignancy-related research. Studies that address a mechanistic correlation between cancer (i.e., lung cancer) and primary pulmonary diseases may be considered within the mission of the NHLBI.  Applications on vaccine development will be considered outside the focus of this FOA. Applications on respiratory pathogens will be considered within the focus of this FOA if they focus on the host immune response. Other potential overlapping areas of interest shared by the NHLBI and other Institutes/Centers of the NIH include myeloproliferative and myelodysplastic disorders, hematological malignancies resulting from disruptions in hematopoiesis, and the use of hematopoietic stem cell transplantation and other cellular therapies. Please consult NHLBI staff for specific guidance on NHLBI mission priorities in these areas.

Major changes in research direction and paradigms have led to a strong public health focus in clinical intervention, health services, and prevention research at the NHLBI. Because of an acute shortage of physician-scientists in these critical research areas, potential applicants who are interested in such careers are especially encouraged to apply. A wide-range of disciplines are appropriate for research training in cardiovascular, lung, blood-related and sleep diseases including (but not limited to) public health, clinical trials, epidemiology, biostatistics, bioinformatics, statistical genetics, health economics, bioethics, computer science and pharmacy.

Potential applicants may be interested in viewing the NHLBI Strategic Plan. The strategic plan is intended to provide the NHLBI with a guide for its research and training programs. Among the areas of emphasis, but not limited to, in research training are Computational Biology, Bioinformatics, Systems Biology or Network Biology, and Interdisciplinary Research.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission

The OER Glossary and the SF 424 (R&R) Individual Fellowship Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

Number of awards is contingent upon funds available, and the submission of a sufficient number of meritorious applications.

Award Budget

Award budgets are composed of stipends, tuition and fees, and institutional allowance, as described below.

Award Project Period

Individuals may receive up to 6 years for dual degree training, i.e., MD/PhD, including any combination of support from institutional training grants (e.g. T32) and an individual fellowship award.

Other Award Budget Information
Stipends

Kirschstein-NRSA awards provide stipends as a subsistence allowance to help defray living expenses during the research and clinical training experiences.

The most recent stipend levels are described on the Kirschstein-NRSA webpage. NIH will adjust awards on the anniversary date of the award to ensure consistency with the stipend level in effect at that time.

Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information.

Tuition and Fees

NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award. The most recent tuition and fees levels are described on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage. Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information.

Institutional Allowance

The application should request a Kirschstein-NRSA institutional allowance to help defray the cost of fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings. The most recent institutional allowance levels are described via a link on the Ruth L. Kirschstein National Research Service Award (NRSA) site. Requests for additional costs (such as to accommodate the disabilities of a fellow) must be explained in detail and justified in the application. Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information.

Indirect Costs

NIH does not separately reimburse indirect costs (also known as Facilitates & Administrative [F&A] Costs) for fellowships. Costs for administering fellowships are part of Institutional Allowance.

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.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

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

For profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.   

Before submitting a fellowship application, the applicant fellow must identify a sponsoring institution. The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research. The research training should occur in a research-intensive environment that has appropriate human and technical resources and is demonstrably committed to research training in the particular program proposed by the applicant fellow. The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories.

Sponsoring Institution

The sponsoring institution must have appropriate staff and facilities available on site to provide a suitable environment for performing high-quality research training.

The PhD phase of the program may be conducted outside the sponsoring institution, e.g., a Federal laboratory including the NIH intramural laboratories. This training, however, must be part of a combined MD/PhD program.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (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/PIs) 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 four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any applicant fellow with the skills, knowledge, and resources necessary to carry out the proposed research training as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her sponsor and 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. Multiple Principal Investigators are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

Although a Kirschstein-NRSA award is not usually made for study leading to the MD, DO, DDS, AuD or similar professional degrees, or for study that is part of residency training leading to a medical specialty, the NHLBI F30 program is specifically designed to support both the clinical and research training components of an accredited, combined MD/PhD program.

Applications to the program will be accepted on behalf of (a) students currently enrolled in a combined MD/PhD program and (b) current medical or graduate students seeking admission to a combined program that provides research training in areas relevant to the NHLBI mission. Awards to these applicants are contingent on subsequently being enrolled in a combined MD/PhD program.

Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are encouraged to apply for NIH support. Such individuals may also consider applying to the Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowships (F31) to Promote Diversity in Health-Related Research (PA-11-112).

Non-citizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Individuals may apply for the Kirschstein-NRSA F30 in advance of admission to the United States as a Permanent Resident recognizing that no award will be made until legal verification of Permanent Resident status is provided.

A candidate must have a baccalaureate degree and show evidence of both high-academic performance in the sciences and substantial interest in research in areas of high priority to the NHLBI. In addition when the application is awarded, the applicant must be enrolled in an accredited combined MD/PhD program at a medical school, accepted in a related scientific PhD program, and be supervised by a funded sponsor conducting research related to the goals of the NHLBI. Applications are generally submitted during the first two years of medical or graduate school, but may be submitted at any stage of predoctoral training provided that at least one year of dissertation-stage research training will remain at the time of application.   

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

NIH will not accept any application that is essentially the same as one already reviewed. An individual may not have two or more competing NIH fellowship applications pending review concurrently.

Awards are not renewable and are not transferable from one PD/PI to another.

Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Duration of Support

Individuals may not exceed the aggregate limit of NRSA support shown above in the Award Project Period. Applicant fellows must consider any prior NRSA research training in determining the duration of support requested. Information regarding previous Kirschstein-NRSA support must be included in the application and will be considered at the time of award. It is not possible to have concurrent NRSA support (e.g., F30 and T32).

Training beyond the six-year aggregate limit may be possible under rare and exceptional circumstances, but a waiver from the NHLBI is required. Individuals seeking Kirschstein-NRSA support beyond the sixth year are strongly advised to consult with relevant NHLBI staff before preparing a justification. Any waiver will require a detailed justification of the need for additional research training. Waiver requests should be discussed with the program officer at the NHLBI at least six months prior to the termination date of the fellowship and should be submitted to the program officer prior to the termination date of the fellowship.

Level of Effort

At the time of award, individuals are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies. Support for subsequent years of the fellowship award beyond the first budget period is based upon evidence of satisfactory progress in both the research training component and/or clinical component of the program; this is determined by the NHLBI Program staff review of information documented in the progress report.

Sponsor

Before submitting the application, the applicant fellow must identify a sponsor (sometimes called a mentor) who will supervise the proposed training and research experience. The sponsor should be an active investigator in the area of the proposed research training and be committed both to the research training of the applicant fellow and to the direct supervision of the applicant fellow’s research. The sponsor must document the availability of sufficient research support and facilities for high-quality research. The sponsor, or a member of the mentoring team, should have a successful track record of mentoring. Applicant fellows are encouraged to identify more than one sponsor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research and training program. In such cases, one individual must be identified as the principal sponsor who will coordinate the applicant fellow’s research. The applicant fellow must work with the sponsor (s) in preparing the application.

The sponsor should describe the research training plan for the applicant fellow (coordinated with the applicant fellow’s research strategy). The sponsor and any co-sponsors are also expected to provide an assessment of the applicant fellow’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described. The description should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g. grant-writing and making effective presentations, is strongly encouraged.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Fellowship 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.

Required and Optional Components

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 application submission. Follow the instructions in the SF 424 (R&R) to determine which components are required.

Page Limitations

All page limitations described in the SF424 (R&R) Individual Fellowship Application Guide and the Table of Page Limits must be followed.

Other Project Information Component

All instructions in the SF424 (R&R) Individual Fellowship Application Guide must be followed, with the following additional instructions:

Additional Educational Information Required (Uploaded via the Other Attachments Section)

This attachment must include:

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

PHS Fellowship Supplemental Form

All instructions in the SF424 (R&R) Individual Fellowship Application Guide must be followed, with the following additional instructions:

Research Strategy (Component of Research Training Plan)

Applicant fellows must describe a tailored research training plan, including a description of the research strategy (preferably hypothesis-driven) well-suited to the stage of his/her career development. Describe the skills and techniques that the applicant fellow will learn during the award period, and discuss the relationship of the proposed research training to the applicant fellow’s career goals. The applicant fellow must describe the background leading to the proposed research, the significance of the research, the research approach (design and methods) for achieving the Specific Aims, the rationale, and expected/alternative outcomes of the proposed studies. It is beneficial to include pertinent preliminary data obtained by the applicant fellow in the current or prior laboratory. The applicant fellow should describe how he/she expects to divide his/her time between medical (or other health professional) and graduate school, e.g., medical school courses, graduate school courses, research, research training, etc., during both the academic year and the summer for each year of the program.

Doctoral Dissertation and Other Research Experience (Component of Research Training Plan)

The applicant fellow should discuss how the proposed research training plan will add to the fellowship experience.

Sponsor and any Co-Sponsor(s) Information

In Training Plan, Environment, Research Facilities, the sponsor(s) must provide a detailed description of the institution's combined MD/PhD degree program and the sequencing of the applicant's graduate research and medical school (or other health professional degree) training within this program. 

Training Potential: The application must include statements that address the planned value of the proposed fellowship experience and research training program, and how these relate to the applicant’s needs in preparation for a career as an independent physician scientist. Applicants should provide evidence of their potential for a productive and successful research career based upon the quality of their previous research training and academic record.

Institutional Environment and Commitment to Training: The Director of the graduate program must describe the department's or program’s commitment to, and proposed role in, guiding and advising the applicant, and any modifications to the department's or program’s usual PhD requirements that are necessary to facilitate this trainee's special needs in progressing through the combined degree program. Additionally, the quality of the facilities and related resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must be described.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, and Sharing Model Organisms) as provided in 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.

Letters of Reference

Applicant fellows must carefully follow the SF424 (R&R) Individual Fellowship Application Guide, including the time period for when letters of reference will be accepted. Applications lacking the required reference letters may be delayed in review or not reviewed. Please note that the specified Fellowship Reference Form must be used. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Referee Information link and not through Grants.gov.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of 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 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.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.  A Kirschstein-NRSA fellowship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award.

Pre-award costs are generally not allowable for Fellowships.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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 Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Cover Letter: It is suggested that the cover letter include information regarding the type of expertise needed to review the application; names of suggested reviewers must not be included.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

For this particular announcement, note the following:

Overall Impact/Merit

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood that the fellowship will enhance the candidate’s potential for, and commitment to, a productive independent scientific research career in a health-related field, in consideration of the scored and additional review criteria.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific and technical 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.

Fellowship Applicant

Are the applicant fellow’s academic record and research experience of high quality? Does the applicant fellow have the potential for, and commitment to, becoming an important contributor to biomedical, behavioral or clinical science as a physician-scientist or clinician-scientist through an MD/PhD program?     

Sponsors, Collaborators, and Consultants

Are the sponsor(s) research qualifications (including successful competition for research support) and track record of mentoring appropriate for the proposed fellowship? Are there (1) evidence of a match between the research interests of the applicant fellow and the sponsor (including an understanding of the applicant’s research training needs) and (2) a demonstrated ability and commitment of the sponsor to assist in meeting these needs? Are the qualifications of any collaborator(s) and/or consultant(s), including their complementary expertise and previous experience in fostering the training of fellows, appropriate for the proposed research project?   

Research Training Plan

Is the proposed research plan of high scientific quality, and does it relate to the applicant fellow’s training plan? Is the training plan consistent with the applicant fellow’s stage of research development?  Will the research training plan provide the applicant fellow with individualized and supervised experiences that will develop research skills needed as a physician-scientist or clinician-scientist?

Training Potential

Does the proposed research training plan have the potential to provide the applicant fellow with the requisite individualized and supervised experiences that will develop his/her research skills? Does the proposed research training have the potential to serve as a sound foundation that will lead the applicant fellow to a productive research career as a physician or clinician scientist?

Institutional Environment & Commitment to Training

Are the research facilities, resources (e.g. equipment, laboratory space, computer time, subject populations), and training opportunities adequate and appropriate?  Is the institutional environment for the scientific development of the applicant fellow of high quality, and is there appropriate institutional commitment to fostering the applicant fellow’s training as a physician-scientist or clinician scientist?   

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/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

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

Not Applicable.

Revisions

Not Allowed.

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/priority score.

Training in the Responsible Conduct of Research

Taking into account the circumstances of the fellow, including level of experience, 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, laboratory safety? Do the plans adequately describe the role of the sponsor/mentor or other faculty involvement in the fellow’s instruction?  Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years?  Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Applications from Foreign Organizations

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).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; and 2) Sharing Model Organisms.

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 training.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NHLBI Advisory Council.  The following will be considered in making funding decisions:

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

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 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Activation: No funds may be disbursed until the fellow has started training under the award, and an Activation Notice (PHS 416-5) has been submitted to the NIH. A fellow has up to six months from the issue date on the award notice to activate the award. Under unusual circumstances, an NIH Institute may grant an extension of the activation period upon receipt of a specific request from the fellow, countersigned by the sponsor and an institutional official.

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. The National Research Service Award (NRSA) policies apply to this program.

Inventions and Copyrights

Fellowships funded primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required. More details, including exceptions for fellows training at NIH are provided in the NIH Grants Policy Statement.

Leave Policies

The NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards describes NRSA leave policies. Applicant fellows may receive stipends for parental leave as described in NOT-OD-08-064

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. Accordingly, recipients are hereby notified that they 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.

3. Reporting

When multiple years are involved, awardees will be required to submit a Kirschstein-NRSA Individual Fellowship Progress Report for Continuation Support (PHS 416-9) annually. The report is due two months before the beginning date of the next budget period and must include information describing the current year's progress as well as the research and training plans for the coming year.

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 Fellowship Reporting Requirements:
Section VII. Agency Contacts

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

Therefore, applicants are strongly encouraged to contact the NHLBI before submitting an application to determine its appropriateness for this FOA and the mission of the NHLBI.
 
Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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: commons@od.nih.gov

Scientific/Research Contact(s)

Drew Carlson, Ph.D.
Program Director
Division of Cardiovascular Sciences, NHLBI
Rockledge II Building, Room 8142
6701 Rockledge Drive, MSC 7940
Bethesda, MD 20892-7940
Telephone: (301) 435-0535
FAX: (301) 480-7404
Email: carlsonde@nhlbi.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Ms. Beckie Chamberlin
NRSA Team Leader
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7154, MSC 7926
Bethesda, MD  20892-7926
Telephone: (301) 435-0183
FAX: (301) 451-5462
Email:  chamberr@nhlbi.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.


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NIH Funding Opportunities and Notices


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